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GOODLIN V. MEDTRONIC, INC. (2/18/1999, NO. 97-5801) Alleging that her Medtronic cardiac pacemaker lead was defective in a way that gave rise to two causes of action under Florida common law. The pacemaker lead is a wire that transmits the heartbeat steadying electrical impulse from the pulse generator to the heart. The MDA classifies devices that either |
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OPINION/ORDER Challenging the FDA's jurisdiction over tobacco products and seeking declaratory and injunctive relief.1 Plaintiffs then filed a 1 When the complaint was filed on August 10. All references in this opinion are to the final version of the rule published in the Federal Register on August 28. They have been added for emphasis unless otherwise indicated. 13 motion for summary judgment in the district court. Jurisdiction over the consolidated appeals is proper in this court under 28 U.S.C. §§ 1292(a)(1) and 1292(b). We are of opinion that the FDA lacks jurisdiction to regulate tobacco products. 1996 regulations of tobacco products are thus invalid. All 50 States have already banned the sale of tobacco to minors under state law. Tobacco products fit within these definitions because they are |
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OPINION/ORDER With him on the brief were Thomas H. Of counsel on the brief were M. Of counsel was Esther H. With him on the brief was David M. Of counsel on the brief were Raphael V. Will & Emery. Of counsel was Donna M. Of counsel on the brief was Charles E. With him on the brief was Robert C. Of counsel was Li Westerlund. With him on the brief was Mark J. With him on the brief was Susan M. With him on the brief were Paul J. BACKGROUND Reference is made to the prior opinions. The patented inventions are described as demonstrating various cell interactions with the extracellular peptide matrix. The validity of the Integra patents was sustained at trial but for one claim. Is not here at issue. Merck KGaA (a German company) and Scripps Research Institute were collaborating in research related to studies that Dr. David Cheresh and others at Scripps were conducting on the inhibition of angiogenesis. 2 The development and growth of undesired blood vessels is a factor in several diseases. Had discovered that angiogenesis is 1 Merck KGaA v. |
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OPINION/ORDER O:\Slip\WP\2005\04 5350 Abigail Alliancea28a.odl.wpd |
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OPINION/ORDER Line 19 |
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OPINION/ORDER Based on its determination that Horn's claims against TCI are preempted by the express preemption provision in the Food Drug and Cosmetic Act (the |
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APOTEX, INC V. TOMMY THOMPSON Argued for plaintiff appellant. With him on the brief were Terrence P. Canade and Hugh S. Balsam. Of counsel on the brief was Arthur Y. Et al. With him on the brief were Eric M. DC. On the brief for defendants appellees were Douglas N. On the brief were Bruce N. Weiswasser. Of counsel was Stephen T. Demonstrating through the presentation of test data that the drug in question is safe and effective. 21 U.S.C. § 355(b)(1)(A). Before 1984. 98 Stat. 1585. The Hatch Waxman Act authorized a company to obtain FDA permission to market a generic version of an approved drug by filing an Abbreviated New Drug Application ( ANDA ). If the ANDA establishes both that the active ingredient in the proposed drug product is the same as the active ingredient in the previously approved drug and that the proposed product is bioequivalent to the approved drug. |
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OPINION/ORDER |
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OPINION/ORDER |
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GOODLIN V. MEDTRONIC, INC. (2/18/1999, NO. 97-5801) Alleging that her Medtronic cardiac pacemaker lead was defective in a way that gave rise to two causes of action under Florida common law. The pacemaker lead is a wire that transmits the heartbeat steadying electrical impulse from the pulse generator to the heart. The MDA classifies devices that either |
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OPINION/ORDER We must decide whether Section 360k(a) preempts common law tort claims regarding medical devices that have entered the market pursuant to the Food and Drug Administration's ( |
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OPINION/ORDER We must decide whether Section 360k(a) preempts common law tort claims regarding medical devices that have entered the market pursuant to the Food and Drug Administration's ( |
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OPINION/ORDER With him on the briefs were Daniel J. Duff were on the brief for amici curiae John E. Edmonds was on the brief for amici curiae Emil Freireich and Stephen Strum in support of appellants. With him on the brief were Peter D. Turner was on the brief for amici curiae American Society of Clinical Oncology. Schultz was on the brief for amici curiae National Organization for Rare Disorders. Circuit Judge: This case presents the question whether the Constitution provides terminally ill patients a right of access to experimental drugs that have passed limited safety 3 trials but have not been proven safe and effective. The district court held there is no such right. A divided panel of this Court held there is. Because we conclude that there is no fundamental right |
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A L PHARMA INC V. SHALALA, DONNA |
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OPINION/ORDER Because we agree with the district court that the FDA's approval of Gensia's generic drug was in accordance with the Federal Food. |
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OPINION/ORDER Were on the briefs. Tsien were on the briefs for appellant Ferring Pharmaceuticals Inc. Peterson were on the brief. That was issued at the behest of the manufac turer of the competing brand name drug. |
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OPINION/ORDER We also hold that Michael's complaint to the extent that it relies on fraud perpetrated by Shiley on the FDA is pre empted. While we will affirm the district court's pre emption rulings as to Michael's negligence. We will reverse the district court's summary judgment to the extent that it entered judgment against Michael on her express warranty and fraud claims. Which was designed and manufactured by Shiley Inc. B. The Shiley valve was one of the first medical devices to be approved under the 1976 Medical Device Amendments to the Food Drug and Cosmetics Act of 1938 (the |
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OPINION/ORDER The fourth claim was for negligent misrepresentation. The plaintiffs also assert that primary jurisdiction was an improper basis for dismissal. That their unjust enrichment claim was improperly dismissed on the ground that they had not pled individual reliance. That they should have been allowed to amend their complaint. We will affirm the judgment of the District Court.1 The District Court had diversity jurisdiction under 28 U.S.C. § 1332(d)(2) and (6). Which confers federal jurisdiction over class actions where |
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OPINION/ORDER With her on the briefs was Paul J. With him on the brief were Kenneth L. Shepard were on the brief for appellees Population Council. The agency would therefore have a nearly impregnable defensive position save for the fact that the statute places the burden |
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ARENT SHEREEN V. SHALALA, DONNA E. |
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OPINION/ORDER Is one of first impression in the courts of appeals. Are the exclusive means for determining the bioequivalence of generic drugs approved pursuant to the abbreviated new drug application procedure ( |
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OPINION/ORDER With him on the briefs was John B. With her on the brief were Peter D. Circuit Judge: This is the second time we have heard an appeal in this matter. I The |
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MOVA PHARM CORP V. SHALALA DONNA Anthony Figg was on the briefs.
Howard S. United States Attorney at the time the briefs were filed. Were on the briefs.
Steven J. Bickart was on the briefs.
Ronald L. Rubin was on the brief.
John F. This section was designated 21 U.S.C. 355(j)(4)(B)(iv). Because the statutory scheme governing the ap proval of successive generic drug applications is quite com plex. We will. The FDA was barred from approving Mylan's similar application until after the end of that 180 day period. Because at the time Mylan submitted its application Mova had not yet |
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OPINION/ORDER Anthony Figg was on the briefs. United States Attorney at the time the briefs were filed. Were on the briefs. Bickart was on the briefs. Rubin was on the brief. This section was designated 21 U.S.C. s 355(j)(4)(B)(iv). Because the statutory scheme governing the ap proval of successive generic drug applications is quite com plex. We will. The FDA was barred from approving Mylan's similar application until after the end of that 180 day period. Because at the time Mylan submitted its application Mova had not yet |
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OPINION/ORDER Inc. |
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OPINION/ORDER The district court determined that the risk benefit analysis employed by the FDA to support an EDS ban was contrary to the intent of Congress and that the FDA had failed to prove by a preponderance of the evidence that EDS pose an unreasonable risk of illness or injury at 10 milligrams ( |
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OPINION/ORDER |
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FLORIDA BRECKENRIDGE, INC. V. SOLVAY PHARMACEUTICALS, INC. (5/11/1999, NO. 98-4606) After receiving notice that Solvay believed that Breckenridge was infringing on its trade rights. Were requested to file supplemental briefs. Arguing that Solvay's appeal was frivolous. A company merely had to file a New Drug Application ('NDA') or an Abbreviated New Drug Application ('ANDA') and prove that their product was safe. The FDCA was amended to require proof that the product was effective as well as safe. The companies producing these drugs were given a two year window to submit revisions of their NDAs to prove their efficacy. Groups of drugs with approved NDAs were evaluated by an independent panel. The evidence was submitted to the FDA. A notice was published in the federal register and a supplemental NDA would be approved for these drugs. All drugs are new drugs and therefore require an approved NDA or ANDA before marketing unless they are generally recognized among experts as safe and effective for their labeled use (the |
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OPINION/ORDER J.) held that Michigan law shields pharmaceutical companies from products liability claims unless there is. The power of states to govern in this field is considerable and undisputed. 756 (1985) ( |
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OPINION/ORDER J.) held that Michigan law shields pharmaceutical companies from products liability claims unless there is. The power of states to govern in this field is considerable and undisputed. 756 (1985) ( |
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FLORIDA BRECKENRIDGE, INC. V. SOLVAY PHARMACEUTICALS, INC. (5/11/1999, NO. 98-4606) After receiving notice that Solvay believed that Breckenridge was infringing on its trade rights. Were requested to file supplemental briefs. Arguing that Solvay's appeal was frivolous. A company merely had to file a New Drug Application ('NDA') or an Abbreviated New Drug Application ('ANDA') and prove that their product was safe. The FDCA was amended to require proof that the product was effective as well as safe. The companies producing these drugs were given a two year window to submit revisions of their NDAs to prove their efficacy. Groups of drugs with approved NDAs were evaluated by an independent panel. The evidence was submitted to the FDA. A notice was published in the federal register and a supplemental NDA would be approved for these drugs. All drugs are new drugs and therefore require an approved NDA or ANDA before marketing unless they are generally recognized among experts as safe and effective for their labeled use (the |
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OPINION/ORDER Eagle argued the cause for appellant. |
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OPINION/ORDER With her on the briefs were Joseph F. With him on the brief were Kenneth L. With him on the brief was Philip A. Appellant argues that the Food and Drug Administration's decision to approve intervenor defendant Baker Norton Pharmaceutical's Abbreviated New Drug Application (ANDA) for a generic version of the cancer treatment Taxol was arbitrary and capricious. I. This case is here for the second time. American Bioscience is a pharmaceutical research firm that has developed a patented process for delivering safer and more effective dosage forms of Taxol. Who are corporate affiliates and hold * Senior Judge Williams was in regular active service at the time of oral argument. The NDA is expensive and time consuming. A firm that wished to make a generic version of an approved drug was required to file a new NDA. NDAs are required to contain a list of any patents which claim the drug or which claim a method of using such a drug and with respect to which a claim of patent infringement could reason ably be asserted but that includes patents held by those other than the NDA holder. |
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OPINION/ORDER With him on the brief were Peter D. Senior Circuit Judge: approval for a generic drug is generally a much simpler and faster process than securing approval for a |
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TEVA PHARMACEUTICALS V. FDA With them on the briefs was David M. Far quhar were on the brief for appellant Purepac Pharmaceuti cal Company.
Andrew E. With him on the brief were David W. With him on the brief were Eugene M. Appellants are |
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OPINION/ORDER The liquid and powder ingredients are mixed together. Was scrutinized by FDA doctors and representatives. Or she was positioned nearby as another nurse mixed the cement. She was diagnosed with asthma. Though the doctor was unable to conclude that Simplex was the cause of Brooks's asthma. Was thereafter restricted from exposure to Simplex. Summary judgment is appropriate when the evidence viewed in the light most favorable to the nonmoving party demonstrates that there are no disputed issues of material fact and the moving party is entitled to judgment as a matter of law. The district court ruled that Howmedica was entitled to summary judgment because Brooks's state law failure to warn claim was preempted by federal law. The MDA contains an express preemption provision that governs federal preemption of state law with respect to medical devices: [N]o State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement (1) which is different from. |
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OPINION/ORDER With them on the briefs was David M. Far quhar were on the brief for appellant Purepac Pharmaceuti cal Company. With him on the brief were David W. With him on the brief were Eugene M. Appellants are |
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OPINION/ORDER Were on brief. Were on brief. Prigmore claims that insufficient evidence supports his conviction and that his sentence is unlawful. We vacate the convictions and remand for further proceedings.
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OPINION/ORDER NJ 08002 Attorneys for Appellant Judge Chertoff heard oral argument in this case but resigned before this opinion was filed. The decision is filed by a quorum of the panel. 28 U.S.C. § 46(d). Wedgewood argues that it is exempt from FDA inspection under provisions of the Food. Wedgewood also contends that it was denied procedural due process. We hold that Wedgewood was not exempt from FDA inspection under the FDCA. We will affirm the decision of the District Court. I. Background Wedgewood is a pharmacy specializing in compounding drugs used for treating humans and animals. Drug compounding is a process by which a pharmacist or doctor combines. Compounding is typically used to prepare medications that are not commercially available. Such as medication for a patient who is allergic to an ingredient in a massproduced product. It is a traditional component of the practice of pharmacy. Is taught as part of the standard curriculum at most pharmacy schools . . . . Drug compounding is frequently regulated by states |
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MINNESOTA MINING AND MANUFACTURING COMPANY V. BARR Argued for plaintiffs appellants. |
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OPINION/ORDER Line 4 the following attorneys are added for Genpharm: |
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ALLERGAN, INC. AND ALLERGAN SALES, INC V. ALCON Argued for plaintiffs appellants. With him on the brief were Jonathan Singer. brimonidine. |
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OPINION/ORDER Third party payor organizations that provide medical benefits for their members which are used to purchase the drug. The plaintiffs assert that the district court erred in dismissing the complaint based on its conclusion that the settlement agreement was not a violation of antitrust law and that the plaintiffs did not suffer antitrust injury as a result of the alleged violation. Arising out of circumstances surrounding a lawsuit in which a drug manufacturer alleged that its patent for the drug tamoxifen citrate ( |
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OPINION/ORDER We further decide that summary judgment ought to have been granted to all defendants on the plaintiffs' claims for abuse of process. Appellees are Matthews. Sigmon learned that he was an FDA employee 2 Nos. 05 5219. This court being unconvinced to a |
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OPINION/ORDER The case was dismissed on summary judgment after the district court1 concluded that her claim was preempted by federal law. A petition for rehearing en banc was granted. The panel opinion was vacated. I. Carol Jean Brooks is a licensed practical nurse whose work as a surgical technician included mixing bone cement. Bone cement is used to bond with a bone or prosthesis in replacements. United States District Judge for the District of Minnesota. 21 1992 she was mixing bone cement or was close to the mixing process during approximately ten surgeries a week. Although Brooks is unable to identify the brand of bone cement used at St. It is undisputed that St. Which was manufactured and marketed by appellees (collectively Howmedica).2 Brooks began to cough at some time in 1989 or 1990. She went to see a doctor about it in 1991 when she was told she had asthma. The restriction included methyl methacrylate which is an ingredient in Simplex. Brooks was later diagnosed to have occupational asthma caused by exposure to methyl methacrylate. |
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OPINION/ORDER The action was brought in federal court on behalf of Abbott shareholders against Abbott's board of directors alleging that the directors breached their fiduciary duties and are liable under Illinois law for harm resulting from a consent decree which required Abbott to pay a $100 million civil fine to the FDA. An order vacating the panel opinion was issued on August 2. Is a diversified health care company that develops and markets pharmaceutical. These products are heavily regulated by the FDA and must be manufactured in accordance with the |
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ANDRX PHARMACEUTICALS V. BIOVAIL CORPORATION INTERNATIONAL Singer were on brief. |
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OPINION/ORDER Third party payor organizations that provide medical benefits for their members which are used to purchase the drug. The plaintiffs assert that the district court erred in dismissing the complaint based on its conclusion that the settlement agreement was not a violation of antitrust law and that the plaintiffs did not suffer antitrust injury as a result of the alleged violation. Arising out of circumstances surrounding a lawsuit in which a drug manufacturer alleged that its patent for the drug tamoxifen citrate ( |
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OPINION/ORDER Singer were on brief. Todaro were on brief. Unless an approval of an application filed pursuant to (b) or (j) of this section is effective with respect to such drug. |
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OPINION/ORDER The Food and Drug Administration ( |
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99-4087 -- PHARMANEX V. SHALALA -- 07/21/2000 That is intended to promote healthy cholesterol levels. Cholestin is made from red yeast rice. Which is chemically identical to the active ingredient. Mevacor. |
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OPINION/ORDER PER CURIAM: This case is the latest flare up in a longrunning dispute between the Food and Drug Administration (FDA) and several generic drug manufacturers as to what qualifies under the Hatch Waxman Act as |
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OPINION/ORDER Yale successfully argued that the denial of the claims on the categorical ground of FDA classification was predicated on a rule altering the previous Medicare practice of conducting device by device review of safety and efficacy. That the rule change was improperly adopted. We agree with the district court that the new rule is unenforceable because the Secretary did not satisfactorily explain his reasons for its promulgation. Which at the time of the events at issue was administered by the Health Care Financing Administration ( |
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OPINION/ORDER With him on the briefs were Christine J. With him on the brief was William B. With him on the brief were Peter D. Were affirmed by this court in a consolidated appeal. At issue in this case is a dispute over the proper interpretation and application of the pre amended version of the 180 day generic marketing exclusivity provision of the Federal Food. Is now running and will not expire until April 2005. Because the parties in this case are the same parties who appeared in TorPharm. A final judgment was rendered against Apotex in TorPharm. There have been no material changes in the facts since the judgment in TorPharm. Because FDA's interpretation of § 355(j)(5)(B)(iv) was reasonable and thus entitled to deference. We vacate the District Court's alternative holding reaching the merits of whether FDA's interpretation of 21 U.S.C. § 355(j)(5)(B)(iv) is reasonable. 4 I. NDAs are usually lengthy. Information demonstrating that the generic version is the bioequivalent of the approved version of the drug. ANDAs must also address patents that apply or might apply to the drug for which the ANDA is submitted. |
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OPINION/ORDER Were on brief for appellant. Were on brief for the Association of Trial Lawyers of America. Were on brief for appellee. Were on brief for Health Industry Manufacturers Association. The district court determined that plaintiff's claims were preempted by the Medical Device Amendments of 1976 ( |
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OPINION/ORDER This Federal Torts Claims Act (FTCA) claim against the Food and Drug Administration (FDA) for granting clearance to market certain types of pedicle screw fixation devices (referred to generally as bone screws) was dismissed by the District Court pursuant to the discretionary function exception to the FTCA.1 Appellants contend here that this jurisdictional exception should not apply because FDA officials were guilty of misconduct in the process of granting the clearance. Because Appellants should have been given more opportunity to discover proof of that misconduct. Is not the type of policy based decision that the exception is designed to protect. We will affirm. BACKGROUND Thousands of plaintiffs nationwide claim to have suffered injuries resulting from the surgical implantation of bone 1. 28 U.S.C. S 2680(a). 22 screws in their spines and have sued their doctors and the manufacturers of the screws. As is relevant here. Some two hundred have also sued the federal government. These actions have been consolidated by the Judicial Panel on Multidistrict Litigation and transferred to the Eastern District of Pennsylvania as MDL No. 1014.2 1. |
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DUPONT V. BRISTOL-MYERS |
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OPINION/ORDER Holding that appellants' claims were preempted by the Medical Device Amendments to the Food. We will affirm in part. Class III devices are the most dangerous. There are two exceptions to this requirement. |
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UNITED STATES V. SIGMA INT'L (3/15/2001, NO. 97-2618) Inc. ( |
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UNITED STATES V. SIGMA INT'L (3/15/2001, NO. 97-2618) Inc. ( |
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OPINION/ORDER Circuit Judge: Gary Duane Ellis was convicted. Ellis contends that there was insufficient evidence from which a jury could conclude that. His failure to register his kitchen laboratory was with an intent to defraud or mislead. Which was banned by the FDA in 1990. Is most commonly used as a party drug for its intoxicating or euphoric effects. It is easy to make. Which is a commercial solvent. Which is a caustic soda known as the main ingredient in some liquid drain openers. GHB is usually ingested in liquid form in doses that would fill a soda bottle cap. The manufacture and distribution of GHB is subject to FDA regulation. The FDA discovered that Ellis was purchasing large quantities of GBL and sodium hydroxide from chemical manufacturers in his own name and through the names of others. Pots and pans and a Pyrex mixing bowl that Ellis admitted were used to manufacture and process GHB. One article indicated that GHB was not |
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OPINION/ORDER Concluding that the FDA did not act unlawfully in approving the generics for an indication that was no longer protected by market exclusivity under the Act. I. Sigma Tau Pharmaceuticals developed a drug to treat a rare condition known as carnitine deficiency in people with inborn metabolic disorders.1 The FDA designated Sigma Tau's levocarnitine drug an Carnitine is a naturally occurring amino acid derivative produced by the liver and kidneys and found in red meat and dairy products. Sigma Tau was entitled to seven years of market exclusivity to sell its drug. Sigma Tau later received FDA approval for use of its levocarnitine drug for the prevention and treatment of a second rare condition carnitine deficiency in patients with end stage renal disease ( |
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PFIZER INC V. SHALALA DONNA E. With him on the briefs were Andrew S. With him on the brief was
Frank W. With him on the brief was Steven Lieberman.
David G. Adams was on the brief for appellee Penwest Pharmaceuticals Group. David M. Durkin were on the brief for amicus curiae National Association of Pharmaceutical Manu facturers.
Before: Edwards. that the osmotic pump is a unique |
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PUB CTZN HLTH RSRCH V. FDA With
her on the briefs were Wilma A. With her on the brief was Brian Wolfman. Powell was on the brief for amicus curiae Pharmaceutical Research and Manufacturers of America.
Before: Ginsburg. Public Citizen argued that the documents could not be withheld under that exemption and that in any event disclosure was required under 21 U.S.C. 355(l). Human) tests showing that the drug is safe and effective. See 21 U.S.C. 355(a). Arguing that although a search of its database identified 230 INDs for which the agency had received safety reports and which were either withdrawn. It could not
without an unduly burdensome manual search of each file determine which of these were discontinued |
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OPINION/ORDER With him on the briefs were Peter D. Dance was on the brief for amicus curiae Blue Cross & Blue Shield Association. With her on the brief were Kate C. With him on the brief were John C. Theodore Case Whitehouse was on the brief for amicus curiae Generic Pharmaceutical Association in support of appellees. Branded drug and markets an approved generic version of that drug or prevails in litigation establishing that the patent is valid or not infringed. Thereby depriving the generic manufacturers of an opportunity to have a period of marketing exclusivity. We hold the FDA's requirement that a generic manufacturer's patent challenge give rise to litigation as a condition of retaining exclusivity when a patent is delisted is inconsistent with the Act. Which provides that the first generic manufacturer to file an approved application is entitled to exclusivity when it either begins commercially to market its generic drug or is successful in patent litigation. Including evidence the drug is safe and effective. |
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OPINION/ORDER With her on the briefs were Wilma A. With her on the brief was Brian Wolfman. Powell was on the brief for amicus curiae Pharmaceutical Research and Manufacturers of America. Public Citizen argued that the documents could not be withheld under that exemption and that in any event disclosure was required under 21 U.S.C. s 355(l). Human) tests showing that the drug is safe and effective. Arguing that although a search of its database identified 230 INDs for which the agency had received safety reports and which were either withdrawn. It could not without an unduly burdensome manual search of each file determine which of these were discontinued |
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OPINION/ORDER With him on the briefs were Andrew S. With him on the brief was Frank W. With him on the brief was Steven Lieberman. Adams was on the brief for appellee Penwest Pharmaceuticals Group. Durkin were on the brief for amicus curiae National Association of Pharmaceutical Manu facturers. That the osmotic pump is a unique |
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OPINION/ORDER Leavitt is automatically substituted for his predecessor. We have jurisdiction pursuant to We affirm the judgment of the district 2 BACKGROUND Joseph. [DA 607] The primary role of CSOs is to maintain the safety of the nation's supplies of food. The FDA received an anonymous telephone call alleging that Joseph had been using cocaine for the last three years and that he was using a government vehicle to purchase the drug. Police were called to Joseph's residence. 239 40] Both of the arresting officers believed that Joseph was under the influence of some substance other than alcohol. 239 40] [DA 237 38. That he was a habitual user of the drug. Was identified as the March 14 caller. [DA 244] Douglas gave the FDA her name and said she was Joseph's live in girlfriend. Asserting that the attack was a result of her having reported Joseph to the FDA. [DA 244] Joseph was arraigned on felony assault charges on March 22. [DA 168] 4 Joseph was placed on administrative leave. Said that her head injuries could also have been self inflicted. |
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LOHR V. MEDTRONIC, INC. This document was created from RTF source by rtftohtml version 2.7.5 > I. BACKGROUND
Because an understanding of the MDA's regulatory scheme is necessary to resolve the question of preemption. We begin with a brief outline of the Act. A. The Regulatory Scheme
The market for medical devices was largely unregulated at the national level until the MDA's passage in 1976. The text of the MDA reveals two competing congressional purposes relevant to this case: |
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LOHR V. MEDTRONIC, INC. This document was created from RTF source by rtftohtml version 2.7.5 > I. BACKGROUND
Because an understanding of the MDA's regulatory scheme is necessary to resolve the question of preemption. We begin with a brief outline of the Act. A. The Regulatory Scheme
The market for medical devices was largely unregulated at the national level until the MDA's passage in 1976. The text of the MDA reveals two competing congressional purposes relevant to this case: |
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OPINION/ORDER Inc. ( |
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OPINION/ORDER Inc. ( |
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OPINION/ORDER The plaintiffs in these cases were injured by several policy decisions made by the Commissioner of the Food and Drug Administration ( |
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OPINION/ORDER Alleging that Pennfield had violated the Lanham Act and state law by falsely advertising that one of its antibiotic animal feed additives was approved for certain 1 uses by the Food and Drug Administration (FDA). Alpharma and Pennfield are the only manufacturers of bacitracin methylene disalicylate (BMD). This interim approval was codified in 21 C.F.R. § 558.15(g)(1). Some of which were approved. Was however never amended to distinguish The Honorable Joseph F. The result was an apparent expansion in the number of uses for which the product of Pennfield's predecessor had been approved for marketing. While the Maryland suit was pending. After these notices were published. The Maryland suit was then dismissed with prejudice. 3 On September 30. That Alpharma's action was an impermissible private attempt to enforce FDCA and FDA regulations. That the Lanham Act was not intended as a means of indirectly enforcing the FDCA and FDA regulations. The court cited a number of factors in concluding that dismissal was proper: the absence of a decision by the FDA clarifying the meaning of |
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OJA V. HOWMEDICA, INC. The section headings are incorrectly labeled. A corrected version of the opinion is attached for your convenience. (2) the jury's finding of negligent failure to warn is inconsistent with its verdict for Howmedica on the strict liability and negligence claims. (4) punitive damages cannot be awarded as a matter of law because the evidence was insufficient to show that Howmedica acted wantonly or recklessly. Because we conclude that the jury's finding of negligent failure to warn is irreconcilably inconsistent with its verdict for Howmedica on the strict liability claim. BACKGROUND The Porous Coated Anatomic One Piece Acetabular Component hip ( |
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OPINION/ORDER O:\Slip\WP\2006\04 5350 Abigail Alli Reh'g22aa.odl.wpd |
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OPINION/ORDER Because we find that the claims in this action were previously disclosed and trigger the public disclosure bar of the False Claims Act. We hold that the district court did not have subject matter jurisdiction and that dismissal was appropriate. I. BACKGROUND Defendant Appellant Medtronic is a medical device manufacturer. Medtronic manufactures four types of heart pacemaker leads which are the subject of this litigation: Models 4004. Stating that |
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OPINION/ORDER With him on the briefs were David W. With him on the brief were Daniel J. Labson were on the brief for amicus curiae Pharmaceutical Research and Manufacturers of America. Prywes were on the brief for amicus curiae American Civil Liberties Union of the National Capital Area. 1 a manufacturer must demon strate that its product is safe and effective for each of its intended uses. It will often be discovered after initial FDA approval. That a drug has uses other than those for which it was 1 For brevity's sake we use the term |
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OPINION/ORDER With him on the joint briefs were James R. On the brief were Frank W. With him on the joint brief were Eugene M. The term 'generic drug' is used to describe a product that contains the same active ingredients but not necessarily the same excipients as a so called 'pioneer drug' that is marketed under a brand name. |
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AMERICAN BIOSCIENCE V. TOMMY THOMPSON With him on the briefs were Carlton A. With him on the brief were David W. With him on the brief was Richard M. 401 U.S. 402 (1971). |
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OPINION/ORDER With him on the briefs were Peter D. With him on the briefs were Christine J. With him on the brief was Steven A. Whichever is earlier. |
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OPINION/ORDER |
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OPINION/ORDER Firehock was on the briefs. Attorney at the time the briefs were filed. Were on the brief. |
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OPINION/ORDER Plaintiff was treated for persistent pain in her neck and shoulders by her physician. Caused liver failure and Plaintiff was required to undergo a liver transplant in 1998 to save her life. The State of Michigan has adopted a drug products liability statute that immunizes drug manufacturers from liability from damages in suits contending that their drug was defective or unreasonably dangerous |
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OPINION/ORDER With him on the briefs were Carlton A. With him on the brief were David W. With him on the brief was Richard M. Although the procedural background of the appeal is complex. Our reasons for vacating and remanding are simple: the administrative record was never filed in court and we cannot tell on what basis the Food and Drug Administration took the agency action the plaintiff seeks to enjoin. The statutory framework is as follows. If new patents claiming the drug or a method of using the drug are filed after the drug has been approved. The statute also includes patent protections when an Ab breviated New Drug Application is filed. Will expire on a particular date. Or (4) that the patent is either invalid or the generic drug will not infringe it. Is central to the case as the parties have framed it. When a generic drug applicant certifies that a patent is invalid or that its proposed generic drug will not infringe upon it. It must also certify that it will give notice to the patent holder that it has entered the Paragraph IV certifica tion. |
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EDWARDS V. BASEL PHARM. Circuit Judges.(1) This matter is before the court on a petition for rehearing with suggestion for rehearing en banc filed by defendant appellee Basel Pharmaceuticals. The hearing panel has concluded its original disposition was correct. The remaining judges of the court in active service have rejected the en banc suggestion. Some background is necessary for a full understanding of the procedural and substantive deficiencies of the petition. Her theory of liability was Basel's failure to warn of the risks of nicotine overdose resulting from smoking and (over)use of the patch. Was included in materials intended for the prescribing physician. Who was apprised of the danger involved. Which represented that |
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00-6135 -- HOLLANDER V. SANDOZ PHARMA CEUTICALS CORP. -- 05/10/2002 It rejected the Hollanders' arguments that it lacked jurisdiction over the remaining claims and that the defendants' removal petition was untimely. The federal district court ruled that the Hollanders' expert testimony regarding the causal connection between Parlodel and intracerebral hemorrhages lacked the necessary reliability and was therefore inadmissible. See Hollander v. (3) the court abused its discretion in ruling that the testimony of their experts was not sufficiently reliable to be admissible. We further hold that the court did not abuse its discretion in finding that the Hollanders' expert testimony was not sufficiently reliable and that the court did not err in granting summary judgment to Sandoz. We agree with the Hollanders that the federal district court should have dismissed their claim against Sandoz. To be taken in two 2.5 mg doses per day. Parlodel is manufactured by Sandoz. The drug's active ingredient is bromocriptine mesylate. Approximately 9 million women in the United States have taken it for that purpose. See Siharath v. |
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OPINION/ORDER P.C. were on brief for appellant. Dan Jarcho and McKenna & Cuneo were on brief for appellee. Jurisdiction is based on diversity of citizenship. All classes of devices are subject to |
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HOECHST-ROUSSEL PHARM. V. LEHMAN |
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INTEGRA LIFESCIENCES I, LTD V. MERCK Argued for defendant appellant Merck KGaA. With him on the brief were Thomas H. Townsend. Of counsel on the brief were M. Of counsel was Esther H. Ltd. and The Burnham Institute. With him on the brief was David M. Beckwith. Of counsel on the brief were Raphael V. Will &. Mso bidi font family: |
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UNITED STATES V. SIGMA INT'L, INC. (11/30/1999, NO. 97-2618) Charles Sternisha (referred to collectively as |
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OPINION/ORDER Which is an oral polio vaccine. Poliomyelitis (or polio) is a disease of the central nervous system that causes illness. That this scourge did not continue through the second half of the twentieth century is a credit to the work of several scientists. The Salk vaccine is known as an inactivated polio vaccine ( |
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UNITED STATES V. SIGMA INT'L, INC. (11/30/1999, NO. 97-2618) Charles Sternisha (referred to collectively as |
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MYLAN PHARMACEUTICALS V. THOMPSON Argued for plaintiff appellee. |
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OPINION/ORDER With him on the briefs was Robert E. With her on the brief were Peter D. I. The dental fillings at issue in this case are comprised of approximately equal parts (1) dental mercury and (2) amalgam alloy comprised of silver and other metals. The two components are separately sealed in one capsule. Are combined to create the |
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OPINION/ORDER Heineman & Itzkowitz were on brief for appellants. Lapp and Palmer & Dodge were on brief for appellee C.R. Keefe with whom Hale and Dorr was on brief for appellee David Prigmore. Kettlewell with whom Dwyer & Collora was on brief for appellee John Cvinar. Were on brief for the United States. Drug and Cosmetic Act ( |
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OPINION/ORDER We are called upon to decide whether a district court has the power under the Federal Food. Because a district court's equitable powers in such a situation are broad. We hold that an order of restitution is properly within the jurisdiction of the court. Andrew Lane is the president. Three products are the subject of this action: (1) BeneFin. Whose main ingredient is arabinoxylan. Lane actively promoted BeneFin and SkinAnswer as potential treatments for cancer and that he was a |
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OPINION/ORDER Were on brief. Bass & Ullman were on brief. Alleging that BCO is a food additive of questionable safety. Certain facts were uncontradicted. BCO is a liquid obtained by squeezing black currant berry seeds. It is composed of polyunsaturated fatty acids. Oakmont markets BCO in capsules which are to be swallowed whole. They are made from gelatin and glycerin (or an equivalent plasticizer) and have no independent nutritional value. As a bottled liquid) falls within section 321(f)(1) and is. Substances classified as |
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WELLIFE PROD V. SHALALA |
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BRISTOL-MYERS V. ROYCE |
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OPINION/ORDER With him on the briefs were Joseph P. With her on the brief were Peter D. Demonstrating to the FDA that its drug is in all relevant aspects equivalent to Marinol. This case was filed under seal pursuant to Petitioner/Appellant's request. The Petitioner/Appellant is referred to as |
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OPINION/ORDER Charles Sternisha (referred to collectively as |
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OPINION/ORDER This is an appeal from the denial of preliminary relief in a trademark infringement action. Because the denial of the preliminary injunction was premised on legal errors. The following facts are undisputed. It advised Andrx to |
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MERCK V. KESSLER |
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OPINION/ORDER Charles Sternisha (referred to collectively as |
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OPINION/ORDER The individual defendants are: (1) John R. I. Because this is an appeal from the District Court's grant of a motion for judgment on the pleadings. Is engaged in the research. Pondimin was marketed together with another drug. Pondimin was approved by the Food and Drug Administration in 1973. Redux was recommended for approval by an FDA Advisory Committee in November 1995 and approved by the FDA in 1996. AHP represented to the FDA that these symptoms were reactions to the drugs and were not caused by any underlying heart condition. AHP's announcement similarly stated that the company was investigating |
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CONNAUGHT LABORATORIES V. SMITHKLINE BEECHAM With him on the brief were Donald R. Of counsel on the brief were Mark S. With him on the brief were Frank W. SmithKline argued that the '787 patent was unenforceable. Maintaining that the documents provided were not sufficient for its purposes. The FDA argued that the only avenue for challenging its refusal to permit its employees' testimony was pursuant to the Administrative Procedure Act. The district court held that SmithKline was proceeding under the Federal Rules of Civil Procedure. The court also rejected the FDA's argument that it is protected by sovereign immunity. The FDA appeals the district court's grant of SmithKline's motion to compel testimony of FDA employees in a lawsuit to which the FDA is not a party. Discussion Our jurisdiction is limited to review of |
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OPINION/ORDER TMJI is a Colorado corporation that manufactures prosthetic total and partial temporomandibular joint (TMJ) implants for use in patients suffering from TMJ disorders. They have filed one brief as the CIGNA appellees. Aetna states that it will not cover either the total or partial TMJ implants manufactured by TMJI. In a similar bulletin CIGNA states that it will not cover TMJI's partial joint device. The district court granted the motions on the ground that the bulletins were protected statements of opinion. We have jurisdiction under 28 U.S.C. 1291 and affirm. The total joint prosthesis is available in three sizes (for both the right and left sides of the jaw) and can also be custom made. The partial joint prosthesis is available in 44 premade sizes (for both sides of the jaw). TMJI is the only manufacturer of a partial joint prosthesis. 000 of TMJI's devices have been implanted in patients. 40% of which have been partial joint prostheses. Clinical studies have shown that the partial joint implants |
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OPINION/ORDER The district court granted summary judgment in favor of Medtronic on the ground that the McMullens' claims are preempted by federal requirements imposed by the Food and Drug Administration ( |
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96-4201 -- U.S. V. THEMY-KOTRONAKIS -- 03/31/1998 Circuit Judge.
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DICOLA CHARLES G. V. FDA |
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OPINION/ORDER This is an appeal of a jury verdict in a products liability action against Metabolife International. Testimony from Plaintiffs' experts was inadmissible. It was denied. Legal Standard This is a toxic tort case. Which authorizes the admission of expert opinion testimony |
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OPINION/ORDER Genendo maintains that the importation is authorized pursuant to certain statutory exemptions for drugs being repackaged within the United States. Some of the drugs it imports were originally intended for sale outside of the United States. 48 boxes containing 20 milligram tablets of Lipitor.1 Lipitor is manufactured by Pfizer. Incorporated and is used to treat high cholesterol. Genendo filed an action for a declaratory judgment that its importation of Lipitor was permissible under the Federal Food. The United States successfully moved to dismiss the action on the grounds that there was not yet an agency action ripe for review. At issue is whether the seized Lipitor is an |
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OPINION/ORDER With him on the briefs were Theodore C. Monroe Sampson were on the brief for amicus curiae Mylan Pharmaceuticals. With him on the brief were Peter D. With him on the brief were Karyn K. Which is the bioequivalent to a |
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OPINION/ORDER The en banc opinion rejecting Fallon's argument was filed February 15. Fallon was convicted by a jury of one count of wire fraud and three counts of mail fraud in the United States District Court for the Eastern District of Pennsylvania. This is an appeal of the District Court's judgment of conviction 2 and sentence entered on October 16. Fallon was the president of Derma Genesis. A company which manufactured and distributed microdermabradors under the name |
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OPINION/ORDER This disposition is not citable as precedent. It is a public record. Pieczenick is the inventor of U.S. He is also the named inventor on a separate published patent application. Pieczenick averred in his complaint that the PTO was dilatory in issuing the '448 and '363 patents. The district court held that those officials were sued in their official capacity. The district court ruled that the PTO and FDA were not |
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OPINION/ORDER An intraocular lens (IOL) is a lens intended to replace surgically the natural lens of the human eye. Is now legally blind in that eye. ORC moved for summary judgment on the ground that Gile's claims were expressly preempted under the Federal Food. We apply the same test the district court should have utilized initially. Summary judgment is appropriate only when it is demonstrated that there is no genuine issue as to any material fact and the moving party is entitled to judgment as a matter of law. An issue of material fact is genuine |
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OPINION/ORDER Circuit Judge: This civil antitrust action was instituted by plaintiffsappellants Apothecon. The suit was brought under §§ 1 and 2 of the Sherman Antitrust Act. Plaintiffs' antitrust claims are based on the alleged anti competitive conduct of defendants appellees Barr Laboratories. Which is the primary chemical ingredient used to make warfarin sodium. This litigation is about protecting the operation of our competitive markets. Safeguard consumers by protecting 1 The code of rules that most directly influenced modern boxing was first published in 1867 under the sponsoring of John Sholto Douglas. There are 12 rules in all. Are not designed to protect competitors from one another's conduct. (Apothecon) is a wholly owned subsidiary of pharmaceutical giant Bristol Myers Squibb. Is a wholly owned subsidiary of Novartis. (Barr) is a competing manufacturer of generic warfarin sodium. Inc. is a Canadian corporation that. Was known as ACIC (Canada) Inc. (hereafter ACIC/Brantford). ACIC/Brantford is a supplier of various chemicals used in manufacturing pharmaceutical drugs. |
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OPINION/ORDER Of counsel was Max F. With her on the brief were Peter D. Of counsel on the brief were John D. Of counsel were Jeanne E. With him on the brief were Michael J. Department of Commerce ( |
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WARNER-LAMBERT COMPANY V. APOTEX Argued for defendant appellee. With him on the brief were Robert L. Smith. Of counsel were Donald J. Argued for defendant appellee. With him on the brief were Hugh L. For amicus curiae Generic Pharmaceutical Association. With him on the brief was Melanie Black Dubis.
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OPINION/ORDER We hold that the district court's primary holding was error. I. Until 2000 most first trimester abortions in this country were surgical abortions performed by vacuum aspiration or curettage. This approval was based on clinical trials which involved the oral ingestion of 600 mg of mifepristone followed two days later by the oral ingestion of 0.4 mg of misoprostol.1 Upon examining the results of these trials. The FDA concluded that this regimen was a safe and effective method of medical abortion when employed up through forty nine days' gestation. The FDA labeling and approval letter indicated that the appropriate treatment regimen was to administer 600 mg of mifepristone orally followed by 0.4 mg of misoprostol administered orally two days later and that mifepristone was not to be administered after forty nine days' gestation. This is a widely employed practice known as |
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OPINION/ORDER Hurst argued the cause for appellant. |
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OPINION/ORDER The HIVcontaminated blood was donated on January 16. At Camp Memorial Blood Center (Blood Center) by Darryl Bonner when he was in basic training for the United States Army in Kentucky. The Food and Drug Administration (FDA) issued a memorandum advising all establishments collecting blood for transfusion to provide: (1) educational programs informing persons in certain |
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OPINION/ORDER Thekkedajh Menon appeals from a judgment in a criminal case in which he was convicted by a jury of violating 18 U.S.C. §§ 2[fn1] and 545[fn2] by knowingly and willfully. Is that to obtain a conviction for passing false invoices under § 545. Menon's second argument is that the evidence was insufficient to show that he reimported previously rejected shrimp. A point which ultimately turns on whether a search of Menon's office which exceeded the scope of a search warrant was nonetheless valid under the |
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OPINION/ORDER Circuit Judge: Michael Barile was convicted of making materially false statements to the Federal Food and Drug Administration (FDA). Because we conclude that the district court erred in its determination that prior statements of a key government witness were consistent. Were indicted by a grand jury in May 1999. All four defendants were employed by the Patient Monitoring Division of Datascope Corporation. Gugnani was president of Patient Monitoring. Sikand was vice president of operations. Milo was director of engineering. Datascope's cardiac monitors are complex. Software driven devices that are continuously being improved. Must demonstrate that the medical device is |
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OPINION/ORDER After con2 ducting a myelogram to identify other problems that might have contributed to Talley's pain. The device was manufactured and distributed by Danek Medical. Talley was instructed to avoid excessive exercise or movement for several weeks. Talley was again instructed to minimize physical activity and to wear a back brace. A nerve injury common among patients who have had multiple back surgeries. Talley has been examined by other doctors who have offered differing opinions as to the stability of the Dyna Lok Device and the screws. A doctor at Georgetown University Hospital advised Talley that the Dyna Lok Device was not loose. A doctor at Johns Hopkins University Hospital advised her that the device was loose. Although Talley has been advised to have the Dyna Lok device removed. She consistently refuses such an operation without a guarantee that it will not worsen her condition. During the period that Talley was Dr. Designing endoscopes and assisting in efforts to secure FDA approval for the use of the endoscopes in the spine work that is unrelated to the use of internal fixation devices. |
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KEY PHARM V. HERCON |
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GLAXO, INC. V. NOVOPHARM, LTD. |
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OPINION/ORDER Who was a member of the panel. He also challenges the constitutionality of the federal statute requiring states to have a federally mandated scheme for licensing wholesale drug distributors engaged in interstate commerce. He contends that his sentence was impermissibly enhanced based on misinterpretations of the Guidelines and on facts not found by the jury. That he is entitled to be resentenced in any event because the Guidelines. Are unconstitutional. The only FDA approved distributor of Eldepryl in the United States was Somerset Pharmaceuticals. The only FDA approved distributor of Pergonal and Metrodin in the United States was Serono Labs USA. Metrodin distributed in the United States by these 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 companies were manufactured and packaged outside the United States in compliance with FDA standards. Of which three are relevant here. The law forbids distribution in interstate commerce of drugs that are misbranded. Prescription drugs are subject to the general federal statutory prohibition of trafficking in counterfeit goods. |
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OPINION/ORDER This matter is before the court on Plaintiffs' petition for panel rehearing. We hold that the district court's primary holding was error. I. Until 2000 most first trimester abortions in this country were surgical abortions performed by vacuum aspiration or curettage. This approval was based on clinical trials which involved the oral ingestion of 600 mg of mifepristone followed two days later by the oral ingestion of 0.4 mg of misoprostol.1 Upon examining the results of these trials. The FDA concluded that this regimen was a safe and effective method of medical abortion when employed up through forty nine days' gestation. The FDA labeling and approval letter indicated that the appropriate treatment regimen was to administer 600 mg of mifepristone orally followed by 0.4 mg of misoprostol administered orally two days later and that mifepristone was not to be administered after forty nine days' gestation. This is a widely employed practice known as |
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OPINION/ORDER With him on the briefs was Christine J. We conclude that the case is moot and. Which relies on the FDA's previous determination that the drug is safe and effective. (III) the patent will expire on a date certain. Or (IV) the patent is invalid or will not be infringed by the drug for which the applicant seeks approval. Rel evant here is the paragraph IV certification. If a patent infringement action is timely brought. Unless this period is altered by the court or a decision of that court. The Hatch Waxman Amendments provide that the first to file a paragraph IV certification for a particular drug is eligible for a 180 day period of marketing protection (i.e. Which was patented by Imperial Chemical Industries. Which is due to expire on August 20. While Imperial's appeal to the United States Court of Appeals for the Federal Circuit was pending. Which was filed shortly before the thirty month statutory stay of Pharmachemie's ANDA was to expire and which sought enforcement of Barr's 180 day exclusivity peri od. |
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OPINION/ORDER The issue is whether substantial evidence supports the conclusion that the Schering Plough settlements unreasonably restrain trade in violation of Section 1 of the Sherman Antitrust Act. We have jurisdiction pursuant to 15 U.S.C. § 45(c). The Upsher Settlement Schering Plough ( |
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MINNESOTA MINING V. BARR LABORATORIES Filed a combined petition for rehearing and rehearing en banc for plaintiffs appellants. |
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ZENECA LTD. V. MYLAN PHARMACEUTICALS With him on the brief were Robert D. Of counsel were Michael J. With him on the brief were Gregory R. Judge Rader and I concur in the judgment of reversal of the order of the Pennsylvania district court.
BACKGROUND
Mylan is a corporation incorporated under the laws of West Virginia with its principal place of business in West Virginia. Mylan is a subsidiary of Mylan Laboratories Inc. Zeneca is a corporation incorporated under the laws of England with its principal place of business in England. Which is a patented drug owned by Zeneca (U.S. Claiming that the '516 patent is invalid or will not be infringed by the manufacture. A |
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OPINION/ORDER Circuit Judge: The issue in this case is whether a 1980 contract between the parties and a 1983 amendment thereto conveyed to American Cyanamid Company ( |
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OPINION/ORDER With them on the briefs were Thomas F. Bernard and Jeremy Kyle Kinner were on the brief of amici curiae Indigenous Environmental Network. With him on the brief were Thomas L. With him on the briefs were Alan F. Nick Goldstein were on the brief of industry intervenors in support of respondent. Henderson were on the brief of amicus curiae Washington Legal Foundation in support of respondent. Wolff were on the brief of amicus curiae John D. Circuit Judge: Petitioners are twelve states. They are opposed by the Environmental Protection Agency as respondent. The controversy is about EPA's denial of a petition asking it to regulate carbon dioxide (CO2) and other greenhouse gas emissions from new motor 5 vehicles under § 202(a)(1) of the Clean Air Act. EPA concluded that it did not have statutory authority to regulate greenhouse gas emissions from motor vehicles and that. Have jurisdiction over citizen suits to compel EPA to perform nondiscretionary acts or duties. 42 U.S.C. § 7604(a)(2). We have jurisdiction only if EPA thereby engaged in |
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BAYER AG & BAYER CORP. V. ELAN PHARMACEUTICAL With him on the brief were Jeffrey B. With him on the brief were Richard M. An ANDA can be filed if the generic drug manufacturer s active ingredient is the ". A manufacturer must certify one of four statements concerning the applicable listed drug: (i) the listed drug is not patented (a ". Is invalid or . . . it will not be infringed by the manufacture. If an ANDA is certified under Paragraph IV. The applicant must notify the patent s owner of the certification. See 21 U.S.C. § 355(j)(2)(B).
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OPINION/ORDER Are parties. Jurisdiction is based on diversity of citizenship. The governing substantive law is that of the state of Washington. Though no peculiarities of Washington law have been drawn to our attention. Is called |
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OPINION/ORDER Circuit Judge: The issue in this case is whether a 1980 contract between the parties and a 1983 amendment thereto conveyed to American Cyanamid Company ( |
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OPINION/ORDER The governing law is the false advertising cause of action provided in § 43 of the Lanham Act. It was also widely prescribed to treat hypertension. day. introduced a sustained release Cardizem product that is taken twice per MMD then developed Cardizem CD. A sustained release drug that is The FDA approved Cardizem CD for hypertension and taken only once per day. for angina. Diltiazem was a pioneer new drug. Cardizem products were immensely successful. A FDA approval as a generic competing drug manufacturers were anxious to penetrate the diltiazem market once per day sustained release tablet. Which is more rigorous than approval substitute. FDA classified Dilacor XR as a |
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OPINION/ORDER Circuit Judge: Kevin Choy was convicted by a jury of conspiracy. We also conclude that the theory of bribery upon which Choy was convicted was legally erroneous and constituted a variance from the bribery offense alleged in the indictment. Because Choy's conspiracy conviction may have been based on the legally insufficient bribery conviction. His only employee was his brother in law. It was agreed that Clopp would use his contacts with a corrupt Food and Drug Administration ( |
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OPINION/ORDER Because the court's ruling was fatal to Glastetter's proof of causation. She was overweight. Her pregnancy and delivery were uneventful. She was later taken to a local hospital. Doctors were unable to identify the cause of Glastetter's stroke. An ICH is a |
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OPINION/ORDER Circuit Judge: Kevin Choy was convicted by a jury of conspiracy. We also conclude that the theory of bribery upon which Choy was convicted was legally erroneous and constituted a variance from the bribery offense alleged in the indictment. Because Choy's conspiracy conviction may have been based on the legally insufficient bribery conviction. His only employee was his brother in law. It was agreed that Clopp would use his contacts with a corrupt Food and Drug Administration ( |
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OPINION/ORDER Page 2 BACKGROUND Relators filed this qui tam false claims action in district court in October of 2000 alleging that the BioPort Corporation ( |
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NAT'L COUNCIL FOR IMPROVED HEALTH V. SHALALA We conclude that plaintiffs do not have standing and therefore reverse the district court's order on standing and vacate the remainder of its decision on the constitutionality of the health claims regulations. The NLEA was passed to |
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OPINION/ORDER Appellants also argue that their sentences were improperly enhanced on the basis of an incorrect loss calculation and in violation of United States v. Nazir was aware that tri mix gel would be unable to achieve the roughly 70% success rate of tri mix injections. Gaudio was the owner of. Because the components of Power Gel were prescription drugs. Both knew that Nazir was writing prescriptions in his 3 patients' names even though his patients were never aware of this fact and never received either the prescriptions or the tri mix prescribed. Munoz claimed that Power Gel was 100% effective as a treatment for impotence and that it had zero contraindications or side effects. Asking Nazir to declare that |
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ELAN PHARM. RESEARCH CORP. V. EMPLOYERS INS. OF WAUSAU (6/26/1998, NO. 96-9249) Plc ( |
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ELAN PHARM. RESEARCH CORP. V. EMPLOYERS INS. OF WAUSAU (6/26/1998, NO. 96-9249) Plc ( |
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OPINION/ORDER With him on the briefs were Patrick Gallagher and Angel M. With him on the brief was Carol S. Nathanson were on the brief for intervenors in support of respondents. The agreements are designed to bring the facilities into compliance with the permitting and reporting requirements of three environmental statutes. Petitioners argue that the agreements are rules disguised as enforcement actions. We dismiss the petitions for review because exercises of EPA's enforcement discretion are not reviewable by this court. I. Animal feeding operations ( |
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OPINION/ORDER Were on brief for respondent. Adams has not persuaded us that he was wrongfully denied an evidentiary hearing or that the Agency otherwise erred in its treatment of his objections. Because Seabrook's septic systems were failing. Effluent was flowing into Seabrook's coastal waters. Will consist of a collection and transportation system. The plant will discharge its treated effluent in approximately 30 feet of water. No pollutant may be emitted into this nation's waters unless a NPDES permit is obtained. NPDES permits are issued by the EPA or. Whether a discharge will cause |
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OPINION/ORDER The defendant cross appellant appeals the district court's decision to grant the insured's motion for summary judgment on the question of coverage under the |
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OPINION/ORDER Honorable Stanley Marcus was a U.S. When this appeal was argued and taken under submission. Plc ( |
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OPINION/ORDER Chief Judge: This case is one of several thousand involving the promotion. Claiming that its defective device was responsible for his failed back surgeries and the accompanying deleterious side effects. The district court dismissed Cooper's claims after determining that Cooper had no admissible medical evidence indicating that Smith & Nephew's device was the proximate cause of his injuries. The Rogozinski System is a medical device consisting of connectors. The Rogozinski System is used to promote a successful fusion between vertebrae by providing stability for the spine. The pedicles are two pieces of bone on each side of the spinal 4 COOPER v. Pedicle fixation is the process by which bone screws are inserted through the pedicles in order to provide increased spinal stability. This practice by physicians is known as |
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OPINION/ORDER A group of consumers and organizations from Minnesota who have purchased prescription drugs in the United States from the defendant drug companies in the United States. The gravamen of the complaint was that the defendants unlawfully conspired to suppress the importation of Canadian prescription drugs for personal use. Including: (1) requiring Canadian pharmacies to certify that they were not selling prescription drugs to persons whom the pharmacies knew or should have known were taking the drugs outside the country. (3) creating |
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ASTRA V. LEHMAN |
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OPINION/ORDER The plaintiffs in this case are eight individuals involved in a clinical drug trial sponsored by Amgen. When the study was terminated. The plaintiffs sued claiming that Amgen was legally required to continue providing them with the drug. I. The plaintiffs are all Kentucky residents that suffer from Parkinson's disease. None of these current treatments are curative. Amgen was now faced with the problem of how to effectively deliver GDNF to the brain. In which the drug is injected directly into the central fluid filled cavities of the patient's brain. Was effective. These studies failed to prove that ICV was safe or effective as a delivery method. Although the study yielded favorable results because the study was open label. Meaning study participants knew they were receiving GDNF and no participants received a placebo. Amgen concluded that more research was necessary. Another open label study was also conducted at the University of Kentucky medical center in which GDNF was administered via IPu to ten patients.1 All ten of these patients showed benefits after six months of treatment but. |
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SUMMIT TECHNOLOGY, INC., V. NIDEK CO., LTD., ET AL. Argued for plaintiff appellant. With him on the brief were Lisa J. Mso bidi font family: |
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OPINION/ORDER With him on the brief were Thomas M. Also on the brief was C. With him on the brief were Chad A. In case we were to disturb the exceptional case finding. |
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97-1475 -- COTTRELL LTD V. BIOTROL INTERNATIONAL INC. -- 09/10/1999 Because the parties' products are antimicrobial pesticides. The cleaners and disinfectants are regulated by the Environmental Protection Agency ( |
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OPINION/ORDER Provide: Every person who is a manufacturer or importer of a device intended for human use shall establish and maintain such records. As the Secretary may by regulation reasonably require to assure that such device is not adulterated or misbranded and to otherwise assure its safety and effectiveness. 21 U.S.C. § 360i(a) (emphasis added). A pacemaker lead is . A lead is an electrical cable used to carry information between the heart and the generator portion of the pacemaker. 2 1 Based upon this statutory authority. Is not limited to. Disclosure of the identities of such reporters is governed by the applicable Federal statutes and regulations. (1) Exceptions. (i) Identities may be disclosed if both the voluntary reporter and the person identified in an adverse event report or that person's legal representative consent in writing to disclosure. Shall be disclosed to the person who is the subject of the report upon request. 3 (2) Preemption. This is because the district court has ordered Medtronic |
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99-3331 -- WRIGHT V. ABBOTT LABORATORIES INC. -- 08/06/2001 BACKGROUND Eric Wright was born on November 10. The Wrights argue that Abbott had a duty to warn the hospital about the risk of inadvertent administration and that Abbott's failure to do so was the proximate cause of Eric's brain damage.
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OPINION/ORDER Unpublished opinions are not binding precedent in this circuit. Lescs filed suit in federal district court seeking compensation for her alleged injuries that resulted from exposure to a pesticide that was applied to her residence. The grant of summary judgment was based primarily on the district court's interpretation of 7 U.S.C.A. § 136v(b) (West Supp. 1998). Dursban is subject to the registration requirements of 7 U.S.C.A. § 136a (West Supp. 1998). Because the odor was so strong. The person with whom she spoke told her that the fumes were not dangerous. . . . was okay to go into homes. |
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CHRISTOPHER V. CUTTER LABORATORIES This document was created from RTF source by rtftohtml version 2.7.5 >
Id. (emphasis added).
21 C.F.R. |
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SCHERING CORP. V. ROUSSEL-UCLAF SA |
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OPINION/ORDER With him on the brief were William B. Of counsel was Abraham W. McDermott Will & Emery LLP. With them on the brief were Charles Rosenberg and Cynthia A. BACKGROUND Optivus and Loma Linda are the purported exclusive licensee and assignee. The '287 patent is directed to a proton beam therapy facility that The generates a proton beam and delivers it to one of multiple treatment rooms. treatment rooms are equipped with movable gantries that enable an operator to direct the beam to a patient at a specific angle. The proton beam therapy system is illustrated in figure 1 of the '287 patent. Which is reproduced below. 05 1518. 1575 2 Claim 1 of the '287 patent is the only independent claim and provides. Transporting the proton beam away from the axis of rotation and returning the proton beam on a path perpendicular to and intersecting the axis at a target isocenter within the patient whereby with rotation of the gantry the proton beam is delivered to the target isocenter from several different angles and ... a control system for the proton beam therapy system including an operator controllable means for (1) selectively switching the first switching magnet between its first and second states and (2) controlling the rotational position of the first gantry to direct the proton beam exiting the first switching magnet in its first state to the target isocenter for the first treatment station along one or more controlled angles. 05 1518. |
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OPINION/ORDER At issue in this appeal is whether the District Court abused its discretion in approving a $44.5 million nationwide settlement agreement between DuPont and the fixed co pay consumers and out of pocket consumers (collectively. Accordingly we will affirm the judgment of the District Court. Factual History Warfarin sodium is a prescription oral anticoagulant medication sold in tablet form that is taken by more than 2 million Americans to treat blood clotting disorders. Fixed co pay consumers refer to those insured consumers who paid the same price for prescription drugs regardless of whether the drugs were name brand or generic. Out of pocket consumers refers to individuals who paid different prices for prescription drugs depending on whether they were name brand or generic. When a generic version of warfarin sodium was released onto the market following approval by the U.S. Class action plaintiffs have alleged that DuPont. DuPont's alleged violations are said to have begun when Barr Laboratories. On the grounds that the methods in place for determining bioequivalence were sufficient. |
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OPINION/ORDER With him on the briefs were Herbert Dym. With him on the brief was David W. With him on the brief was Bart G. Circuit Judge: When is a pill a capsule rather than a tablet? A different |
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OPINION/ORDER With him on the brief were Milton Sherman. With him on the brief were A. The ANDA product sought to be approved by Apotex is a generic version of Pfizer's amlodipine besylate drug product. Which is commercially sold in tablet form in the United States under the trademark Norvasc®. Norvasc® is approved by the FDA for treating hypertension and chronic stable and vasospastic angina. |
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OPINION/ORDER Unpublished opinions are not binding precedent in this circuit. The district court found that Murphy's state law claims relating to the failure of Playtex to adequately warn her of the dangers of using tampons were preempted by federal regulation in the field. TSS is a rare but potentially life threatening illness caused by the bacterium staphylococcus aureus. The disease is most commonly linked to the use of high absorbency tampons in young women. Because higher absorbency tampons are more likely to cause TSS. The researchers concluded that although tampon use was associated with TSS. Tampons were not in themselves dangerous. Playtex contended that Murphy's failure to warn claims were preempted by § 360k(a) of the Federal Devices Act. That her other claims were insufficient under Maryland law. Preemption is appropriate. Where a plaintiff seeks to impose labeling requirements which are |
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OPINION/ORDER Szaller contends that he was unlawfully terminated for reporting alleged violations of Food and Drug Administration regulations and a consent decree to a Red Cross hotline. I. Joseph Szaller was employed by the Red Cross for three and a half years as a medical team manager. He supervised several other staff members and was responsible for collecting blood from volunteer donors on bloodmobiles in Howard County. Szaller was suspended from work the day after he called the hotline. His employment with the Red Cross was terminated on March 7. Szaller claims that he was suspended and fired because he complained to the hotline. Alleging that his termination violated a clear mandate of Maryland public policy and was therefore a wrongful discharge under Maryland law. The district court recognized that Maryland law provides a cause of action for wrongful discharge when an at will employee's termination |
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CHRISTOPHER V. CUTTER LABORATORIES This document was created from RTF source by rtftohtml version 2.7.5 >
Id. (emphasis added).
21 C.F.R. |
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OPINION/ORDER With him on the brief were Bruce M. With him on the brief were Francis D. With him on the brief were David M. Of counsel was Kenneth A. 450 ( |
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OPINION/ORDER Adderall is a central nervous system stimulant used in treating attention deficit hyperactivity disorder (ADHD) available only by prescription 3 and dispensed to patients in pharmacy vials labeled |
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OPINION/ORDER Whose actions were transferred to. I. This litigation was occasioned by the diet drug Meridia. The rights to Meridia were purchased by Knoll Pharmaceuticals. The plaintiffs claimed to have incurred various injuries e.g. Death and claimed that Meridia is ineffective. The plaintiffs also claimed that they were at increased risk of developing a future injury. Some of the claims were filed originally in federal court. Which is an Illinois company. Nearly 100 Meridia actions from 18 states1 were consolidated and assigned to the Honorable James S. Schwartz was not permitted to testify as to the physiological effects of high blood pressure. These states are: Alabama. No plaintiff was actually from Illinois. Where Abbott Labs is incorporated. 616 (6th Cir. 2002) ( |
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OPINION/ORDER |
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OPINION/ORDER Their cases were consolidated with Kemp v. After all cases were consolidated in the Southern District of Ohio and after the district court denied Plaintiffs class certification. That case was fully litigated and appealed. To raise arguments that are distinguishable from the arguments made in Kemp. The district court found that counts V through VIII were directly precluded by Kemp. It also found that count IV was preempted because it was. The district court additionally found that counts I and II were preempted by federal law because they would impose state requirements |
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OPINION/ORDER Class members were entitled to opt out at various stages. Those who chose to opt out initially were freed to pursue their remedies elsewhere. Those who did not opt out at the beginning were afforded opportunities to opt out |
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OPINION/ORDER The providers are exempted from the standard drug approval requirements imposed by the Food and Drug Administration. We have jurisdiction over this appeal pursuant to 28 U.S.C. § 1291. I Plaintiffs are a group of licensed pharmacies. They have prepared written promotional materials that they distribute by mail and at medical conferences to inform patients and physicians of the uses and effectiveness of specific compounded drugs. |
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OPINION/ORDER The providers are exempted from the standard drug approval requirements imposed by the Food and Drug Administration. We have jurisdiction over this appeal pursuant to 28 U.S.C. § 1291. I Plaintiffs are a group of licensed pharmacies. They have prepared written promotional materials that they distribute by mail and at medical conferences to inform patients and physicians of the uses and effectiveness of specific compounded drugs. |
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OPINION/ORDER |
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OPINION/ORDER Trosclair was on the brief. Although hired as an at will employee. He con tends that his discharge was in retaliation for his threat to report to the Federal Drug Administration ( |
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OPINION/ORDER The case is therefore ordered submitted without oral argument. (1) This order and judgment is not binding precedent. R. 36.3. This is a products liability action alleging that plaintiff appellant. The radiofrequency device This procedure was performed by Dr. Rosenthal was well experienced in use of the radiofrequency device. As was the nurse who assisted him. The device is designed to therapeutically destroy painful nerve tissue by creating lesions in the tissue. An electrode was then inserted into the needle to produce the radiofrequency waves. The device was designed to operate in two basic modes. The usual procedure is to use the stim mode to locate the tissue to be lesioned. Which are controlled by a rate select button. The higher frequency setting (50 Hz) is used to stimulate the sensory part of the nerve. A lower frequency setting (2 Hz) is used to stimulate the motor portion of the nerve. b. Voltage adjustments There are also voltage adjustments to be made within the stim mode. The closer the needle is to the affected tissue. |
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OPINION/ORDER P.C. were on brief. Burling were on brief. Flom LLP were on brief. Was on brief. Were on brief. Chief Judge. |
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OPINION/ORDER Unpublished opinions are not binding precedent in this circuit. William Schwieterman was acting within the scope of his employment when he filed criminal charges against her. Based on that application Dachman was arrested on July 22. The FDA subsequently concluded that the claim against Dachman was unsubstantiated. Certi2 fying that Schwieterman was acting within the scope of his employment and. The plaintiff's sole remedy was against the United States. 28 U.S.C. § 2679. We held that the plaintiff has the burden of proving by a preponderance of the evidence that the government employee was not acting within the scope of his employment. Properly held that further discovery on the scope of employment issue was unnecessary. The court undertook its duty to determine whether Schwieterman was acting within the scope of his employment. The district court's review was not the kind of rubber stamp denounced in Gutierrez de Martinez. Dachman claims that further discovery is required on a number of disputed facts. Are undisputed. 3 Schwieterman received a threat that he correctly took seriously. |
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ANDERSON V. SECRETARY OF HEALTH AND HUMAN SERVS. I This litigation is before this court for the third time. Argued that the information was confidential and should not be released. Shortly before the district court was to conduct an in camera inspection of the remaining disputed documents. Was no longer asserting a claim of confidentiality. Plaintiff was concerned. The district court assured plaintiff that she could still pursue her fee application even if the merits of the case were dismissed as moot and specifically reserved the fee issue in its final order on the merits. We stated that |
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THE ARNOLD PARTNERSHIP V. JON DUDAS, ACTING UNDER SECRETARY OF COMMERCE FOR INTELLECTUAL PROPERTY, ET AL. Argued for defendants appellees. With her on the brief were John M. For amicus curiae GlaxoSmithKline. With him on the brief was David E. Korn. Of counsel on the brief was Scott A. The Arnold Partnership (Arnold) is the owner of record for the 252 patent. Mso bidi language:AR SA'>[1] The 252 patent was filed on December 18. Was issued on May 6. Is due to expire on December 18. 2004. The commercial embodiment of the 252 patent is Vicoprofen® a combination of hydrocodone bitartrate (a salt of hydrocodone) and ibuprofen. Because these components had only been available separately. The PTO determined the patent was not eligible for patent term extension to compensate for the period of regulatory review. In particular. |
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OPINION/ORDER FACTS AND PROCEDURAL HISTORY The underlying facts are not in dispute. We have reviewed both tapes. All other pending motions are denied. 2 Under 21 U.S.C. § 321. Is a |
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OPINION/ORDER Inc. ( |
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OPINION/ORDER I. BACKGROUND According to the complaint our only source of the facts the defendant Ivax Corporation is a manufacturer of generic drugs. Ivax was profitable in 1995. The full text of the release is found in Appendix I to this opinion. The full text of such a release would not be part of the record under review for a dismissal under Fed.R.Civ.P. 12(b)(6) unless it was attached to the complaint. A document central to the complaint that the defense appends to its motion to dismiss is also properly considered. Provided that its contents are not in dispute. $104 million of which was a reduction in the carrying value of the goodwill ascribed to certain of Ivax's businesses. There are two theories of liability: first. That Ivax's economic projections were fraudulent. The plaintiffs argue that the district court should have granted them leave to amend the complaint. moreover. Which are [sic ] not subject to material dispute. The usual rules for considering 12(b)(6) motions are thus bent to permit consideration of an allegedly fraudulent statement in its context. 3 Appendix II contains the full text of this release. 15 U.S.C. § 78u 5(c). 15 U.S.C. § 78u 4(b). 4 5 Both the defendants' motion to dismiss. |
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HARRIS V. IVAX CORP. (7/27/1999, NO. 98-4818) Background According to the complaint our only source of the facts the defendant Ivax Corporation is a manufacturer of generic drugs. Ivax was profitable in 1995. $104 million of which was a reduction in the carrying value of the goodwill ascribed to certain of Ivax's businesses. There are two theories of liability: first. That Ivax's economic projections were fraudulent. The plaintiffs argue that the district court should have granted them leave to amend the complaint. Corporations and individual defendants may avoid liability for forward looking statements that prove false if the statement is |
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RIDER V. SANDOZ PHARMACEUTICALS CORP. (6/24/2002, NO. 01-11965) Circuit Judge:
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HARRIS V. IVAX CORP. (7/27/1999, NO. 98-4818) Background According to the complaint our only source of the facts the defendant Ivax Corporation is a manufacturer of generic drugs. Ivax was profitable in 1995. $104 million of which was a reduction in the carrying value of the goodwill ascribed to certain of Ivax's businesses. There are two theories of liability: first. That Ivax's economic projections were fraudulent. The plaintiffs argue that the district court should have granted them leave to amend the complaint. Corporations and individual defendants may avoid liability for forward looking statements that prove false if the statement is |
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RIDER V. SANDOZ PHARMACEUTICALS CORP. (6/24/2002, NO. 01-11965) Circuit Judge:
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OPINION/ORDER We are satisfied the district court* correctly applied state law. United States District Judge for the Eastern District of Missouri. * they are thoroughly familiar with the issues before this court. (Because Corometrics is now part of GE. HUAMs are medical devices regulated by the Food and Drug Administration (FDA). A manufacturer must give the FDA 90 days' notice that the manufacturer intends to market a medical device (1) which is substantially equivalent to a device already approved by the FDA. GE argues it was entitled to judgment as a matter of law because the contract. Because the contract is governed by Connecticut law under which the waiver provision is valid. We have considered all of GE's arguments. |
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OPINION/ORDER FACTS AND PROCEDURAL HISTORY The underlying facts are not in dispute. We have reviewed both tapes. All other pending motions are denied. 2 Under 21 U.S.C. § 321. Is a |
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OPINION/ORDER Circuit Judge: This case involves an issue that has repeatedly come before federal courts: whether expert testimony purporting to link the drug Parlodel with hemorrhagic stroke is admissible to prove causation. Alleging that their postpartum hemorrhagic strokes were caused by ingestion of Parlodel. The district court held that the plaintiffs' expert testimony was not sufficiently reliable to meet the standards established by Daubert v. In our judgment this is a grossly distorted understanding of the decision of the district court and is unsupported in the record. The district court was unable to find sufficiently reliable scientific evidence to support a decision that bridged the gap between the conclusion that Parlodel caused other injuries. The conclusion that Parlodel was a probable cause of the hemorrhagic strokes suffered by plaintiffs. We have reviewed the opinion. The active ingredient in Parlodel is bromocriptine. Issues were the same in both cases. The district court held a Daubert hearing to determine whether the evidence was admissible. |
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OPINION/ORDER With him on the brief were Bruce M. Of counsel was Herbert W. Inc. were Darrell L. Of counsel on the brief were David M. Nor do we conclude that the district court abused its discretion in determining that infringement is likely and that the harm and public interest favors enjoining Teva and Ranbaxy. injunction. Many ACE inhibitors including quinapril are susceptible to degradation due to cyclization. They chose excipients known to have low moisture content. Claim 1 is a composition claim: A pharmaceutical composition which contains: (a) a drug component which comprises a suitable amount of an ACE inhibitor which is susceptible to cyclization. Claim 16 is a process claim: A process for stabilizing an ACE inhibitor drug against cyclization which comprises the step of contacting the drug with: For more background on the development of ACE inhibitors. Drug and Cosmetic Act.2 Because Teva was the first company to file an ANDA for the generic version of Accupril®. Teva was entitled to a 180 day generic market exclusivity period pursuant to 21 U.S.C. § 355(j)(5)(B)(iv). |
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OPINION/ORDER I. BACKGROUND According to the complaint our only source of the facts the defendant Ivax Corporation is a manufacturer of generic drugs. Ivax was profitable in 1995. The full text of the release is found in Appendix I to this opinion. P. 12(b)(6) unless it was attached to the complaint. A document central to the complaint that the defense appends to its motion to dismiss is also properly considered. Provided that its contents are not in dispute. Which are [sic] not subject to material dispute. The usual rules for considering 12(b)(6) motions are thus bent to permit consideration of an allegedly fraudulent statement in its context. 3 2 Appendix II contains the full text of this release. 2 million of which was a reduction in the carrying value of the goodwill ascribed to certain of Ivax's businesses. There are two theories of liability: first. That Ivax's economic projections were fraudulent. The plaintiffs argue that the district court should have granted them leave to amend the complaint. Corporations and individual defendants may avoid liability for forward looking statements that prove false if the statement is |
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OPINION/ORDER Unpublished opinions are not binding precedent in this circuit. District Judge: This case is before the court on appellant's claim that the district court erred in granting appellee's motion for summary judgment. Rebecca Dachman is an Orthodox Jew. At issue in this case are adverse employment actions taken against appellant by her supervisors beginning in January 1995.1 The allegedly discriminatory acts occurring prior to January 1995 are time barred because appellant failed to exhaust her administrative remedies as required by law. These acts are not part of a continuing violation because. As will be shown. Appellant has not established even one claim of discrimination and/or retaliation that was timely filed. SHALALA 3 Although appellant claimed that she was an exemplary employee. Appellant was suspended on January 21. Appellant's supervisor stated that she was suspended because of insubordinate. Appellant was detailed for a period of ninety days to the Division of Biostatistics and Epidemiology. Where appellant claimed that she was given only administrative work. |
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ELLIS V. BARD, INC. (11/12/2002, NO. 01-15182) Are liable for her mother's brain damage because of their defective labeling and specifically their failure to warn adequately of the danger of having a person other than a doctor or patient activate the morphine pump that was prescribed for her mother. FACTS
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OPINION/ORDER With her on the brief were Sona De and Herbert F. With him on the brief were Thomas J. Of counsel on the brief was Jules E. |
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OPINION/ORDER I. Roggy was a licensed pesticide applicator and distributor in Minnesota and elsewhere. Roggy was regarded by his peers as an expert in the field of pesticide application. (General Mills) hired Roggy to apply pesticide to raw oats that were to be used in making cereal. Reldan was approved by the Environmental Protection Agency (EPA) for use on raw oats. A product that was not approved by the EPA for use on raw oats. The difference between the cost of Dursban and the invoice price for Reldan was approximately $85. Chlorpyrifosethyl is not approved for use on raw oats and is found in the pesticide Dursban. Widespread Dursban contamination was found in oats and oat flour from these facilities. Approximately 16 million bushels of oats and 160 million boxes of cereal were tainted by the unapproved pesticide. 2 The investigation eventually focused on Roggy. One barrel displayed a Reldan label but was empty. The other barrel was unlabeled but contained some pesticide. On the same day that he was interviewed by the FDA investigator. |
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UNITED STATES V. FISHER (5/2/2002, NO. 01-11320) The Government charged Appellants with knowledge of the commission of a felony involving the substance gamma butyrolactone ( |
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DIAL A CAR INC V. TRANS INC |
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ABBOTT LABORATORIES V. TORPHARM Argued for plaintiff appellee. |
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UNITED STATES V. FISHER (5/2/2002, NO. 01-11320) The Government charged Appellants with knowledge of the commission of a felony involving the substance gamma butyrolactone ( |
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OPINION/ORDER The court has determined that this opinion should not be published and is not precedent except under the limited circumstances set forth in 5TH CIR. R. 47.5.4. * No. 03 41391 2contain a conspiring to defraud the United States allegation and therefore differed from the offense for which he was convicted and sentenced. Provides for a maximum term of imprisonment of five years if the object of the conspiracy is the commission of a felony. Willhite's suggestion The that he never intended to defraud the FDA is disingenuous. count of the indictment to which he pleaded guilty is replete with allegations that he intended to defraud and mislead the FDA and there is nothing in the record to suggest otherwise. 1043 (5th Cir. 1987) is unavailing. Haga was convicted and No. 03 41391 3sentenced for |
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OPINION/ORDER Line 5 |
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FOREST LABORATORIES V. ABBOTT With him on the brief were Herbert F. Argued for defendant appellant. With him on the brief was Maggie J. Schneider. Of counsel was Linda T. Which are directed to a lung surfactant composition for treating respiratory distress syndrome in premature babies. Pursuant to an exclusive license of the 301 and 839 patents. Abbott informed ONY that CLSE was likely not patentable in light of two pertinent references. Abbott in |
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OPINION/ORDER Although the action was not technically mooted by events subsequent to the initiation of the action. We affirm the judgment of the district court because the action was not ripe. Cox Nos. 01 2392/2518 Ammex is a Michigan corporation that operates a United States Customs Class 9 bonded warehouse and duty free store in Detroit. The Ammex store is |
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OPINION/ORDER Which was within the advisory guidelines range. Santisteban was involved in an international conspiracy to manufacture and distribute counterfeit prescription drugs. Santisteban's defense at trial was that his participation was unwitting. The central figure of the conspiracy was Julio Cruz. At about 50% above what he typically would have charged. Although the heading indicated that it was from Pfizer in Brazil. The theory of the prosecution was that the conspiracy evaded the Food and Drug Administration's regulatory control and thus defrauded the United States. A. Santisteban's first contention is that the government violated his rights under the Due Process Clause by failing to disclose certain impeachment evidence. Santisteban's defense was that he believed Cruz to be a legitimate businessman. That the body of the letter was blank when he gave the letterhead to Santisteban. Concluding that there was no clear inconsistency between the prosecution memorandum and Cruz's testimony. The court reasoned that the prosecution memorandum may have referred only to the creation of the letterhead. |
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01-1509 -- GRANT V. PHARMACIA 7 UPJOHN CO. -- 12/23/2002 That any ambiguity in the contract is properly resolved in Defendant Upjohn's favor. The doctors were partly responsible for the discovery that minoxidil (marketed by Upjohn as Rogaine) stimulates hair growth. The terms of which are the basis of this litigation. The ISA provides: UPJOHN further agrees to pay an earned royalty of three and three quarter percent (3 3/4%) of UPJOHN's NET SALES of the INVENTION where the sale of the INVENTION would infringe any claim of the PATENT or the APPLICATION or any subsequently issued patent in which UPJOHN was assigned or could have been assigned an interest pursuant to this Agreement. UPJOHN also agrees to pay an earned royalty of two percent (2%) of UPJOHN'S NET SALES of the INVENTION where the manufacture of the INVENTION would infringe but the sale of the INVENTION would not infringe any claim of the PATENT or the APPLICATION or any subsequently issued patent in which UPJOHN was assigned or could have been assigned an interest pursuant to this Agreement. Aplt. |
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ELLIS V. BARD, INC. (11/12/2002, NO. 01-15182) Are liable for her mother's brain damage because of their defective labeling and specifically their failure to warn adequately of the danger of having a person other than a doctor or patient activate the morphine pump that was prescribed for her mother. FACTS
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OPINION/ORDER With him on the brief were Alexander L. With him on the brief were Robert S. Of counsel on the brief was Ronald S. The NSAID is the active ingredient for reducing eye inflammation. Neither ingredient is water soluble. These complexes will eventually cause the mixture to look cloudy or lose its antibacterial properties. The appellees are collectively referred to as |
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CARDIAC PACEMAKERS, INC., ET AL. V. ST. JUDE MEDICAL, INC., ET AL. Argued for plaintiffs appellants. With him on the brief was Jeffrey B. Of counsel on the brief was Richard R. Font family:Arial'>. Also on the brief were J. Argued for defendants cross appellants. With him on the brief was H. Mark Lyon. Also on the brief was Mark A. Font family:Arial'>. Of counsel on the brief were Jeffrey M. Font family:Arial'>This patent infringement action was brought by Cardiac Pacemakers. Or quivering fashion (fibrillation). Arrhythmias may occur in varying degrees. In treating such heart abnormalities it is important to determine the form and degree of arrhythmia present. Font family:Arial'>The inventions subject of this lawsuit are implantable cardiac defibrillators (ICDs) that are permanently installed under the skin. |
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OPINION/ORDER Are liable for her mother's brain damage because of their defective labeling and specifically their failure to warn adequately of the danger of having a person other than a doctor or patient activate the morphine pump that was prescribed for her mother. I. FACTS The factual background in this case is largely undisputed. The Product The product at issue is the Bard Ambulatory Patient Controlled Analgesia Infusion Pump (the |
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OPINION/ORDER Jorge Marrero Narvaez were on brief. Were on brief. The gist of EPA's decision was straightforward: having previously established secondary treatment requirements because PRASA's POTW emitted pollutants into stressed waters. The NPDES permit issued to 1 |
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OPINION/ORDER This is a products liability matter. Who are the recipients of temporomandibular joint (TMJ) implants. Seek to impose liability upon The Dow Chemical Company (Dow Chemical) for injuries alleged to have been caused by the implants. The pretrial proceedings in these various personal injury actions were consolidated in the District of Minnesota by the Judicial Panel on Multidistrict Litigation pursuant to 28 U.S.C. § 1407 (1994). A TMJ implant is a device 1 Plaintiffs appeal the final order of the We granting summary judgment in favor of Dow Chemical. that is surgically inserted to replace an improperly functioning TMJ. Plaintiffs assert that Dow Chemical is liable because of its The Honorable Paul A. All nonbreast implant claims pending against Dow Corning have been transferred to the United States District Court for the Eastern District of Michigan. Among Dow Chemical's services were approximately a dozen limited toxicology tests performed on a variety of silicone compounds from 1943 through the early 1970s. used safely as a medical implant.3 Three Dow Chemical scientists. |
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OPINION/ORDER The court has determined that this opinion should not be published and is not precedent except under the limited circumstances set forth in 5TH CIR. R. 47.5.4. * No. 03 41391 2contain a conspiring to defraud the United States allegation and therefore differed from the offense for which he was convicted and sentenced. Provides for a maximum term of imprisonment of five years if the object of the conspiracy is the commission of a felony. Willhite's suggestion The that he never intended to defraud the FDA is disingenuous. count of the indictment to which he pleaded guilty is replete with allegations that he intended to defraud and mislead the FDA and there is nothing in the record to suggest otherwise. 1043 (5th Cir. 1987) is unavailing. Haga was convicted and No. 03 41391 3sentenced for |
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OPINION/ORDER This document was created from RTF source by rtftohtml version 2.7.5 > |
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GLAXO GROUP LIMITED, ET AL. V. APOTEX, INC. Argued for plaintiffs appellees. With him on the brief were Michael F. Pennisi. Of counsel was Thomas M. Argued for defendant appellant. With him on the brief were Hugh L. Also affirm that the patents at issue are not invalid. Line height:200%'>Glaxo is the owner by assignment of a series of patents directed to antibiotics in the cephalosporin family. In the 1970s. 153. Cefuroxime required intravenous or intramuscular injection because of bioabsorption difficulties and was therefore of limited usefulness. Glaxo then synthesized a family of cefuroxime esters that were capable of oral administration and obtained U.S. Patent disclosed CA |
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OPINION/ORDER Were on brief. Were on brief. The NTEU made two proposals to require mid term bargaining unless the matter at issue was |
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OPINION/ORDER This document was created from RTF source by rtftohtml version 2.7.5 > |
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OPINION/ORDER United States Attorney at the time the briefs were filed. Were on the briefs. Javitt were on the briefs. Stanley was on the briefs. Frey was on the briefs for amicus curiae Pharmaceutical Research and Manufacturers of America. Hedg peth were on the briefs for amicus curiae The Jane Goodall Institute for Wildlife Research. The regulated parties are not obligated to make them available to members of the public. Jurnove's affidavit is an uncontested statement of the injuries that he has suffered to his aesthetic interest in observing animals living under humane conditions. 49 (D.D.C. 1996) (granting summary judgment to plaintiffs on all legal claims except one that plaintiffs have not appealed. [he is] very familiar with the needs of and proper treatment of wildlife. |
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OPINION/ORDER With him on the brief was Bruce M. With him on the brief was Roy H. Of counsel on the brief was Alfred B. Because the language of § 156 is unambiguous and fulfills a purpose unrelated to and not in conflict with that of § 253. Inc. ( |
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OPINION/ORDER On the brief were Marc R. Will & Emery. With him on the brief were Dennis J. Both parties are biotechnology companies that are engaged in gene silencing. A cell is exposed to a piece of foreign DNA that is specifically engineered to contain certain portions or copies of the target gene to be silenced. This technology is known as RNA interference ( |
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ELI LILLY AND COMPANY V. BARR LABORATORIES, INC. With him on the brief were Allen M. Of counsel was L. Of counsel on the brief were Douglas K. With him on the brief were James F. Of counsel on the brief was Mark E. Of counsel was Derek . Fluoxetine hydrochloride is the active ingredient in Eli Lilly and Company |
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PFIZER, INC., V. DR. REDDY'S LABORATORIES, LTD., ET AL. With him on the brief were Gerald Sobel. DC. Of counsel on the brief was David E. Argued for defendants appellees. With him on the brief were Andrew J. Ltd. With him on the brief were Barbara L. Inc. With him on the brief were Nicolas G. Stanley. Of counsel on the brief were Paul D. For amicus curiae Wyeth. With him on the brief was Gregory A. Chopskie. Of counsel on the brief was David A. For amicus curiae Pharmaceutical Research and Manufacturers of America. With him on the brief were Robert A. For amicus curiae Eli Lilly and Company. With him on the brief were Robert A. For amicus curiae Washington Legal Foundatio |
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OPINION/ORDER Of counsel on the brief was Alan H. With him on the brief were Julian D. Of counsel were Ross R. With him on the brief were Ronald P. This invention includes both |
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OPINION/ORDER Circuit Judge: Appellant Robert Ruhe was tried and convicted of conspiring to transport stolen property in interstate commerce and aiding and abetting the transportation of stolen property in interstate commerce. Ruhe asserts that illegally seized evidence was improperly used. That the evidence was insufficient to convict him. After such parts were mutilated they were sold as steel scrap. These parts were designated by placing red tags on them. 2 Sometime around 1993 or 1994 Byard began stealing aircraft parts from the scrap cage and selling them to Ruhe. The main trial issue was whether Ruhe knew that these parts were stolen. Byard never told Ruhe that he was stealing the parts. That Ruhe had to know that they were stolen. Ruhe maintained that Byard never told him that they were stolen. For over one year Byard once a week or once a month would bring parts to Ruhe's businesses or his residence (which is located directly next to his businesses). The aircraft industry apparently has a pedigree system whereby aircraft parts are accompanied by documentation indicating their source and usage. |
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OPINION/ORDER Of counsel on the brief were John S. With him on the brief were Peter D. Of counsel on the brief was Chi S. That the mints are sugar free. Warner Lambert presented expert evidence that Certs® is |
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OPINION/ORDER I. This case is another case arising from the fraudulent loan scheme orchestrated by Edward J. Reiners' fraud was uncovered Philip Morris was not involved in any way with Project Star and in fact there was no such project and the banks involved in the Project Star credit facility lost large sums of money. Because Signet was a lead bank and arranged for the participation of several of the other banks. Many of these banks have sued Signet. Although the facts behind Reiners' scheme have been described elsewhere. They are repeated here insofar as they are relevant to the present appeal. Nelson and Mooney were familiar with Reiners' name from prior deals in which Reiners had executed documents on behalf of Philip Morris for computer leasing transactions. Nelson repeated to Mooney the story that Reiners had told him that Reiners was still employed with Philip Morris and that Project Star was a top secret project being conducted offshore by Philip Morris which required large amounts of computer equipment. The participation of Philip Morris was a vital component of the security for the loans. |
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OPINION/ORDER Of counsel were Edward C. Of counsel was Robert J. With him on the brief were Constance S. Of counsel on the brief were Nicholas L. Of counsel on the brief was Scott A.M. This is a patent case. Determined that the patents were unenforceable due to inequitable conduct that occurred during prosecution before the United States Patent and Trademark Office ( |
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OPINION/ORDER Of counsel on the petition was Thomas J. With him on the opposition were Jeffrey J. With him on the brief was Roy H. With him on the brief were John D. ORDER A combined petition for panel rehearing and rehearing en banc was filed by the Appellant. A response thereto was invited by the court and filed by the Appellee.1 The petition for rehearing was referred first to the merits panel that heard the appeal. The amici curiae briefs were referred to the circuit judges who are authorized to request a poll whether to rehear the appeal en banc. A poll was requested. IT IS ORDERED THAT: (1) The petition for panel rehearing is denied. 1 Amicus curiae briefs were filed by: 1 The Federal Trade Commission. 2 The Generic Pharmaceutical Association. 3 Ivax Pharmaceuticals. Schumer. (2) The petition for rehearing en banc is denied. (3) The mandate of the court will issue on April 11. This is a critical issue under the Hatch Waxman Act.1 The failure of this court by en banc action to correct the Teva court's decision. The Teva court's reasonable apprehension analysis is the wrong test for a concrete. |
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OPINION/ORDER With him on the briefs were Elliot J. With her on the brief were Kenneth L. Attorney at the time the brief was filed. Circuit Judge: This Freedom of Information Act appeal is a footnote to the long trade dispute in which the United States and American softwood lumber companies have raised complaints about alleged unfair trade practices by the Canadian Government and Canadian softwood lumber exporters. The Department of Commerce imposed duties on imports of Canadian softwood lumber to the United States (duties that have since been rescinded as a result of the recent bilateral settlement). At issue in this appeal are 17 third party letters that the Department had received from American lumber companies. Also at issue are 51 sets of internal Department notes. The Department has provided Baker Hostetler numerous other softwood lumber related documents that are not at issue on appeal. The firm argues it is a |
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ANIMAL LEG DEF FUND V. GLICKMAN DANIEL United States Attorney at the time the briefs were filed. Were on the briefs.
Harris Weinstein argued the cause for appellant National Association for Biomedical Research. Javitt were on the briefs.
Katherine A. Stanley was on the briefs.
Andrew L. Frey was on the briefs for amicus curiae Pharmaceutical Research and Manufacturers of America.
Leslie G. Hedg peth were on the briefs for amicus curiae The Jane Goodall Institute for Wildlife Research. The regulated parties are not obligated to make them available to members of the public. See id.
The individual plaintiffs. Jurnove's affidavit is an uncontested statement of the injuries that he has suffered to his aesthetic interest in observing animals living under humane conditions. See Ani mal Legal Defense Fund. 49 (D.D.C. 1996) (granting summary judgment to plaintiffs on all legal claims except one that plaintiffs have not appealed. |
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OPINION/ORDER THOMPSON Unpublished opinions are not binding precedent in this circuit. Who is a Hispanic female. Filed this action asserting that her failure to be hired for various positions within the Department of Health and Human Services was motivated by racial and age based discrimination. Summary judgment is appropriate only if there are no genuine issues of material fact and the moving party is entitled to judgment as a matter of law. The evidence is viewed in the light most favorable to the non moving party. Discrimination claims under Title VII are analyzed under the burden shifting frame GONZALEZ LORD v. Gonzalez Lord must show: (1) she is a member of a protected class. (3) she was qualified for the position. (4) the position was filled by a similarly qualified applicant outside the protected class. The burden shifts to the employee to show the employer's proffered reason was a pretext for illegal discrimination. We dispense with oral argument because the facts and legal contentions are adequately presented in the materials before the court and argument would not aid the decisional process. |
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OPINION/ORDER The product's primary active ingredient.1 Although the scientist who devel Olivenol is now sold not only in tablet form. As there is no relevant difference between the three dosage methods for purposes of this appeal. We will use |
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OPINION/ORDER This case is part of the massive VIOXX related litigation. The primaryand narrowissue on this appeal is whether the District Court erred by refusing to allow the plaintiffs leave to amend their complaint with additional materials they had proffered to the court to show that amendment would not be futile.1 The parties have also briefed the issue of whether the District Court properly granted Merck's motion to strike additional materials proffered by the plaintiffs in their opposition to the defendant's motion to dismiss. This legal issue is not significantly different than the after acquired information issue we directly confront. The plaintiffs are correct that this issue |
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OPINION/ORDER Claimant James Axford and similarly situated class members represented by the Hariton and Napoli Firms whose claims are affected by Pretrial Order No. 2929. On behalf of themselves and all other class members who have ingested fen phen and who suffer. Or will suffer. Whose claims are affected by Pretrial Order No. 3849. This appeal is the consolidation of challenges by three different groups of Appellants. We find that all three groups of Appellants are bound by the Settlement Agreement and we will affirm the District Court's decision. We will refer to it as Wyeth. 5 1 The history of this case is detailed in In re Diet Drugs Prods. 225 29 (3d Cir. 2002) and will only be briefly summarized here. The remedies provided depended on whether the class members were ultimately diagnosed with one of several heart conditions. Each class member was placed into one of five groups. Was further subdivided into class members who had used the diet drugs for more than 60 days |
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OPINION/ORDER The district court's judgment is reversed and remanded. BACKGROUND This securities fraud case is a class action on behalf of investors who purchased Dura Pharmaceutical securities between April 15. This appeal is drawn specifically to alleged misleading and untrue statements made by Dura and its officials (collectively |
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OPINION/ORDER Defendants Appellees. *A complete list of the appellants and appellees with district court case numbers is set forth in a separate. Certain appellants on that list were dismissed in this court's orders filed on January 14. The names of some of the dismissed appellants who were lead plaintiffs in multi plaintiff cases have been retained on the caption for reference purposes only. 10293 10294 IN RE PHENYLPROPANOLAMINE LESLIE ACKEL. Were randomly assigned to two panels. For which separate unpublished dispositions have been filed. 1 All judges participated in deciding. II and III which are common to all appeals. Judges Nelson and Leavy participated in deciding and sign an opinion only with respect to those appeals assigned to the panel of which they were respectively a member. Circuit Judge: These appeals are from judgments of dismissal entered in a multidistrict litigation (MDL) proceeding for failure to comply with case management orders. The orders were entered with the agreement of all sides that they were necessary to move hundreds of cases and thousands of plaintiffs toward resolution on the merits. |
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OPINION/ORDER This is an appeal in a diversity case from an order dismissing a physician's deceptive marketing claim under 2 the Pennsylvania Unfair Trade Practices and Consumer Protection Law (CPL) for lack of standing. We will affirm. I. Richard Balderston is a Philadelphia orthopedic surgeon who specializes in spinal surgery. Believing that pedicle screws were safe and appropriate for this use. Leading him and other orthopedic surgeons to believe they were FDA approved. Because the screws were not FDA approved for spinal fusion surgeries. Balderston alleged he was exposed to lawsuits by patients claiming they did not give informed consent.2 Dr. The products are officially labeled as |
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OPINION/ORDER Unpublished opinions are not binding precedent in this circuit. Which |
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OPINION/ORDER Which they are in a habit of doing. |
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OPINION/ORDER The defendant is a manufacturer of surgical and orthopedic devices. That such a violation was either negligence per se. William Gondring treated plaintiff's fracture with an 11mm intramedullary supracondylar (IMSC) nail that was manufactured by the defendant. The place where marrow is made. The IMSC nail was to serve as an internal splint to hold the broken pieces of bone together while the bone healed. Plaintiff was fully weightbearing on his leg. Plaintiff was advised to reduce his weightbearing. Because the leg was not healed. 1996 (18 months after the original complaint was filed). Also stated that the time provided was generous. Which stated in part: The proposed amendments previously submitted contained claims for relief specifically due to violations of the MDA amendments to the FDA Act and negligence per se claims which are omitted from the attached proposed First Amended Petition. The plaintiffs' first argument is that Instruction No. 11 was an incorrect statement of the law. This instruction stated: The manufacturer of an Intramedullary Supracondylar Nail is not a guarantor that nobody will get hurt in using the article. |
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OPINION/ORDER Entered by the district court2 pursuant to a jury verdict. 1 2 Section 43(a) of the Lanham Act is codified at 15 U.S.C. § 1125(a) (1994). The facts underlying the parties' dispute are as follows. Only Pall's BB50T is sufficiently |
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OPINION/ORDER Consolidating approximately 280 products liability actions for pretrial purposes under 28 U.S.C. § 1407 (1994) ( |
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OPINION/ORDER Hearing Express argued in response that the Missouri statute was preempted by the Medical Devices Amendment to the Federal Food. Hearing Express is an Illinois corporation that is in the business of selling hearing aids through the mail and on the internet. It is undisputed that Hearing Express conducts its business in full compliance with the applicable federal law and regulations. Hearing Express removed the case to the federal district court on the grounds that the Missouri statute is preempted by the Medical Devices Amendment (MDA). The district court did not consider § 360k(a) to be an express preemption statute and concluded that it is not preempted by the MDA because the state requirements for fitting procedures are not covered by the federal law. Hearing Express contends on its appeal that the Missouri statute is preempted by the MDA and regulations promulgated under it because the state law falls directly within the express preemption language of the federal statute. The FDA concluded that statutes which require mandatory audiological evaluations are preempted and it denied exemptions from the MDA's preemptive reach to states with statutes similar to Missouri's. |
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OPINION/ORDER Moreno argues the district court erred (1) in applying the learned intermediary doctrine to bar the plaintiffs' claims and ruling Shire adequately warned Ehlis's treating physician about psychosis resulting from ingestion of Adderall and (2) in ruling their claims are preempted by the Food. Only Moreno is pursuing this appeal. To whom this case was referred for final disposition by consent of the parties pursuant to 28 U.S.C. § 636(c) (2000). Is now known as Shire US. Inc. 23 2 1 contains amphetamine salts and is manufactured for treating ADHD in children and narcolepsy in adults. Adderall is approved by the Food and Drug Administration (FDA). Who is Ehlis's girlfriend and the mother of his children. Ehlis was charged with murder. The charges were dismissed after various doctors testified about Ehlis's mental condition. Reporting Ehlis suffered from an |
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BIO-TECHNOLOGY V. GENENTECH |
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OPINION/ORDER He was sentenced to concurrent terms of 21 months' imprisonment. Between 1994 and 1997 Snook was the |
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OPINION/ORDER This disposition is not citable as precedent. It is a public record. 998 ( |
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NOVARTIS CORPORATION V. BEN VENUE LABS Argued for plaintiff appellant. |
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OPINION/ORDER With him on the briefs was David K. With her on the brief were Karen D. Hamlin were on the brief for intervenor. The NRC subsequently dismissed Whistleblower's petition when Whistleblower failed to file contentions within the NRC's deadline. * Judge Williams' dissent will be filed at a later date. Because we conclude that the |
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GLAXO GROUP LIMITED AND GLAXO WELLCOME, INC V. RANBAXY PHARMACEUTICALS Argued for plaintiffs appellees. |
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OPINION/ORDER The defendant contends that the district court erred in granting summary judgment because the plaintiff failed to set forth any objective evidence that the product was damaged under the terms of the insurance policy and that the plaintiff cannot maintain the breach of contract claim because it failed to adhere to a two year period of limitation set forth in the insurance policy. (Edwards) is a wholesale seller of Virginia ham. (4) certification from the FDA that the meat is contaminated and cannot be sold. While Edwards was waiting for the results of the tests from Microbac. Samples of the repackaged product were also sent to Microbac Edwards & Sons notified its insurance agent of the ammonia incident on October 7. It is not clear from the record whether this would be regulated by the FDA or the USDA. The plaintiff stated in its brief that the USDA is the agency that regulates meat products. The plaintiff was informed that. The meat packer had the responsibility for assuring that the product was safe for human consumption and the USDA remained neutral until the product had been released into commerce. 1 4 EDWARDS & SONS v. |
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OPINION/ORDER We will reverse. We have jurisdiction under 28 U.S.C. § 1291 (1988). Our review of these issues of standing and statutory construction is plenary. 1530 n.19 (3d Cir. 1993) ( |
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OPINION/ORDER With him on the brief were Philip J. With him on the brief were Curt J. Of counsel on the brief was Joseph Kirk. That the '814 patent was invalid and unenforceable. That it failed to prove (1) that the '814 patent is unenforceable due to inequitable conduct and (2) that claims 1 5 of the '814 patent are invalid as anticipated. As far as the anticipation issue is concerned. A. Impax is a Delaware corporation with its principal place of business in Hayward. Aventis is a Delaware corporation with its principal place of business in Bridgewater. Aventis was formed in 1999 as part of a merger between 05 1313 2 Rhone Poulenc. Is a disease of the central nervous system. ALS is characterized by the death of the nerves that control motor function (also called motor neurons). Riluzole is the chemical compound 6 trifluoromethoxy 2 benzothiazolamine. The purpose of the testing was to determine whether the compounds would be effective in treating ALS. The effects of riluzole and the other compounds on the rat spinal cords were analyzed based on the following criteria: (1) number of neurons in the cells (used to screen for extraneous effects of the compound). |
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OPINION/ORDER Is amended. Is deleted and replaced by the following footnote 17: 17. USDA instituted a policy of barring the importation of ruminants1 and ruminant products from countries where BSE was known to exist. Bovine Spongiform Encephalopathy BSE was first diagnosed in England in the late 1980s. It conRuminants are hoofed mammals generally defined by their fourchambered stomachs and their practice of chewing a cud consisting of regurgitated. BSE is a species of Transmissible Spongiform Encephalopathy ( |
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OPINION/ORDER Unpublished opinions are not binding precedent in this circuit. See Local Rule 36(c). 3 OPINION PER CURIAM: This is an appeal from an order of the district court granting summary judgment in favor of Smith & Nephew. The manufacturer of an allegedly defective medical device referred to as the Rogozinski Spinal Rod System ( |
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OPINION/ORDER The district court found that Andrx's allegations regarding a licensing agreement entered into by Elan and another competitor to settle a separate infringement suit were insufficient to support an antitrust action under the Sherman Anti Trust Act. The district court's order is AFFIRMED in part. We will begin by briefly summarizing the relevant statutory provisions. After which we will recount the relevant facts specific to the parties. Different FDA approval standards apply depending on the drug the applicant is attempting to market. The facts are derived from the allegations in Andrx's complaint. Are presented in the light most favorable to Andrx. Our inquiry is limited to the allegations in the first amended complaint. 3 1 requirements outlined in § 355(b). Or would only violate a patent on a § 355(b) approved drug which is invalid. Which is then given forty five days to initiate patent infringement proceedings against the ANDA applicant. § 355 grants the first manufacturer to file an ANDA application for a generic drug using the type of certification outlined in § 355(j)(2)(A)(vii)(IV) an exclusive 180 day period to market the generic drug before another ANDA application is approved for a similar generic drug. § 355(j)(5)(B)(iv)(I). |
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OPINION/ORDER On behalf of themselves and their clients who are specifically identified in and/or whose claims are affected by Pretrial Order No. 2778. The Sixth Amendment was approved by the District Court in Pretrial Order ( |
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OPINION/ORDER CV 03 06386 JKS *Nancy Ruthenbeck is substituted for Del A. P. 43(c)(2). ** Mike Johanns is substituted for Ann M. Chief Judge Schroeder and Judge Graber have voted to deny the petition for rehearing en banc. The petitions for rehearing and rehearing en banc are DENIED. Plaintiffs Appellees' motion for clarification with regard to the applicability of the opinion to both 36 C.F.R. §§ 215.12(f) and 215.4(a) and inapplicability of the opinion to 36 C.F.R. § 215.18(b)(1) is GRANTED. Is amended and. The attached amended opinion is substituted in its place. Overview This is a government appeal from a district court judgment enjoining Forest Service regulations that govern review of decisions implementing forest plans. On the ground that the regulations were manifestly contrary to the governing statute. The environmentalist plaintiffs Earth Island Institute et al. challenge the four regulations the district court held were valid. We agree with the district court that plaintiffs have established standing. 36 C.F.R. §§ 215.12(f) and 215.4(a) have actually been applied to a proposed project. |
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OPINION/ORDER With him on the brief were Shepard M. Of counsel on the brief were Allyn Z. With him on the brief were Robert L. Each of which covers and is directed to various aspects of Famvir®. The '937 patent is directed to the active ingredient in Famvir®. While the remaining Orange Book patents are directed to methods of therapeutic use ( |
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OPINION/ORDER Defendants Appellees. *Nancy Ruthenbeck is substituted for Del A. Overview This is a government appeal from a district court judgment enjoining Forest Service regulations that govern review of decisions implementing forest plans. On the ground that the regulations were manifestly contrary to the governing statute. RUTHENBECK held were valid. We agree with the district court that plaintiffs have established standing. We hold that only that regulation is ripe for review. The Sierra Club (collectively |
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OPINION/ORDER With him on the brief was Mark K. Of counsel on the brief was Marcus T. With him on the brief were Eric M. This was not a case of mistake or negligence the prosecuting attorney testified that he would make all the same nondisclosure decisions again if prosecuting the same applications today. The issues of materiality and intent are fact driven. The law recognizes that deceptive intent is virtually never shown or disproved by direct evidence. McKesson must demonstrate that the district court's findings of fact are clearly erroneous. This is accomplished first by providing a set of bar codes associated with a given patient such that one bar code from the set is physically attached to the 2006 1517 2 patient and the other bar codes from the set are physically attached to. Because the handheld patient terminals are portable. It is desirable to prevent one such terminal from wirelessly communicating with a base station in. The portable handheld patient terminal means including electromagnetic wave transceiver means including means for transmission of patient and item data as an electromagnetic wave which is representative of the first and second bar code identifier means scanned by the bar code reader means and including means for receipt of data as an electromagnetic wave. |
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NOVAMEDIX V. NDM ACQUISITION With him on the brief was Reginald R. With her on the brief was Anne F. We hold that the settlement agreement incorporated into the consent decree is not a contract for the sale of goods and therefore the implied warranties of fitness and merchantability of UCC 2 314 and 2 315 do not apply. |
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OPINION/ORDER USDA instituted a policy of barring the importation of ruminants1 and ruminant products from countries where BSE was known to exist. We reverse.2 Ruminants are hoofed mammals generally defined by their fourchambered stomachs and their practice of chewing a cud consisting of regurgitated. Bovine Spongiform Encephalopathy BSE was first diagnosed in England in the late 1980s. BSE is a species of Transmissible Spongiform Encephalopathy ( |
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OPINION/ORDER |
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OPINION/ORDER With him on the brief were Peter J. With him on the brief was Francis C. Of counsel on the brief were Jeffrey S. That the claims of the '712 patent are invalid and/or not infringed by the manufacture. Or sale of the products for which approval was sought. Cipla is the intended supplier of EO for Ivax and contributed information for the filing of the ANDA. Stereoisomers are compounds that contain the 1 35 U.S.C. § 271(e)(2)(A) provides: It shall be an act of infringement to submit an application under section 505(j) of the Federal Food. Cosmetic Act or described in section 505(b)(2) of such Act for a drug claimed in a patent or the use of which is claimed in a patent if the purpose of such submission is to obtain approval under such Act to engage in the commercial manufacture. Or sale of a drug or veterinary biological product claimed in a patent or the use of which is claimed in a patent before the expiration of such patent. 2007 1059 2 same constituent atoms and the same bonding between those atoms but have different spatial arrangements. |
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OPINION/ORDER |
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UNITED STATES V. CARLSON This document was created from RTF source by rtftohtml version 2.7.5 > |
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OPINION/ORDER |
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UNITED STATES V. CARLSON This document was created from RTF source by rtftohtml version 2.7.5 > |
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OPINION/ORDER Appellants are present and former employees of defendant Rhone Poulenc Rorer Pharmaceuticals. Who are appealing from a final order entered in the United States District Court1 for the District of Minnesota. Manufacturers are prohibited from promoting such off label uses. That appellants were |
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OPINION/ORDER This document was created from RTF source by rtftohtml version 2.7.5 > |
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OPINION/ORDER This document was created from RTF source by rtftohtml version 2.7.5 > |
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BAYER AG V. BIOVAIL CORPORATION Argued for plaintiffs appellants. |
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01-4140 -- COMPUTERIZED THERMAL IMAGING INC. V. BLOOMBERG -- 11/26/2002 The latter defeated by the absence of a proper plea for special damages which was not achieved in its motion for relief from judgment. Is a development stage company. Which promotes business ventures by selling stock to raise capital. |
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OPINION/ORDER PER CURIAM:* Rosa Maria Nunez was convicted of conspiracy to introduce an adulterated device into interstate or foreign commerce with the intent to commit fraud. Nunez first argues that the evidence was insufficient to establish that these substances were |
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OPINION/ORDER It was too difficult and costly to produce commercially until the early 1980s. Baxter was not willing to bear the costs of the required medical testing. 2 No. 02 2039 So in 1988 it granted to Maruishi Pharmaceutical Company. An exclusive worldwide license to practice the sevoflurane process patents Baxter owned or was pursuing. Where it was a great success. Today sevoflurane is the best selling gas used for anesthesia in the United States. Isoflurane is not protected by any patent and sells for less. It is slower in both onset and recovery and has an irritating taste and smell. Though its properties otherwise are comparable to sevoflurane which therefore has become the anesthetic of choice and commands a premium price. Ohmeda could receive approval without costly tests just by showing that the finished product is identical to Abbott's. It was acquired (in 1998) by Baxter which decided to proceed No. 02 2039 3 with Ohmeda's plans and compete with the sevoflurane made by Maruishi and sold in the United States by Abbott. |
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OPINION/ORDER Unpublished opinions are not binding precedent in this circuit. The district court held that the '657 patent was invalid because it failed to name Dr. The court therefore concluded that the agreement between the Levins and Septodont was unenforceable for lack of consideration. A numbing cream that is used to reduce the pain caused by mouth ulcers. Harmony was unable to find a solution. Non alcoholic mouth rinse was patentable. Inc.) received an exclusive license to use the patent with an option to have the patent assigned to it free of charge at any time. The Patent Office initially rejected Eastman's patent application on the ground that the mouth rinse was obvious in light of the prior art. Non irritating solvent was a non obvious contribution to the field. Five Eastman scientists were listed as the inventors of the mouth rinse. Eastman was listed as the patent's assignee. Including a claim for a declaratory judgment that the '657 patent was invalid because it failed to list Dr. Contending that the contract was unenforceable for lack of consideration because the Levins had failed to convey valid patent rights. |
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OPINION/ORDER Unpublished opinions are not binding precedent in this circuit. Circuit Judge: Suhas Sardesai and Edmund Striefsky were both convicted of conspiracy to defraud the United States Food and Drug Administration. Which was decided shortly after Sardesai and Striefsky were convicted. Sardesai and Striefsky were executives at Mutual Pharmaceutical Company. Testimony also showed that employees were often told to sign records documenting work they had not done and not to document the work they had done in violation of FDA procedures. At least six different drugs were affected by Mutual's illegal practices. 1319 (8th Cir. 1988) (applying abuse of discretion 1 Federal law requires that a drug manufacturer submit detailed data to the F.D.A. regarding the exact process which will be used in making and testing a drug product. 21 U.S.C. § 355. Drugs not made in accordance with approved processes or drugs for which inaccurate records are kept regarding manufacturing and testing are |
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OPINION/ORDER With him on the brief were Nicolas G. Of counsel on the brief were Paul D. With him on the brief were Maria Luisa Palmese and William G. The patent was filed on August 14. Bisphosphonates are a family of chemical compounds that are known to selectively inhibit the bone destruction process that contributes to osteoporosis and other bone diseases. '329 patent. At issue in this case are once weekly dosages of alendronate monosodium trihydrate. Teva does not challenge the district court's determination that the `329 patent is enforceable or that it would be infringed by Teva's proposed drug product. 2 04 1005 1 Bisphosphonates are not readily absorbed by the gastrointestinal ( |
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OPINION/ORDER With him on the briefs were Katharine S. With him on the briefs were Frank W. Attorney at the time the brief was filed. Are defendants in an action in district court (the |
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PEARSON DURK V. FDA It is
ORDERED that the suggestion be denied.
Per Curiam FOR THE COURT:
Mark J. Bonner Deputy Clerk
A statement by Circuit Judge Silberman is attached.
Silberman. We are told that the panel's decision is anomalous in light of the regime that governed the sale and labeling of dietary supplements prior to Congress' enactment of the Nutrition Labeling and Edu cation Act of 1990. The government asserts that neither employing a health claim as a trigger to the drug approval process (which was never tested in litigation). We stated that |
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NATIONAL WHISTLEBLOWER CENTER V. NUCLEAR REGULATORY COMMISSION With him on the briefs was David K. Argued the cause for respondent. With her on the brief were Karen D. Hamlin were on the brief for intervenor. Before: Edwards. The NRC affirmed the decision. The NRC subsequently dismissed Whistleblower's petition when Whistleblower failed to file contentions within the NRC's deadline.
* Judge Williams' dissent will be filed at a later date.  . Because we conclude that the |
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OPINION/ORDER IT IS HEREBY ORDERED. DECREED that the judgments of conviction are AFFIRMED. Except that the case is remanded solely for consideration of whether to modify Bacanovic's sentence. The District Court decided not to modify the sentence that was imposed on July 16. Procedural history Defendants Martha Stewart and Peter Bacanovic were charged in Superseding Indictment S1 03 Cr. 717 with offenses that arose from their communications to government investigators who were probing trading activity of ImClone Systems. Five months of which were to be served in home confinement. Stewart and Bacanovic were ordered to pay fines of $30. The stays were subsequently vacated and amended judgments of conviction were entered as to Stewart on September 22. Concluding that it would have imposed the same sentence even if the Sentencing Guidelines had not been mandatory at the time of sentencing. His application is granted. Was attempting to sell all of his own shares in the company. Stewart was interviewed twice. To demonstrate that the story Defendants told to investigators was a cover up of the events of December 27th. |
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OPINION/ORDER Because the challenged statements are constitutionally protected and therefore not actionable. Stating that Biospherics' stock was overvalued. The article was one of three in the column. The Biospherics piece is accompanied by a downward arrow. The Biospherics article is titled |
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OPINION/ORDER Loew with whom Loew & Tamkin was on brief for appellant. P.C. was on brief for appellees. The determinative legal question is whether or not Abruzzi. We have read the record and conclude that it did not. Namely that it is |
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OPINION/ORDER Were on brief for Philip Morris appellants. Were on brief for United States Tobacco Company appellants. Were on brief for appellees. The specific plaintiffs appellants are Philip Morris Incorporated. The specific defendants appellees are L. We consider the statutes' respective texts along with the relevant historical and legislative contexts in which they were enacted. Normally we consider the record evidence with respect to each motion separately |
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97-2370 -- FOREST GUARDIANS V. BABBITT -- 12/22/1998 The administrative process was set in motion to list the Rio Grande silvery minnow as an endangered species and designate its critical habitat under the Endangered Species Act of 1973 and its subsequent amendments ( |
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97-2370 -- GUARDIANS V. BABBITT -- 04/22/1999 The petition for rehearing is denied by the panel that rendered the decision. The Court will. As follows: The first sentence of the first full paragraph in column two at 164 F.3d 1269 of the West's Federal Reporter advance sheets (first sentence of first full paragraph on page 20 of our slip opinion) is amended to read: Even in mandamus cases. We have often spoken in strong. Language with regard to the court's duty to enforce agency action mandated by Congress. The first sentence of the first full paragraph in column two at 164 F.3d at 1274 of the West's Federal Reporter advance sheets (first sentence of first full paragraph on page 34 of the slip opinion) is amended to read: While we hold that the Secretary must be ordered to comply with his statutory duty to publish a final regulation regarding designation of the critical habitat for the silvery minnow without regard to his preferred priorities. Any order now to impose a new deadline for compliance must consider what work is necessary to publish the final rule and how quickly that can be accomplished. The last paragraph of the opinion. |
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OPINION/ORDER The Davises argue that the district court erred by concluding they lacked prudential standing to pursue their claims because their rights were not within the |
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OPINION/ORDER Kennedy asserts the district court should not have admitted testimony and a document about Federal Drug Administration (FDA) employee statements to glove manufacturers that the FDA did not want allergy warnings on rubber gloves. Because the informal FDA pronouncements were probative of whether Baxter acted reasonably in designing. Kennedy also contends the district court should have admitted a medical opinion by her expert on the issue of product defect. Who is not a physician or a toxicologist. Was unqualified to give an opinion about what makes a rubber glove safe or unsafe for allergy purposes or what level of proteins or allergens are necessary to achieve a safe level for allergy purposes. Because the evidentiary rulings were not a manifest abuse of discretion affecting substantial justice. An extended discussion of the facts and the controlling legal principles would have no precedential value in this fact intensive case. |
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02-2089 -- NISH V. RUMSFELD -- 11/14/2003 Plaintiffs are non profit agencies representing the blind and severely handicapped. Have preferred status in the provision of goods and services to the federal government. The mess hall contract was then awarded to NMCB. Plaintiffs contend that (1) the interpretation of the RS Act by the Department of Education (DOE) is not entitled to deference. (2) the RS Act does not apply here because the KAFB mess hall is not a |
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OPINION/ORDER The Davises argue that the district court erred by concluding they lacked prudential standing to pursue their claims because their rights were not within the |
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FARSIAN V. PFIZER, INC. This document was created from RTF source by rtftohtml version 2.7.5 > |
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OPINION/ORDER The 2 Fishers filed a products liability lawsuit against Teva in the United States District Court for the District of New Jersey.1 Personal jurisdiction was premised on specific and general jurisdiction and the defendant's contacts with New Jersey. We will affirm the District Court's order. An appeal is pending before the Ninth Circuit. General jurisdiction may exist where the cause of action does not arise out of and is not related to the defendant's contacts with the state. The plaintiff must show that the defendant's contacts with the forum are |
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OPINION/ORDER With him on the brief were Robert D. With her on the brief were Hugh L. Of counsel were Paul J. Inc. (collectively Apotex) will not infringe claim 1 of U.S. Because claim 1 of the '723 patent is invalid as anticipated under 35 U.S.C. § 102(b). Curzons's test results established that the new product was the hemihydrous form of PHC (PHC hemihydrate). Ferrosan's original form was anhydrous PHC (PHC anhydrate). The only claim at issue in this case is claim 1. SmithKline alleges that Apotex's proposed drug will infringe claim 1 of the '723 patent. PHC anhydrate the Ferrosan discovery is prior art for the '723 patent. SmithKline asserts that Apotex will infringe by manufacturing PHC anhydrate tablets that necessarily contain. Including cross motions for summary judgment that claim 1 of the '723 patent was invalid (or valid) under 35 U.S.C. § 102(b) for an impermissible public use. Holding that the '723 patent was not invalid for public use under § 102(b). Supp. 2d at The trial record contained uncontested testimony that a PHC anhydrate hemihydrate mixture would need to possess a percentage of PHC hemihydrate in the |
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OPINION/ORDER It is ORDERED that the suggestion be denied. Bonner Deputy Clerk A statement by Circuit Judge Silberman is attached. We are told that the panel's decision is anomalous in light of the regime that governed the sale and labeling of dietary supplements prior to Congress' enactment of the Nutrition Labeling and Edu cation Act of 1990. The government asserts that neither employing a health claim as a trigger to the drug approval process (which was never tested in litigation). We stated that |
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FRIEDLANDER V. PDK LABS This document was created from RTF source by rtftohtml version 2.7.5 >
PER CURIAM:
CERTIFICATION FROM THE UNITED STATES COURT OF APPEALS FOR THE ELEVENTH CIRCUIT TO THE SUPREME COURT OF GEORGIA PURSUANT TO O.C.G.A. |
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OPINION/ORDER They were subject to increased prices on one of Wyeth's drugs. Are the named representatives of a certified class of pharmaceutical wholesalers and retailers that purchased Premarin. The class and individual appellants have adopted each other's briefs in their entirety. A brand name prescription conjugated estrogen replacement medication.1 Premarin is a form of estrogen replacement therapy ( |
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OPINION/ORDER Delong was on brief for the appellant. Were on brief for the appellee. To update EPA's interim benzene report constituted a federal |
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OPINION/ORDER LLP were on brief. Were on brief. Who were charged in a multi count indictment arising from Bard's manufacturing and distribution of heart catheters. They were each sentenced to 18 months of imprisonment and two years of supervised release. The execution of their sentences was stayed pending the outcome of appeal. Cvinar (and other defendants) were indicted on over 390 counts stemming from Bard's manufacture and sale of non FDA approved heart catheters. The execution of the sentences have been stayed pending the outcome of appeal. None of the appellants is now in prison. DISCUSSION The jurisdiction of this court is limited to |
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OPINION/ORDER With him on the brief were Robert D. With her on the brief were Hugh L. Of counsel were Paul J. Inc. (collectively Apotex) will not infringe claim 1 of U.S. Because claim 1 of the '723 patent is invalid as anticipated under 35 U.S.C. § 102(b). Curzons's test results established that the new product was the hemihydrous form of PHC (PHC hemihydrate). Ferrosan's original form was anhydrous PHC (PHC anhydrate). The only claim at issue in this case is claim 1. SmithKline alleges that Apotex's proposed drug will infringe claim 1 of the '723 patent. PHC anhydrate the Ferrosan discovery is prior art for the '723 patent. SmithKline asserts that Apotex will infringe by manufacturing PHC anhydrate tablets that necessarily contain. Including cross motions for summary judgment that claim 1 of the '723 patent was invalid (or valid) under 35 U.S.C. § 102(b) for an impermissible public use. Holding that the '723 patent was not invalid for public use under § 102(b). Supp. 2d at The trial record contained uncontested testimony that a PHC anhydrate hemihydrate mixture would need to possess a percentage of PHC hemihydrate in the |
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OPINION/ORDER Mohadjerin terminated his Interferon treatment for Hepatitis C contrary to the recommendation of a specialist and did not prescribe Rebetron until two years after it was approved by the FDA and six months after the DOC treatment protocol was approved. Chimenti claimed that Horn knew prisoners were infected with Hepatitis C and failed to ensure the speedy approval of a protocol for Rebetron. Chimenti asserted that Rebetron was approved by the FDA in June of 1998 but that Horn did not issue a protocol until January 2000. Chimenti alleged that as a result of the delay in receiving Rebetron his liver was damaged to the point where he needs a transplant and that in January 2001 he was diagnosed with cirrhosis of the liver.1 The District Court concluded that the proposed amended complaint did not cure The proposed amended complaint was not included in the record on appeal. Mohadjerin were dismissed for failure to exhaust. We have jurisdiction under 28 U.S.C. § 1291. The Court should not dismiss a complaint unless it is clear that no relief could be granted under any set of facts that could be proved. |
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SCHERING CORPORATION V. GENEVA PHARMACEUTICALS Of counsel on the brief were David P. New York. Of counsel were John F. Whitehall Robbins Healthcare). With him on the brief were Barbara R. Mason. Of counsel on the brief were David A. New Jersey. On the brief was Julie A. Inc. Of counsel were Peter J. Gray. Also on the brief were Edgar H. Inc. With him on the brief were Frederick H. Inc. and Novartis Corporation. With him on the brief were Patricia J. Kokoski. Of counsel on the brief was Kevin M. 716 (the 716 patent) are invalid. Schering Corp. v. The active component of a pharmaceutical that Schering markets as CLARITIN . Unlike conventional antihistamines w |
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OPINION/ORDER TO THE SUPREME COURT OF GEORGIA AND ITS HONORABLE JUSTICES: It appears to the United States Court of Appeals for the Eleventh Circuit that this case involves an unanswered question of Georgia law that is determinative of this appeal. Obtained a patent on a diet control drug and is in the process of obtaining approval for his patented product from the Food and Drug Administration (FDA). He alleges that PDK has failed to disclose to consumers that its products are untested and lack FDA approval. Friedlander contends that purchasers have relied on these misrepresentations. Friedlander also claims that PDK's alleged misrepresentations have eroded general consumer confidence in weight control products. PDK's actions have reduced the desirability of his product and thereby injured his business. Explaining that Friedlander was either |
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OPINION/ORDER Defendant Appellee cross appeals the district court's finding that Plaintiff met its burden of production showing that the information at issue was in the public domain. Inner City Press/Community on the Move ( |
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OPINION/ORDER |
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OPINION/ORDER This appeal is taken from the District Court's Pretrial Order No. Their subsequent state lawsuits were removed to the MDL court from the Louisiana state courts and appellants sought to have their tort cases remanded to state courts. I. We have previously set forth the basic facts in the Diet Drug litigation. Because this opinion is written only for the parties. It is those side effects that are the subject of the Diet Drug litigation at hand. The federal Diet Drug actions were consolidated for pretrial purposes in the Eastern District of Pennsylvania pursuant to MDL 1203 and. Appellants are forty eight intermediate opt outs from the Settlement Agreement. Along with eight manufacturers of phentermine (the |
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OPINION/ORDER On behalf of themselves and their clients who are specifically identified and/or whose claims are affected by Pretrial Order No. 2677. Circuit Judge This appeal is taken from the District Court's Pretrial Order (PTO) No. 2677 by two law firms on behalf of class members who had previously settled their mass tort claims in the M DL 1203 Diet Drug litigation. Because we conclude that the District Court's extension of the deadlines was a permissible exercise of its discretion. We will affirm. I. We have previously set forth the basic facts in the Diet Drug litigation. Because this opinion is written only for the parties. It is those side effects that are the subject of the Diet Drug litigation at hand. The federal Diet Drug actions were consolidated for pretrial purposes in the Eastern District of Pennsylvania pursuant to MDL 1203 and. Notice to the class explained the nature of the injuries claimed by the plaintiffs and that diagnosis of those injuries (and therefore potential qualification for participation in the Settlement Agreement) was possible through an echocardiogram. |
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OPINION/ORDER The manager told the agent that he had just told Kassim that his order was not yet ready. That Kassim said he was disappointed because people from Colorado were coming that day to pick up the labels. The motion to suppress was denied on the recommendation of Chief United States Magistrate Judge John Maughmer. 21 plastic. Contending that they were the fruit of arrests that the agents had made without probable cause. Were sentenced. Or was soon to be. The facts available to the agents prior to their arrest of Fahsi and Ouared are not in dispute. Probable cause is a practical concept. The search was conducted pursuant to a warrant. Which was supported with the additional fact that the labels were no longer in Kassim's car (the only other place they could have been). The labels were validly seized. The convictions are affirmed. |
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OPINION/ORDER Circuit Judge: These seven appeals have been filed by counsel to various claimants in the Diet Drugs Product Liability Multidistrict Litigation ( |
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OPINION/ORDER With him on the brief was Charles J. Of counsel was Richard H. With her on the brief were Daniel J. Of counsel was Christl M.N. 548 (the `548 patent) are infringed by Ormco's |
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SMITHKLINE BEECHAM CORP., ET AL. V. APOTEX CORP., ET AL. Argued for plaintiffs appellants. With him on the brief were Robert D. Argued for defendants cross appellants. With her on the brief were Hugh L. Nelson. Of counsel were Paul J. Inc. (collectively Apotex) will not infringe claim 1 of U.S. Apotex s prod |
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ASTRAZENECA AB, ET AL. V. MUTUAL PHARMACEUTICAL COMPANY, INC. Argued for plaintiffs appellees. With her on the brief were Michael P. Argued for defendant appellant. With him on the brief were Robert F. Under which it is an act of infringement to submit an Abbreviated New Drug Application ( ANDA ) to the Food and Drug Administration ( FDA ) to obtain approval to market a drug that is claimed in a nonexpired patent. We reverse and remand for entry of judgment of noninfringement. Because we hold that the term solubilizer is limited to surfactants. 611 (the 611 patent ) and the 081 patent. The 611 patent was directed to certain chemical compounds including felodipine having antihypertensive qualities. The application that matured into the 611 patent was filed on |
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BYRD DANIEL V. EPA Delong was on brief for the appellant.
Thomas M. Were on brief for the appellee. Alisa B. To update EPA's interim benzene report constituted a federal
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OPINION/ORDER Defendant Appellant Daahir Caseer was convicted on May 15. Was illegal. The evidence is insufficient to support a finding that. Caseer knew that khat was a controlled substance. Yemen have chewed or made tea from the stems of the native khat shrub (Catha edulis). Which is known to have stimulant properties. Khat is often consumed in social settings. Khat is legal in many parts of East Africa. Khat is illegal in the United States because it contains cathinone. Caseer explained to Eldridge that he could not make the trip himself because of visa issues.1 Caseer assured Eldridge that khat was an agricultural product and. Khat was no stronger than caffeine. Caseer was awaiting approval of his application for permanent residency status. Customs Service's practice at that time was to levy $500.00 fines for small amounts of khat intended for personal use if federal or local authorities decided not to prosecute. 2 1 No. 02 2268 United States v. Caseer Page 3 Amsterdam was unrelated to the khat and was bound for Somalia and that the khat was a gift from a Mr. |
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OPINION/ORDER Defendant Appellee cross appeals the district court's finding that Plaintiff met its burden of production showing that the information at issue was in the public domain. Inner City Press/Community on the Move ( |
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OPINION/ORDER With him on the brief were Benjamin C. With him on the brief were Daniel L. With her on the brief were William A. This is a patent infringement action concerning the pharmaceutical compound ramipril. Which is marketed by King Pharmaceuticals. Concluded after a bench trial that the asserted claims of the '722 patent were not invalid. 1 Lupin appeals from these decisions. We conclude that the subject matter of the asserted claims of the '722 patent would have been obvious. The cross appeal and the remaining issues raised by the parties are deemed moot and are not addressed. BACKGROUND The Claimed Technology The patent at issue in this appeal is directed to the pharmaceutical compound ramipril in a formulation |
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FARSIAN V. PFIZER, INC. This document was created from RTF source by rtftohtml version 2.7.5 > |
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OPINION/ORDER In March 1999 fenfluramine was formally listed as a |
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OPINION/ORDER With him on the brief were Richard J. Of counsel on the brief were Robert L. With him on the brief were Robert S. With him on the brief was Richard S. The active ingredient in Plavix® is clopidogrel bisulfate. Which is covered by Sanofi's patent. Which will expire on November 17. It is necessary to have a generalized understanding of stereochemistry. Stereochemistry refers to the threeMolecules that dimensional spatial arrangement of a molecule's constituent atoms. have the same chemical substituents. Are referred to as stereoisomers. They exist as nonsuperimposable mirror images of each other and are referred to as enantiomers. Enantiomers are optically active because they are capable of rotating plane polarized light. Enantiomers that rotate polarized light to the right are referred to as dextrorotatory enantiomers. Enantiomers rotating polarized light to the left are referred to as levorotatory enantiomers. Or l enantiomers.1 A mixture of equal amounts of both types of enantiomers is referred to as a racemic mixture. |
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OPINION/ORDER Were on brief for appellant.
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OPINION/ORDER |
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FRIEDLANDER V. PDK LABS This document was created from RTF source by rtftohtml version 2.7.5 >
PER CURIAM:
CERTIFICATION FROM THE UNITED STATES COURT OF APPEALS FOR THE ELEVENTH CIRCUIT TO THE SUPREME COURT OF GEORGIA PURSUANT TO O.C.G.A. |
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OPINION/ORDER Were on brief for appellant.
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OPINION/ORDER Taranto were on brief. Were on brief. Its accouterments are not the most clearly delineated. Bear witness to that point.
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OPINION/ORDER At the time this lawsuit was filed. He was the company's sole officer and director. Like other small companies with which Mabie was connected. Maxxon was engaged in developing a |
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MENTOR H/S INC V. MEDICAL DEVICE ALLIANCE Argued for plaintiffs appellants. |
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OPINION/ORDER Eli Lilly and Company. |
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GLAXO V. TORPHARM |
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RICHARDSON-VICKS V. UPJOHN |
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U.S. V. CHERRY HILL TEXTILES, INC. |
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CYGNUS V. ALZA |
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SIERRA APPLIED SCIENCES, INC. V. ADVANCED ENERGY INDUSTRIES, INC. Argued for plaintiff appellant. The briefs were submitted by Susan E. For the appellant. Of counsel was Bruce E. Argued for defendant appellee. With him on the brief were Kristen M. Haney. Of counsel on the brief was Craig A. Mso pagination:widow orphan no line numbers'> The following facts are uncontested. Including power supplies designed for use in reactive sputtering. AEI describes reactive sputtering as a process whereby the surface of an item is coated with a thin film formed through chemical reactions in the presence of a plasma of charged particles in a vacuum chamber. Reactive sputtering is used in. The occurrence of elec |
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ELAN CORPORATION, PLC V. ANDRX PHARMACEUTICALS, INC. Argued for plaintiff appellant. With him on the brief were Michael J. Browning. Of counsel was James R. Argued for defendant cross appellant. With him on the brief were James V. Costigan. Of counsel on the brief was Gerald J. is a non steroidal anti inflammatory drug sold under various tradenames. Line height:normal'>It was a pleasure to meet you and your colleagues on August 5. Believe that we will need a clinical program involving enrollment of 500 patients and running for up to two years to generate the necessary data for N.D.A. filing. Ideally. We want to have our partner |
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KNOLL PHARMACEUTICAL COMPANY, INC., ET AL. V. TEVA PHARMACEUTICALS USA, INC. Argued for plaintiffs appellants. With him on the brief was Michele L. Argued for defendant appellee. With him on the brief were Carl M. Mso bidi language:AR SA'>[1] The judgment is reversed. We remand for further proceedings. The '252 patent is directed to methods and compositions for treating pain by administering a combination of hydrocodone and ibuprofen in specified amounts. The claims are as follows: With him on the brief were Nicolas G. Garber. Of counsel on the brief were Paul D. Inc. With him on the brief were Maria Luisa Palmese and William G. Inc. With him on the brief was Stephen F. That the patent is not invalid. |
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MCNEIL-PPC, INC V. L. PERRIGO Argued for plaintiff appellant. With him on the brief were Raymond N. Argued for defendants appellees. With him on the brief were Steven L. Pa. 2002). Because the d |
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GENEVA V. GLAXOSMITHKLINE PLC Inc. Of counsel was Leslie Morioka. Of counsel were William R. Inc. With him on the brief were Steven J. Cerwinski. Of counsel on the brief was C. Argued for defendant |
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ABBOTT LABORATORIES V. BAXTER PHARMACEUTICALS Argued for plaintiffs appellants. With him on the brief were Edward L. Peggy Balesteri. Of counsel were Blake T. Argued for defendants appellees. With him on the brief were David T. Cass. Of counsel on the brief was Thomas S. Its presence in an anesthetic is harmful. HF also etches glass. Line height:200%'>Baxter filed an Abbreviated New Drug Application (ANDA) with the Food and Drug Administration (FDA) proposing to market generic sevoflurane. Baxter s proposed product is a compositi |
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ABBOTT LABORATORIES V. NOVOPHARM LTD. Abbott Laboratories. With him on the brief were Daniel E. Reidy. Argued for plaintiffs appellants Fournier Industrie Sante and Laboratoires Fournier S.A. With him on the brief were Timothy C. Chambers. Of counsel on the brief was Mark Shanks. Argued for defendant appellee. With him on the brief was M. Inc. With him on the brief were D. Line height:200%'>BACKGROUND Fournier is the assignee of the 726 patent. The 726 patent includes claims directed to a therapeutic fenofibrate composition (claims 1 7). A method for treatment of hyperlipidemia or hypercholesterolemia using the claimed fenofibrate composition (claims 11 and 12). Abbott is Fournier s exclusive licensee under the 726 patent. Abbott also holds a New Drug Application ( NDA ) approved by the United States Food and Drug Administration ( FDA ). |
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BAYER AG V. CARLSBAD Argued for plaintiffs appellees. |
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BAYER AG V. SCHEIN Argued for plaintiffs/counterclaim defendants appellees. |
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TELECOM RESELLERS V. FCC |
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ANIMAL LEG DEF FUND V. SHALALA DONNA E. |
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FREEMAN ENG ASSOC V. FCC |
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FTC V. GLAXOSMITHKLINE Schwarz argued the cause for appellant. |
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MOHAMED AL-FAYED AND PUNCH LIMITED V. CIA Spitzer and Kate Martin were on the brief for amici curiae Reporters Committee for Freedom of the Press. Argued the cause for appellees. |
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SULLIVAN V. NAT'L R.R. PASSENGER CORP. (3/25/1999, NO. 98-4080) Amtrak argues that the district court should have granted its motion for judgment as a matter of law or. Claiming that he was the victim of sexual harassment and retaliation stemming from an incident in December 1993 when Sullivan's immediate supervisor. Sullivan claims that the incident occurred while the two were traveling on business and staying at a hotel in Tampa. Scott further assured him that he would have nothing to worry about for as long as the two continued to work together. Which were cashed at a grocery store near his home. Sullivan's work schedule was changed from four to five days a week. Amtrak claims that this change was necessary to satisfy a Food and Drug Administration (FDA) regulation that all inbound trains be inspected and cleaned upon arrival. 2) there was no evidence of retaliation. Amtrak additionally claims that the damage amounts awarded by both the jury and the magistrate judge were not supported by the evidence. Discussion We first address Amtrak's claim that. |
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NAT'L PARKS CONSERVATION ASS'N V. NORTON (3/18/2003, NO. 02-10555) Accordingly the National Park Service ( |
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OXFORD ASSET MGMT., LTD. V. JAHARIS (7/16/2002, NO. 99-11690) (Kos) is a pharmaceutical company that develops and markets prescription drugs. The offering price was $42.75. 000 shares were sold in the secondary offering. 000 shares.
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TECHNICAL RESOURCE SERVICES, INC. V. DORNIER MED. SYS., INC. (2/12/1998, NO. 95-2565) Sitting by designation. These consolidated appeals arise from a civil antitrust dispute which was the subject of two jury trials. Which are manufactured by Dornier Medizintechnik. Lithotripters are medical devices which dissolve kidney stones through the use of shock waves. Inc. ( |
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OPINION/ORDER This document was created from RTF source by rtftohtml version 2.7.5 > |
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SULLIVAN V. NAT'L R.R. PASSENGER CORP. (3/25/1999, NO. 98-4080) Amtrak argues that the district court should have granted its motion for judgment as a matter of law or. Claiming that he was the victim of sexual harassment and retaliation stemming from an incident in December 1993 when Sullivan's immediate supervisor. Sullivan claims that the incident occurred while the two were traveling on business and staying at a hotel in Tampa. Scott further assured him that he would have nothing to worry about for as long as the two continued to work together. Which were cashed at a grocery store near his home. Sullivan's work schedule was changed from four to five days a week. Amtrak claims that this change was necessary to satisfy a Food and Drug Administration (FDA) regulation that all inbound trains be inspected and cleaned upon arrival. 2) there was no evidence of retaliation. Amtrak additionally claims that the damage amounts awarded by both the jury and the magistrate judge were not supported by the evidence. Discussion We first address Amtrak's claim that. |
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NAT'L PARKS CONSERVATION ASS'N V. NORTON (3/18/2003, NO. 02-10555) Accordingly the National Park Service ( |
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OXFORD ASSET MGMT., LTD. V. JAHARIS (7/16/2002, NO. 99-11690) (Kos) is a pharmaceutical company that develops and markets prescription drugs. The offering price was $42.75. 000 shares were sold in the secondary offering. 000 shares.
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TECHNICAL RESOURCE SERVICES, INC. V. DORNIER MED. SYS., INC. (2/12/1998, NO. 95-2565) Sitting by designation. These consolidated appeals arise from a civil antitrust dispute which was the subject of two jury trials. Which are manufactured by Dornier Medizintechnik. Lithotripters are medical devices which dissolve kidney stones through the use of shock waves. Inc. ( |
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OPINION/ORDER This document was created from RTF source by rtftohtml version 2.7.5 > |
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00-3395 -- RALSTON V. SMITH & NEPHEW RICHARDS, INC. -- 12/26/2001 The case is therefore submitted without oral argument. Plaintiff appellant Karen Ralston appeals the district court's grant of summary judgment in favor of defendant appellee Smith &. We will affirm the judgment.
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97-3220 -- FRANKLIN SAVINGS CORP. V. U.S. -- 05/04/1999 PROCEDURAL AND FACTUAL BACKGROUND This is the third appeal to this court and the seventh published opinion involving disputes over the conservation and liquidation of the long gone but not forgotten Franklin Savings Association. See Franklin Sav. This court has distilled the following summary of the litigation from Franklin II. See 35 F.3d at 1468. In 1990 the Director of the Office of Thrift Supervision (OTS ) determined that FSA was
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OPINION/ORDER With him on the brief were Barbara L. Of counsel on the brief was Mark Chao. With him on the brief were Edgar H. 777 was not shown to be invalid under 35 U.S.C. § 103. Because we conclude that the district court did not err in determining that the claimed compounds would not have been obvious in light of the prior art. BACKGROUND Diabetes is a disease that is characterized by the body's inability to regulate blood sugar. It is generally caused by inadequate levels of insulin a hormone produced in the pancreas. Which is derived from food. There are two types of diabetes. Their bodies are unable to effectively use the insulin that is produced. This is also referred to as insulin resistance. Glucose is unable to enter the cells. Type 2 diabetes is the most common form of diabetes affecting over 90% of diabetic individuals. A class of drugs known as thiazolidinediones ( |
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OPINION/ORDER With him on the brief were Paul K. With him on the brief was Sharon A. A. The Technology and Patent BACKGROUND Acumed is the assignee of the '444 patent. Which is directed to an orthopedic nail for the treatment of fractures in the humerus (the upper arm bone which ends in the shoulder ball at top and the elbow joint at the bottom). Regarding the humeral nail Stryker was in the process of developing. I advised that the nail must not be provided with a curvature as this is a feature of independent claim 1. In which he echoed Graalfs' concerns: [T]he Stryker Trauma humeral nail would have each and every element of claim 1 . . . of the '444 patent. . . . [I]t is our opinion that there is no strong invalidity argument which could be used against all the '444 issued claims based on the prior art known at this time. . . . It is our opinion that a curved version of the Stryker Trauma humeral nail . . . should not be marketed in the United States. This opinion letter was longer and more detailed than the earlier memo to file. |
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OPINION/ORDER With him on the brief were Edward L. With him on the brief were David T. Of counsel on the brief was Thomas S. Of counsel was Marc A. Inc. and Baxter Healthcare Corp. (collectively |
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OPINION/ORDER This disposition is not citable as precedent. It is a public record. Although there are no genuine issues of material fact with respect to materiality. Expressly disclose the dosages at which the half life comparisons were made. 144 LMWH data was for a 60 mg dose. The '618 patent and the '743 reissue patent purportedly cover drug compositions called Lovenox® that are approved by the Food and Drug Administration ( |
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OPINION/ORDER With him on the brief were L. Of counsel on the brief were James P. With him on the brief were Roy H. Of counsel on the brief were Jeffrey S. Joining in the brief were Steven J. With him on the brief were Ellen T. The defendants stipulate to infringement if the '382 patent is valid and enforceable. A method of claim 7 wherein the effective amount is from 0.1 to 20 mg per day of 2 methyl 10 (4 methyl 1 piperazinyl) 4H thieno[2. Clozapine was thus the first |
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OPINION/ORDER With him on the brief were Robert D. With him on the brief were Scott B. Of counsel were Keith D. Arguing that the `944 patent was invalid. We agree that the claims of the `944 patent are invalid and thus affirm. The `723 patent also disclosed that the product is |
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OPINION/ORDER With him on the brief was Jeffrey I.D. With him on the brief were Joseph A. 580 ( |
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OPINION/ORDER This disposition Is not citable as precedent. It is a public record. (Michael Foods) is the exclusive licensee of United States Patent Nos. 4. (Sunny Fresh) sought declaratory judgment in the District of Minnesota that the claims of these patents are invalid. Ultrapasteurization reduces the number of spoilage microorganisms by increasing the temperature to which the eggs are heated and reducing the product's exposure time at that temperature. During which the liquid whole egg product is heated to a predetermined real temperature. The method is practiced so that the total thermal treatment received by the liquid whole egg product is described by an equivalent temperature and an equivalent time . . . . The effects of an entire thermal curve on the liquid egg product are reduced to a single |
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OPINION/ORDER Are seriously ill Californians who use marijuana for medical purposes on the recommendation of their doctors. Such use is legal under California's Compassionate Use Act. That ruling is now before us. Marijuana is a schedule I controlled substance. (3) that there is |
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OPINION/ORDER Interlocking safeguards |
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OPINION/ORDER 2002 is amended as follows: At slip opinion page 5765. The fourth sentence that begins |
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OPINION/ORDER Inc.'s (Kimmel) complaint on the ground that Kimmel's state law claims are preempted by the Federal Insecticide. We have jurisdiction pursuant to 28 U.S.C. § 1291. Background Defendant Appellee DowElanco is the manufacturer of Vikane. Vikane is regulated by the Environmental Protection Agency ( |
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OPINION/ORDER Argued the case and were on the briefs for the appellants/cross appellees. Argued the case and was on the briefs for the appellees/cross appellants. Were on the briefs for amicus curiae California Board of Equalization. We hold that an importer of goods destined for domestic consumption is not exempt from state excise taxes and administrative searches by federal Customs officials simply because it stores its merchandise in a foreign trade zone. Was licensed by the Bureau of Alcohol. The term |
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OPINION/ORDER Geborde was convicted of manslaughter in state court and sentenced to prison. Although GHB is now a controlled substance as defined by federal law. The problem is that the FDCA was not designed to deal with the wholly gratuitous distribution of homemade substances. We now have to decide whether the square pegs of Geborde's conduct can be pounded into the round holes of the FDCA. Geborde was convicted of one count of operating an unregistered drug manufacturing facility with the intent to defraud or mislead in violation of 21 U.S.C. §§ 331(p). A violation of 21 U.S.C. § 331(p) is a misdemeanor unless the failure to register is committed with the intent to defraud or mislead. Because Geborde was charged with failure to register. The government presented no evidence from which a jury could have inferred that in failing to register Geborde had the intent to defraud or mislead. The government failed to prove an essential statutory element of the offense that the misbranding occurred while the drug was |
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OPINION/ORDER Inc.'s (Kimmel) complaint on the ground that Kimmel's state law claims are preempted by the Federal Insecticide. We have jurisdiction pursuant to 28 U.S.C. § 1291. Background Defendant Appellee DowElanco is the manufacturer of Vikane. Vikane is regulated by the Environmental Protection Agency ( |
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OPINION/ORDER Circuit Judge: The Transmission Agency of Northern California (TANC) is a joint exercise of powers agency composed of over a dozen Northern and Central California municipalities. We have jurisdiction under 28 U.S.C.§ 1291. All facts alleged in TANC's complaint are taken as true and construed in the light most favorable to it. Which was to be constructed by defendant Sierra Pacific. If the Alturas Intertie is operating at its maximum 300 MW capacity. Alleging that the Alturas Intertie would create a megawatt formegawatt reduction in the capacity of the California Oregon 2 The Pacific AC Intertie is located south of the California Oregon border and is owned by utilities not parties to this litigation. It was already connected to the Northwest AC Intertie. TANC requested that FERC ensure that procedures were put in place to protect the |
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OPINION/ORDER Are |
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OPINION/ORDER OPINION PER CURIAM: This appeal is the final chapter in a long saga of trial. In a sense the case made new law Congress disapproving the Supreme Court's interpretation of Title VII in this case changed the law but explicitly made it inapplicable to further proceedings in this case.1 1 The salient changes to Title VII are set forth in Atonio v. 490 U.S. 642 (1989) for the Court of the factual setting that gave rise to this litigation is succinct. We quote it here: The claims before us are disparate impact claims. They are inoperative and vacant for the rest of the year. Upon a showing that the elements of that process are inseparable for analysis. 42 U.S.C. § 2000e 2(k)(1)(B)(i) (Sup. It restates the business necessity defense and places on the employer the burden of proving that a practice causing a disparate impact is |
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OPINION/ORDER OPINION PER CURIAM: This appeal is the final chapter in a long saga of trial. In a sense the case made new law Congress disapproving the Supreme Court's interpretation of Title VII in this case changed the law but explicitly made it inapplicable to further proceedings in this case.1 1 The salient changes to Title VII are set forth in Atonio v. 490 U.S. 642 (1989) for the Court of the factual setting that gave rise to this litigation is succinct. We quote it here: The claims before us are disparate impact claims. They are inoperative and vacant for the rest of the year. Upon a showing that the elements of that process are inseparable for analysis. 42 U.S.C. § 2000e 2(k)(1)(B)(i) (Sup. It restates the business necessity defense and places on the employer the burden of proving that a practice causing a disparate impact is |
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OPINION/ORDER James Arthur is a neurosurgeon at St. Arthur performs is called an anterior cervical diskectomy and fusion surgery ( |
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OPINION/ORDER Heaney resigned while this matter was pending. This opinion is being filed by the remaining judges of the panel pursuant to 8th Cir. I. BACKGROUND Source Food is a Minnesota company that sells cooking oil and shortening containing beef tallow from which the cholesterol has been removed ( |
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OPINION/ORDER A test conducted by SJM showed a slightly higher risk of paravalvular leaks at the site where the valves were implanted. Numerous suits were then filed across the nation. The cases were later consolidated in Minnesota. The cases were consolidated for pretrial proceedings in Minnesota pursuant to the Judicial Panel on Multidistrict Litigation. A class action was the superior method to adjudicate those claims. [found] that only significant variations in state law will be sufficient to require different subclasses. The district court found no two states' laws were substantially alike. Conditionally certifying the class only as to |
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OPINION/ORDER Even though the text of this law is materially identical to one held constitutional in Planned Parenthood of Southeastern Pennsylvania v. [by] the physician who is to perform the abortion. The district court concluded that the higher cost will reduce by 10% to 13% the number of abortions performed in Indiana. Some of these women will travel to states that do not require two trips. Others will forego an abortion. Some who do have an abortion in Indiana will delay that procedure until the second trimester. The judge also thought that experience in Indiana showing that the demand for abortion did not decline when information was provided on paper or over the telephone implies that the reduction in the number of abortions is attributable to higher cost (a bad reason) rather than to the statutory information (a valid reason). No. 01 2107 Indiana's statute reads as follows: 3 An abortion shall not be performed except with the voluntary and informed consent of the pregnant woman upon whom the abortion is to be performed. |
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OPINION/ORDER We affirm. 1 Judge Rovner was a member of the original panel. Remicade is a prescription drug approved by the FDA for treatment of Crohn's disease and is manufactured by Centor. Ervin was hospitalized and diagnosed with arterial thrombosis. Which are blood clots located in the artery of his left leg. Protein S is a naturally occurring anticoagulant. Which is a substance that prevents clotting. McKinley opined that |
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OPINION/ORDER The sentencing judge is first to compute and consider the guidelines range for the defendant's offense and then to select and impose a sentence which can be inside or outside that range (provided of course that it is within the statutory sentencing range) guided by the sentencing factors in 18 U.S.C. § 3553(a). We must uphold his sentence unless it is unreasonable. Since the statutory sentencing factors are multiple and vague. It will be the rare case in which it is possible to say that the judge who has complied with the procedural requirements set forth above imposed an unreasonable sentence. Is discretionary and subject therefore to only light review. |
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OPINION/ORDER LaGrou was convicted of three felony counts: the knowing improper storage of poultry products. LaGrou was sentenced to a five year term of probation. I. Background The conditions at LaGrou's cold storage warehouse at 2101 Pershing Road in Chicago were enough to turn even the most enthusiastic meat loving carnivore into a vegetarian. The Pershing Road warehouse was a cold storage facility that stored raw. The record is unclear as to how long the rodent problems existed. It is clear that LaGrou was aware of the problem in 1999. Smith (a codefendant who pleaded guilty to misdemeanor charges) was hired as the manager of the Pershing Road warehouse. In 2001 LaGrou employees were catching more rats and finding more rodent droppings. Rodent damaged product was coming from all over the warehouse. LaGrou did not conduct any tests to make sure that other boxes that appeared okay were not similarly contaminated by rodents. To report back about the number of rats they were removing from traps each day. Stewart did not give Smith authorization to implement these recommendations because he concluded that the project was too expensive. |
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OPINION/ORDER Kmart's bankruptcy announcement was followed by a predictable drop in its stock price. As the plaintiffs have failed adequately to plead |
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OPINION/ORDER Stratienko was entitled to an opportunity to demonstrate that Cordis used his catheter design by relying on circumstantial evidence. Summary judgment was. Stratienko's other contentions on appeal are without merit. Stratienko's device is a modified catheter used for gaining medical access to blood vessels. Which is consistent with the description of conventional practice in Dr. Which is located close to the surface of the skin in the groin area. A wire called a guidewire is then inserted through the needle into the artery. The needle is withdrawn. Another device called a sheath is then inserted over the guidewire into the artery. A sheath is a 4 9 inch hollow tube with a valve at the end which remains outside the body ( |
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OPINION/ORDER He was prescribed Prozac by Dr. We agree with the District Court that Eli Lilly was not a state actor and that the alleged negligence of the FDA. 849 (1998)( |
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OPINION/ORDER We will affirm. Our discussion of the facts is limited to those necessary to adjudication of the case. Abreva is an FDA approved. Her friends who tried the compound agreed that it was helpful. Merix is a small company. Merix's annual revenues have recently run to several million dollars. 2 Glaxo brought the instant suit against Merix because it believed the claims Merix made about Releev were false and misleading. This is not the first time Glaxo challenged Merix's claims about Releev. Participation in NAD proceedings is voluntary. The results are non binding. Releev is endorsed by the University of Chicago. The top line is displayed in a more prominent typeface than the second. The prospective purchaser is referred to them by an exhortation on the front of the package to |
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OPINION/ORDER Appeals an order of the District Court denying Palay's motion to compel the AHP 2 Settlement Trust to audit Palay's claim and to declare Palay's age to have been 49 when he was first diagnosed with a reduced left ventricular ejection fraction. We will affirm the District Court's order. I We have previously set forth the facts of the diet drugs litigation. The primary risk from diet drug use for present purposes is valvular heart disease ( |
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OPINION/ORDER This is a breach of contract action disputing Appellant Ligand Pharmaceuticals' right to withhold $2.1 million of the consideration due to Appellees1 ( |
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OPINION/ORDER Circuit Judge: Sejid Smriko was a lawful permanent resident of the United States for less than five years when he committed a crime involving moral turpitude that. Smriko was admitted to the United States. None of which were met here. Conclude that his view of refugee statusthat it can only be terminated pursuant to specific enumerated grounds contained in the INAis consistent with the text and some of the legislative history of the INA. We then examine Smriko's contention that his case was improperly subjected to the BIA's affirmance without opinion process. This agency action deprived us of a Board interpretation of the INA that we believe the applicable agency regulations intended us to have before addressing the merits of Smriko's petition. We will grant the petition for review and remand so that the BIA may exercise its expertise and address Smriko's proposed reading of the INA. I. The facts before us are neither complicated. Smriko is a native and citizen of Bosnia Herzegovina who was admitted to the United States as a refugee on October 20. |
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OPINION/ORDER This appeal is being decided by the remaining two members of the panel. Who are in agreement. Judge) as sentenced John Canova to a one year term of probation after a jury trial at which defendant was found guilty of various substantive and conspiratorial crimes relating to his involvement in a multi million dollar Medicare fraud. Its request for de novo review of the district court's departure decision pursuant to 18 U.S.C. § 3742(e) is now foreclosed by United States v. We conclude that there was such an error in the district court's calculation of the loss amount relevant to the fraud guideline. Was charged in a six count indictment with (1) conspiring to defraud the United States from October 1999 through October 2001 by making false statements to Medicare agents in violation of 18 U.S.C. § 1001. 1999 letter to Medicare that Raytel was in compliance with Medicare specifications for testing pacemakers when he knew that it was not. By directing Raytel's Connecticut employees falsely to represent that Raytel was in full compliance with government testing specifications. |
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OPINION/ORDER Bodie is as follows. When he was diagnosed with severe spinal and cervical stenosis. After Bodie's neurosurgeon determined that there was little more that could be done to improve Bodie's condition. Mangieri gave him a prescription for 30 milligrams of OxyContin to help with his back pain.1 OxyContin is a prescription drug manufactured by Purdue. The drug's sole active ingredient is oxycodone. An opioid that is. A synthetic opiate similar to other opium derivatives such as morphine.2 The drug was approved by the Food There is some confusion over whether Dr. Mangieri testifiedand the medical records admitted into evidence reflectthat it was actually Dr. Fernandez saw him are incorrect. We will assume that Dr. Doctors have prescribed it to treat chronic back and neck pain similar to the kind suffered by Bodie. OxyContin is listed by the FDA as a Schedule II narcotic. OxyContin is tightly regulated. Mangieri and Fernandez were licensed to prescribe OxyContin to their patients. When Bodie was first prescribed OxyContin by Dr. |
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OPINION/ORDER Ballinger claims that § 247 is an unconstitutional exercise of Congress' commerce power. We have little trouble concluding that § 247. Is a constitutional expression of Congress' well established power to regulate the channels and instrumentalities of interstate commerce in order to prevent their use for harmful purposes. Concluding that § 247 was constitutional both facially and as applied. The panel held that although § 247 was a constitutional exercise of the commerce power. Ballinger is a practicing |
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OPINION/ORDER The motions to dismiss were made by defendants appellees Kos Pharmaceuticals. (Kos) is a pharmaceutical company that develops and markets prescription drugs. The offering price was $42.75. 000 shares were sold in the secondary offering. Underwriter Defendants). 3 Kos's only prescription drug product that was publicly available at the time of the secondary offering was an extended release niacin preparation called Niaspan. Niaspan was approved by the Food and Drug Administration in July 1997. Uhl's report was premised on estimates2 of the numbers of new and refill prescriptions for Niaspan during the first eight weeks that Kos's sales force marketed Niaspan. Uhl's conclusions were based on the assumption (that he and many other pharmaceutical analysts apparently share) that the number of new prescriptions filled during the eighth week of a new prescription drug product's initial marketing is particularly predictive of the market success the product will enjoy. 000 new prescriptions of Niaspan during the eighth week were needed. |
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OPINION/ORDER Amtrak argues that the district court should have granted its motion for judgment as a matter of law or. Claiming that he was the victim of sexual harassment and retaliation stemming from an incident in December 1993 when Sullivan's immediate supervisor. Sullivan claims that the incident occurred while the two were traveling on business and staying at a hotel in Tampa. Scott further assured him that he would have nothing to worry about for as long as the two continued to work together. Which were cashed at a grocery store near his home. Sullivan's work schedule was changed from four to five days a week. Amtrak claims that this change was necessary to satisfy a Food and Drug Administration (FDA) regulation that all inbound trains be inspected and cleaned upon arrival. 2) there was no evidence of retaliation. Amtrak additionally claims that the damage amounts awarded by both the jury and the magistrate judge were not supported by the evidence. The jury could not find against Sullivan on his sexual harassment claim while finding for him on the retaliation claim.1 Amtrak argues that Sullivan's harassment claim is based on a single incident which Amtrak maintains never occurred. |
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OPINION/ORDER Amtrak argues that the district court should have granted its motion for judgment as a matter of law or. Claiming that he was the victim of sexual harassment and retaliation stemming from an incident in December 1993 when Sullivan's immediate supervisor. Sullivan claims that the incident occurred while the two were traveling on business and staying at a hotel in Tampa. Scott further assured him that he would have nothing to worry about for as long as the two continued to work together. Which were cashed at a grocery store near his home. Sullivan's work schedule was changed from four to five days a week. Amtrak claims that this change was necessary to satisfy a Food and Drug Administration (FDA) regulation that all inbound trains be inspected and cleaned upon arrival. 2) there was no evidence of retaliation. Amtrak additionally claims that the damage amounts awarded by both the jury and the magistrate judge were not supported by the evidence. The jury could not find against Sullivan on his sexual harassment claim while finding for him on the retaliation claim.1 Amtrak argues that Sullivan's harassment claim is based on a single incident which Amtrak maintains never occurred. |
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OPINION/ORDER Were on brief for appellee. Circuit Judge. ez |
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OPINION/ORDER 1995 is amended as follows: The coversheet should state that it is an appeal from the United States District Court for the District of Maine. Were on brief for appellant Smith & Nephew Dyonics. Were on brief for appellee Russell Violette. Hottentot's diagnosis was carpal tunnel syndrome. The outcome of the surgery was not as doctor and patient had hoped Violette's ulnar nerve and artery were severed. Dyonics asserted four affirmative defenses: 1) the product was designed and manufactured using techniques representing the state of the art at the time it was manufactured and sold. 2) any harm to Violette was caused entirely by the fault of third parties for which Dyonics cannot be held liable. Which was denied. Preemption The thrust of Dyonics' appeal is that provisions of the 4 Federal Food. It is simply too late. The question of waiver is controlled by a recent decision of this court. Westvaco's failure to |
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OPINION/ORDER The complaint was served upon the administrator of the Massachusetts Executive Office of Energy Resources ( |
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OPINION/ORDER Were on brief. |
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OPINION/ORDER Were on brief. Were on brief. The common drive for financial returns now brings us a dispute over rights to the income stream of the fastest growing ophthalmic drug in history. The entire range of claims articulated by plaintiff appellant was dismissed by the district court on summary judgment. We will begin our analysis. |
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OPINION/ORDER Were on the brief. The IJ held that Petitioner was barred from being granted asylum by 8 U.S.C. § 1101(a)(42)(B) which stipulates that an alien is not a refugee for purposes of asylum if he has persecuted others on account of nationality or political opinion. Was commanded by Yoweri Museveni. Petitioner was placed in the mobile unit of the Fourth Division. Petitioner was involved in several regional conflicts in Uganda. Petitioner was imprisoned by the UPDF. Petitioner asserts that he was jailed for complaining about the UPDF's presence in the Congo. Petitioner was charged with planning to plot a coup against the UPDF. Kiyaga asserts that he was tortured while in prison. Kiyaga was allowed to escape. His application was denied. He held that asylum was barred by 8 U.S.C. § 1101(a)(42)(B). Or political opinion. |
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OPINION/ORDER Were on brief for Petitioner.
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OPINION/ORDER Appeals an order granting summary judgment to Prudential Insurance Company on her claim that Stanley Harrow and a putative class of plaintiffs were wrongfully denied insurance coverage for Viagra. We will affirm. 2 I. Stanley Harrow was insured under the Prudential HealthCare HMO Plan through his wife. Harrow was prescribed Viagra. She was informed by an unidentified person that the plan did not cover Viagra because it was a |
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OPINION/ORDER At which advanced point the four studies were unfit for Food and Drug Administration review. Therefore were worthless. It defended on the ground that the nurses' actions were not dishonest because they had acted on their belief that strict adherence to protocol was unnecessary. That while their actions might have been negligent. Federal also maintained that even if the nurses' actions were dishonest. Federal contended that even if it were liable for Scirex's losses. Because the losses across the four ruined studies were related. 2 Following a bench trial. The nurses' |
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OPINION/ORDER New York 10022 Attorney for Appellant * Judge Lewis heard argument in this matter but was unable to clear the opinion due to illness. New York 10018 Will Levins Ballon. Although those rules were not applicable to foreign litigation. They were not without influence. It was not surprising that within three decades there would be a concerted effort to liberalize the procedures in the United States for assisting foreign and international tribunals and litigants in obtaining oral and documentary evidence in the United States. The question before us is whether the district court relied on inapplicable or erroneous considerations when it denied Bayer's request. 2 I. Which is the United States sales agent for Chemo Iberica. Claiming that Chemo and Quimica had infringed and were infringing its Spanish process patent no. 505. Bayer believed the document it had received from Barr in discovery in the New York action was important for its case in Spain. The New York magistrate judge was reported to have signified his satisfaction that this order |
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OPINION/ORDER Circuit Decisions for April |
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OPINION/ORDER Brown and Barak Cohen were on the brief for amicus curiae the National Association of Criminal Defense Lawyers in support of appellant. With her on the brief were Kenneth L. Attorney at the time the brief was filed. J. Gerald Hebert was on the brief for amicus curiae Campaign Legal Center in support of appellee. 2 Before: GINSBURG. The cash was apparently a reward for Valdes's searching several police databases to supply otherwise publicly available information to the informant. Valdes was convicted under 18 U.S.C. § 201(c)(1)(B) of three counts of receiving an illegal gratuity |
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OPINION/ORDER Watson were on brief. United States Department of Justice were on brief. Have been automatically substituted as parties. 1 3 154. 15758 (1997).2 The Secretary is further charged with developing and implementing a |
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OPINION/ORDER With him on the briefs were Stephen A. With him on the brief was John F. Several companies have applied to the Food and Drug Administration for permission to sell generic versions of Paxil when GSK's patents expire. The Federal Trade Commission is investigat ing whether GSK. Because GSK declined to pro duce hundreds of others primarily on the ground that they were shielded by the attorney client privilege the Commis sion petitioned the district court to enforce the subpoena. The Commission would |
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OPINION/ORDER Spitzer and Kate Martin were on the brief for amici curiae Reporters Committee for Freedom of the Press. With him on the brief were Wilma A. Attorney at the time the brief was filed. I The plaintiffs in this case are Mohamed Al Fayed and Punch Limited. The French government investigated the accident and concluded that it was caused by Paul's intoxication and excessive speed. Plaintiffs allege that the National Security Agency (NSA) may have secretly recorded Princess Diana's telephone con versations. Al Fayed was the victim of an attempted fraud by Oswald LeWinter. Who tried to sell Al Fayed fabricated documents indicating that MI6 was involved in the automobile crash. He was arrest ed and incarcerated by Austrian authorities. They further contend that the CIA and FBI may have been involved in efforts to prevent those prosecutions. Plaintiffs 1 The ten were: the CIA. One of the agencies has been voluntarily dismissed from the case and five more have completed processing plaintiffs' underlying document requests. |
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OPINION/ORDER Pahl was on the briefs. Was on the brief. Badami were on the brief for intervenor. We also conclude that MD's objections to DEA's decisions are without merit. The level of restriction on any given drug is determined by its classification into one of five schedules. Is required to classify each drug into a schedule. Methylphenidate is a Schedule II drug. The Administrator grants a certificate only if he determines that |
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OPINION/ORDER Unpublished opinions are not binding precedent in this circuit. I. Appellee Novo Nordisk is one of only two suppliers of insulin in the United States and operates an insulin manufacturing facility in Clayton. Appellant Walker was employed by Novo Nordisk from April 1995 to April 1997. Walker's first position with Novo Nordisk was that of a filling operator. Walker and the others were required to work because the |
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OPINION/ORDER Concluding that SLU's contribution claims were barred by principles of collateral estoppel. Was liable in contribution to SLU. The Vaccine There are three types of poliomyelitis. An oral polio vaccine ( |
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OPINION/ORDER Line 2 the reference to |
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OPINION/ORDER Concluding it was not an available remedy under the FDCA as a matter of law. Which was then filled by a Canadian pharmacy and sent directly to the customer in the United States. The district court determined disgorgement was not available under the FDCA as a matter of law. |
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OPINION/ORDER That motion is (1) After examining the briefs and appellate record. This order and judgment is not binding precedent. Barnes's motion for a temporary restraining order is DENIED. Barnes is an inmate at the United States Penitentiary in Leavenworth. Barnes] was never again given a Podo[f]ilox treatment from an unlabelled bottle. |
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OPINION/ORDER Williams ( |
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OPINION/ORDER Williams ( |
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OPINION/ORDER Other selected case materials |























































Gill then amended the complaint to assert that TRPB acted as the Gulfstream defendants' agent in preparing this defamatory Report. Which was opposed by TRPB. Arguing that the names of the tipsters were protected from disclosure. The stated mission of TRPB is to







The case raises two issues. First is the classic question whether each of the plaintiffs meets the amount in controversy requirement for diversity jurisdiction. 28 U.S.C. § . Using an analytic approach that we have since rejected. Held that it was a legal certainty that none of the plaintiffs' claims was worth $75. We reverse and hold that it is not a legal certainty that she could not recover an award over $75. We uphold the district court's conclusion that none of Beatriz's family members satisfies the amount in controversy requirement.
The second question is whether Beatriz's family members may nonetheless remain as plaintiffs under the supplemental jurisdiction statute.











































































Biomune is a biotech company which. Was developing a protein called Immuno C to be used in enhancing human immune systems. David Derrick was Biomune's President. Aaron Gold and Charles Quantz were directors of Biomune. Was a member of Biomune's Business Advisory Board. Whose beneficiaries are Solomon's family members. Genesis Trust was at one time Biomune's largest shareholder. Both Derrick and Gold were directors of Genesis. Was also a shareholder of Biomune. Who was subject to a consent decree for previous securities violations. NASDAQ notified Biomune that it was deferring consideration of its application pending a review by the NASDAQ Listing Qualifications Committee. NASDAQ was concerned with disciplinary actions taken against



Jose Aurelio Verduzco Martinez (Verduzco Martinez) appeals his convictions for conspiracy to possess with intent to distribute and to distribute methamphetamine and attempt to possess with intent to distribute methamphetamine. The California Highway Patrol stopped Andrade for failure to have a working rear license plate light. Andrade was then arrested for possession of illegal narcotics. Seven packages were recovered from the van containing approximately 3.2 kilograms of methamphetamine.
At the Barstow Police Department. That he was being paid $2. He also told Officer Silva that he knew he was transporting




8 hydroxy quinoline sulfate 0.3% is carried in a petrolatum and lanolin base.". Are suspect because ". Baldness is generally accepted in the art as being incurable . . . .". Offered no proof that such an off set occurs and has disclosed that this is only speculation.". Scalp is the skin of the head.". There is no per se requirement for clinical evidence to establish the utility of any invention". The examples in Cortright's application are objective evidence. Cortright did not prevail because the board found a new ground for rejecting the claims: that they are based on a non enabling disclosure in violation of 35 U.S.C. 112. The board explained that claim 1 is not enabled because it claims ". That is. The board's rejection was not based on complete non enablement. There is no evidence of record that the resultant hair growth is due to (i) the stimulation of the papilla.



















This appeal is taken from an order granting summary judgment to Plaintiff Appellee Commercial Union Insurance Company (





Exercising jurisdiction pursuant to 28 U.S.C.



J. McGee is the former Vice Chairman of the Department of Surgery at the University of Oklahoma College of Medicine in Tulsa. McGee was the sponsor/investigator of the study. They locked him out of his office and his files and charts were confiscated. He was informed that his tenure was to be abrogated.
Sometime thereafter. A formal hearing subsequently was scheduled before the Faculty Appeals Board (FAB).
Dr. When these protests were not resolved in his favor. The district court concluded that the defendants were entitled to qualified immunity. Those allegations are viewed in the light most favorable to the nonmoving party.









Christopher E. He knew it was illegal under Oklahoma law to take paddlefish roe out of Oklahoma. Wever was found guilty of poaching paddlefish roe. Swan was subsequently indicted for violating. Arguing that he was




42 U.S.C.








The treatment and subsequent hospitalization involved in the recommended HDC/PSCR is described by appellant as:
1. induction phase or chemotherapeutic agents administered in low doses. The removal of the stem cells which are subsequently frozen and stored. Supplies or equipment are not Covered Services under this Contract. The insured is solely responsible for the payment of charges for all services or supplies excluded in this Section.
. . . . .
32. Breast cancer or germ cell malignancies.
It is Mire's contention that while the above clause excludes any and all treatment.






The treatment and subsequent hospitalization involved in the recommended HDC/PSCR is described by appellant as:
1. induction phase or chemotherapeutic agents administered in low doses. The removal of the stem cells which are subsequently frozen and stored. Supplies or equipment are not Covered Services under this Contract. The insured is solely responsible for the payment of charges for all services or supplies excluded in this Section.
. . . . .
32. Breast cancer or germ cell malignancies.
It is Mire's contention that while the above clause excludes any and all treatment.









Background
The '321 patent. As is done to improve the storage life of donated blood and minimize disease transmission. Which is usually sterile air. A hydrophilic membrane allows the gas to pass only until the membrane is contacted and wetted by liquid. Is described in the specification as comprising a hydrophilic membrane located between the receiving container and the outside environment (or connected to a gas recycle system). It allows the gas in the system to escape as it is displaced by the moving blood. Whereby the displaced air escapes when the membrane is dry. Then seals itself when it is wetted by the blood. The system of the '321 patent is illustrated in Figure 1 of the '321 patent:
In Fig. 1. The gas inlet (13) is upstream of the leukocyte filter and the gas outlet (16) downstream.
Hemasure stipulated to the validity and enforceability of claim 39.









him on the briefs was Jan Witold Baran.
David Kolker. With him on the brief were
Lawrence M. The
Commission contends that we do not have jurisdiction over
this case because (1) Appellants did not properly intervene
and (2) the district court's denial of Appellants' motion was
not a final. The district
court's decision is therefore reversed.
I. BACKGROUND
Appellants are the focus of an ongoing FEC investigation
concerning alleged violations of the Federal Election Cam
paign Act (". Its assertion is based on two separate premises.
the FEC suggests that Appellants were not parties to the
subpoena enforcement action and did not seek to intervene.
See Fed. These decisions are not
appealable because they did not ". That is. 2000).
Both the district court and the FEC were aware of Appel
lants' desire to intervene. The March 17 Motion was entered
on the district court's docket sheet as a motion ".






petitioner Time Warner Entertainment Co. Leanza and Harold
Feld were on the briefs for petitioner Consumers Union.


and Robert Wiygul were on the briefs.
E. Cole were on the briefs.
Jill E. Grinspoon was on the
briefs.
Eliot R. With whom John E.
Putnam and Stacie Brown were on the briefs.
Ronald M. Were on the brief. Anne S. Kidney and Robert Wi
ygul were on the brief for intervenors Grand Canyon Trust. Grinspoon were on the brief
for intervenor Hualapai Indian Tribe.
John E. Cutler and Stacie Brown were
on the brief for intervenors Clark County Department of
Aviation. We do so not because we
necessarily believe the rule is ". Because many of petitioners' attacks
are not yet ripe in light of the phased nature of the FAA's
proposed solution to the problem of aircraft noise.
I
The rule now before the court has a tortuous and complex
history. We recount only so much
of that history as is necessary to aid in our discussion.
A
In June 1987.

the briefs was Grant Crandall.
Robin A. With her on the brief was
W. Were on the
brief for intervenor National Mining Association.
Before: Wald. Because all parties agree that
MSHA is currently working on two other rulemakings with
greater significance for miners' health. Because the agency's response was not definite. Concentrations in excess of permissi
ble exposure limits (PELs) set by the agency are forbidden.
Id.1 Since the early 1970s. Those regulations have incorporat
ed PELs established in 1972 by the American Conference of
Governmental Industrial Hygienists. MSHA recognizes
that those levels are



















him on the briefs were Frank W. With him on the briefs were David H. The more they were
reimbursed.







him on the briefs were Mark E. Seiver were on the briefs for intervenors Prism
Communication Services. With him on the brief were Christopher J. With him on
the brief were Randal S. Feinberg were on
the brief for intervenor Public Service Commission of the
State of New York.
Before: Randolph. The FCC's approval of Bell
Atlantic's application was the first time since the 1982 break
up of AT&. The BOCs continued to have a
monopoly in local phone service in their respective service
areas. Because









