Justia Health Law Opinion Summaries

Roy Lee Williams, a death-row inmate with a history of mental illness, was held in solitary confinement for twenty-six years. Williams filed a lawsuit claiming that his prolonged solitary confinement without penological justification violated the Eighth Amendment's prohibition against cruel and unusual punishment and the Americans with Disabilities Act (ADA). The District Court granted summary judgment in favor of the defendants, ruling that the former Secretary of the Pennsylvania Department of Corrections (DOC) was entitled to qualified immunity on the Eighth Amendment claim and that Williams could not prove deliberate indifference under the ADA.Before the summary judgment, the District Court dismissed Williams' Fourteenth Amendment claim for failure to state a claim. Williams appealed both the summary judgment and the dismissal of his Fourteenth Amendment claim.The United States Court of Appeals for the Third Circuit reviewed the case. The court concluded that the Secretary had "fair and clear warning" that keeping Williams in solitary confinement without penological justification was unconstitutional, thus rejecting the qualified immunity defense. The court held that it was clearly established that someone with a known preexisting serious mental illness has a constitutional right not to be held in prolonged solitary confinement without penological justification.Regarding the ADA claim, the court found that the District Court erred in concluding that a trier of fact could not find the DOC deliberately indifferent to the risk of harm caused by placing and keeping Williams in solitary confinement despite his mental illness. The court vacated the District Court's grant of summary judgment on both the Eighth Amendment and ADA claims and remanded for further proceedings. However, the court affirmed the dismissal of Williams' Fourteenth Amendment claim. View "Williams v. Secretary Pennsylvania Department of Corrections" on Justia Law

The case involves hundreds of plaintiffs who allege that they were injured by the drug Fosamax, manufactured by Merck Sharp & Dohme Corp. (Merck), due to inadequate warnings about the risk of atypical femoral fractures. The plaintiffs claim that they would not have taken the drug if they had been properly warned. Merck contends that it proposed a label change to the Food and Drug Administration (FDA) to address this risk, but the FDA rejected the proposed change due to insufficient scientific support.The United States District Court for the District of New Jersey granted summary judgment in favor of Merck, concluding that the plaintiffs' state law claims were preempted by federal law. The court found that Merck had fully informed the FDA of the justifications for the proposed warning and that the FDA had rejected the proposed label change, thus preempting the state law claims. The court relied on the FDA's Complete Response Letter and other communications to determine that the FDA's rejection was based on a lack of sufficient scientific evidence linking Fosamax to atypical femoral fractures.The United States Court of Appeals for the Third Circuit reviewed the case and vacated the District Court's judgment. The Third Circuit concluded that the District Court erred in its preemption analysis by giving too little weight to the presumption against preemption. The appellate court found that the FDA's Complete Response Letter was ambiguous and that the District Court placed too much reliance on informal FDA communications and an amicus brief to interpret the letter. The Third Circuit emphasized that the presumption against preemption is strong and that Merck did not meet the demanding standard of showing that federal law prohibited it from adding any and all warnings that would satisfy state law. The case was remanded for further proceedings. View "In re: Fosamax" on Justia Law

Residents of St. Croix, Virgin Islands, sued Limetree Bay Terminals and Limetree Bay Refining after the companies reopened an oil refinery that released oil mist onto nearby properties, contaminating water supplies. The residents, who rely on cisterns for water, claimed the contamination posed health risks. The companies attempted to clean the cisterns and compensate affected residents, but not all residents had access to clean water. The residents sought a preliminary injunction to require the companies to provide bottled water.The District Court for the Virgin Islands granted the preliminary injunction, finding that both Terminals and Refining were responsible for the contamination under their federal operating permit. The court determined that the residents were likely to succeed on the merits of their case and faced irreparable harm without access to clean water. The court limited the bottled-water program to residents in certain neighborhoods who received need-based government assistance and required the residents to post a $50,000 bond.The United States Court of Appeals for the Third Circuit reviewed the case and affirmed the District Court's decision. The Third Circuit agreed that the residents were likely to succeed on the merits and faced irreparable harm. The court also found that the balance of equities and public interest favored the residents. The Third Circuit upheld the $50,000 bond, noting that the District Court had carefully considered the residents' ability to pay and the relative hardships to each party. The court concluded that the District Court had properly applied the law and exercised its discretion in granting the preliminary injunction and setting the bond amount. View "Boynes v. Limetree Bay Ventures LLC" on Justia Law

The case involves Alice Chu, who was indicted in September 2019 and convicted of one count of conspiracy to commit health care fraud and five counts of health care fraud. Chu's trial was initially set for February 22, 2021, but due to the COVID-19 pandemic, the Chief Judge of the District of New Jersey issued multiple standing orders that delayed trials and excluded these delays from Speedy Trial Act (STA) calculations. Chu's trial eventually commenced on March 1, 2022.Chu moved to dismiss multiple times on STA grounds, arguing that the delays denied her right to a speedy trial under the Sixth Amendment and that the government abused the grand jury process causing inexcusable delay. The District Court denied these motions. After her conviction, Chu filed two motions for a new trial, claiming she was unfairly prejudiced by trial testimony about prior bad acts and that newly discovered evidence could change the probability of a conviction at trial. The District Court denied both motions.The United States Court of Appeals for the Third Circuit affirmed the District Court's decisions. The Court of Appeals agreed with the District Court that the exclusions resulting from the COVID-19 pandemic did not violate defendants’ rights under the STA. The Court also found no clear error in the District Court’s adoption of the factual findings contained within the COVID Standing Orders. The Court of Appeals further agreed with the District Court that Chu failed to show that the government’s “sole or dominant purpose” was to impermissibly delay her trial. The Court of Appeals concluded that the District Court did not abuse its discretion in denying Chu's motions for a new trial and that the evidence at trial was sufficient to prove Chu’s knowledge and intent to commit health care fraud. View "United States v. Chu" on Justia Law

In a class action suit, the plaintiffs, a group of patients, alleged that the Trustees of the University of Pennsylvania (Penn), who operate the Hospital of the University of Pennsylvania Health System (Penn Medicine), were in violation of Pennsylvania privacy law. The plaintiffs claimed that Penn Medicine shared sensitive health information and online activity of its patients with Facebook through its patient portal. Penn removed the case to federal court, asserting that it was "acting under" the federal government, referencing the federal-officer removal statute. However, the District Court rejected this argument and returned the case to state court.This case was primarily focused on whether Penn was "acting under" the federal government in its operation of Penn Medicine's patient portal. The United States Court of Appeals for the Third Circuit affirmed the District Court's decision to remand the case back to state court. The Court of Appeals determined that Penn was not "acting under" the federal government, as it did not demonstrate that it was performing a delegated governmental task. The court declared that Penn was merely complying with federal laws and regulations, which does not qualify as "acting under" the federal government. The court noted that just because a private party has a contractual relationship with the federal government does not mean that it is "acting under" the federal authority. In conclusion, the court determined that the relationship between Penn and the federal government did not meet the requirements for Penn to be considered as "acting under" the federal government, thus the case was correctly returned to state court. View "Mohr v. Trustees of the University of Pennsylvania" on Justia Law

The Family Smoking Prevention and Tobacco Control Act requires any tobacco product not on the market before February 15, 2007, to receive FDA approval, 21 U.S.C. 387j(a)(1)–(2). Only if the FDA concludes that “permitting such tobacco product to be marketed would be appropriate for the protection of the public health” can the product be approved. Manufacturers seeking advance permission to market new products. In 2020, the FDA began taking aggressive action to remove fruit- and dessert-flavored e-cigarettes (electronic nicotine delivery systems (ENDS)) from the market, leaving aside tobacco- and menthol-flavored ENDS. More recently, based on additional studies and market data, the FDA has denied the applications of importers and manufacturers to market menthol-flavored ENDS.An importer challenged that denial, arguing that it was arbitrary and capricious for the FDA to apply the same regulatory framework to menthol that it used to assess the appropriateness of sweeter flavors, to ultimately reject its applications for its menthol-flavored ENDS to remain on the market, and to do so without granting a transition period. The Third Circuit denied a petition for review. The FDA applied a regulatory framework consistent with its statutory mandate, provided a reasoned explanation for its denial, and based its decision on scientific judgments that courts may not second-guess. View "Logic Technology Development LLC v. United States Food and Drug Administration" on Justia Law

Former employees of Alternatives, a for-profit hospice provider, sued under the False Claims Act, 31 U.S.C. 3729, alleging that Alternatives submitted claims for Medicare reimbursement despite inadequate documentation in the patients’ medical records supporting hospice eligibility, under 42 C.F.R. 418.22(b)(2). For a patient to be eligible for Medicare hospice benefits, and for a hospice provider to be entitled to reimbursement, a patient must be certified as “terminally ill.” The district court granted Alternatives summary judgment based on lack of materiality, finding “no evidence” that Alternatives’ insufficiently documented certifications "were material to the Government’s decision to pay.” The court reasoned that “[t]he Government could see what was or was not submitted” yet never refused any of Alternatives’ claims, despite the inadequacy or missing supporting documentation or where compliance was otherwise lacking.The Third Circuit vacated. When a government contractor submits a claim for payment but fails to disclose a statutory, regulatory, or contractual violation, that claim does not automatically trigger liability. The Act requires that the alleged violation be “material” to the government’s decision to pay. The Supreme Court has identified factors to assist courts in evaluating materiality. In this case, the court based its decision principally on the government’s continued payments after being made aware of its deficient documentation, overlooking factors that could have weighed in favor of materiality— and despite an open dispute over the government’s “actual knowledge.” View "Druding v. Care Alternatives" on Justia Law

Drug makers participating in Medicare or Medicaid must offer their drugs at a discount to certain “covered entities,” which typically provide healthcare to low-income and rural individuals, 42 U.S.C. 256b, 1396r-8(a)(1), (5) (Section 340B). Initially, few covered entities had in-house pharmacies. A 1996 HHS guidance stated that covered entities could use one outside contract pharmacy each; a 2010 HHS guidance stated that covered entities could use an unlimited number of contract pharmacies. Drug makers thought that contract pharmacies were driving up duplicate discounting and diversion and adopted policies to limit any covered entity’s use of multiple contract pharmacies. A 2020 HHS Advisory Opinion declared that Section 340B required drug makers to deliver discounted drugs to an unlimited number of contract pharmacies.In 2010, Congress told HHS to establish a process for drug makers and covered entities to resolve Section 340B–related disputes. In 2016, HHS issued a notice of proposed rulemaking and accepted comments on the proposed ADR Rule. HHS subsequently listed the proposed rule as withdrawn. In 2020, HHS stated that it had just “paus[ed] action on the proposed rule,” responded to the four-year-old comments. and issued a final ADR Rule.Drug companies sued. The Third Circuit held that Section 340B does not require drug makers to deliver discounted drugs to an unlimited number of contract pharmacies. HHS did not violate the APA by purporting to withdraw the proposed ADR Rule before later finalizing it. View "Sanofi Aventis US LLC v. United States Department of Health and Human Services" on Justia Law

In March 2020, New Jersey Governor Murphy responded to the spread of COVID-19; Executive Order 107 prohibited in-person gatherings and ordered New Jersey residents to “remain home or at their place of residence,” except for certain approved purposes, such as an “educational, political, or religious reason.” EO 107 excepted businesses deemed “essential,” including grocery and liquor stores, which could continue to welcome any number of persons (consistent with social distancing guidelines). Violations of EO 107 were subject to criminal prosecution for “disorderly conduct.” The order granted the Superintendent of the State Police, “discretion to make clarifications and issue [related] orders[.]” He exercised that power, declaring (Administrative Order 2020-4) that gatherings of 10 or fewer persons were presumptively permitted. Neither EO 107 nor AO 2020-4 contained an exception for religious worship gatherings or other First Amendment activity.Two New Jersey-based, Christian congregations, believing that the Bible requires them to gather for in-person worship services, violated the Orders and were cited. Less than a week after the filing of their complaint, challenging the Orders, Governor Murphy raised indoor gathering limits to 50 persons or 25 percent of room capacity (whichever was less), allowing outdoor religious gatherings without any gathering limits. The district court denied the congregations’ motion for a preliminary injunction. The Third Circuit dismissed an appeal as moot. View "Clark v. Governor of New Jersey" on Justia Law

Liquid Labs manufactures and sells e-liquids that generally contain nicotine and flavoring for use in e-cigarettes. The e-liquids qualify as “new tobacco product[s]” under the Family Smoking Prevention and Tobacco Control Act, 21 U.S.C. 387-387u, and may not be introduced into interstate commerce without the FDA’s authorization. The FDA must deny a premarket tobacco product application (PMTA) if the applicant fails to “show[] that permitting such tobacco product to be marketed would be appropriate for the protection of public health,” as determined with respect to the risks and benefits to the population as a whole, including users and non-users of the tobacco product.” FDA Guidelines have highlighted that flavored e-liquids’ had a “disproportionate appeal to children.”Liquid Labs submitted PMTAs covering 20 e-liquid products and submitted a marketing plan setting forth plans to discourage youths from using its products. The FDA denied the PMTAs, concluding that Liquid Labs had not shown that the benefits of the products sufficiently outweighed the risks they posed to youths. The documents indicated that evidence could have been provided through “randomized controlled trial[s] and/or longitudinal cohort stud[ies],” or other evidence that reliably and robustly evaluated the impact of the new flavored vs. tobacco-flavored products on adult smokers’ switching or cigarette reduction over time.” The Third Circuit denied a petition for review. The FDA’s order was within its statutory authorities and the Administrative Procedure Act. View "Liquid Labs LLC v. United States Food and Drug Administration" on Justia Law