In 2010, Lewis Guvenoz was given a prescription for the generic version of Darvocet just months before the Food and Drug Administration pulled the drug from the market for a high risk of heart arrhythmias. While taking the drug as prescribed, Guvenoz suffered cardiac arrest that caused serious brain injuries and ultimately his death.
His wife, Nicole Guvenoz, filed a lawsuit in Cook County Circuit Court against Teva Pharmaceuticals USA Inc. and Target corp., whose Batavia pharmacy dispensed the prescription.
Guvenoz contended Teva and Target should not have marketed or sold the drug in the first place – once they knew the drug product was unsafe.
In a 34-page opinion written by 1st District Appellate Justice Robert E. Gordon, the panel found that the facts in the current case are different enough from those in the U.S. Supreme Court’s 2011 Mensing ruling and its 2013 Bartlett ruling that federal pre-emption does not apply.
“In the case at bar, plaintiff alleges that there was no group of patients for whom the drug’s benefits outweighed its risks,” Gordon wrote. “By contrast, in both Bartlett and Mensing, the drug was safe for the vast majority of patients taking it, and only a ‘very small number of patients suffered an adverse and severe reaction.’”
Because the drug was banned by the FDA, there was no issue whether Teva and Target should have stopped selling the drug.
“They should have, and they did,” Gordon wrote. “However, defendants argue that federal law provided them with a safe harbor for failing to stop earlier. Unfortunately for defendants, the Bartlett court has already rejected that idea.”
The panel ruled that federal law would pre-empt the negligence claim over altering the drug warnings – but that was not what Guvenoz alleged.
The Appellate Court also found that federal law requiring generic drugs to be the same as their name-brand equivalent does not shield generic manufacturers from strict-liability claims when they sell a drug that fails to perform as expected or has high risks that outweigh benefits.
Guvenoz was represented by Robert J. Napleton and Bradley Z. Schulman of Motherway & Napleton, LLP.