Justia Drugs & Biotech Opinion Summaries

An executive at a group of medical device companies that sell products to the federal government raised internal concerns in early 2024 that the company was violating Food and Drug Administration (FDA) regulations related to product design, quality management, and testing. He believed that selling a particular product without addressing these regulatory deficiencies could result in misrepresenting data to the FDA to obtain approval. Over a two-week period, he communicated these concerns to multiple executives and suggested implementing changes to improve compliance. Shortly after these communications, his position was eliminated.Following his termination, the executive filed suit in the United States District Court for the Eastern District of Pennsylvania, alleging, among other claims, that his employer retaliated against him in violation of the False Claims Act (FCA)’s anti-retaliation provision. The District Court dismissed the FCA retaliation claim, holding that the complaint failed to allege a sufficient connection between the plaintiff’s concerns about FDA violations and the submission of false claims for payment to the federal government, and thus did not constitute protected conduct under the FCA.On appeal, the United States Court of Appeals for the Third Circuit reviewed two questions: whether FCA retaliation claims are subject to Rule 9(b)’s heightened pleading standard, and what constitutes protected conduct under the “other efforts” prong of the FCA’s anti-retaliation provision. The court held that FCA retaliation claims are not subject to Rule 9(b), but instead require only notice pleading under Rule 8(a). It further held that, to constitute protected conduct, a plaintiff’s actions must be motivated by an objectively reasonable belief that the employer is submitting or will submit false or fraudulent claims for payment to the government. Finding no such allegation in the complaint, the Third Circuit affirmed the District Court’s dismissal of the FCA retaliation claim. View "Lisenby v. Olympus Corporation of the Americas" on Justia Law

Several plaintiffs alleged that they suffered injuries, such as renal, bone, or tooth damage, from taking a drug manufactured by Gilead Sciences, Inc. known as tenofovir disoproxil fumarate (TDF). Plaintiffs conceded that TDF was not defective but claimed that Gilead had developed an alternative drug, tenofovir alafenamide fumarate (TAF), which was equally effective and less toxic. Plaintiffs argued that Gilead unreasonably delayed bringing TAF to market, allegedly to maximize profits, and that this delay deprived them of a safer drug option, causing their injuries.In the San Francisco City and County Superior Court, Gilead moved for summary judgment, asserting that negligence liability could not attach for injuries caused by a nondefective product. The trial court denied Gilead’s motion. Gilead then petitioned the Court of Appeal, First Appellate District, Division Four, which partially granted the petition. The Court of Appeal directed summary adjudication on the fraudulent concealment claim but allowed the negligence claim to proceed. It held that drug manufacturers may owe a duty of reasonable care to users of a nondefective drug in deciding whether and when to commercialize a safer alternative.The Supreme Court of California reviewed the case and reversed the Court of Appeal’s judgment. The court held that, even assuming drug manufacturers might owe a broader duty of care beyond marketing nondefective drugs, the factors set forth in Rowland v. Christian justify an exception in this context. Specifically, the court determined that a manufacturer’s decision to delay commercialization of a safer drug during early development stages is too remote and unforeseeable to establish a duty of care, and imposing such liability would unduly burden innovation and public health. The Supreme Court directed the trial court to grant summary judgment for Gilead on all claims. View "Tenofovir Cases" on Justia Law

The dispute centers on allegations by a Minnesota-based health insurer that several related pharmaceutical companies carried out an unlawful scheme involving the distribution and sale of repackaged and adulterated oncology drugs. The scheme allegedly involved breaking sterile seals on medication vials, pooling overfill amounts—which were not intended for patient use—and creating pre-filled syringes that were then sold to healthcare providers. These syringes were ultimately administered to cancer patients, including many insured under programs operated by the plaintiff. The defendants did not themselves submit claims for reimbursement, but the plaintiff asserts it paid for treatments using these adulterated drugs, unaware of their compromised quality.Prior to this lawsuit, the scheme was the subject of other civil actions and federal investigations, including qui tam actions and a federal criminal prosecution. The defendants disclosed these investigations in annual reports filed with the Securities and Exchange Commission and the events received media attention beginning in 2012. In 2017, a related company pleaded guilty to federal charges, admitting to the repackaging scheme, and paid significant fines and settlements. The plaintiff filed suit in 2023, asserting claims for common-law fraud, unjust enrichment, and violations of several Minnesota consumer protection statutes. The United States District Court for the District of Minnesota dismissed the complaint, finding the claims were barred by the applicable six-year statute of limitations, and that the plaintiff had failed to sufficiently plead fraudulent concealment to toll the limitations period.The United States Court of Appeals for the Eighth Circuit reviewed the district court’s dismissal de novo. It concluded that publicly available disclosures and the plaintiff’s own allegations established that the plaintiff should have discovered its causes of action no later than 2016. Because the plaintiff did not file suit until 2023, its claims were untimely. The court affirmed the district court’s judgment, holding that all claims were barred by the statute of limitations. View "United HealthCare Services, Inc. v. AmerisourceBergen Corporation" on Justia Law

Buyers of over-the-counter nasal decongestants containing oral phenylephrine brought numerous class actions against drug manufacturers and retailers, alleging that for years these companies sold and advertised decongestant products they knew to be ineffective. The plaintiffs claimed that scientific studies, particularly since 2016, had shown oral phenylephrine to be no better than a placebo at relieving congestion, yet the companies continued to market their products as effective decongestants and complied with Food and Drug Administration (FDA) labeling requirements. The FDA, despite mounting evidence, did not remove oral phenylephrine’s designation as an effective decongestant under its regulations.The Judicial Panel on Multidistrict Litigation consolidated nearly one hundred class actions and transferred them to the United States District Court for the Eastern District of New York. Plaintiffs filed a complaint asserting New York statutory and common-law claims as well as a federal RICO claim. The district court granted the defendants’ motion to dismiss, holding that the Federal Food, Drug, and Cosmetic Act (FDCA) expressly preempted the state law claims because the drugs’ labels complied with FDA requirements, and that the plaintiffs lacked standing to bring the RICO claim. The court also dismissed a Lanham Act claim brought by one pharmacy plaintiff.On appeal, the United States Court of Appeals for the Second Circuit held that the FDCA expressly preempts most of the state law claims because the federal regime requires manufacturers to follow the FDA-approved labeling, but it vacated the dismissal for claims regarding “Maximum Strength” labeling and brand-name drugs approved via the New Drug Application process, remanding those for further proceedings. The court affirmed dismissal of the RICO claim, adopting the indirect purchaser rule, and upheld denial of the pharmacy’s motion for reconsideration regarding its Lanham Act claim. View "Yousefzadeh v. Johnson & Johnson Consumer Inc." on Justia Law

The plaintiff participated in a clinical trial for an experimental COVID-19 vaccine manufactured by AstraZeneca in November 2020. Before receiving the vaccine, she signed an informed-consent form stating that AstraZeneca would compensate her for injuries caused by the vaccine, including providing medical care and reimbursement, and that the company had an insurance policy to cover such costs. The form also disclosed that federal law may limit her right to sue for vaccine-related injuries, referencing the Public Readiness and Emergency Preparedness Act (PREP Act), which provides broad immunity to vaccine manufacturers during a public health emergency.After suffering debilitating medical injuries from the vaccine, the plaintiff requested compensation and care from AstraZeneca, which was denied. She then filed suit in the United States District Court for the District of Utah, alleging breach of contract and breach of the contractual duty of good faith and fair dealing. AstraZeneca moved to dismiss the complaint, arguing that the PREP Act immunized it from liability. The district court denied the motion, holding that the PREP Act’s immunity provision applies only to tort claims, not to contract-based claims. The court further reserved judgment on whether AstraZeneca had waived its statutory immunity in the informed-consent form.The United States Court of Appeals for the Tenth Circuit reviewed the case and reversed the district court’s ruling. The appellate court held that the PREP Act’s immunity provision applies to “all claims for loss,” including those arising from breach of contract, provided they bear a causal relationship to the administration or use of a covered countermeasure like a vaccine. The court remanded the case for the district court to consider whether AstraZeneca waived immunity in the informed-consent form. View "Dressen v. AstraZeneca AB" on Justia Law

Several third-party payors who covered prescriptions for Avandia, a diabetes medication manufactured by GlaxoSmithKline LLC, brought a putative class action alleging that the company misrepresented Avandia’s cardiovascular risks and benefits. They claimed these misrepresentations led health care providers to prescribe Avandia more frequently than less expensive alternatives, causing the payors to reimburse for prescriptions that otherwise would not have been issued. The plaintiffs sought class certification on behalf of entities that paid for Avandia prescriptions during a specified period.The United States District Court for the Eastern District of Pennsylvania previously reviewed this case. It denied GlaxoSmithKline’s motion to dismiss the plaintiffs’ Racketeer Influenced and Corrupt Organizations Act (RICO) claim, and the Third Circuit affirmed that denial. Later, the District Court granted summary judgment to GlaxoSmithKline on certain claims, but the Third Circuit reversed in part and remanded for further proceedings. Most recently, the District Court granted class certification, finding the class ascertainable and concluding that common issues would predominate regarding causation. It relied on evidence of a common scheme to deceive and statistical analyses showing marketing campaigns increased prescriptions.The United States Court of Appeals for the Third Circuit reviewed the District Court’s class certification. The Third Circuit held that while the class is ascertainable, the record does not yet demonstrate that common questions predominate on causation. The court clarified that plaintiffs in pharmaceutical fraud RICO class actions may use statistical evidence to prove causation, but such evidence must establish causation, not merely correlation. Because the plaintiffs’ statistical evidence failed to satisfy this standard, the Third Circuit vacated the District Court’s class certification and remanded for further fact-finding on predominance under the clarified standard. View "In re Avandia Marketing" on Justia Law

Several pharmaceutical manufacturers and a trade association challenged a Louisiana statute enacted in 2023, which prohibits drug manufacturers and distributors from interfering with the acquisition or delivery of discounted drugs—purchased under the federal Section 340B Drug Pricing Program—to pharmacies contracted by certain healthcare providers. The 340B Program requires drug manufacturers participating in Medicaid and Medicare to provide discounted outpatient drugs to designated healthcare providers serving low-income and rural populations. Many of these providers lack in-house pharmacies and use external contract pharmacies. In response to manufacturer-imposed limits on contract pharmacy use, Louisiana enacted Act 358 to preserve covered entities’ ability to use such pharmacies.The plaintiffs, including AbbVie, AstraZeneca, and the Pharmaceutical Research and Manufacturers of America, filed separate lawsuits in the United States District Court for the Western District of Louisiana against the Louisiana Attorney General, arguing that Act 358 is preempted by federal law, constitutes an unconstitutional taking, impairs contracts in violation of the Contracts Clause, and is unconstitutionally vague. The district court consolidated the cases, granted summary judgment for Louisiana and the Louisiana Primary Care Association (an intervenor), and rejected all of the manufacturers’ claims.On appeal, the United States Court of Appeals for the Fifth Circuit affirmed the district court’s judgment. The Fifth Circuit held that Act 358 is not preempted by federal law, as the federal 340B Program does not regulate drug distribution logistics or the use of contract pharmacies, and thus leaves room for state regulation. The court further concluded that Act 358 does not effect a taking under the Fifth Amendment, does not substantially impair contractual obligations under the Contracts Clause, and is not unconstitutionally vague under the Due Process Clause. The Fifth Circuit thus upheld summary judgment for Louisiana on all claims. View "AbbVie v. Murrill" on Justia Law

A pharmaceutical manufacturer participating in the federal 340B Drug Pricing Program challenged a Missouri law that prohibits manufacturers from restricting the delivery of discounted 340B drugs to contract pharmacies associated with covered entities. The manufacturer argued that its policy of limiting deliveries to only one contract pharmacy conflicted with Missouri’s statute, which requires delivery to all contract pharmacies designated by covered entities. The manufacturer sought declaratory and injunctive relief, claiming the Missouri statute violated the dormant Commerce Clause and was preempted by federal law.The United States District Court for the Western District of Missouri granted a motion to dismiss the manufacturer’s preemption claims, finding Missouri’s statute did not conflict with federal patent or drug exclusivity laws or the 340B Program, and that Eighth Circuit precedent foreclosed the field preemption argument. The court denied the motion to dismiss the dormant Commerce Clause claim, but ultimately denied the manufacturer’s motion for a preliminary injunction, concluding the manufacturer was unlikely to succeed on the merits of its claims, had not shown irreparable harm, and that the balance of equities and public interest weighed against preliminary relief.The United States Court of Appeals for the Eighth Circuit reviewed the district court’s denial of preliminary injunction under the abuse of discretion standard. The appellate court affirmed the district court’s decision, holding that the Missouri statute regulates only in-state delivery of 340B drugs and does not impermissibly control extraterritorial commerce, discriminate against interstate commerce, or impose excessive burdens in relation to local benefits. The court also found the manufacturer’s preemption claims foreclosed by Eighth Circuit precedent and concluded the statute is neither field nor conflict preempted. The district court’s denial of preliminary injunctive relief was affirmed. View "Novartis Pharmaceuticals Corp. v. Hanaway" on Justia Law

Norwich Pharmaceuticals sought to market a generic version of Xifaxan, a drug invented by Salix Pharmaceuticals for treating irritable bowel syndrome with diarrhea and hepatic encephalopathy. Norwich submitted an Abbreviated New Drug Application (ANDA) to the FDA, identified as number 214369. Salix believed this ANDA infringed its patents and sued Norwich in the United States District Court for the District of Delaware. That court found Norwich’s ANDA infringed Salix’s patents related to hepatic encephalopathy, while the patents for irritable bowel syndrome were invalid as obvious. The court’s final judgment barred FDA approval of Norwich’s ’369 ANDA until Salix’s hepatic encephalopathy patents expired in October 2029.Following the judgment, Norwich amended its ’369 ANDA to remove the indication for hepatic encephalopathy and requested the Delaware District Court modify its judgment to allow immediate FDA approval of the amended ANDA. The court denied this motion, reasoning that Norwich could not change its ANDA after final judgment to circumvent the prior ruling. Norwich appealed to the United States Court of Appeals for the Federal Circuit, which agreed the judgment restricted approval of the entire ANDA, including non-infringing indications, until 2029, and affirmed the Delaware District Court’s decision.After the FDA declined to grant final approval of Norwich’s amended ANDA, instead issuing only tentative approval, Norwich sued in the United States District Court for the District of Columbia, arguing the FDA acted arbitrarily and capriciously. The court granted summary judgment to the FDA and Salix. On appeal, the United States Court of Appeals for the District of Columbia Circuit held that the Delaware District Court’s judgment applied to Norwich’s ANDA as amended, so the FDA correctly delayed final approval until October 2029. The appellate court affirmed the district court’s judgment. View "Norwich Pharmaceuticals, Inc. v. Kennedy" on Justia Law

A plaintiff alleged that she suffered serious eye injuries, including blindness in one eye, after receiving an injection of a pharmaceutical product manufactured by the defendant. The specific unit used was from a lot later recalled due to the possible presence of silicone particulates. The plaintiff had a history of eye conditions and prior treatments but argued that her injuries followed the use of the recalled product. She presented two experts on causation: a retained ophthalmologist who provided a report and deposition, and her treating physician, who did not provide a written expert report.The Superior Court, Law Division, denied the defendant’s motions to bar the experts’ testimony and for summary judgment. The court did not conduct the “gatekeeping” inquiry regarding expert reliability required by New Jersey law. The defendant appealed, and the Appellate Division reversed. It found the experts’ opinions to be inadmissible net opinions, lacking evidentiary support for the proposed theory of causation and methodology. The Appellate Division thus also reversed the denial of summary judgment, holding the plaintiff had not established causation.The Supreme Court of New Jersey reviewed the case and held that its decision in In re Accutane Litigation requires trial courts to resolve disputes about the reliability of expert testimony by undertaking a “rigorous” gatekeeping analysis, potentially including a hearing under N.J.R.E. 104. The Supreme Court found the record insufficient for this determination and ordered a remand so the trial court could conduct the proper reliability inquiry. The Court held the retained expert’s report was not a net opinion but left open whether the treating physician’s testimony could be admitted, depending on whether a proper expert report is served. The Supreme Court reversed the Appellate Division’s judgment and remanded the matter to the trial court for proceedings consistent with its opinion. View "Beavan v. Allergan U.S.A., Inc." on Justia Law