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# 7th Circuit Upholds Generic Drug Preemption
- URL: https://www.fdaweb.com/7th-circuit-upholds-generic-drug-preemption/
- Published: 2016-02-10T12:00:00.000Z
- Updated: 2026-09-15T02:34:59.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5134726

> The 7th Circuit Court of Appeals has dismissed with prejudice a case seeking to avoid federal preemption of a state action against Qualitest, manufacturer of generic allopurinol, indicated to treat gout. The case was brought by a man who developed Stevens-Johnson-Syndrome after taking allopurinol.  
>  
> The federal government asked to have the case dismissed for failure to exhaust administrative remedies and Qualitest moved to dismiss on the grounds that the state tort claims were preempted by federal drug regulations that impose an “ongoing duty of sameness” on generic drug manufacturers to mirror the chemical design and labeling of their brand-name counterparts, according to a *Product Liability Monitor* [report](http://product-liability.weil.com/pharmaceutical-law/state-law-claims-generic-drug-manufacturer-cannot-escape-mensing-preemption-7th-circuit/?ref=fdaweb.com).  
>  
> The court rejected all three of the plaintiff’s arguments why the case should not be preempted. He first said that his state-level claims did not necessarily require Qualitest to change the drug’s design or label. The court said that argument was “self-defeating” because the lawsuit alleged that under state law the company should have labeled or designed the drug differently.  
>  
> The second argument relied on a line of Supreme Court cases involving deceptive advertising claims against cigarette and pesticide makers. The court held that in contrast to the plaintiff’s suit, claims in those cases did not require manufacturers to violate any federal duty.  
>  
> Finally, the suit said that court decisions establishing preemption should not apply because the claims in this case arose after passage of the FDA Amendments Act of 2007, which gave FDA authority to negotiate changes in drug labeling with generic drug manufacturers. The court noted that the FDA amendments still “forbid a generic drug maker from violating the duty of sameness without FDA permission.”