United States: Welcome To The Preemption Family

Last Updated: June 28 2019
Article by Michelle Yeary

If preemption had a family tree, the drug and device branch would be heavy. And, as our scorecards and cheat sheets demonstrate, there are obvious sub-branches that sprouted out of major Supreme Court decisions. We have the Wyeth v. Levine, 555 U.S. 555 (2009) pharmaceutical branch; the Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996) medical device branch with its subsequent post- Riegel v. Medtronic, Inc., 552 U.S. 312 (2008) off-shoot; the PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011) generic arm; the Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001) implied preemption/fraud-on-the-FDA limb. Now we have a post- Merck Sharp & Dohme Corp. v. Albrecht, ___ S. Ct. ___, 2019 WL 2166393 (U.S. May 20, 2019) ("Albrecht") twig and that twig has its first bud – Delfino v. Medtronic, Inc., 2019 Minn App. Unpub. LEXIS 530 (Minn. Ct. App. Jun. 10, 2019).

Just in case you missed it, Albrecht held, in the context of a branded prescription drug case, that preemption is "a question of law, normally for a judge to decide without a jury." Albrecht, 2019 WL 2166393, at *9. For more on the decision, see <here and <here. We should note that Albrecht has its own jurisprudential fork in the road as it not only ruled on the "legal question" issue, but also made some inroads on defining "clear evidence" under Wyeth v. Levine.

But "clear evidence" wasn't at issue in Delfino. Delfino is a medical device case involving express PMA preemption. So, we already have a ruling extending Albrecht beyond drugs and implied preemption. We certainly read the reasoning of Albrecht to be equally applicable to the resolution of factual disputes in express preemption cases and Delfino shows us we weren't off-base.

Delfino involved an ICD which had to be removed from plaintiff based on premature battery depletion. Medtronic discovered the issue with a certain type of ICD, informed doctors and patients of the issue, analyzed the plaintiff's device after it was removed, and offered a credit towards a replacement device. Id. at *3-5. Plaintiff then filed suit alleging claims for strict liability manufacturing defect, breach of express and implied warranties, negligence, and negligent infliction of emotional distress. Id. at *6. After the close of discovery, defendant moved for summary judgment on preemption grounds. Plaintiff argued that her claims were not preempted because they were based on defendant's violation of requirements of the PMA and that there were genuine issues of material fact regarding those violations that were required to be decided by the jury. Id. at *7-8. Plaintiff also submit a report from an expert regarding the purported PMA violations. Id. at *8-9.

The trial court granted defendant's motion and this appeal followed. Without going into all of the technical details specific to this device, at the heart of the dispute was whether the use of copper in the ICD's capacitor end terminations violated PMA requirements and whether the capacitor therefore also failed to meet PMA requirements for battery leakage and longevity. The court's first ruling was that plaintiff's claimed PMA-violations were in fact not violations at all. The court documents the undisputed testimony and affidavits of defendant's employees that the ICD was manufactured in compliance with its PMA-requirements. Id. at *20-21. The court went onto examine the specifications cited by plaintiff and determined that they did not prohibit the use of copper as plaintiff claimed. Therefore, plaintiff had not presented sufficient evidence to show that the specifications were violated. Id. at *21-23.

Similarly with respect to the battery leakage and longevity alleged violations, the FDA approved warnings and the ICD's limited warranty were clear that the demands of the human body may reduce the longevity of the device and that defendant did not guarantee the product would last its entire 5-year warranty period. Id. at *27. Further, the ICD's reference manual, which was submitted to the FDA as part of the PMA application, "expressly used the terms, 'projected service life' and 'estimate' throughout. Id. So, plaintiff also lacked sufficient evidence to show a federal violation as to longevity.

Then we move to the Albrecht portion of the decision. Plaintiff had relied on the Third Circuit's In re Fosamax decision to argue that fact issues regarding whether defendant believed it had to comply with a certain specification was a question for the jury and therefore precluded summary judgment. Id. at *24. But, while the Delfino appeal was still pending, along came Albrecht. Contrary to plaintiff's position, Albrecht "held that issues concerning the nature and scope of FDA determinations are questions of law to be decided by a judge." Id. at *25. Leading the Delfino court to hold

that the issue of whether [the specification] constituted a federal requirement is a question of law to be decided by a judge. . . . And, if [the specification] constituted a federal requirement, Medtronic would be required to follow it, regardless of its subjective belief. We, therefore, reject [plaintiff's] contention that there are factual disputes concerning whether Medtronic believed [the specification] constituted a federal requirement with which it had to comply.

Id. at *25-26.

But the gift of Albrecht didn't stop there. The court also used it as a basis for excluding testimony from plaintiff's purported FDA expert. The expert's report primarily consisted of legal conclusions ("the product as manufactured violated the PMA"). But because "determining compliance with a regulation . . . is a question of law . . . [a]nd expert opinion as to a legal matter is generally inadmissible," plaintiff's expert was properly excluded. Id. at *32-33. We were hoping that Albrecht would mean limiting experts like Kessler and Parisian to testifying to judges rather than juries, but getting rid of them altogether is even better.

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

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