Insurance Marketplace Realities 2024 – Life sciences

The following items remain a concern for underwriters:

• Acetaminophen: Acetaminophen MDL is being closely monitored, and mounting concern surrounding this product has led to broadened exclusionary language. In addition to exclusions for in-utero ingestion of acetaminophen linked to neurodevelopmental disorders, some carriers are adding exclusions for other issues, such as acute liver failure, acute generalized exanthematous pustulosis, Stevens-Johnson Syndrome and toxic epidermal necrolysis.
• Product impurities: We continue to see recalls for products containing benzene, which tends to be prevalent in personal care products, such as lotions, deodorants, antiperspirants, sunscreen, shampoo/conditioners, body wash and hand sanitizers. As a result, we are commonly seeing benzene added to the list of excluded impurities.
  • In response to the nitrosamine impurities issues stemming from as far back as 2018, the FDA has now provided drug manufacturers with critical guidelines for conforming their products to what the agency has determined to be safe nitrosamine exposure limits for patients. The product liability insurance marketplace continues to exclude claims in any way related to nitrosamines.
• PFAS: As with several other sectors, litigation over per-and polyfluoroalkyl substances (PFAS) in the United States is causing concern for life sciences product liability carriers. These forever chemicals are prevalent in cosmetics as well as medical devices and pharmaceutical products. While there is still much unknown about the long-term effects of these chemicals, PFAS exclusions on product liability programs are becoming more prevalent.

As always, capacity for certain litigated product classes such as orthopedic implants and proton pump inhibitors remains limited.

The convergence of the consumer product and healthcare industries continues to create coverage challenges that the insurance marketplace is struggling to keep up with. We are continually working to push the boundaries of traditional insurance policies to ensure that insureds have adequate coverage in place to meet their evolving needs.

With the demand for pharmaceuticals and medical devices rising, along with the rapid advances in technology and science, this sector is set to see strong growth well into the future. It is critical to the long-term success of life science companies that they can effectively quantify, mitigate and transfer risk wherever it is appropriate.