Plan Ahead to Protect Your Innovation: Product Liability Risks for Medtech Startups

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 before funding a company. The hypothetical risk of future product liability litigation is not as high a priority for startup companies who have yet to commercialize. However, with the recent surge in such litigation pursuing the life sciences industry, companies are on notice to start prioritizing product liability risk management.

Read the MD+DI article by Sean Burke, vice chair of Duane Morris’ Products Liability and Toxic Torts division.

The Latest Changes to the Beauty Regulatory Landscape

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 Congress at the end of 2022, cosmetics companies across the U.S. are required to register their facilities to the Food and Drug Administration by Monday, pushed back from the original deadline of December. They must also list each marketed cosmetic product, including product ingredients, and provide any updates annually. […]

As for what else is still to come, the industry is awaiting the FDA to issue guidance on good manufacturing practices, set to be published in 2025.

On this, Kelly A. Bonner, an associate at law firm Duane Morris, said: “They’re not reinventing the wheel. There are standards out there. It’s just going to be what the FDA say is the standard in the United States.” […]

Bonner, for one, believes the industry has been taking the changes seriously and that the goal for the FDA is to get through the first few years of MoCRA and then take stock.

“Ultimately FDA is going to take a hard look at it and think, ‘OK, what are our enforcement priorities now that we have the data, now that we’ve got everything in place? How do we tweak this? How do we refine this to better assist the industry, to better aid consumers?’”

To read the full text of this article, please visit the WWD website

Updated Federal Rules Can Improve Product Liability MDLs

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 William R. Heaston on the Duane Morris website

FDA Again Confirms No Asbestos in Cosmetic Talc Products

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, which also failed to detect asbestos in any of the 50 cosmetic samples tested for those years. Read the full Alert on Duane Morris’ website.

Court’s Decision Affects Evidence Involving Industry & Gov’t Standards

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 clarifying these issues for trial courts and litigants, the Court’s plurality decision creates a potential unbalanced playing field for defendant manufacturers relying upon such standards in the design of their products.

Continue reading “Court’s Decision Affects Evidence Involving Industry & Gov’t Standards”

Pa. Supreme Court Rules on Proper Venue Standards

By Alan Klein and Ethan Feldman

In Hangey v. Husqvarna, the Pennsylvania Supreme Court recently ruled that the percentage of a corporate defendant’s total revenue generated from a forum county alone is insufficient to support the proposition that a defendant does not “regularly conduct business” in the county when analyzing whether a lawsuit’s venue is proper. This long awaited decision provides much needed clarity for trial courts that previously wrestled with the question of how much business must a defendant have in the forum for venue to attach. Continue reading “Pa. Supreme Court Rules on Proper Venue Standards”

Deadline for MoCRA Facility Registration and Product Listing Requirements Pushed Back to July 1, 2024

Today, FDA announced updated guidance regarding its MoCRA rollout.

FDA  does not intend to enforce the requirements related to cosmetic product facility registration and cosmetic product listing for an additional six months after the December 29, 2023, statutory deadline, or until July 1, 2024, to provide regulated industry additional time to comply with these requirements.

To read the full text of this post by Kelly Bonner,  please visit the Duane Morris Fashion, Retail and Consumer Branded Products Blog.

The Unseen Legal Turmoil Driving Beauty Brands to Shutter in 2023

Despite positive projections about the future of the beauty industry, insiders say brands of all sizes are quietly grappling with unseen legal struggles.

[Founders] blamed, in large part, the California Safe Drinking Water and Toxic Enforcement Act of 1986, better known as Prop 65.

“[Prop 65] requires products sold in California to have a special warning label if use of the product causes an exposure to one or more chemicals identified as causing cancer, birth defects or other reproductive harms,” Duane Morris partner Robert Kum told Glossy. Continue reading “The Unseen Legal Turmoil Driving Beauty Brands to Shutter in 2023”

Why Talc Claimants’ Experts Should Fear New Jersey Courts

Sharon Caffrey,  co-chair of Duane Morris’  Trial Practice Group,  is quoted in the Law360 article “Why Talc Claimants’ Experts Should Fear New Jersey Courts.”

From the article:

Cleavage fragments, or mineral particles that are found in rocks, can look like asbestos chemically, but they don’t have the same cancer-causing fibrogenic characteristics that asbestos does, Duane Morris LLP partner Sharon Caffrey told Law360.

“It’s not asbestos, and it’s … never been established as a cause of mesothelioma,” Caffrey said.

Visit the Law360 website to read the full article. 


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The opinions expressed on this blog are those of the author and are not to be construed as legal advice.

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