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Device Preemption Win In Louisiana

By James M. Beck and Mark Herrmann

A tip of the cyberhat to blog reader Ed Fitzgerald at Gordon & Rees for sending us the latest preemption win in the post-Riegel device world. It's Bencomo v. Guidant Corp., slip op. (E.D. La. June 30, 2009). The case involves a PMA-approved stent. It's all about express warranty claims because the plaintiff abandoned everything else in the complaint and chose to hunker down with that single remaining claim.

That claim was based upon alleged discrepancies between the stent's Patient Guide (which the plaintiff claimed - only by omitting significant language - promised to "capture all emboli") and the device's labeling. Slip op. at 2.

Didn't work. Preemption applied to the express warranty claim for several reasons.

First of all, not only the labeling, but the patient guide as well, had been presented to the FDA and approved. Slip op. at 13 (there's a long discussion of Riegel on the intervening pages). Preemption precluded plaintiff from basing an express warranty claim on FDA-approved language. Id. at 14. Any alleged inconsistencies between the patient guide and the device labeling were "of no moment" because both documents had FDA approval, and plaintiff's claim was a state-law attempt to change one or the other:

The plaintiff raises the issue of an alleged discrepancy in an effort to prove that the Guide that he read was untrue. Even assuming arguendo that there are inconsistencies. . .the plaintiff's argument is of no moment. Both [documents] were approved by the FDA as a part of the premarket approval process. . . . The plaintiff argues that the inconsistency is important because it will enable him to prove that the statements he relied upon in the Guide were untrue. . . .[I]t is for the precise reason that the plaintiff must demonstrate untruthfulness under [state law] that the. . .breach of warranty claim. . .is preempted.

Id. at 15.

Then the court dealt with plaintiff's obligatory "parallel violation" argument. Slip op. at 16-17. That failed as well. Plaintiff claimed broadly "that FDA regulations require that all labeling of medical devices must accurately represent the device. . .consistently with the [labeling]." Id. at 16. On its face the court found that this claim "relate[s] to and [is] potentially inconsistent with" the FDA's approval of both documents. Id. at 17.

Congrats to Guidant and its counsel. Keep those wins coming.

Full post as published by Drug and Device Law on July 02, 2009 (boomark / email).