Federal District Court Judge Rules That Brand Name Manufacturer Can Be Found Negligent For Warning Label On Generic Drug

March 13, 2014

Recently, a federal district court in Illinois ruled that GlaxoSmithKline could face liability for the suicide of a partner from Reed Smith, even though the partner took a generic version of the company's product, Paxil, instead of the named brand. This is significant, as for a long time, it has been an established belief that brand name manufacturers could not be sued for the flaws in the generic versions. This was the first case of its kind to be considered in the Seventh Circuit.

pills-1161455-m.jpgBack in 2010, six days after he began taking paroxetine hydrochloride for anxiety and depression, Stewart Dolin committed suicide. Dolin's wife, Wendy, then sued GlaxoSmithKlein and the manufacturer of the generic drug, Mylan Inc., arguing that they failed to warn adult users that the drug increased the risk of suicidal behavior. The Illinois district court judge, James Zagel, dismissed part of the lawsuit on the grounds that GlaxoSmithKlein could not be sued for product liability. However, he permitted the rest of the lawsuit to go forward on the issue of whether GlaxoSmithKlein was negligent.

The judge noted that negligence was still available due to a question of whether the warning label on the generic Paxil contained sufficient information highlighting the drug's dangers. His ruling deviated from nearly 90 other decisions on this subject, which found that the brand name manufacturers could not be held responsible for the generic's defects under any circumstances, even in the case of negligence. Only a handful of courts in California, Alabama, and Vermont had determined otherwise.

Judge Zagel's reasoning was based on his reading of the Hatch Watchman Act, which prohibits generic drug manufacturers from independently changing warning labels that had been established by the brand name company. He therefore claimed that the brand name company had a legal duty to ensure that the warning label properly warned users of potential dangers.

This ruling may only apply to a federal district in Illinois, but it has the potential to influence decisions about drug manufacturer lawsuits across the Seventh Circuit and even across the country. If GlaxoSmithKlein is found liable and appeals to the Seventh Circuit, and that court sides with Judge Zagel, then Indiana and other states in the Seventh Circuit could be impacted. Yet even if that never happens, Judge Zagel's ruling has provided a strategy for personal injury attorneys who have long sought to hold brand name manufacturers responsible for product failings. Until then, personal injury attorneys have found themselves constrained by a United States Supreme Court ruling in 2011, which stated that federal labeling law preempted claims against generic drug manufacturers.

As generic drugs are a large part of our pharmaceutical purchases, it is important that manufacturers be held accountable for them, even if only in regards to whether the warning label was proper. Judge Zagel's ruling is an encouraging development for consumers everywhere.

Miller & Falkner is an Indiana and Kentucky plaintiffs law firm serving residents of Kentucky and Indiana. Located in Louisville, Kentucky, the firm provides representation in the areas of personal injury and employment law. If you need an Indiana personal injury attorney, contact us today for a free consultation.

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