Justia Drugs & Biotech Opinion Summaries

The case involves United Therapeutics Corporation (UTC), a biotechnology company, and the Commissioner of Internal Revenue. The dispute centers on the interpretation of a tax provision that coordinates two tax credits: the research credit and the orphan drug credit. The Commissioner claimed that UTC disregarded one of the provision’s two commands, improperly reducing its tax liability by over a million dollars. UTC argued that the relevant half of the coordination provision lost effect in 1989 and has been moribund since.The United States Tax Court disagreed with UTC's argument. The court interpreted the statute’s terms by reference to their ordinary meaning, giving effect to the full coordination provision. The court rejected UTC's argument that changes to the tax law since its enactment rendered part of the coordination provision ineffective. The court also disagreed with UTC's interpretation of two regulations it relied on for support.The United States Court of Appeals for the Fourth Circuit affirmed the tax court's decision. The appellate court agreed with the tax court's interpretation of the coordination provision according to its ordinary meaning. The court also found that the tax court correctly rejected UTC's arguments based on the interpretation of predecessor statutes and regulations. The court concluded that the tax court correctly resolved the case in favor of the Commissioner. View "United Therapeutics Corporation v. Commissioner of Internal Revenue" on Justia Law

The case involves the Iowaska Church of Healing (the "Church"), an organization whose religious practices involve the consumption of Ayahuasca, a tea containing the hallucinogenic drug dimethyltryptamine (DMT), which is regulated under the Controlled Substances Act (CSA). The Church had applied for tax-exempt status under 26 U.S.C. § 501(c)(3) but was denied by the Internal Revenue Service (IRS) on the grounds that the Church's religious use of Ayahuasca was illegal. The Church challenged this decision in the District Court, arguing that the IRS's determination was based on an incorrect assumption of illegality and that the denial of tax-exempt status violated the Religious Freedom Restoration Act of 1993 (RFRA).The District Court denied the Church's motion and granted the Government's motion for summary judgment. The court held that the Church lacked standing to assert its RFRA claim and that the lack of standing also undermined its tax-exemption claim. The court found that the Church's religious use of Ayahuasca was illegal without a CSA exemption, and the IRS had no authority to assess whether the Church's proposed Ayahuasca use warranted a religious exemption from the CSA.On appeal, the United States Court of Appeals for the District of Columbia Circuit affirmed the District Court's judgment. The Court of Appeals held that the Church lacked standing to assert its RFRA claim because the economic injury it claimed was neither an injury-in-fact nor redressable. Without a cognizable RFRA claim, the Church's tax-exemption claim also failed. The Court of Appeals found that the Church could not proffer evidence of a CSA exemption to show it passed the organizational and operational tests for tax-exempt status. View "Iowaska Church of Healing v. Werfel" on Justia Law

The case involves Roland Black, who was convicted of attempting to possess with intent to distribute a controlled substance, specifically furanyl fentanyl. Law enforcement intercepted a package addressed to Black, believing it contained narcotics. After obtaining a warrant, they found the substance, replaced it with sham narcotics, and delivered the package to Black's residence. Black was arrested after the package was opened and he was found with luminescent powder from the sham narcotics on his hands.Prior to his trial, Black had unsuccessfully moved to dismiss the indictment and suppress all evidence derived from the seizure of the package. He argued that the officers lacked reasonable suspicion to seize the package and requested an evidentiary hearing to resolve related factual disputes. The district court denied these motions, ruling that the totality of the circumstances supported the officers' reasonable suspicion determination.In the United States Court of Appeals for the Seventh Circuit, Black appealed his conviction, raising four arguments. He contended that the officers lacked reasonable suspicion to seize the package, the jury instruction about his requisite mens rea was erroneous, the jury’s verdict was not supported by sufficient evidence, and the court erred in denying his motion to dismiss based on the court’s treatment of furanyl fentanyl as an analogue of fentanyl.The Court of Appeals affirmed the lower court's decision. It found that the officers had reasonable suspicion to seize the package, the jury instruction accurately stated the law, the jury’s verdict was supported by more than sufficient evidence, and Black's motion to dismiss argument was foreclosed by precedent. View "USA v. Black" on Justia Law

Insulet Corp. and EOFlow are medical device manufacturers that produce insulin pump patches. Insulet began developing its OmniPod product in the early 2000s, and EOFlow started developing its EOPatch product after its founding in 2011. Around the same time, four former Insulet employees joined EOFlow. In 2023, reports surfaced that Medtronic had started a process to acquire EOFlow. Soon after, Insulet sued EOFlow for violations of the Defend Trade Secrets Act (DTSA), seeking a temporary restraining order and a preliminary injunction to enjoin all technical communications between EOFlow and Medtronic in view of its trade secrets claims.The U.S. District Court for the District of Massachusetts temporarily restrained EOFlow from disclosing products or manufacturing technical information related to the EOPatch or OmniPod products. The court then granted Insulet’s request for a preliminary injunction, finding strong evidence that Insulet is likely to succeed on the merits of its trade secrets claim, strong evidence of misappropriation, and that irreparable harm to Insulet crystallized when EOFlow announced an intended acquisition by Medtronic. The injunction enjoined EOFlow from manufacturing, marketing, or selling any product that was designed, developed, or manufactured, in whole or in part, using or relying on alleged trade secrets of Insulet.The United States Court of Appeals for the Federal Circuit reversed the district court’s order. The court found that the district court had failed to address the statute of limitations, lacked a tailored analysis as to what specific information actually constituted a trade secret, and found it hard to tell what subset of that information was likely to have been misappropriated by EOFlow. The court also found that the district court had failed to meaningfully engage with the public interest prong. The court concluded that Insulet had not shown a likelihood of success on the merits and other factors for a preliminary injunction. The case was remanded for further proceedings consistent with the opinion. View "INSULET CORP. v. EOFLOW, CO. LTD. " on Justia Law

Mohamed Gamar Ahmed was charged with possession of cocaine and fentanyl with intent to distribute, and possession of a firearm in furtherance of a drug trafficking crime. The charges stemmed from a search warrant executed at Ahmed's residence in Nebraska, where law enforcement officers discovered loaded handguns, ammunition, drug paraphernalia, marijuana, cocaine, and counterfeit Percocet pills containing fentanyl. Ahmed pleaded guilty to the charges. The United States Probation Office prepared a presentence investigation report (PSR), which alleged that Ahmed had supplied one of the fentanyl-laced pills to a minor female, who overdosed after ingesting it. The Government filed a motion for an upward departure or variance on the drug-possession count, arguing that the United States Sentencing Guidelines range of 15-21 months’ imprisonment failed to adequately account for the extent of the harm caused by Ahmed’s drug-dealing.The District Court for the District of Nebraska conducted an evidentiary hearing at sentencing that involved testimony from two witnesses. After hearing the direct- and cross-examinations of both witnesses, the district court overruled Ahmed’s objection to the PSR, finding that the testimony was consistent with the allegation that Ahmed supplied the pill that caused the minor to overdose. The district court then proceeded to sentencing, stating that it had considered all the federal sentencing factors enumerated in 18 U.S.C. § 3553(a), including the serious nature of the offense and Ahmed’s history and characteristics. The district court varied upward on the drug-possession count to reflect the seriousness of the offense, to promote respect for the law, and to provide just punishment, ultimately sentencing Ahmed to 48 months’ imprisonment. Ahmed also received a mandatory minimum term of 60 months’ imprisonment on the firearm-possession count, to be served consecutively, for a total of 108 months’ imprisonment.Ahmed appealed to the United States Court of Appeals for the Eighth Circuit, alleging that the district court committed procedural error and imposed a substantively unreasonable sentence. The appellate court affirmed the district court's decision, finding no procedural error and concluding that the district court imposed a substantively reasonable sentence. View "United States v. Ahmed" on Justia Law

In 2019, Emily Wheeler, a property owner, was charged with various violations of the Los Angeles Municipal Code related to unlicensed cannabis activity on her property. Wheeler, who was 85 years old and had no criminal record, claimed she had no knowledge of the illegal activity. The trial court dismissed the charges against her, citing her age, clean record, and lack of knowledge about the illegal activity on her property. The People appealed the dismissal, arguing that the trial court erred in considering Wheeler's lack of knowledge because the charges were strict liability offenses.The appellate division of the superior court reversed the dismissal, agreeing with the People that the trial court should not have considered Wheeler's lack of knowledge. The appellate division reasoned that since the charges were strict liability offenses, Wheeler's lack of knowledge was not mitigating. Wheeler then petitioned the Court of Appeal for a writ of mandate to affirm the trial court's dismissal, but the Court of Appeal affirmed the appellate division's decision.The Supreme Court of California reversed the Court of Appeal's judgment. The Supreme Court held that a trial court has discretion to consider a defendant's lack of knowledge when deciding whether to dismiss charges in furtherance of justice under Penal Code section 1385, even for strict liability offenses. The Supreme Court reasoned that the nature of the charged offense and a defendant's minimal culpability can be relevant considerations for a section 1385 dismissal. The Supreme Court remanded the case to the Court of Appeal with instructions to issue a writ of mandate directing the appellate division to affirm the trial court's dismissal. View "Wheeler v. Appellate Division of Superior Court" on Justia Law

The case involves four plaintiffs who took docetaxel, a chemotherapy drug, as part of their treatment for early-stage breast cancer and subsequently suffered permanent chemotherapy-induced alopecia (PCIA). The plaintiffs allege that the manufacturers of the drug, Hospira, Inc., Hospira Worldwide, LLC, and Accord Healthcare, Inc., violated state law by failing to warn them that docetaxel could cause PCIA.The case was initially heard in the United States District Court for the Eastern District of Louisiana, where the defendants moved for summary judgment on the basis that the plaintiffs' state law failure-to-warn claims were preempted by federal law. The district court denied the motion, and the defendants appealed.The United States Court of Appeals for the Fifth Circuit was tasked with determining whether federal law preempts the plaintiffs' state law failure-to-warn claims against the defendant drug manufacturers. The court found that the district court had erred in its interpretation of what constitutes "newly acquired information" under the changes-being-effected (CBE) regulation, which allows manufacturers to file a supplemental application with the FDA and simultaneously implement a labeling change before obtaining FDA approval. The court held that the district court failed to enforce the requirement that newly acquired information must "reveal risks of a different type or greater severity or frequency than previously included in submissions to FDA."The court vacated the district court's judgment on the plaintiffs' failure-to-warn claims and remanded the case for further consideration of one outstanding issue: whether the Bertrand Abstract, a scientific study, constituted "newly acquired information" that revealed a greater risk of PCIA than previously known. If the Bertrand Abstract does not meet this standard, the court held that the defendants would not be liable to the plaintiffs on their state law failure-to-warn claims. View "Hickey v. Hospira" on Justia Law

The case involves Novartis Pharmaceuticals Corporation and United Therapeutics Corporation, both drug manufacturers, and the Health Resources and Service Administration (HRSA). The dispute centers around Section 340B of the Public Health Service Act, which mandates drug manufacturers to sell certain drugs at discounted prices to select healthcare providers. These providers often contract with outside pharmacies for distribution. The manufacturers argued that these partnerships have left the Section 340B program vulnerable to abuse, leading them to impose their own contractual terms on providers, such as limits on the number of pharmacies to which they will make shipments. The government contended that these restrictions violate the statute.The case was initially heard in the United States District Court for the District of Columbia. The district court ruled that Section 340B does not prohibit manufacturers from limiting the distribution of discounted drugs by contract.The case was then reviewed by the United States Court of Appeals for the District of Columbia Circuit. The court agreed with the district court's ruling, stating that Section 340B does not categorically prohibit manufacturers from imposing conditions on the distribution of covered drugs to covered entities. The court further held that the conditions at issue in this case do not violate Section 340B on their face. The court did not rule out the possibility that other, more onerous conditions might violate the statute or that these conditions may violate Section 340B as applied in particular circumstances. The court affirmed the district court's decision to set aside the enforcement letters under review, while reserving the possibility of future enforcement under theories of liability narrower than the one pressed here. View "Novartis Pharmaceuticals Corporation v. Johnson" on Justia Law

Carlos Esteras and Raphael Frias were convicted of fentanyl trafficking charges and appealed their sentences, arguing that the district court erred in calculating their respective Guidelines ranges. Esteras contended that the district court wrongly calculated his base offense level by applying a two-level increase for maintaining a premises for narcotics trafficking and declining to apply a two-level reduction for being a minor participant in the trafficking scheme. He also argued that the district court wrongly applied a two-point increase to his criminal history score after finding that he was on parole at the time of the offense. Frias argued that the district court erred in applying the two-level premises enhancement and a four-level increase for being an organizer or leader of the scheme, and failed to adequately consider his mitigating evidence in declining to vary downwards.The United States District Court for the Northern District of New York had sentenced Esteras to 84 months' imprisonment and Frias to 135 months' imprisonment. The court had applied several sentencing enhancements, including a two-level enhancement for maintaining a premises for narcotics trafficking and a four-level enhancement for being an organizer or leader of the scheme.The United States Court of Appeals for the Second Circuit affirmed each of the district court’s sentencing decisions except its application of the organizer or leader enhancement to Frias. The court affirmed Esteras’s sentence and vacated and remanded Frias’s sentence for further proceedings consistent with its opinion. The court found that Esteras's home qualified for the stash-house enhancement and that he was not a minor participant in the conspiracy. The court also found that Esteras was on parole when he committed his offenses, warranting a two-point increase to his criminal history score. However, the court found that Frias did not qualify as an organizer or leader under the Guidelines, warranting a remand for further proceedings. View "United States v. Frias" on Justia Law

Dr. Randy Lamartiniere, an internal medicine doctor, was convicted of twenty counts of unlawful distribution of controlled substances. Lamartiniere had been practicing medicine for approximately thirty years and had a growing number of chronic pain patients. Concerns arose about his management of opioid and narcotic prescriptions and his inability to maintain timely patient records, leading to his termination from a clinic. He then opened his own practice, where a significant portion of his patients were pain management patients. The Drug Enforcement Administration (DEA) launched an investigation into his prescription practices, which included undercover agents posing as chronic pain patients. Lamartiniere was subsequently charged with twenty-eight counts of unlawful distribution of Schedule II controlled substances.At trial, the Government presented evidence from Lamartiniere’s former patients, undercover agents, and expert witnesses. Lamartiniere testified in his own defense, arguing that he was genuinely trying to treat his patients' legitimate medical conditions. The jury convicted Lamartiniere on twenty counts, and he was sentenced to 180 months per count, to run concurrently. Lamartiniere appealed, challenging the jury instructions and the sufficiency of the evidence supporting his convictions. The United States Court of Appeals for the Fifth Circuit affirmed the convictions, finding no reversible error. View "United States v. Lamartiniere" on Justia Law