The Fifth Circuit has agreed with the Sixth Circuit (and widened a split with the Second Circuit) by holding that a pharmaceutical failure-to-warn claim was preempted by federal law because Texas law requires plaintiffs to prove fraud on the FDA to recover. Lofton v. McNeil Consumer & Specialty Pharms., No. 10-10956. (Download Lofton Opinion.)
The Loftons sued McNeil Consumer & Specialty Pharmaceuticals and Johnson & Johnson, claiming that Christopher M. Lofton died after taking Motrin. They asserted that the defendants had failed to warn them of a risk of severe autoimmune allergic reactions to Motrin that they claimed caused Christopher’s death.
Texas law provides a drug manufacturer with a rebuttable presumption that it is not liable for failure to warn if the FDA approved the "warnings or information" given with the product. Tex. Civ. Prac. & Rem. Code § 82.007(a)(1). One of the ways to rebut this presumption is to show that the defendant withheld information from or made misrepresentations to the FDA, and that the misrepresentations or withheld information was causally related to the claimed injury. Id. § 82.007(b).
The defendants invoked the presumption and asserted that the Loftons' failure-to-warn claim was preempted by federal law. This argument was based on the Supreme Court's holding in Buckman Co. v. Plaintiffs' Legal Committee that federal law preempts state-law causes of action claiming that a medical device manufacturer made fraudulent representations to the FDA. 531 U.S. 341 (2001). The defendants argued that because the Loftons would have to prove fraud on the FDA to overcome the presumption, their claim was preempted.
The circuit courts have split about how to apply Buckman to statutes similar to 82.007. Interpreting a Michigan statute, the Second Circuit held that proving fraud on the FDA to rebut a presumption is different from proving it as part of the plaintiff's claim. Desiano v. Warner-Lambert & Co., 467 F.3d 85 (2d Cir. 2006), aff’d by an equally divided court sub nom. Warner-Lambert & Co. v. Kent, 552 U.S. 440 (2008). Interpreting the same Michigan statute, the Sixth Circuit found that the claim was preempted. Garcia v. Wyeth-Ayerst Labs., 385 F.3d 961 (6th Cir. 2004).
The Fifth Circuit agreed with the Sixth Circuit, relying on the fact that the Loftons could recover under Texas law only by establishing fraud on the FDA. The court found that it did not matter whether this proof was required as an element of the plaintiffs’ claim or as part of rebutting an affirmative defense. In either case, the jury would be “intrud[ing] on the competency of the FDA and its relationship with regulated entities.”
The Fifth Circuit’s decision leaves one key question undecided. For the first time on appeal, the Loftons argued that 82.007(b) (the rebuttal provision) is not severable from 82.007(a) (the provision that provides the presumption of no liability). Therefore, the Loftons argued, if 82.007(b) is preempted, then 82.007(a) must also be preempted, and the defendants are not entitled to the presumption in the first instance. Because this argument was not raised in the trial court, the Fifth Circuit did not address it on appeal. Undoubtedly, plaintiffs in future cases will raise the severability argument in response to claims of preemption. It will be interesting to see how the Fifth Circuit addresses this question when it is squarely before them.
(Full disclosure -- Thomson & Knight represented the defendants in this case.)
-- Rich Phillips, Thompson & Knight
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