Justia Drugs & Biotech Opinion Summaries

Articles Posted in Health Law
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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

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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

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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

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Appellees, Rite Aid Corporation, Rite Aid Hdqtrs. Corp., and Rite Aid of Maryland, Inc. (collectively, “Rite Aid”), held a general liability insurance policy underwritten by defendany Chubb, Limited ("Chubb"). Rite Aid and others were defendants in multi-district litigation before the United States District Court for the Northern District of Ohio (the “MDL Opioid Lawsuits”). Plaintiffs in that suit filed over a thousand suits in the MDL Opioid Lawsuits against companies in the pharmaceutical supply chain for their roles in the national opioid crisis. Certain suits were bellwether suits - including the complaints of Summit and Cuyahoga Counties in Ohio (“the Counties”) which were at issue here. The question this case presented for the Delaware Supreme Court was whether insurance policies covering lawsuits “for” or “because of” personal injury required insurers to defend their insureds when the plaintiffs in the underlying suits expressly disavowed claims for personal injury and sought only their own economic damages. The Superior Court decided that Rite Aid’s insurance carriers were required to defend it against lawsuits filed by two Ohio counties to recover opioid-epidemic-related economic damages. As the court held, the lawsuits sought damages “for” or “because of” personal injury because there was arguably a causal connection between the counties’ economic damages and the injuries to their citizens from the opioid epidemic. The Supreme Court reversed, finding the plaintiffs, governmental entities, sought to recover only their own economic damages, specifically disclaiming recovery for personal injury or any specific treatment damages. Thus, the carriers did not have a duty to defend Rite Aid under the governing insurance policy. View "ACE American Insurance Company v. Rite Aid Corporation" on Justia Law

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Several entities that owned or operated hospitals in Alabama ("plaintiffs") filed suit against manufacturers of prescription opioid medications, distributors of those medications, and retail pharmacies ("defendants"), alleging that defendants' marketing or selling of the medications resulted in an epidemic of opioid abuse in Alabama. Plaintiffs sought to recover unreimbursed medical expenses incurred in treating individuals with opioid-related medical conditions. Among other theories of liability, plaintiffs asserted that defendants had created a public nuisance in the form of the epidemic. The trial court entered a case-management order directing the parties to try each of plaintiffs' causes of action separately. The public-nuisance claim was to be tried first and is itself to be bifurcated into two separate trials. The first trial on the public-nuisance claim was to involve "liability," and the second trial was to involve "special damage." Defendants, asserting that the trial court had erred in bifurcating the public-nuisance claim, petitioned the Alabama Supreme Court for a writ of mandamus directing the trial court to vacate the relevant portion of the case-management order. The Supreme Court granted the writ: "conducting a trial on the issue of the defendants' 'liability' for a public nuisance and a second trial on 'special damage' neither avoids prejudice nor furthers convenience, expedition, or economy. We can only conclude that the trial court exceeded its discretion. We therefore grant the defendants' petition and issue a writ of mandamus." View "Ex parte Endo Health Solutions Inc. et al." on Justia Law

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The Food and Drug Administration denied Breeze’s Premarket Tobacco Product Applications for its electronic nicotine delivery systems (ENDS). Breeze sought a stay of the FDA’s order. Under the Family Smoking Prevention and Tobacco Control Act “any person adversely affected by” the denial of a Premarket Tobacco Product Application may seek judicial review of the denial, 21 U.S.C. 387l(a)(1)(B). Breeze argued that seeking a stay from the FDA would have been impracticable because the order takes effect immediately and the FDA can take months to consider an agency-level request for a stay.The Sixth Circuit denied the requested stay, finding that Breeze had not made a strong showing that it is likely to succeed on the merits.” Breeze has not made a strong showing that it would likely succeed on its claim that the FDA’s review of its application was arbitrary or capricious nor that the FDA’s denial of its application contradicted the FDA’s nonbinding 2019 guidance. That guidance contemplated more rigorous scientific data than contained in Breeze's application that its ENDS product adequately protected public health. The FDA cited well-developed evidence showing that flavored ENDS products’ special appeal to youths harms public health to a degree not outweighed by the (far-less-supported) effects of adult cigarette smokers switching to e-cigarettes. View "Breeze Smoke, LLC v. United States Food and Drug Administration" on Justia Law

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An opioid manufacturer appealed a $465 million verdict following a bench trial in a public nuisance lawsuit. The district court held the opioid manufacturer liable under Oklahoma's public nuisance statute for its prescription opioid marketing campaign. The State of Oklahoma counter-appealed. The Oklahoma Supreme Court retained the appeal and held that the opioid manufacturer's actions did not create a public nuisance. The district court erred in extending the public nuisance statute to the manufacturing, marketing, and selling of prescription opioids. View "Oklahoma ex rel. Attorney General of Oklahoma v. Johnson & Johnson" on Justia Law

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Smith’s hip resurfacing implant consists of a metal ball that covers the top of the femur and a cup that fits inside the hip socket. When a surgeon puts these ball-and-cup surfaces in the joint, the polished metal surfaces are supposed to allow smoother movement than the damaged bone or cartilage they replace. Gall, who had hip resurfacing surgery for his left hip, recovered and became physically active. Years later, convinced his implant was unsatisfactory, Gall sued Smith.Gall argued that Smith failed to properly warn Gall’s surgeon, Dr. Hernandez, about the risks of using Smith’s product. The trial court granted Smith summary judgment because Hernandez independently knew these risks and whether Smith gave Hernandez redundant warnings did not matter. Gall also argued that Smith’s product was defective. The trial court granted summary judgment because Gall did not show anything was wrong with his implant. Gall did show Smith’s quality control procedures once failed to satisfy regulatory authorities, but the court concluded this fact did not imply the parts Gall received were defective. The court of appeal affirmed. Gall’s claims share the same causation element and Gall did not establish causation. View "Gall v. Smith & Nephew, Inc." on Justia Law

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A drug manufacturer cannot distribute a drug in interstate commerce without obtaining the FDA’s approval for the uses listed on the drug’s official label, 21 U.S.C. 355(a). The Act does not prohibit doctors from prescribing FDA-approved drugs for “off-label” use but leaves the regulation of doctors to the states. Hydroxychloroquine is approved to treat malaria, lupus, and arthritis but not to treat COVID-19. In 2020, the FDA relied on then-available data and issued an Emergency Use Authorization, permitting hydroxychloroquine in the federal government’s strategic stockpile to be distributed to treat COVID-19 patients in limited circumstances.The Association, a nonprofit organization with physician members, sued, challenging restrictions barring use of hydroxychloroquine to treat COVID-19 except for hospitalized patients. The Association alleged that these restrictions violated the implied equal-protection guarantee in the Fifth Amendment; violated the First Amendment right to associate by limiting access to medication useful for meeting in groups; and violated the Administrative Procedure Act. The Association alleged an injury to itself: it was considering canceling a conference purportedly due to the restrictions. It also invoked associational standing on behalf of its physician members who could not prescribe hydroxychloroquine for COVID-19.The district court held that none of these injuries plausibly pleaded the Association’s standing to challenge the Authorization. The court dismissed the complaint for lack of subject matter jurisdiction. The Sixth Circuit affirmed. The Associaiton failed to plausibly plead that any member has been injured by the FDA’s actions. View "Association of American Physicians & Surgeons v. United States Food & Drug Administration" on Justia Law

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Educational Center treats patients with severe mental disabilities, some of whom suffer from severe self-injurious and aggressive behaviors that are difficult or impossible to treat using conventional behavioral and pharmacological techniques. Some patients have suffered brain trauma, broken and protruding bones, and blindness as a result of their behaviors. Before the ban, the Center treated some self-injurious and aggressive patients with an electrical stimulation device called a graduated electronic decelerator, which briefly shocks patients causing them to reduce or cease their self-injurious behaviors. The Center is the only facility in the country that uses electric shock therapy to treat individuals who severely self-injure or are aggressive. Other health care practitioners administer electrical stimulation devices to treat a wide variety of other conditions, including tobacco, alcohol, and drug addictions, as well as inappropriate sexual behaviors following traumatic brain injuries. The Center manufactures its own devices, which are regulated by the FDA, 21 U.S.C. 360c(a)(1)(B).In 2020, the FDA determined that the devices presented a substantial and unreasonable risk to self-injurious and aggressive patients and banned the devices for that purpose. The D.C. Circuit vacated the rule. Banning a medical device for a particular purpose regulates the practice of medicine in violation of 21 U.S.C. 396. View "The Judge Rotenberg Educational Center, Inc. v. United States Food and Drug Administration" on Justia Law