Justia Drugs & Biotech Opinion Summaries

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

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

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

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

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

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 First Circuit affirmed the judgment of the district court dismissing Amyndas Pharmaceuticals, S.A.'s claims against Zealand Pharma A/S and vacated the dismissal of Amyndas's claims against Zealand Pharma U.S., Inc., holding that the district court erred in dismissing Amyndas's claims against Zealand Pharma U.S.When Amyndas was considering separate joint ventures with Zealand Pharma and Alexion Pharmaceuticals, Inc. it shared trade secrets before understanding that neither of the joint ventures would materialize. Zealand Pharma and Zealand US, its newly established affiliate, subsequently announced a partnership with Alexion Pharmaceuticals, Inc. Amyndas sued for misappropriation of trade secrets and other confidential information. The district court (1) dismissed Amyndas's claims against Zealand Pharma on the ground that Amyndas was required to litigate those claims in Denmark; and (2) dismissed Amyndas's claims against Zealand US for failure to state a claim. The First Circuit vacated in part and remanded the case for further proceedings, holding that the district court (1) correctly dismissed Amyndas's claims against Zealand Pharma; and (2) erred in concluding that Amyndas's claims against Zealand US were futile. View "Amyndas Pharmaceuticals, S.A. v. Zealand Pharma A/S" on Justia Law

Gripum manufactures and distributes flavored liquids for use in e-cigarette devices. Gripum submitted a “premarket tobacco product application” to the federal Food and Drug Administration (FDA) in 2021. The agency denied the application, reasoning that Gripum had failed to demonstrate public-health benefits as required by the Family Smoking Prevention and Tobacco Control Act, 21 U.S.C. 387j. The 2016 “Deeming Rule,” promulgated under the Act requires denial of an application to market a new tobacco product if the manufacturer fails to show that the product would be “appropriate for the protection of public health,” considering the risks and benefits to the population as a whole, including users and non-users, the “increased or decreased likelihood that existing users of tobacco products will stop using such products and those who do not use tobacco products will start using such products.The Seventh Circuit upheld the denial. The FDA required Gripum to show that its flavored e-cigarette products were relatively better at reducing rates of tobacco use than products already on the market. It properly applied the comparative standard mandated by the statute. Gripum failed to provide evidence specific to its products; its studies of other products did not even compare tobacco-flavored e-cigarette products to flavored products resembling Gripum’s products. View "Gripum, LLC v. United States Food and Drug Administration" on Justia Law

Ethicon manufactures a mesh sling, used to treat stress urinary incontinence, and a posterior mesh “Prolift, “designed to treat pelvic organ prolapse. In 2009, Dr. Guiler surgically implanted both devices to treat Thacker. Before the surgery, Thacker reviewed and signed an informed consent form that listed several risks, including: “infections and/or erosions of the mesh” which could require additional follow-up surgeries, urinary retention, “[p]ainful intercourse and vaginal shortening,” and treatment failure. After the surgery, Thacker’s incontinence worsened, and she suffered from shooting pain in her groin area and severe abdominal swelling and bloating. In 2010, Thacker started experiencing severe and unbearable pain during intercourse.Thacker ultimately sued Ethicon, alleging strict liability and negligence claims under the Kentucky Product Liability Act for design defect and failure to warn. The district court granted Ethicon summary judgment. The Sixth Circuit reversed. Dr. Guiler’s testimony suggested that he likely would have recommended a different course of treatment had Ethicon given adequate information. Thacker’s expert testified that no reasonable physician would have used the Pelvic Mesh Devices to treat Thacker had Ethicon given adequate information in 2009. A jury could accept that expert’s opinion that a feasible alternative design would have prevented Thacker’s injuries. View "Thacker v. Ethicon, Inc." on Justia Law