This post is from the non-Reed Smith side of the blog.
It’s not a long decision – but there’s still a lot to it. Maybe that’s because there wasn’t a lot to plaintiff’s complaint. Regardless, Sharp v. St. Jude Medical, S.C., Inc., 2019 WL 3821895 (N.D.GA Aug. 14, 2019) makes some key defense rulings.
The case involves an implantable cardiac defibrillator (“ICD”) that plaintiff alleges malfunctioned and did not deliver the necessary shock when plaintiff’s husband went into cardiac arrest. Plaintiff alleges the reason for the failure was friction between the insulation and the wires. Id. at *1. Plaintiff brought claims for manufacturing defect, failure to warn, and negligence per se. Defendant raised by both preemption and TwIqbal grounds for dismissal.
In deciding the motion to dismiss, the court first held that plaintiff cannot state a viable manufacturing defect claim premised solely on allegations that the device malfunctioned. Id. at *4. A malfunction is not the equivalent of a defect and the latter cannot be inferred from the former. Plaintiff also tried to rely on Bausch v. Stryker Corp., 630 F.3d 546 (7th Cir. 2010) to argue that she needed discovery of defendant’s PMAs before she could plead a parallel violation claim. But Georgia is in the Eleventh Circuit where Wolicki-Gables v. Arrow Int’l, Inc., 634 F.3d 1296 (11th Cir. 2011) controls which requires the complaint “point to specific PMA requirement[s] that have been violated and not wait for discovery on such matters.” Sharp at *4.
On failure to warn, the court starts by applying Georgia’s learned intermediary doctrine. So any duty to warn extended to plaintiff’s husband’s physician. Id. at *5. In this case, the court also applied the sophisticated user doctrine which provides that a manufacturer need not warn a physician of risks from prescription medical devices that are “generally known” to physicians. Id. Having pointed to multiple public sources of information concerning the ICD leads at issue, the court was able to conclude that the risk was well-known in the medical community which barred plaintiff’s failure to warn claim.
Turning to preemption, plaintiff appears to allege different causes for the failure of the ICD but doesn’t link them to any specific PMA requirement that was allegedly violated. Id. at *7. Without a causal connection between the ICD implanted in plaintiff’s husband and a PMA violation, plaintiff’s claim is preempted. The court didn’t even have to go that far on failure to warn, agreeing with defendant that “Plaintiff’s claim that Defendants should have provided additional or different warnings is preempted, no matter how the arguments are construed.” Id. Failure to warn premised on a failure to file a report with the FDA is the equivalent of “fraud-on-the-FDA” and therefore preempted. Id. The fact that the product was recalled does not change the preemption analysis. Id. And to the extent plaintiff tried to bring a claim for failure to provide adverse event reports directly to patients and physicians – that would be a state duty that exceeds federal requirements and is likewise preempted. Id. at *8.
Finally, plaintiff’s negligence per se claim is impliedly preempted as an attempt at private FDCA enforcement. Id.
Sometimes good things do come in small packages. We’ll take a short, sweet, and solid defense win any day.