Justia Drugs & Biotech Opinion Summaries

Articles Posted in Drugs & Biotech
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In this appeal arising out of a multidistrict litigation concerning the pharmaceutical drug ondansetron hydrochloride, better known as Zofran, the First Circuit affirmed the order of the district court granting summary judgment in favor of GlaxoSmithKline (GSK), holding that there was no error or abuse of discretion.Various plaintiffs filed separate lawsuits alleging that the use of Zofran during pregnancy caused birth defects and that GSK engaged in an intentionally misleading plan to market Zofran for pregnancy in violation of state law. The district court granted summary judgment in favor of GSK, holding that federal law preempted Plaintiffs' state law claims. The First Circuit affirmed, holding that federal law preempted Plaintiffs' state law claims that GSK should have warned both prescribing doctors and pregnant people that "animal studies showed harm to the fetus when Zofran was ingested during pregnancy." View "Perham v. GlaxoSmithKline, LLC" on Justia Law

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Pirfenidone is a drug used to treat idiopathic pulmonary fibrosis (IPF), a chronic, irreversible lung disease. There is no cure for IPF. Patients living with the disease face an average survival of two-five years. The FDA has approved two drugs for the treatment of IPF, pirfenidone, and nintedanib; differences center on side effects and metabolism. Pirfenidone was first studied as an investigational new drug in 1973. In 2004, the FDA granted pirfenidone orphan drug status for treatment of IPF. In 2014, pirfenidone was approved to treat IPF in the U.S. as Esbriet®, sold by Genentech. Sandoz submitted two Abbreviated New Drug Applications, seeking FDA approval to market a generic version of pirfenidone. Genentech then brought this Hatch-Waxman suit, asserting that Sandoz’s generic product would induce the infringement of its patents. The asserted patents do not claim pirfenidone itself, or the use of pirfenidone to treat IPF but claim methods for managing side effects when using pirfenidone to treat IPF.The Federal Circuit affirmed district court holdings that the claims of Genentech’s Liver Function Test patents are unpatentable as obvious, sales of Sandoz’s generic product would not induce infringement of the LFT patents, and sale of Sandoz’s generic product would not directly infringe Genentech’s Drug-Drug Interaction patents. View "Genentech, Inc. v. Sandoz Inc." on Justia Law

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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

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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

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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

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April Mancini owned the Jah Healing Kemetic Temple of the Divine Church, Inc. (the Church), whose adherents consume cannabis blessed by Church pastors as “sacrament.” The County of San Bernardino (the County) determined that the Church routinely sold cannabis products in violation of a County ordinance prohibiting commercial cannabis activity on unincorporated County land. The trial court found that the Church was operating an illegal cannabis dispensary and issued a permanent injunction against Mancini and the Church, among other relief. Mancini and the Church appealed, but finding no reversible error, the Court of Appeal affirmed. View "County of Santa Barbara v. Mancini" on Justia Law

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Guaranteed was a “reverse distributor,” paid by healthcare providers to return unused or expired pharmaceutical drugs to the drug manufacturers, for refunds for the healthcare-provider clients. Refunds were wired directly to Guaranteed’s general operating account; the company then issued refund checks to the relevant clients, less a service fee. In 2001, the Department of Defense contracted with Guaranteed. The government began investigating Guaranteed after the District of Columbia noticed that it did not receive the full refund on a return of some of its pharmaceuticals. The investigation uncovered a series of schemes that Guaranteed used to defraud its clients.Guaranteed, its CEO, and its CFO, were convicted of multiple counts of wire fraud, mail fraud, conspiracy to launder money, and theft of government property. In addition to prison sentences, the court imposed more than $100 million in restitution and forfeitures. The Third Circuit reversed the money laundering convictions and remanded for resentencing. Viewing the evidence in the light most favorable to the government, there is not sufficient evidence to prove beyond a reasonable doubt that the alleged complex financial transactions—after the initial receipt of “commingled” fraudulent and lawfully obtained funds—were designed for "concealment money laundering." The court otherwise affirmed, rejecting challenges to a search warrant, the sufficiency of the evidence, the jury instructions, and the court’s refusal to permit proposed expert testimony. View "United States v. Fallon" on Justia Law

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The United States Court of Appeals for the Eleventh Circuit certified a question of law to the Alabama Supreme Court. Dr. Dino Ferrante, a gastroenterologist, prescribed LIALDA, which is manufactured by Shire U.S., Inc., and Shire, LLC (referred to collectively as "Shire"), to help patient Mark Blackburn with his Crohn's disease. "LIALDA is the brand name for Shire's mesalamine drug, which is an anti-inflammatory drug specifically aimed at the gut. LIALDA is not approved by the FDA to treat Crohn's, but it is approved to treat ulcerative colitis, Crohn's 'sister' disease." After taking LIALDA for between 12 to 16 months, Blackburn discovered that he had developed kidney disease, specifically advanced chronic interstitial nephritis, which had resulted in irreversible scarring and had diminished his kidney function to 20% of normal capacity. As a result, Blackburn is awaiting a kidney transplant. The federal appellate court asked: (1) consistent with the learned intermediary doctrine, may a pharmaceutical company's duty to warn include a duty to provide instructions about how to mitigate warned-of risks?; and (2) might a plaintiff establish that a failure to warn caused his injuries by showing that his doctor would have adopted a different course of testing or mitigation, even though he would have prescribed the same drug? The Supreme Court answered both questions in the affirmative. View "Blackburn v. Shire U.S., Inc., et al." on Justia Law

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Merck’s 708 patent describes sitagliptin dihydrogen phosphate (sitagliptin DHP), which belongs to the class of dipeptidyl peptidase-IV (DP-IV) inhibitors that can be used for treating non-insulin-dependent (Type 2) diabetes. Mylan petitioned for inter partes review, arguing that claims 1–3, 17, 19, and 21–23 were anticipated by the Merck-owned 489 publication, and the equivalent 871 patent (collectively, Edmondson) Edmondson is directed to compounds that are DP-IV inhibitors, useful in the treatment or prevention of diseases in which the dipeptidyl peptidase-IV enzyme is involved, such as diabetes and particularly type 2 diabetes. Mylan also argued that claims 1–4, 17, 19, and 21–23 would have been obvious over Edmondson and two additional publications.The Federal Circuit affirmed the Patent and Trademark Office Patent Trial and Appeal Board holding that Mylan failed to show that claims 1–4, 17, 19, and 21–23 were anticipated or would have been obvious over the cited prior art at the time the alleged invention was made. Merck reduced to practice more than what is shown in Edmondson for the claimed subject matter. View "Mylan Pharmaceuticals Inc. v. Merck Sharp & Dohme Corp.," on Justia Law

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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