Last week we discussed the Jacob v. Mentor Worldwide, LLC case, in which a pro se plaintiff alleged injuries from breast implants and complained that the manufacturer had inadequately warned of the risks. The claim boiled down to an attack on the FDA-approved labeling of a class III medical device, and that meant it was
No writer made as strong an impression on us in high school as Albert Camus. The opening of The Stranger is arresting: “Mother died today. Or maybe it was yesterday, I don’t know.” Our teacher pronounced The Plague to be an even better book, and he often quoted the bit about how we had “to
The recent spate of gadolinium cases brought by patients with normal kidney function are looking like fertile ground for federal preemption, and we are not saying that just because we like the results. Our point is that if you had to come up with an example of a case where federal law ought to preempt
In Tinkler v. Mentor Worldwide, LLC, 2019 WL 7291239 (S.D. Fla. Dec. 30, 2019), the plaintiff claimed that a breast implant leached chemicals into her tissue, causing a constellation of symptoms known as Breast Implant Illness. Her lawsuit alleged that the manufacturer knew of this danger but failed to warn the implanting surgeon who,
We were going back through some old cases the other day and came across a gem from our hometown court right here in in San Francisco. It caught our eye because it deals with an angle of federal preemption on which we have written before and which we think is underappreciated, so we’re going to
We understand that we write a lot about federal preemption. You might even be rolling your eyes at yet another post on this most powerful of defenses, but we just can’t help ourselves. Federal regulation runs deep in the drug and medical device world, and the possibility that federal law might preempt state-law claims is
It took a while for courts to catch on that implied preemption in drug cases depends on whether the plaintiffs can present “newly acquired evidence” of a relevant risk, but the argument seems to be gaining some traction. The first case to recognize the “newly acquired evidence” argument was the First Circuit’s Marcus v. Forest
The Seventh Circuit taught us recently that the letter “A” is a powerful thing. Of course, we already knew that a well-placed A can convert the ordinary (“typical”) into the extraordinary (“atypical”), the melodic (“tonal”) into the dissonant (“atonal”), and the virtuous (“moral”) into the indifferent (“amoral”). Adding a single A to a Scrabble board
Today is the birthday of Gilbert O’Sullivan, who scored a hit back in 1972 with “Alone Again, Naturally,” the saddest song we can think of this side of Albinoni’s Adagio. That is fitting, given our postscript.
December 1 is also the birthday of Sarah Silverman and Bette Midler, two women who consistently bring smiles,
The Ninth Circuit filed a preemption opinion the other day that should help prevent the “foodification” of medical device litigation. That made-up word refers to the wasteful food-related class action litigation that has somewhat thrived in California. The template is familiar: Opportunistic plaintiffs’ lawyers find some aspect of food labeling that they claim is misleading—e.g., that a product is “wholesome” or “natural”—and they recruit a plaintiff to say that he or she would not have purchased the food or would have paid less for it had truth been told. We wrote more than two years ago about a class action claiming that Hershey chocolates made misleading “healthy diet claims.” Who would possibly rely on “healthy diet claims” for chocolate treats? That class action obviously had no legs, but others have gotten by.
Attempts to extend this business model to medical devices have failed, and one reason is federal preemption. That is our takeaway from DeBons v. Globus Medical, Inc., No. 14-5645, 2016 WL 4363171 (9th Cir. Aug. 16, 2016), where the Ninth Circuit affirmed the district court’s order dismissing a putative class action involving bone putty, an allograft tissue product that the FDA regulates as a medical device. See the district court’s dismissal order, DeBons v. Globus Medical, Inc., No. 2:13-cv-08518, 2014 WL 12495351 (C.D. Cal. Aug. 8, 2014). Taking a page from the food playbook, the plaintiff claimed that the device was “not in fact FDA approved,” which we take to mean that product was “cleared” through the 510k process rather than formally “approved.” He alleged therefore that “had made it known that the product was not FDA approved,” he would not have paid for it. Id. at *1. He asserted a raft of consumer fraud claims, including a claim under California’s broadly written Unfair Competition Law, and purported to represent a class of other bone putty patients. Id. Bear in mind that the plaintiff alleged no surgical complication; the device evidently worked just fine. This was strictly a play for a price refund.
Here is where it gets interesting. The main reason why medical device class actions are so rare these days is that medical treatment unavoidably presents individualized issues, making class treatment impossible. Another reason is Section 337(a) of the FDCA, which gives the FDA exclusive authority to enforce the Act’s provisions. This provision impliedly preempts any private action right of action filed because a device manufacturer’s conduct allegedly violates the FDCA. See Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (2001). When combined with the Medical Device Amendments’ express preemption provision, would-be plaintiffs face the “narrow gap” between implied preemption and express preemption on which we often comment (such as here). On the one hand, the MDA’s express preemption provision bars states from enforcing requirements “different from or in addition to” federal requirements. 21 U.S.C. § 360k(a). On the other hand, private litigants cannot enforce the FDCA. A plaintiff therefore “must be suing for conduct that violates the FDCA (or else his claim is expressly preempted . . . ), but the plaintiff must not be suing because the conduct violates the FDCA (such a claim would be impliedly preempted under Buckman).” DeBons, 2016 WL 43463171, at *1 (quoting Perez v. Nidek Co., Ltd., 711 F.3d 1109, 1120 (9th Cir. 2013)).