Justia Health Law Opinion Summaries

The Government of Puerto Rico sued several pharmaceutical benefit managers (PBMs) and pharmaceutical manufacturers in the Commonwealth of Puerto Rico Court of First Instance. The Commonwealth alleged that the PBMs, including Express Scripts and Caremark, schemed to unlawfully inflate insulin prices through rebate negotiations and price setting. The PBMs removed the case to federal court under 28 U.S.C. § 1442(a)(1), arguing that they acted under federal authority in negotiating rebates and setting drug prices, and that the lawsuit related to their federal service.The United States District Court for the District of Puerto Rico remanded the case back to the Court of First Instance. The district court found that the Commonwealth's disclaimer, which stated that it was not seeking relief related to any federal program or contract, effectively excluded any claims upon which the PBMs could base removal under § 1442(a)(1). The district court concluded that the PBMs could not claim they acted under federal authority for their non-federal PBM services and that dividing the work done for federal and non-federal clients was possible.The United States Court of Appeals for the First Circuit reversed the district court's decision. The appellate court held that the disclaimer did not prevent removal because Caremark's rebate negotiations for federal and non-federal clients were indivisible. The court found that Caremark acted under federal authority when negotiating rebates for FEHBA plans and possessed a colorable federal defense under FEHBA's express preemption provision. The court concluded that the disclaimer did not eliminate the possibility that the Commonwealth would recover for Caremark's official acts, thus justifying removal under § 1442(a)(1). The case was remanded to the district court with instructions to return it to federal court. View "Government of Puerto Rico v. Express Scripts, Inc." on Justia Law

The case involves Lucas Sirois and Alisa Sirois, who were indicted for conspiracy to distribute and possess with intent to distribute marijuana under the Controlled Substances Act (CSA). They sought to enjoin the Department of Justice (DOJ) from prosecuting them, arguing that their conduct was in substantial compliance with the Maine Medical Use of Cannabis Act, which allows for the use, distribution, possession, and cultivation of medical marijuana under state law. The defendants claimed that the DOJ's prosecution violated the Rohrabacher-Farr Amendment, which prohibits the DOJ from using funds to prevent states from implementing their medical marijuana laws.The United States District Court for the District of Maine denied the defendants' request for injunctive relief. The court held a hearing where the government presented evidence that the defendants' operations, particularly a grow operation known as the "Shoe Shop," violated Maine's medical marijuana laws by operating as a collective and engaging in black-market sales. The court found that the government had met its burden of production, showing a substantial evidentiary basis for the prosecution. However, the defendants failed to meet their burden of persuasion to demonstrate that the prosecution lacked a substantial evidentiary basis or was arbitrary or irrational.The United States Court of Appeals for the First Circuit reviewed the case and affirmed the District Court's decision. The appellate court held that the defendants did not show by a preponderance of the evidence that they were in substantial compliance with Maine's medical marijuana laws. The court noted significant evidence that the Shoe Shop operated as a collective and that Lucas Sirois engaged in black-market sales. The court concluded that the defendants failed to demonstrate that the DOJ's prosecution would prevent Maine from giving practical effect to its medical marijuana laws, as required under the Rohrabacher-Farr Amendment. Therefore, the denial of the motion to enjoin the prosecution was affirmed. View "United States v. Sirois" on Justia Law

The case involves Juan Rodriguez and Junito Melendez, who were convicted of conspiracy to distribute and possess with intent to distribute more than 500 grams of cocaine. Melendez was identified as the front man of the operation, interacting with customers and suppliers, while Rodriguez managed backend operations from his residence. The operation involved acquiring cocaine from suppliers, cooking some into crack cocaine, and selling it. The Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF) began investigating the defendants in 2018, leading to the seizure of Melendez's iPhone and subsequent wiretaps that provided evidence of their drug activities.In the United States District Court for the District of Massachusetts, a jury found both defendants guilty of the conspiracy charges. Melendez was also found guilty of distributing 500 grams or more of cocaine and had a prior conviction for a serious drug felony. He pleaded guilty to conspiracy to commit Hobbs Act robbery. The district court sentenced Rodriguez to 52 months and Melendez to 156 months in prison. Melendez's sentence included enhancements for drug quantity and his role as an organizer or leader in the conspiracy.The United States Court of Appeals for the First Circuit reviewed the case. The court affirmed the district court's decisions, finding no error in the denial of motions to suppress evidence from Melendez's iPhone and wiretaps, the admission of certain evidentiary testimony, and the jury instructions. The court also upheld the sentencing enhancements for Melendez, concluding that the evidence supported the drug quantity attributed to him and his role as an organizer in the conspiracy. The court found that any potential errors were harmless and did not affect the overall outcome of the case. View "United States v. Rodriguez" on Justia Law

Manish Kumar was involved in a scheme to smuggle misbranded prescription drugs and controlled substances into the United States from March 2015 to August 2019. Kumar, an Indian national, was a partner in Mihu, a New Delhi-based company that sold generic versions of drugs like Viagra, Cialis, Adderall, and tramadol without FDA approval or proper prescriptions. Kumar managed call centers in India where representatives made false statements to U.S. customers, claiming the drugs were FDA-approved and that no prescriptions were needed. Kumar was arrested in August 2019 on unrelated identity theft charges and later charged in Massachusetts with conspiracy to smuggle drugs, distribute controlled substances, and make false statements. He pled guilty to all charges in October 2022.The United States District Court for the District of Massachusetts sentenced Kumar to 87 months in prison. The court applied a fraud cross-reference in the Sentencing Guidelines and accepted the government's estimate of the loss amount involved in the offense, which was approximately $3.8 million. Kumar objected to both the application of the fraud cross-reference and the loss amount calculation, arguing that the evidence was insufficient.The United States Court of Appeals for the First Circuit reviewed the case. The court held that the fraud cross-reference was correctly applied because the false statements made by call center representatives were within the scope of Kumar's conspiracy and were made in furtherance of the criminal activity. The court also found that the sentencing court did not clearly err in its loss amount calculation, as it relied on detailed government estimates and supporting data. The First Circuit affirmed Kumar's 87-month sentence. View "United States v. Kumar" on Justia Law

The case involves BioPoint, Inc., a life sciences consulting firm, which accused Catapult Staffing, LLC, and Andrew Dickhaut of misappropriating trade secrets, confidential business information, and engaging in unfair trade practices. BioPoint alleged that Catapult, with the help of Dickhaut and Leah Attis (a former BioPoint employee and Dickhaut's fiancée), used BioPoint's proprietary information to recruit candidates and secure business from BioPoint's clients, including Vedanta and Shire/Takeda.The U.S. District Court for the District of Massachusetts handled the initial proceedings. The jury found Catapult liable for misappropriating BioPoint's trade secrets concerning three candidates and two clients, and for tortious interference with BioPoint's business relationship with one candidate. The jury awarded BioPoint $312,000 in lost profits. The judge, in a subsequent bench trial, found Catapult liable for unjust enrichment and violations of the Massachusetts Consumer Protection Law (chapter 93A), awarding BioPoint $5,061,444 in damages, which included treble damages for willful and knowing conduct, as well as costs and attorneys' fees.The United States Court of Appeals for the First Circuit reviewed the case. The court largely affirmed the lower court's findings but reduced the judge's award by $157,068, as it found that BioPoint could not recover both lost profits and unjust enrichment for the same placement. The court also reversed the district court's imposition of joint-and-several liability on Andrew Dickhaut, ruling that he could not be held liable for profits he did not receive. The case was remanded for further proceedings to determine Dickhaut's individual liability. View "BioPoint, Inc. v. Dickhaut" on Justia Law

Hector Rodriguez-Pena was convicted in 1993 for his involvement in a drug trafficking conspiracy, firearms possession, and the attempted murder of federal law enforcement officers. He was sentenced to a total of 622 months' imprisonment, which was later reduced to 570 months. Over the years, Rodriguez-Pena has repeatedly challenged his sentence and conviction through various legal avenues, including direct appeals and motions for sentence modifications, all of which were denied.Rodriguez-Pena filed a motion for compassionate release in the U.S. District Court for the District of Puerto Rico, citing his vulnerability to COVID-19 due to his health conditions and the prevalence of the virus in his prison facility, FCI Coleman Low. He argued that his medical conditions, including high blood pressure and hyperlipidemia, increased his risk of severe complications from COVID-19. The district court denied his motion, concluding that he did not demonstrate extraordinary and compelling reasons for a sentence reduction, particularly noting his vaccination status and the low COVID-19 infection rates in his facility.The United States Court of Appeals for the First Circuit reviewed the case and affirmed the district court's decision. The appellate court found that the district court did not abuse its discretion in concluding that Rodriguez-Pena's risk from COVID-19, given his vaccination status and the conditions at FCI Coleman Low, did not constitute an extraordinary and compelling reason for compassionate release. The court also noted that the district court properly considered the evidence and arguments presented, including the effectiveness of COVID-19 vaccines and the current state of the pandemic within the prison. View "US v. Rodriguez-Pena" on Justia Law

A Rhode Island oral and maxillofacial surgeon, Dr. Stephen T. Skoly, refused to comply with a COVID-19 Emergency Regulation issued by the Rhode Island Department of Health (RI DOH) that required all healthcare workers and providers to be vaccinated against COVID-19. Following his public declaration of noncompliance, the RI DOH issued a Notice of Violation and Compliance Order against him. Skoly then filed a lawsuit in federal court against the state and its officials, alleging violations of equal protection, due process, and First Amendment rights. The district court dismissed his complaint under Federal Rule of Civil Procedure 12(b)(6).The district court's decision was based on the fact that the state officials were either entitled to absolute or qualified immunity for their actions. The court held that the RI DOH directors were exercising prosecutorial authority delegated to them by Rhode Island law, thus granting them absolute immunity. As for Governor McKee, the court found that he was protected by qualified immunity as Skoly had no clearly established right to continue practicing while violating the vaccine mandate. The court also rejected Skoly's First Amendment retaliation claim, stating that the posting of the Notice constituted government speech, which could not form the basis of a plausible First Amendment retaliation claim.Upon appeal, the United States Court of Appeals for the First Circuit affirmed the district court's dismissal of Skoly's complaint. The appellate court agreed with the lower court's findings that the state officials were entitled to either absolute or qualified immunity and that Skoly's constitutional claims were without merit. The court also upheld the dismissal of Skoly's First Amendment retaliation claim, stating that Skoly had not sufficiently alleged that he was targeted due to his opposition to the First Emergency Regulation. View "Skoly v. McKee" on Justia Law

In 2010, Ángel M. Ayala-Vázquez was indicted and convicted on multiple drug-related charges, including conspiring to possess with intent to distribute and aiding and abetting the possession of with intent to distribute over 280 grams of cocaine base. He was sentenced in 2011 to life imprisonment. In 2021, Ayala filed a motion to reduce his sentence under the First Step Act and for compassionate release due to his hypertension and obesity making him vulnerable to COVID-19.The District Court denied Ayala's motion, concluding that he was ineligible for a sentence reduction under the First Step Act because his sentences were imposed "in accordance with" the amendments made by the Fair Sentencing Act. The court also rejected his request for compassionate release, finding that Ayala failed to demonstrate extraordinary and compelling reasons to warrant such relief. Moreover, the court determined that Ayala posed a danger to other persons and the community.On appeal to the United States Court of Appeals for the First Circuit, the court affirmed the District Court's decision. It concluded that Ayala was indeed convicted of offenses involving 280 grams or more of cocaine base, and his life sentences were in accordance with the Fair Sentencing Act. Therefore, he was not eligible for a sentence reduction under the First Step Act. As for the compassionate release, the court found no abuse of discretion in the District Court's evaluation of Ayala's health conditions and perceived danger to the community. View "United States v. Ayala-Vazquez" on Justia Law

A group of individuals filed a lawsuit against Genzyme Corporation, a drug manufacturer, for injuries allegedly caused by the company's mishandling of a prescription drug shortage between 2009 and 2012. The lawsuit was filed several years after the events in question occurred and would typically have been considered too late under the applicable statutory limitations periods. However, the plaintiffs argued that previous class actions, a savings statute, and a tolling agreement between the parties allowed the lawsuit to proceed. The district court partially agreed and rejected Genzyme's argument that the delay in filing required dismissal of the lawsuit. However, it dismissed the claims of all but four plaintiffs for lack of standing, and dismissed the remaining claims on the merits.On appeal, the United States Court of Appeals for the First Circuit found that all plaintiffs have standing and the court has jurisdiction to proceed with the case, at least with respect to the plaintiffs' individual claims. However, it concluded that four plaintiffs waited too long before filing this lawsuit, and their claims are time-barred. For the remaining plaintiffs, the court vacated the judgment dismissing their claims and remanded the case to the district court for further proceedings. View "Wilkins v. Genzyme Corporation" on Justia Law

A pregnant inmate, Lidia Lech, filed a lawsuit against several healthcare providers and staff at the Western Massachusetts Regional Women's Correctional Center (WCC), alleging that they ignored her serious medical symptoms and denied her requests to go to the hospital, resulting in the stillbirth of her baby. The district court permitted most of Lech's claims to proceed to trial, but granted summary judgment in favor of one of the correctional officers. The jury returned a verdict in favor of the defense. On appeal, the United States Court of Appeals for the First Circuit found that the district court abused its discretion in two evidentiary rulings. The first error was allowing the defense to use Lech's recorded phone calls to impugn her character for truthfulness. The second error was excluding testimony from Lech's friend, which would have corroborated her version of events. The court concluded that at least one of these evidentiary rulings was not harmless, vacated the jury verdict, and remanded for a new trial against most of the defendants. However, the court affirmed the district court's grant of summary judgment to the correctional officer, as well as the jury verdict in favor of one of the medical providers. View "Lech v. Von Goeler" on Justia Law