United States: A Pair of Pain Pump PMA Preemption Cases

Last Updated: March 8 2017
Article by Michelle Yeary

This post is from the non-Reed Smith side of the blog.

Within days of each other, courts in Ohio and California entered decisions finding all claims brought against Medtronic's pre-market approved ("PMA") pain pump device completely preempted – Warstler v. Medtronic Inc., 2017 WL 769810 (N.D. Ohio Feb. 28, 2017) and Martin v. Medtronic Inc., 2017 U.S. Dist. LEXIS 26350 (E.D. Cal. Feb. 24, 2017). While the two courts eventually reached the same destination – the route each took to get there was a little bit different. So, let's compare the journey.

Manufacturing defect: In both cases plaintiffs appear to attempt to base their claims on alleged violations of Current Good Manufacturing Practices ("CGMPs") – general, open-ended, non-device specific regulations. There is a current split in authority on whether CGMPs are specific enough to support a parallel violation claim. We think not. Ohio leaned more toward our thinking on this issue. Plaintiff Warstler failed to allege that the defendant deviated from any "specific FDA-prescribed manufacturing requirement." Warstler, at *6. Without an alleged violation, plaintiff is essentially arguing that the FDA's manufacturing process is insufficient. That would make Ohio state law different from or in addition to federal law and therefore the claim is preempted. When the court looked at the CGMPs cited by plaintiff, it couldn't find one that "is not so vague as to be incapable of enforcement." Id. at *7. In California, on the other hand, the court found that plaintiff's allegations about CGMP violations were sufficient to state a parallel claim so that plaintiff's claim survived express preemption. Martin, at *18-19. But, because plaintiff based his claim entirely on alleged violations of federal requirements, the claim was impliedly preempted. Id. at *19. To have a non-preempted parallel claim, plaintiff must be suing for conduct that violated the FDCA but not because the conduct violates the FDCA. The Martin complaint apparently gave only a cursory nod to the state law basis for his claim, alleging only generally that plaintiff did not take reasonable care in manufacturing. Id. at *20.

Failure to Warn: Again, Ohio is a bit more straightforward. If a failure to warn claim requires a defendant to provide any warning different than that required by the FDA, the claim is expressly preempted. Warstler, at *7. So plaintiff tried a Stengel failure to report adverse events to the FDA claim. But Ohio doesn't have any substantially identical requirement – the duty to report to the FDA is not the same as the state law duty to warn physicians or their patients. Id. at *8. Without a state law basis, the claim was preempted. And the court also noted that a failure to report adverse events to the FDA is not really a failure to warn. There is no obligation that the FDA make the adverse events reported to it public. We think this should undermine any argument that a failure to report claim is a failure to warn claim. They aren't the same. In California, however, the court is bound by Stengel. Plaintiff, however, alleged not only a Stengel failure to warn claim, but also a traditional failure to warn plaintiff and physicians. The latter is expressly preempted. The court made no effort to parse out the Stengel portion of the claim and dismissed failure to warn in its entirety. Martin, at *22-23.

Express Warranty: In Warstler, plaintiff alleged that defendant breached express warranties that the device was safe and effective. So, to prevail on this claim, the jury would have to find the device was not safe and effective – directly contrary to the FDA's PMA finding that the device is both safe and effective. That's express preemption. Warstler, at *8. In Martin, plaintiff based his express warranty claim on statements made in product literature and labeling. To prevail on this claim, the jury would have to find that the device did not conform to the FDA approved labeling. Another direct contradiction to the FDA's PMA findings and so another ruling of express preemption. Id. at *25.

Implied Warranty: In Warstler, the court dismissed plaintiff's implied warranty claim for the same reasons it dismissed express warranty. In Martin, the grounds were a little different. The court ruled that during the PMA process the FDA is determining whether the device is fit for ordinary use and then establishes federal requirements to assure the device is so fit. But plaintiff was not alleging that the device was used for a purpose other than that approved by the FDA. Rather, plaintiff's sole allegation is that the defendant violated FDA requirements. So, like with the manufacturing defect claim, plaintiff's breach of implied warranty was also impliedly preempted. Martin at *26-27.

Misrepresentation and Fraud: Here both courts use reasoning similar to that used to dismiss the express warranty claims. Warstler's analysis is virtually identical. Warstler at *9. Martin found the claims both expressly and impliedly preempted. Expressly to the extent plaintiff takes issue with FDA approved statements in product labeling and literature. Impliedly to the extent plaintiff alleges defendant misrepresented something to the FDA (fraud-on-the-FDA). Martin at *29.

Negligence: Plaintiff in Warstler alleged a general negligence claim which the court dispensed with by stating that imposing a reasonableness standard would be different or additional requirement to the FDA's PMA established requirements for the device. Warstler at *9-10.

Duty to Train: In Martin, plaintiff brought a duty to train claim but failed to allege that defendant's training procedure deviated from the one approved by the FDA in the PMA process. Martin at *31. So, if defendant adhered to the federal requirements, any finding that it failed to properly train would impose a requirement different from or in addition to federal requirements. The claim was expressly preempted. Id. at *32.

Consumer Protection: Plaintiff in Martin also alleged that defendant violated the California Unfair Competition Law. Once again, however, plaintiff appears to have overplayed his hand. In the briefing on the motion to dismiss, plaintiff conceded that his claim was "entirely based on violation of federal law." Id. at *34. That was enough for the court to find the claim impliedly preempted.

The Martin decision goes on to find that plaintiff also failed to sufficiently plead any of this causes of action and dismisses the claims on that basis as well. Id. at *35-46.   It appears some of that poor pleading is also what led to some aspects of the preemption dismissals as well. So, plaintiff is being given an opportunity to amend his complaint. The Warstler decision doesn't say anything about leave to amend and the more direct preemption rulings may be more difficult to plead around, but plaintiff could give it another try there to.

Some say the journey is more important than the destination. Frankly, we don't care if courts choose express preemption or implied preemption, as long as they don't choose that narrow gap in the middle.

This article is presented for informational purposes only and is not intended to constitute legal advice.

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