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# Lawyer Praises Minn. Court Preemption Decision
- URL: https://www.fdaweb.com/lawyer-praises-minn-court-preemption-decision/
- Published: 2016-06-08T12:00:00.000Z
- Updated: 2026-09-14T21:08:25.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5135873

Attorney **John Sullivan**, writing in a *Drug & Device Law* blog [post](https://www.druganddevicelawblog.com/2016/06/minnesota-gives-us-another-excellent-preemption-decision.html?ref=fdaweb.com), praises a Minnesota state court decision that all claims in a suit against Medtronic are preempted by federal regulations. The case involved allegations that the plaintiff had complications from a pain pump implant. The suit alleged a number of state law claims that must be preempted unless the plaintiff can properly state parallel violation claims. “The court effectively described how express and implied preemption work together to create a near air-tight seal that leaves plaintiffs only a ‘narrow gap’ in which to try to fit such claims,” Sullivan writes. “Their claims must be premised on conduct that violates FDA regulations but cannot seek to directly enforce those regulations. Rather, their state-law claims must be such that they would give rise to a recovery even if the FDA regulations didn’t exist.”

Claims the court dismissed included: 

- Medtronic’s alleged violations of current good manufacturing practice (cGMP) as evidenced through FDA Warning Letters, a complaint for permanent injunction, and a consent decree for permanent injunction. The court held that the plaintiffs never identified a particular cGMP that was violated or alleged that the cGMP was specific to the pain pump’s PMA approval, as required to state a parallel violation claim.
- Medtronic’s alleged failure to provide a warning related to post-marketing events. “Since this claim did not point to conduct that violated an FDA requirement, but rather was based on requirements different from or additional to FDA requirements,” Sullivan writes, “the court held that this claim was also preempted.”
- Medtronic’s alleged improper promotion of the pain pump for off-label use. The plaintiffs identified no Minnesota law that prohibits off-label promotion.
- Medtronic’s alleged failure to train medical providers on the proper techniques to install the pain pump. The court held that the plaintiffs alleged nothing suggesting that the alleged failure to train violated any requirement in the pump’s PMA approval.

 Sullivan says that while the court gave the plaintiffs another opportunity to plead their claims, it’s highly doubtful that they will be able to do so.