Federal preemption can be a very powerful defense. For example, claims concerning Class III medical devices requiring pre-market approval are generally preempted by the Medical Device Amendments of 1976, 21 U.S.C. § 360c, et...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
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
The Ninth Circuit has confirmed in quadrophonic sound that plaintiffs cannot avoid preemption by relying on vague and speculative allegations to establish a parallel claim. The court affirmed the dismissal of four lawsuits...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
On December 18, 2018, the Arizona Supreme Court issued an opinion clarifying manufacturers’ duty to warn consumers under Arizona common law. The Court held that the federal Medical Device Amendments (“MDA”) impliedly...more
To prepare the best product liability defense for pharmaceuticals and medical devices as well as anticipate and strategically plan for future challenges in the medical and life sciences legal world, it is often helpful to...more
Massachusetts Federal Court In Multi-District Litigation Holds Under Six States’ Laws That Manufacturer Of Brand-Name Pharmaceutical Is Not Liable For Injuries Caused By Generic Equivalents Whose Manufacturers Were Required...more
Summer is in full swing and certain topics are (staying) hot—especially regulatory issues, from new proposed rules to challenges to case law to strategic considerations. Generic preemption remains a hot topic. In Storm...more
Massachusetts Supreme Judicial Court Holds Failure-to-Warn Claim Against Drug Manufacturer Not Preempted Because There Was No “Clear Evidence” FDA Would Not Have Approved Plaintiffs’ Suggested Warning; Also Holds...more