Chapter 4.C.6--Products Liability

In a major decision, the Supreme Court ruled in Riegel v. Medtronic Inc., 128 S. Ct. 999 (2008) that FDA review of a medical device's safety and efficacy preempts a state law suit for liability against the manufacturer of a balloon catheter that burst during surgery.  Commenting on this case, see Gregory Curfman, et al., Why Doctors Should Worry about Preemption, 359 New Eng. J. Med. 1 (2008).  Commenting on this controversial issue more generally, see David A. Kessler & David C. Vladeck, A critical examination of the FDA's efforts to preempt failure-to-warn claims. 96 Geo. L.J. 461-495 (2008).

On the Vioxx litigation, see Frank M. McClellan, The Vioxx litigation: a critical look at trial tactics, the tort system, and the roles of lawyers in mass tort litigation, 57 DePaul L. Rev. 509-537 (2008).

In a potentially ground-breaking decision, the West Virginia Supreme Court held that the learned intermediary doctrine generally no longer applies due to the pharamceutical industry's widespread use of direct-to-consumer advertising, which has reduced the role of physicians in selecting medications.  State v. Karl, 647 S.E.2d 899 (W.Va. 2007).  Criticizing this decision, see Note, 48 Jurimetrics J. 285 (2008).