Justia Drugs & Biotech Opinion Summaries

Articles Posted in US Court of Appeals for the Eleventh Circuit
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After plaintiff filed suit against Mentor and Mentor Corporation for compensatory and punitive damages for injuries she suffered as a result of the surgical implantation of a polypropylene mesh sling manufactured by Mentor to treat her stress urinary incontinence, a jury found Mentor liable and awarded $400,000 in compensatory and $4 million in punitive damages. The district court upheld the jury's verdict with respect to liability and compensatory damages, but concluded that the punitive damages award exceeded Florida's statutory cap, reducing the punitive damages award to $2 million. The Eleventh Circuit affirmed, holding that the trial court acted well within the bounds of its discretion in allowing the jury to consider an expert's testimony relating to specific causation and Mentor was not entitled to judgment as a matter of law. The court also held that, in this case, which was focused on the physiological response to a design defect in a medical device, the dose-response relation was not implicated and there was no abuse of discretion in admitting the testimony. The court considered Mentor's remaining evidentiary challenges and held that the district court at no point exceeded the bounds of its discretion. Therefore, Mentor was not entitled to a new trial. Finally, the court affirmed the district court's reduction of the punitive damages award where evidence that Mentor knew of a high incidence of injury was not sufficient for finding a specific intent to harm. View "Taylor v. Mentor Worldwide, LLC" on Justia Law

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This case arose from the FDA's seizure from Hi-Tech a substantial quantity of products containing 1,3-dimethylamylamine or DMAA, which is used in fitness products aimed at bodybuilders and other athletes. The district court granted the FDA's motion for summary judgment, holding that the seizure of DMAA was both substantively and procedurally proper. The Eleventh Circuit affirmed and held that DMAA is not an "herb or other botanical" and is not a "constituent" of an herb or other botanical under the Dietary Supplement Health and Education Act of 1994. Furthermore, the court held that DMAA is not generally recognized by qualified experts, as adequately shown through scientific procedures, to be safe under the conditions of its intended use. The court also held that the district court did not abuse its discretion when it declined to reopen discovery, and Hi-Tech was afforded the full range of procedural due process available in federal court. View "United States v. Hi-Tech Pharmaceuticals, Inc." on Justia Law

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Hi-Tech filed suit alleging that the label of a protein-powder supplement distributed by HBS misled customers about the quantity and quality of protein in each serving, violating both the Georgia Uniform Deceptive Trade Practices Act and the federal Lanham Act. The district court dismissed the complaint. The Eleventh Circuit affirmed the district court's dismissal of the state law claim because it was preempted by the Food, Drug, and Cosmetics Act (FDCA). However, the court reversed the district court's dismissal of the Lanham Act claim, and rejected HBS's arguments that the FDCA barred the claim under the Lanham Act. In this case, Hi-Tech's Lanham Act claim would only require a court to determine whether the protein-content representations on the HexaPro label were misleading to consumers in the context of the label's failure to specify the sources of the nitrogen measured by the federal test. Therefore, this inquiry would not require a court to interpret or apply the FDCA to determine whether or not the marketing of the supplement was deceptive. View "Hi-Tech Pharmaceuticals, Inc. v. HBS International Corp." on Justia Law

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The Eleventh Circuit denied the petition for review of the DEA's denial of Jones Pharmacy and SND Healthcare's application for certificates of registration to dispense controlled substances under the Controlled Substances Act (CSA), 21 U.S.C. 801 et seq. The court held that substantial evidence supported the DEA's determination that Jones Pharmacy's owner did not credibly accept full responsibility; the DEA's refusal to consider Jones Pharmacy's remedial measures did not render its decision arbitrary or capricious in this case; and the chosen sanction was not arbitrary or capricious. View "Jones Total Health Care Pharmacy, LLC v. DEA" on Justia Law