Justia Drugs & Biotech Opinion Summaries

The Fourth Corner Credit Union applied for a master account from the Federal Reserve Bank of Kansas City. The Reserve Bank denied the application, effectively crippling the Credit Union’s business operations. The Credit Union sought an injunction requiring the Reserve Bank to issue it a master account. The district court dismissed the action, ruling that the Credit Union’s stated purpose, providing banking services to marijuana-related businesses, violated the Controlled Substances Act. The Tenth Circuit vacated the district court’s order and remanded with instructions to dismiss the amended complaint without prejudice. By remanding with instructions to dismiss the amended complaint without prejudice, the Court’s disposition effectuated the judgment of two of three panel members who would allow the Fourth Corner Credit Union to proceed with its claims. The Court denied the Federal Reserve Bank of Kansas City’s motion to strike the Fourth Corner Credit Union’s reply-brief addenda. View "Fourth Corner Credit Union v. Federal Reserve Bank of Kansas" on Justia Law

The Supreme Court's opinion in CRST Van Expedited Inc. v. E.E.O.C., 136 S. Ct. 1642, 1646 (2016), effectively overruled Branson v Nott's holding that when a defendant wins because the action is dismissed for lack of subject matter jurisdiction he is never a prevailing party. In this case, Amphastar filed a qui tam action against Aventis under the False Claims Act (FCA), 31 U.S.C 3730, alleging that Aventis obtained an illegal monopoly over the drug enoxaparin and then knowingly overcharged the United States. The district court dismissed the suit based on lack of subject matter jurisdiction. The Ninth Circuit held that Amphastar's allegations were based on publicly disclosed information, and it lacked the direct and independent knowledge needed to be an original source. Therefore, the panel upheld the district court's judgment on the merits. However, the panel held that the district court erroneously concluded that it could not award attorneys' fees, because the FCA's fee-shifting provision contained an independent grant of subject matter jurisdiction and because a party who wins a lawsuit on a non-merits issue is a "prevailing party." The panel remanded for resolution of the attorneys' fees issue. View "Amphastar Pharmaceuticals v. Aventis Pharma" on Justia Law

The Eighth Circuit affirmed the dismissal of relator's False Claims Act (FCA), 31 U.S.C. 3729 et seq., suit based on the public disclosure bar. Relator alleged that CSL Behring conspired with pharmacies to submit false claims to the United States for reimbursement for prescription drugs. The Eighth Circuit concluded that, viewed collectively, the public disclosures provided enough information about the participants in the scheme to directly identify the defendants and the subject drugs; the disclosures would have set the government squarely on the trail of the defendants' participation in the purported fraudulent reporting; and the essential elements of relator's claims -- the purported fraud -- were publicly disclosed prior to him filing suit. View "Lager v. CSL Behring" on Justia Law

The Cervenys sued the manufacturer of Clomid (Aventis, Inc.), asserting various tort claims under Utah law: failure to warn under theories of strict liability and negligence, breach of implied warranty, negligent misrepresentation, and fraud. They presented two theories, pointing to two types of warning labels that Aventis had allegedly failed to provide: (1) a label that warned of risks to the fetus when a woman takes Clomid before becoming pregnant; and (2) a label that unmistakably warned about harm to the fetus when Clomid is taken during pregnancy. The district court rejected the Cervenys’ claims based on preemption. The Tenth Circuit held that the district court ruling was correct on the Cervenys’ first theory, because the undisputed evidence showed that the FDA would not have approved a warning about taking Clomid before pregnancy. But on the second theory, the Tenth Circuit found the district court did not explain why a state claim based on the FDA’s own proposed language would be preempted by federal law. The district court also erred in failing to distinguish the remaining claims (breach of implied warranty, negligent misrepresentation, and fraud) from the failure-to-warn claims. These claims are based at least partly on affirmative misrepresentations rather than on a failure to provide a warning. The district court failed to explain why claims involving affirmative misrepresentations would have been preempted. View "Cerveny v. Aventis, Inc." on Justia Law

Plaintiff appealed the dismissal of his suit brought under the False Claims Act (FCA), 31 U.S.C. 3729(a)-(b), and state analog. Plaintiff alleged that Pfizer, his former employer, improperly marketed Lipitor as appropriate for patients whose risk factors and cholesterol levels fall outside the National Cholesterol Education Program Guidelines; the Guidelines are incorporated into and made mandatory by the drug’s label; and Pfizer thus induced doctors to prescribe the drug, pharmacists to fill the prescriptions, and federal and state health care programs to pay for “off‐label” prescriptions. Judge Cogan dismissed the claims because he determined that the FDA’s approval of Lipitor was not dependent upon compliance with the Guidelines. The court expressly endorsed and adopted Judge Cogan’s carefully considered and thorough analysis, and affirmed on that basis. View "United States ex rel. Polansky v. Pfizer" on Justia Law

The People filed a complaint charging defendants with causing, aiding, and abetting the illegal delivery of marijuana. The trial court granted an injunction barring defendants from further developing or marketing their marijuana delivery app. At issue on appeal is whether Proposition D, L.A. Mun. Code, 45.19.6, which City voters enacted in 2013 to regulate medical marijuana businesses, generally prohibits the delivery of marijuana by vehicles. The court concluded that the City established a likelihood of proving defendants’ app caused, aided, or abetted the violation of Proposition D because, outside of the narrow exception for designated primary caregivers, it prohibits the vehicular delivery of medical marijuana to qualified participants, identification card holders, or primary caregivers in the City. Further, defendants’ opposition to the City’s unfair competition allegations necessarily fails because the City has demonstrated a likelihood of success on its claim that defendants facilitated a violation of Proposition D. In this case, defendants made no showing at all concerning the balance of hardships, much less that the balance tipped sharply in their favor. Accordingly, the court affirmed the trial court's judgment. View "People v. Nestdrop, LLC" on Justia Law

Relators filed a qui tam action under the False Claims Act (FCA), 31 U.S.C. 3729 et seq., against Purdue, alleging that the company was involved in a fraudulent scheme regarding the equianalgesic ratio of OxyContin. The court declined realtors' invitation to read United States ex rel. Siller v. Becton Dickinson & Co., so as to render it internally inconsistent and at odds with the public disclosure bar’s purpose. Indeed, by foreshadowing the court’s conclusion in this case, Siller itself eschews the interpretation relators urge. Here, relators’ claims are based on facts their counsel learned in the course of making the prior public disclosure of Purdue’s allegedly fraudulent scheme. The court held, consistent with its reasoning in Siller and the public disclosure bar’s purpose, that the district court correctly dismissed the relators’ suit. View "United States ex rel. May v. Purdue Pharma L.P." on Justia Law

After Congress directed the FDA to establish a twelve-member Tobacco Products Scientific Advisory Committee to, among other things, report on the safety of menthol cigarettes, plaintiffs filed suit claiming that the FDA appointed to the Committee three members with pecuniary interests hostile to their products, in violation of relevant conflict-of-interests statutes and regulations, and that these appointments injured plaintiffs. Plaintiffs claim that the FDA’s appointments of these Committee members caused them three injuries: (1) an increased risk that the FDA will regulate menthol tobacco products adversely to plaintiffs’ interests; (2) access by the challenged Committee members to plaintiffs’ confidential information, with a probability of their using the information to plaintiffs’ detriment; and (3) the shaping of the menthol report to support the challenged members’ consulting and expert witness businesses, with injuries flowing both from the report itself and from its use as support for their expert testimony and consulting. The court concluded that plaintiffs' alleged injuries are too remote and uncertain. Because the alleged injuries are insufficiently imminent to confer standing, the court vacated the district court's grant of summary judgment for lack of jurisdiction and dissolved the district court's injunction barring the use of the menthol report and ordering the reconstitution of the Committee. View "R.J. Reynolds Tobacco Co. v. FDA" on Justia Law

The State of Mississippi brought a civil action against generic pharmaceutical provider Sandoz, Inc., alleging that Sandoz impermissibly exploited Mississippi’s Medicaid reimbursement program by routinely and exponentially reporting fictitious “Average Wholesale Prices,” a key data factor in the federally supervised formula used by the Mississippi Division of Medicaid to reimburse pharmacies serviced by Sandoz. The trial court, sitting as fact-finder, found Sandoz in violation of the Mississippi Consumer Protection Act and liable for common-law fraud. Sandoz appealed, and the State cross-appealed. On a deferential standard of review, the Supreme Court affirmed the trial court in full. View "Sandoz, Inc. v. Mississippi" on Justia Law

Madel sued the Department of Justice and Drug Enforcement Administration for a response to Freedom of Information Act, 5 U.S.C. 552, requests that sought information on oxycodone transactions in Georgia by five private companies. DEA withheld some documents as confidential commercial information. The district court granted summary judgment to DEA, finding it produced all non-exempt information. The court denied declaratory and injunctive relief and attorney fees. The Eighth Circuit reversed and remanded. Rejecting a claim that DEA did not justify withholding the five documents under FOIA Exemption 4, the court concluded that DEA showed that substantial competitive harm was likely. DEA did not make “barren assertions” that the documents were exempt, but linked each document to identifiable competitive harms. The court remanded for consideration of FOIA’s segregability requirement. DEA did not show “with reasonable specificity why documents withheld pursuant to a valid exemption cannot be further segregated.” Its Declaration does not address how disclosure of the data from, for example, 2007, leads to the proffered substantial competitive harms of a competitor “target[ing] specific markets” or “forecast[ing] potential business of new locations.” View "Madel v. Dep't of Justice" on Justia Law