By Sean K. Burke and Gabrielle Pelura
On March 11, 2025, Judge Kenneth Bell in the Western District of North Carolina granted summary judgment in favor of Merck & Co. Inc. and Merck Sharp Dohme LLC against the “bellwether plaintiffs” in a multidistrict litigation who were vaccinated with Gardasil at various dates from 2012 to…
The global market for intimate wellness products is expected to grow to $81.4 billion by 2028, up from $51.9 billion in 2021, according to recent market research reports. Once taboo, or the topic of hush-hush conversations, intimate wellness brands are increasingly crossing over into mainstream wellness marketing, collaborating with well-known fashion and beauty brands and…
On August 15, 2024, the United States Court of Appeals for the Third Circuit held in Schaffner v. Monsanto that the plaintiff’s Pennsylvania state-law claims, which asserted that Monsanto failed to warn about alleged cancer risks presented by glyphosate (the active ingredient in the weed killer Roundup), were expressly preempted by the Federal Insecticide,…
The U.S. Consumer Product Safety Commission (CPSC) recently found Amazon to be a “distributor” with product liability responsibility for products sold on its website. In a July 29, 2024, ruling, the CPSC said Amazon is legally responsible for over 400,000 allegedly hazardous items sold by third-party sellers on its site. Amazon.com, Inc., CPSC…
By Jim Steigerwald, Harry Byrne, and Ryan Monahan
The potential for rulemaking in 2024 from the National Highway Traffic Safety Administration (NHTSA) and the Federal Motor Carrier Safety Administration (FMCSA) has been deferred to 2025 at the earliest, including on key state-of-the-art technologies such as automatic emergency braking (AEB) in heavy and medium-duty…
A medtech startup typically focuses on two key legal needs: (1) ensuring that its technology has proper and thorough intellectual property protection, and (2) outlining a detailed pathway for FDA clearance. Those two priorities are understandable. The areas of intellectual property protection and a regulatory pathway are threshold issues that every potential investor wants addressed…
Duane Morris attorney Kelly Bonner was quoted in an article in WWD on June 25, 2024.
“A big deadline in the beauty and personal care regulatory landscape is fast approaching, with much more to come — although some experts believe this still isn’t enough.
Under the Modernization of Cosmetics Regulation Act, or MoCRA, passed by…
In the evolving universe of multidistrict litigation, begun in the antitrust cases against major electronics manufacturers in the 1960s, federal courts have developed varying approaches to fulfilling their responsibilities to achieve efficiency and reduce costs. This process continues today almost 60 years since the creation of the first MDL. Read the Law360 article by Alan Klein and…
On April 5, 2024, the U.S. Food and Drug Administration (FDA) confirmed that its third-party testing of cosmetic talc products for 2023 identified no traces of asbestos in any of the 50 cosmetic samples tested. FDA’s 2023 results, which were reported in a Cosmetics Constituent Update, are consistent with its testing for 2022 and 2021…
By Alan Klein, Duane Morris LLP
A recent Pennsylvania Supreme Court decision has reaffirmed the applicability of strict liability standards under Restatement Second’s §402(a) in products liability cases filed in the State, and has barred evidence of compliance with industry or governmental standards to demonstrate that a product was safe and not defective. While…
