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This post comes from the non Reed Smith side of the blog.


Minnesota is one of our most beautiful states and the setting for much of the terrific TV anthology series Fargo. But Minnesota is also home to a significant number of well-reasoned preemption decisions. While we’ll concede that beautiful lakes and Fargo are (way) more interesting and entertaining than preemption law, this is a drug and device law blog. So today’s visit to Minnesota will offer you the wonderful opportunity to review a well-reasoned preemption decision, not to enjoy a lazy, scenic day on a lake or a mesmerizing, voyeuristic view of fake true-crime drama. You can visit Minnesota and its lakes on your own time. And we’ll certainly talk about Fargo once season three starts next year. But, for now, you get Lutz Cummings v. Medtronic, Inc., 2016 WL 3082314 (Minn. D. Ct. May 31, 2016) and preemption.

In Lutz, one of the plaintiffs had complications from a pain-pump implant and filed a complaint in Minnesota state court alleging a host of state-law claims. Since the pain pump is a PMA device, plaintiffs’ state-law claims are preempted unless they 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” into which try to fit such claims. 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:

Narrow Gap Between Express and Implied Preemption. State law claims involving an FDA-approved medical device are expressly and impliedly preempted by federal laws and regulations. A plaintiff may pursue state law claims involving an FDA-approved medical device only to the extent plaintiff can show that such claims escape express and implied federal preemption as contemplated by existing federal regulations and case law. In evaluating an allowable claim, the Minnesota federal district court in Riley v. Cordis Corp., states:

Riegel and Buckman create a narrow gap through which a plaintiff’s state-law claim must fit if it is to escape express or implied preemption. The plaintiff must be suing for conduct that violates the FDCA (or else his claim is expressly preempted by section 360 k(a)), but the plaintiff must not be suing because the conduct violates the FDCA (such a claim would be impliedly preempted under Buckman). For a state-law claim to survive, then, the claim must be premised on conduct that both (1) violates the FDCA and (2) would give rise to a recovery under state law even in the absence of the FDCA.

625 F. Supp.2d 769, 777 (D. Minn. 2009).

Lutz, 2016 WL 3082314, at *4 (all emphasis in original). Not only did plaintiffs have to deal with the limited availability of parallel violation claims, they also had to allege facts that made those claims plausible under the pleading requirements of TwIqbal. With this construct in place, the court set about dismissing plaintiffs’ attempted parallel violation claims one at a time.

The court dismissed Plaintiffs’ claim premised on defendants’ alleged violation of cGMPs. While plaintiffs attempted to support this claim with four FDA warning letters, an FDA complaint for a permanent injunction and a consent decree for a permanent injunction, they 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. Id. at *5. Having failed to allege conduct that violated an FDA requirement, the court dismissed this claim.

Plaintiffs claimed that the defendants failed to provide a warning related to post-marketing events. But a failure to warn claim, whether based on post-marketing events or not, is a preempted claim. It seeks “to impose obligations on the Defendants beyond those mandated by federal law.” Id. 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, the court held that that this claim was also preempted.

Plaintiffs claimed that defendants failed to report post-marketing adverse events to the FDA. But plaintiffs alleged no link between the alleged failure to report adverse events and plaintiffs’ injuries: “Plaintiffs’ have not pled sufficient facts to establish that Defendants’ alleged failure to report to the FDA adverse events contributed to Plaintiff’s injuries.” Id. at *6.

Plaintiffs claimed that defendants improperly promoted the off-label use of the pain pump. But plaintiffs identified no Minnesota state law that prohibits off-label promotion:

The Minnesota Court of Appeals held in Angeles v. Medtronic, Inc. 863 N.W.2d 404, 416 (Minn. Ct. App. 2015) that “there is no state-law duty to abstain from off-label promotion.” Since there is no Minnesota state cause of action for alleged misrepresentations in off-label promotion of a federally pre-approved device, such a claim cannot be the basis of an allowable parallel claim. See, Riley v. Cordis Corp., 625 F. Supp. 2d 769, 777 (D. Minn. 2009).

Id. Frankly, plaintiffs will struggle to identify an FDA regulation that prohibits such promotion. The court held that this claim was also preempted.

Finally, plaintiffs claimed that defendants failed to train medical providers on the proper techniques to install the pain pump. But plaintiffs alleged nothing suggesting that this alleged failure to train violated any requirement set out in the pain pump’s PMA approval. Id. And, although the court didn’t mention it, we suspect that plaintiffs would be unable to identify a Minnesota state law claim addressing such a failure to train. The court dismissed this claim too.

The Lutz court, relying on and citing other Minnesota decisions, laid out a construct that illustrates how difficult it is and should be for plaintiffs to allege parallel violation clams. They are rare exceptions, not just another set of claims that plaintiffs can successfully make if they simply check off the right boxes.

The Lutz court gave plaintiffs another chance to try to plead their claims. It’s highly doubtful that they will be able to do so, which is as it should be.