We’re sticking to a plain-vanilla report on a recent Virginia case because of our involvement in the Hormone Therapy litigation, but it is a good decision worth noting. In Torkie-Tork v. Wyeth, 2010 U.S. Dist. LEXIS 133179 (E.D. Va. Dec. 15, 2010), the plaintiff nominally asserted inadequate warning and design defect claims. At the close of the plaintiff’s case in chief, the court granted Wyeth’s Rule 50 motion for judgment as a matter of law on the plaintiff’s design defect claims, and the case proceeded to verdict on the warning claim alone, where the jury returned a unanimous defense verdict.
The court’s decision is of particular interest, however, because it addressed a lurking “failure to test” claim. Pretrial, Wyeth moved to exclude evidence relating to any alleged “failure to test” the drug. Id. at *3. The court denied that motion; although “plaintiff apparently was not asserting a separate claim for negligent failure to conduct additional studies of Prempro, it was unclear prior to trial whether evidence relevant to this issue might also be relevant to plaintiff’s negligent failure to warn claim.” Id. As the trial unfolded, however, “it became clear…that plaintiff intended to argue to the jury that Wyeth had a duty to conduct additional studies and that the failure to do so was part of the negligent failure to warn claim.” Id. at *4. The court thus had to decide whether any such “duty to test” arises under Virginia law.
Relying on prior Virginia Supreme Court precedent, the court concluded that a “manufacturer’s duty to warn of a product’s dangers imposes no underlying duty to conduct additional studies or tests because a failure to warn claim rests on a reason to know standard rather than the broader should have known standard.” Id. at *14 (citing Owens-Corning Fiberglas Corp. v. Watson, 413 S.E.2d 630 (Va. 1992) (emphasis in original)). Under this standard, “[t]he only dangers for which Wyeth had a duty to warn adequately are those dangers which Wyeth knew or had reason to know existed based on the science available at the time the product left Wyeth’s hands.” Id. at *17.
This result represents a “proper balance between the costs to manufacturers of additional studies and tests – costs which are subsequently passed onto consumers, often in the form of delays in releasing the product – and the benefits of bringing the drug to market expeditiously based on existing knowledge of the product’s dangers.” Id. at *14-15. Indeed, the court concluded, Virginia’s “reason to know” standard “is particularly sensible given the FDA already requires testing of any drug as a qualification for approval.” Id. at *17.
We can’t say much else, but there you have it – in Virginia, plaintiffs can’t pursue a claim based on any alleged failure to conduct “additional testing” of an FDA-approved product. For more on failure to test see our cheat sheet here.