Justia Drugs & Biotech Opinion Summaries

Law enforcement executed a search warrant at Ryan Dewayne Myrick’s apartment, discovering 69.01 grams of methamphetamine, drug packaging, a digital scale, and other paraphernalia. In his vehicle, they found additional drug packaging. Myrick was charged with conspiracy to distribute methamphetamine and possession with intent to distribute. He pleaded guilty to the latter charge, admitting to possessing 69.01 grams of methamphetamine, with the intent to distribute at least 50 grams. The government agreed to dismiss the conspiracy charge and recommend a reduction for acceptance of responsibility, contingent on Myrick’s continued demonstration of acceptance.The United States District Court for the Southern District of Iowa reviewed the case. The Presentence Investigation Report (PSR) recommended holding Myrick responsible for 4.5 kilograms or more of methamphetamine, resulting in a base offense level of 38. It also suggested a two-level enhancement for maintaining a premises for drug distribution and a three-level reduction for acceptance of responsibility. Myrick objected to the drug quantity and the premises enhancement, while the government objected to the reduction for acceptance of responsibility. The district court overruled Myrick’s objections and sustained the government’s, resulting in a total offense level of 40 and an advisory Guidelines range of 360 months to life. Myrick was sentenced to 300 months of imprisonment and 5 years of supervised release.The United States Court of Appeals for the Eighth Circuit reviewed the case. Myrick challenged the district court’s drug quantity determination, the premises enhancement, and the denial of a reduction for acceptance of responsibility. The appellate court found no clear error in the district court’s findings, including the credibility of witness testimony and the application of relevant conduct principles. The court affirmed the district court’s judgment, upholding Myrick’s sentence. View "United States v. Myrick" on Justia Law

The case involves Jamie Christopher Henderson, who was convicted and sentenced following a jury trial for conspiracy to distribute cocaine and cocaine base, possession with intent to distribute cocaine base, and possession of firearms in furtherance of his drug trafficking crimes. Henderson appealed his convictions and sentence, arguing that the evidence was insufficient to support these convictions, and that his sentence is procedurally and substantively unreasonable.The case originated from an incident on April 30, 2019, when law enforcement officers executed a search warrant at Henderson’s residence. They witnessed Henderson toss items underneath a vehicle, including a gun. The officers recovered a loaded handgun, a plastic bag with cocaine and crack cocaine, a cigarette lighter, and a glass crack pipe from underneath the vehicle. Henderson was arrested. Inside the trailer, police found a loaded rifle, a loaded handgun, cocaine powder and crack cocaine in a toilet tank, and a second loaded handgun in a kitchen trash can. They also seized three digital scales and a digital video recorder containing footage from security cameras showing Henderson and other men, armed with multiple handguns and a rifle, standing in the front yard of the residence as cars and people would approach it.Henderson was charged with conspiracy to distribute cocaine and cocaine base, possession of a firearm in furtherance of the drug-distribution conspiracy, possession with intent to distribute cocaine and cocaine base, possession of a firearm in furtherance of the possession-with-intent offense, and possession of a firearm as a felon. He pleaded not guilty. At trial, the Government presented the testimony of the law enforcement officers, Henderson’s videotaped confession, the security footage from the trailer, and a letter Henderson had written to his brother. Henderson presented the testimony of his mother and daughter who claimed that Henderson was a drug user, thief, and liar—but not a drug dealer. The jury convicted Henderson on all counts.The United States Court of Appeals for the Fourth Circuit affirmed the convictions and sentence. The court found that there was substantial evidence to support the conviction and that the sentence was not procedurally or substantively unreasonable. The court noted that Henderson faced a heavy burden in challenging the sufficiency of the evidence and that the court's role was limited to considering whether there was substantial evidence to support the conviction. The court found that there was abundant independent evidence that Henderson was engaged in a large-scale drug trade, which supported the trustworthiness of his confessions. The court also found that the district court did not err in calculating the quantity of drugs attributable to Henderson for sentencing purposes. The court concluded that Henderson's sentence was substantively reasonable and that he failed to overcome the presumption of reasonableness that applies to a below-Guidelines sentence. View "United States v. Henderson" on Justia Law

A nurse practitioner, Lisa Hofschulz, and her ex-husband, Robert Hofschulz, were convicted of conspiracy and multiple counts of distributing drugs in an unauthorized manner, including one count resulting in a patient's death. The charges stemmed from their operation of a "pain clinic" that functioned as a front for an opioid mill, dispensing opioid prescriptions for cash-only payments. Robert Hofschulz was also convicted for his role in assisting Lisa Hofschulz in running the opioid mill.The Hofschulzes were initially tried in the United States District Court for the Eastern District of Wisconsin. They were found guilty on all counts, with Lisa Hofschulz receiving a minimum 20-year prison term for the count of unlawful distribution resulting in death, and Robert Hofschulz receiving concurrent terms of 36 months in prison on each of his five convictions. The Hofschulzes appealed their convictions on three grounds: they claimed the jury instructions were inconsistent with a Supreme Court decision, that the judge wrongly permitted the government’s medical expert to testify about the standard of care, and that the evidence was insufficient to support their convictions.The case was then reviewed by the United States Court of Appeals for the Seventh Circuit. The court found no instructional error, stating that the district judge had correctly instructed the jury that the government must prove beyond a reasonable doubt that the Hofschulzes intended to distribute controlled substances and intended to do so in an unauthorized manner. The court also found that the judge had correctly permitted the government’s medical expert to testify about the standard of care in the usual course of professional pain management. Lastly, the court dismissed the Hofschulzes' challenge to the sufficiency of the evidence, deeming it frivolous. The court affirmed the convictions of the Hofschulzes. View "United States v. Hofschulz" on Justia Law

The case involves Amarin Pharma, Inc., Amarin Pharmaceuticals Ireland Limited, and Mochida Pharmaceutical Co., Ltd. (collectively, “Amarin”) and Hikma Pharmaceuticals USA Inc. and Hikma Pharmaceuticals PLC (collectively, “Hikma”). Amarin markets and sells icosapent ethyl, an ethyl ester of an omega-3 fatty acid commonly found in fish oils, under the brand name Vascepa®. In 2012, the U.S. Food and Drug Administration (“FDA”) approved Vascepa for the treatment of severe hypertriglyceridemia. In 2019, following additional research and clinical trials, the FDA approved Vascepa for a second use: as a treatment to reduce cardiovascular risk in patients having blood triglyceride levels of at least 150 mg/dL.In the United States District Court for the District of Delaware, Hikma moved to dismiss Amarin’s complaint for failure to state a claim. The court granted Hikma’s motion, concluding that Amarin’s allegations against Hikma did not plausibly state a claim for induced infringement.The United States Court of Appeals for the Federal Circuit reversed the decision of the district court. The court held that Amarin had plausibly pleaded that Hikma had induced infringement of the asserted patents. The court noted that the case was not a traditional Hatch-Waxman case or a section viii case, but rather a run-of-the-mill induced infringement case arising under 35 U.S.C. § 271(b). The court concluded that the totality of the allegations, taken as true, plausibly plead that Hikma “actively” induced healthcare providers’ direct infringement. View "AMARIN PHARMA, INC. v. HIKMA PHARMACEUTICALS USA INC. " on Justia Law

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