WASHINGTON — A national group and a state group both are praising a recently passed piece of legislation that would bring West Virginia in line with other states regarding the legal responsibility of drug manufacturers.

Senate Bill 15 would adopt the intermediary doctrine as a defense to civil action due to lack of warnings or instructions. The bill now awaits Gov. Earl Ray Tomblin's signature.

A learned intermediary doctrine essentially means that if a drug manufacturer tells a physician of a drug's possible risks, the drug company doesn't have to warn the patient given the drug.

Lisa A. Rickard, president of the U.S. Chamber Institute for Legal Reform (ILR), applauded the Legislature for passing the bill. The ILR owns The West Virginia Record.

“We applaud the West Virginia Legislature for taking action to bring state courts back into the mainstream on general principles of legal fairness," Rickard said in a statement. "Most states accept that a drug manufacturer has fulfilled its legal responsibilities once it provides all necessary information about its product to a doctor who interacts with patients.

“While federal courts in the state have applied this same reasoning in other contexts, the West Virginia Supreme Court of Appeals opened the door for abusive lawsuits in an outlier decision. This bill would correct that misguided ruling.

Rickard praised House Judiciary Chair John Shott, Senate Judiciary Chair Charlie Trump, and Senator Greg Boso, who sponsored the bill, for their work on the matter.

"(We) urge Governor Tomblin to swiftly sign this bill into law,” Rickard said.

West Virginia Citizens Against Lawsuit Abuse also hailed the measure.

"We applaud the Legislature for reinstating the learned intermediary doctrine in West Virginia," WV CALA Executive Director Roman Stauffer said. "The well-established learned intermediary doctrine is the law of every other state. We are hopeful that Governor Earl Ray Tomblin will sign this legislation into law and align West Virginia with the majority of other states.

"We appreciate that Senate President Bill Cole and House Speaker Tim Armstead continue to look at much-needed lawsuit reforms that will help our state attract jobs creators, grow our economy, and bring our legal system in line with a majority of other states."

In 2007's State ex rel. Johnson & Johnson Corp. v. Karl, a state Supreme Court rejected the learned intermediary doctrine, noting that changes in the prescription drug industry since the doctrine’s origin has led to an increased role of the patient in the prescription process. Also, it said the increase of manufacturers’ direct-to-consumer advertising and its effect on the doctor-patient relationship and the development of the Internet as a method of dispensing and obtaining prescription drug information, had fundamentally changed the doctor-patient relationship.

It said the learned intermediary doctrine was “largely outdated and unpersuasive."

In recent years, two West Virginia federal courts have said that Karl ruling only applies to cases with “drug manufacturers that engage in DTC advertising.” Both decisions said the learned intermediary doctrine still applied to medical device cases — which can only be obtained and implanted through a physician — where the manufacturer never engaged in direct-to-consumer advertising.

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Organizations in this Story

State of West Virginia U.S. Chamber Institute for Legal Reform (ILR) West Virginia Supreme Court of Appeals




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