United States: Post-Recall Negligence Claims Preempted

Last Updated: July 8 2016
Article by Michelle Yeary

We post a lot about preemption. We post a lot about PMA preemption. That's because thanks to Riegel v. Medtronic, Inc., 552 U.S. 312 (2008) and Buckman Co. v. Plaintiffs' Legal Committee, 531 U.S. 341 (2001), almost all claims brought against pre-market approved medical devices are either expressly or impliedly preempted. What remains is a "narrow gap" through which a PMA medical device claim must fit in order to withstand a preemption challenge. And as demonstrated by our Device Preemption Scorecard which now has 336 entries – the gap just keeps getting narrower.

There are still a few claims that continue to squeeze by as "parallel violation" claims – misrepresentation claims come to mind – but they tend to fail on pleadings grounds and/or tend to be the more difficult of the claims to prove (with elements like reliance often being the sticking point). And a few courts have allowed some claims to slip through that we think should have crashed on the shoals. One word, Stengel. Even these, however, remain in the minority.

But all of this defense-friendly case law hasn't stopped plaintiffs from still trying to thread the needle. We've seen some creative pleading in recent years and PMA complaints have become more upfront with allegations of alleged parallel violations. Fortunately most courts haven't been persuaded by the use of "magic words" to create a parallel claim. It's not enough to say the claim violates federal law. If we are talking about a duck, you better show that what you have looks like a duck, swims like a duck, and quacks like a duck. Otherwise, it's no duck. It's a preempted claim. Plaintiffs in Gates v. Medtronic, Inc., slip op., No. 1:15-cv-00726-RP (W.D. Tex. Jun. 29, 2016) didn't have a duck.

A Medtronic cardioverter defibrillator (ICD) was implanted in plaintiff's husband. The ICD included Sprint Fidelis leads. About one and half years later, Medtronic voluntarily recalled the Sprint Fidelis leads based on vulnerability to fracture. Id. at 2. The notice about the recall stated that for implanted devices, removal was "inadvisable due to the risks associated with surgery." Id. After the recall, Plaintiff's husband underwent replacement of his ICD, but his Sprint Fidelis leads were not removed. About 2 years after that replacement surgery, plaintiff's husband experienced the symptoms of a lead fracture and he underwent another surgery to replace the leads. Id. at 3.

Plaintiff brought claims for common law negligence and gross negligence, id. at 9, based on defendant's post-recall communications. Id. at 6. Essentially plaintiff is arguing that the defendant should not have sent the recall notice that removal of implanted was "inadvisable" due to the risk of surgery. Medtronic argued that plaintiff's claim, like other PMA negligence claims, was preempted. Plaintiff made a few attempts to pass through the twin hurdles of Riegel and Buckman.

First plaintiff argued that the Sprint Fidelis leads did not undergo a full PMA. Id. at 7. Without a PMA, there would be no federal requirements and the case would not meet the first prong of the Riegel preemption test. However, the leads did go through a PMA supplement "which is virtually identical to the ordinary PMA process and, by extension, status." Id. So, to the extent the PMA process imposes federal requirements, so too does the PMA supplement process – thereby satisfying Riegel.

Plaintiff's second attempt to avoid preemption was to argue that post-recall communications are not subject to FDA regulation, and therefore once again the first prong of Riegel would not be satisfied. Plaintiffs were just wrong. The Gates opinion sets forth all the ways in which the FDA was involved in the recall process – from regulating the communication to publishing it on their website – the FDA has authority over medical device recalls. Id. at 8.

Having established that there were federal requirements applicable to the ICD leads, the court moved on to determine if plaintiff's claims were non-preempted parallel violation claims. The court first noted that nowhere in the complaint did plaintiff allege that defendant violated federal law. If defendant did not violate federal law, then plaintiff's state law claims are premised on it having done something other than what was required by federal law. Id. at 9. In other words, plaintiffs were alleging a state law requirement that was different from or in addition to federal requirements – more perpendicular than parallel.

The court was willing to look a little deeper at the allegations, but still came up empty. The complaint contained allegations of general duties and breaches of those duties, but it did not contain any allegation of any specific federal regulation that "mirrors" those duties. Id. at 10. Without a "closely parallel" federal requirement, plaintiff's negligence claims are preempted. Id.

This may not be a common set of facts, but we like any case that establishes more claims are preempted. Here we have two rulings — a PMA supplement is the same as a PMA for purposes of Riegel and post-recall communications are regulated and therefore subject to preemption. Another notch on the scorecard.

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

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