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# FDAAA Doesn’t Change Preemption: 7th Circuit
- URL: https://www.fdaweb.com/fdaaa-doesnt-change-preemption-7th-circuit/
- Published: 2016-10-26T12:00:00.000Z
- Updated: 2026-09-14T21:42:47.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137182

The 7th Circuit Court of Appeals has rejected a plaintiff’s argument that the FDA Amendments Act of 2007 (FDAAA) changed generic drug labeling requirements such that failure-to-warn claims are no longer preempted. Attorney **Stephen McConnell** (Reed Smith) [writes](https://www.druganddevicelawblog.com/2016/10/seventh-circuit-holds-that-fdaaa-does-not-affect-mensingbartlett-preemption.html?ref=fdaweb.com) online in the *Drug and Device Law* blog that the plaintiff said she had taken both branded and generic versions of hormone therapy drugs and they caused her to get breast cancer. She alleged defective product and failure-to-warn claims under Wisconsin law.

The generic manufacturers argued that the claims were preempted by federal law, McConnell writes, and a federal district court agreed and granted their motion for summary judgment. The plaintiff appealed to the 7th Circuit, arguing that FDAAA changes meant her claims were not preempted and also saying that her claims are not preempted to the extent they are based on the failure to update the generic drug labels to match updated labels on the innovator drug.

“The FDAAA imposed certain obligations on generic drug manufacturers when they propose labeling changes,” the court ruled. “But the FDAAA did not remove the prohibition against doing so unilaterally.” Thus, McConnell says, the Supreme Court *Mensing* and *Bartlett* decisions remain in full force and the tort claims are preempted.

Addressing the plaintiff’s alternative approach saying that her claims were not preempted to the extent they were based on the failure to update the generic label to match the innovator label, the court cited a procedural problem, according to McConnell. Since the plaintiff had failed to raise that theory in her initial complaint, the court reasoned that she was making “an untimely request of this court for leave to file a second amendment complaint.” She didn’t seek leave to amend her complaint before the district court and can’t do so now, the appeals court held.