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Fraud on the FDA - It's Garcia over Desiano in Texas

By James M. Beck and Mark Herrmann

Texas, like Michigan, imposes a strong presumption of non-defectiveness on drug labeling approved by the FDA.  As to the Michigan statute (which has been around longer), the Sixth Circuit (where Michigan is located) ruled that an exception to the presumption for fraud on the FDA was preempted by Buckman.  Garcia v. Wyeth-Ayerst Labs., 385 F.3d 961, 965-66 (6th Cir. 2004).  The Second Circuit, which ordinarily has nothing to do with Michigan, held to the contrary in Desiano v. Warner-Lambert & Co., 467 F.3d 85, 98 (2d Cir. 2006), aff'd by equally divided court, 552 U.S. 440 (2008).  Everyone knows we prefer Garcia (where Bexis filed an amicus brief) to Desiano - and that overall Garcia's been winning.

We're pleased to say that the streak continues.  The other day a federal court in Texas came down strongly on the Garcia side of the line, holding that the Texas exception for fraud on the FDA was preempted:

this court determines that the rationale in Garcia is persuasive and that extending the holding of Buckman to fraud-on-the-FDA exceptions is warranted. The court finds that the concerns in Buckman hold true not only where a plaintiff brings a fraud-on-the-FDA claim but also where it seeks to show an exception to the presumption here. To avoid any intrusion upon the FDA's right to police fraud itself, the court follows Garcia and finds that section 82.007(b)(1) [the Texas fraud on the FDA exception] is preempted in some circumstances, including as here, where Plaintiffs ask the court to reach the conclusion opposite of that reached by the FDA, that Defendants did not withhold information or mislead it.

Lofton v. McNeil Consumer & Specialty Pharmaceuticals, 2010 U.S. Dist. Lexis 6390, at *32 (N.D. Tex. Jan. 27, 2010).  Because there was no dispute that the drug's label was approved, the failure to warn claim was dismissed.

There's other interesting stuff in Lofton, some good, some bad, but we'll save that for some other post.

Full post as published by Drug and Device Law on January 29, 2010 (boomark / email).