Justia Health Law Opinion Summaries

The Association for Accessible Medicines (AAM), representing generic drug manufacturers, challenged a Minnesota law regulating drug prices, Minn. Stat. § 62J.842, arguing it violated the dormant Commerce Clause. The law prohibits manufacturers from imposing excessive price increases on generic or off-patent drugs sold in Minnesota. The district court granted AAM's motion for a preliminary injunction, finding the law likely violated the dormant Commerce Clause.The United States District Court for the District of Minnesota concluded that AAM was likely to succeed on the merits of its claim, faced a threat of irreparable harm, and that the balance of harms and public interest factors were neutral. Minnesota appealed, contesting the likelihood of success on the merits and the balance of harms/public interest.The United States Court of Appeals for the Eighth Circuit reviewed the district court’s ruling for abuse of discretion and its legal conclusions de novo. The court found that the Minnesota law had the impermissible extraterritorial effect of controlling prices outside the state, similar to laws previously struck down by the Supreme Court. The court rejected Minnesota's argument that the law did not control out-of-state prices, noting that it effectively regulated out-of-state transactions if the drugs ended up in Minnesota.The Eighth Circuit affirmed the district court’s decision, agreeing that AAM was likely to succeed on the merits of its dormant Commerce Clause claim. The court also found no abuse of discretion in the district court’s assessment of the balance of harms and public interest, noting that protecting constitutional rights is always in the public interest. The preliminary injunction against the Minnesota law was upheld. View "Ass'n for Accessible Medicines v. Ellison" on Justia Law

SWT Global Supply, Inc. (SWT Global), a Missouri-based manufacturer of electronic nicotine delivery system (ENDS) vaping products, sought review of the U.S. Food and Drug Administration's (FDA) denial of market authorization for its menthol-flavored ENDS products. The FDA denied the premarket tobacco product applications (PMTAs) submitted by SWT Global, citing insufficient evidence that the products would benefit adult users enough to outweigh the risks to youth.The FDA's decision was based on the Family Smoking Prevention and Tobacco Control Act of 2009, which requires new tobacco products to receive FDA authorization before being sold. The FDA determined that SWT Global's PMTAs lacked product-specific evidence demonstrating that the menthol-flavored ENDS products would attract adults away from combustible cigarettes and reduce overall harm. The FDA also found SWT Global's marketing plan insufficient to prevent youth access to the products.The United States Court of Appeals for the Eighth Circuit reviewed the case. SWT Global argued that the FDA's denial was arbitrary and capricious, claiming the FDA changed its position on the required scientific evidence and failed to justify its finding that the marketing plan was insufficient. The court referenced the Supreme Court's decision in Food & Drug Administration v. Wages & White Lion Investments, L.L.C., which held that the FDA's denial of PMTAs for flavored ENDS products was consistent with its guidance and did not violate the change-in-position doctrine.The Eighth Circuit found that the FDA did not change its position regarding the scientific evidence required for PMTAs and provided a satisfactory explanation for its decision. The court also determined that the FDA's treatment of menthol-flavored ENDS products was reasonable and consistent with its approach to other non-tobacco-flavored ENDS products. Consequently, the court denied SWT Global's petition for review. View "SWT Global Supply, Inc. v. U.S. Food & Drug Administration" 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

On March 15, 2022, law enforcement responded to a drug overdose in Rapid City, South Dakota, where they found K.S. conscious but sluggish after receiving Narcan. Officers suspected two individuals, including a woman with purple hair, of distributing fentanyl to K.S. Surveillance at a hotel led to a traffic stop of a red Ford Fiesta, where officers found Anthony Ward in the backseat. Ward was arrested for false impersonation after providing false names. A search of the vehicle revealed drugs, a stolen gun, and cash. Ward was charged with distribution of a controlled substance resulting in serious bodily injury and conspiracy to distribute fentanyl.The United States District Court for the District of South Dakota denied Ward's motions to suppress evidence from the traffic stop and to dismiss the indictment for failure to preserve evidence. After a five-day trial, the jury convicted Ward on both counts, and the court imposed concurrent 360-month sentences. Ward appealed the district court's decisions.The United States Court of Appeals for the Eighth Circuit reviewed the case. The court upheld the district court's denial of Ward's motions to suppress and dismiss, finding no unreasonable extension of the traffic stop and no bad faith in the handling of evidence. The court also found sufficient evidence to support Ward's convictions. The court concluded that the evidence showed Ward distributed fentanyl that caused K.S.'s serious bodily injury and that Ward was involved in a conspiracy to distribute fentanyl. The judgment of the district court was affirmed. View "United States v. Ward" on Justia Law

The case involves Elaine Neidig, who had three mammograms at Valley Health System's Winchester Medical Center between 2016 and 2019. In 2019, the FDA found that some mammograms performed at the facility had serious image quality deficiencies. Neidig received a notification from Valley Health about these issues and subsequently filed a class action lawsuit alleging that Valley Health misrepresented the quality of its mammography services. She claimed that the mammograms were worthless and sought economic damages, including statutory damages for consumer protection violations, compensatory damages, and contract damages. Neidig did not claim any physical or emotional injury.The United States District Court for the Northern District of West Virginia dismissed Neidig's complaint, ruling that her claims fell under the West Virginia Medical Professional Liability Act (MPLA) and were barred by the MPLA’s statute of limitations. The court found that the MPLA applied because the claims were related to health care services, despite Neidig's argument that her claims were purely economic and not based on physical or emotional injury.The United States Court of Appeals for the Fourth Circuit certified a question to the Supreme Court of Appeals of West Virginia, asking whether the MPLA applies to claims where the plaintiff disclaims any form of physical or emotional injury. The Supreme Court of Appeals of West Virginia reformulated the question to ask whether the MPLA applies when the plaintiff claims only economic damages and disclaims all liability based on physical injury, emotional injury, or death.The Supreme Court of Appeals of West Virginia held that the MPLA does not apply to a suit against a health care provider or health care facility when the plaintiff claims only economic damages and disclaims all liability based on physical injury, emotional injury, or death. The court emphasized that the MPLA requires a predicate claim arising from the death or injury of a person, and since Neidig's claims were solely for economic damages, the MPLA did not apply. View "Neidig v. Valley Health System" on Justia Law

Employees of United Airlines, including pilots, flight attendants, and other staff, challenged the company's COVID-19 vaccination mandate and masking requirement issued in 2021. United required employees to either get vaccinated or apply for religious or medical exemptions by specific deadlines. Plaintiffs alleged that despite submitting or attempting to submit exemption requests, they were either fired, placed on unpaid leave, or subjected to a hostile work environment.The United States District Court for the Northern District of Illinois dismissed the plaintiffs' claims with prejudice, finding that they had not stated any viable claim for relief despite having sufficient opportunities to do so. The court addressed each of the plaintiffs' twelve claims, noting that many were forfeited due to the plaintiffs' failure to respond to substantive arguments. The court also found deficiencies in the proposed amended complaints and ultimately dismissed the action with prejudice after determining that further amendments would be futile.The United States Court of Appeals for the Seventh Circuit reviewed the case and affirmed the district court's decision. The appellate court agreed that the plaintiffs' claims were either improperly preserved or inadequately pled. The court found that the plaintiffs had forfeited their FDCA, invasion of privacy, and negligence claims by failing to address the district court's findings of forfeiture. The court also upheld the dismissal of the Illinois Whistleblower Act claim, as the plaintiffs did not show how receiving a COVID-19 vaccine would violate federal regulations. Additionally, the court affirmed the dismissal of the Title VII claims due to the plaintiffs' failure to obtain right-to-sue letters from the EEOC, which is a prerequisite for such lawsuits. The appellate court concluded that the district court did not err in denying further opportunities to amend the complaint. View "Anderson v. United Airlines" on Justia Law

Abigail Stratton filed a petition with the Office of Special Masters under the National Childhood Vaccine Injury Act, alleging that the Gardasil® vaccine caused her to develop postural orthostatic tachycardia syndrome (POTS) and autonomic dysfunction. These conditions are not listed in the Vaccine Injury Table, requiring her to prove actual causation by a preponderance of the evidence. After filing a Notice of Intent to Withdraw to pursue her claim in federal district court, the Chief Special Master concluded the proceedings on the merits and later awarded her partial attorneys’ fees and costs.The Secretary of Health and Human Services opposed the fee application, arguing that Stratton did not file her petition with the good faith intent of litigating the claim and that there was no reasonable basis for her claim. The Chief Special Master found that Stratton had satisfied both the good faith and reasonable basis requirements and awarded partial fees. The Court of Federal Claims affirmed the Chief Special Master’s decision, concluding that the finding of a reasonable basis was not arbitrary and capricious, and awarded $8,876.86 for attorneys’ fees and costs. The Secretary appealed this decision.The United States Court of Appeals for the Federal Circuit reviewed the case and found that the Chief Special Master failed to adequately explain the determination that Stratton’s petition had a reasonable basis. The court noted that the Chief Special Master acknowledged the Secretary’s concerns about the sufficiency of the medical records but dismissed them without sufficient explanation. The Federal Circuit vacated the decision and remanded the case for further proceedings consistent with its opinion, requiring a more detailed explanation of why the evidence provided a reasonable basis for Stratton’s claim. View "Stratton v. Health and Human Services" on Justia Law

Quintan Cockerell, a marketer for two compounding pharmacies, was convicted for receiving illegal kickbacks as part of a conspiracy to induce physicians to prescribe highly lucrative prescriptions. These pharmacies, including Xpress Compounding, focused on formulating expensive topical creams, resulting in significant reimbursements from federal insurers like TRICARE. Cockerell was involved in recruiting physicians, developing new formulas, and receiving commissions disguised as payments to his then-wife. He also provided financial incentives to physicians, including lavish vacations and investment opportunities, to encourage them to prescribe these creams.The United States District Court for the Northern District of Texas convicted Cockerell of violating the Anti-Kickback Statute, conspiracy, and money laundering. He was sentenced to 29 months of imprisonment, two years of supervised release, and ordered to pay $59,879,871 in restitution. Cockerell appealed, challenging the sufficiency of the evidence, alleged misstatements of law by the Government during trial, and the restitution order.The United States Court of Appeals for the Fifth Circuit reviewed the case and found that a reasonable jury could have convicted Cockerell based on the evidence presented. The court held that the Government provided sufficient evidence of Cockerell's involvement in the illegal kickback scheme and his intent to influence physicians. The court also found no reversible error in the Government's statements during closing arguments and upheld the restitution order, noting that Cockerell failed to provide evidence of legitimate services to offset the loss amount. Consequently, the Fifth Circuit affirmed the district court's judgment. View "United States v. Cockerell" on Justia Law

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

T.M. has a medical condition that causes psychosis when she ingests gluten. After an episode in 2023, she was involuntarily committed to Baltimore Washington Medical Center. Despite her and her father's request for voluntary admission, an administrative hearing led to her involuntary commitment. A clinical review panel approved forcibly injecting T.M. with antipsychotic medication, a decision affirmed by a Maryland administrative law judge. T.M. and the medical center later reached an oral agreement for her release, which was formalized in a consent order by a state court. The consent order required T.M. to follow certain conditions, including taking prescribed medications and dismissing other lawsuits.The United States District Court for the District of Maryland dismissed T.M.'s claims, citing the Rooker-Feldman doctrine, which prevents federal courts from reviewing state court judgments. The court found it lacked subject matter jurisdiction over T.M.'s claims and dismissed the parents' claims for failure to state a claim. T.M.'s claims were dismissed with prejudice, while the parents' claims were dismissed without prejudice.The United States Court of Appeals for the Fourth Circuit affirmed the district court's dismissal of T.M.'s claims for lack of subject matter jurisdiction under the Rooker-Feldman doctrine. The court held that T.M. was a state court loser seeking to overturn a state court judgment, which is barred by the doctrine. The court vacated the dismissal with prejudice and remanded with instructions to modify the judgment to dismiss T.M.'s claims without prejudice. The court also affirmed the dismissal of the parents' claims for failure to state a claim, noting that the complaint did not allege a violation of their First Amendment rights. View "T.M. v. University of Maryland Medical System Corporation" on Justia Law