For years, West Virginia was one of a small minority of states that rejected the learned intermediary doctrine--a key doctrine in pharmaceutical product liability litigation holding that a drug manufacturer's duty runs to the prescribing physician and not the patient. That is no longer the case. The West Virginia legislature recently passed S.B. 15, adopting the learned intermediary doctrine as a defense to civil actions based upon inadequate warnings or instructions.
Generally, manufacturers have a duty to warn consumers of the risks of using their products. The learned intermediary doctrine serves as an exception to that rule, by acknowledging that the learned intermediary (typically the prescribing physician) has primary responsibility to warn patients of the risks of prescription drugs. The principle operates to shift drug manufacturers' duty to adequately warn to the prescribing physician, and relieves them of most obligations to warn the consumer directly of the risks. Up until now, West Virginia has been the only state in the nation to broadly reject the learned intermediary rule. See State ex rel. Johnson & Johnson Corp. v. Karl, 647 S.E.2d 899, 903-05 (W. Va. 2007).
By adopting the new Code of West Virginia § 55-7-30, West Virginia will now limit civil liability for manufacturers or sellers of prescription drugs or medical devices who provide warnings to a learned intermediary. The Act provides in relevant part that a "manufacturer or seller of a prescription drug or medical device may not be held liable in a product liability action for a claim based upon inadequate warning or instruction unless the claimant proves" that: (1) the "manufacturer or seller . . . 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) the "[f]ailure to provide reasonable instructions or warnings was a proximate cause of harm" to the claimant. § 55-7-30(a)(1)-(2).
S.B. 15 will become effective on May 17, 2016. However, there is currently an open question as to whether § 55-7-30 applies retroactively to existing litigation.