Justia Drugs & Biotech Opinion Summaries

After the Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization returned abortion regulation to the states, the Food and Drug Administration (FDA) changed its rules to allow the abortion drug mifepristone to be prescribed online and sent by mail, eliminating the prior requirement for in-person doctor visits. The State of Louisiana, joined by an individual plaintiff, challenged this 2023 regulation (the “2023 REMS”) under the Administrative Procedure Act (APA), arguing that the FDA’s decision was not supported by sufficient data and resulted in illegal abortions and increased Medicaid costs within the state.The United States District Court for the Western District of Louisiana found that Louisiana had standing, was likely to succeed on the merits, and was suffering irreparable harm. However, the district court declined to stay the regulation, reasoning that the balance of equities and public interest favored denying immediate relief. Instead, the district court stayed the litigation to allow the FDA to complete its ongoing review of mifepristone’s safety protocols, which the FDA admitted had previously lacked adequate consideration.On appeal, the United States Court of Appeals for the Fifth Circuit reviewed whether a stay of the 2023 REMS pending appeal was warranted under 5 U.S.C. § 705. The Fifth Circuit concluded that Louisiana was strongly likely to succeed on the merits because the FDA’s removal of the in-person dispensing requirement was arbitrary and capricious, relied on insufficient data, and was inadequately explained. The court further found that Louisiana faced ongoing irreparable harm to its sovereign interests and financial losses. The appellate court determined that neither the FDA’s nor the manufacturers’ interests outweighed Louisiana’s injuries or the public interest, and that a stay of the regulation was appropriate. The court therefore granted Louisiana’s motion for a stay pending appeal. View "Louisiana v. FDA" on Justia Law

A group of businesses and consumers involved in the sale and manufacture of consumable hemp products containing manufactured delta-8 THC challenged actions taken by the Texas Department of State Health Services and its commissioner. Following federal and state legislative changes in 2018 and 2019 that removed “hemp” and certain tetrahydrocannabinols (THC) in hemp from the definition of controlled substances, the Texas commissioner objected to a federal rule that would have further decontrolled hemp-derived extracts, including delta-8 THC. The commissioner then amended the state schedules to clarify that manufactured delta-8 THC remained a Schedule I controlled substance, leading to substantial business disruption for the vendors who had entered the delta-8 market.The vendors sued in district court, arguing that the commissioner exceeded her authority both procedurally and substantively under Texas law by modifying the schedules in a way that contradicted the Texas Farm Bill, and that the Department’s website statement about delta-8 THC was an invalid rule under the Texas Administrative Procedure Act (APA). The trial court denied the Department’s plea to the jurisdiction (challenging standing and sovereign immunity) and issued a temporary injunction against enforcement of the amended schedules and the website statement. The Court of Appeals for the Third District of Texas affirmed, concluding that the vendors had standing, the claims were justiciable, and a temporary injunction was appropriate.The Supreme Court of Texas held that the vendors had standing and their claims were ripe for review. However, it concluded that the commissioner acted within her broad statutory discretion and followed proper procedures under Health & Safety Code § 481.034(g) in objecting to the federal rule and amending the schedules. The court also held that the website statement was not an APA “rule.” Accordingly, it reversed the injunction and rendered judgment for the Department, with the only affirmed portion being the finding of standing. View "TEXAS DEPARTMENT OF STATE HEALTH SERVICES v. SKY MARKETING CORP." on Justia Law

The case involves a Massachusetts psychiatrist who owned and operated a clinic providing treatment for addiction with imported drugs. The drugs included naltrexone and disulfiram in forms not approved by the FDA for use in the United States. The shipments were brought in from Hong Kong and falsely described on import documents as “plastic beads in plastic tubes,” with their value understated. The government charged the defendant with several crimes, including international money laundering, unlawful importation of merchandise, and receipt and delivery of misbranded drugs. The jury found the defendant guilty on some counts but acquitted him on others, including all counts against his wife.The United States District Court for the District of Massachusetts conducted the trial. After the jury’s verdict, the court sentenced the defendant to 36 months’ imprisonment on each count, to be served concurrently, and calculated the sentence using the fraud guideline in the United States Sentencing Guidelines. The defendant appealed, arguing that the district court erred in its evidentiary rulings, in admitting or excluding certain testimony, and in its application of the Sentencing Guidelines.The United States Court of Appeals for the First Circuit reviewed the case. It affirmed the defendant’s convictions, finding no reversible error in the district court’s evidentiary decisions or in its exclusion of expert testimony. The appellate court vacated the sentence for the misdemeanor misbranding conviction because it exceeded the statutory maximum. The court retained jurisdiction over the appeal and remanded to the district court for clarification regarding the application of the fraud guideline, specifically instructing the lower court to explain the basis for its use of that guideline and to address the impact of recent amendments related to acquitted conduct. View "US v. Shafa" on Justia Law

The case involves a dispute between two biopharmaceutical companies over the distribution of a biosimilar drug following the expiration of a key patent. After Janssen’s patent for the composition of its biologic drug expired, Samsung sought to introduce its biosimilar product. Janssen and Samsung had previously settled related patent litigation through an agreement that granted Samsung a limited license to enter the market at a set date and restricted Samsung’s ability to sublicense, except to certain commercialization partners. Samsung subsequently entered into agreements with both Sandoz and Quallent, a subsidiary of the Cigna Group, allowing Quallent to distribute the biosimilar under its own label. Janssen argued that the sublicense to Quallent violated the settlement agreement and would cause it irreparable harm by altering market dynamics, reducing its market share and negotiation leverage, and sought a preliminary injunction to prevent Samsung from supplying Quallent during the litigation.The United States District Court for the District of New Jersey denied Janssen’s motion for a preliminary injunction. The court found that while Janssen was likely to succeed on the merits of its breach-of-contract claim, it had not demonstrated irreparable harm because any injury could be measured and compensated by monetary damages. The court credited Samsung’s expert's view that harm to Janssen would be quantifiable, did not find persuasive evidence of brand loyalty or reputational harm, and concluded that Janssen’s asserted loss of negotiation leverage was too speculative.On appeal, the United States Court of Appeals for the Third Circuit reviewed the District Court’s denial for abuse of discretion and affirmed. The Court held that loss of market share in a complex market does not categorically constitute irreparable harm in contract cases, and that mere difficulty in calculating damages does not meet the threshold for irreparable harm. The Court concluded that Janssen had not shown the requisite irreparable harm to justify preliminary injunctive relief. View "Johnson & Johnson v. Samsung Bioepis Co Ltd" on Justia Law

A group of pharmaceutical manufacturers that participate in the federal 340B drug pricing program challenged a new West Virginia law, S.B. 325, which imposed restrictions and penalties on manufacturers regarding the delivery of discounted drugs to contract pharmacies. The 340B program is a federal scheme where drug manufacturers provide discounts to designated health care providers (“covered entities”) in exchange for access to the Medicaid market. Dissatisfied with the federal program’s scope, West Virginia enacted S.B. 325, which specifically barred manufacturers from restricting delivery of 340B drugs to any location authorized by a covered entity (including contract pharmacies), and from requiring data submission as a condition for delivery, with significant penalties for violations.The manufacturers sued in the United States District Court for the Southern District of West Virginia seeking to enjoin enforcement of S.B. 325, arguing that it was preempted by federal law. The district court found that the manufacturers were likely to succeed on the merits of their preemption claim, that they faced irreparable harm, and that the balance of equities and public interest favored injunctive relief. The court granted a preliminary injunction against enforcement of the statute.On appeal, the United States Court of Appeals for the Fourth Circuit addressed whether S.B. 325 was preempted by federal law. The Fourth Circuit held that S.B. 325 likely interferes with the federal 340B program by imposing additional conditions on manufacturers solely because of their participation in a federal program, thereby intruding into a domain reserved for federal regulation. The court found that Congress had struck a careful bargain in the 340B program and that West Virginia’s law sought to alter that bargain in a way that conflicted with federal objectives and the enforcement scheme administered by the Department of Health and Human Services. The Fourth Circuit affirmed the district court’s preliminary injunction, barring enforcement of S.B. 325. View "Pharmaceutical Research & Manufacturers of America v. McCuskey" on Justia Law

Two pharmaceutical companies developing treatments for achondroplasia, a genetic disorder, became involved in litigation after one company (Ascendis) filed a New Drug Application (NDA) for its product. The other company (BioMarin), holding a relevant patent, filed a complaint with the United States International Trade Commission (ITC) alleging patent infringement by Ascendis’s product. Shortly afterward, Ascendis filed a declaratory judgment action in the United States District Court for the Northern District of California, seeking a judgment of non-infringement and arguing that its activities were protected under the statutory “safe harbor” for regulatory approval.More than thirty days after filing its district court complaint, Ascendis moved for an expedited hearing. BioMarin responded by seeking to dismiss or stay the district court action pending the ITC’s investigation. Ascendis voluntarily dismissed its complaint without prejudice and promptly refiled a nearly identical complaint, this time moving for a mandatory stay under 28 U.S.C. § 1659(a)(2), which requires a district court to stay its proceedings if requested within thirty days of the action’s filing or of being named as a respondent in the ITC. BioMarin opposed, contending Ascendis’s request was untimely, and sought a discretionary stay instead.The United States District Court for the Northern District of California granted BioMarin’s motion for a discretionary stay and denied Ascendis’s motion for a mandatory stay as moot. On appeal, the United States Court of Appeals for the Federal Circuit held that § 1659(a)(2) does not permit a litigant to restart the thirty-day period for a mandatory stay by voluntarily dismissing and refiling a substantially identical action. The court reasoned that the statutory deadline applies to the original action and that allowing refiling would circumvent the statute’s purpose. The Federal Circuit affirmed the district court’s decision. View "ASCENDIS PHARMA A/S v. BIOMARIN PHARMACEUTICAL INC. " on Justia Law

A California-based company that produces lab-grown chicken sought to distribute and sell its product in Florida. After the company received federal approval from the USDA and FDA to market its lab-grown chicken, Florida enacted SB 1084, a law banning the manufacture, sale, and distribution of all lab-grown meat within the state. The company had previously held tasting events and developed business relationships in Florida but had no plans to manufacture its product there.Following the enactment of SB 1084, the company filed suit in the U.S. District Court for the Northern District of Florida against state officials, seeking declaratory and injunctive relief. The company argued that the federal Poultry Products Inspection Act (PPIA) preempted Florida’s ban, claiming the state’s law imposed “additional or different” ingredient or facilities requirements in violation of the PPIA. The district court denied the company’s motion for a preliminary injunction, finding the company unlikely to succeed on its preemption claims because SB 1084 did not regulate the company’s ingredients, premises, facilities, or operations. The court also addressed standing and procedural questions, ultimately dismissing the preemption claims after the company amended its complaint.On appeal, the United States Court of Appeals for the Eleventh Circuit reviewed whether the filing of an amended complaint or the district court’s dismissal order rendered the appeal moot and whether the company could challenge the Florida law as preempted. The Eleventh Circuit held the appeal was not moot and that the company could bring a preemption action in equity. However, the court concluded the company was unlikely to succeed on the merits. The court held that Florida’s ban did not impose ingredient or facilities requirements preempted by the PPIA, as it simply banned the product’s sale and manufacture. Therefore, the district court’s denial of a preliminary injunction was affirmed. View "Upside Foods Inc v. Commissioner, Florida Department of Agriculture" on Justia Law

A former employee of a pharmaceutical manufacturer brought a qui tam lawsuit under the False Claims Act, alleging that the company improperly calculated and reported its “Best Price” for certain drugs to the Centers for Medicare and Medicaid Services (CMS), as required under the Medicaid Rebate Statute. The plaintiff claimed that, during a period from 2005 to 2014, the company failed to aggregate multiple rebates and discounts given to different entities on the same drug, resulting in inflated “Best Price” reports and underpayment of rebates owed to Medicaid. The complaint asserted that the company was subjectively aware that CMS interpreted the statute to require aggregation of all such discounts, especially after the company’s communications with CMS during a 2006–2007 rulemaking process and the company’s subsequent internal audit.After the government and several states declined to intervene, the United States District Court for the District of Maryland dismissed the amended complaint, finding that, even under the subjective scienter standard established in United States ex rel. Schutte v. SuperValu Inc., the plaintiff had not plausibly alleged that the company acted with actual knowledge, deliberate ignorance, or reckless disregard as to the truth or falsity of its reports. The district court also suggested that ambiguity in the statute precluded a finding of falsity.On appeal, the United States Court of Appeals for the Fourth Circuit reviewed the dismissal de novo. The Fourth Circuit held that the plaintiff’s allegations—including the company’s awareness of CMS’s interpretation of the rule, its targeted audit and compliance efforts, and its continued use of non-aggregated reporting—plausibly alleged the requisite subjective scienter under the False Claims Act. The court clarified that statutory ambiguity does not, at the pleading stage, negate scienter or falsity, and remanded for the district court to address other elements, including falsity, in the first instance. The Fourth Circuit reversed the dismissal and remanded for further proceedings. View "United States ex rel. Sheldon v. Allergan Sales, LLC" on Justia Law

A resident of Puerto Rico suffered work-related injuries in 1994, resulting in permanent total disability. His employer and its insurance carrier were ordered to provide medical care under Section 7 of the Longshore and Harbor Workers’ Compensation Act, as extended by the Defense Base Act. In 2019, a Puerto Rico-licensed physician recommended medical cannabis-infused edibles to treat the petitioner’s chronic pain. The petitioner sought reimbursement for these products from the employer’s insurance carrier, which denied the request.The petitioner then asked the United States Department of Labor’s Office of Administrative Law Judges to order reimbursement, arguing that medical cannabis was a reasonable and necessary treatment. The Administrative Law Judge denied the request, finding that marijuana’s classification as a Schedule I substance under the Controlled Substances Act (CSA) meant it could not have an accepted medical use under federal law. On appeal, the Department of Labor Benefits Review Board affirmed this decision by a 2-1 vote, agreeing that reimbursement was barred by the CSA and rejecting arguments that recent federal appropriations riders or executive actions altered the federal legal status of marijuana.On further appeal, the United States Court of Appeals for the Second Circuit reviewed the case. The court held that because marijuana remains a Schedule I substance under the CSA, it cannot be considered a reasonable and necessary medical expense for purposes of reimbursement under the Longshore and Harbor Workers’ Compensation Act. The court found that neither appropriations riders nor recent executive or legislative actions had changed marijuana’s federal classification or its legal status under the Act. Therefore, the court denied the petition for review. View "Garcia v. Department of Labor" on Justia Law

A man was convicted by a Michigan state jury for delivering oxycodone to a friend, resulting in her death from a drug overdose. The evidence showed that the man and the deceased had a longstanding relationship, and after her release from jail, he purchased 40 Percocet pills—containing oxycodone and acetaminophen—and spent time with her at a hotel where she died. Medical experts found oxycodone in her blood and acetaminophen in her urine, both components of Percocet, and testified that oxycodone was a substantial factor in causing her death.After his conviction, the defendant sought a new trial in the Michigan courts, arguing that his trial counsel was ineffective for two reasons: failing to investigate an “acetaminophen-based” defense (that the absence of acetaminophen in the blood meant the deceased had not consumed Percocet), and failing to call an expert witness to challenge the prosecution’s case on causation. The trial court held a hearing and ultimately rejected these claims. The Michigan Court of Appeals affirmed, and the Michigan Supreme Court denied further review.The United States District Court for the Eastern District of Michigan then denied the defendant’s petition for habeas corpus, and the case was appealed to the United States Court of Appeals for the Sixth Circuit. The Sixth Circuit held that, under the highly deferential standards of the Antiterrorism and Effective Death Penalty Act (AEDPA), the state courts did not unreasonably apply clearly established Supreme Court law or make unreasonable determinations of fact in rejecting the ineffective assistance claims. The court further held that counsel’s strategic decisions were not objectively unreasonable and that the alleged failures did not prejudice the outcome of the trial. The Sixth Circuit affirmed the denial of habeas relief. View "DeBruyn v. Douglas" on Justia Law