In pharmaceutical litigation, the learned intermediary doctrine—which provides that a manufacturer of prescription pharmaceuticals fulfills its duty to warn of known risks by providing adequate warnings to the prescribing physician—is well established. A notable exception has been West Virginia. In fact, in 2007, the West Virginia Supreme Court specifically rejected the application of a common-law learned intermediary doctrine throughout the state, finding that prescription-drug manufacturers had the same duty to warn ultimate consumers as any other product. See State ex rel. Johnson & Johnson v. Karl, 647 S.E.2d 899 (W. Va. 2007). The court based its holding on the belief that with the advent of direct-to-consumer advertising, and recent changes to the physician-patient relationship, the “justifications for the learned intermediary doctrine [are] largely outdated and unpersuasive.”
Nine years later, however, another arm of the state government reached a different conclusion. On February 17, 2016, the West Virginia legislature passed, and the governor signed, S.B. 15, which adopts the learned intermediary doctrine. This is an important development for litigation involving prescription pharmaceuticals, and it is obviously a marked change in West Virginia law.
The text of the new law, which becomes effective 90 days from passage, is as follows:
AN ACT to amend the Code of West Virginia, 1931, as amended, by adding thereto a new section, designated §55-7-30, relating generally to manufacturers and sellers of prescription drugs and medical devices and liability of those entities for alleged inadequate warning or instruction; and adopting the learned intermediary doctrine as defense to civil action based upon inadequate warnings or instructions.
Be it enacted by the Legislature of West Virginia:
That the Code of West Virginia, 1931, as amended, be amended by adding thereto a new section, designated §55-7-30, to read as follows:
ARTICLE 7. ACTIONS FOR INJURIES.
§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.
NOTE: The purpose of this bill is to adopt and codify the learned intermediary doctrine as a defense to a civil action against a manufacturer or seller of a prescription drug based upon inadequate warnings or instructions.
The law will become effective on April 17, 2016. It is silent as to whether it will apply to existing litigation.