Readers of the blog will remember that I have been following the debate and the cases on preemption of claims against manufacturers of generic drugs based on inadequate warnings (most recently here and here.)
In an interesting twist to the plot, now comes a decision of the Illinois Appellate Court involving a claim based on a design defect. In this case, called Guvenoz v. Target Corp., 2015 IL App (1st) 133940 (March 27, 2015), the plaintiff Guvenoz alleged that her husband, Lewis Guvenoz, suffered severe
brain damage and eventually died from a heart attack caused by
prescribed dosages of propoxyphene, a generic version of a brand name drug known as Darvocet. The plaintiff sued the manufacturer
manufactured of the generic version taken by her husband. Six months after the decedent's cardiac arrest resulted in anoxic
encephalopathy, the Food and Drug Administration banned Darvocet as
unreasonably dangerous. But Guvenoz argued the manufacturers knew about
correlations between Darvocet and fatal heart arrhythmias, knew the
medication wasn’t very effective and knew the risk of death and serious
injury outweighed the drug’s benefits.
Because the plaintiff argued that the drug was so dangerous and of so little benefit that it
should not have been manufactured or sold (the essence of a design defect claim), the crucial question of law for the Illinois Appellate
Court was whether Nicole Guvenoz’s state law claims were pre-empted by
the Bartlett/Mensing line of cases which hold state claims for inadequate warnings against manufacturers of generic drugs are pre-empted by federal law (because federal law forces them to use the exact same warnings used by brand name manufacturers).
Directly addressing this question, the court concluded that “the logic of Bartlett and Mensing does not apply to plaintiff’s claims, and their holdings do not pre-empt the state law claims in this case.” According to the court, the facts in the case at bar are very different from the facts in both Bartlett and Mensing. In the case at bar, plaintiff alleges that there was no group of
patients for whom the drug’s benefits outweighed its risks. 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. In the case at bar, plaintiff alleged that the drug was simply unsafe
and should not have been sold at all, and there was no warning which
could have cured the problem.