Justia U.S. 1st Circuit Court of Appeals Opinion Summaries
Articles Posted in Health Law
United States v. Burgos-Montes
Edison Burgos-Montes, serving a life sentence, sought compassionate release due to serious medical conditions, including severe hypertension and obstructive sleep apnea. He argued that the Bureau of Prisons (BOP) failed to provide adequate treatment for these conditions. Burgos filed a motion with the district court in late 2021, presenting evidence of his ongoing severe hypertension and lack of treatment for his sleep apnea. The district court found that Burgos was receiving adequate medical care and denied his motion without prejudice.Burgos appealed, contending that the district court's finding was clearly erroneous. He pointed to evidence that, nearly a year after his sleep apnea diagnosis, the BOP had not provided him with a CPAP machine, the standard treatment for sleep apnea. The district court had relied on a letter from Dr. Gary Venuto, Clinical Director at FCC Coleman, stating that Burgos was receiving adequate care. However, Burgos argued that this assessment overlooked significant evidence of inadequate treatment.The United States Court of Appeals for the First Circuit reviewed the case. The court found that the district court clearly erred in concluding that Burgos was receiving adequate treatment for his sleep apnea. The appellate court noted that Burgos had not received a CPAP machine or any other treatment for his sleep apnea, despite a diagnosis and a recommendation from an outside cardiologist. The court vacated the district court's order and remanded the case for further proceedings to determine if Burgos had demonstrated an "extraordinary and compelling" reason for compassionate release under 18 U.S.C. § 3582(c)(1)(A). View "United States v. Burgos-Montes" on Justia Law
Posted in:
Criminal Law, Health Law
Flanagan v. Fresenius Medical Care Holdings, Inc.
Martin Flanagan, a former employee of Fresenius Medical Care Holdings, Inc., filed a qui tam lawsuit under the False Claims Act (FCA) against his former employer. He alleged that Fresenius engaged in a fraudulent kickback scheme to induce referrals to its dialysis clinics, violating the Anti-Kickback Statute (AKS). Flanagan claimed that Fresenius offered below-cost contracts to hospitals, overcompensated medical directors, and provided other benefits to secure patient referrals, which were then billed to Medicare and Medicaid.The U.S. District Court for the District of Maryland initially handled the case, which was later transferred to the U.S. District Court for the District of Massachusetts. The district court dismissed Flanagan's complaint for failing to meet the heightened pleading standard under Rule 9(b) of the Federal Rules of Civil Procedure. The court found that the amended complaint did not adequately allege specific false claims or provide representative examples. Additionally, the court ruled that some of Flanagan's claims were barred by the FCA's public-disclosure and first-to-file rules. The district court also denied Flanagan's motion to amend his complaint, citing undue delay and potential prejudice to Fresenius.The United States Court of Appeals for the First Circuit reviewed the case. The court affirmed the district court's dismissal, agreeing that Flanagan failed to plead the alleged fraud with the required particularity. The appellate court also upheld the denial of the motion to amend, noting that Flanagan had ample time to address the deficiencies in his complaint but failed to do so. The First Circuit concluded that the district court did not abuse its discretion in its rulings. View "Flanagan v. Fresenius Medical Care Holdings, Inc." on Justia Law
United States v. Vega-Figueroa
In the 1990s, José A. Vega-Figueroa was involved in a drug-trafficking operation in Puerto Rico. He was charged in 1994 with multiple offenses, including first-degree murder, but was acquitted by a jury in 1995. In 1997, a federal grand jury indicted him for his role in a criminal enterprise involving the distribution of various drugs and related violent acts. After a thirty-day trial, he was found guilty on all counts and sentenced to multiple life sentences. Vega has since made several unsuccessful attempts to challenge his conviction and sentence.In February 2021, Vega filed a motion for compassionate release in the District of Puerto Rico, citing his health conditions and the risk of COVID-19 complications. He also argued that his rehabilitation efforts and the double jeopardy of being tried for the same conduct warranted his release. The district court denied his motion, finding that the Bureau of Prisons had taken adequate measures to protect inmates from COVID-19 and that Vega's health conditions did not meet the criteria for compassionate release. The court also determined that Vega remained a danger to the community, given his criminal history and prison infractions.The United States Court of Appeals for the First Circuit reviewed the case. The court affirmed the district court's decision, agreeing that Vega's health conditions and the measures taken by the Bureau of Prisons did not constitute extraordinary and compelling reasons for release. The appellate court also upheld the district court's assessment that Vega continued to pose a danger to the community, thus justifying the denial of his motion for compassionate release. View "United States v. Vega-Figueroa" on Justia Law
Posted in:
Criminal Law, Health Law
Waltermeyer v. Hazlewood
Broc Waltermeyer, an incarcerated federal inmate, alleged that he received inadequate medical treatment for his chronic knee pain while at the Federal Correctional Institute in Berlin, New Hampshire. He claimed that despite receiving various non-surgical treatments, including cortisone injections, pain medication, special shoes, knee braces, access to a low bunk, and a cane, he continued to experience pain. Waltermeyer argued that he should have been provided with knee replacement surgery, which was recommended to be deferred by an outside specialist until he was older.The United States District Court for the District of New Hampshire dismissed Waltermeyer's complaint, holding that his claims failed because he had an alternative administrative remedy. The district court also denied his motion for a preliminary injunction, as he had been transferred to a different facility, making the defendants no longer responsible for his care. Waltermeyer then amended his complaint to seek only money damages, leading to the current appeal.The United States Court of Appeals for the First Circuit reviewed the case and affirmed the district court's dismissal. The court held that Waltermeyer's claims were meaningfully different from those in Carlson v. Green, where the Supreme Court recognized a Bivens-type Eighth Amendment claim against federal prison officials for deliberate indifference to serious medical needs. The court found that Waltermeyer received substantial treatment, albeit not the treatment he preferred, and that the medical procedures administered were in accordance with doctors' recommendations. The court concluded that the differences in the nature of the medical care provided and the absence of gross inadequacy or deliberate indifference made Waltermeyer's case distinct from Carlson, thus precluding the extension of a Bivens remedy. View "Waltermeyer v. Hazlewood" on Justia Law
United States v. Regeneron Pharmaceuticals, Inc.
The case involves the United States government alleging that Regeneron Pharmaceuticals violated the Anti-Kickback Statute (AKS) by covering copayments for patients prescribed Eylea, a drug used to treat wet age-related macular degeneration. The government contends that this action induced doctors to prescribe Eylea, leading to Medicare claims that were "false or fraudulent" under the False Claims Act (FCA) because they "resulted from" the AKS violation.The United States District Court for the District of Massachusetts reviewed the case and agreed with Regeneron's interpretation that the phrase "resulting from" in the 2010 amendment to the AKS requires a but-for causation standard. This means that the government must prove that the AKS violation was the actual cause of the Medicare claims. The district court noted the conflict in case law and sought interlocutory review, which was granted.The United States Court of Appeals for the First Circuit affirmed the district court's ruling. The court held that the phrase "resulting from" in the 2010 amendment to the AKS imposes a but-for causation requirement. The court reasoned that the ordinary meaning of "resulting from" requires actual causality, typically in the form of but-for causation, unless there are textual or contextual indications to the contrary. The court found no such indications in the 2010 amendment or its legislative history. Therefore, to establish falsity under the FCA based on an AKS violation, the government must prove that the kickback was a but-for cause of the submitted claim. View "United States v. Regeneron Pharmaceuticals, Inc." on Justia Law
Humana Inc. v. Biogen, Inc.
Humana, a health insurance company and Medicare Part C and Part D sponsor, filed a lawsuit against Biogen, a drug manufacturer, and Advanced Care Scripts, Inc. (ACS), a specialty pharmacy, in the District of Massachusetts. Humana alleged that Biogen and ACS engaged in fraudulent schemes involving three multiple sclerosis drugs, violating the civil RICO statute. Humana claimed that Biogen "seeded" the market with these drugs, funneled patients into Medicare, and indirectly funded patient copays through third-party patient-assistance programs (PAPs). Humana also alleged that ACS aided Biogen's scheme by steering patients and acting as an intermediary between Biogen and the PAPs, causing the submission of false certifications to Humana.The district court dismissed the case, ruling that Humana lacked standing to bring RICO claims because it was an indirect purchaser and failed to plead the RICO claims with particularity as required by Federal Rule of Civil Procedure 9(b). The court found that Humana did not specify the time, place, and content of the alleged fraudulent communications and failed to detail the false certifications' language, timing, and context. Humana's motion for leave to amend the complaint was also denied.The United States Court of Appeals for the First Circuit reviewed the case. The court affirmed the district court's dismissal, agreeing that Humana failed to meet the heightened pleading standard of Rule 9(b) for its RICO claim. The court held that Humana did not provide specific details about the fraudulent certifications or the use of mail or wire communications in furtherance of the scheme. The court also upheld the denial of leave to amend, citing undue delay and the inefficiency of seeking amendment after dismissal. View "Humana Inc. v. Biogen, Inc." on Justia Law
Parente v. Lefebvre
Plaintiffs Luther C. Parente and Eric L. Stewart sued the Rhode Island Department of Corrections (RIDOC) and its staff for failing to properly treat their preexisting medical conditions. They alleged various federal and state constitutional, statutory, and common law bases for relief, including a claim under the Rhode Island Civil Rights Act of 1990 (RICRA). The plaintiffs claimed that RIDOC's medical and correctional staff failed to meet their medical needs, resulting in harm and discrimination.The United States District Court for the District of Rhode Island denied RIDOC's motion for summary judgment on Eleventh Amendment grounds as to the RICRA claim. The district court held that Rhode Island's general waiver of sovereign immunity under the State Tort Claims Act applied to RICRA claims, reasoning that discrimination actions under RICRA sounded in tort. RIDOC appealed this decision, arguing that the district court erred in holding that violations of civil rights under RICRA were subject to the general waiver of Eleventh Amendment immunity.The United States Court of Appeals for the First Circuit reviewed the case and determined that there was a "special reason" to certify the underlying state-law issue to the Rhode Island Supreme Court. The appellate court noted that the question of whether RICRA claims are "actions of tort" under the State Tort Claims Act is a matter of state law that has not been definitively resolved by the Rhode Island Supreme Court. Therefore, the First Circuit certified the question to the Rhode Island Supreme Court to determine whether discrimination claims under RICRA are covered by the general waiver of sovereign immunity under the State Tort Claims Act. The First Circuit retained jurisdiction over the issue pending resolution of the certified question. View "Parente v. Lefebvre" on Justia Law
Government of Puerto Rico v. Express Scripts, Inc.
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
Posted in:
Civil Procedure, Health Law
United States v. Sirois
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
United States v. Rodriguez
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