In Tinkler v. Mentor Worldwide, LLC, 2019 WL 7291239 (S.D. Fla. Dec. 30, 2019), the plaintiff claimed that a breast implant leached chemicals into her tissue, causing a constellation of symptoms known as Breast Implant Illness. Her lawsuit alleged that the manufacturer knew of this danger but failed to warn the implanting surgeon who, in turn, was unable to convey the risks to the plaintiff, rendering her incapable of making an informed decision about whether to proceed with the implant. The manufacturer moved to dismiss the complaint on the grounds of express and implied preemption. The Tinkler court ended up dismissing the case with prejudice.
The breast implant was a Class III medical device, meaning it had to go through the rigorous premarket approval ("PMA") process. Under 21 U.S.C. Section 360k(a), no state may impose on any Class III device any safety requirement (including via jury verdicts) that is different or in addition to what was required by the FDA. The U.S.Supreme Court interpreted and applied this express preemption in the Riegel case. To the extent a plaintiff claims that a medical device manufacturer violated FDA requirements, such a claim would be impliedly preempted per another SCOTUS case, Buckman.
All of this means that it is pretty tough for a plaintiff to sue a Class III medical device manufacturer. But tough isn't the same thing as impossible. Through a combination of thin logic and judicial disinclination to shut down plaintiff claims entirely, courts have fashioned a "narrow gap" through which plaintiffs can sometimes navigate their way to a viable cause of action against a Class III device. A plaintiff can proceed if she bases her claim on a violation of state law that parallels an FDA requirement. To our jaded eyes, this "narrow gap" should be nonexistent, as it is premised on dicta and is too often applied sloppily.
Perhaps the most sloppy application was in the Seventh Circuit's Bausch decision (2010). The Tinkler case cites Bausch early on in the decision, and that citation triggered within us feelings of fear and loathing. (If our children can be triggered by name-calling or references to nasty realities, why can't we be triggered by shoddy and destructive court opinions?) Nevertheless, to our pleasant surprise, the Tinkler court ended up concluding that, rather than traverse a narrow gap, the breast implant claims in the case ran into a preemption wall. We think a large reason for that outcome, besides the district court's good sense, is that while it nodded to Bausch out of (excessive) politeness, the controlling law was to be found in the Eleventh, not Seventh, Circuit. The Mink and Wolicki-Gables decisions make considerably better reading than Bausch. (Then again, so would a LEGO instruction manual, the Philadelphia phone book, or random scribblings on a Chuck E. Cheese placemat.)
The Tinkler failure to warn claims failed because the complaint did not specifically identify which federal regulations were violated. (That is a huge difference from the execrable Bausch decision, which did not require identification of a specific federal law.) In attempting to fend off the motion to dismiss, the plaintiff began citing some regulations, but it was too late. It was also too little, since most of the regulations involved duties owed to the FDA — slamming into Buckman preemption. At its heart, the theory behind the plaintiff's complaint was that Florida law somehow (presumably through negligence or strict liability principles) required the manufacturer to include more or different warnings than the FDA saw fit to require. Shed of all sophistry, such a claim begs to be preempted. The Tinkler court complied.
The Tinkler court's example of a claim that could fit within the narrow gap is, indeed narrow: if a device omitted warning language required by the FDA, and such omission also violated state-imposed duties. That is not what happened in Tinkler, of course, and it is not a fact-pattern any of us are likely to see. For the types of failure to warn claims we are likely to see (until plaintiff lawyers give up the ghost), preemption fully applies. There is no narrow gap; there is only an abyss.
This article is presented for informational purposes only and is not intended to constitute legal advice.
