A couple of weeks ago we reported on our visit to the Women’s Health Litigation Conference. One of the conference panels discussed the most interesting ongoing litigations involving women’s health products. Essure, a permanent contraception implant, was among those products. The standard claim is that the Essure implant can cause women to suffer pelvic pain, blood clots, and various other injuries. A plaintiff lawyer at the conference recounted (from a certain point of view) the Essure development and medical stories, concluding that Essure would be a “slam dunk … if not for the fact that it is a PMA product.”
Aye, there’s the rub. Essure is, indeed, a medical device that went through, and passed, the FDA’s rigorous Pre-Market Approval process. PMA approval means that almost all product liability theories are preempted by federal law. If state law, including jury verdicts, would impose any requirement different from, or in addition to, the FDCA, then such state law must yield. Consequently, tort claims against PMA products are difficult to sustain. Still, difficult is not the same as impossible. Plaintiff lawyers have tried all sorts of clever ways to circumvent PMA preemption. But clever is not the same as correct. Good for courts that can tell the difference.
Such a court issued the opinion in Norman v. Bayer Corp., 2016 U.S. Dist. LEXIS 96993 (D. Conn. July 26, 2016). As is typical, the complaint in that case covered the product liability waterfront, with claims for strict liability, negligent failure to warn, negligent training, negligent manufacturing, negligent misrepresentation, negligence per se, and breach of warranty. As is typical, the complaint devoted most of its girth to the generic development and medical stories alluded to above. In the 29 pages of the Norman complaint, “only four short paragraphs” related to the plaintiff and her experience with the product.
Inevitably, the plaintiff invoked the “parallel violation” exception to PMA preemption. As any reader of this blog must know, we have our doubts about this exception. It is, to our mind, the pernicious spawn of a SCOTUS throwaway line. Now, one cannot read an opinion about a PMA product without subjecting oneself to Derrida-esque prose about the “narrow gap” for conduct that violates the FDCA but is based on state law that is reasonably specific without being wholly derivative of the federal law. Huh? The incoherence of the analysis ends up permitting some result-oriented courts to wave by claims that the courts either like or are too indolent or confused to grab hold of and squash. The Norman court took the time to see through the plaintiff’s claims and see that, rather than occupy the parallel violation “narrow gap,” the claims themselves were full of gaps.
For example, the manufacturing defect claim never explained how any deviation from specs caused the plaintiff any harm. The only specified defect was use of nonconforming materials, but the complaint did not allege that the particular device at issue came from the nonconforming batch, or that the plaintiff’s injuries were caused by such defect.
The failure to warn claim was based, not on any failure to warn the plaintiff’s doctors, and not on any failure to warn the plaintiff, but on an alleged failure to report adverse events to the FDA. The problem with this theory is that Connecticut law imposes no duty on manufacturers to report adverse events to third parties who might then report the danger to the plaintiff. The Norman court distinguished away the much-reviled Stengel case on two grounds: (1) in Stengel the Ninth Circuit pretended to interpret Arizona law, not Connecticut law’ and (2) Stengel misinterpreted Restatement (Second) of Torts section 388, comment n, which addressed the responsibility of manufacturers to disclose risks to middlemen such as distributors — which occupy a very different position vis-à-vis the consumer than the FDA. In any event, the plaintiff offered no plausible reason to believe that reporting the adverse events to the FDA would have prompted action that would have prevented the plaintiff from undergoing the implantation.
The negligent training claim went nowhere because, even assuming that a failure to train claim exists in the Nutmeg state, the facts alleged in the complaint do not connect any failure to train to the plaintiff’s injuries. The plaintiff did not even allege that the device was improperly implanted.
A claim for negligence per se rests on a claim that the defendant violated some statute or regulation, and such violation per se establishes negligence. Here, the plaintiff alleged that the defendant violated certain FDA statutes and regulations. Those violations do not hover in any narrow gap. Rather, they are squarely within the zone of Buckman preemption. They are matters for the FDA, not some jury marinating in anger, confusion, and torpor.
The misrepresentation and warranty claims most exhibited the plaintiff lawyers’ creativity. The plaintiff could not rely on any representation or promise in the FDA-approved label, because that would land them in preemption-ville. And yet, like any responsible company, the defendant’s representations were all consistent with the label. What’s a poor plaintiff lawyer to do? Sophistry is the answer. Thus, the plaintiff seized on a statement that the product implantation was a “gentle” in office procedure, when the label said the procedure was “simple” and did not take much time. The plaintiff seized upon language that the device’s mechanism of action is “the body’s natural healing response,” whereas the label referred to the process of how the “body will form tissue” around the inserts, developing “a natural barrier.” There were other, similar, arguments, each one dancing dirtily on the head of a pin. As the Norman court concluded, “[f]or each statement, the claim is either so similar to the approved language as to be substantively the same, or plaintiff has not properly alleged any actual misrepresentation, or that she was actually deceived or that she actually relied” on the statements.
In other words, nice try. Except this was not the plaintiff’s first try. She had already amended her complaint three times, once after the defendant’s motion to dismiss was filed, so she must have known the legal issues. The court concluded that further amend would would be futile and, therefore, dismissed the Norman complaint with prejudice.