PFAS “Forever Chemicals” in Medical and Life Sciences Products – Who Should Be Worried?

posted in Life Sciences

(It all began with Teflon…)

Per- and poly-fluoroalkyl substances (PFAS) are synthetic chemicals that may be toxic to human health.  PFAS accumulate in the environment, such as in waterways, in the fish that swim in those waterways, and in public drinking water systems. Blood serum tests of male and female subjects between the ages of 12 and 80 found PFAS in 98% of those tested. Links have been established between human exposure to PFAS and adverse effects on the immune, endocrine, metabolic, and reproductive systems (including fertility and pregnancy outcomes) and an increased risk for cancer. 

The first PFAS, a heat-resistant chemical with non-stick and lubricating properties, later patented as Teflon, was accidentally developed at DuPont during an experiment with gases to develop a better coolant. Teflon became widely used in cookware in the 1950s and 1960s, and its discovery also led to years of research and the development of thousands of additional PFAS chemicals. The beneficial properties of PFAS chemicals, such as their stability under intense heat or use as a surfactant, made them attractive for industrial and military use (firefighting foams, lubrication of machinery, aircraft, and electronics manufacturing), and for use in consumer products (food packaging, textiles, cosmetics, stain-resistant carpeting). Life science companies have used PFAS as coatings on medical devices such as nebulizers and sutures, and in some pharmaceuticals. 

Who Should Worry about PFAS Litigation Lawsuits

Because of recent high-profile lawsuits brought by states and communities against the manufacturers of these “forever chemicals,” PFAS are gaining wide recognition as potentially hazardous to human and environmental health. At the end of June 2023, 3M, for many years one of the primary manufacturers of PFAS, agreed to a $10.3 billion settlement to be used for cleaning up PFAS-contaminated drinking water systems in 300 communities. This follows close on the heels of another settlement in June 2023, this time a $1.185 billion settlement by PFAS manufacturers DuPont, Chemours, and Corteva.

Pharmaceuticals that contain PFAS, include antidepressants (fluoxetine) and antibiotics (levofloxacin).  These drugs have been reviewed and approved by the FDA and are considered safe and effective following extensive clinical studies.  However, many medical devices do not undergo similar clinical testing, and as such, there is limited human data on the impact of PFAS from these products.  Testing methods for PFAS continue to improve and scientists are now able to measure smaller levels of specific PFAS chemicals in human blood serum and tissue. Research on health impacts is growing.  Testing standards for both pharmaceuticals and medical devices are likely to continue to evolve. 

Most PFAS litigation to date focuses on lawsuits against the manufacturers of PFAS, alleging personal injury from PFAS exposure. The regulatory environment is also changing in the U.S. and the European Union. In the U.S., the Biden Administration has secured funding for the US Environmental Protection Agency (EPA) to establish acceptable, legally enforceable levels of PFAS in drinking water. In March 2023, the EPA proposed the National Primary Drinking Water Regulation (NPDWR) that would establish and regulate enforceable levels for six PFAS in drinking water.  These six chemicals include perfluorooctanoic acid (PFOA), perfluorooctane sulfonic acid (PFOS), perfluorononanoic acid (PFNA), hexafluoropropylene oxide dimer acid (HFPO-DA, commonly known as GenX Chemicals), perfluorohexane sulfonic acid (PFHxS), and perfluorobutane sulfonic acid (PFBS).  In addition, the Administration has called for federal agencies to boost research aimed at improving PFAS detection through testing and screening, assessing PFAS health effects, developing remediation technologies, and identifying PFAS alternatives.

In February of this year, the European Chemicals Agency proposed a ban on the manufacture, import, and use of PFAS above a certain concentration level. The proposal is currently in the public comment stage, with new PFAS restrictions likely by 2025.   The proposed ban indicated that exemptions may be warranted for some products in the life science area, including pharmaceuticals and medical devices, due to limited feasibility and availability of appropriate substitutes.  The proposed regulations note that the banning of PFAS could have adverse outcomes for patients unless other suitable materials with an improved safety profile are developed.    The industry will need to follow these proposals to determine if the regulations are enacted and if similar regulations are adopted in other countries, including the United States.

Mitigating the Risks of “Forever Chemicals” 

PFAS create multiple challenges for life science companies. PFAS contamination continues to occur, and litigation is expanding rapidly. As noted above, multiple regulatory agencies both in the United States and abroad are looking closely at safety concerns around these substances; however, at this time, no comprehensive regulatory guidance exists on how companies should manage PFAS in their products or disclose their presence to the consumer.

That said, companies can take steps to proactively mitigate their exposure to PFAS contamination and the potential for product litigation. Suggested approaches include:

  • Monitoring both regulatory evolution and developing litigation related to PFAS;
  • Conducting risk assessments of company products and supply chains to identify susceptibility to PFAS contamination;
  • Ensuring that raw materials and water sources are tested for PFAS;
  • Testing finished products to confirm the absence of PFAS or confirming the use of PFAS-containing materials is within specifications for your product;
  • Evaluating whether to include information about the presence of PFAS product labels.

Conclusion

At this point in time, there is minimal regulation of per- and poly-fluoroalkyl substances (PFAS) in medical and other life science products. This likely will change in the next few years. Consumers also are becoming more aware that “forever chemicals” are potentially toxic to human health and the environment. This will impact both litigation and buying behavior. Life sciences companies are well-advised to act proactively now to identify PFAS-related risk and to mitigate that risk through a hybrid strategy of insurance protections, testing, transparency in informing consumers of the presence or absence of PFAS, and, where possible, finding alternatives to the use of PFAS chemicals.

Authored by Christopher Dorko, ARM, ARM-PE, CFPS, CHMM

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1     Ryan C. Lewis, Lauren E. Johns, and  John D. Meeker, ‘Serum Biomarkers of Exposure to Perfluoroalkyl Substances in Relation to Serum Testosterone and Measures of Thyroid Function among Adults and Adolescents from NHANES 2011–2012’, NIH.gov, Int J Environ Res Public Health. 2015 Jun; 12(6): 6098–6114. Published online 2015 May 29, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4483690/ (accessed June 2023).

2  Bevin E. Blake and Suzanne E. Fenton, ‘Early life exposure to per- and polyfluoroalkyl substances (PFAS) and latent health outcomes: A review including the placenta as a target tissue and possible driver of peri- and postnatal effects’, NIH.gov, Toxicology. 2020 Oct; 443: 152565. 

Published online 2020 Aug 27.   https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7530144/ (accessed June 2023).  

3 Jeffrey Kluger, ‘3M's Historic $10 Billion 'Forever Chemical' Payout Is Just The Tip of the PFAS Iceberg’, Time.com, June 24, 2023, https://time.com/6289893/3m-forever-chemical-pfas-settlement/ (accessed June 2023).