United States: PMA Preemption Win At Summary Judgment Stage

Last Updated: June 12 2018
Article by Michelle Yeary

This post is from the non-Reed Smith side of the blog.

What happens when a case involving a medical device that received Pre-Market Approval from the FDA survives, or at least some part of it survives, a motion to dismiss based on preemption? In recent years, as the law has developed and become increasingly favorable for defendants, most of our posts about PMA preemption are at the motion to dismiss stage. That's because usually not much survives beyond that point. So when we happened upon Delfino v. Medtronic, Inc., 2018 WL 2688420 (Minn. Dist. May 18, 2018), we decided it warranted more than just a notch on our PMA preemption scorecard.

It looks like all the claims in this case were originally tossed back in 2012 but plaintiff was given an opportunity to amend her complaint to properly allege parallel violation claims. Now, almost 6 years since that decision – during which time we assume significant discovery was conducted – all of plaintiff's claims are being dismissed again. Plaintiff's negligence and strict liability claims are preempted for lack of evidence of a violation of a federal requirement and plaintiff's warranty claims are barred by the express terms of the limited warranty of the device.

The device at issue is an implantable cardioverter defibrillator ("ICD") and there is no dispute that it is a Class III, PMA medical device and therefore subject to preemption under Riegel v. Medtronic, 552 U.S. 312 (2008). Any state law tort claim must therefore parallel, rather than add to, federal requirements. Id. at *3. In other words plaintiff has to prove the violation of a federal requirement applicable to the device, violation of an identical state-law duty, and causation. Id. It is also not disputed that the device's battery prematurely depleted and required replacement earlier than anticipated. Id. at *1.

We won't walk through all the nitty-gritty, but section I.C of the opinion documents how Medtronic went about introducing manufacturing and testing records to refute plaintiff's manufacturing defect claim. Via records, deposition testimony, and affidavits Medtronic was able to demonstrate "the manufacturing and inspection history" of the device which in turn proved that the device "passed all quality control inspections, and complied with the FDA-imposed requirements." Id. at *4. Defendant also established that they learned that a subset of the ICD's were suffering from premature battery depletion due to the copper used in certain of the electrodes in the device's capacitors. It was found that copper from one supplier was at the root of the problem and defendant stopped using that copper going forward. Id.

Against that history, the question for the court was whether there was any violation of a federal requirement. Plaintiff first argued that by using copper in it capacitors, defendant was violating a federal manufacturing specification that the end terminations of the capacitors consist of plated tin over nickel. Putting aside that the copper was not used in the end terminations and that defendant's end terminations were plated tin over nickel – there was nothing in the requirement that barred the use of copper. Id. at *5-6. As the court more fully explains, PMA silence doesn't mean PMA forbiddance. The court points first to the language of the requirement at issue to show that when the FDA wanted to impose a prohibition it did so expressly. Id. at *6. And, if plaintiff's theory were correct, no PMA would ever have to include prohibitory language because everything not expressly allowed would in fact be prohibited. If silence is going to be so all-encompassing, the result would be an even greater review burden on the FDA. Id. Otherwise the silence would almost assuredly be deafening.

Moreover, if plaintiff wants to rely on a "prohibited-unless-expressly-authorized" theory, she's walking herself away from a parallel violation claim. "If the federal requirements are silent on a particular matter, than any state-law requirement as to that matter is necessarily 'in addition to' federal requirements." Id. That means plaintiff's attempt to circumvent preemption actually ran her head first into it.

Finally, in opining that the ICD should have been made without copper, plaintiff's expert neglects to explain how the capacitors could function without it. It's a technical argument about electrodes (and that's not this blogger's area of expertise) but the more general takeaway is that you can't argue a design that is non-functional. "State tort law that requires a manufacturer's [device] to be safer, but hence less effective, than the model the FDA has approved disrupts the federal scheme no less than a state regulatory law to the same effect." Id. at *7 (citation omitted).

Plaintiff's next argument centered on device longevity. In its PMA submission, defendant included a projection that the ICD would generally perform for 5.1 years. Plaintiff argued that that projection became a requirement when the PMA was approved. But while the FDA could have established a performance standard for the ICD, it did not. Id. "Indeed, the mere fact that a device malfunctioned is not evidence that the device violated any federal requirement. Id. at *8 (with a lengthy list of citations to demonstrate the point). PMA approval is a "reasonable assurance" of safety, not a guarantee. In fact, PMA devices are by definition those with higher risks. That's why they go through the heightened scrutiny and a risk/benefit analysis for approval. "If premature device failure were enough to withstand preemption, then few if any medical device claims would be preempted." Id. The MDA and Riegel would be "dead letters." Id.

Plaintiff's final argument to try to establish a parallel violation claim was that at the time the ICD was returned to defendant, three years after manufacture, the capacitor leakage current measured higher than allowed. Id. But that's an irrelevant fact. "For her claim to survive preemption, Plaintiff must offer evidence that [defendant] violated a federal manufacturing requirement during the device's manufacture." Id. To which we point you back to the really nice way Medtronic confirmed that its manufacturing process was fully compliant.

That left only plaintiff's warranty claims. First, they were barred by the terms of defendant's limited warranty, which defendant honored and under which plaintiff made no claim. Id. at *10. But, they were also impliedly preempted. To prevail on a warranty claim that implicates safety or effectiveness, plaintiff must convince the jury that the device was not safe and effective – directly contrary to the FDA's conclusions. Juries can't be allowed to "substitute their own cost-benefit analysis in place of that applied by the experts at the FDA." Id. at *10-11.

Would we prefer an early out on a motion to dismiss? Sure. But, sometimes a few claims squeak by and when they do, as we've always opined, plaintiffs still face a daunting uphill battle to survive summary judgment scrutiny.

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

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