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Saturday, October 19, 2019

Appeals court tosses $3M verdict vs GSK, says FDA, not drugmaker, controlled Paxil warning label


By Jonathan Bilyk | Aug 22, 2018

While not directly addressing the question of whether brand-name pharmaceutical makers should bear responsibility for the effects of a generic equivalent drug they did not make or sell, a federal appeals panel in Chicago has tossed out a $3 million verdict against pharmaceutical company GlaxoSmithKline, declaring the drugmaker can’t be sued under Illinois law for insufficiently warning of suicide risk on a drug’s label, when that label’s language was set by federal regulators.

On Aug. 22, a three-judge panel of the U.S. Seventh Circuit Court of Appeals said two U.S. District Court judges erred when they allowed to go to trial a lawsuit brought by the widow of a Chicago lawyer who committed suicide after taking paroxetine, a generic version of GSK’s name-brand antidepressant drug, Paxil.

The appeals judges said GSK had presented sufficient evidence time and again through the proceedings – before, during and after trial – to demonstrate it had no control of the drug labeling at the center of the case. Therefore, they said, the lawsuit should have been dismissed.

Michael Baum | Baum Hedlund

“GSK asked the FDA for permission to modify the paroxetine label as plaintiff argues was needed,” the appeals judges said. “The (U.S. Food and Drug Administration) said no, repeatedly.

“Federal law thus preempted plaintiff’s Illinois‐ law claim that GSK should have warned of a risk of adult suicidality on the paroxetine label in 2010.”

The decision was authored by Seventh Circuit Judge David Hamilton. Circuit Chief Judge Diane P. Wood and Circuit Judge Diane Sykes concurred in the decision.

Last year, a jury in Chicago federal court ordered GSK to pay $3 million to Wendy Dolin, the wife of Stewart Dolin, a lawyer who worked at the firm of Reed Smith LLP in downtown Chicago, and who committed suicide in 2010 by stepping in front of a CTA L train in Chicago’s Loop.

According to the lawsuit, Stewart Dolin committed suicide after taking paroxetine. Dolin filed suit against GSK in 2012 in Chicago federal court, asserting the warning label on the paroxetine allegedly did not adequately warn of the risk of suicidal behavior that could accompany taking the drug.

While the paroxetine prescribed to Dolin was made by another drug company, Dolin’s legal team asserted GSK should still be made to pay because the warning label for the generic paroxetine was required to be identical to that of the name-brand drug, Paxil. And that label, they asserted, had been written by GSK.

In response, GSK argued Dolin’s lawsuit shouldn’t be allowed to continue because it did not make the paroxetine prescribed to and taken by Dolin, and it did not have control of the warning label’s language. Rather, GSK noted repeatedly, that language was set under an order from the FDA – and the federal agency also repeatedly refused GSK’s requests to change that language to address potential suicide risk from paroxetine.

Throughout the proceedings, however, the federal district judges presiding over the lawsuit refused GSK’s attempts to dismiss Dolin’s lawsuit on those grounds, agreeing with Dolin’s lawyers that they believed GSK did not press the FDA enough to revise the warning labels.

Ultimately, GSK appealed the decision.

And the appeals judges said GSK’s assertions had been correct all along.

Specifically, in his decision, Judge Hamilton noted GSK had asked the FDA on four separate occasions to revise the labels to address adult suicide risk. The FDA, however, refused each time, and in 2007, ordered GSK to include standard language the FDA had approved for paroxetine and all similar antidepressants, which specifically referenced only suicide risk for those taking the drug who are 24 years old and younger.

And Hamilton said he found “unreasonable” the plaintiffs’ assertions GSK essentially didn’t try hard enough to win approval of a new label with more suicide-specific language, as the plaintiffs asserted the FDA merely objected to GSK’s suggestion for where to include the language on the label.

“Plaintiff asks us to believe that the FDA - after deciding against an adult‐suicidality warning based on its own analysis - rejected GSK’s warning only because GSK proposed putting it in the wrong place,” Hamilton wrote. “That is unreasonable.”

During oral arguments for the case earlier this year, Hamilton had repeatedly voiced doubts over the issue of so-called “innovator liability,” or the theory that the original makers of a drug – the “innovator” – should be held liable for the effects caused by others’ imitation product.

At that time, Hamilton voiced concerns such a theory could significantly harm the pharmaceutical industry, and consumers and patients who rely on the medications invented and manufactured by the industry.

His opinion, however, did not reference any of those concerns, instead centering entirely on the question of whether GSK should bear responsibility for the label, which he repeatedly noted was controlled by the FDA.

Since the label’s language was essentially dictated by the FDA, despite repeated attempts by GSK to revise the label, Hamilton said legal precedent should have required the judges to find the lawsuit was preempted by federal law, and therefore, to dismiss the lawsuit.

GSK is represented in the case by attorney Lisa Blatt, of Arnold & Porter Kaye Scholer LLP, of Washington, D.C. The company is also represented by Dentons US LLP, of Chicago and King & Spalding, of Atlanta, Ga.

Dolin is represented by the firm of Baum, Hedlund, Aristei & Goldman, of Los Angeles. Dolin is also represented by Rapoport Law Offices, of Chicago.

In response to the ruling, Michael Baum, senior partner at Baum Hedlund, released a prepared statement, saying: “We are surprised and disappointed by the ruling and respectfully disagree with the Court. We will be exploring what options are available for Ms. Dolin going forward.”

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Organizations in this Story

Arnold & Porter Kaye Scholer LLP Baum Hedlund Aristei & Goldman P.C. Dentons - Chicago Glaxo Smith Kline King & Spalding LLP Rapoport Law Offices PC Reed Smith LLP U.S. Court of Appeals for the Seventh Circuit U.S. District Court for the Northern District of Illinois U.S. Food and Drug Administration (FDA)

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