As earlier reported last week [WSJ Apr. 13; WSJ Law Blog], a Harris County judge has thrown out Ledbetter v. Merck's failure-to-warn claim and stayed 1300 or so other Vioxx cases pending appeal. (Ledbetter herself has other claims pending; the press coverage inaccurately states the entire set of cases are gone.) Contrary to some press and blog reports, the judge's decision, released earlier today, was made not based on the FDA preamble statement to its new disclosure rule, but based on a 2003 Texas statute, Tex. Civ. Prac. & Rem. Code Ann. �82.007, that was apparently ignored by the last two Texas state judges to consider Vioxx cases. (It's possible that the statute doesn't apply to those two cases if they were filed before the statute became law in 2003.) The Texas statute has an exception for fraud-on-the-FDA, but that is preempted by federal law—not by the FDA's recent regulation, but by the U.S. Supreme Court in Buckman, 531 U.S. 341 (2001), which held that fraud on the FDA was a federal inquiry that could only be resolved by federal officials. [Merck press release; WSJ Law Blog]
We'll see what the Texas Supreme Court has to say down the road, but a plain-language reading of the statute would appear to support the claim that all of the Texas failure-to-warn cases against Merck must be dismissed. One would think that this is fatal reversible error in the two multimillion-dollar Texas plaintiffs' verdicts in Garza and Ernst, if those cases were filed after the statute was passed in 2003.