Justia Health Law Opinion Summaries

Vanda Pharmaceuticals, Inc. sought fast track designation from the FDA for its investigational drug, tradipitant, intended to treat gastroparesis. The FDA denied the request, citing a partial clinical hold on the drug due to the lack of long-term animal studies to assess its toxicological effects. Vanda argued that the FDA's denial was arbitrary, capricious, and contrary to law.The United States District Court for the District of Columbia granted summary judgment in favor of the FDA, upholding the agency's decision. Vanda then appealed to the United States Court of Appeals for the District of Columbia Circuit.The Court of Appeals affirmed the District Court's decision, holding that the FDA's denial of Vanda's fast track application was neither contrary to law nor arbitrary and capricious. The court found that the FDA properly considered the drug's development plan, including the clinical hold, in assessing whether tradipitant demonstrated the potential to address unmet medical needs. The court also noted that the FDA's definition of the unmet medical need as long-term treatment of gastroparesis symptoms was reasonable, given the chronic nature of the condition and the existing short-term treatment options. The court rejected Vanda's arguments that the FDA's decision was inconsistent with its prior positions and that the agency improperly considered the clinical hold. The court concluded that the FDA's decision was supported by a rational connection between the facts found and the choice made. View "Vanda Pharmaceuticals, Inc. v. FDA" on Justia Law

Dr. Susan Neese and Dr. James Hurly, both doctors in Amarillo, Texas, filed a pre-enforcement challenge against the Department of Health and Human Services (HHS) regarding the Notification of Interpretation and Enforcement of Section 1557 of the Affordable Care Act and Title IX of the Education Amendments of 1972. The Notification, issued in May 2021, interprets the prohibition on sex discrimination to include discrimination based on sexual orientation and gender identity. The plaintiffs, who are unwilling to provide certain gender-affirming care, feared that their medical practices might be viewed as discriminatory under the Notification, potentially leading to enforcement actions and loss of federal funding.The United States District Court for the Northern District of Texas granted summary judgment in favor of the plaintiffs. The district court found that the plaintiffs had standing to challenge the Notification and ruled in their favor.The United States Court of Appeals for the Fifth Circuit reviewed the case and determined that the plaintiffs lacked Article III standing. The court found that the plaintiffs had not demonstrated how their conduct constituted gender-identity discrimination under any plausible interpretation of the Notification. The plaintiffs did not view their own practices as discriminatory, nor did they provide evidence that HHS would view them as such. Additionally, there was no indication that an enforcement proceeding was imminent. As a result, the Fifth Circuit vacated the district court's judgment and remanded the case with instructions to dismiss the plaintiffs' claims for lack of jurisdiction. View "Neese v. Becerra" on Justia Law

Randell Shepherd, a career coal miner, filed a claim for benefits under the Black Lung Benefits Act (BLBA), invoking the Act’s presumption that he was entitled to benefits due to his over fifteen years of mining and total disability from chronic obstructive pulmonary disease (COPD), bronchitis, and emphysema. Incoal, Inc., Shepherd’s most recent employer, contested his entitlement, arguing that his disability was caused by smoking, not mining. An administrative law judge (ALJ) found Incoal’s expert opinions unpersuasive and inconsistent with the Act’s regulations and preamble, which recognize pneumoconiosis as a latent and progressive disease. The ALJ ruled that Incoal failed to rebut the presumption that Shepherd was entitled to benefits. The Benefits Review Board (BRB) affirmed the ALJ’s decision.Incoal petitioned the United States Court of Appeals for the Sixth Circuit for review, arguing that the ALJ improperly relied on the regulatory preamble over their evidence and that the presumption was effectively irrebuttable, violating the Constitution and the Administrative Procedure Act (APA). The court reviewed the case de novo, focusing on whether the ALJ’s decision was supported by substantial evidence and correctly applied the law.The Sixth Circuit held that the ALJ was entitled to reference the preamble to assess the credibility of expert opinions and found that the ALJ’s decision was supported by substantial evidence. The court noted that the BLBA’s rebuttable presumption is constitutional, as it is based on a rational relationship between the length of a miner’s career and the risk of pneumoconiosis. The court concluded that Incoal’s arguments were unpersuasive and that the ALJ applied the correct legal principles. Consequently, the court denied Incoal’s petition for review. View "Incoal, Inc. v. OWCP" on Justia Law

The Montana State Legislature passed Senate Bill 99 (SB 99) in 2023, which prohibits the use of medications and surgeries to treat gender dysphoria in minors. The bill aims to protect minors from receiving harmful, experimental treatments and imposes professional consequences on healthcare providers who violate its provisions. Plaintiffs, including a transgender minor receiving treatment banned by SB 99, their parents, and healthcare providers, filed a lawsuit seeking declaratory and injunctive relief, arguing that SB 99 violates their constitutional rights to privacy and equal protection.The District Court of the Fourth Judicial District granted a preliminary injunction, temporarily enjoining SB 99. The court found that the plaintiffs had standing to challenge the bill and demonstrated a likelihood of success on the merits of their privacy claim. The court applied the Armstrong standard, which protects an individual's right to obtain lawful medical procedures from licensed healthcare providers unless the state can demonstrate a bona fide health risk. The court concluded that the state did not clearly and convincingly show that the treatments proscribed by SB 99 posed such a risk.The Supreme Court of the State of Montana reviewed the case and affirmed the District Court's decision. The court held that the plaintiffs had established a prima facie case of a violation of their right to privacy and demonstrated a likelihood of irreparable harm if the injunction were not granted. The court also found that the balance of equities and public interest favored the plaintiffs, as the potential harm to minors with gender dysphoria outweighed the state's interests. The preliminary injunction was upheld, allowing the case to proceed to trial for a final determination on the constitutional issues. View "Cross v. State" on Justia Law

A group of 53 California hospitals challenged the Secretary of Health and Human Services' (HHS) 2020 low-wage-index policy, which adjusted Medicare payment rates by inflating the rates for the lowest quartile of hospitals and reducing payments to all hospitals by a small percentage. The hospitals argued that the policy violated statutory provisions, was arbitrary and capricious, resulted from a faulty administrative procedure, and was unsupported by evidence.The United States District Court for the Central District of California denied HHS's motion for summary judgment, granted the hospitals' motion for summary judgment, and remanded the matter to the Secretary without vacating the policy. The court held that HHS lacked authority to implement the low-wage-index policy under either the Wage Index Provision or the Exceptions and Adjustments Provision and found procedural defects in the policy's implementation.The United States Court of Appeals for the Ninth Circuit affirmed the district court's holding that the Secretary exceeded his statutory authority in establishing the 2020 wage index. The court held that the low-wage-index policy did not "reflect" area differences in hospital wage levels as required by the statute and that the Exceptions and Adjustments Provision could not independently authorize the policy. The court also vacated the district court's decision to remand the case without vacating the policy, stating that when an agency cannot issue the challenged policy in another way, the only appropriate remedy is vacatur. Judge Nguyen dissented, arguing that the low-wage-index policy was consistent with the statutory text and that the majority's decision would have negative repercussions for vulnerable communities. View "Kaweah Delta Health Care District v. Becerra" on Justia Law

Sekhar Rao was involved in a scheme to defraud TRICARE, a federal health benefit plan, by ordering medically unnecessary toxicology and DNA cancer screening tests. These tests were billed to TRICARE through a shell company, ADAR Group, LLC, which set up fraudulent testing sites. Rao, a physician, was hired to sign off on these tests without reviewing patient medical information or meeting the patients. He was paid per test ordered. The scheme involved using a signature stamp of Rao’s signature to sign requisition forms, which Rao allegedly knew about and consented to.In the United States District Court for the Northern District of Texas, Rao was acquitted of conspiracy to commit health care fraud but was convicted of two counts of substantive health care fraud related to specific fraudulent claims submitted to TRICARE. The district court sentenced him to 48 months of imprisonment, followed by three years of supervised release, and calculated the loss amount under the United States Sentencing Guidelines based on the intended loss.The United States Court of Appeals for the Fifth Circuit reviewed the case. Rao raised three issues on appeal: the sufficiency of the evidence for his convictions, the exclusion of testimony regarding statements made to him by the scheme’s leader about legal vetting, and the calculation of the loss amount under the Sentencing Guidelines. The Fifth Circuit found no reversible error in the district court’s decisions. The court held that there was sufficient evidence for a reasonable jury to conclude that Rao caused the submission of the fraudulent claims and that he knew about and authorized the use of his signature stamp. The court also held that the district court did not plainly err in excluding the testimony about legal vetting and did not err in calculating the intended loss amount. The Fifth Circuit affirmed Rao’s convictions and sentence. View "United States v. Rao" on Justia Law

Galderma Laboratories, L.P. and TCD Royalty Sub LP (collectively, Galderma) own and market Oracea®, a doxycycline-based treatment for rosacea. They hold U.S. Patent Nos. 7,749,532 and 8,206,740 (the Asserted Patents), which cover a specific formulation of doxycycline. Lupin Inc. and Lupin Ltd. (collectively, Lupin) filed an abbreviated new drug application (ANDA) to market a generic version of Oracea®, claiming bioequivalence. Galderma sued Lupin for patent infringement under the Hatch-Waxman Act, asserting that Lupin’s product infringed the Asserted Patents.The United States District Court for the District of Delaware held a three-day bench trial and found that Lupin’s ANDA product did not infringe the Asserted Patents. The court concluded that Galderma failed to prove that Lupin’s product met the specific formulation requirements of the Asserted Patents, particularly the immediate release (IR) and delayed release (DR) portions of doxycycline. The court also found that Galderma did not demonstrate infringement under the doctrine of equivalents.The United States Court of Appeals for the Federal Circuit reviewed the case. Galderma argued that the district court erred in disregarding dissolution test data from Lupin’s ANDA, admitting evidence from a rebuttal batch, imposing additional claim limitations, and not finding infringement under the doctrine of equivalents. The Federal Circuit found no clear error in the district court’s findings. It held that the district court correctly determined that the two-stage dissolution test did not represent in vivo behavior and that Galderma did not prove its theory of infringement. The court also found no abuse of discretion in admitting the rebuttal batch evidence and no imposition of additional claim limitations. Finally, the court upheld the district court’s finding that Galderma did not prove infringement under the doctrine of equivalents.The Federal Circuit affirmed the district court’s decision, concluding that Lupin’s ANDA product did not infringe the Asserted Patents. View "Galderma Laboratories, L.P. v. Lupin, Inc." on Justia Law

Kathan Daniel Wiley was convicted of conspiracy to distribute fentanyl and possession with intent to distribute fentanyl resulting in serious bodily injury. On October 30, 2021, Wiley's 18-month-old child ingested fentanyl pills, leading to severe health issues but ultimately surviving. Wiley had been distributing fentanyl pills for months, and evidence showed he obtained the pills shortly before the incident. The jury found him guilty on both counts, and the district court sentenced him to 240 months for the conspiracy charge and 324 months for possession with intent to distribute, to be served concurrently.The United States District Court for the Southern District of Iowa denied Wiley's motion for judgment of acquittal. Wiley appealed, arguing insufficient evidence for the conspiracy charge, claiming his possession was to support his addiction rather than for distribution. He also contended that the evidence did not support the conviction for possession with intent to distribute resulting in serious bodily injury, asserting the fentanyl ingested by his child was intended for personal use.The United States Court of Appeals for the Eighth Circuit reviewed the sufficiency of the evidence de novo, affirming the district court's decision. The court held that the evidence, including Facebook messages and testimony, supported the jury's finding of a conspiracy and intent to distribute. The court also upheld the district court's application of a four-level enhancement under U.S.S.G. § 2D1.1(b)(13) for misrepresenting the substance as another drug. Additionally, the court found no abuse of discretion in the district court's consideration of the § 3553(a) factors, affirming the 324-month sentence as substantively reasonable. The judgment was affirmed. View "United States v. Wiley" on Justia Law

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

James Lowe appealed a decision by Workforce Safety and Insurance (WSI) regarding the denial of his request for continued opioid medication exceeding 90 Morphine Milligram Equivalents (MME) daily. Lowe argued that WSI abused its discretion in denying his request for approval of the medication.The District Court of McKenzie County, Northwest Judicial District, reviewed the case and affirmed WSI's decision. The court found that WSI had not acted arbitrarily, unreasonably, or capriciously in its decision-making process. The court also noted that Lowe's medical provider had not provided sufficient documentation to support the medical necessity for exceeding the 90 MME limit, as required by the new law effective July 1, 2022.The Supreme Court of North Dakota reviewed the case and upheld the lower court's decision. The court found that WSI had conducted a full review of Lowe's request and had properly applied the guidelines governing long-term opioid pain management. The court concluded that WSI did not abuse its discretion in denying Lowe's request for continued opioid medication in excess of 90 MME daily. The court affirmed the district court judgment affirming the managed care binding dispute resolution decision by WSI. View "Lowe v. Workforce Safety and Insurance" on Justia Law