Law

The West Virginia legislature has passed, and the governor signed today, S.B. 15, adopting the learned intermediary rule.  Here is a link to the legislative history of the bill.  Here is the text of the bill:

[Passed February 17, 2016;  in effect 90 days from passage.]

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.

We note that §55-7-30(a)(1) is very similar to Restatement (Third) of Torts, Products Liability §§6(d) & 6(d)(1), but that it does not include the exception that the Restatement provides in §6(d)(2), which is essentially the "mass immunization" exception.  That omission cannot have been accidental.  Thus in one fell swoop West Virginia goes from the bottom to the top of our learned intermediary rule headcount, having adopted the rule without any of the various exceptions that some other jurisdictions have recognized.

We further note that the bill become effective "90 days from passage," passage being on February 17, 2016.  That would be April 17, 2016.  Whether "effective" includes application to existing litigation, we don't know (maybe a West Virginia practitioner could enlighten us).  We expect litigation over this point.