Some of us of a certain age were fans of Parliament/Funkadelic back in the day. The group even released an album entitled “Medicaid Fraud Dogg.” That was the most drug/device adjacent rock-and-roll since the Rolling Stones released “Mother’s Little Helper.” One classic Parliament line was “make my funk the p-funk.” Every time we think about PFAS litigation, our first response is “make my FAS the PFAS.” That’s appropriate because that litigation is – as we’ve already observed – a whole lotta nuthin.
The FDA evidently thinks so, too.
Last year, in August, the agency issued a report on “PFAS in Medical Devices,” which detailed an “independent safety review” it conducted together with the patient safety organization ECRI. The bottom line: “The ECRI review found no conclusive evidence of patient health issues associated with PTFE as a material.” Id.
Other significant points from the FDA safety review are:
- “The PFAS materials used in medical devices (known as fluoropolymers) have a long history of use. The best-known of these materials is polytetrafluoroethylene (PTFE).”
- “Many medical devices rely on plastic materials . . ., which are part of the PFAS family and have been safely used for decades.”
- “Medical devices [that] . . . rely on the unique properties of PFAS . . . are necessary to save and sustain lives.”
- “Currently, no other materials exist that can perform the critical roles of fluoropolymers in these devices. The materials have unique properties that are essential for devices to function.”
Id.
The FDA conducted a second evaluation of PFAS in connection with its oversight of cosmetics. In late 2025 the agency released its “Report on the Use of PFAS in Cosmetic Products & Associated Risks.” PFAS are used in cosmetics “because they are water- and oil-resistant, and are long-lasting.” Id. at 8. In response to the same overblown allegations of purported health risks that we’ve seen in litigation, the FDA evaluated the safety of the 25 most commonly used PFAS compounds in cosmetics. Id. at 9. First, it concluded that, because:
There are currently no federal regulations that specifically address the use of PFAS in cosmetic products in the U.S.[,] PFAS that are intentionally added to cosmetic products as an ingredient are not currently prohibited and do not, based on presence alone, render the cosmetic product adulterated or misbranded,
Id. at 8 (footnote omitted).
As to the 25 particular PFAS compounds specifically evaluated, the FDA concluded, based on a “comprehensive search of PubMed, . . . [the] Web of Science, [and] existing official safety assessments from government agencies and scientific advisory groups,” id. at 9, that five of them had a “[l]ow safety concern based on available data,” 19 others had “insufficient data for safety conclusion,” and only one showed even a “potential safety concern based on available data at highest concentration of use.” Id. at 9-10. That’s a far cry from the hysterical bleatings of the plaintiffs’ bar and their hired gun “experts.”
Given the conclusions in these two 2025 FDA reports, any attempts to assert PFAS-related product liability claims in prescription medical product liability litigation should be both expressly and impliedly preempted. To the extent products are governed by the MDA’s “different from or in addition to” express preemption clause in 21 U.S.C. §360k(a), the FDA has evaluated the PFAS used in medical devices and expressly concluded that no safety-based basis for either design changes or new warnings exists. To the extent that implied preemption under Merck Sharp & Dohme Corp. v. Albrecht, 587 U.S. 299 (2019), is involved, the FDA has expressly concluded that no available evidence suggests any basis for requiring different warnings. So at least through the end of 2025, there is no basis to conclude that any “newly acquired information” exists that could support any warning-based claim.
In sum, we haven’t seen any product liability litigation in our drug/device sand box based on the presence of PFAS in prescription medical products. These FDA evaluations establish that there is a good reason for the absence of such claims – they, too, would amount to a “nuthin.”