Justia Health Law Opinion Summaries

A pharmaceutical company participated in a federal program that required it to report the average price it received for drugs sold to wholesalers, which in turn affected the rebates it owed the government under Medicaid. From 2005 to 2017, the company sold drugs to wholesalers at an initial price, but if it raised the price before the wholesaler resold the drugs to pharmacies, it required the wholesaler to pay the difference. The company reported only the initial price as the average manufacturer price (AMP), excluding the subsequent price increases, which resulted in lower reported AMPs and thus lower rebate payments to the government. The company justified this exclusion by categorizing the price increases as part of a bona fide service fee to wholesalers, even though the increased value was ultimately paid by pharmacies.The United States District Court for the Northern District of Illinois reviewed the case after a qui tam action was filed by a relator, who alleged that the company’s AMP calculations were false and violated the False Claims Act (FCA). The district court granted summary judgment to the relator on the issue of falsity, finding the AMP calculations and related certifications were factually and legally false. The issues of scienter (knowledge) and materiality were tried before a jury, which found in favor of the relator and awarded substantial damages. The company appealed, challenging the findings on falsity, scienter, and materiality, while the relator cross-appealed on the calculation of the number of FCA violations.The United States Court of Appeals for the Seventh Circuit affirmed the district court’s judgment. The court held that the company’s exclusion of price increase values from AMP was unreasonable and contradicted the plain language and purpose of the relevant statutes, regulations, and agreements. The court also held that the jury reasonably found the company acted knowingly and that the false AMPs were material to the government’s payment decisions. The court rejected the cross-appeal on damages, finding the issue was not properly preserved for appeal. View "Streck v Eli Lilly and Company" on Justia Law

A former sales representative for a pharmaceutical company alleged that the company engaged in an aggressive campaign to market one of its drugs, Vraylar, for uses not approved by the Food and Drug Administration (FDA), specifically for substance abuse and major depressive disorder (MDD). The representative, who was responsible for promoting the drug to medical providers, claimed that the company trained its sales force to encourage off-label prescriptions and incentivized providers to prescribe Vraylar for these unapproved uses. He further asserted that he faced adverse employment actions, such as loss of promotion and increased workload, after raising concerns internally about the legality and compliance of these marketing practices.After the representative filed a qui tam action under the False Claims Act (FCA) in the United States District Court for the Northern District of Indiana, the government declined to intervene. The plaintiff then amended his complaint, dropping his direct fraud claim and proceeding solely on a theory of retaliation under 31 U.S.C. §3730(h). The district court dismissed the complaint with prejudice, finding that the plaintiff’s internal complaints to the company focused on regulatory noncompliance rather than fraud against the government, and thus did not put the employer on notice of protected activity under the FCA.The United States Court of Appeals for the Seventh Circuit reviewed the case de novo. The court held that, to state a claim for FCA retaliation, an employee must plausibly allege that the employer was on notice that the employee was attempting to prevent fraud against the government, not merely regulatory violations. Because the plaintiff’s communications only referenced regulatory and policy concerns, and did not suggest government fraud, the court found the notice requirement unmet. The Seventh Circuit affirmed the district court’s dismissal and found no abuse of discretion in denying leave to amend. View "Lewis v AbbVie Inc." on Justia Law

Cordell Sanders, an inmate at Pontiac Correctional Center, suffered from serious mental health issues and spent over eight years in segregation housing due to multiple disciplinary infractions. He received mental health services from various providers employed by Wexford Health Sources, the prison’s contracted healthcare provider. Sanders alleged that these providers were deliberately indifferent to his mental health needs, offering inadequate treatment and failing to advocate for him during disciplinary proceedings. He also claimed that Wexford maintained a widespread practice of denying mental health care until inmates were in crisis and failed to implement policies guiding provider participation in disciplinary hearings.The United States District Court for the Central District of Illinois granted summary judgment in favor of all defendants. The court found that Sanders had not presented sufficient evidence to support his claims of deliberate indifference or to establish a Monell claim against Wexford. Sanders appealed this decision, arguing that the providers’ treatment was ineffective and that Wexford’s practices and lack of policy amounted to constitutional violations.The United States Court of Appeals for the Seventh Circuit reviewed the district court’s summary judgment order de novo. The appellate court held that Sanders failed to provide evidence from which a reasonable jury could find that the providers’ conduct constituted deliberate indifference under the Eighth Amendment. The court emphasized the lack of expert testimony regarding the effectiveness of Sanders’s treatment and found no substantial departure from professional standards. Regarding Wexford, the court concluded that Sanders did not demonstrate a widespread practice of denying care or that the absence of a more detailed policy caused constitutional harm. The Seventh Circuit affirmed the district court’s grant of summary judgment for all defendants. View "Sanders v. Moss" on Justia Law

Lauren Richwine, through her business Death Done Differently, provides services as a “death doula,” assisting clients and their families with end-of-life planning, emotional support, and guidance on funeral arrangements. Richwine is not a licensed funeral director, and her website notes that her services are performed under the supervision of a licensed funeral director. In 2021, a complaint was filed with the Indiana Public Licensing Agency alleging that Richwine was practicing funeral services without a license. Following an investigation, the Indiana Attorney General sought a cease-and-desist order from the State Board of Funeral and Cemetery Service, which was approved. The order prohibited Richwine and her company from advertising or providing certain services related to funeral planning, community death care, and support with funeral homes.After the cease-and-desist order was issued, Richwine and Death Done Differently filed suit in the United States District Court for the Northern District of Indiana, Fort Wayne Division, arguing that enforcement of the Indiana statute against them would violate their First Amendment rights. The district court granted a preliminary injunction, enjoining enforcement of the statute against the plaintiffs. The defendants appealed, arguing that the plaintiffs had waived their rights by signing the cease-and-desist agreement and that federal abstention doctrine barred the suit. The district court rejected these arguments, finding no clear and unmistakable waiver of federal rights and no ongoing state proceeding that would justify abstention.The United States Court of Appeals for the Seventh Circuit reviewed the district court’s decision. The Seventh Circuit held that the Indiana statute, as applied to Richwine and Death Done Differently, burdens substantially more speech than necessary to further the state’s interests in public health, safety, and consumer protection. The court found that the statute’s restrictions on the plaintiffs’ speech and advertising likely violate the First Amendment. The Seventh Circuit affirmed the district court’s preliminary injunction and remanded for further proceedings. View "Richwine v. Matuszak" on Justia Law

Two children, E.R. and G.S., have severe, complex medical conditions that require constant, skilled care. Their mothers, who are their primary caregivers and sole financial supporters, have been trained by medical professionals to provide the necessary care at home. For years, Indiana’s Medicaid program reimbursed these mothers for providing “attendant care services” under a waiver program designed to keep individuals out of institutions. In July 2024, the Indiana Family and Social Services Administration (FSSA) implemented a policy change that would make parents ineligible to be paid providers of attendant care for their children, threatening to force E.R. and G.S. into institutional care due to the lack of available in-home nurses.The Indiana Protection and Advocacy Services Commission, along with E.R. and G.S., sued to block the policy change and require FSSA to secure in-home nursing. The United States District Court for the Southern District of Indiana initially granted a preliminary injunction requiring FSSA to take steps to obtain in-home nurses and to pay the mothers for a different, lower-paid service. After further proceedings, the court modified its order, ultimately requiring FSSA to pay the mothers for attendant care at the previous rate until in-home nursing could be secured.The United States Court of Appeals for the Seventh Circuit affirmed the district court’s October 1 injunction. The court held that the plaintiffs are likely to succeed on their claims under the Americans with Disabilities Act’s integration mandate, which requires states to provide services in the most integrated setting appropriate. The court found that prohibiting the mothers from providing paid attendant care placed the children at serious risk of institutionalization and that FSSA had not shown that allowing such care would fundamentally alter the Medicaid program or violate federal law. The case was remanded for further proceedings. View "Indiana Protection and Advocacy Services Comm'n v Indiana Family and Social Services Administration" on Justia Law

Frederick Brewer was convicted by a jury of distributing fentanyl, possessing with intent to distribute fentanyl, and participating in a conspiracy to distribute fentanyl. The jury, however, found that the government did not prove beyond a reasonable doubt that Brewer's conspiracy and possession convictions involved at least 40 grams of fentanyl. Brewer moved for acquittal twice, arguing insufficient evidence, but the district court denied both motions. Brewer appealed, contending that the evidence was insufficient to support his convictions and that the district court erred in calculating the drug quantity for sentencing.The United States District Court for the Eastern District of Wisconsin initially denied Brewer's motions for acquittal. The court found sufficient evidence to establish that Brewer and his co-defendant, Don James, Jr., were engaged in a conspiracy to distribute fentanyl, rather than a simple buyer-seller relationship. The court also rejected Brewer's argument that the jury's finding regarding the drug quantity undermined the guilty verdicts. At sentencing, the district court attributed 1.2 to 4 kilograms of fentanyl to Brewer, resulting in a higher base offense level and a sentence of 144 months in prison followed by 120 months of supervised release.The United States Court of Appeals for the Seventh Circuit reviewed the case and affirmed the district court's decisions. The appellate court held that the evidence was sufficient to support Brewer's convictions for conspiracy, possession, and distribution of fentanyl. The court also upheld the district court's drug quantity determination for sentencing purposes, noting that the sentencing court could consider conduct underlying acquitted charges if proven by a preponderance of the evidence. Brewer's conviction and sentence were affirmed. View "United States v. Brewer" on Justia Law

Dr. Alan Braid, a Texas OB/GYN, admitted in a Washington Post editorial to performing an abortion in violation of the Texas Heartbeat Act (S.B. 8). This led to three individuals from different states filing lawsuits against him under the Act's citizen-suit enforcement provision, seeking at least $10,000 in statutory damages. Facing potential duplicative liability, Dr. Braid filed a federal interpleader action in Illinois, seeking to join the claimants in a single suit and also sought declaratory relief to declare S.B. 8 unconstitutional.The United States District Court for the Northern District of Illinois dismissed Dr. Braid’s suit, citing the Wilton-Brillhart abstention doctrine due to the existence of parallel state-court proceedings. The court reasoned that the Texas state courts were better suited to resolve the issues, particularly given the unique enforcement mechanism of S.B. 8. The district court also questioned whether Dr. Braid had a reasonable fear of double liability but ultimately found that it had jurisdiction before deciding to abstain.The United States Court of Appeals for the Seventh Circuit affirmed the district court’s dismissal. The appellate court agreed that the district court had jurisdiction over the interpleader action but concluded that abstention was appropriate under the Colorado River doctrine, which allows federal courts to defer to parallel state-court proceedings in exceptional cases. The court emphasized that the Texas courts were better positioned to resolve the complex state-law issues and that abstention would avoid piecemeal litigation and conflicting judgments. The court also noted that the Texas courts could adequately protect Dr. Braid’s rights and that the federal suit appeared to be an attempt to avoid the state-court system. View "Braid v. Stilley" on Justia Law

Ferida H. Moy suffers from severe PTSD due to her experiences during the Yugoslav Wars. She applied for disability insurance benefits and supplemental security income, citing her PTSD and related mental health issues. An administrative law judge (ALJ) denied her application, finding that she had the residual functional capacity to perform simple, routine tasks with minimal contact with supervisors and co-workers. This decision was upheld by the district court, leading Moy to appeal.The ALJ found that Moy had moderate limitations in concentrating, persisting, or maintaining pace but concluded that she could work at a consistent production pace. The ALJ's decision was based on the testimony of a vocational expert who stated that a person with Moy's limitations could work as a dining room attendant, bus person, scrap sorter, industrial cleaner, or dishwasher. However, the vocational expert also testified that regular absences or being off-task for more than 15% of the workday would result in job loss. The ALJ's decision was affirmed by the district court.The United States Court of Appeals for the Seventh Circuit reviewed the case and found that the ALJ failed to build a logical bridge between Moy's limitations and the conclusion that she could work at a consistent production pace. The court noted that the ALJ's determination did not adequately account for Moy's limitations in concentration, persistence, and pace. The court emphasized that the ALJ's reasoning was internally inconsistent and did not reflect Moy's documented symptoms and treatment needs. Consequently, the Seventh Circuit vacated the judgment and remanded the case to the Commissioner of Social Security for further consideration consistent with its opinion. View "Moy v Bisignano" on Justia Law

Alicia Rae Pufahl applied for disability insurance benefits from the Social Security Administration in August 2012, citing limitations due to Wegener’s granulomatosis, depression, pulmonary disease, back injury, bipolar disorder, and excessive fatigue. She needed to establish disability between August 8, 2011, and December 31, 2016. Her application was initially denied in November 2012, followed by several unfavorable decisions from Administrative Law Judges (ALJs), appeals, and remands. The most recent ALJ decision concluded that she was not disabled during the relevant period, and the district court affirmed this decision.The United States District Court for the Eastern District of Wisconsin affirmed the ALJ’s decision, finding that substantial evidence supported the agency’s determination. The Appeals Council denied further review, making the ALJ’s decision the final decision of the Commissioner of Social Security.The United States Court of Appeals for the Seventh Circuit reviewed the case and affirmed the district court’s judgment. The court held that the ALJ properly weighed the medical opinion evidence, including the opinions of Ms. Pufahl’s neurologist, primary care provider, and psychiatrist, and found substantial evidence supporting the ALJ’s decision to not give controlling weight to these opinions. The ALJ’s evaluation of Ms. Pufahl’s subjective complaints was not patently wrong, as it was supported by specific reasons and evidence. Additionally, the hypothetical question posed to the vocational expert (VE) sufficiently accounted for Ms. Pufahl’s mental limitations, including her ability to maintain attention and concentration for two-hour segments. The court concluded that the ALJ’s decision was supported by substantial evidence and affirmed the district court’s judgment. View "Pufahl v Bisignano" on Justia Law

Joe Feazell, an inmate at Pontiac Correctional Center, sued his doctor, Andrew Tilden, and the prison’s healthcare contractor, Wexford Health Sources, Inc., alleging deliberate indifference to his hemorrhoid condition and significant gastrointestinal bleeding, violating the Eighth Amendment. Feazell claimed that Dr. Tilden failed to respond promptly to his abnormal lab results and adequately treat his hemorrhoids, while Wexford's treatment protocol was ineffective and deliberately indifferent.The United States District Court for the Central District of Illinois initially denied the defendants' motion for summary judgment. The parties consented to proceed before a magistrate judge, who later granted summary judgment for Wexford and partial summary judgment for Dr. Tilden. Feazell went to trial on his remaining claim against Dr. Tilden but was barred from testifying about his medical diagnoses or their causes. The jury returned a verdict for the defense.The United States Court of Appeals for the Seventh Circuit reviewed the case. The court affirmed the magistrate judge's summary judgment decision, finding no evidence that Wexford's Collegial Review policy caused Feazell to receive deficient care or that Dr. Tilden was aware of Feazell's hemorrhoids before the colonoscopy. The court also upheld the magistrate judge's evidentiary rulings, barring Feazell from testifying about medical diagnoses or causation, as he was not qualified to provide such testimony.The Seventh Circuit concluded that Feazell failed to demonstrate a genuine issue of material fact regarding Wexford's policy causing a violation of his Eighth Amendment rights and that Dr. Tilden was not deliberately indifferent to Feazell's medical needs. The court affirmed the district court's judgment. View "Feazell v Wexford Health Sources, Inc." on Justia Law