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

It’s been awhile since we’ve posted about PMA preemption in an Infusion case – but that litigation continues to make good law.  This time in Minnesota state court which fortunately took a lot of its cues from strong federal law.  In Stiltner v. Medtronic Inc., 2016 WL 4005471 (Minn.Dist.Ct. Jul. 25, 2016) the court dismissed all of plaintiffs’ claims as preempted and while the dismissal is without prejudice, the court laid down tough pleading standards for plaintiff to meet if he wants to try a comeback.

Plaintiff had an Infusion pain pump installed and that particular pump model was recalled about one year later.  Three years after the recall, plaintiff began experiencing complications which necessitated revision and re-implantation surgeries.  Id. at *1.   Plaintiff brought claims for manufacturing defects, failure to warn, negligence, breach of express and implied warranties, and violations of the Minnesota Consumer Fraud Act.  Id.  Because the Infusion pain pump was Pre-Marketed Approved (“PMA”) by the FDA, it is subject to both Riegel express preemption and Buckman implied preemption.  Therefore, in response to defendants’ motion to dismiss, plaintiff had to demonstrate that his claims fit within the “narrow gap” left open between Riegel andBuckman – emphasis on the “narrow” part.  To pass through, plaintiff needs to be suing for conduct that violates the FDCA (the state law claim must parallel device-specific regulations to survive express preemption) but not suing solely because the conduct violates the FDCA (such a claim would be impliedly preempted).  Id. at *4.

Plaintiff attempted to overcome preemption by relying on the recall and by citing to certain FDA actions such as warning letters issued to defendants to establish that defendants violated Current Good Manufacturing Practices (“CGMP”) regulations.  Id. at *1.  But in assessing the sufficiency of plaintiff’s pleadings, the court concluded that plaintiff simply surmised that “because of the [FDA warnings] and Defendants’ . . . recall of the Device, Defendants must have violated federal regulations which must have resulted in injury to Plaintiff.”  Id. at *6.  “Must have” is about on par with “would of, should of, could of.”  Not nearly enough.

On this point the court was clear.  To even have the chance at surviving a PMA preemption challenge, plaintiff had to plead that defendants failed to comply with device-specific regulations implemented through the PMA process, that such failure to comply caused the product to malfunction, and must plead sufficient facts to establish a causal nexus between the plaintiff’s alleged injury and the alleged regulation violations.  Id. at *4.   We are used to seeing these types of strict pleadings requirements in federal court and are happy to see them being embraced in the states.  Plaintiff has to point to specific PMA requirements for the specific device at issue that were violated that caused plaintiff’s specific injury.   Without that level of specificity the court can only assume plaintiff is attempting to impose requirements on defendants that are different from or in addition to federal regulations.  Id.

As to whether CGMP regulations, which are not device-specific, are specific enough to form the basis for a parallel violation claim, the Minnesota court acknowledged the split in the federal circuits.  While the Eighth Circuit has concluded that CGMPs are too generic, the Minnesota Court of Appeals “stopped short” of reaching that conclusion based on insufficient pleadings in the case they considered.  Id. at *5.  The Stiltnercomplaint being similarly deficient, this court likewise did not reach the ultimate issue of whether CGMPs could ever serve as a basis for a parallel claim, but did find that plaintiff failed to plead sufficient facts to demonstrate “a causal connection between aspecific CGMP violation and the alleged malfunction of the specific Device implanted in Plaintiff’s body that allegedly caused Plaintiff’s injury.”  Id. (emphasis added).

Finally, on failure to warn, plaintiff alleged defendant failed to provide the FDA with post-marketing adverse event reports.  We think the best decision on such claims is to call them impliedly preempted – attempts at private enforcement of FDA regulations – without any need for further inquiry.  If a court is unwilling to make that broad pronouncement, then we certainly appreciate adoption of a narrow interpretation of the alleged duty enforced via tight pleadings requirements:

[Plaintiffs] may, however, seek relief for a parallel claim under state law for Defendants’ alleged failure to advise the FDA of adverse events if Plaintiffs can show: (a) that Defendants violated an FDA-imposed specific PMA requirement to the Device that Defendants advise or warn the FDA of post PMA adverse events involving said Device; (b) that Defendants’ alleged conduct would give rise under state law to recovery in the absence of the FDCA requirement; (c) that the alleged failure to advise the FDA caused Plaintiff’s injuries.

Id. at *7.  We aren’t convinced that any duty to report to the FDA can be rooted in traditional state tort law, so we think no plaintiff should ever pass point (b) on the above checklist, but even if they do, the causal nexus won’t be easy to overcome either.  In this case, the court only needed to find that plaintiff failed to allege causation to dismiss the failure to warn claim.  Id.

The court used the word specific 21 times in its decision – which we consider a not subtle directive to plaintiff that if he files an amended complaint it better have a whole lot more than “must have” to justify his claims.  And if the best plaintiff has is CGMPs and failure to report to the FDA, we specifically doubt his specific ability to be sufficiently specific.