As animal medications become more prevalent and sophisticated, animal health companies may face a litigation environment that looks like the one long familiar to human pharmaceutical manufacturers.
During a recent Venable webinar, partners Kathleen Hardway and Jason Rose, moderated by counsel Sarah Scott, explored how the growth of the animal health industry is driving a corresponding increase in product liability litigation, particularly failure-to-warn claims involving prescription and over the counter medications. Using the fictional animal health company Tripaw Health and its canine weight-loss drug QuadraSlim as a case study, the panel examined the regulatory, scientific, and strategic considerations companies should evaluate when defending these claims.
Animal Health Manufacturers Face a Changing Litigation Landscape
Historically, litigation involving animal health products is often centered on false advertising or deceptive marketing allegations. According to Rose, however, "plaintiffs' lawyers have discovered the explosive growth of the animal health industry," and as a result, manufacturers are increasingly confronting product liability claims, primarily centered on allegations that pet owners weren't properly warned about side effects that their pets suffered from those medications.
Hardway recommended that animal drug manufacturers should begin thinking about shifting their defensive strategies "to account for product liability claims like failure to warn, which can have a strict liability element to them and be subject to state-specific statutory regimes in certain jurisdictions."
Regulatory Compliance Can Become a Litigation Defense
A recurring theme throughout the discussion was the importance of robust post-market safety monitoring. Once a product reaches the market, manufacturers are responsible for monitoring adverse event reports and communicating relevant information to FDA's Center for Veterinary Medicine (CVM).
Rose explained that "a company's ability to show that it undertook kind of a robust review and analysis of adverse event reports is going to be an important component of any defense." Adverse event reports may reveal potential safety signals, but they also require careful evaluation to determine whether reported outcomes reflect true safety concerns or, for example, simply increased product utilization.
The speakers also highlighted the litigation implications of labeling decisions. They noted that disputes in human prescription and over the counter medication litigation frequently arise not only over whether a warning was provided, but also where any changes or warnings appear within the label. Hardway said, "It can make a big difference whether the change is in the post-approval experience section where no causal relationship between the drug and the event needs to be established or in the warnings and precautions section." This can become a focal point in litigation, especially when plaintiffs argue that a warning should have been presented more prominently.
Traditional Defenses Continue to Evolve
The discussion also examined several defenses that may become increasingly important in animal health litigation. Among them was the learned intermediary doctrine, which generally provides that a manufacturer's duty to warn runs to the prescribing veterinarian rather than directly to the pet owner. The panel discussed recent decisions suggesting courts may be increasingly willing to apply the doctrine in the animal health context.
The speakers also explored the role of causation, emphasizing that adverse event reports alone do not establish that a medication caused a particular injury. As Hardway observed, "correlation is not causation, and even association is not causation." Plaintiffs must still demonstrate both that a drug can cause the alleged injury and that it actually caused the injury in the animal at issue.
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