By: Jonathan A. Knoll, Attorney
In a previous blog article, I wrote about the impact that the United States Supreme Court’s 2013 decision in Mutual Pharmaceutical Co., Inc. v. Bartlett had on injured consumers of generic drugs. In Bartlett, the Court held that state-law design defect claims against generic drug manufacturers that turn on the adequacy of a drug’s warnings are pre-empted by federal law. Bartlett was an extension of the Court’s 2011 decision in PLIVA, Inc. v. Mensing, which found that state-law failure to warn claims against generic manufacturers are pre-empted under federal law.
A recent opinion from the United States District Court for the Northern District of Illinois provides some much needed good news for injured consumers of generic drugs. In an opinion by District Judge James B. Zagel, the Court ruled that a name-brand drug manufacturer could be held liable for injuries sustained by a consumer, even though the consumer used a generic form of the drug.
In Dolin v. Smithkline Beecham Corporation d/b/a GlaxoSmithKline et al., No. 12 C 6403, plaintiff brought a wrongful death action against defendants SmithKline Beecham Corporation d/b/a/ GlaxoSmithKline (GSK) and Mylan Inc. Plaintiff’s husband was prescribed Paxil, which is the name-brand version of the drug paroxetine hydrochloride (“paroxetine”). Paxil is manufactured by GSK. However, the husband’s prescription was filled with, and thus he ultimately used, a generic version of paroxetine that was manufactured by Mylan.
Tragically, the husband committed suicide. At the time of the husband’s death, the label for paroxetine did not warn of the drug’s association with the increased risk of suicidal behavior in adults. Plaintiff alleged that GSK and Mylan failed to warn of the risk of harm.
GSK moved for summary judgment and Mylan moved to dismiss plaintiff’s claims. The Court dismissed Mylan, finding that plaintiff’s claims against the generic manufacturer were preempted under federal law pursuant to Mensing and Bartlett. While the Judge granted GSK’s summary judgment motion with regards to plaintiff’s strict-liability claim, the Judge held that GSK could be found negligent.
Judge Zagel rejected GSK’s argument that plaintiff’s negligence claims were merely disguised products liability claims. Plaintiff’s negligence claims concerned the adequacy of the drugs’ warning label, which is extrinsic to the manufacturing process of the brand-named drug. If plaintiff’s allegations were true, GSK’s negligence “could proximately cause injury to consumers of all versions of paroxetine,” including the generic drug that was used by the plaintiff’s husband.
Judge Zagel noted that (1) generic drug manufacturers are required by law to use the warning label produced by the name-brand manufacturer of the drug, and (2) any defects in the warning label can only be fixed by the brand-name manufacturer. GSK failed to show why the likelihood of harm was “so remote as to undo GSK’s duty of care.” It was foreseeable that if GSK was negligent with regards to the adequacy of the drug’s warning label, GSK’s negligence could result in injuries to consumers taking the generic version of the drug.
As the Judge noted, “[w]hether a consumer ingests the name-brand or generic version of a given drug is immaterial as to the likelihood that negligence in the design or warning label of that drug will cause injury.” Accordingly, the Judge allowed plaintiff’s negligence claims to proceed past summary judgment. Contact us for a free consultation.