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Thursday, July 18, 2024 | Back issues
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Firms May Be Liable for Acne Treatment Woes

(CN) - A college student whose liver failed allegedly as a result of using the acne treatment Solodyn may sue Medicis and Ranbaxy Pharmaceuticals for negligence, a federal judge ruled.

Brittani Tigert, a 21-year-old college student, was prescribed Solodyn to treat her acne.

After allegedly filling six prescriptions for the drug, Tigert suffered serious liver damage and experienced liver failure.

Tigert claims that when she was originally prescribed Solodyn, the drug's packaging insert "grossly understated the risks associated" with the treatment, though its label was approved by the Food and Drug Administration (FDA).

Tigert, who continues to receive treatment for her allegedly permanent injuries, sued skin health specialist Medicis Pharmaceutical Corp. and Indian generics maker Ranbaxy Pharmaceuticals, Inc., who manufacture, market, and distribute Solodyn, in the Camden Vicinage in the District of New Jersey.

Medicis has been sued over Solodyn before, when a woman claimed the drug gave her lupus and hepatitis in Maricopa County Court in May 2012.

Tigert now contends that Medicis failed to adequately warn consumers of Solodyn's dangers, and seeks damages under claims of strict products liability and negligence. Her original complaint also brought common law claims for misrepresentation of facts, breach of implied warranty, and fraudulent concealment, which were later dismissed.

Medicis filed a motion asserting its presumption of non-liability under Texas law, urging the court to rely on the Supreme Court's decision in Buckman Co. v Plaintiff's Legal Comm. to find that Texas Civil Practices and Remedies Code §82.007(b)(1) - which says that if a defendant misrepresented to the FDA information related to a product's performance and a claimant's injury, a presumption of non-liability may be rebutted - is preempted by federal law.

U.S. District Judge Robert Kugler disagreed and denied the motion on Dec. 18.

"While this court finds persuasive defendant's argument that similar concerns of judicial oversight of the FDA manifest with §82.007(b)(1), these concerns were not the decisive factors in the Supreme Court preempting fraud on the agency claims," Kugler wrote. "The court reached concerns of interference only after first finding that fraud on the agency claims presented a unique circumstance in which the traditional presumption against preemption of state law did not apply. Such is not the case here. As such, the Supreme Court's narrow ruling in Buckman is unstable ground on which to rest a finding of preemption," he added.

The court tossed aside Medicis's argument that Tigert failed to sufficiently allege fraud under federal law.

"In both the answer and brief in support of the motion for judgment on the pleadings, defendant contends that plaintiff failed to allege fraud with particularity only with respect to the misrepresentation, breach of implied warranty, and fraudulent concealment claims, all of which were voluntarily dismissed. Consequently, the court will decline to consider this argument," Kugler concluded.

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