(Then, as now, Bexis played no role in writing posts about the case, since his firm is involved in the Vioxx defense. Blame Herrmann alone for what follows.)
Judge Randy Wilson, in Harris County, Texas, was overseeing the Texas statewide Vioxx proceedings.
A Texas statute says that if the warnings accompanying a “pharmaceutical product” were approved by the FDA, then “there is a rebuttable presumption that the” drug manufacturer is “not liable with respect to the allegations involving failure to provide adequate warnings.” Tex. Civ. Prac. & Rem. Code Sec. 82.007(a). Vioxx was of course approved by the FDA, so Merck was presumptively not liable for failure to warn. That’s the immunity.
A plaintiff can, however, rebut the immunity — the presumption of non-liability established by subsection (a) — “by establishing that” the drug manufacturer “withheld from or misrepresented to the United State Food and Drug Administration required information that was material and relevant to the performance of the product and was causally related” to the plaintiff’s injury. Tex. Civ. Prac. & Rem. Code Sec. 82.007(b)(1). That’s the fraud-on-the-FDA exception to immunity.
Seven years ago, in a different context, the U.S. Supreme Court held that private plaintiffs cannot pursue claims of fraud on the FDA. Buckman v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001).
In the trial court decision in Ledbetter, Judge Wilson held that Buckman applies to preempt the fraud-on the-FDA exception to non-liability under Texas law, leaving only the immunity intact. That was a big win for Merck — it would not be liable for failure to warn.
Last month, on May 15, 2008, the Texas Court of Appeals dismissed Ledbetter’s appeal. See Ledbetter v. Merck & Co., No. 14-07-00551-CV, 2008 WL 2066580 (Tex. App. –Hous. (14th Dist.) May 15, 2008). Ledbetter had asked the court not only to dismiss the appeal, but also to dismiss the underlying lawsuit and vacate Judge Wilson’s orders in the trial court — which would have erased an important precedent for the defense. The appellate court, however, granted only the motion to dismiss the appeal; the court denied the motion to vacate the trial court order, leaving it intact.
That’s a subsequent history that drug and device lawyers should be aware of, so we’re spreading the word here.