Justia Drugs & Biotech Opinion Summaries

This case involves a pharmaceutical manufacturer, Gilead Life Sciences, Inc., and its development and sale of a drug, tenofovir disoproxil fumarate (TDF), to treat HIV/AIDS. The approximately 24,000 plaintiffs allege that they suffered adverse effects from TDF, including skeletal and kidney damage. Gilead developed a similar but chemically distinct drug, tenofovir alafenamide fumarate (TAF), which could potentially treat HIV/AIDS with fewer side effects. The plaintiffs claim that Gilead delayed the development of TAF to maximize profits from TDF.The plaintiffs do not claim that TDF is defective. Instead, they assert a claim for ordinary negligence, arguing that Gilead's decision to delay the development of TAF breached its duty of reasonable care to users of TDF. They also assert a claim for fraudulent concealment, arguing that Gilead had a duty to disclose information about TAF to users of TDF.The Court of Appeal of the State of California, First Appellate District, Division Four, partially granted Gilead's petition for a writ of mandate and held that the plaintiffs could proceed with their negligence claim. The court concluded that a manufacturer's legal duty of reasonable care can extend beyond the duty not to market a defective product. However, the court reversed the trial court's decision denying Gilead's motion for summary adjudication of the plaintiffs' claim for fraudulent concealment. The court held that Gilead had no duty to disclose information about TAF to users of TDF, as TAF was not available as an alternative treatment at the time. View "Gilead Tenofovir Cases" on Justia Law

The defendant, Rodriquies Evans, was convicted of four criminal offenses related to his involvement in a multistate conspiracy to transport and distribute methamphetamine and other controlled substances. The district court sentenced him to the statutory maximum of 80 years in prison. The Fourth Circuit United States Court of Appeals found that the district court had erred in calculating Evans’s Sentencing Guidelines range and vacated his sentence, remanding the case for resentencing. The court determined that the district court had incorrectly attributed nearly three kilograms of crystal methamphetamine seized from a co-conspirator to Evans. The court held that for sentencing purposes under the Sentencing Guidelines, only acts that fall within the scope of the criminal activity the defendant agreed to jointly undertake can be considered relevant conduct. The district court had attributed the drugs based on the broader standard of substantive liability under Pinkerton, which allows a defendant to be held liable for the acts of co-conspirators if they are within the scope of the overall conspiracy and reasonably foreseeable to the defendant. The court also found that the district court had erred in applying a threat enhancement in calculating Evans's Sentencing Guidelines range, as the possession of a firearm enhancement could not by itself be the basis for a threat enhancement. View "US v. Evans" on Justia Law

In the case of Wages and White Lion Investments, L.L.C., doing business as Triton Distribution; Vapetasia, L.L.C., versus the Food & Drug Administration, the court found that the FDA acted arbitrarily and capriciously in its denial of Premarket Tobacco Product Applications (PMTAs) for flavored e-cigarette products.The petitioners, Triton Distribution and Vapetasia, are manufacturers of flavored e-cigarette liquids. They filed PMTAs for their products, as required by the Family Smoking Prevention and Tobacco Control Act, which prohibits the sale of any “new tobacco product” without authorization from the FDA. The FDA, after issuing detailed guidance on the information it required for approval of e-cigarette products, subsequently denied all flavored e-cigarette applications, including those of the petitioners, on the grounds that they failed to predict new testing requirements imposed by the FDA without notice.The court found that the FDA had failed to provide the manufacturers with fair notice of the rules, had not acknowledged or explained its change in position, and had ignored the reasonable and serious reliance interests that manufacturers had in the pre-denial guidance. Furthermore, the FDA attempted to cover up its mistakes with post hoc justifications at oral argument.As a result, the court granted the petitions for review, set aside the FDA's marketing denial orders, and remanded the matters to the FDA. The court rejected FDA's argument that even if it arbitrarily and capriciously denied petitioners’ applications, that error was harmless, stating that the harmless error doctrine is narrow and does not apply to discretionary administrative decisions. The court also rejected FDA's contention that it gave manufacturers fair notice of their obligations to perform long-term scientific studies in its pre-denial guidance documents. View "Wages and White Lion Invest v. FDA" on Justia Law

The United States Court of Appeals for the Ninth Circuit upheld the drug-trafficking and money-laundering convictions of Benjamin Galecki and Charles Burton Ritchie for their distribution of "spice," a synthetic cannabinoid product. The defendants were found guilty of manufacturing and distributing spice through their company, Zencense Incenseworks, LLC. The drug-trafficking charges were based on the premise that the cannabinoid used, XLR-11, was treated as a controlled substance because it was an "analogue" of a listed substance. The court rejected the defendants' arguments that their convictions should be set aside due to Fourth Amendment violations, insufficient evidence, and vagueness of the Controlled Substance Analogue Enforcement Act of 1986. However, the court reversed their mail and wire fraud convictions due to insufficient evidence. The case was remanded for further proceedings. View "USA V. GALECKI" on Justia Law

In this case, Virginia Cora Ward, as the administratrix of the estate of Edmund Edward Ward, brought a case against AlphaCore Pharma, LLC (ACP) and Bruce Auerbach. The decedent, Edmund Ward, was a participant in a clinical trial for a drug known as ACP-501, which was developed by ACP and administered by the National Institutes of Health (NIH). The trial took place in Maryland, where Ward traveled from his home in Massachusetts to receive treatment. Ward later withdrew from the trial due to deteriorating kidney function.In 2016, Ward filed a complaint against ACP, Auerbach, and several others, alleging fraudulent inducement to participate in the clinical trial. ACP and Auerbach moved to dismiss the case for lack of personal jurisdiction, arguing that they lacked sufficient contacts with Massachusetts. The United States District Court for the District of Massachusetts agreed with them and dismissed the case. Ward appealed to the United States Court of Appeals for the First Circuit.The First Circuit affirmed the district court's decision. The court held that neither ACP nor Auerbach had sufficient related and purposeful contacts in and with Massachusetts to establish personal jurisdiction. The court rejected Ward's claims that ACP and Auerbach had contacts with Massachusetts through their interactions with Ward's Massachusetts-based doctor, their alleged shipment of the drug to Massachusetts, their involvement in drafting the clinical trial protocol, and their alleged reimbursement of Ward's travel expenses. The court found that these claims were either unsupported by evidence or were not sufficient to establish personal jurisdiction. As a result, the court affirmed the district court's dismissal of the case against ACP and Auerbach for lack of personal jurisdiction. View "Ward v. Schaefer" on Justia Law

A case involving Lebanon County Employees' Retirement Fund and Teamsters Local 443 Health Services & Insurance Plan, as plaintiffs-appellants, and Steven H. Collis, Richard W. Gochnauer, Lon R. Greenberg, Jane E. Henney, M.D., Kathleen W. Hyle, Michael J. Long, Henry W. McGee, Ornella Barra, D. Mark Durcan, and Chris Zimmerman, as defendants-appellees, was heard by the Supreme Court of the State of Delaware. The plaintiffs, shareholders in AmerisourceBergen Corporation, brought a derivative complaint against the directors and officers of the Corporation alleging that they failed to adopt, implement, or oversee reasonable policies and practices to prevent the unlawful distribution of opioids. The plaintiffs claimed that this led to AmerisourceBergen incurring liability exceeding $6 billion in a 2021 global settlement related to the Company's role in the opioid epidemic. The Court of Chancery of the State of Delaware initially dismissed the complaint, basing its decision on a separate federal court finding that AmerisourceBergen had complied with its anti-diversion obligations under the Controlled Substances Act. However, the Supreme Court of the State of Delaware reversed the Court of Chancery's dismissal of the complaint, ruling that the lower court had erred in considering the federal court's findings as it changed the date at which demand futility should be considered and violated the principles of judicial notice. The case was remanded for further proceedings. View "Lebanon County Employees' Retirement Fund v. Collis" on Justia Law

Former executives of medical device manufacturer Acclarent, Inc., William Facteau and Patrick Fabian, were found guilty of multiple misdemeanor violations of the Federal Food, Drug, and Cosmetic Act (FDCA) for commercially distributing an adulterated and misbranded medical device. They appealed their convictions, claiming First Amendment violations, due process violations, and insufficiency of evidence. The United States Court of Appeals for the First Circuit rejected all of these claims and affirmed the convictions. The court held that the use of promotional speech as evidence of a device's intended use did not implicate the First Amendment. The court also found that the term "intended use" was not unconstitutionally vague and that Facteau and Fabian had fair warning of the conduct prohibited under the FDCA. Finally, the court found that the evidence was sufficient to support the convictions and that Fabian's fine did not violate the Eighth Amendment. View "United States v. Facteau" on Justia Law

In this case before the United States Court of Appeals for the Eighth Circuit, the defendant, Bradley Ready, appealed his sentence following his guilty plea for possession with intent to distribute methamphetamine and possession of a firearm as an unlawful user of a controlled substance. The court affirmed the district court's decision.During a search of Ready's residence, law enforcement officers found drug paraphernalia, scales, a loaded hunting rifle, and three bags of methamphetamine. Ready was subsequently charged and pleaded guilty to both counts. At sentencing, the U.S. Probation Office recommended grouping the drug and gun counts together and applying a two-level enhancement due to the possession of a dangerous weapon. Ready objected to this enhancement, but the district court overruled this objection.On appeal, Ready argued that the district court erred in applying the enhancement for possession of a dangerous weapon and applied the wrong standard in determining his eligibility for safety valve relief. The appellate court found no error in the district court's conclusions.The appellate court held that the district court did not err in applying the enhancement for possession of a dangerous weapon, as it was not "clearly improbable" that the rifle found in Ready's bedroom was connected to the distribution of methamphetamine from his home. The court also held that the district court did not err in its application of the standard for determining Ready's eligibility for safety valve relief. Therefore, the district court's judgment was affirmed. View "United States v. Ready" on Justia Law

In this case, the United States Court of Appeals for the Federal Circuit considered whether the defendants' Abbreviated New Drug Applications (ANDAs) infringed two patents owned by the plaintiffs. The patents pertained to the use of the drug vortioxetine in the treatment of patients who had previously taken certain other antidepressant medications and had to cease or reduce use due to sexually related adverse events, and for the treatment of cognitive impairment. The defendants were seeking approval to market vortioxetine for the treatment of Major Depressive Disorder (MDD) in adults, a use not covered by the patents. The plaintiffs sought to block the defendants from marketing a generic version of the drug until after the expiration of the patents.The court held that the defendants' ANDA filings did not infringe the plaintiffs' patents. The court found that the defendants' intended use of the drug, for the treatment of MDD in adults, did not infringe the patents which pertained to other specific uses of the drug.Moreover, the court found no induced or contributory infringement. Regarding induced infringement, the court held that the defendants' proposed labels for the drug did not encourage, recommend, or promote an infringing use. Regarding contributory infringement, the court held that the defendants' sale of the drug would have substantial noninfringing uses, thus there would be no contributory infringement.Additionally, the court rejected Lupin's cross-appeal, which challenged the district court's determination that Lupin infringed a patent concerning a process for manufacturing vortioxetine. The court affirmed the district court's construction of the term "reacting" in the patent and its determination of infringement. View "H. LUNDBECK A/S v. LUPIN LTD. " on Justia Law

Cloudbreak’s patent discloses compositions and methods for treating pterygium, an eye condition in which a tumor-like growth extends from the nasal or temporal side of the eye to the cornea, by administering multikinase inhibitors to the eye to inhibit specific growth factors that contribute to tumor growth and hyperemia (i.e., eye redness). The patent discloses that nintedanib in particular “may be one of the most powerful multikinase inhibitors for reducing corneal neovascularization.”In inter partes review, the Patent Trial and Appeal Board held that the petitioner, Allgenesis, failed to prove two claims of the patent are unpatentable. The Federal Circuit dismissed an appeal. Allgenesis failed to establish an injury in fact sufficient to confer standing to appeal. Allgenesis identified no concrete plans to develop and bring to market a nintedanib treatment for pterygium and has not shown its activities will create a substantial risk of infringement or will likely cause Cloudbreak to assert a claim of infringement. The court rejected an argument that Allgenesis suffered an injury in fact based on the Board’s priority determination that will have a preclusive effect on the scope of its pending patent application. Allgenesis has not established that the Board’s decision will have preclusive effect. View "Allgenesis Biotherapeutics Inc. v. Cloudbreak Therapeutics, LLC" on Justia Law