Per- and poly-fluoroalkyl substances (PFAS) are colloquially called “forever chemicals” because they allegedly break down slowly over time and linger in the environment for many years. PFAS claims assert injury or damage caused by exposure to PFAS, and the nature and variety of these claims continue to evolve rapidly. Plaintiffs have alleged that PFAS are present in many different products and across a wide range of industries, including medical devices. PFAS are useful in medical products because they offer advantages such as chemical resistance, heat resistance, and durability. Medical devices and related products that have been alleged to use or contain PFAS include stents, catheters, surgical mesh, pacemakers, heart patches, CPAP machines, prosthetics, surgical instruments, and asthma inhalers.
Notwithstanding the role that PFAS play in medical devices, claimants have alleged that PFAS-containing medical devices are dangerous because PFAS exposure in humans has been purportedly linked to cancers and other bodily injuries. Medical device companies dispute these allegations. Fortunately, liability insurance coverage is available to cover many types of PFAS claims, both for the costs of defense and for any settlements or judgments. Medical device companies can best position themselves to address these claims by understanding (A) the nature of PFAS and PFAS claims, and (B) which insurance policies may cover them.
Insurance Coverage for PFAS Risks and Liability
The types of policies most likely to respond to medical device-related PFAS claims are general liability policies and specialized liability policies providing coverage for personal or bodily injury relating to products, such as product liability policies, and policies tailored specifically for companies in the life sciences and medical sectors. Because PFAS claimants may allege exposure to PFAS through medical devices over a period of many years or decades, a policyholder should look to all of its past and present policies, starting from the first year of alleged PFAS exposure up to the date of the claim. These sorts of “longtail” allegations often implicate “occurrence”-based policies, which cover claims for injury or damage occurring during the policy period, regardless of when those claims are made—even if a claim is not made until 40 or more years after that policy period. Medical device companies should therefore organize and maintain records of historical insurance policies, including, to the extent possible, historic policies issued to predecessor companies or to acquired companies. Suppliers, vendors, and distributors may also be important sources of coverage: under the terms of its contracts with other entities, the medical device company may have gained “additional insured” status under those entities’ policies. In addition to these historic and third-party policies, when presented with a PFAS claim, medical device companies of course should also examine their current policies, which may provide coverage on a “claims-made” or “claims-reported” basis. In contrast to the historic “occurrence” policies, such policies provide coverage, respectively, when a claim is made against the insured during the policy period, or reported to the insurer during the policy period or within a defined “discovery period” thereafter.
Policyholders should promptly collect and carefully evaluate all insurance policies that might respond to PFAS claims. Exclusions, endorsements, and other policy language may affect whether (and to what extent) any given insurance policy covers PFAS-related liabilities, and the particular wording of a policy exclusion or coverage grant can mean the difference between coverage and no coverage. Because of time limitations on notifying insurers of claims, particularly under claims-reported policies, this insurance coverage review needs to be an integral part of a company’s response plan for PFAS claims.
PFAS in Medical Devices
PFAS are alleged to have been used in a wide variety of medical devices due to their properties. For example, PFAS have been described or alleged to have the following roles: insulators in high-frequency signaling devices like pacemakers and defibrillators; friction reducers in endoscopies; propellants in metered inhalers; and protective barriers in hospital supplies and materials. PFAS have also been alleged to have been used in components of a medical device, and even in the coating of a component or the packaging of a device.
These types of medical devices—and the PFAS alleged to reside in those devices—are pervasive in our modern world. About three million people in the U.S. live with a pacemaker and about 300,000 pacemakers are implanted in the U.S. every year. Americans receive about 75 million endoscopies every year. These are just a few illustrative examples of the scale of the medical devices potentially implicated in allegations involving the presence of PFAS and/or alleged harm from such PFAS.
Recent PFAS-Related Healthcare Lawsuits
PFAS have increasingly become the subject of civil litigation in the health care/medical device context. Civil PFAS claims that have targeted manufacturers and sellers of products in the healthcare or medical sectors include:
- In January 2023, Colgate was sued on the basis that its so-called “natural” mouthwash contained PFAS. See Esquibel v. Colgate-Palmolive Co., No. 1:23-cv-00742 (S.D.N.Y.).
- In April 2024, Johnson & Johnson was sued by a consumer alleging that its bandages contained PFAS at the time of sale. See Moultrie v. Johnson & Johnson, 3:24-cv-4757, (D.N.J.).
Lawsuits like these have been filed across a wide range of industries, and medical device companies may have exposure to such lawsuits.
Insurer Defenses for Medical-Device-Related PFAS Claims
Many insurance companies have denied coverage or reserved rights to deny coverage for PFAS liabilities on multiple grounds, some of which are listed below.
- Pollution Exclusion: Various liability policies contain pollution exclusions that, generally speaking, bar coverage for the discharge or release of pollutants into the environment. PFAS claims generally present fact patterns far removed from traditional pollution claims, and medical device companies should have particularly strong arguments against the pollution exclusion, since the alleged exposure to PFAS often occurs through direct contact with medical devices and products that are being used as intended (i.e., for their intended life-saving purpose).
- Trigger: The expression “trigger of coverage” is used to describe the event that must take place before a liability policy applies to a given loss. Under occurrence-based policies, personal or bodily injury occurring during a given policy period is the event that “triggers” coverage for that policy. Though the law varies across jurisdictions, policyholders generally have strong arguments that a PFAS claimant’s exposure to a PFAS-containing medical device triggers all liability policies in effect from the date of first exposure through the manifestation of the injury.
- Knowledge-Based Defenses: Liability policies exclude “known losses,” i.e., losses known to the insured before purchasing the policy; and harms that are “expected or intended from the standpoint of the insured.” The application of these knowledge-based exclusions to particular PFAS-related losses can be highly fact-intensive, and insurers traditionally face a heavy burden of proof to prevail on these coverage defenses.
Each of these asserted coverage defenses depends on the particular policy language and specific facts of the PFAS claim; all can be—and have been—overcome by PFAS-related policyholders. Therefore, medical device companies need not automatically accept insurers’ coverage denials or reservations. Nonetheless, during the course of the insurance claim process, it is important for policyholders to comply reasonably with policy conditions—including notice, cooperation, and voluntary payment requirements—to avoid handing insurers additional coverage defenses
Covington’s Insurance Practice
Whether your company is currently responding to PFAS claims or is considering how to assess and prepare for potential claims in the future, Covington’s award-winning insurance recovery team can help. Covington has long been recognized as the preeminent policyholder-side law firm, and our experience successfully pursuing coverage for claims of “long-tail” exposures similar to the PFAS claims extends back over four decades. That deep experience has benefited our clients handsomely. Representing companies facing all manner of potential PFAS liabilities, we have already secured over half a billion U.S. dollars to date for our clients in PFAS-related coverage matters alone.
If you have any questions concerning the material discussed in this client alert, please contact the members of our Insurance Recovery practice.
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