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
Crafting the perfect medical device is never an exact science—but a patient should never suffer because of defects in a product that was intended to improve their quality of life. Determining whether a device manufacturer or...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
From pharmaceuticals to toothpaste, preemption to public health, New York state and federal courts issued decisions in 2022 that further shaped the landscape in the medical and life sciences legal world. To prepare the best...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
A recent Second Circuit preemption decision illustrates the importance of a clear-eyed approach to medical device preemption issues. In Glover v. Bausch & Lomb, Inc., 6 F.4th 229 (2d Cir. 2021), the district court...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
In the game of “20 Questions,” one player secretly chooses an object and the other players are allowed 20 questions to identify it. In that spirit, answering the following 20 questions may identify a defense strategy that...more
In August 2018, the Province of British Columbia (Province) commenced a class action on behalf of itself and other provincial and federal governments against approximately 50 pharmaceutical manufacturers, wholesalers, 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
After two years of consideration, the FDA has restricted the sale of breast implants to healthcare providers that use an FDA-approved patient-decision checklist to discuss the benefits and risks of the implants with patients....more
Foley Hoag LLP publishes this quarterly Update primarily concerning developments in product liability and related law from federal and state courts applicable to Massachusetts, but also featuring selected developments for New...more
Earlier this year, the California Court of Appeals in Mize v. Mentor Worldwide LLC, 51 Cal.App.5th 850 (2020), reversed a trial court’s dismissal of failure to warn and other claims against a medical device manufacturer,...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
Massachusetts state and federal courts issued a number of important product liability decisions in 2019. The Product Liability practice group at Nutter recently reviewed these cases. Highlighted below are some of the key...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