drug

Alvarez v. Smith

Issues

When law enforcement officers seize personal property in the course of a drug investigation, how quickly should they be required to provide property owners with an opportunity to contest the validity of the seizure?

 

Civil forfeiture statutes allow law enforcement agencies to seize personal property without a warrant if the property is connected to illegal drug activity. A group of Chicago residents whose vehicles were seized organized a class action challenging the Illinois civil forfeiture statute on constitutional grounds. Specifically, they alleged that civil forfeiture improperly deprived them of due process because of the extensive delay the statute allowed before requiring actual civil forfeiture proceedings. After the trial court dismissed their complaint, the Seventh Circuit held the statute unconstitutional. The Supreme Court granted certiorari and now has an opportunity to clarify exactly what process is due to property owners facing statutory civil forfeiture proceedings.

Questions as Framed for the Court by the Parties

In determining whether the Due Process Clause requires a State or local government to provide a post-seizure probable cause hearing prior to a statutory judicial forfeiture proceeding and, if so, when such a hearing must take place, should district courts apply the “speedy trial” test employed in United States v. $8,850, 461 U.S. 555 (1983) and Barker v. Wingo, 407 U.S. 514 (1972) or the three-part due process analysis set forth in Mathews v. Eldridge, 424 U.S. 319 (1976)?

Forfeiture Laws

The Fourteenth Amendment guarantees that no citizen can be deprived of property without due process of law. See U.S. Const. amend.

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Additional Resources

·      Wex: Law about Due Process

·      Wex: Law about Forfeiture

·      Rules governing Krimstock hearings in New York City

·      Though civil forfeiture proceedings are necessarily civil in nature, readers may find the LII Wex Overview of Criminal Procedure helpful to understand the basic investigative process, including probable cause and exceptions to the warrant requirement.

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Riegel v. Medtronic

Issues

Do the Medical Device Amendments, which were intended to replace state regulation of medical devices with centralized federal regulation, forbid injured patients from asserting state-law claims against manufacturers that received premarket approval from the Food and Drug Administration?

 

In 1996, a catheter burst during Charles Riegel's angioplasty. Riegel and his wife filed a product liability complaint against the catheter's manufacturer, Medtronic, Inc. A federal district court dismissed the complaint, holding that the Medical Device Amendments ("MDA") preempted most of the claims. The U.S. Court of Appeals for the Second Circuit affirmed the dismissal and the Riegels appealed to the U.S. Supreme Court. The MDA generally forbids states from imposing requirements on devices that received premarket approval from the Food and Drug Administration ("FDA"). Because the complaint depends on state law, Medtronic argues that letting it proceed would impose state requirements, usurp the power of the FDA, and stifle innovation in the medical field. Mrs. Riegel, who was substituted as plaintiff after her husband died, argues that while Congress gave the FDA power to regulate medical devices, it never meant to stop private citizens from suing negligent manufacturers. The outcome in this case will likely depend on the Supreme Court's style of statutory interpretation as well as its beliefs about the best way to manage the complex world of medical devices.

Questions as Framed for the Court by the Parties

Whether the express preemption provision of the Medical Device Amendments to the Food, Drug, and Cosmetic Act, 21 U.S.C. § 360k(a), preempts state-law claims seeking damages for injuries caused by medical devices that received premarket approval from the Food and Drug Administration.

In 1996, Dr. Eric Roccario attempted to unclog a "diffusely diseased" and "heavily calcified" artery supplying Charles Riegel's heart. See Riegel v. Medtronic, Inc., 451 F.3d 104, 107 (2d Cir.

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Wyeth v. Levine

Issues

Whether a drug manufacturer that has complied with the Food and Drug Administration’s labeling requirements can still be liable under state product liability laws on grounds that the label was inadequate.

Court below

 

In 2000, Diana Levine was treated with Phenergan to relieve nausea caused by a migraine headache.  The drug was incorrectly administered into Levine’s vein, causing gangrene that ultimately led to the amputation of part of her arm. Levine sued Wyeth, Phenergan’s manufacturer, in Vermont Superior Court and the Supreme Court of Vermont on claims of negligence and products liability, arguing that Phenergan’s label was inadequate in warning consumers about its possible risks. Wyeth, on the other hand, argued that federal law preempted Levine’s state law claims, as state law directly conflicted with the requirements of the Federal Food, Drug and Cosmetic Act. With both lower courts ruling in favor of Levine, this case gives the Supreme Court an opportunity to further define the federal preemption doctrine by clarifying whether a drug manufacturer can be liable under state law after complying with the labeling requirements of the Food and Drug Administration. Stakeholders on both sides argue that the outcome of this case will have a direct impact on the kind of information included on drug labels and as such, has serious implications for patient safety and public health.

Questions as Framed for the Court by the Parties

Whether the prescription drug labeling judgments imposed on manufacturers by the Food and Drug Administration ("FDA") pursuant to FDA's comprehensive safety and efficacy authority under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq., preempt state law product liability claims premised on the theory that different labeling judgments were necessary to make drugs reasonably safe for use.

In April of 2000, Diana Levine sought medical treatment for symptoms, such as pain and nausea, caused by a migraine headache. See Levine v. Wyeth, 944 A.2d 179, 182 (Vt.

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Additional Resources

·   Drug and Device Law Blog:  Views on issues related to pharmaceutical and medical device product liability litigation.

·   Pharmaceutical and Medical Devices:  Fulbright & Jaworski L.L.P. Briefing on Wyeth v. Levine.

·   Drug Injury Watch Blog:. Information about prescription drug side effects.

·   Mass Tort Litigation Blog

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