United States: Lengthy Decision, Simple Conclusion – Preemption Win Across The Board

Last Updated: January 18 2017
Article by Michelle Yeary

Some bloggers on this site have openly admitted to being swayed by the length of an opinion in choosing whether to blog about it. Shorter decision, shorter post. Less words, less work. In all honesty, a 56-page summary judgment opinion does tend to elicit a slight groan or at least an audible sigh. But sometimes, if you can manage to push through, you find that 16,000 words can be summed up very succinctly – preemption, preemption, preemption.

That's not to say that the 15,999 other words in Babayez v. Medtronic, Inc., 2017 WL 90403 (E.D.N.Y. Jan. 5, 2017) are not important or interesting but there is a lot of case specific detail and a fairly lengthy recitation of preemption law, including the division among the circuits and within the Second Circuit as to the scope of implied preemption in the context of parallel violation claims. Id. at *14-20. We've covered this history in significant detail and anyone with even a passing familiarity with our blog knows well our feeling that the Eighth Circuit's interpretation of the interplay between Riegel and Buckman gets it right – that there is only "a narrow gap through which a plaintiff's state-law claim must fit if it is to escape express or implied preemption." In re Medtronic, Inc., Sprint Fidelis Leads Products Liab. Litig., 623 F.3d 1200, 1204 (8th Cir. 2010). Babayez goes on to lay out the split in the circuits on the issue of whether Current Good Manufacturing Practices (CGMPs) are specific FDA regulations on which a parallel violation claim can be based. Babayez, at *22-23. Again, we align with the Eighth Circuit's conclusion that CGMPs, which apply to all devices, not just PMA-devices, are too general to give rise to a parallel violation claim. Rather, a parallel claim that survives preemption must be based on an alleged violation of a PMA, device-specific requirement. Id. at *22. While Babayez doesn't go quite as far as the Eighth Circuit, it went far enough to reach the right result here – the federal violations alleged by plaintiff aren't specific enough to warrant surviving preemption.

Babayez involved an implanted neurostimulator. Following surgery, a technician employed by the manufacturer assisted in testing the device and making sure it was functioning. As plaintiff prepared to leave the hospital he connected the device as instructed and received a shock that caused him to spasm and jump. Plaintiff did not fall. Id. at *6. The device was disconnected and plaintiff was sent home. He returned to the hospital in pain and the leads were removed. Over one week later it was discovered that plaintiff had a fractured hip which he alleged he suffered during the shock incident. Id. at *6-7.

Plaintiff brought causes of action for strict liability, negligence, breach of implied warranty, breach of express warranty, and failure to warn. To the extent any of the claims are premised on allegations that the FDA-approved design, manufacturing process, or labeling are defective, those claims are preempted. Id. at *20. To the extent plaintiff attempted to state any alleged parallel violation claims, he did not. On both strict liability and breach of implied warranty, plaintiff "conclusorily alleges" the device was defective or adulterated, but provides not plausible facts to support either allegation. Id. But this is a summary judgment motion, so the court looked beyond the pleadings and still found nothing. Plaintiff offered no evidence (rather arguing a spoliation claim that the court rejected) to contradict the evidence offered by defendant that the device was manufactured, tested, and labeled in accordance with its PMA requirements. Id. at *21. Plaintiff's failure to warn claim failed for the same reasons – only conclusory allegations of adulteration and no facts to support that defendant violated installation procedures. Id. at *26.

Plaintiff alleged that defendant breached an express warranty by representing the device was safe and effective for its intended purpose. The court found this was actually another implied warranty that suffered the same fate as the one described above. To the extent plaintiff was actually alleging an express warranty, he failed to establish any of the elements required under New York law (such as a material statement and reliance). Id. at *21.

This leaves only plaintiff's negligence claim; the only claim that "contains more than conclusory allegations." Id. But that wasn't enough for it to survive. Plaintiff alleged defendant violated two CGMPs. The first requires manufacturers to establish a process for receiving, reviewing and evaluating complaints. Id. The second requires manufacturers of devices requiring installation to establish adequate installation instructions and that the person installing the device adhere to those instructions. Id. at *22. While the court was unwilling to go as far as to say a parallel violation claim can never be based on a CGMP, it did conclude that neither cited by plaintiff were specific enough. The court distinguished these open-ended guidances from the manufacturing-based CGMPs used to form the basis of manufacturing defect claims in other cases. While we dispute even those manufacturing CGMPs are sufficient for a parallel violation claim, we are happy to see it being at least limited and certainly not extended. After all, what do the CGMPs cited by plaintiffs here really say – that manufacturers have to establish processes and procedures. But they don't provide any specifics for what those processes and procedures should include. "Accordingly, state-law claims premised on a violation of these CGMPs have the potential to create varying standards that would be different from, or in addition to' those required by the federal scheme, and are therefore preempted." Id. at *24 (citations and quotations marked omitted).

The court also examined whether if these claims were allowed, plaintiff had adduced any evidence to support that they were violated or that any violation was related to plaintiff's injury. As to the requirement to receive and investigate complaints, plaintiff alleged that was violated because the defendant didn't report the incident, which occurred in February 2007, to the FDA until April 2010. But the facts are that plaintiff never reported his hip fracture to defendant until filing his lawsuit in February 2010. Id. As to the second CGMP, there was no dispute that the defendant had installation instructions, plaintiff alleged that they were not followed. But in this instance, it was plaintiff's physicians not the manufacturer who installed the device. While the defendant's representative may have been present, "there is no evidence that he was consulted with respect to any of these issues." Id. Nor was there any evidence the installation instructions weren't followed. Nor any evidence that any deviation of the instructions caused plaintiff's injury. Id. at *25. And so on, and so on.

Bottom line – plaintiff's claims were preempted, and even if they hadn't been, plaintiff had no facts to support his allegations. Complicated facts, simple result.

Thanks to John Lavelle at Morgan Lewis for tipping us off about this decision.

This article is presented for informational purposes only and is not intended to constitute legal advice.

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