Justia Drugs & Biotech Opinion Summaries

Lawsuits brought by governmental bodies and health clinics alleged that Quest, a wholesale pharmaceutical distributor, engaged in misconduct that contributed to a nationwide epidemic of opioid abuse. The plaintiffs plead violations of the RICO Act and state statutes, common law public nuisance, and negligence, seeking damages for “significant expenses for police, emergency, health, prosecution, corrections, rehabilitation, and other services.” Some complaints clarify that the claims “are not based upon or derivative of the rights of others” and that the plaintiffs “do not seek damages for death, physical injury to person, emotional distress, or physical damages to property[.]”Quest's insurance policies covered "damages because of 'bodily injury' or 'property damage'" and explain that “[d]amages because of ‘bodily injury’ include damages claimed by any person or organization for care, loss of services or death resulting at any time from the ‘bodily injury.’” “Bodily injury” is defined as “bodily injury, sickness or disease sustained by a person, including death resulting from any of these at any time.”The insurers sought declaratory judgments that they had no duty to defend or indemnify Quest. The district court granted the insurers summary judgment. The Sixth Circuit affirmed. Based on the plain language of the policies and their overall context and purpose, the court concluded that the Kentucky Supreme Court would find that the insurers have no duty to defend because the lawsuits do not seek damages “because of bodily injury” and claim only economic damages. View "Westfield National Insurance Co. v. Quest Pharmaceuticals, Inc." on Justia Law

Under the Hatch-Waxman Act, a drug may receive “new chemical entity exclusivity” if no active ingredient in the drug was previously “approved.” The drug Aubagio was awarded this exclusivity because the Food & Drug Administration (“FDA”) determined that Aubagio’s only active ingredient, teriflunomide, had never previously been approved. This case concerns a challenge to Aubagio’s exclusivity period, which Sandoz Inc. raises to secure a solo period of marketing exclusivity for its generic equivalent. Sandoz maintains that teriflunomide was previously “approved” as an impurity in the drug Arava. In the alternative, Sandoz argued that teriflunomide was in fact approved as an active ingredient in Arava. The district court granted summary judgment for the FDA, agreeing with the agency that Aubagio was entitled to exclusivity because teriflunomide had never previously been approved.   The DC Circuit affirmed the district court’s judgment. The court held that while Sandoz did not exhaust its statutory argument before the FDA, in the absence of a statutory or regulatory exhaustion requirement, the court found it appropriate to decide Sandoz’s challenge. When the FDA approves a new drug, it does not also “approve” known impurities in that drug for the purpose of new chemical entity exclusivity. And the record is clear the FDA did not approve teriflunomide as an active ingredient when it approved Arava. Aubagio was therefore entitled to new chemical entity exclusivity, and Sandoz cannot benefit from a solo exclusivity period for its generic equivalent. View "Sandoz Inc. v. Xavier Becerra" on Justia Law

Amiodarone was developed in the 1960s for the treatment of angina and was released in other countries. Amiodarone is associated with side effects, including pulmonary fibrosis, blindness, thyroid cancer, and death. In the 1970s, U.S. physicians began obtaining amiodarone from other countries for use in patients with life-threatening ventricular fibrillation or ventricular tachycardia who did not respond to other drugs. In 1985, the FDA approved Wyeth’s formulation of amiodarone, Cordarone, as a drug of last resort for patients suffering from recurring life-threatening ventricular fibrillation and ventricular tachycardia. The FDA’s “special needs” approval issued without randomized clinical trials. In 1989, the FDA described Wyeth’s promotional activities as promoting an unapproved use of the drug. In 1992, the FDA objected to promotional labeling pieces for Cordarone. Other manufacturers developed generic amiodarone, which has been available since 1998.Consolidated lawsuits alleged that plaintiffs suffered unnecessary, serious side effects when they took amiodarone, as prescribed by their doctors, for off-label use to treat atrial fibrillation, a more common, less serious, condition than ventricular fibrillation. The FDA never approved amiodarone for the treatment of atrial fibrillation, even on a special-needs basis. The court of appeal affirmed the dismissal of the lawsuits. The claims are preempted as attempts to privately enforce the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 301, regulations governing medication guides and labeling and have no independent basis in state law. The court also rejected fraud claims under California’s unfair competition law and Consumers Legal Remedy Act. View "Amiodarone Cases" on Justia Law

This appeal arose from an Idaho district court decision affirming a declaratory ruling issued by Respondent Dave Jeppesen (the Director) in his capacity as Director of the Idaho Department of Health and Welfare (the Department). Appellant Grace at Twin Falls, LLC (Grace), a residential assisted living and memory care facility, partnered with a preferred pharmacy to offset costs associated with a software system that coordinated the tracking and delivery of residents’ prescription medications. Because residents who failed to choose the preferred pharmacy did not receive the offset, Grace sought to charge those residents an additional $10.00 each month to cover the difference. Grace brought a petition for declaratory ruling to the Department, asking the Director to declare that Idaho Code section 39-3316(12)(b) and IDAPA 16.03.22.550.12.b did not prohibit Grace from charging the $10.00 fee to those residents who did not choose the preferred pharmacy. The Director denied the petition, declaring that Grace would not “be permitted to assess a non-preferred-pharmacy fee as such fee violates residents’ right to choose their pharmacy or pharmacist . . . .” Grace sought judicial review before the district court, which affirmed the Director’s declaratory ruling. Grace then appealed to the Idaho Supreme Court. Finding no reversible error, the Supreme Court affirmed the district court. View "Grace at Twin Falls, LLC v. Jeppesen" on Justia Law

Liquid Labs manufactures and sells e-liquids that generally contain nicotine and flavoring for use in e-cigarettes. The e-liquids qualify as “new tobacco product[s]” under the Family Smoking Prevention and Tobacco Control Act, 21 U.S.C. 387-387u, and may not be introduced into interstate commerce without the FDA’s authorization. The FDA must deny a premarket tobacco product application (PMTA) if the applicant fails to “show[] that permitting such tobacco product to be marketed would be appropriate for the protection of public health,” as determined with respect to the risks and benefits to the population as a whole, including users and non-users of the tobacco product.” FDA Guidelines have highlighted that flavored e-liquids’ had a “disproportionate appeal to children.”Liquid Labs submitted PMTAs covering 20 e-liquid products and submitted a marketing plan setting forth plans to discourage youths from using its products. The FDA denied the PMTAs, concluding that Liquid Labs had not shown that the benefits of the products sufficiently outweighed the risks they posed to youths. The documents indicated that evidence could have been provided through “randomized controlled trial[s] and/or longitudinal cohort stud[ies],” or other evidence that reliably and robustly evaluated the impact of the new flavored vs. tobacco-flavored products on adult smokers’ switching or cigarette reduction over time.” The Third Circuit denied a petition for review. The FDA’s order was within its statutory authorities and the Administrative Procedure Act. View "Liquid Labs LLC v. United States Food and Drug Administration" on Justia Law

Nexus Pharmaceuticals, Inc. (Nexus) developed the trademarked and FDA-approved drug Emerphed, ready-to-use ephedrine sulfate in a vial. Drug compounding by “outsourcing facilities” is permitted without FDA approval, but 21 U.S.C. Section  353b, a part of the Food, Drug, and Cosmetic Act, excludes from this exception compounded drugs that are “essentially a copy of one or more approved drugs.” To avoid the Act’s bar on private enforcement, Nexus alleged violation of state laws that prohibit the sale of drugs not approved by the FDA.   The Ninth Circuit affirmed the district court’s dismissal, for failure to state a claim, of state law claims brought by Nexus against Central Admixture Pharmacy Services, Inc., operator of a network of compounding pharmacies that sold the drug ephedrine sulfate pre-loaded into ready-to-use syringes without FDA approval.   The panel affirmed the district court’s conclusion that, under the implied preemption doctrine, Nexus’s state law claims were barred because they were contrary to the Food, Drug, and Cosmetic Act’s exclusive enforcement provision, which states that proceedings to enforce or restrain violations of the Act, including the compounding statute, must be by and in the name of the United States, not a private party. The panel held that all of Nexus’s claims depended on a determination of whether Central Admixture’s ephedrine sulphate was “essentially a copy” of Nexus’s Emerphed, and the plain text of the Food, Drug, and Cosmetic Act left that determination in the first instance to the FDA and its enforcement process. View "NEXUS PHARMACEUTICALS, INC. V. CAPS, ET AL" on Justia Law

The Supreme Court reversed the decision of the court of appeals reversing the judgment of the trial court concluding that Acuity, an insurer, did not owe Masters Pharmaceutical, Inc. a duty to defend it in the several lawsuits brought by cities and counties in three states (the governments) for losses caused by the opioid epidemic, holding that Acuity did not owe Masters a duty to defend.Cities and counties in West Virginia, Michigan, and Nevada brought the underlying lawsuits against Masters, a wholesale distributor of pharmaceutical products, including prescription opioids, alleging that Masters's conduct contributed to the opioid epidemic. Acuity filed an action for a declaratory judgment that it owed no duty to defend or indemnify Masters in the underlying suits. The trial court granted summary judgment for Acuity. The court of appeals reversed. At issue was whether the governments sought damages for their own economic losses and not "damages because of bodily injury." The Supreme Court reversed, holding (1) the governments did not seek "damages because of bodily injury"; and (2) therefore, Acuity did not owe Masters a duty to defend it in the underlying suits. View "Acuity v. Masters Pharmaceuticals, Inc." on Justia Law

The Supreme Court affirmed the judgment of the district court dismissing the complaint in this case for failure to state a claim, holding that an employee discharged after testing positive at work based on recreational marijuana use does not have a common-law tortious discharge claim.Plaintiff was terminated from his employment based on a positive test result for marijuana. Plaintiff brought this complaint arguing that he did not use marijuana in the twenty-four hours before that shift and that his use complied with Nevada's recreational marijuana laws. The district court dismissed the complaint. At issue before the Supreme Court was whether adult recreational marijuana use qualifies for protection under Nev. Rev. Stat. 613.333. The Supreme Court answered the question in the negative, holding that because federal law criminalizes the possession of marijuana in Nevada, marijuana use is not lawful in the state and does not support a private right of action under Nev. Rev. Stat. 613.333. View "Ceballos v. NP Palace, LLC" on Justia Law

In this case concerning the medical marijuana licensing and regulatory process the Supreme Court affirmed in part and dismissed in part this interlocutory appeal from the circuit court's denial of Defendants' motion to dismiss this action on the basis of sovereign immunity, holding that the circuit court erred in its ruling.Plaintiff brought this complaint seeking a writ of mandamus and declaratory relief to compel Defendants - the Arkansas Department of Finance and Administration, the Arkansas Alcoholic Beverage Control Division, and the Arkansas Medical Marijuana Commission - to revoke a cultivation facility license granted to another company and instead award it to Plaintiff. The circuit court denied Defendants' motion to dismiss on the doctrine of sovereign immunity. The Supreme Court remanded the action, holding (1) the circuit court did not err in denying the motion to dismiss the writ of mandamus on the basis of sovereign immunity; (2) the circuit court erred in denying gate State's motion to dismiss Plaintiff's claim of declaratory relief; and (3) to the extent that Appellants were seeking relief under the APA the case must be dismissed for lack of subject matter jurisdiction. View "Arkansas Department of Finance & Administration v. 2600 Holdings, LLC" on Justia Law

Johnson & Johnson, Ethicon, Inc., and Ethicon US, LLC (collectively, Ethicon) appealed after a trial court levied nearly $344 million in civil penalties against Ethicon for willfully circulating misleading medical device instructions and marketing communications that misstated, minimized, and/or omitted the health risks of Ethicon’s surgically-implantable transvaginal pelvic mesh products. The court found Ethicon committed 153,351 violations of the Unfair Competition Law (UCL), and 121,844 violations of the False Advertising Law (FAL). The court imposed a $1,250 civil penalty for each violation. The Court of Appeal concluded the trial court erred in just one respect: in addition to penalizing Ethicon for its medical device instructions and printed marketing communications, the court penalized Ethicon for its oral marketing communications, specifically, for deceptive statements Ethicon purportedly made during one-on-one conversations with doctors, at Ethicon-sponsored lunch events, and at health fair events. However, there was no evidence of what Ethicon’s employees and agents actually said in any of these oral marketing communications. Therefore, the Court of Appeal concluded substantial evidence did not support the trial court’s factual finding that Ethicon’s oral marketing communications were likely to deceive doctors. Judgment was amended to strike the nearly $42 million in civil penalties that were imposed for these communications. View "California v. Johnson & Johnson" on Justia Law