Justia Drugs & Biotech Opinion Summaries

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

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

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

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

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

The case revolves around a dispute over a medical marijuana cultivation license issued by the Arkansas Medical Marijuana Commission to Bennett Scott “Storm” Nolan II. 2600 Holdings, LLC, an unsuccessful applicant for the same license, filed a lawsuit against the Commission and other state entities, alleging that Nolan's application did not meet the minimum merit selection criteria and that the Commission violated its own rules and the Arkansas Constitution in awarding the license to Nolan. Nolan was not initially named as a defendant or joined as a party in the lawsuit.The Pulaski County Circuit Court denied Nolan's multiple motions to join the lawsuit as an indispensable party under Rule 19(a) of the Arkansas Rules of Civil Procedure and granted summary judgment in favor of 2600 Holdings. The court ruled that the Commission had exceeded its discretion and violated the Arkansas Constitution and its own rules in awarding the license to Nolan.On appeal, the Supreme Court of Arkansas reversed the lower court's decision, finding that Nolan was indeed an indispensable party under Rule 19(a)(2). The court held that the lower court erred in not joining Nolan as an indispensable party to the litigation. As a result, the court vacated the order granting summary judgment to 2600 Holdings and remanded the case for further proceedings. The court did not address Nolan's remaining issues as they were deemed moot due to the reversal and remand. View "Nolan v. 2600 Holdings, LLC" on Justia Law

In 2019, MO CANN Do, Inc. (MCD) applied for a medical marijuana cultivation license in Missouri. However, the Department of Health and Senior Services (DHSS) rejected MCD's application as it failed to include a certificate of good standing demonstrating its authorization to operate as a business in Missouri. An administrative hearing commission upheld DHSS's decision, and MCD appealed to the circuit court, which also affirmed the decision.The Supreme Court of Missouri found that MCD's application did not meet the minimum standards for licensure, as it failed to provide a certificate of good standing from the Secretary of State, as required by DHSS's regulations. MCD argued that its certificate of incorporation satisfied the standard requiring proof of authorization to operate as a business in Missouri, but the Court disagreed, stating that the regulatory language was unambiguous and the certificate of good standing was a specific requirement.MCD further argued that DHSS waived the certificate of good standing requirement by failing to specify it in the deficiency letter sent to MCD. The Court rejected this argument, stating that DHSS never affirmatively waived the deficiencies in MCD's application.Lastly, MCD claimed that DHSS should be estopped from denying its application based on the missing certificate of good standing due to its failure to notify MCD of this specific deficiency. The Court denied this claim, stating that it is generally inappropriate to estop governmental agencies tasked with administrating licensure in highly regulated industries, which include the marijuana industry. In conclusion, the Supreme Court of Missouri affirmed the circuit court’s judgment. View "MO CANN Do, Inc. vs. Missouri Department of Health and Senior Services" on Justia Law