Justia Drugs & Biotech Opinion Summaries

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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

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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

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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

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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

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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

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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

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The case involves Amber C., the mother of a two-year-old child, Kieran S., who appealed from the juvenile court’s jurisdiction findings and disposition orders after the court sustained a petition by the Los Angeles County Department of Children and Family Services. The petition was filed under Welfare and Institutions Code section 300, subdivision (b), alleging that Amber's substance abuse posed a substantial risk of serious physical harm to Kieran. The Department received a referral in April 2019, stating that the parents used drugs in the child's presence. Amber tested positive for amphetamine, methamphetamine, and morphine. Despite her positive test results, Amber denied using methamphetamine and claimed she did not use any drugs while with Kieran. After failing to cooperate with welfare checks and evading the Department, Amber absconded with Kieran.The juvenile court sustained counts under section 300, subdivision (b), alleging Amber abused substances, failed to protect Kieran from Victor’s mental and emotional issues, and absconded with Kieran. At the disposition hearing, the juvenile court declared Kieran a dependent child of the court, removed him from his parents, ordered Amber to attend a drug treatment program, and ordered reunification services. Amber appealed from the jurisdiction findings and disposition orders, arguing that there was no evidence she was under the influence of drugs when Kieran was detained and that there was no evidence of neglect or risk of harm to Kieran in her care.The Supreme Court granted Amber’s petition for review and transferred the case back to the Court of Appeal with directions to vacate its prior decision and reconsider Amber’s appeal in light of In re N.R., which held that substance abuse is not prima facie evidence of a parent’s inability to provide regular care to a child of tender years. The Court of Appeal found that substantial evidence supported the juvenile court’s finding Amber’s drug abuse created a substantial risk of physical harm to Kieran and affirmed the juvenile court’s jurisdiction findings and disposition orders. View "In re Kieran S." on Justia Law

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The case involves Terrence Jordan and Damara Sanders, who were pulled over by a state trooper for speeding. During the stop, the trooper noticed inconsistencies in their travel plans and observed Jordan's heavy breathing, which raised his suspicion. He called for a canine unit, which detected the presence of drugs. A subsequent search of the vehicle and the defendants revealed marijuana, pill presses, digital scales, plastic baggies, firearms, and a significant quantity of pills containing a fluorofentanyl-fentanyl mixture.The defendants were charged with possessing a firearm as a felon, possessing a controlled substance with the intent to distribute, and possessing firearms in furtherance of drug trafficking. They sought to suppress the evidence obtained from the traffic stop, arguing that the trooper lacked reasonable suspicion to extend the stop. The District Judge denied the motion. The defendants also proposed a lesser-included-offense instruction for simple possession of a controlled substance, which the court rejected, citing the quantity of drugs and distribution paraphernalia as evidence of intent to distribute.The United States Court of Appeals for the Sixth Circuit affirmed in part, vacated in part, and remanded for further proceedings. The court held that the trooper had reasonable suspicion to extend the stop, based on the defendants' suspicious travel plans, Sanders's implausible explanations, and Jordan's heavy breathing. The court also agreed with the district court's decision not to give a lesser-included-offense instruction, given the substantial evidence of the defendants' intent to distribute drugs. However, the court vacated the defendants' convictions for possessing firearms in furtherance of drug trafficking due to an error in the jury instructions. The case was remanded for further proceedings consistent with the court's opinion. View "United States v. Jordan" on Justia Law

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The case involves James Fejes, a pilot who held a certificate issued by the Federal Aviation Administration (FAA) under 49 U.S.C. § 44703. Fejes used his aircraft to transport and distribute marijuana to retail stores within Alaska, an activity that is legal under state law but illegal under federal law. After an investigation, the FAA revoked Fejes's pilot certificate under 49 U.S.C. § 44710(b)(2), which mandates revocation when a pilot knowingly uses an aircraft for an activity punishable by more than a year's imprisonment under a federal or state controlled substance law.Fejes appealed the FAA's decision to an Administrative Law Judge (ALJ), who affirmed the revocation. He then appealed the ALJ's decision to the National Transportation Safety Board (NTSB), which also affirmed the ALJ. Throughout the agency proceedings, Fejes admitted that he piloted an aircraft to distribute marijuana within Alaska, but argued that his conduct fell outside of § 44710(b)(2)'s reach.The United States Court of Appeals for the Ninth Circuit denied Fejes's petition for review of the NTSB's order affirming the FAA's revocation of his pilot certificate. The court rejected Fejes's argument that the FAA lacked jurisdiction to revoke his pilot certificate because Congress cannot authorize an administrative agency to regulate purely intrastate commerce like marijuana delivery within Alaska. The court held that airspace is a channel of commerce squarely within congressional authority, and therefore, Congress can regulate Fejes's conduct. The court also rejected Fejes's argument that his conduct was exempt under FAA regulation 14 C.F.R. § 91.19, and that the FAA misinterpreted § 44710(b)(2). The court concluded that the FAA's revocation of Fejes's pilot certificate was not arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law. View "FEJES V. FAA" on Justia Law

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The case involves two defendants, Christopher Yates and Shawn Connelly, who were convicted for conspiring to distribute methamphetamine. The conspiracy operated out of Macomb, Illinois, and lasted thirteen months, from January 2019 to February 2020. Yates supplied the methamphetamine, initially purchasing the drugs from an unknown source in Joliet, Illinois, with alleged Mexican cartel connections. After the arrest of that supplier, Yates sought out a new source. Connelly was among the distributors.The United States District Court for the Central District of Illinois sentenced both defendants. Yates argued that the government failed to prove the purity of all the methamphetamine involved in the conspiracy, having only tested a small, unrepresentative amount. Connelly argued that the court should not have relied on his coconspirators’ statements to calculate the total drug weight, and that the full weight was not reasonably foreseeable to him. The district court rejected both arguments and sentenced Yates to 168 months in prison and Connelly to 188 months’ imprisonment.On appeal, the United States Court of Appeals for the Seventh Circuit vacated Yates’s sentence and remanded the case. The court found that the government did not provide reliable evidence to support the district court's finding that the conspiracy involved at least 737.1 grams of “ice” methamphetamine. Therefore, Yates was entitled to resentencing. However, the court affirmed Connelly’s sentence, finding that the district court did not err in its calculation of the total drug weight attributable to him. View "United States v. Connelly" on Justia Law