Product Liability Claims and Comment K

Jan 01, 2013
By Pharmaceutical Executive Editors

Andrew Solow
Consider the following hypothetical: After three weeks of listening to the evidence, eight jurors—none of whom have taken a science class beyond high school chemistry—are sent back to a jury room in a state court courthouse to determine whether the plaintiff and her lawyer have successfully proven that your prescription drug was defectively designed, simply because the plaintiff's injury outweighed the benefits that caused her to take your blockbuster FDA approved medication in the first place.

Daniel Meyers
Unless the recent shift in product liability law reverses course, this scene might repeat itself around the country with you on the receiving end of this update from your trial counsel. In the past, prescription drug manufacturers (and by extension, medical device manufacturers) have been able to limit common-law product liability lawsuits to claims that defendant's warnings were inadequate. Recently, however, trial and appellate courts around the country have begun empowering juries (and plaintiffs' lawyers) to decide whether or not a prescription drug is defectively designed. It is critical, therefore, that pharmaceutical companies and their counsel embark on a coordinated effort to educate the judiciary about the social consequences of giving juries (or courts) the responsibility of determining a prescription drug's therapeutic value.


Until recently, the overwhelming state of the law was that a pharmaceutical company facing litigation based on the sale of a prescription drug was able to rely on two legal doctrines to generally limit a plaintiff's claims to proving that a defendant's warnings were inadequate. First, almost every state applies the "learned intermediary" doctrine, which obviates pharmaceutical companies' need to directly warn consumers, and allows pharmaceutical companies to avoid liability provided they adequately warn the plaintiff's prescribing physician. Second—and the focus of this article—is "Comment K" of the Restatement (Second) of Torts, which effectively barred strict liability design defect claims against pharmaceutical companies. Comment K states that some products are "unavoidably unsafe" and therefore are neither defective nor unreasonably dangerous provided they are properly prepared and accompanied by adequate warnings.

Based on these two legal doctrines, claims against pharmaceutical companies were, for the most part, limited to a negligence standard (or a strict liability-in-name-only standard) that required a jury to weigh the adequacy of the warnings either in light of the company's duty of care, or in other words, what the company knew or should have known (negligent failure to warn theory), or the state of the science at the time the product was sold (strict liability failure to warn theory). Such standards avoided the harsher impact of a strict liability claim faced by non-prescription products like automobiles, chainsaws, and hot-water heaters. The rationale for this was that prescription drugs are useful and desirable for society even though they are incapable of being made safe for their intended and ordinary use without proper warnings. Based on this strong public policy, strict liability claims against prescription drugs were generally limited to a much harder burden of proving a safer and feasible alternative design.

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