As a federal appeals court in Chicago prepares to hear arguments later this month on the question of whether a drug company should bear responsibility for the effects of a generic equivalent medication they did not make or sell, pharmaceutical company GlaxoSmithKline has asked the judges to lend weight to a West Virginia Supreme Court delivered in recent days, which declared using drug warning labels to hold innovators liable for harm caused by a generic copy of their product would “sever the connection between risk and reward,” both raising drug prices and limiting innovation.
“That holding joins the overwhelming consensus of courts refusing to recognize a negligent-failure-to-warn claim against brand manufacturers where the plaintiff consumed a generic drug,” wrote attorney Lisa S. Blatt, of the firm of Arnold & Porter, representing GSK in a May 14 letter to the U.S. Seventh Circuit Court of Appeals.
Last year, GSK appealed to the Seventh Circuit a verdict from a federal jury in Chicago, ordering the drugmaker to pay $3 million to Wendy Dolin, the widow of Chicago lawyer Stewart Dolin, who committed suicide by stepping in front of a train in Chicago’s Loop in July 2010 after taking a generic version of Paxil, an antidepressant developed by GSK.
Lisa Blatt
| Arnold & Porter LLP
In her lawsuit, Wendy Dolin alleged GSK should be held liable for her husband’s death because the warning label on the paroxetine – the generic equivalent of Paxil – he was taking at the prescription of his doctor, did not adequately warn of the risk of suicidal behavior.
GSK centered its defense in briefs filed in U.S. District Court in Chicago, and in arguments at trial, on the contention the language used on the warning label – which notes “a statistically significant increase in the frequency of suicidal behavior in patients treated with paroxetine” – was set by the U.S. Food and Drug Administration, and was left that way even after GSK attempted to persuade the regulatory agency to alter it further to address concerns over suicide risk.
GSK also argued, under legal precedent, it cannot be held liable for the decision of a patient who took a medication it did not manufacture, distribute or sell.
Judges presiding over the case, however, repeatedly refused to grant GSK’s motions for judgment on those grounds, noting they believed GSK did not press the agency enough to the warning label’s language.
Ultimately, the jury found Dolin, prompting the appeal.
In the months since, both sides have exchanged briefs to the Seventh Circuit, and oral arguments have been set for May 30 in the case, which is being closely watched by many, as it tests the legal limits of liability that can be imposed on the makers of a name brand drug for the alleged effects of a generic equivalent made by others.
However, it is only one of several such cases pending on that question nationwide.
In West Virginia, that state’s Supreme Court weighed in on May 11, after being asked by the U.S. Fourth Circuit Court of Appeals, based in Cincinnati, to rule on the question of what West Virginia law may hold on the question of “innovator liability.”
In the West Virginia case, plaintiffs Kimmy and Larry McNair had sued Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, in 2012, alleging Kimmy had developed acute respiratory distress (ARDS) after taking levofloxacin, a generic equivalent of Janssen’s Levaquin.
The couple alleged Janssen was aware that ARDS had been linked to the use of the drug, but had failed to properly warn of the risk on the drug’s label, which, as in GSK’s case, was approved by the FDA, and also applied to the generic equivalent.
The case eventually landed before the Fourth Circuit, which submitted a certified question to the West Virginia state Supreme Court to interpret the state’s law.
The West Virginia court issued a 3-2 decision on May 11, finding “that a brand manufacturer does not owe a duty to a consumer who uses a generic drug.”
"We find that a consumer allegedly injured by a generic drug cannot bring a strict liability failure to warn claim against the brand manufacturer who did not manufacture that drug," West Virginia Supreme Court Justice Allen Loughry wrote in the majority opinion. "We, likewise, find that a negligent misrepresentation claim against a brand manufacturer for injuries allegedly caused by a generic drug is not viable under our products liability law.”
The majority noted its findings were in line with decisions from “all federal circuit courts that have considered the question … under the laws of different states.”
In dissent, West Virginia Chief Justice Margaret Workman warned: "The failure to impose liability will necessarily invite inattention and neglectfulness by brand-name manufacturers, a transgression for which our citizens will have no legal recourse. The majority’s decision is short-sighted and ill-advised.”
The West Virginia decision, however, is just one of several delivered by state supreme courts in recent months and years, producing mixed results from state to state. In Massachusetts, for instance, that state’s high court came down exactly opposite of West Virginia, finding “a brand-name manufacturer that controls the contents of the label on a generic drug owes a duty to consumers of that generic drug not to act in reckless disregard of an unreasonable risk of death or grave bodily injury.”
In her May 14 letter to the Seventh Circuit, however, GSK attorney Blatt urged the panel to give credence to the West Virginia court’s findings, drawing attention to the “policy considerations” concerning potential damage an alternative finding could wreak on the marketplace.
“Because brand manufacturers receive no revenue from generic sales, the court explained, innovator liability ‘would sever the connection between risk and reward … that forms the basis of products liability law,’” Blatt wrote. “Innovator liability also would add ‘significant litigation costs … to the price of new drugs to the disadvantage of consumers.’
“Increased costs ‘could stifle the development of new drugs, which would have negative health consequences for society.’ … ‘[T]he proper remedy for consumers harmed by generic drugs,’ McNair concludes, ‘rests with Congress or the FDA.’”
Editor's note: The West Virginia Record contributed to this report.