Last November we blogged about “specialized” preemption issues in several cases, including Mink v. Smith & Nephew, Inc., 2015 WL 7356285 (S.D. Fla. Nov. 19, 1015). The plaintiff in Mink claimed physical injuries from a metal-on-metal hip replacement. What made the Mink case unusual was that the plaintiff had been a clinical trial participant. Thus, in addition to the usual product liability personal injury claims, the plaintiff also challenged the early termination from the clinical trial, calling it a breach of contract. The hip replacement system had made it through the FDA’s rigorous Pre-Market Approval (PMA) process, and the court dismissed the plaintiff’s claims because, as summarized in our deathless prose, “participation in post-approval clinical trials doesn’t provide any extra basis for a plaintiff avoiding Riegel preemption.”
The plaintiff was afforded an opportunity to amend the complaint, and did so by adding much specificity as to how the medical device allegedly deviated from manufacturing and regulatory requirements. The claims at issue were: (1) negligence, (2) strict liability, (3) breach of contract, and (4) misrepresentation. But the result was no different: the court still dismissed the claims. Check that; the result was different. This time the dismissal was with prejudice. That decision is Mink v. Smith & Nephew, Inc., 2016 U.S. Dist. LEXIS 32519 (S.D. Fla. March 11, 2016), and some of the court’s prose, as well as its reasoning, is pretty deathless, too.
Though the plaintiff on this go-around offered more detail on what allegedly went wrong with the product, the claims again ran afoul of Riegel express preemption and, as well, Buckman implied preemption. How’s that? Because Florida law does not allow parallel claims as a matter of state law, it simply does not matter how elaborately a plaintiff pleads the purported FDCA violations – it is still an improper private enforcement case without state-law sanction. The court saw the negligence action as, “in essence, an action seeking to enforce the PMA requirements” against the defendant.
The court admits to being “perplexed” as to what kind of claim could survive the “narrow gap” between express and implied preemption. The answer in Florida is “none” because Florida state law has never recognized so-called parallel claims. The court was unaware of “any Florida law that requires a medical device manufacturer to include a specific patient in a product study, fund patient monitoring, report defects or adverse effects to the FDA, or the like.” (Note the Mink court’s admirable Erie restraint. Some other courts have not been the least bit shy about discovering, or – let’s be frank about it – inventing state causes of action that run eerily parallel to vague FDA proscriptions.) The Mink plaintiff’s breach of contract claim, alleging wrongful termination from a post-marketing clinical trial, cannot be a parallel claim because no FDCA regulation precludes his termination. Even aside from those specific wrinkles in the Mink case, the larger point is also correct: the parallel claim exception under Riegel is perplexing, and it has led to a plaintiff-run nonsense factory. If courts would shut it down, plaintiffs would stop trying to cobble together specious parallel claims, courts could stop wrestling with the issue, and we could (happily) stop blogging about it.
But, for now, we are not the least bit unhappy to report on a court that got the issue right.
Once again, we offer a tip of the cyber cap to Dave Walz for sending us this case, and congrats to Dave, Ed Gereke, Doug Moore, and David O’Quinn for the win.