Learned-intermediary doctrine rejected in West Virginia.

Citing the "current state of the prescription drug industry and physician/ patient relationships," three of the five justices of the West Virginia Supreme Court of Appeals ruled in a case of first impression that the state would not adopt the learned-intermediary doctrine. (Johnson & Johnson v. Karl, 2007 WL 1888777 (W. Va. June 27, 2007).)

The doctrine provides that pharmaceutical companies have no duty to warn consumers directly about the harmful effects of prescription drugs because the companies provide the warnings to doctors, who are "learned intermediaries" between the manufacturers and drug consumers.

On May 19, 1999, Nancy Gellner began taking Propulsid to treat acid reflux. Three days later, she died from sudden cardiac arrhythmia. Her estate sued manufacturer Janssen Pharmaceutica and its parent company, Johnson & Johnson, along with her prescribing doctor. Claiming strict liability, breach of express and implied warranties, and negligence, the complaint alleged that the drug's labeling failed to give adequate warnings about the risk of heart problems associated with use of Propulsid.

The FDA approved Propulsid in 1993 to treat heartburn. After several warning label changes concerning cardiac risks and over 100 reported deaths, Johnson &Johnson stopped marketing the drug in the United States in 2000. Multidistrict litigation concerning the drug is now in settlement talks in Louisiana.

In the Gellner case, a county court denied the drug company's motion for summary judgment based on the learned-intermediary doctrine, because questions of fact remained about whether the warning was sufficient. The company then filed a motion in limine, seeking to preclude any evidence about whether the warning was sufficient and saying that the company had no obligation to warn consumers directly because of the learned-intermediary doctrine.

In June 2006, Judge Mark Karl denied the motion, finding that the state's high court had not recognized the learned-intermediary doctrine and that existing state law would allow full development of claims regardless of whether the state adopted the doctrine. In other words, Karl concluded, the sufficiency of drug warnings is a question of fact for a jury under West Virginia law.

Johnson & Johnson then petitioned the state's high court for a writ of prohibition on enforcement of that ruling, saying that the court had exceeded its powers by declining to apply the learned-intermediary doctrine.

Denying the writ, Chief Justice Robin Davis wrote that, contrary to court decisions claiming that an "overwhelming majority" of jurisdictions have adopted the learned-intermediary doctrine, "we find that a mere 21 state [high courts] have expressly adopted" it, with 6 other state high courts using it "in a context other than prescription drugs." And of those jurisdictions that have adopted it, wrote Davis, their justifications are "largely outdated and unpersuasive."

"When the learned-intermediary doctrine was developed [in 1925], direct-to-consumer advertising of prescription drugs was utterly unknown.... Since the 1997 proliferation of drug advertising, only four high courts have adopted the learned-intermediary doctrine.... None of those courts gave thorough consideration to the changes that have occurred in the prescription drug industry with respect to direct-to-consumer advertising. We, however, find such changes to be a significant factor in deciding this issue...."

Davis noted that drug companies have spent billions of dollars on ads aimed directly at consumers since 1997, when the FDA set forth new drug advertising guidelines. This surge of advertising has changed the doctor-patient relationship, she explained: Patients have become more involved in medical decisions and are likely to ask about prescription drugs they have seen advertised, and doctors have less time under managed care to inform patients about drug risks.

The Restatement (Third) of Torts contains several exceptions to the learned-intermediary doctrine to accommodate these changes, Davis noted, including exceptions for inadequate warnings and for situations in which manufacturers fail to warn consumers directly even when the companies know that health care providers "will not be in a position to reduce the risks of harm in accordance with the warnings."

"We ascertain no benefit to adopting a doctrine that would require the simultaneous adoption of numerous exceptions in order [for the doctrine] to be justly utilized," Davis wrote. "This is particularly so when our existing law of comparative contribution among joint tortfeasors is adequate to address issues of liability among physicians and drug companies in those cases where patients sue for injuries related to the use of prescription drugs.

"Furthermore, we believe that if drug manufacturers are able to adequately provide warnings to consumers under the numerous exceptions to the learned-intermediary doctrine, then they should experience no substantial impediment to providing adequate warnings to consumers in general."

For Gregory Gellner of Wheeling, West Virginia--who is Nancy Gellner's son and co-counsel for her estate with Wheeling attorney Robert Fitzsimmons--the ruling is bittersweet.

"My mom would not have taken [Propulsid] if she knew that death was even a remote possibility. The good news is that this ruling will help the end user of these drugs," Gellner said. "Manufacturers have got to get the message to these consumers in plain language, just like for any other product."--VALERIE JABLOW