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Lofton v. McNeil Consumer & Specialty Pharmaceuticals

February 22, 2012


Appeal from the United States District Court for the Northern District of Texas.

The opinion of the court was delivered by: Edith H. Jones, Chief Judge

Before JONES, Chief Judge, and STEWART and SOUTHWICK, Circuit Judges.

Christopher M. Lofton tragically died from a rare disease called Toxic Epidermal Necrolysis ("TEN") after taking Motrin. Lofton's wife and children brought suit against the Appellees asserting that Motrin caused the disease and the Appellees had failed to warn consumers about the risk of these severe autoimmune allergic reactions. The district court entered summary judgment for the Appellees. The only issue on appeal is whether the district court correctly found that federal law preempts a Texas tort reform law that requires plaintiffs to assert, in failure to warn cases, that a drug manufacturer withheld or misrepresented material information to the FDA. See TEX. CIV. PRAC. & REM.CODE § 82.007(b)(1). We agree with the district court and AFFIRM.


Christopher M. Lofton took over-the-counter Motrin between May 20 and May 22, 2000 to combat a fever. On May 24, after noticing a rash on his skin, Lofton went to the Plano Medical Center emergency room, where he reported both the fever and the rash. After his release, he resumed taking Motrin for pain. When his skin condition worsened, Lofton saw a dermatologist on May 26. The dermatologist diagnosed him with Stevens–Johnson Syndrome ("SJS"), a less advanced form of TEN. The following day, Lofton returned to the emergency room and was soon admitted to the burn unit of Parkland Hospital for treatment of TEN. He died on June 3.

SJS and TEN are extremely rare maladies, occurring in only several people per million each year. One known cause of the diseases is an autoimmune reaction to medication. Whether ibuprofen is among the medications that can cause TEN is a contested issue. In a similar case, the Seventh Circuit noted that "[t]here is unquestionably an association between SJS/TEN and ibuprofen," but such association might arise only from patients' use of ibuprofen to combat the headaches and fevers associated with SJS/TEN. Robinson v. McNeil Consumer Healthcare, 615 F.3d 861, 868 (7th Cir.2010).

The FDA is aware of the connection between ibuprofen and SJS/TEN and, starting in February of 2005, required that ibuprofen labels carry a warning about the symptoms of SJS/TEN. The warning listed skin reddening, rash, and blisters among the signs of an allergic reaction. Also during February 2005, a group that Appellees describe as "experts retained by plaintiffs in Motrin litigation," filed a Citizen's Petition with the FDA. The petition sought additional labeling requirements, including an express reference to SJS/TEN, and alleged that McNeil and other manufacturers had withheld information from the FDA regarding the risk of severe skin disorders. The FDA rejected the petition, explaining that warnings beyond those already added would not be useful. Regarding the allegations that McNeil and other manufacturers withheld information, the agency stated: "[petitioners] provide no evidence to support this allegation. In addition, we have no evidence that there is additional undisclosed safety information that was withheld by the ibuprofen manufacturers."

Against this background, Lofton's family filed suit asserting common law negligence and strict products liability claims. Appellees moved for summary judgment on all claims, asserting in particular that the failure to warn claims, which are subject to a "fraud-on-the-FDA" proof requirement under Texas law, are preempted by Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341, 121 S.Ct. 1012, 148 L.Ed.2d 854 (2001). The district court delayed ruling on the motion until the Supreme Court decided Wyeth v. Levine, 555 U.S. 555, 129 S.Ct. 1187, 173 L.Ed.2d 51 (2009), which asked the Court whether FDA approval of drug labels preempted state failure to warn claims. Although Levine rejected a sweeping view of preemption, the district court in this case nevertheless granted the motion for summary judgment insofar as it related to the preemption of the Texas provision. Lofton v. McNeil Consumer & Specialty Pharms., 682 F.Supp.2d 662, 676–78 (N.D.Tex.2010). The Loftons' other claims have been dismissed.

Only one issue survives on appeal. Under Texas law, a drug manufacturer enjoys a rebuttable presumption that it is not liable for failure to warn if the FDA has approved "the warnings or information" accompanying the product alleged to have harmed the plaintiff. TEX. CIV. PRAC. & REM.CODE § 82.007(a)(1).*fn1 A plaintiff may rebut the presumption, inter alia,

by establishing that ... the defendant ... withheld from or misrepresented to the United States Food and Drug Administration required information that was material and relevant to the performance of the product and was causally related to the claimant's injury.

§ 82.007(b)(1). As an affirmative defense, McNeil raised the § 82.007(a)(1) presumption, and the district court concluded that the conditions for invoking the provision were satisfied because McNeil complied with all FDA requirements governing the labels of over-the-counter ibuprofen. Lofton, 682 F.Supp.2d at 673. The court went on to consider the plaintiffs' attempt to rebut that presumption based on § 82.007(b)(1). The court first concluded that "extending the holding of Buckman to fraud-on-the-FDA exceptions is warranted." Id. at 675. In addition, after noting that the FDA rejected the 2005 Citizen's Petition, the court held that "section 82.007(b)(1) 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." Id. As a result, the district court granted the Appellees' motion for summary judgement. Id. at 681. This appeal followed.


This court reviews a district court's grant of summary judgment de novo applying the same standard as the district court. Onoh v. Northwest Airlines, Inc., 613 F.3d 596, 599 (5th Cir.2010). The court views all evidence in the light most favorable to the nonmoving party and grants summary judgment if there is no genuine issue of material fact and the movant is entitled to judgment as a matter of law. Id. Questions of law regarding preemption ...

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