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Oh, so many years ago we started calling cases that prevent innovator liability and preempt generic liability the “one-two punch.”  But really any decision that strikes a substantive blow and follows it up with a preemption jab is OK in our books.  And that is just what happened in Harris v. Medtronic Inc., 2024 WL 1747385 (D. Minn. Apr. 3, 2024). 

Plaintiff brought a putative class action on behalf of himself and others who received an implantable cardioverter defibrillator (ICD) manufactured after a certain date by the defendant.  The ICDs at issue were voluntarily recalled due to a potential for the devices to deliver a low or no energy output when high voltage therapy was needed.  The FDA issued a notice about the recall advising that the ICDs should not be replaced for this issue, which would necessitate surgery and further risks. Rather the issue could be addressed with reprogramming and monitoring.  Id. at *1-2.  Plaintiff files claims for consumer protection and products liability alleging that his ICD causes him discomfort and blood clots in his arm, that he is “at risk of additional extensive medical procedures,” and he spent money to purchase the ICD.  Id. at *2.

First up, a direct hit due to lack of a cognizable injury, and thus standing.  To have standing, plaintiff has to have suffered an injury-in-fact that is “concrete and particularized” and not “conjectural or hypothetical.”  Id. at *3.  In the case of a claim of a defective product, there is no injury-in-fact “where the alleged defect has not manifested itself in the product [plaintiff] own[s].”  Id.  It is not enough for there to be a risk of a possible malfunction sometime in the future.  Here, plaintiff conceded that his ICD had never malfunctioned.  Moreover, plaintiff did not dispute that the “risk” could be resolved through external reprogramming, thereby eliminating the risk without the need for “additional extensive medical procedures.”  Id. at *3-4.

Despite the Eighth Circuit decisions holding explicitly that absent a manifestation of the defect plaintiff has no standing, plaintiff argued his case was distinguishable because “demonstrating a high probability of a severe injury is sufficient to state an injury-in-fact.”  Id. at *4.  Let’s call this the “super risk” theory.  Plaintiff offered zero legal support for his “super risk” theory.  That’s because there is none.  For that reason alone, the court declined to depart from binding precedent.  In addition, plaintiff would not have met his own “super risk” standard.  The FDA described the likelihood of a reduced or no-energy output as a “rare potential.”  So, at most, plaintiff has alleged a “rare potential” of a defect, not a “high probability of severe injury.” 

Nor were plaintiff’s claimed injuries–discomfort and blood clots and future medical procedures—traceable to the alleged product defect–failure to produce sufficient voltage.  Id. at *5.  Primarily because plaintiff’s ICD has never malfunctioned, but also because the FDA specifically advised against surgical intervention in favor of external reprogramming.  Id. Without a causal connection between the alleged injury and alleged defect, plaintiff has no standing. 

While plaintiff was still reeling from that first hit, the court landed its preemption punch.  The ICD was subject to premarket approval (PMA).  Therefore, plaintiff’s claims are subject to Riegel preemption.  That is, plaintiff’s claim must “parallel” federal requirements rather than impose “additional” requirements.  Therefore, the claim must involve conduct that violates the FDCA and plaintiff must plead a deviation from federal requirements with “sufficient specificity.”  Id. at *6.  Where plaintiff’s claims attack the safety of the device and the adequacy of the FDA-approved warnings, preemption is generally unavoidable. 

Plaintiff’s first claims were for violations of consumer protection statutes, unjust enrichment, and breach of warranties.  All of which were premised on allegations that defendant misrepresented the safety and effectiveness of the ICD.  To succeed on these claims, plaintiff would have to convince a jury that the device was in fact not safe and effective which would be in direct conflict with FDA’s approval of the device through the PMA process.  Id. at *7.  Hence, not parallel claims.

Plaintiff also brought manufacturing and design defect claims but failed to “adequately allege[] a specific violation of the device’s PMA process.” Id.  Plaintiff did not even mention the PMA process in the complaint, much less plead a deviation from it.  However, since this dismissal is based on conclusory allegations, the court gave plaintiff an opportunity to replead his manufacturing and design defect claims.  That’s a problem for this would-be class representative, since more detail, particularly as to unit-specific manufacturing defects, tends to defeat class certification. But, even if he can “beef up” his allegations, standing remains a punch plaintiff needs to dodge.