One doesn't see many new PMA preemption issues raised, but we found a case that does just that – Vincent v. Medtronic, Inc., 2016 WL 7374271 (N.D. Ill. Dec. 20, 2016). We are used to seeing plaintiffs try to use off-label use to circumvent PMA preemption. Just check out any of our Infuse posts to see how badly that has worked out for plaintiffs. They largely unsuccessfully have argued that if a product is used off-label, it is used for a purpose for which its PMA approval does not apply and therefore, the PMA requirements likewise don't apply which plaintiffs contend means preemption should not apply. The courts have disagreed.
In Vincent, plaintiffs tried a similar end run around preemption. Plaintiff underwent surgical implantation of a pacemaker on February 12, 2004. The pacemaker lead used in the surgery was a Class III, PMA medical device. Shortly before plaintiff's surgery, Medtronic had submitted the lead for supplemental pre-market approval. The approval was granted on March 10, 2004. Id. at *1. Ten years later, plaintiff had to undergo explant surgery due to a fractured lead and then filed a products liability suit. Id. at *2. In addition to standard claims based on failure to warn and design defect, plaintiff alleged that the lead had not received FDA approval at the time of the initial procedure, which was not disclosed to plaintiff or his surgeon. Id.
Plaintiff used this allegation as a basis for attempting to avoid preemption altogether. He claimed that the device was not approved at the time of his surgery and therefore there were no applicable federal requirements on which preemption could be based. Id. at *3. But that argument would require a significant distortion of reality. The pacemaker lead at issue had been subject to the original premarket approval process, along with other supplemental premarket approvals obtained prior to the surgery. Therefore, regardless of whether the additional supplemental approval had yet to be approved, the earlier approvals established federal requirements which give rise to preemption. Id. at *4. "Obtaining supplemental premarket approval for a change in the lead's specifications might change those requirements, but failing to obtain that approval would not cause previously established requirements to simply evaporate." Id.
So, like off-label use, pending PMA supplements don't make preemption disappear. With preemption operating as usual, and because plaintiff doesn't allege that Medtronic violated any federal regulations in designing, manufacturing, or labeling the lead, plaintiff's traditional design defect, manufacturing defect, and failure to warn claims are all preempted. Id. The only federal violation plaintiff did allege is the failure to comply with procedures governing the supplemental PMA process – distributing the pacemaker lead before receiving the approval. But as there is no state law tort duty for premature sale of a device later fully-FDA approved, any claim based on that violation is impliedly preempted under Buckman. Id. In sum, plaintiff's state law weren't based on any violations of federal law and the only violation of federal law plaintiff did allege wasn't grounded in a recognized state law duty.
The court did acknowledge the possibility that plaintiff could state a parallel claim based on an injury caused by the temporarily unapproved design change. Plaintiff would have to specifically allege that the aspect of the device that caused his injury was the unapproved design change. Then, because at the time of the surgery the device was not in conformity with then existing PMA requirements, plaintiff could potentially have a non-preempted parallel violation claim. That's a pretty specific claim. And it wasn't pleaded here. Plaintiff is getting one more try to plead a non-preempted claim, but from where we're sitting, it doesn't look good.
This article is presented for informational purposes only and is not intended to constitute legal advice.
