Massachusetts federal and state courts issued several important product liability decisions in 2023. Nutter’s Product Liability practice group reviewed these cases and report on their significant holdings as follows ...more
MASSACHUSETTS - First Circuit Holds Failure-To-Warn Claims Against Drug Manufacturer Preempted By Federal Food, Drug, And Cosmetic Act Because Animal Studies Cited By Plaintiffs Did Not Demonstrate Risks Beyond Those In...more
MASSACHUSETTS - Massachusetts Federal Court Holds State Law Claims Alleging Misleading “Rapid Release” Labeling Of OTC Acetaminophen Tablets Preempted By Federal Food, Drug, And Cosmetic Act, As Tablets’ Dissolution Rate...more
Zofran (ondansetron) has often been used to combat nausea during pregnancy. It has never been approved by the FDA for that indication, but clinical experience has not supported an association with pregnancy-related risks –...more
As we ring in the new year, it is time once again to reflect on some of the most significant legal developments for drug and device companies this year. The list below is by no means exhaustive (who could forget the Rule 702...more
We have written before about the Supreme Court’s impossibility preemption decision, Merck Sharpe & Dohme Corp. v. Albrecht, 139 S. Ct. 1668 (2019) (Albrecht) (here, here, here, and here), highlighting some open questions and...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
By the time the COVID-19 pandemic began, society was well into the so-called “Digital Age,” relying heavily on electronic communications, apps, websites, and the like to go about daily activities. Everything from ordering...more
Drug warning labels must comply with federal regulations and receive approval from the Food and Drug Administration (“FDA”) before going to market. Therefore, manufacturers may argue that state law actions related to the...more
Litigation Update - On January 30, 2020, class action, consumer protection and pharmaceutical lawyers from around the country will be in federal court in Tampa, Florida to argue before a panel of federal judges whether...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
Welcome to the third 2019 issue of Product Lines – our quarterly e-newsletter that focuses on toxic torts and products liability issues.... In This Edition: - Vitamin E Found in Cannabis-Containing Vape Products Linked...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
Welcome to 2019! We hope that your New Year’s resolutions included time to sit down and enjoy our latest edition of Pro Te: Solutio. We have three intriguing articles in this edition, which are sure to provide useful...more