Justia Drugs & Biotech Opinion Summaries

This case stemmed from Cytori's application to the FDA to market two new medical devices, the Celution 700 and the StemSource 900. Two devices that use adipose tissue as a source of stem cells that could later be used in lab analysis or, potentially, in regenerative medicine. The FDA concluded that the Celution and the StemSource were not substantially similar to devices on the market that extract stem cells from blood or bone marrow. Thus, the FDA ruled that Cytori must go through an extensive premarket approval process for new medical devices, rather than go through the streamlined premarket notification process for new devices that would be substantially equivalent to another device already on the market. Cytori appealed. As a preliminary matter, the court concluded that it was the proper forum for direct review of the FDA's substantial equivalence determination. On the merits, the court concluded that the FDA reasonably concluded and reasonably explained, for purposes of the Administrative Procedures Act, 5 U.S.C. 500 et seq., that the Celution and StemSource did not meet either the "intended use" requirement or the "technological characteristics" requirement for a substantial equivalence determination. View "Cytori Therapeutics, Inc. v. FDA" on Justia Law

The DEA, under the authority of the Controlled Substances Act of 1970, 21 U.S.C. 812(b)(1)(B), classified marijuana as a Schedule I drug, the most restricted drug classification under the Act. Petitioners challenged the DEA's denial of its petition to initiate proceedings to reschedule marijuana as a Schedule III, IV, or V drug. The principal issue on appeal was whether the DEA's decision was arbitrary and capricious. First, the court denied the Government's jurisdictional challenge because the court found that at least one of the named petitioners had standing to challenge the agency's action. On the merits, the court held that the DEA's denial of the rescheduling petition survived review under the deferential arbitrary and capricious standard where the petition asked the DEA to reclassify marijuana, which, under the terms of the Act, required a "currently accepted medical use." A "currently accepted medical use" required, inter alia, "adequate and well-controlled studies proving efficacy." The court deferred to the agency's interpretation of these regulations and found that substantial evidence supported the agency's determination that such studies did not exist. Accordingly, the court denied the petition for review. View "Americans for Safe Access, et al v. DEA" on Justia Law

Congress enacted section 703 of the National Defense Authorization Act for Fiscal Year 2008, 10 U.S.C. 1074g(f), which subjected all prescriptions purchased at retail pharmacies by service members to the same price caps as drugs procured directly by the Department of Defense. Pursuant to this provision, the Secretary of Defense issued a regulation requiring pharmaceutical manufacturers to refund to the federal government the difference between the retail price and the price cap. The Coalition, a multi-industry interest group that represented pharmaceutical companies, filed suit challenging these actions. The court concluded that the Secretary reasonably interpreted section 703 to impose involuntary price caps and held that the statute itself imposed retroactive rebate liability on pharmaceutical manufacturers. View "Coalition For Common Sense in Government Procurement v. United States, et al" on Justia Law

Appellants, researchers in the field of adult stem cells who oppose the use of federal funding for the development of embryonic stem cell (ESC) research, filed a complaint seeking declaratory and injunctive relief against the Secretary's implementation of regulations allowing federal funding of such research. The court, applying Chevron analysis, held that the NIH had reasonably interpreted the Dickey-Wicker Amendment's ban on funding "research in which . . . embryos are destroyed" to allow federal funding of ESC research. Further, the preliminary-injunction exception was not applicable to the law-of-the-case preclusion. The court also held that the NIH's interpretation of the Dickey-Wicker Amendment's actual language was reasonable and the NIH's decision to dismiss the comments categorically objecting to ESC was not arbitrary or capricious. Accordingly, the court affirmed summary judgment in favor of the government. View "Sherley, et al. v. Sebelius, et al." on Justia Law

Plaintiff sought to develop a rapid, self-administered test to determine a person’s HIV status. The development process included collection of human blood and saliva samples. Plaintiff sued the United States under the Federal Tort Claims Act for the destruction of its blood and saliva specimens by the Food and Drug Administration. The specimens had been seized during a criminal investigation and the freezer in which they were stored broke down. The district court entered summary judgment that the suit arose from a law enforcement officer’s detention of property, excepting the claims from the FTCA waiver of sovereign immunity, 28 U.S.C. 2680(c). The Seventh Circuit affirmed. The government presented uncontroverted evidence that the officer detained the specimens as a law enforcement officer View "On-Site Screening, Inc. v. United States" on Justia Law

Olivia, born in 2000, apparently healthy, became ill after her first vaccinations. Her condition required extensive hospitalization; she still requires a ventilator and a wheelchair. Her parents filed a petition with the National Vaccine Injury Compensation Program, 42 U.S.C. 300aa-1 to34. Olivia's injuries are not covered by a table of injuries presumed to be caused by vaccines, so the parents were required to show that one of the administered vaccines caused or significantly aggravated her condition. They submitted two reports by experts. The special master identified unanswered questions, but the parents took the position that it was unreasonable to require such detail at the pre-hearing stage. Based on failure to submit a supplemental report and failure to identify a clear theory of causation, the special master dismissed. The claims court affirmed. The Federal Circuit reversed. The special master did not appropriately review the evidence of causation under the summary judgment standard. View "Simanski v. Sec'y of Health & Human Servs." on Justia Law

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. View "Lofton, et al. v. McNeil Consumer & Specialty Pharmaceuticals, et al." on Justia Law

Cody Laboratories, Inc. and Lannett Co., Inc. (collectively, "Cody") appealed a district court's dismissal of their action for declaratory judgment against the Food and Drug Administration (FDA). Cody has been manufacturing and distributing morphine sulfate since 2005. At the time Cody filed its complaint, the company had not received FDA approval for its morphine sulfate product. Cody contends that the product falls under the "grandfather clause" of the Food, Drug, and Cosmetic Act (FDCA). The FDA claims that the grandfather clause is exceedingly narrow and applies only to drugs that have been marketed in essentially identical form since 1938. The FDA sent Cody a warning letter in March 2009 stating that Cody's manufacture and distribution of morphine sulfate was in violation of the FDCA. Meanwhile, in August 2009, Roxane Laboratories, Inc., Cody's main competitor, submitted a New Drug Application ("NDA") for its own morphine sulfate product. Following its policy of granting expedited review of an NDA if no approved alternative drug exists, the FDA quickly reviewed and approved Roxane's NDA in January 2010. Cody submitted an NDA for its product the following month. The company's requests for expedited review were denied. Cody brought suit claiming the FDA acted arbitrarily, capriciously and contrary to law in violation of the Administrative Procedure Act by: (1) improperly determining that Cody's product was a "new drug" and thus not entitled to grandfathered status under the FDCA; and (2) treating Cody disparately from Roxane in processing the companies' respective NDAs. The court subsequently dismissed Cody's complaint for lack of jurisdiction, holding that the FDA had yet to complete "final agency action" under section 704 of the APA. Upon review of the record, the Tenth Circuit concluded that one of Cody's claims was mooted by post-judgment events and that Cody failed to exhaust available administrative remedies with respect to its remaining claim. The Court affirmed the district court's dismissal for lack of jurisdiction on the grandfathering claim, and dismissed Cody's disparate treatment claim as moot. View "Cody Laboratories, Inc. v. Sebelius" on Justia Law

Plaintiff, engaged in treatment and disposal of regulated biomedical waste, had trouble with its shredder and obtained approval from the Puerto Rico Environmental Quality Board to use autoclaves. After a few years, an inspector recommended that plaintiff's facility be shut down and ordered a landfill to stop accepting plaintiff's waste. Unable to resolve the matter with EQB, plaintiff sought a federal court injunction. The injunctions were denied, but plaintiff resumed handling waste. When a second shredder broke, an inspector again ordered the landfill to stop accepting waste and rejected several proposals for dealing with accumulated waste. Plaintiff's suit alleges more favorable treatment of a competitor and other constitutional violations. The district court dismissed for failure to link allegations to any particular defendant. The First Circuit affirmed, finding failure to meet minimal pleading standards. The complaint failed the plausibility test "spectacularly." View "Redondo Waste Sys., Inc.v. Lopez-Freytes" on Justia Law

The FTC sued Lundbeck, Inc., alleging that its acquisition of the drug NeoProfen violated the Federal Trade Commission Act, 15 U.S.C. 41 et seq., the Sherman Act, 15 U.S.C. 1-7, the Clayton Act, 15 U.S.C. 12-27, the Minnesota Antitrust Law of 1971, and unjustly enriched Lundbeck. At issue was whether the district court properly determined that the FTC failed to identify a relevant market where the FTC did not meet its burden of proving that the drugs Indocin IV and Neoprofen were in the same product market. The court held that the district court's finding was not clearly erroneous and affirmed the judgment. View "Federal Trade Commission v. Lundbeck, Inc." on Justia Law