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Drug makers must warn patients of risks, Justices rule

By Steve Korris | Jun 28, 2007


CHARLESTON, W. Va. - Drug companies cannot escape liability for harmful prescriptions in West Virginia by laying all responsibility on doctors, the West Virginia Supreme Court of Appeals ruled Wednesday.

Three of five Justices denied a writ that would have kept Marshall Circuit Judge Mark Karl from holding trial against Janssen Pharmaceutica.

They upheld Karl's rejection of a doctrine that would define a doctor as a "learned intermediary" between a drug maker and a patient.

Chief Justice Robin Davis treated the doctrine as a useless 82-year-old relic.

"When the learned intermediary doctrine was developed, direct to consumer advertising of prescription drugs was utterly unknown," she wrote. "Pharmaceutical manufacturers never advertised their products to patients, but rather directed all sales efforts at physicians."

She wrote that the law created an exception to the duty of a manufacturer to warn consumers directly of risks.

"For good or ill, that has all changed," Davis wrote. "... we now hold that, under West Virginia products liability law, manufacturers of prescription drugs are subject to the same duty to warn consumers about the risks of their products as other manufacturers."

The decision must have startled West Virginia's federal judges. In both the northern and southern districts, they have applied the doctrine as West Virginia law.

"While federal court opinions applying West Virginia law are often viewed persuasively, we are not bound by those opinions," Davis wrote.

In reaching a decision the other four Justices changed partners.

In many instances, Spike Maynard and Brent Benjamin take one side while Larry Starcher and Joseph Albright take the other side.

This time Starcher and Maynard agreed, siding with Davis. Albright and Benjamin agreed, siding with Janssen Pharmaceutica.

In another unusual element, Albright and Maynard delivered their opinions the same day Davis delivered the decision. Separate opinions normally follow majority opinions by days or weeks.

Albright called the majority "exceptionally shortsighted." Benjamin joined him in his dissent.

"Just because a warning can be printed and advertised as part of the marketing plan for a prescription drug does not mean that a consumer, especially one not educated in medical jargon, can digest or comprehend the significance of that warning in a useful fashion," Albright wrote.

Maynard fired back that if the dissenters had their way a small town doctor would become solely responsible for an injury, "while an out of state multi million dollar drug manufacturer is off the hook."

If Karl brings the case to trial, jurors can choose to divide damages between Janssen and physician Daniel Wilson.

Janssen, a subsidiary of Johnson & Johnson, manufactured Propulsid and supplied samples to Wilson.

In 1999, Wilson prescribed Propulsid for patient Nancy Gellner.

"Mrs. Gellner died suddenly on the third day after she began taking Propulsid," Davis wrote.

Her estate sued the doctor and the drug maker in 2001.

Janssen moved for summary judgment under the learned intermediary doctrine, arguing that it warned Wilson. Karl denied the motion.

Janssen pushed the doctrine again, moving in 2005 to exclude evidence that it had a duty to warn Gellner personally.

Karl denied the motion in June 2006, ruling that the Supreme Court of Appeals had not embraced the concept of the learned intermediary.

Janssen attorneys Stephen Farmer and Kenneth Robertson of Charleston figured the Justices would embrace it if they could.

They petitioned for a writ of prohibition, pleading that Karl exceeded his legitimate powers by refusing to apply the doctrine.

Gregory Gellner and Robert Fitzsimmons of Wheeling represented the Gellner estate before the Justices.

D. C. Offutt Jr., Stephen Burchett, Jody Offutt and Randall Saunders of Huntington represented Wilson. So did Patrick Casey of Wheeling.

The Justices heard oral arguments in January. It took them five months to reach a decision.

Davis opened the majority opinion by debunking reports that 48, 44, or 34 states applied the doctrine.

"Considering decisions of only the highest state courts, we find that a mere 21 states have expressly adopted the learned intermediary doctrine," she wrote. "The highest courts of six other states have either referred to the doctrine favorably in dicta, or have adopted it in a context other than prescription drugs ..."

She wrote that these "do not make up the overwhelming majority that has often been suggested by courts and commentators."

She found justifications for the doctrine "outdated and unpersuasive."

She wrote that the doctrine originated in 1925, prevailed for the first time in 1948, and took its name in 1967.

"The very age of the doctrine requires us to pause and engage in a thorough examination," she wrote. "Drug manufacturers now directly advertise products to consumers on the radio, television, the Internet, billboards on public transportation, and in magazines."

She wrote that in 1997 the U. S. Food and Drug Administration issued guidelines that led to rapid proliferation of advertisements.

She quoted a law review report that drug makers spend more money advertising to consumers than to doctors.

A footnote showed that in 2001 drug makers spent $2.38 billion advertising directly to consumers.

Davis quoted a law review report that patients increasingly pressure doctors to prescribe drugs they have seen advertised.

She wrote that courts have addressed the shortcomings of the learned intermediary doctrine by developing exceptions.

"We ascertain no benefit in adopting a doctrine that would require the simultaneous adoption of numerous exceptions," she 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 ...

"West Virginia physicians naturally have duties and responsibilities regarding their role in providing prescription medicine to consumers. It would be unreasonable not to require the manufacturers of those medicines to accept similar responsibilities."

Albright wrote in dissent that the doctrine may still serve a useful purpose for drugs that are not heavily marketed.

He recommended a distinct category of drugs marketed by mass media.

He wrote that by attaching undue importance to advertising the majority downplayed the role of the physician. He also noted that the majority appeared to presume that advertising relegated the physician's role to a mere dispensary.

Maynard pretty well confirmed that presumption in his concurrence.

"Americans cannot watch an hour of television or skim through a magazine without being bombarded by commercials and advertisements extolling the benefits of Viagra, Vioxx, Prilosec, Claritin, Paxil, Zocor, Celebrex, Flonase, Allegra, Pravachol, Zyrtec, Singulair, Lipitor, Nasonex, Lamisil and others," he wrote. "We consumers are well educated about the salutary effects of these drugs. There is no reason why we should not be just as educated about their potential risks.

"Drug manufacturers have a ready forum in which to warn health care consumers about the risks of their products.

"Ultimately, drugs are a product like any other."

Maynard wrote that no one would argue that a John Deere dealer should be liable alone to a plaintiff injured by a John Deere lawn mower since the dealer was an expert who had a duty to warn.

Although the Justices did not let Janssen off the hook, Janssen attorneys see two ways to get off the hook at trial.

They have told Karl they will establish that Janssen provided adequate warnings to Wilson.

They also aim to establish that Wilson shouldn't have prescribed Propulsid to Gellner.

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