Tripolskiy v. Boston Sci. Corp., 2023 U.S. Dist. LEXIS 146689 (C.D. Cal. Aug. 18, 2023), is a case that has much to recommend it. The opinion is clear. It is short. It is from the district where we once prosecuted criminals amidst the palm trees and smog. Most important, Tripolskiy is a premarket approval preemption win involving a recalled device.
The plaintiff sued the manufacturer of an implantable cardioverter defibrillator (ICD) because the battery depleted more quickly than it should have. He was not factually wrong about that. Indeed, the ICD had been subject to multiple recalls because of the accelerated battery depletion. The plaintiff’s battery started beeping after four years, but the battery life had been represented to be over eight years.
The manufacturer had mailed recall notices to field representatives and implanting surgeons, but the plaintiff alleged that the defendant had failed to furnish adequate notice to his physician. The plaintiff filed his complaint in state court, but the defendant removed the case to federal court. Then the defendant got the case dismissed on the grounds of express preemption. But the dismissal was without prejudice and the plaintiff was allowed to file a first amended complaint. That amended complaint included causes of action for negligence, strict liability, breach of warranty, concealment, misrepresentation, intentional infliction of emotional distress, etc.
Again, the defendant moved to dismiss.
The ICD was a class III medical device, meaning it had gone through the FDA’s “rigorous” premarket approval (PMA) process and meaning that any legal claim seeking to impose any requirement “different from, or in addition to” FDA regulations was expressly preempted. Inevitably, the plaintiff tried to salvage his claim by invoking the dreaded and disdained (at least by us) parallel claim exception. (Aside from the “all deliberate speed” language in Brown v. Board, it’s hard to think of SCOTUS language that has visited more mischief on the law than the Riegel parallel claim ditty.)
The court in Tripolskiy did not buy the plaintiff’s parallel claim argument. Mind you, the court managed to worry us for a bit by reminding us that “[t]he Ninth Circuit is particularly hostile to motions to dismiss under Rule 12(b)(6).” But the SCOTUS requirement under TwIqbal of plausibility and concrete, non-vague factual allegations carried the day, at least for now.
At the defendant’s request, the court took judicial notice of PMA materials, the recall notice, and the defendant’s public device lookup information from its website. The PMA materials on the FDA website were the sorts of things that courts will pretty much always judicially notice. The defendant’s website was a different matter, or at least it could have been. The plaintiff did not dispute the judicial notice of the website. In any event, the website was considered as it related to notice, not the truth of the contents.
The problem with the plaintiff’s amended complaint was that its recitation of FDA regulations was conclusory. For example, references to failed process controls is so broad and vague as to be meaningless. The plaintiff listed FDA regulations without identifying how exactly the defendant violated them. Importantly, neither a device malfunction nor FDA recalls, by themselves, “create a presumption that FDA requirements have been violated.”
Did we mention that the plaintiff was acting as his own attorney? As is too often the case, the court in Tripolskiy extended undue mercy to the pro se plaintiff, and permitted him to try again. It was not yet clear to the court that the allegation of other facts could not possibly cure the deficiency.
Really? Whither finality?
Still, Tripolskiy is potentially useful to the defense side re judicial notice and the effect of product recalls, so we should be grateful for that.
In life, finality is not always welcome.
Over the past year the DDL bloggers have lost loved ones, including a father and a sister, among others. There has been entirely too much death. It hurts. The law matters a lot to us, but it is nothing compared to the departures of family and friends.
Last week saw the sudden, untimely death of a lovely man, Mike Henningsen, who had the wisdom to marry into our family. He was kind and generous. He solved problems. He had a ready grin and a hearty, authentic laugh. He always brought the fun.
Mike shared our Bruce Springsteen fandom. A couple of years ago, he called to tell us he had tickets for a Springsteen concert in Glendale, Arizona. Good tickets. A five hour plane ride later, we were together in the pit, twenty feet from the Boss, and singing along to “Rosalita.” “I ain’t here on business baby/I’m only here for fun.” Good times.
On his current tour, Springsteen has been ending his concerts with “I’ll See You in My Dreams.” We’d rather see Mike in his 1985 Targa, or at a game, or at the dining room table. But for now, we’ll have to content ourselves with seeing Mike in our memories and dreams.
“When all our summers have come to an end
I’ll see you in my dreams
We’ll meet and live and laugh again
I’ll see you in my dreams
Yeah, up around the river bend
For death is not the end
And I’ll see you in my dreams.”