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Lowndes Client Corner Podcast Episode 5 - Winter Park Distilling Company Brews One-Of-A-Kind Facility in Winter Park
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Polsinelli Podcasts - The Latest on a Shift in Regulation in Dietary Supplements
PATIENT PRIVACY IN AN ERA OF SOCIAL MEDIA
In 1990, Congress enacted the Nutrition Labeling and Education Act (NELA) as an amendment to the Food, Drug and Cosmetic Act (FDCA). Among other things, NELA 1) provided for modernization and standardization of the familiar...more
Several recent cases arising under the federal Food, Drug, and Cosmetic Act (“FDCA” or the “Act”), 21 U.S.C. § 301 et seq., highlight the usefulness of preemption as a defense against putative class actions concerning drugs,...more
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
President Biden signed into law the Modernization of Cosmetics Regulation Act of 2022 (“MoCRA”), as part of the Consolidated Appropriations Act, 2023. This is the first major reform of cosmetics regulation since the Federal...more
On December 29, 2022, U.S. President Biden signed into law the "Consolidated Appropriations Act, 2023," which includes the Modernization of Cosmetics Regulation Act of 2022 (MOCRA). MOCRA reflects the most significant...more
The U.S. Supreme Court’s 2019 decision in Merck Sharp & Dohme, Inc. v. Albrecht, 139 S.Ct. 1668 (2019), discussed... addressed impossibility preemption in label change lawsuits. In Albrecht, the Supreme Court purported to...more
In the simplest case for federal preemption, federal law prohibits conduct that a state tort duty would require, such as a change in the design of an approved medical device to cure an alleged defect. Because federal law is...more
Pro Te: Solutio returns for its second edition of 2019. As the year grinds on, our attorneys at Butler Snow are taking proactive and creative steps to confront and solve the issues that affect our areas of practice. The...more
Consumer class actions involving goods regulated by the Food and Drug Administration (“FDA”) coexist in parallel with FDA enforcement efforts. Consumers have no private right of action to enforce the Food, Drug, and...more
Water: two parts hydrogen, one part oxygen. It seems simple enough, but for companies selling bottled water, liability lurks below the surface. According to a recent lawsuit, consumers care not only about what is in their...more
On December 13, 2018, the FDA withdrew a proposed rule that would have authorized manufacturers of generic drugs to use the Changes Being Effected (CBE) procedure to add new safety information to their labeling—something that...more
After several years of delay, FDA announced this summer that it expects to publish new rules in April 2017 that will permit generic drug companies to make unilateral changes to their warning labels, even if the brand does...more
Last week, a federal court in Utah granted Aventis Inc.’s motion for summary judgment based on federal preemption of failure-to-warn claims. Cerveny v. Aventis, Inc., 2016 U.S. Dist. LEXIS 34182 (D. Utah Mar. 16, 2016). The...more
Federal Circuit Interprets Statutory Requirements for Biosimilar Regulatory Pathway - Amgen Inc., v. Sandoz Inc., (Fed. Cir. July 21, 2015): In a case of first impression, the U.S. Court of Appeals for the Federal...more
It’s summertime, and for many of us that means buying and applying sunscreen. Lots of it. Indeed, when selecting sunscreen rated at, say, SPF 30, we rely on national standards promulgated by the FDA. It thus comes as no...more
The U.S. is a step closer to enacting a consistent, national approach to certifying and labeling genetically modified (GMO) foods. On July 23, 2015, the U.S. House of Representatives passed H.R. 1599, the Safe and Accurate...more
In April 2015, the Ninth Circuit held in a cosmetic labeling class action that the Food, Drug, and Cosmetic Act (FDCA) did not expressly preempt state causes of action predicated on federal cosmetics labeling laws and that...more
In Eckler v. Neutrogena (certified for publication 7/1/15, Case No. B2536910), the California Court of Appeal, Second Appellate District, upheld the trial court’s determination that plaintiffs’ claims of mislabeling sunscreen...more
An opinion issued by the U.S. Court of Appeals for the First Circuit on February 20, 2015 held that the Federal Food, Drug, and Cosmetic Act (“FDCA”) preempted claims that Lexapro’s U.S. Food and Drug Administration (FDA)...more
On Tuesday, the U.S. Food and Drug Administration (FDA) announced that it has reopened the comment period for its proposed rule on generic drug labeling. It has also scheduled a day-long public meeting to hear comments and...more
In the watershed case of PLIVA, Inc. v. Mensing, the United States Supreme Court determined that federal law preempts state law failure-to-warn claims against generic pharmaceutical manufacturers. More specifically, Mensing...more
On June 24, 2012, the U.S. Supreme Court handed down its decision in Mutual Pharmaceutical Co. Inc. v. Bartlett, 570 U.S. ____ (2013), finding that design-defect claims against generic drug companies are pre-empted where...more
The Sixth Circuit recently held that a failure-to-warn claim could proceed against a generic manufacturer that had failed to timely follow the brand-name label. Fulgenzi v. Pliva Inc., Case No. 12-3504 (6th Cir. March 13,...more
Today, the Supreme Court of the United States held oral argument in Mutual Pharmaceutical Co. v. Bartlett, a follow-up to its landmark ruling in PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011), which addressed federal...more