Wednesday, September 28, 2011

Successful Class II Medical Device Preemption Decision

We don't see many successful applications of preemption with respect to 510k, Class II medical devices since Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), so when we do, it's a big deal.  Here's one.  Today, in Degelmann v. Advanced Medical Optics, Inc., No. 10-15222, slip op. (9th Cir. Sept. 28, 2011), the Ninth Circuit held that a claim that a contact lens solution manufacturer should have tested its product against a particular microorganism was preempted.

Here's the reasoning, in a nutshell.  (1) there can be "specific requirements," even in 510k, Class II cases; (2) an FDA guidance document (significantly, not a formal regulation) allowed contact lens solutions to come to market under 510k provided the manufacturer did certain specific things; (3) one of those things was the "primary performance criteria" of a "stand alone procedure" - that the solution "show[] the prescribed level of efficacy in killing five representative microorganisms"; (4) the defendant's solution undisputably met this test in wiping out the five specified bugs; (5) plaintiff's claim demanded that the solution also kill a different microorganism that was not on the FDA's list; (6) since plaintiff's demand related to a different microorganism, it was "different from" and "in addition to" the FDA's device specific requirement; (7) all claims "different from" or "in addition to" a device specific requirement" are expressly preempted.  Degelman, slip op. at 18567-70.

So if you're a 510k, Class II device manufacturer, and the FDA's tagged your product with a device-specific guidance document, you may be able to assert preemption after all, at least against some claims.

Given the strength of the preemption defense, it's something worth looking into.

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