Justia U.S. 11th Circuit Court of Appeals Opinion Summaries

Articles Posted in Drugs & Biotech
by
The Eleventh Circuit vacated the district court's dismissal of plaintiffs' claims against defendants based on lack of standing. The court held that plaintiffs plausibly alleged that they suffered an economic loss when they purchased supplements that were worthless because the Federal Food, Drug, and Cosmetic Act (FDCA) prohibited sale of the supplements. The court explained that Congress, through the FDCA and the Dietary Supplement Health and Education Act (DSHEA), banned adulterated supplements to protect consumers from ingesting products that Congress judged to be insufficiently safe. In this case, the complaint's allegations establish that plaintiffs purchased adulterated dietary supplements that they would not have purchased had they known that sale of the supplements was banned. The court also held that plaintiffs sufficiently alleged sufficient facts to show that their injuries were fairly traceable to defendants. Accordingly, plaintiffs had Article III standing to pursue their claims. View "Debernardis v. IQ Formulations, LLC" on Justia Law

by
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

by
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

by
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

by
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

by
Ranbaxy, a pharmaceutical company, seeks money damages and injunctive relief for alleged misrepresentations made by FDB, a company that publishes a drug information database for use by pharmacies across the United States. Ranbaxy alleges that FDB’s database, MedKnowledge, falsely represents that Ranbaxy’s acne drug Absorica is non-unique. The district court granted summary judgment to FDB. The court affirmed the order and judgment, concluding that Ranbaxy has not raised a genuine issue of material fact with regard to falsity. The court concluded that, because FDB provides ample explanation of the information and terms in its database, no reasonable reader would conclude that Absorica was therapeutically equivalent to or substitutable for other drugs. View "Ranbaxy Labs. Inc. v. First Databank, Inc." on Justia Law

Posted in: Drugs & Biotech
by
VRC filed suit against HHS and the Secretary, seeking the recoupment of payments VRC returned to Medicare after it was issued notice of an overpayment. At issue is the reimbursement rate of the intravitreal injection of Lucentis. VRC did not follow the Lucentis label’s instructions limiting dosage to one per vial. Instead, VRC treated up to three patients from a single vial. Because VRC was extracting up to three doses from a single vial, it was reimbursed for three times the average cost of the vial and three times the amount it would have received had it administered the drug according to the label. The court affirmed the denial of recoupment, concluding that VRC's charge to Medicare did not reflect its expense and was not medically reasonable; the Secretary's decision was supported by substantial evidence; and VRC is liable for the overpayment. View "Vitreo Retinal Consultants v. U.S. Dep't of Health & Human Servs." on Justia Law

by
This case involved disputes over licensing agreements for, inter alia, the RS 3400 blood irradiation device. At issue was whether the Federal Circuit has exclusive jurisdiction to hear an appeal of a breach of contract claim that would require the resolution of a claim of patent infringement for the complainant to succeed. The court concluded that it did not have appellate jurisdiction and resolved dispositive issues in favor of Rad Source, leaving a single dispositive issue for certification: When a licensee enters into a contract to transfer all of its interests in a license agreement for an entire term of a license agreement, save one day, but remains liable to the licensor under the license agreement, is the contract an assignment of the license agreement, or is the contract a sublicense? View "MDS (Canada) Inc., et al. v. Rad Source Technologies, Inc." on Justia Law

by
Plaintiff brought claims of negligence, strict liability, breach of warranty, misrepresentation and fraud, and negligence per se against defendants, alleging that she developed tardive dyskinesia after taking generic metoclopramide manufactured by Defendant Teva for a period of greater than 12 weeks, contrary to administrative guidance issued by the FDA. The court affirmed the district court's dismissal of plaintiff's claims against Teva as preempted by federal law and because, preemption aside, the learned intermediary doctrine prevented her from stating a claim upon which relief could be granted under Florida law; affirmed the district court's grant of summary judgment in favor of Defendant Brand Manufacturers because Florida law did not permit an injured consumer to recover from the brand manufacturer of a prescription drug if the consumer is known to have ingested only the generic form of that drug; and noted that, insofar as plaintiff sought redress for her injuries, such redress lies with Congress or the Florida legislature. Accordingly, the court affirmed the judgment. View "Guarino v. Wyeth, et al." on Justia Law

by
This case involved a confidential document called the Project Tulip Financial Analysis (Tulip FA), which projected profits, as well as discussed the appropriate terms and benefits from a settlement, involving Solvay's highly lucrative patent on AndroGel, a topical testosterone gel. Solvay subsequently appealed the district court's decision to modify an earlier protective order and unseal the Tulip FA. The court affirmed the district court's judgment, concluding that the district court did not abuse its considerable discretion to modify its own protective order. The district court found that the passage of time had altered the balance enough so that the value of public access to the Tulip FA exceeded the value of confidentiality to Solvay. The court also vacated the stay entered by a panel of the court. View "Federal Trade Commission v. AbbVie Products LLC" on Justia Law