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

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

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

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

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

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

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

This case involved a type of patent litigation settlement known as a "pay for delay" or "reverse payment" agreement. In this type of settlement, a patent holder paid the allegedly infringing generic drug company to delay entering the market until a specified date, thereby protecting the patent monopoly against a judgment that the patent was invalid or would not be infringed by the generic competitor. This case began when the FTC filed a complaint in district court alleging that the reverse payment settlements between the holder of a drug patent and two generic manufacturers of the drug were unfair restraints on trade that violated federal antitrust laws. The court's precedent established the rule that, absent sham litigation or fraud in obtaining the patent, a reverse payment settlement was immune from antitrust attack so long as its anticompetitive effects fell within the scope of the exclusionary potential of the patent. The court rejected the FTC's claims to the contrary and affirmed the judgment. View "FTC v. Watson Pharmaceuticals, Inc., et al." on Justia Law