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Before we dive into today’s case, Avrin v. Mentor Worldwide LLC, 2024 WL 115672 (C.D. Cal. March 15, 2024), we offer two preliminary observations:

1. We love to hear from our readers.  Sometimes we get emails commenting on a post.  Often, those comments arrive in the form of gushing reviews. That’s nice.  Less often, people gripe about a post, telling us that we got something wrong, or elided over some complexity, or descended into rank punditry.  Guess what? That’s nice, too.  If lawyers suffer hurt feelings from criticism, they are in the wrong business.  Sometimes clients express gratitude for providing a user-friendly resource for spelunking into difficult legal issues.  That’s nice.  Last week a prospective client during a pitch meeting showered the blog with praise.  That’s not only nice, but gives us hope that the prospective client will soon become an existing client. And sometimes colleagues send us cases that are interesting and blog-worthy.  That’s not only nice, it’s a huge help. Our gratitude is enormous, and not quite fully captured by our usual tip of the cyber cap at the end of a case discussion (and which you will see at the bottom of this post). 

2. Express preemption for medical devices applies to manufacturing defect claims.  We’d like to think that is a self-evident proposition.  But we encounter many plaintiff lawyers and, sadly, some courts, that think that while express preemption might put the kibosh on design defect and warning claims, manufacturing defect claims somehow escape preemption.  We are working on several cases where our preemption notion eliminated every product liability claim … save for manufacturing defect.  We also have cases where manufacturing defect was the only claim, as if the plaintiff thought that such leanness or restraint would avoid a preemption headache.  To be sure, the manufacturing defect claims are occasionally design defect claims in disguise.  Moreover, most manufacturing defect claims never get to the finish line, because there is simply no evidence of any deviation from design specs.  Rather, the manufacturing defect claim presumes that an alleged malfunction itself proves the manufacturing defect.  Wrong. But wouldn’t it be splendid if we could head off all those debates by embracing our old friend, preemption?

That’s what the court did in Avrin.  The plaintiff alleged that she developed Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) from implantation of the defendant’s textured breast implants.  (The name of the injury is not great from the perspective of a defendant contesting medical causation.) The plaintiff alleged that the process of producing the defendant’s textured shell produces adulterated implants with excessive silicone debris fragments and particles that remained on the implants in violation of the FDA’s quality system regulation and current good manufacturing practice (CGMP) requirements. 

It’s not hard to see how the plaintiff was trying to evade 21 USC section 360k(a), which bars any claim that would impose any health safety oriented  requirement on a Pre-Market Approved (PMA) medical device (which the class III breast implants are) that is “different from, or in addition to, any requirement” developed by the FDA. The plaintiff’s proposed evasion follows the “parallel claim” route, in which the plaintiff asserts that the medical device violates both federal and state law.  A parallel claim must navigate the “narrow gap” between merely enforcing federal law or contradicting it, neither of which is permissible. 

The plaintiff’s manufacturing defect claim attacks the process by which the defendant manufactures the implants at issue. As such, the claim would require the defendant “to have manufactured, designed, or marketed the [implants] in a manner different from, or in addition to, the FDA’s PMA of the [implants].”  The plaintiff argued that she was not asking to impose any requirement different from or in addition to the federal regulations; rather, her claims paralleled federal requirements that products be manufactured in conformance with CGMP and not be “adulterated.”  

This maneuver is nothing new. It seems to be part of the current plaintiff lawyer playbook. Sometimes they get away with it. Sometimes they don’t. 

Avrin is in the latter, happier, sane category. The Avrin court reasoned that “saying the implants were ‘adulterated’ does not invoke a magic word that automatically saves plaintiffs’ claims from preemption.”  If the plaintiff succeeded in her lawsuit, she would force the manufacturer to stop using the precise manufacturing process approved by the FDA.  Moreover, because her claim was that the process caused not only her breast implants to be “adulterated,” but many or all of the relevant implants to be adulterated, the lawsuit would “encourage, and in fact require, lay judges and juries to second-guess the balancing of benefits and risks of a specific device to their intended patient population — the central role of FDA — sometimes on behalf of a single individual or group of individuals.”  

It’s good to know that “magic words” such as manufacturing defect, adulteration, or CGMP do not make medical device preemption disappear.  Chalk Avrin up as one for the good guys, and be ready to cite it the next time your client gets hit with the manufacturing defect/adulteration evasion. 

The plaintiff also alleged failure to warn. There was a choice of law question as to whether California or Colorado law applied.  California might have recognized a claim for failure to warn based on failure to report adverse events (boo/hiss), while Colorado law would not. The plaintiff was a resident of Colorado, Colorado had the greater interest in having its law applied to its citizens, so Colorado applied, and, therefore, the failure to warn claim was a goner.  

We are grateful to Dustin Rawlin for sending this case our way, and we congratulate him, Monee Hanna, Rachel Byrnes, and the entire Nelson Mullins team for earning such an excellent result.