It’s a short work week, and we’ve got a short case for today’s discussion. Ebrahami v. Mentor Worldwide LLC, 2020 WL 2510760 (9th Cir. May 12, 2020), eats up only one page when we set our printer to double-sided (which we always do now, since the pandemic work-at-home routine gobbles up paper and ink cartridges). As with Cuban coffee, a Hemingway story, or an episode of Children’s Hospital, short here means good. Very good. (We’ve written about the Ebrahimi litigation before, including here and here and here. Ebrahimi is clearly a gift that keeps on giving.)
The plaintiff in Ebrahimi alleged injuries from a silicone breast implant. Such implants are class III medical devices, which means that they went through the premarket approval process of the Medical Device Amendments to the Food, Drug, and Cosmetic Act. And that means that any state law tort claim that tries to impose requirements that are different from or in addition to FDA requirements would be preempted.
That preemption is pretty iron clad for design defect claims. Lately, we’ve seen more and more plaintiffs attempt to circumvent that preemption by styling their claim as manufacturing defect rather than design defect. That’s a bit of a change from what had been standard practice. More often, manufacturing defect claims were mere makeweight – the plaintiffs just about never really sniffed any evidence that the product at issue wandered from specs, and they would ultimately not even oppose the inevitable summary judgment motion. But the times they are a changing.
And yet, a rose by any other name would still be preempted. In Ebrahimi, the plaintiff claimed that the breast implant failed because the manufacturer violated the FDA’s Current Good Manufacturing Practices (“CGMP”). That’s the usual maneuver to try to state a parallel claim, which would elude preemption by alleging that the defendant deviated from a particular Pre-market approval or other FDA requirement applicable to the class III medical device. Anybody can claim a CGMP violation. But is more than an incantation of those four letters required? Bad courts say no, while good courts say yes. The district court was a good court, and granted the defendant’s Rule 12(b)(6) motion to dismiss.
Would the Ebrahimi appellate court also be a good court? Yes, and it is the court where we clerked, the Ninth Circuit. That circuit has long been unfairly maligned. Sure, it can let loose the occasional stinker (E.g., Stengel), but its overall output is as sound as any other court. Sometimes we get used to thinking negatively about something long past the point when it stopped being true. Adam Sandler, it turns out, is capable of fine acting. American cars are well-made. Philly sports fans are actually … okay, so some things don’t change. But the Ninth Circuit has smart judges who get things right.
The Ebrahimi court got it right: “Ebrahimi essentially contends that the court can plausibly infer that Mentor must have violated at least one of the FDA’s CGMPs by not catching her allegedly defective implants. However, even if more general FDA’s requirements are sufficient for a parallel claim, mere allegations suggesting that [Ebrahimi’s] particular breast implant[s] w[ere] defective do not show that [Mentor] failed to comply with the FDA’s Current Good Manufacturing Practices.”
Let’s count the things the Ninth Circuit got right in Ebrahimi:
1. It rejected the parallel claim.
2. It rejected the attempt to recast the claim as manufacturing defect.
3. It rejected the vague reliance on violations of CGMP.
4. It rejected the plaintiff’s reliance on a quasi res ipsa loquitur theory (that the defendant must have done something wrong because the device injured the plaintiff).
That’s a nice litany of correctness for such a short opinion.