Justia Drugs & Biotech Opinion Summaries

The Association for Accessible Medicines (AAM), representing generic drug manufacturers, challenged a Minnesota law regulating drug prices, Minn. Stat. § 62J.842, arguing it violated the dormant Commerce Clause. The law prohibits manufacturers from imposing excessive price increases on generic or off-patent drugs sold in Minnesota. The district court granted AAM's motion for a preliminary injunction, finding the law likely violated the dormant Commerce Clause.The United States District Court for the District of Minnesota concluded that AAM was likely to succeed on the merits of its claim, faced a threat of irreparable harm, and that the balance of harms and public interest factors were neutral. Minnesota appealed, contesting the likelihood of success on the merits and the balance of harms/public interest.The United States Court of Appeals for the Eighth Circuit reviewed the district court’s ruling for abuse of discretion and its legal conclusions de novo. The court found that the Minnesota law had the impermissible extraterritorial effect of controlling prices outside the state, similar to laws previously struck down by the Supreme Court. The court rejected Minnesota's argument that the law did not control out-of-state prices, noting that it effectively regulated out-of-state transactions if the drugs ended up in Minnesota.The Eighth Circuit affirmed the district court’s decision, agreeing that AAM was likely to succeed on the merits of its dormant Commerce Clause claim. The court also found no abuse of discretion in the district court’s assessment of the balance of harms and public interest, noting that protecting constitutional rights is always in the public interest. The preliminary injunction against the Minnesota law was upheld. View "Ass'n for Accessible Medicines v. Ellison" on Justia Law

On March 15, 2022, law enforcement responded to a drug overdose in Rapid City, South Dakota, where they found K.S. conscious but sluggish after receiving Narcan. Officers suspected two individuals, including a woman with purple hair, of distributing fentanyl to K.S. Surveillance at a hotel led to a traffic stop of a red Ford Fiesta, where officers found Anthony Ward in the backseat. Ward was arrested for false impersonation after providing false names. A search of the vehicle revealed drugs, a stolen gun, and cash. Ward was charged with distribution of a controlled substance resulting in serious bodily injury and conspiracy to distribute fentanyl.The United States District Court for the District of South Dakota denied Ward's motions to suppress evidence from the traffic stop and to dismiss the indictment for failure to preserve evidence. After a five-day trial, the jury convicted Ward on both counts, and the court imposed concurrent 360-month sentences. Ward appealed the district court's decisions.The United States Court of Appeals for the Eighth Circuit reviewed the case. The court upheld the district court's denial of Ward's motions to suppress and dismiss, finding no unreasonable extension of the traffic stop and no bad faith in the handling of evidence. The court also found sufficient evidence to support Ward's convictions. The court concluded that the evidence showed Ward distributed fentanyl that caused K.S.'s serious bodily injury and that Ward was involved in a conspiracy to distribute fentanyl. The judgment of the district court was affirmed. View "United States v. Ward" on Justia Law

Evan Brown Bull was convicted by a jury of conspiracy to distribute 500 or more grams of methamphetamine. The government presented evidence from thirteen witnesses and various forms of documentation, including videos and Facebook messages, detailing Brown Bull's drug dealings from 2016 to 2023. The Probation Office's Presentence Investigation Report (PSR) recommended a base offense level of 32, with adjustments that increased the total offense level to 40, resulting in an advisory guidelines sentencing range of 360 months to life imprisonment. Brown Bull objected to the PSR's findings and requested a downward variance to 180 months.The United States District Court for the District of South Dakota overruled Brown Bull's objections and applied three sentencing enhancements: a two-level increase for obstruction of justice, a four-level increase for being an organizer or leader of a criminal activity involving five or more participants, and a two-level increase for committing the offense as part of a pattern of criminal conduct engaged in as a livelihood. The court ultimately sentenced Brown Bull to 400 months imprisonment and five years of supervised release.The United States Court of Appeals for the Eighth Circuit reviewed the case and affirmed the district court's decision. The appellate court found no clear error in the district court's application of the sentencing enhancements. The court held that Brown Bull's pretrial jail messages and Facebook post constituted obstruction of justice, that he was an organizer or leader of the drug conspiracy, and that his criminal conduct was part of his livelihood. The court concluded that the district court's findings were supported by the evidence and upheld the 400-month sentence. View "United States v. Bull" on Justia Law

In 2008, Santiago Alirio Gomez Rivera began working with co-conspirators in Latin America to obtain and transport cocaine for importation into the United States. Rafael Segundo Castro Diaz joined the conspiracy later, helping transport 1,200 kilos of cocaine in April 2013. The United States Coast Guard intercepted the boat carrying the cocaine, and the men aboard were arrested. Years later, a federal grand jury returned three indictments against Gomez Rivera and Castro Diaz, with the second superseding indictment expanding the conspiracy period from January 2008 to September 2013.The United States District Court for the Southern District of Florida denied the defendants' motions to dismiss the second superseding indictment, which they argued was untimely and broadened the original charges. The defendants then negotiated a stipulated bench trial, preserving their right to appeal the denial of their motions to dismiss. The district court adjudicated them guilty, but there were clerical errors in Castro Diaz's judgment documentation.The United States Court of Appeals for the Eleventh Circuit reviewed the case. The court held that a superseding indictment can satisfy the statute of limitations if it is independently timely or relates back to a timely prior indictment. The second superseding indictment was independently timely, as it was returned within five years of the alleged conspiracy period. The court also found sufficient evidence to support the convictions, as both defendants stipulated to facts indicating their involvement in the conspiracy until September 2013. The court affirmed the convictions and sentences but remanded for the correction of clerical errors in Castro Diaz's judgment. View "USA v. Santiago Alirio Gomez Rivera" on Justia Law

The City of Huntington and the Cabell County Commission filed lawsuits against AmerisourceBergen Drug Corp., Cardinal Health, Inc., and McKesson Corp., alleging that the defendants contributed to the opioid epidemic by distributing excessive quantities of opioids to pharmacies. The plaintiffs claimed that the defendants' actions created a public nuisance that should be abated under West Virginia common law. The cases were consolidated and remanded to the United States District Court for the Southern District of West Virginia, which held a ten-week bench trial.The district court ruled in favor of the defendants, concluding that the plaintiffs failed to prove that the defendants' conduct was unreasonable or that it proximately caused the opioid epidemic. The court found that the defendants substantially complied with their duties under the Controlled Substances Act (CSA) and that the plaintiffs did not provide sufficient evidence to show that the volume of opioids distributed was excessive or that the defendants failed to maintain effective controls against diversion. The district court also determined that the plaintiffs' proposed abatement plan was not appropriate.The plaintiffs appealed to the United States Court of Appeals for the Fourth Circuit, contesting the district court's factual findings and legal conclusions. The Fourth Circuit certified a question to the Supreme Court of Appeals of West Virginia, asking whether conditions caused by the distribution of a controlled substance can constitute a public nuisance under West Virginia common law and, if so, what the elements of such a claim are.The Supreme Court of Appeals of West Virginia declined to answer the certified question, citing the disputed factual findings and related legal conclusions on appeal. The court emphasized that it could not address the legal issue without a sufficiently precise and undisputed factual record, and any answer would be advisory given the unsettled facts. View "City of Huntington and Cabell County Commission v. AmerisourceBergen Drug Corporation" on Justia Law

Incyte Corporation and Incyte Holdings Corporation (collectively, Incyte) own U.S. Patent No. 9,662,335, which claims deuterated versions of ruxolitinib, a Janus kinase (JAK) modulator used to treat autoimmune disorders. Sun Pharmaceutical Industries, Ltd. and Sun Pharmaceutical Industries, Inc. (collectively, Sun) secured FDA approval for an oral deuterated ruxolitinib product, branded as Leqselvi, to treat alopecia areata (AA) and planned to launch it in October 2024. Incyte sued Sun for allegedly infringing the ’335 patent and moved for a preliminary injunction to prevent Sun from launching Leqselvi.The United States District Court for the District of New Jersey granted Incyte’s motion for a preliminary injunction, finding that Incyte would suffer irreparable harm if Sun launched Leqselvi. The district court based its decision on the theory that Sun’s launch would give it an unjust head start in the AA market, diminishing the value of Incyte’s investments in developing its own topical deuterated ruxolitinib product.Sun appealed the district court’s decision to the United States Court of Appeals for the Federal Circuit. The Federal Circuit reviewed the grant of the preliminary injunction for an abuse of discretion, focusing on whether the district court made a clear error in its irreparable harm analysis. The Federal Circuit found that the district court clearly erred in its finding of irreparable harm, as it was based on the incorrect assumption that Incyte would be first to market if the injunction were granted. The court noted that Sun’s multi-year head start was inevitable regardless of the injunction, as Incyte’s product would not launch until several years after the ’335 patent expired.The Federal Circuit reversed the district court’s order granting the preliminary injunction, concluding that Incyte failed to provide non-speculative evidence of irreparable harm. View "INCYTE CORPORATION v. SUN PHARMACEUTICAL INDUSTRIES, LTD. " on Justia Law

Jazz Pharmaceuticals, Inc. and Jazz Pharmaceuticals Ireland Limited (collectively, "Jazz") manufacture and sell sodium oxybate products, Xyrem and Xywav, for treating narcolepsy and idiopathic hypersomnia (IH). Avadel CNS Pharmaceuticals, LLC ("Avadel") sought FDA approval for Lumryz, a sodium oxybate product, for treating narcolepsy. Jazz sued Avadel, alleging that Avadel's FDA submission infringed Jazz's U.S. Patent 11,147,782. The district court found in favor of Jazz, issuing a permanent injunction against Avadel from seeking FDA approval for Lumryz for IH and from marketing Lumryz for that indication.The U.S. District Court for the District of Delaware initially ruled that Avadel's submission of its New Drug Application (NDA) constituted infringement under 35 U.S.C. § 271(e)(2). The court issued a permanent injunction prohibiting Avadel from seeking FDA approval for Lumryz for IH, offering open-label extensions (OLEs) to clinical trial participants, and initiating new clinical trials. Avadel appealed, arguing that the injunction was overly broad and that certain activities were protected under the safe-harbor provision of 35 U.S.C. § 271(e)(1).The United States Court of Appeals for the Federal Circuit reviewed the case. The court reversed the injunction prohibiting Avadel from initiating new clinical trials and offering OLEs, finding these activities to be protected under the safe-harbor provision. The court vacated the injunction preventing Avadel from seeking FDA approval for new indications of Lumryz, remanding the issue to the district court for further consideration. The court instructed the district court to determine whether Avadel's submission of a paper NDA for additional indications would constitute an act of infringement under 35 U.S.C. § 271(e)(2) and to reassess the eBay factors if necessary. View "JAZZ PHARMACEUTICALS, INC. v. AVADEL CNS PHARMACEUTICALS, LLC " on Justia Law

Detectives with the Fort Myers Police Department observed Alphonso Lataurean James engaging in suspected drug transactions at a gas station. James was seen wearing a cross-body bag, which he later took into a vehicle. After stopping the vehicle, detectives found the bag containing a handgun and ammunition. They also discovered drugs in the car, including fentanyl and cocaine. James admitted to possessing the bag but denied knowledge of the firearm. DNA testing linked James and others to the gun. James, a convicted felon, was charged with possession of a firearm by a convicted felon.The United States District Court for the Middle District of Florida sentenced James to ninety-two months in prison, applying a four-level enhancement under U.S.S.G. § 2K2.1(b)(6)(B) for possessing a firearm in connection with another felony offense. James objected, arguing that the enhancement was improperly applied based on the Sentencing Guidelines' commentary. The district court overruled his objections, finding that the firearm was in close proximity to the drugs, thus meeting the "in connection with" requirement.The United States Court of Appeals for the Eleventh Circuit reviewed the case. The court held that the phrase "in connection with" in U.S.S.G. § 2K2.1(b)(6)(B) is unambiguous and does not require deference to the Sentencing Guidelines' commentary. Despite the district court's error in relying on the commentary, the appellate court found that the district court's factual findings were sufficient to support the enhancement. The court affirmed James's sentence, concluding that he possessed the firearm in connection with drug trafficking. View "USA v. James" on Justia Law

Roy Lee Jones, Jr. was involved in a methamphetamine-trafficking organization in North-Central Louisiana. He received large shipments of methamphetamine from his California-based supplier, DeLewis Johnson IV, and redistributed them to Willie Todd Harris, who then sold them to street-level dealers. After a ten-month investigation, federal law enforcement initiated grand jury proceedings, resulting in a five-count indictment. Jones was charged under 21 U.S.C. §§ 841(a)(1) and 846 for conspiracy to distribute and possess with intent to distribute methamphetamine.Jones and Johnson were tried as co-defendants and convicted by a jury. The initial presentence report (PSR) calculated Jones' offense level as 37, recommending a Guidelines range of 210-262 months. The district court sentenced Jones to 210 months' imprisonment. Jones appealed his conviction and sentence, which were affirmed by the United States Court of Appeals for the Fifth Circuit. The Supreme Court denied Jones' petition for a writ of certiorari.Jones filed a motion for a sentence reduction under Amendments 821 and 825 of the United States Sentencing Guidelines. The district court denied the motion, finding that Jones was ineligible for a reduction under USSG § 4C1.1(a)(10) because he had received an aggravating role enhancement under § 3B1.1 and had engaged in a continuing criminal enterprise as defined in 21 U.S.C. § 848.The United States Court of Appeals for the Fifth Circuit reviewed the district court's decision for abuse of discretion, its interpretation of the Guidelines de novo, and its findings of fact for clear error. The court held that either receiving a § 3B1.1 adjustment or engaging in a continuing criminal enterprise is sufficient to disqualify a defendant from a sentence reduction under § 4C1.1(a)(10). Since Jones received an aggravating role enhancement, he was ineligible for a reduction. The court affirmed the district court's decision. View "United States v. Jones" on Justia Law

Dr. Timothy Baxter, while working for Indivior, a pharmaceutical company, distributed misleading information to Massachusetts’s Medicaid program about the safety of new opioid drugs. This led to his conviction for misdemeanor drug misbranding. Following his conviction, the Secretary of Health and Human Services banned him from participating in federal healthcare programs for five years. Baxter challenged this exclusion, arguing that his crime did not categorically relate to the delivery of an item or service under a state healthcare program.The United States District Court for the Eastern District of Virginia granted summary judgment in favor of the Secretary, rejecting Baxter’s claims. Baxter then appealed to the United States Court of Appeals for the Fourth Circuit.The Fourth Circuit reviewed the case and held that the exclusion statute, 42 U.S.C. § 1320a-7(a), does not require a categorical approach. Instead, it employs a circumstance-specific approach, meaning it looks at the actual conduct of the individual rather than the elements of the statute of conviction. The court found that Baxter’s conduct—misbranding drugs to influence MassHealth’s coverage decisions—was related to the delivery of an item under a state healthcare program. Therefore, his exclusion was mandatory under the statute.The Fourth Circuit affirmed the district court’s decision, upholding Baxter’s exclusion from federal healthcare programs. View "Baxter v. Kennedy" on Justia Law