Learned Intermediary

As many of you may know, West Virginia has finally decided to jump onto the learned intermediary band wagon. From eliminating the learned intermediary rule completely in State ex rel. Johnson & Johnson Corp. v. Karl, 647 S.E.2d 899 (W. Va. 2007), to adopting the learned intermediary rule with the passage of W. Va. Code §55-7-30 (effective May 17, 2016), West Virginia can count itself among the clear majority of jurisdictions now. Perhaps this sea change will permanently remove West Virginia from the (far from coveted) number-one spot on the Drug and Device Law’s blog post – The Best and Worst of 2007: The Worst – a dubious distinction which it earned with its Karl decision.

West Virginia’s new statute is significant because it adopts the learned intermediary rule as it is seen in the Third Restatement of Torts, but without any exceptions. W. Va. Code §55-7-30:

Adequate pharmaceutical warnings; limiting civil liability for manufacturers or sellers who provide warning to a learned intermediary.

(a) A manufacturer or seller of a prescription drug or device may not be held liable in a product liability action for a claim based upon inadequate warning or instruction unless the claimant proves, among other elements, that:

(1) The manufacturer or seller of a prescription drug or medical device acted unreasonably in failing to provide reasonable instructions or warnings regarding foreseeable risks of harm to prescribing or other health care providers who are in a position to reduce the risks of harm in accordance with the instructions or warnings; and

(2) Failure to provide reasonable instructions or warnings was a proximate cause of harm.

(b) It is the intention of the Legislature in enacting this section to adopt and allow the development of a learned intermediary doctrine as a defense in cases based upon claims of inadequate warning or instruction for prescription drugs or devices.

Nonconformists to the learned intermediary rule are even more distinctly the “exception to the rule” now.

And contrary to the forecasts at the time, the “DTC advertising” exception to the learned intermediary rule in Perez v. Wyeth Laboratories, Inc., 734 A.2d 1245 (N.J. 1999) (“when direct warnings to consumers are mandatory, the learned intermediary doctrine … drops out of the calculus”), and the ruling in Karl, were not harbingers of an anti-learned intermediary rule movement. In fact, despite their attempts, plaintiffs have been unsuccessful in pushing expansion of Perez and Karl: “not a single state’s high court (or any other court, for that matter) has followed Karl down the path to perdition. And now Karl itself is history.” Renaissance of the Learned Intermediary Rule, http://www.druganddevicelaw.blogspot.com (March 3, 2016). And “every state now has pro-learned intermediary precedent.” Id.

It is almost as if the Karl decision launched a movement to avoid its ramifications, resulting in adoption or reaffirmance of the learned intermediary rule, because “recent precedent uniformly refutes” the proposition that the rule is obsolete or archaic. See Id.

The Drug and Device Law’s blog has provided an excellent summary of the law in this area, and we encourage our readers to take a look. (http://www.druganddevicelaw.blogspot.com; http://druganddevicelaw.blogspot.com/search?q=renaissance).