Inflated jury verdicts in the first two preterm infant formula cases tried in the country have raised significant concerns for manufacturers and the broader medical community. These cases not only spotlight the legal challenges faced by manufacturers of highly specialized products, such as the formulas involved in these cases, but also underscore the potentially devastating effects on the availability and use of essential formula to provide preterm infants with adequate nutrition. In response to these bloated jury verdicts, the president of the American Academy of Pediatrics, Benjamin Hoffman, M.D., issued a statement declaring that preterm infant formula “is a routine and necessary part of care of these preterm infants” and warning that “[c]ourtrooms are not the best place to determine clinical recommendations for the care of infants . . . we must take steps to protect the supply of infant formula for those who need it.”
Product Safety
Proposed California Legislation on Silicosis Prevention in Manufactured Stone Industry is Withdrawn
In July, a proposed bill named the Silicosis Prevention Act was withdrawn from consideration in California. This proposed bill would have substantially affected the manufactured stone industry by banning dry fabrication activities, imposing licensing requirements for employers and workers, and implementing a public database for violations and other state enforcement actions. Even though this version of the proposed bill was withdrawn, further legislative efforts targeting the manufactured stone industry are anticipated in the future.
Legal Implications Following the FDA’s Release of Data on Talc-Containing Cosmetics, Which Confirm Absence of Asbestos for Third Consecutive Year
In April, the U.S. Food and Drug Administration (FDA) released the results of its 2023 sampling assignment, testing for asbestos in talc-containing products. The results confirmed the absence of asbestos in all 50 samples tested, marking the third consecutive year of asbestos-free talc products in the United States. While this news is reassuring for industry participants, the legal landscape remains complex due to ongoing litigation. This article explores the legal implications, potential risks, and regulatory changes related to asbestos detection in cosmetic talc products.
OSHA’s Controversial “Walkaround” Rule Goes into Effect
The Occupational Safety and Health Administration (OSHA) “walkaround” rule went into effect on May 31, 2024. The rule is controversial, to say the least, and even before its effective date, it was targeted by industry and trade groups, with perhaps the most high-profile of these efforts being a federal lawsuit in Texas filed by the U.S. Chamber of Commerce, the National Association of Manufacturers, and Associated Builders and Contractors, Inc., among other plaintiffs.
MoCRA: What’s on the horizon for PFAS?
This article is one of a series of posts diving into each aspect of The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) as the industry awaits MoCRA’s full implementation. This installment focuses on MoCRA’s approach to the regulation of perfluoroalkyl and polyfluoroalkyl substances (PFAS) in cosmetic products.
0.005% of National Revenue from Philadelphia County Held Sufficient to Support Venue
Philadelphia County has long been a preferred forum for plaintiffs’ bar in Pennsylvania. Until last week, a motion to dismiss for improper venue under Pa. R. Civ. P. 1028(a)(1) was a tool at the disposal of any corporate defendant improperly entangled into Philadelphia County litigation. However, the Pennsylvania Supreme Court’s decision in Hangey v. Husqvarna, 14 EAP 2022 (Pa. Nov. 22, 2023, Dougherty, J.) may have effectively foreclosed improper venue dismissal except for those defendants who conduct no business in Philadelphia County whatsoever.
MoCRA: Talc Testing and Sample Preparation Requirements
As discussed in the Product Perspective, the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) represents a major shift in cosmetic industry regulations. This article, in a continuing series of posts diving into each aspect of MoCRA, covers the talc testing and sample preparation requirements which will be established by the FDA under MoCRA.
MoCRA: FDA Draft Guidance on Facility Registration and Product Listing
As we previously discussed, MoCRA requires cosmetic product manufacturer and processors to register their facilities with the U.S. Food and Drug Administration (FDA). On August 7, 2023, FDA announced that it had published a draft guidance on cosmetic product facility registration and product listings, as required under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). The draft guidance intends to help the industry by providing relevant requirements and definitions, explaining who is responsible for making submissions, what details to include, and how and when to make the submissions. It also provides information on exemptions, such as those for certain small businesses.
MoCRA: Updates to FDA Safety Substantiation Requirements
As discussed in the Product Perspective, the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) represents a major shift in cosmetic industry regulations. This article, in our continuing series of posts diving into each aspect of MoCRA, covers the process for substantiating safety of cosmetic products.
Car Break-Ins Expose Shocking Vehicle Vulnerabilities and Spark Multidistrict Litigation: A $200M Settlement Reached by Kia and Hyundai
A Multidistrict Litigation started by a TikTok trend of individuals breaking into cars recently settled for an estimated $200 million. The Plaintiffs alleged that the Defendants—Hyundai and Kia—knowingly sold defective vehicles that were vulnerable to theft while also asserting that Defendants prioritized profits over safety. The vehicles at issue included 2011-2022 Kia vehicles and 2015-2022 Hyundai vehicles that were equipped with traditional “insert-and-turn” steel key ignition systems. Plaintiffs argued that vehicles lacking immobilizer technology were particularly susceptible to theft. According to Plaintiffs, without an immobilizer, anyone with a USB cable could steal the vehicle. Plaintiffs’ lawsuit encompassed various claims, including consumer fraud, unjust enrichment, and deceptive trade practices.