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Last week we saw an article on a baseball website about batters who, through umpire forgetfulness or whatever, were not called out until strike four.  Then we read Comatov v. Medtronic, Inc., 2023 WL 2922830 (C.D. Cal. March 16, 2023), in which the court did not call a complete and final stop (like what the teenagers running the roller coaster tell you to wait for before attempting to exit the ride) to the lawsuit until the Fourth Amended Complaint.  (Is that four strikes or five strikes?) Mind you, we’re not suggesting there was any form of umpire forgetfulness in the Comatov case.  The judge who wrote the opinion is very smart, and he did not get the case until it had been amended four times. 

How did that happen? Well, Comatov was a bit of a roller coaster ride.  The claim was that the decedent died because a pacemaker malfunctioned.  After some ups and downs (mostly downs), the plaintiff tried to convert the case from medical malpractice to product liability.  As part of that conversion, the Fourth Amended Complaint added causes of action for strict liability due to a manufacturing defect, strict liability due to a failure to warn, negligence and negligence per se, and a survivor action under California law. Also as part of that conversion, the Fourth Amended Complaint dropped all California defendants (including the doctors), and thereby (perhaps inadvertently) creating diversity of citizenship and permitting the defendant to remove the case to federal court.  The C.D. Cal. wheel sent the case to a no-nonsense judge, and the roller coaster soon came to an abrupt stop. 

The pacemaker at issue had gone through premarket approval (PMA), which implicates our favorite defense, express preemption per the Medical Device Amendments (MDA) to the Food, Drug and Cosmetics Act (FDCA), which ousts state laws (including jury verdicts) to the extent they impose standards that are “different from, or in addition to” the federal regulatory regime. The Comatov court correctly rejected any presumption against express preemption, and quickly focused on the by now classic inquiry: is the plaintiff “suing for conduct that violates the FDCA (or else his claim is expressly preempted by section 360k(a)) … [or] suing because the conduct violates the FDCA (such a claim would be impliedly preempted under Buckman).”  (Emphases in original.) The answers to that inquiry turned out to be not so good for the plaintiff, whose claims were held preempted.

The warning claim was expressly preempted under the MDA.  The plaintiff alleged that the defendant failed to warn either the decedent or the decedent’s doctors about the device’s adverse events.  But, as the Comatov court pointed out, “the MDA requires only that Defendant report adverse events to the FDA.”  Thus, the plaintiff’s warning claim would impose a requirement that is “different from, or in addition to” federal law.  

The plaintiff’s remaining claims failed to “thread the preemption needle” via a parallel claim.  That failure was not for want of trying. The plaintiff set forth several federal regulations that the defendant allegedly violated.  But all the plaintiff did was recite a laundry list of conclusory FDA regulation violations (Quality System Regulations, failing to manufacture with a material meeting FDA requirements for hardness, durability, composition, and finish, etc.). Conspicuously missing were factual allegations supporting an inference of any actual violations.  

The plaintiff’s most specific alleged violation was the FDA’s issuance of a safety warning that at least three of the pacemakers had suffered from cracked capacitors that caused a sudden drain in battery level.  But the Fourth Amended Complaint did not allege that the cracked capacitor was at issue in the Comatov case, or that any specific manufacturing defect was attributable to a violation of FDA regulations.  Moreover, the court concluded that it was implausible to infer a manufacturing defect in plaintiff’s device from a general FDA safety communication.  Since the FDA already knew about the claimed problem, as demonstrated by its communication, no failure to report could possibly be causal.  Finally, FDA recalls or similar actions, by themselves, cannot create a presumption of a regulatory violation.  

Maybe our use of the word “finally” was premature.  The plaintiff engaged in what the court called a “last-ditch effort” to save the lawsuit by arguing that the inaccessibility of “confidential information” should relax the pleading requirements.  The Comatov court rejected this argument: “The near total absence of non-conclusory allegations is fatal to Plaintiff’s claims.” After four amended complaints, the court dismissed the case with prejudice.  The roller coaster ride was over, the batter was called out, and the case was done.