Getting it Right on PMA Preemption

We all know that getting it right isn’t as easy as it sounds. Straightforward application of established law ought to be simple.  If only it were so. Today’s decision gets it right, and we’re happy to report on Wilhite v. Medtronic, Inc., 2024 WL 968867 (N.D. Ala., Mar. 6, 2024). 

Wilhite involved allegations that a Class III defibrillator malfunctioned and resulted in the plaintiff’s death.  The defendant recalled the defibrillator in 2021 due to possible battery depletion. Plaintiff had the device implanted prior to the recall, and she died about two months after the recall.  The amended complaint alleged that a physician determined that the cause of death was due to a problem with the defibrillator—either its generator stopped working or the device stopped emitting shocks.

After an initial round of removal, motion to dismiss, and an amendment, plaintiff brought claims under Alabama’s Extended Manufacturer’s Liability Doctrine (AEMLD) and asserted claims for negligence, negligence per se, wantonness, and breach of implied warranty. Plaintiff also included a general claim that the defendant made misrepresentations about the reliability and longevity of the defibrillator.  Before addressing the specific counts of the amended complaint, the Court provided an overview of the PMA preemption analysis.  The Court noted the rigorous process for PMA approval, emphasizing that the FDA spends an average of 1,200 hours reviewing an application for PMA.  Describing the role of the FDA, the Court recognized that the FDA may “approve devices that present great risks if they nonetheless offer great benefits in light of available alternatives.”  Id. at *3 (citing Riegel v. Medtronic, Inc., 552 U.S. 312, 318 (2008)).  The Court also walked through the express and implied preemption provisions of the Medical Device Amendments of 1976 (MDA), and recognized the possibility of a parallel state law claim.

The Court then turned to the plaintiff’s claims under the AEMLD and for negligence, negligence per se, wantonness and breach of warranty.  The Court read all these claims as asserting that the defibrillator was not reasonably safe either as approved by the FDA or because the design and manufacture of the defibrillator deviated from FDA requirements.  For the claims that the device was not reasonably safe as approved, the Court got it exactly right and recognized that those claims were expressly preempted by the MDA.

The Court also got it right on the plaintiff’s claim that the design and manufacture of the defibrillator deviated from the FDA’s approval requirements. Although the Court noted that such a claim might be capable of escaping express preemption, it is well settled in the Eleventh Circuit that for a claim to survive preemption, a complaint must allege specific facts establishing the deviation from FDA requirements. The plaintiff’s amended complaint fell short of this standard, alleging only that the defendant had a continuing duty to comply with the FDA requirements and that a violation of those requirements gave rise to a violation of state law duties. 

The Court characterized these allegations as nothing more than an “oblique suggestion” of a violation of an FDA requirement, and the “ultimate failing” of the amended complaint was “the absence of factual allegations accompanying the oblique suggestion.”  Id. at *5.  The amended complaint did not contain any factual allegations identifying a specific deviation from a federal requirement that caused sudden battery depletion. Absent those allegations, the claims in the amended complaint sought to impose requirements different from, or in addition to, the FDA’s requirements and were expressly preempted.

The Court also held that the plaintiff’s failure to warn claims were preempted.  Plaintiff alleged that the defendant failed to report certain adverse events to the FDA, but the Court could find no independent duty under Alabama law requiring a manufacturer to report adverse events to the FDA. Absent such an identified state law duty, plaintiff’s claims sought to enforce a duty owed only to the FDA, and those claims were impliedly preempted by the MDA. The same analysis applied to the plaintiff’s claim that the defendant should have recalled the device sooner. There was not an independent duty under Alabama law to recall the device, so that claim was also preempted.  The Court got it right again, and its straightforward application of established law is refreshing.

Turning to the last count of the amended complaint, the Court dismissed the plaintiff’s false representation claims under the good, old fashioned Rule 9(b) fraud analysis. The amended complaint did not include the substance of any false representations made by the defendant regarding the reliability or longevity of the defibrillator.  Instead, the amended complaint included only generalizations and legal conclusions.  Absent specific factual allegations of the actual misrepresentation, any claim sounding in fraud failed, and the Court did not need to determine whether those claims would have been impliedly preempted if sufficiently pleaded.

Finally, the Court held that the dismissal of the plaintiff’s claims was with prejudice.  The Court recognized that a plaintiff must be given at least one chance to amend. The prior amendment was filed “as a matter of course” and could not be considered a prior opportunity to amend. But in the Eleventh Circuit a district court is not required to afford a plaintiff leave to amend sua sponte where the plaintiff is represented by counsel. Since the plaintiff was represented by counsel and did not request leave to amend in response to the motion to dismiss, the Court was within its authority to dismiss the amended complaint with prejudice.  Id. at *7, n.6. Getting it right indeed.