California Proposition 65, officially known as the Safe Drinking Water and Toxic Enforcement Act of 1986, has long been a significant regulatory framework for businesses operating within the state. Over the summer, the California Office of Environmental Health Hazard Assessment (OEHHA) proposed amendments to its safe harbor warning requirements for consumer products which have sparked considerable discussion among business owners and industry stakeholders.
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 is one of a series of posts diving into each aspect of MoCRA. Here, we will introduce the FDA’s online portal, FDA Direct, and show how it can be used for complying with MoCRA’s Facility Registration and Cosmetic Listing requirements.
In October 2023, a New York medical doctor sat down for a fateful meal with her husband and her mother-in-law at a Florida restaurant owned by the adjacent theme park.[1] The doctor, who suffered from severe nut and dairy allergies, received numerous confirmations from restaurant staff that the food she ordered complied with her dietary restrictions.[2] Before selecting the restaurant, she relied on statements made on the theme park company’s website that the restaurant offered allergen-free foods.[3] After dinner, while perusing nearby shops by herself and away from her family, the doctor suffered a severe allergic reaction.[4] She self-administered an epi-pen and was rushed to the hospital but died as a result of anaphylaxis due to elevated levels of dairy and nut in her system.[5]
As the demand for clean energy and transportation grows, so does the need for rechargeable batteries. Lithium-ion batteries are widely used, from small toys to electric cars to large energy storage systems. While some lithium-ion batteries are already subject to regulations, rechargeable batteries used in “micro-mobility devices” such as electric bikes and scooters are currently not subject to any federal safety standards. Some advocates contend that a lack of regulation has led to an increase in fires caused by poor quality, defective batteries. According to a report by CBS News New York, defective lithium-ion batteries have allegedly resulted in 400 fires, 300 injuries, and 12 deaths between 2019 and 2023 in New York City alone.
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.”
Observers of filing trends in personal injury mesothelioma matters alleging exposure to talc contaminated with asbestos have noted that the bankruptcy filing of a predominant defendant in those matters did little to slow the pace of such filings. Instead, as the filing of new matters continued, the number of defendants named in such filings substantially increased.
The Third Circuit recently affirmed entry of summary judgment in favor of General Electric (“GE”) on grounds of derivative sovereign immunity. The Third Circuit found that GE was entitled to derivative sovereign immunity under current established doctrine in Yearsley and Boyle because all of GE’s work and equipment at issue was performed and/or designed pursuant
In 1968, the Multidistrict Litigation Act provided the framework for multidistrict litigation (MDL); where civil actions involve “one or more common questions of fact . . . pending in different districts, such actions may be transferred to any district for coordinated or consolidated pretrial proceedings.” 28 U.S.C. § 1407(a).
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.
The number of cases involving so-called “nuclear verdicts” — that is, verdicts with awards of $10 million or more — have risen sharply, and many of those cases concern product liability claims. For large corporations, such verdicts can be damaging, both from a financial and reputational standpoint, but rarely do they significantly impact operations beyond the quarter or year in which they are booked. For middle-market and smaller corporations, however, product liability litigation can be enterprise-threatening; therefore, it is vital for smaller corporations — especially those with limited in-house legal resources — to understand the claims most often brought in product liability litigation, how to triage inbound lawsuits, and when to call on outside legal advice to resolve disputes.