Justia Health Law Opinion Summaries
SOUTH COAST SPECIALTY SURGERY CENTER, INC. V. BLUE CROSS OF CALIFORNIA
In this case, the United States Court of Appeals for the Ninth Circuit reversed the district court's dismissal of an ERISA action brought by South Coast Specialty Surgery Center, Inc. against Blue Cross of California, d/b/a Anthem Blue Cross.South Coast, a healthcare provider, sought reimbursement from Blue Cross for the costs of medical services provided to its patients. South Coast argued that although it was not a plan participant or a beneficiary under ERISA, it had the right to enforce ERISA's protections directly because its patients had assigned it the right to sue for the non-payment of plan benefits via an "Assignment of Benefits" form. The district court disagreed and dismissed South Coast's suit, concluding that the form only conveyed the right to receive direct payment from Anthem, and not the right to sue for non-payment of plan benefits.The Ninth Circuit held that a healthcare provider can enforce ERISA's protections if it has received a valid assignment of rights. The court determined that South Coast's patients had effectuated a valid assignment through the "Assignment of Benefits" form. Therefore, South Coast had the right to seek payment of benefits and to sue for non-payment. The court reversed the lower court's decision and remanded the case for further proceedings. View "SOUTH COAST SPECIALTY SURGERY CENTER, INC. V. BLUE CROSS OF CALIFORNIA" on Justia Law
Sarmiento v. Super. Ct.
This case concerns a defendant, Jeanette Sarmiento, who requested mental health diversion after being charged with attempted robbery. Sarmiento suffers from posttraumatic stress disorder (PTSD), major depressive disorder, and stimulant use disorder, all of which have never been treated. Despite meeting many of the requirements for diversion, her request was denied by the Superior Court of San Diego County due to her history of drug abuse and the court's conclusion that she posed an unreasonable risk of danger to the public.Sarmiento sought a writ of mandate from the Court of Appeal, Fourth Appellate District Division One, State of California. The court determined that her past failures in drug treatment did not predict her response to mental health treatment, since her underlying mental health conditions, which were the core of her substance abuse issues, were never previously addressed. The court also found that the trial court's concern about Sarmiento's lack of success in past attempts at substance abuse treatment did not support the finding that the recommended treatment would not meet her specialized needs. Further, the court found that the trial court misapplied the statutory criteria in determining that residual concerns for public safety could justify the denial of diversion.Given these findings, the Court of Appeal granted the writ and directed the Superior Court to approve Sarmiento's request for mental health diversion. The court emphasized that the purpose of mental health diversion is to treat individuals with mental disorders in order to prevent them from entering and reentering the criminal justice system, and to protect public safety. The court concluded that the trial court's decision failed to follow the Legislature's direction to focus less on Sarmiento's past and more on the promise of her future and that of her community. View "Sarmiento v. Super. Ct." on Justia Law
Gilead Tenofovir Cases
This case involves a pharmaceutical manufacturer, Gilead Life Sciences, Inc., and its development and sale of a drug, tenofovir disoproxil fumarate (TDF), to treat HIV/AIDS. The approximately 24,000 plaintiffs allege that they suffered adverse effects from TDF, including skeletal and kidney damage. Gilead developed a similar but chemically distinct drug, tenofovir alafenamide fumarate (TAF), which could potentially treat HIV/AIDS with fewer side effects. The plaintiffs claim that Gilead delayed the development of TAF to maximize profits from TDF.The plaintiffs do not claim that TDF is defective. Instead, they assert a claim for ordinary negligence, arguing that Gilead's decision to delay the development of TAF breached its duty of reasonable care to users of TDF. They also assert a claim for fraudulent concealment, arguing that Gilead had a duty to disclose information about TAF to users of TDF.The Court of Appeal of the State of California, First Appellate District, Division Four, partially granted Gilead's petition for a writ of mandate and held that the plaintiffs could proceed with their negligence claim. The court concluded that a manufacturer's legal duty of reasonable care can extend beyond the duty not to market a defective product. However, the court reversed the trial court's decision denying Gilead's motion for summary adjudication of the plaintiffs' claim for fraudulent concealment. The court held that Gilead had no duty to disclose information about TAF to users of TDF, as TAF was not available as an alternative treatment at the time. View "Gilead Tenofovir Cases" on Justia Law
Neidig v. Valley Health System
Elaine Neidig, individually and on behalf of a class, sued Valley Health System, a health care provider, for unfair and deceptive practices, unjust enrichment, and breach of contract. Neidig had received three mammograms at Valley Health's Winchester Medical Center between March 2016 and June 2019. In July 2019, federal inspectors found that the center's staff were not correctly positioning or compressing women's breasts during mammograms, leading to serious image quality deficiencies. Valley Health then had to alert all at-risk patients, including Neidig, of the mammography quality problems. Neidig, who did not allege any physical or emotional harm resulting from the low-quality mammograms, sued Valley Health in August 2022. Valley Health moved to dismiss the case on the basis that it was filed beyond the two-year statute of limitations provided by the West Virginia Medical Professional Liability Act. The United States District Court for the Northern District of West Virginia agreed with Valley Health and dismissed Neidig's claims as untimely. Neidig appealed the decision to the United States Court of Appeals for the Fourth Circuit.Upon review, the Fourth Circuit concluded that the case presented a novel issue of state law that needed to be addressed by the Supreme Court of Appeals of West Virginia. The issue was whether a plaintiff's claims can fall under the West Virginia Medical Professional Liability Act if the plaintiff does not claim any form of physical or emotional injury. The Fourth Circuit certified this question to the Supreme Court of Appeals of West Virginia for resolution. View "Neidig v. Valley Health System" on Justia Law
United States v. O’Lear
In the case before the United States Court of Appeals for the Sixth Circuit, the defendant, Thomas O’Lear, was convicted of healthcare fraud, making a false statement in connection with healthcare services, and aggravated identity theft. O’Lear ran a company that provided mobile x-ray services to residents in nursing homes. However, he used the company to defraud Medicare and Medicaid programs by billing for fictitious x-rays using the identities of nursing-home residents. When an audit revealed the fraud, O’Lear attempted to conceal it by forging staff names and duplicating x-rays in the patient files.On appeal, O’Lear raised several questions. Firstly, he questioned whether his Sixth Amendment right to an impartial jury was violated by excluding individuals who had not been vaccinated against COVID-19 from the jury pool. The court ruled that the unvaccinated do not qualify as a “distinctive group” that can trigger Sixth Amendment concerns. Secondly, O’Lear questioned whether the nursing-home residents were “victims” of his fraud under a “vulnerable victims” sentencing enhancement, even though the monetary losses were suffered by Medicare and Medicaid. The court ruled that the residents were indeed victims, as O’Lear had used their identities and health records without their permission, which constituted taking advantage of them.O’Lear also challenged his two aggravated-identity-theft convictions and objected to his 180-month sentence on various grounds, but these arguments were also dismissed by the court. Ultimately, the court affirmed O’Lear's conviction and sentence. View "United States v. O'Lear" on Justia Law
Meyers v. State Health Benefits Commission
The Supreme Court of New Jersey affirmed the judgment of the Appellate Division in a case concerning the New Jersey State Health Benefits Program Act. The case was brought by James Meyers, a retired state police officer, who challenged the State Health Benefits Commission's (SHBC) decision that he was not exempt from health benefits premium-sharing obligations imposed by the Act. The Act requires public employees to contribute towards the cost of their healthcare benefits upon retirement, with an exemption for employees who had 20 or more years of creditable service in a state or locally administered retirement system as of June 28, 2011. Meyers had 17 years and 9 months of creditable service at that time. Upon his retirement in 2015, he was erroneously offered retiree health benefits at no premium cost. This mistake was discovered in 2017, and the state began deducting premium-sharing contributions from his pension payments.The Court held that Meyers was not eligible for the exemption under the Act, and correcting the erroneous exemption was proper. The court found that neither Meyers' subsequent service nor his purchase of four years of military service credit could change the fact that he did not meet the Act's requirement as of June 28, 2011. The court also agreed with the Appellate Division's determination that it was not necessary to reach the issue of equitable estoppel. The court noted that a governmental entity cannot be estopped from refusing to take an action that it was never authorized to take under the law, even if it had mistakenly agreed to that action. In this case, the SHBC was never authorized to offer Meyers free healthcare benefits, an act beyond the jurisdiction of the SHBC and therefore ultra vires in the primary sense. Thus, the doctrine of equitable estoppel did not apply. View "Meyers v. State Health Benefits Commission" on Justia Law
US v. Evans
The defendant, Rodriquies Evans, was convicted of four criminal offenses related to his involvement in a multistate conspiracy to transport and distribute methamphetamine and other controlled substances. The district court sentenced him to the statutory maximum of 80 years in prison. The Fourth Circuit United States Court of Appeals found that the district court had erred in calculating Evans’s Sentencing Guidelines range and vacated his sentence, remanding the case for resentencing. The court determined that the district court had incorrectly attributed nearly three kilograms of crystal methamphetamine seized from a co-conspirator to Evans. The court held that for sentencing purposes under the Sentencing Guidelines, only acts that fall within the scope of the criminal activity the defendant agreed to jointly undertake can be considered relevant conduct. The district court had attributed the drugs based on the broader standard of substantive liability under Pinkerton, which allows a defendant to be held liable for the acts of co-conspirators if they are within the scope of the overall conspiracy and reasonably foreseeable to the defendant. The court also found that the district court had erred in applying a threat enhancement in calculating Evans's Sentencing Guidelines range, as the possession of a firearm enhancement could not by itself be the basis for a threat enhancement. View "US v. Evans" on Justia Law
Wages and White Lion Invest v. FDA
In the case of Wages and White Lion Investments, L.L.C., doing business as Triton Distribution; Vapetasia, L.L.C., versus the Food & Drug Administration, the court found that the FDA acted arbitrarily and capriciously in its denial of Premarket Tobacco Product Applications (PMTAs) for flavored e-cigarette products.The petitioners, Triton Distribution and Vapetasia, are manufacturers of flavored e-cigarette liquids. They filed PMTAs for their products, as required by the Family Smoking Prevention and Tobacco Control Act, which prohibits the sale of any “new tobacco product” without authorization from the FDA. The FDA, after issuing detailed guidance on the information it required for approval of e-cigarette products, subsequently denied all flavored e-cigarette applications, including those of the petitioners, on the grounds that they failed to predict new testing requirements imposed by the FDA without notice.The court found that the FDA had failed to provide the manufacturers with fair notice of the rules, had not acknowledged or explained its change in position, and had ignored the reasonable and serious reliance interests that manufacturers had in the pre-denial guidance. Furthermore, the FDA attempted to cover up its mistakes with post hoc justifications at oral argument.As a result, the court granted the petitions for review, set aside the FDA's marketing denial orders, and remanded the matters to the FDA. The court rejected FDA's argument that even if it arbitrarily and capriciously denied petitioners’ applications, that error was harmless, stating that the harmless error doctrine is narrow and does not apply to discretionary administrative decisions. The court also rejected FDA's contention that it gave manufacturers fair notice of their obligations to perform long-term scientific studies in its pre-denial guidance documents. View "Wages and White Lion Invest v. FDA" on Justia Law
Raper v. Commissioner of Social Security
In this appeal, Marcus Raper contested the Social Security Administration’s (SSA) 2020 denial of his claim for disability insurance benefits. Raper raised three arguments: (1) that the administrative law judge's (ALJ) initial lack of constitutional appointment under the Appointments Clause tainted his later constitutionally appointed review of his case, (2) that the ALJ failed to clearly articulate good cause for not fully crediting his treating physician’s medical opinion, and (3) that the ALJ wrongly discredited his subjective complaints of pain by not properly considering evidence other than objective medical evidence.The United States Court of Appeals for the Eleventh Circuit affirmed the lower court’s decision. First, the court found no Appointments Clause violation as the ALJ's initial decision, made when he was unconstitutionally appointed, had been vacated on the merits and the case was remanded to the same ALJ who was then constitutionally appointed. Second, the court held that the ALJ articulated good cause for discounting Raper's treating physician’s opinion, finding the opinion inconsistent with the record. Lastly, the court found that the ALJ had properly considered Raper’s subjective complaints in light of the record as a whole and adequately explained his decision not to fully credit Raper’s alleged limitations on his ability to work. View "Raper v. Commissioner of Social Security" on Justia Law
Texas v. Becerra
In a case involving the State of Texas, the American Association of Pro-Life Obstetricians & Gynecologists, and the Christian Medical & Dental Associations as plaintiffs, and the United States Department of Health and Human Services (HHS), its Secretary Xavier Becerra, the Centers for Medicare and Medicaid Services (CMS), and other officials as defendants, the United States Court of Appeals for the Fifth Circuit affirmed the district court's decision. The plaintiffs challenged HHS's guidance on the Emergency Medical Treatment and Active Labor Act (EMTALA), which they alleged mandated providers to perform elective abortions beyond HHS's authority and contrary to state law. The plaintiffs sought to enjoin the enforcement of this guidance. The district court granted the injunction within Texas or against any member of a plaintiff organization, and HHS appealed.The Court of Appeals held that the HHS guidance constituted a final agency action as it binds HHS to a particular legal position and has clear legal consequences should a physician or hospital violate it. The court found that HHS's guidance exceeds the statutory language of EMTALA, which does not mandate any specific type of medical treatment, let alone abortion care. The court also held that HHS was required to subject the guidance to notice and comment as it "establishes or changes a substantive legal standard." The court affirmed the injunction, finding it not overbroad, but rather tailored based on the parties, issues, and evidence before it. View "Texas v. Becerra" on Justia Law