Drug scheduling is the statutory process of classifying a drug into one of five categories by balancing the drug’s risk of abuse with its accepted medical uses. The guidelines for drug scheduling are outlined in the Controlled Substances Act.
Schedule I drugs have no recognized medicinal use while having a high potential for abuse.
Does the Federal Insecticide, Fungicide, and Rodenticide Act bar a failure-to-warn claim based on labeling when the EPA has not mandated the warning?
This case asks whether the Federal Insecticide, Fungicide, and Rodenticide Act (“FIFRA”) bars a lawsuit alleging that a product failed to provide adequate warnings or instructions when the Environmental Protection Agency (“EPA”) has not required such warnings. Petitioner Monsanto Company argues that Respondent John L. Durnell’s claim is preempted by FIFRA, which bars changes to a product label following approval by the EPA, as well as by the impossibility of compliance with both state and federal law. Durnell argues that Missouri law and FIFRA are equivalent laws, and that Missouri law imposes no additional labeling requirements for pesticides. The outcome of this case carries significant policy implications for federalism and regulatory authority. The case may also have an impact on nationwide agricultural and economic interests.
Whether the Federal Insecticide, Fungicide, and Rodenticide Act preempts a label-based failure-to-warn claim where EPA has not required the warning.
In January 2019, Respondent John L. Durnell sued Petitioner Monsanto Company (“Monsanto”) in Missouri state court under claims of strict liability for failure to warn, defective design, and negligence. Durnell v.
Does a geofence warrant violate the Fourth Amendment to the Constitution?
This case asks the Supreme Court to consider whether a geofence warrant violated the Fourth Amendment of the United States Constitution. Law enforcement collected Okello Chatrie’s location data from his cellphone using a geofence warrant issued after an armed credit union robbery, which the government used as evidence against him. Chatrie argues that the geofence warrant constitutes an unconstitutional search because the Location History data collected by the warrant violates both users’ property interests in their electronic data and reasonable expectations of privacy. Additionally, Chatrie contends that the warrant violates the probable cause and particularity requirements imposed by the Fourth Amendment. The United States asserts that geofence warrants do not violate users’ reasonable expectation for privacy, and that American law does not recognize the property interests asserted by Chatrie in raw data. The United States further argues that this geofence warrant complies with probable cause requirements and is sufficiently particular to pass constitutional muster. This case will impact both the privacy and public safety interests of all Americans.
Whether the execution of a geofence warrant violated the Fourth Amendment.
On May 20, 2019, an armed individual entered the Call Federal Credit Union in Midlothian, Virginia, stealing $195,000 from its vault. United States v. Chatrie at 69. Before law enforcement responded, the robber fled the scene.
Does a “skinny label” insulate a generic drug manufacturer from induced patent infringement liability – and can a complaint state such a claim when the drug is marketed as the generic version of a brand-name equivalent?
This case asks the Supreme Court to consider whether the Hatch-Waxman Act permits generic manufacturers to rely on “skinny labeling” (an FDA-approved label that omits patented uses of the brand-name drug) to avoid liability for induced patent infringement, or whether they may still be held liable when their product is used for patented indications despite a carve-out. This case originates from a dispute between Hikma and Amarin and involves Hikma’s generic version of Amarin’s drug Vascepa. Hikma used a skinny label omitting certain patented cardiovascular indications while retaining approval for unpatented uses. Hikma argues that the FDA’s approval of the carve-out label under the Hatch-Waxman framework should shield it from liability since it did not actively promote the patented uses and followed regulatory requirements. Amarin argues that Hikma nonetheless infringed because of its labeling, marketing context, and foreseeability of physicians prescribing or encouraging use of the drug for the patented indications. A decision in favor of Hikma would strengthen the protection of generic drugs afforded by skinny labeling and reduce litigation risk for generics entering partially patented markets, while a decision in favor of Amarin would expand induced infringement liability and potentially weaken the practical effectiveness of the skinny labeling pathway under the Hatch-Waxman Act.
(1) Whether, when a generic drug label fully carves out a patented use, allegations that the generic drugmaker calls its product a “generic version” and cites public information about the branded drug (e.g., sales) are enough to plead induced infringement of the patented use; and (2) whether a complaint states a claim for induced infringement of a patented method if it does not allege any instruction or other statement by the defendant that encourages, or even mentions, the patented use.
Amarin Pharmaceutical (“Amarin”) is a pharmaceutical company that specializes in a sole commercial product, Vascepa. Amarin Pharma, Inc. v.
Do the Alien Tort Statute and the Torture Victim Protection Act support a judge-made private cause of action for aiding and abetting liability?
This case asks the Supreme Court to consider whether the Alien Tort Statute (“ATS”) and the Torture Victim Protection Act (“TVPA”) allow individuals to sue someone for aiding and abetting the commission of an international human rights violation. The ATS allows foreign nationals to sue in U.S. federal courts for violations of international law or U.S. treaties, while the TVPA allows individuals to sue for damages caused by torture. Cisco Systems, Inc. argues that neither the ATS nor the TVPA provides a valid cause of action for aiding and abetting, and that the current judicial landscape does not allow for creating a new cause of action under these statutes. Fourteen unnamed members of the Falun Gong (referred to as “Doe”) argue that aiding and abetting is a universal norm in international law, which the ATS was intended to enforce, and that the language of the TVPA allows for an aiding and abetting claim. This ruling could have impacts on U.S. foreign relations and foreign direct investment by U.S. corporations, and on the accountability for U.S. corporations’ involvement with countries committing human rights violations.
(1) Whether the Alien Tort Statute allows a judicially implied private right of action for aiding and abetting; and (2) whether the Torture Victim Protection Act allows a judicially implied private right of action for aiding and abetting.
Falun Gong is a religious practice that emerged in China in the early 1990s. Doe I v.
A deferred prosecution agreement (DPA) is an agreement between the government and a defendant in which the government pauses prosecution against the defendant while the defendant is fulfilling specified requirements.
A non-prosecution agreement (NPA) is an agreement between the government and a person or entity under investigation, in which the government agrees to not charge or prosec
Matter of Dubreuil, is a 1993 Florida Supreme Court case in which a woman refused a medically necessary blood transfusion for religious reasons after she had successfully delivered her child via caesarean section.
Does the Rooker-Feldman doctrine prohibit a plaintiff from challenging a state court judgment in federal court while an appeal in state court is still possible?
The Supreme Court will decide whether the Rooker-Feldman doctrine applies to Petitioner T.M.’s case, wherein T.M. filed a claim in a federal court challenging a state court judgment before the state court judgment’s appeal window closed. T.M. argues that the Rooker-Feldman doctrine does not apply to her case because her state court judgment was not final or issued by the state’s highest court. If Rooker-Feldman applies to her case, T.M. asks the court to overturn the doctrine. Respondents, including the University of Maryland Medical System Corporation (“UMMS”), counter that the Rooker-Feldman doctrine should bar T.M.’s case because it meets all elements required by the doctrine. UMMS posits that any arguments that ask the Court to overturn Rooker-Feldman are beyond the scope of the question the Court has before it. The outcome of this case will have significant implications for litigation incentives and the relationship between federal and state courts.
Whether the Rooker-Feldman doctrine, which prevents parties who lose in state courts from challenging injuries caused by state-court judgments, can be triggered by a state-court decision that remains subject to further review in state court.
The petitioner, whose identity has been anonymized to the initials “T.M.,” experienced a medical episode in 2023. T.M. v. University of Maryland Medical System Corporation at 3a. T.M.
Can the SEC pursue equitable disgorgement under 15 U.S.C. §§ 78u(d)(5) and (d)(7) without showing that investors suffered financial harm?
This case asks the Supreme Court to decide whether a showing of financial harm is necessary for the Securities and Exchange Commission (“SEC”) to pursue equitable disgorgement under 15 U.S.C. §§ 78u(d)(5) and (d)(7). Ongkaruck Sripetch argues that congressional intent and prior precedent support a showing of pecuniary harm requirement for disgorgement. The SEC counters that Sripetch misapprehends both congressional intent and Liu v. SEC as mandating a showing of pecuniary harm. Instead, the SEC argues that congressional intent and Liu both limit disgorgement to its usage as a form of compensation for unjust enrichment, which does not require a demonstration of financial harm. This case will have significant ramifications for the effectiveness of disgorgement both as an enforcement tool and as a means of compensating victims.
Whether the SEC may seek equitable disgorgement under 15 U.S.C. §§ 78u(d)(5) and (d)(7) without showing investors suffered pecuniary harm.
Beginning in the 1970s, courts began ordering disgorgement of wrongfully gained profits as an equitable remedy in securities cases. SEC v. Sripetch at 3a–4a.
