In a post Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), world – plaintiffs most often attempt to avoid preemption of products liability suits involving PMA (Premarket Approval) medical devices by alleging a parallel violation. While they’ve had some success in getting past the pleadings stage on this theory, to the extent any PMA medical device case survives preemption, what survives is only a small slice of the usual panoply of products claims. Further, proving a state law claim for violation of a federal regulation is far from a slam dunk.
So, what’s a better way to avoid PMA preemption? Claim the product at issue isn’t actually a PMA medical device. But if the device actually did go through the PMA process, how do you claim it didn’t? By taking the device apart. Well, at least that’s what plaintiffs have tried to make courts believe. But so far, no takers.
And, just yesterday, a New Jersey court said no to both – rejecting plaintiffs’ component theory of liability and casting serious doubt on the viability of parallel violation claims in PMA medical device cases. The case is Smith v. Depuy Orthopaedics, Inc., No. 11-4139 (JAP), slip op. (D.N.J. Mar. 18, 2013). To start, if you aren’t versed in the PMA process, the decision contains a thoughtful recitation of the process and of the defendant’s compliance with FDA requirements at every turn. See slip op. at 2-9. It also explains the difference between the rigorous PMA process, during which the FDA determines whether the device is safe and effective for its intended purpose, and the 510k premarket approval process, which has to do with a finding of substantial equivalence rather than safety and efficacy. Id. at 7. It was this distinction that led to Riegel and PMA preemption. And, it is what has plaintiffs attempting to strip medical devices like a mechanic disassembling a junker for its parts. Sometimes that’s all an old car is good for. Sometimes, the whole – say a 1967 Mustang GT 500 – even with scratches and dents, is worth significantly more than the sum of its parts.
The same is true for medical devices. When determining whether state law claims are preempted, you look at the device as a whole. “[A] device receiving premarket approval cannot be separated into its component parts to avoid application of express preemption.” Slip op. at 21 (citations omitted). It doesn’t matter if some of its components were originally cleared through the 510k process. Once those components are made part of a medical device that gets submitted to the FDA for PMA, then those components go through the PMA process too. Id.
Therefore, because the artificial knee at issue in Smith, and all its components, received premarket approval, plaintiff’s product liability claims under the New Jersey Products Liability Act (NJPLA) (manufacturing and design defect, failure to warn and breach of implied warranty), are preempted because they conflict with federal law. The state law claims would require a finding that the medical device was “defective and unreasonably dangerous, a finding that would contradict the FDA’s determination that the device was safe and effective.” Id. at 17. The same reasoning applies to plaintiff’s express warranty and fraud and misrepresentation claims: “[b]ecause these allegations question the safety of the device and would require the Court to find that Defendants misrepresented that the device was safe and effective to succeed, they are preempted.” Id. at 19-20. Of note to New Jersey practitioners, the court also found the fraud and misrepresentation claims subsumed by the NJPLA. Id. at 20.
Striking out on circumventing PMA preemption altogether, plaintiff did try to argue a parallel violation claim as well. But, the court found plaintiff failed to plead any alleged violation with sufficient specificity to satisfy Riegel or the TwIqbal federal pleading standards. Id. at 21-23. Here, we are happy to report that the court adopted the reasoning of Gross v. Stryker, 858 F.Supp.2d 466 (W.D. Pa. 2012) that we blogged about here. Namely, that because Riegel requires device-specific PMA requirements to establish preemption, it also requires a violation of device-specific PMA requirements to avoid preemption through the parallel violation loophole:
To properly allege parallel violation claims, [a] complaint must set forth facts showing action or inaction in [defendants’] efforts to take part in the PMA process or implement its results. A plaintiff cannot plead non-specific violations as a basis for a parallel claim because this is inconsistent with Riegel and the pleading requirements under Twombly, Iqbal, and Fowler.
Smith, slip op. at 21-22 (citations omitted). In denying plaintiff’s request for leave to amend his complaint as futile, the court appeared to go even a little further, questioning the parallel violation loophole at all – certainly suggesting it’s closer in size to the eye of a needle:
Any proposed amended claims in which Plaintiff seeks to allege a parallel violation would fail to state a claim because Defendants have not violated a federal regulation. . . . Plaintiff, here, would be unable to state a claim and show inaction regarding Defendants’ efforts to take part in the PMA process because the facts clearly show that Defendants went through the PMA process and received PMA for the device. This Court confesses it’s unable to discern how a plaintiff pleads around the 360k preemption.
Id. at 24-25 (citations omitted). That question has plagued us too and in New Jersey, it just became a lot harder to do so.
Finally, one last interesting aspect of this case. It was decided on a motion for summary judgment brought before discovery was conducted. Id. at 11. While defendant had to produce some manufacturing records, all other discovery was stayed pending resolution of the preemption issue. Bringing a summary judgment motion allowed defendant to go beyond the pleadings and establish the extensive regulatory history with this product. This seemed to be very persuasive – especially on the parallel violation claim. And, it gave the court what it needed to dismiss the case with prejudice, finding any attempt to amend or any request for additional discovery futile. No second bites. No protracted discovery. Just savvy lawyering leading to a great decision. We can’t argue with that.