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Hot Topics in International Trade A Year in Review (Quickly)
The U.S. Court of Appeals for the Sixth Circuit, in a full en banc decision, raised the pleading and proof standards for plaintiffs seeking to certify multistate automotive defect class actions. The court’s June 27, 2025,...more
A federal court in New Jersey granted summary judgment to a car manufacturer, holding that a retailer coalition cannot state a claim on behalf of its members under the New Jersey Franchise Practices Act (NJFPA). N.J. Coal. of...more
Massachusetts federal and state courts issued several important product liability decisions in 2021. Nutter’s Product Liability practice group reviewed these cases and report on their significant holdings as follows...more
On remand from the U.S. Supreme Court, the U.S. Court of Appeals for the Third Circuit has in turn remanded the case to the district court to determine whether state law claims are preempted by federal law in the 500+...more
Article I, Section 10, Clause 1 of the United States Constitution provides that “[n]o state shall . . . pass any . . . Law Impairing the Obligation of Contracts . . . .” On August 2, 2019, a panel of the US Court of Appeals...more
Merck v. Albrecht: Impossibility Preemption Defense as a Question of Law and Guidance on the “Clear Evidence” Standard. A decade ago in Wyeth v. Levine, the Supreme Court held that drug manufacturers, when faced with...more
For some long-awaited events, a little time and distance can add a measure of clarity. Not always – many still are processing the Game of Thrones finale, with no end in sight. But over the past few weeks pharmaceutical...more
The United States Supreme Court finally clarified its 11-year-old “clear evidence” standard for pharmaceutical preemption. In its much-anticipated opinion delivered by Justice Breyer, the Court unanimously reversed the Third...more
The US Supreme Court held on May 20 that a judge, not a jury, must decide the question of whether federal law prohibited drug manufacturers from adding warnings to the drug label that would satisfy state law. To succeed on a...more
Opinion highlights importance of a "clear" record at FDA - On 20 May the U.S. Supreme Court unanimously ruled that federal preemption questions arising under the Federal Food, Drug, and Cosmetic Act (FD&C Act) are for a...more
Following confusion from a 2009 decision, the US Supreme Court on May 20, 2019, decided a significant impossibility preemption case. This new decision will change the dynamics of litigation involving the impossibility...more
The Situation: Name-brand pharmaceutical manufacturers are often sued with claims that they should have strengthened the warnings on their labels, even where (as here) the Food and Drug Administration ("FDA") would not allow...more
Last week, in Merck Sharp & Dohme Corp. v. Albrecht, the Supreme Court continued its explication of the balance between state law tort liability that can be imposed on drug makers and the extent to which this liability can be...more
On Monday, the United States Supreme Court found that a judge is better suited than a jury to decide if consumers’ tort claims are preempted by federal regulations. In the case, Merck Sharp & Dome, Corp. v. Albreecht, the...more
On May 20, the U.S. Supreme Court issued its latest opinion on preemption in cases involving prescription medications, Merck Sharp & Dohme Corp. v. Albrecht, No. 17-290 (U.S. May 20, 2019). ...more
The U.S. Supreme Court issued its potentially most significant preemption decision in several years, Merck Sharp & Dohme Corp. v. Albright, 587 U.S. ____ (2019), reversing what some had dubbed the worst drug and device...more
On May 20, 2019, the Supreme Court of the United States decided Merck Sharp & Dohme Corp. v. Albrecht, No. 17-290, holding that the judge, not the jury, must decide whether state-law failure-to-warn claims are preempted by...more
A judge, and not the jury, is the better-positioned and appropriate decisionmaker to determine whether a failure-to-warn claim is federally preempted, the U.S. Supreme Court held on Monday, May 20, 2019. The Court also...more
The Supremacy Clause of the United States Constitution declares federal law to be the “supreme Law of the Land.” Thus, when federal law and state law conflict, the state law is “preempted,” or rendered without effect. Under...more
By Memorandum Opinion entered by The Honorable Richard G. Andrews in State of Delaware v. Purdue Pharma L.P. et al., Civil Action No. 18-383-RGA (D.Del. April 25, 2018), the Court granted Plaintiff State of Delaware’s Motion...more
Recently the Eleventh Circuit spent a lot of ink discussing how the marketing and sale of sashimi-grade tuna is affected when myoglobin reacts with oxygen to produce oxymyoglobin, and with carbon monoxide to form...more
Seventh Circuit Rule 52 allows the U.S. Court of Appeals for the Seventh Circuit, when faced with “questions arising under the laws of [a] state which will control the outcome of a case pending in the federal court” to...more
A Michigan district court judge determined last week that product liability claims against an FDA approved medical device manufacturer were preempted by federal law, but allowed the plaintiff’s claim of fraud against the...more