Articles Posted in Drugs & Biotech

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The Fifth Circuit affirmed defendant's sentence for methamphetamine-related offenses. The court held that the district court did not clearly err by denying a mitigating-role adjustment under USSG 3B1.2 where defendant certainly understood that she was illegally transporting contraband into the United States and that she was being paid for her participation. The court also held that the district court did not impermissibly rely on her integral role to the exclusion of all else, and remand was not warranted where the district court need not weigh each USSG 3B1.2 factor on the record. View "United States v. Bello-Sanchez" on Justia Law

Posted in: Drugs & Biotech

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The Fifth Circuit affirmed the district court's grant of summary judgment to Solvay on relators' False Claims Act (FCA) claims. The court held that relators failed to produce sufficient evidence to survive summary judgment on any of their briefed claims where the public disclosure bar applied to relators' AndroGel claims; at bottom, the probative value of relators' off-label marketing causation evidence was primarily based on conjecture and speculation and was insufficient to create a genuine issue of material fact for trial; and summary judgment was appropriate as to relators' claim that Solvay unduly influenced P&T committees to place Solvay's drugs on preferred drug lists and as to relators' FCA retaliation claims. Finally, the court affirmed the district court's ruling that partly granted court costs to Solvay. View "King v. Solvay Pharmaceuticals, Inc." on Justia Law

Posted in: Drugs & Biotech

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NiGen, manufacturer and distributor of dietary supplements, Isodrene and The HCG Solution, appealed the dismissal of its constitutional and state law claims against the Attorney General based on state sovereign immunity. NiGen had filed suit under 42 U.S.C. 1983 after the AG sent letters to NiGen and its retailers, intimating that formal enforcement was on the horizon for both NiGen and its retailers. The retailers pulled the products from their shelves in Texas and other states, allegedly costing NiGen millions of dollars in lost revenue. The court concluded that it is at least partially correct that NiGen’s claims are not barred from federal jurisdiction on the basis of Ex parte Young; federal jurisdiction plainly exists over most of the constitutional claims pled; and NiGen has standing to sue. Accordingly, the court affirmed in part, and vacated, remanding in part for further proceedings. View "NiGen Biotech, L.L.C. v. Paxton" on Justia Law

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Plaintiff filed a products liability suit against generic and brand-name manufacturers of the prescription drug metoclopramide, alleging that her long-term use of generic metoclopramide caused her to develop tardive dyskinesia and that manufacturers provided misleading and inadequate warnings. The court affirmed the district court's judgment on the pleadings for the generic manufactures under Rule 12(c) on plaintiff's failure-to-warn, design-defect, and express-warranty claims because the claims were preempted by federal law; affirmed the dismissal of plaintiff's claims against the brand-name manufacturers under Rule 12(b)(6) because the claims were barred by Louisiana state law where plaintiff never ingested Reglan manufactured by brand-name manufacturers; even if Louisiana law did not apply, plaintiff has not established that name-brand defendants owed her a duty of care; and denied plaintiff leave to amend her complaint. Accordingly, the court affirmed the judgment of the district court.View "Johnson v. Teva Pharmaceuticals USA, Inc., et al." on Justia Law

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Plaintiffs filed suit against Novartis in the Western District of Texas, then the case was transferred by the Judicial Panel on MDL to the Middle District of Tennessee. Plaintiffs' compliant alleged, inter alia, that Novartis failed to notify the public and physicians of the possibility of suffering osteonecrosis of the jaw until 2004 and failing to notify dental professionals until 2005. The MDL court granted partial summary judgment to Novartis and ruled that: (1) Texas law applied to plaintiffs' case, and (2) Tex. Civ. Prac. & Rem. Code 82.007(a) - which provides manufacturers a rebuttable presumption against liability for failing to warn - foreclosed plaintiffs' failure to warn claims. On remand, the district court granted summary judgment on plaintiffs' remaining claims. The court affirmed the denial of plaintiffs' Rule 56(d) and Rule 60(b) motions; the remand court properly applied the law of the case when it refused to reconsider the MDL court's rulings that section 82.007 applied to plaintiffs' failure to warn claims; and the remand court properly granted summary judgment on plaintiffs' warranty claims. Accordingly, the court affirmed the judgment of the district court. View "McKay, et al v. Novartis Pharmaceutical Corp." on Justia Law

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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

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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

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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.