Justia Drugs & Biotech Opinion Summaries

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

The United States District Court for the Northern District of Ohio certified two questions to the Georgia Supreme Court regarding whether a state entity could continue asserting claims against opioid manufacturers and distributors after the State of Georgia entered into a settlement with the pharmaceutical companies, and as part of the settlement, the General Assembly enacted OCGA § 10-13B-1, et seq. (the “Settlement Act”) in 2022, which included a litigation preemption provision that “bar[s] any and all past, present or future claims on behalf of any governmental entity seeking to recover against any business or person that is a released entity under the terms of the relevant settlement.” OCGA § 10-13B-3 (a) (the “preemption provision”). In April 2019, before Georgia entered into the state-wide settlement with the pharmaceutical companies, the Hospital Authority of Wayne County, Georgia (“HAWC”) filed suit against a number of such entities, seeking to recover unreimbursed amounts it claims to have expended in treating opioid-dependent patients. HAWC subsequently chose not to participate in the state-wide settlement and did not individually release any of its claims. At some point, HAWC’s litigation was consolidated, along with over 3,000 other cases, into a federal multidistrict litigation in the District Court. See In re Natl. Prescription Opiate Litigation, (MDL No. 2804). Seven defendants named in HAWC’s complaint filed a motion to dismiss HAWC’s claims against them (the “Motion”), contending that the suit was barred by the preemption provision. The Georgia Supreme Court concluded that the Georgia General Assembly's passage of the preemption provision took away any power HAWC otherwise might have had under OCGA § 31-7-75 to pursue claims that the preemption provision and the Settlement Act were unconstitutional, and the answer to the first question certified by the District Court was no. In light of this answer, the Supreme Court did not need to answer the second certified question. View "Hospital Authority of Wayne County v. AmeriSourceBergen Drug Corp, et al." on Justia Law

Genentech manufactures and sells Rituxan, a drug used to treat leukemia and lymphoma. Rituxan is sold in single-use vials. Williamson was diagnosed with follicular lymphoma and was treated with Rituxan. Williamson later sued Genentech, on behalf of himself and a putative class of similarly situated individuals. He claims that Genentech violates the unfair competition law by selling Rituxan (and three other medications) in excessively large single-use vials; because the appropriate dosage varies based on a patient’s body size, Genentech’s vial sizes are too large for most patients. He argues Genentech should be required to offer smaller vials to reduce the waste of expensive medicine. In addition to injunctive relief, Williamson seeks to recover the amount the class spent on wasted Rituxan (and three other medications). Williamson took only Rituxan, not the other three medications, and paid a $231.15 deductible– the rest of the payments were made by his health insurer.The court of appeal affirmed the dismissal of the case for lack of standing under California’s unfair competition law (Bus. & Prof. Code 17200). Williamson suffered no economic injury caused by the alleged unfair practices and cannot establish standing by borrowing an economic injury from his insurer. The collateral source rule, under which a tortfeasor must fully compensate a victim and cannot subtract compensation the victim may have received from their insurer or another collateral source, does not apply. View "Williamson v. Genentech, Inc." on Justia Law