A Banner Week For Buckman Preemption

There used to be a TV show called "That Was the Week That Was." It was a satirical look at the news of the prior week, but perhaps it's most lasting accomplishment was to launch David Frost's career. Without an ounce of satire, however, we have to say that the business week of August 15 through 19, 2016 was a heck of a week for implied preemption utilizing Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001). We've already blogged about the Ninth Circuit's decision in DeBons v. Globus Medical, Inc., ___ F. Appx. ___, 2016 WL 4363171 (9th Cir. Aug. 16, 2016), which invoked Buckman preemption to affirm dismissal of a consumer protection class action that was seeking to recover based on allegations that a medical device wasn't properly "approved" (but rather cleared under §510(k)) by the FDA.

But DeBons was only one part of that week's Buckman hat trick.

On the same day, the Fifth Circuit got into the act, affirming a preemption-based dismissal of another medical device product liability suit in Estes v. Lanx, Inc., ___ F. Appx. ___, 2016 WL 4375644 (5th Cir. Aug. 16, 2016). We've already blogged about favorable district court results in the Estes case three times. The Fifth Circuit affirmed all of them. Estes involved a spinal fixation system anchored with bone screws, some of which broke under the intense pressures of holding the human body upright. The screws were explanted and replaced, but "neither the hospital nor [defendant] retained" them. Id. at *1.

Plaintiff first screamed "spoliation" - he lost. Id. ("we find no basis for disturbing the district court's finding of no bad faith").

Unable to establish a conventional defect without the product, plaintiff tried "fraudulent concealment" instead. That's where his claim collided with Buckman. The alleged "fraud" involved how the defendant allegedly presented the device to the FDA:

[Plaintiff's] claim for fraudulent concealment was premised on the allegation that by submitting component-based applications (rather than a single application) for 510(k) approval for the [device] system, [defendant] violated the Federal Food, Drug, and Cosmetic Act ("FDCA").

Estes, 2016 WL 4375644, at *2. Buckman, of course, famously held that there can't be a private right of action for enforcing FDCA violations, and this claim plainly failed the Buckman preemption test because it could not exist without the FDCA - since there wouldn't have been an FDA application process at all unless statute...

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