Justia U.S. 5th Circuit Court of Appeals Opinion SummariesArticles Posted in Drugs & Biotech
Eckhardt, et al. v. Qualitest Pharmaceuticals, Inc., et al.
Plaintiff filed various products liability and general tort claims against the Brand Defendants - who initially developed and received FDA approval for metoclopramide - and Generic Defendants - who manufactured and sold the product that plaintiff used. Plaintiff alleged that as a result of his prolonged use of the drug metoclopramide, he developed tardive dyskinesia. On appeal, plaintiff challenged the district court's dismissal of his claims against the Brand Defendants and grant of summary judgment to the Generic Defendants. The court held that plaintiff's products liability claims against the Generic Defendants were preempted under the holdings and reasoning of PLIVA, Inc. v. Mensing and Mutual Pharmaceutical Co., Inc. v. Bartlett, and that plaintiff failed to adequately plead any parallel claims. The court also held that plaintiff's claims against the Brand Defendants failed because plaintiff did not use the Brand Defendants' products and because Texas did not recognize a duty to a consumer who uses a competitor's products. Accordingly, the court affirmed the district court's dismissal of plaintiff's claims against the Generic Defendants and grant of summary judgment to the Brand Defendants. View "Eckhardt, et al. v. Qualitest Pharmaceuticals, Inc., et al." on Justia Law
Daniels Health Sciences, L.L.C v. Vascular Health Sciences, L.L.C.
DHS sued VHS for misappropriation of trade secrets, breach of contract, and trademark violations. DHS engaged VHS to market and sell the drug Provasca. After that relationship ended, VHS began to manufacture, market, and sell Arterosil, a product similar in many respects to Provasca. The court held that the district court granted DHS's request for a preliminary injunction after making sufficient findings of fact to support each element of the analysis and applying the correct legal standard to those facts. Therefore, the court affirmed the district court's grant of the preliminary injunction in full and lifted the stay of the injunction. The court remanded and directed the district court to expedite the trial on the permanent injunction and to attempt to narrow the breadth of its preliminary injunction. View "Daniels Health Sciences, L.L.C v. Vascular Health Sciences, L.L.C." on Justia Law
Lofton, et al. v. McNeil Consumer & Specialty Pharmaceuticals, et al.
Christopher M. Loften died from a rare disease called Toxic Epidermal Necrolysis (TEN) after taking Motrin. Lofton's wife and children brought suit against defendants asserting that Motrin caused the disease and defendants had failed to warn consumers about the risk of these severe autoimmune allergic reactions. At issue on appeal was whether the district court correctly found that federal law preempted Tex. Civ. Prac. & Rem. Code 82.007(b)(1), which required plaintiffs to assert, in failure to warn cases, that a drug manufacturer withheld or misrepresented material information to the FDA. The court held that section 82.007(b)(1) required a Texas plaintiff to prove fraud-on-the-FDA to recover for failure to warn and this requirement invoked federal law supremacy. Therefore, because the court concluded that section 82.007(b)(1) was a fraud-on-the-FDA provision analogous to the claim considered in Buckman Co. v. Plaintiffs' Legal Comm., the court held that it was preempted by the Food, Drug and Cosmetic Act (FDCA), 21 U.S.C. 301 et seq., unless the FDA itself found fraud. Accordingly, the court affirmed the district court's grant of summary judgment in favor of defendants.