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# 2 Courts Dismiss Claims in Medtronic Cases for Different Reasons
- URL: https://www.fdaweb.com/2-courts-dismiss-claims-in-medtronic-cases-for-different-reasons/
- Published: 2017-03-08T12:00:00.000Z
- Updated: 2026-09-14T22:10:30.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5138156

Attorney **Michelle Yeary** (Reed Smith) says that federal courts in Ohio and California both found that all claims brought against Medtronic’s PMA-approved pain pump device were completely preempted, although they reached their conclusions through different means. Writing in an online blog [post](http://www.mondaq.com/unitedstates/x/575022/Life+Sciences+Biotechnology/A+Pair+of+Pain+Pump+PMA+Preemption+Cases?ref=fdaweb.com), she compares the two decisions: 

- **Manufacturing Defect**—in both cases, she says, plaintiffs appeared to attempt to base their claims on alleged violations of current good manufacturing practices (CGMPs), which are general, open-ended, non-device specific regulations. Yeary says there is a current split in authority on whether CGMPs are specific enough to support a parallel violation claim. She does not think they are, and the Ohio decision tended more in that direction, she writes. Without an alleged specific violation, she says, the plaintiff is essentially arguing that FDA’s manufacturing process is insufficient. Because that would make Ohio state law different from or in addition to federal law, the claim is preempted. In California, the court found that the plaintiff’s allegations about CGMP violations were sufficient to state a parallel claim that survived express preemption. But because the plaintiff based his claim entirely on alleged violations of federal requirements, the claim was impliedly preempted.
- **Failure to Warn**—In Ohio, Yeary says, the claim was preempted because the state does not have a requirement to report adverse events to FDA, holding that the duty to report to FDA is not the same as the state law duty to warn doctors or their patients. The court also noted that a failure to report adverse events to FDA is not really a failure to warn. In California, the court allowed a failure to report adverse events to FDA claim, but the plaintiff also alleged a traditional failure to warn patients and doctors claim. Yeary says that such a claim is expressly preempted and the court made no effort to separate the two portions of the failure to warn claim and dismissed it in its entirety.
- **Express Warranty**—In the Ohio case, the plaintiff alleged that the company breached express warranties that the device was safe and effective. To approve the claim, the jury would have had to find that the device was not safe and effective, directly contrary to FDA’s PMA finding. That led to express preemption. The California plaintiff based an express warranty claim on statements made in product literature and labeling. For that claim to succeed, the jury would have to find that the device did not conform to the approved labeling. That also would contradict the agency’s PMA findings and so is expressly preempted.
- **Implied Warranty**—The Ohio court dismissed an implied warranty claim for the same reasons it dismissed the express warranty claim. In California, the court ruled that during the PMA process FDA is determining whether a device is fit for ordinary use and then establishes federal requirements to assure that the device is so fit. The defendant’s sole allegation was that Medtronic violated FDA requirements. So as with the manufacturing defect claim, the breach of implied warranty claim was impliedly preempted.

Yeary also describes the courts’ decisions in terms of misrepresentation and fraud, negligence, duty to train, and consumer protection.