PFAS in Medical & Life Sciences Products: A Regulatory & Litigation Update

In 2023, Berkley Life Sciences published a blog post titled PFAS “Forever Chemicals” in Medical and Life Sciences Products – Who Should Be Worried?. At that time, most per- and polyfluoroalkyl substances (PFAS) litigation to date focused on lawsuits against PFAS manufacturers, alleging personal injury from PFAS exposure. Since then, PFAS litigation has evolved, and both the U.S. Food and Drug Administration (FDA) and European Chemicals Agency (ECHA) have issued updates, warranting a fresh look at this topic. 

Regulatory Developments

In August 2025, the FDA released its position on PFAS in Medical Devices. According to the FDA’s evaluation, “currently there is no reason to restrict [PFAS] continued use in devices.” The agency distinguishes between small and large molecule fluoropolymers, noting that large molecule fluoropolymers used in medical devices “have been safely used for decades.” The FDA also recognized the unique properties of fluoropolymers in medical device applications and stated that, currently, no alternative materials exist that can perform these critical applications. In making this determination, the FDA, in partnership with the Emergency Care Research Institute (ECRI), conducted an independent safety review. The review, which collected data from 1,800 health care provider organizations and 1,750 published and peer-reviewed scientific articles, found no conclusive evidence of patient health issues associated with PTFE—the most widely used PFAS in medical devices. It is important to note that the FDA’s position and understanding is based on currently available evidence and technology and may be subject to change in the event new research emerges.

While this development may be reassuring for companies distributing medical devices in the United States, the European Union continues to consider restrictions that may significantly impact the market. As discussed in the prior 2023 post, the ECHA proposed a ban on the manufacture, import, and use of PFAS above a certain concentration level. Public comments have advocated for a meaningful distinction between polymer and non-polymer PFAS, with the former (i.e., fluoropolymers) recognized by the FDA as safe. In August 2025, ECHA published an updated proposal. While the definition and scope of PFAS chemicals impacted remain unchanged, the update provides some flexibility regarding fluoropolymers: Instead of a complete ban, operations involving fluoropolymers would require a site-specific management plan, including justification of use. The updated proposal also contemplates derogations for implantable medical devices.

Litigation Developments

Traditional environmental toxic tort litigation against PFAS manufacturers continues, with claims including water contamination, personal injury, medical monitoring, and “greenwashing,” among others. Several PFAS manufacturers have reached significant settlements in water contamination lawsuits. Manufacturers of aqueous film-forming foam (AFFF), a product used by firefighters and the military, are currently subject to multidistrict litigation in the U.S. District Court for the District of South Carolina (MDL No. 2873). In February 2025, certain pharmaceutical companies were named in a water contamination lawsuit brought by the Village of Nyack, N.Y., based on generic allegations of PFAS in the pharmaceutical industry and proximity to a water supply that tested positive for PFAS. While one pharmaceutical defendant was dismissed, others remain (Village of Nyack, N.Y. v. Professional Disposables Inc., et al., Case No. 7:25-cv-01409-PMH).

Against this backdrop, there have also been developments in consumer products and PFAS litigation. While no consumer product PFAS litigation has alleged personal injury, there has been an increase in consumer protection claims involving products (such as menstrual products, cosmetics, diapers, and bandages) purportedly containing PFAS. These lawsuits have been filed against various manufacturers but are often dismissed for failure to demonstrate a link between the product purchased by the named plaintiff and the product tested for PFAS. Plaintiffs must also allege a concrete injury; claims based solely on fear of exposure or diminished value may not suffice. Note, however, that litigation outcomes may vary as scientific methods and legal theories continue to develop.

Key Takeaways

Federal and state agencies in the U.S. continue to issue PFAS regulations that may impact operations and supply chains. Uncertainty remains as to how the concept of “essential use” and distinctions between fluoropolymers and non-polymers will be sorted out in other markets such as the European Union, where restrictions on PFAS use have been proposed. Even where PFAS restrictions do not yet exist, ongoing litigation and adverse publicity may continue to present challenges, underscoring the need for close monitoring. Because regulatory positions and litigation outcomes may change quickly as new information becomes available, companies should consult with counsel for specific guidance regarding PFAS-related risks and compliance.

Authored by Lori G. Cohen (Vice Chair, Shareholder), Sydney Fairchild Williamson (Shareholder), and Rachel Kagan (Associate) of Greenberg Traurig, LLP’s Pharmaceutical, Medical Device & Health Care Litigation Group.

Greenberg Traurig, LLP’s Pharmaceutical, Medical Device & Health Care Litigation Practice is a premier life sciences litigation team, involved in pharmaceutical and medical device industries’ top mass torts and class actions. As national, regional, trial, and settlement counsel for industry leaders, GT’s team routinely tries cases involving cutting-edge medical and scientific issues. Distinguished by its depth of experience and thorough understanding of the industry, this nationwide team of 130+ litigators deliver top-of-class client service. GT has assembled a cross-functional litigation team that meets the unique needs of environmental toxic tort cases that implicate the life science industry. www.gtlaw.com