The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) establishes a number of new requirements for the cosmetics industry. Among other things, facilities that manufacture and process cosmetics in the U.S. will need to be registered with the FDA, and companies that manufacture cosmetics will need to submit a list of all cosmetics (and their ingredients) to the FDA.
Consumer-driven lawsuits that follow a product recall often focus on what the company knew, when it knew it, and how it acted in response. And for companies who are hoping to avoid such a lawsuit, one of the biggest questions is what do they need to disclose to consumers and how far does that obligation reach? Certainly, companies cannot disclose what they did not know, and manufacturers are not required to warn for every conceivable risk, regardless of how remote. A recent class action, Gurkov v. Real Kosher Ice Cream Inc., No. 1:23-cv-06128 (E.D.N.Y Aug. 14, 2023), brings these issues into focus.
Continue Reading Recall Litigation Report: Real Kosher Ice Cream Sued Over Listeria Contamination
In December 2022, the Modernization of Cosmetics Regulation Act (“MoCRA”)—the most significant expansion of the U.S. Food and Drug Administration’s authority to regulate cosmetics in nearly 85 years—was signed into law. Among other things, MoCRA gives the FDA authority to require facility registration and reporting of serious adverse events, impose certain record-keeping obligations, recall cosmetic products, and establish good manufacturing practices. With many of MoCRA’s provisions going into effect at the end of this year, cosmetics companies need to prepare to address these requirements and regulations, which may also have a considerable impact on the litigation landscape.
Crowell’s Product Risk Management team has written two publications to help cosmetics companies prepare for the big changes ahead.
Continue Reading Modernization of Cosmetics Regulation Act (“MoCRA”) White Paper
The second half of 2022 proceeded much like the first, with manufacturers busy navigating recalls and related litigation, although not necessarily in that order.
Philips CPAP/ BiPAP Machines Still Under Fire
Philips is still battling an onslaught of cases stemming from a June 2021 recall of CPAP and BiPAP breathing machines, including a consolidated consumer class action, In re Philips Recalled CPAP, Bi-Level PAP, & Mechanical Ventilator Products Liability Litigation, No. 2:21-mc-01230 (W.D. Pa.), MDL No. 3014, and a medical device supplier suit, Baird Respiratory Therapy, Inc. v. Philips, 2:22-cv-00886 (E.D. Pa.). Since early 2021, there have been reports of over 260 deaths and thousands of health problems associated with the degrading polyurethane foam found in these devices, which was used inside millions of CPAP and BiPAP machines for over a decade. Philips claims that it has produced over 3.95 million repair kits and replacement devices to date and continues to research potential health risks to users from its machines. Despite these efforts, its legal troubles will continue into 2023, with even more consumer-facing lawsuits, including Braverman v. Koninklijke Philips N.V., No. 2:22-cv-7927, which was first filed at the end of December 2022 in the U.S. District Court for the Eastern District of New York and is one of the first CPAP/BiPAP suits to allege the inhalation of the toxic foam particles caused mouth and tongue cancer.
Continue Reading Recall Litigation Report: Year in Review (2022)
When a product is recalled, class action lawsuits are not the only threat. Recalled products can also give rise to droves of individual actions. This is the case for Exactech, Inc., a manufacturer of implants, instruments, and technologies for joint replacement.
Following an initial pause in elective procedures at the start of the COVID-19 pandemic, the number of hip arthroplasty surgeries has grown at a steady pace. These procedures commonly use acetabular liners to increase the stability of the total hip arthroplasty. Now, Exactech, a manufacturer of acetabular liners, is under fire nine months after the U.S. Food and Drug Administration (“FDA”) announced a Class II recall of the Exactech Connexion GXL acetabular polyethylene liner in June 2021. A Class II recall involves situations in which consumers may experience temporary or medically reversible health consequences or the likelihood of serious adverse health consequences is remote.
Continue Reading Recall Litigation Report: Exactech Joint Replacement Products