Justia Health Law Opinion Summaries

A case involving Lebanon County Employees' Retirement Fund and Teamsters Local 443 Health Services & Insurance Plan, as plaintiffs-appellants, and Steven H. Collis, Richard W. Gochnauer, Lon R. Greenberg, Jane E. Henney, M.D., Kathleen W. Hyle, Michael J. Long, Henry W. McGee, Ornella Barra, D. Mark Durcan, and Chris Zimmerman, as defendants-appellees, was heard by the Supreme Court of the State of Delaware. The plaintiffs, shareholders in AmerisourceBergen Corporation, brought a derivative complaint against the directors and officers of the Corporation alleging that they failed to adopt, implement, or oversee reasonable policies and practices to prevent the unlawful distribution of opioids. The plaintiffs claimed that this led to AmerisourceBergen incurring liability exceeding $6 billion in a 2021 global settlement related to the Company's role in the opioid epidemic. The Court of Chancery of the State of Delaware initially dismissed the complaint, basing its decision on a separate federal court finding that AmerisourceBergen had complied with its anti-diversion obligations under the Controlled Substances Act. However, the Supreme Court of the State of Delaware reversed the Court of Chancery's dismissal of the complaint, ruling that the lower court had erred in considering the federal court's findings as it changed the date at which demand futility should be considered and violated the principles of judicial notice. The case was remanded for further proceedings. View "Lebanon County Employees' Retirement Fund v. Collis" on Justia Law

Former executives of medical device manufacturer Acclarent, Inc., William Facteau and Patrick Fabian, were found guilty of multiple misdemeanor violations of the Federal Food, Drug, and Cosmetic Act (FDCA) for commercially distributing an adulterated and misbranded medical device. They appealed their convictions, claiming First Amendment violations, due process violations, and insufficiency of evidence. The United States Court of Appeals for the First Circuit rejected all of these claims and affirmed the convictions. The court held that the use of promotional speech as evidence of a device's intended use did not implicate the First Amendment. The court also found that the term "intended use" was not unconstitutionally vague and that Facteau and Fabian had fair warning of the conduct prohibited under the FDCA. Finally, the court found that the evidence was sufficient to support the convictions and that Fabian's fine did not violate the Eighth Amendment. View "United States v. Facteau" on Justia Law

In the case, a defendant, Mario Rodriguez, was charged with several felonies, each carrying a maximum sentence exceeding two years. In 2018, Rodriguez was found mentally incompetent to stand trial and committed to a state hospital. After a certificate indicating his restoration to competency was filed within the two-year time limit, Rodriguez was returned to court. However, due to COVID-19 restrictions, his hearing to confirm his competency did not take place within the two-year period. Rodriguez sought to dismiss the charges against him, claiming the time for commitment had run out.The Supreme Court of California held that under the relevant statutes, the time between the filing of a certificate of restoration of mental competency and the court's ruling on that certificate counts towards the two-year maximum commitment period mandated by section 1370(c)(1) of the California Penal Code. Therefore, the filing of a certificate of restoration does not end the period of mental incompetency commitment.The court sent the case back to the Court of Appeal to decide whether the two-year limit was exceeded in this case, and if so, what remedy Rodriguez might be entitled to. The court did not decide whether Rodriguez was entitled to the remedy of dismissal he sought, or whether and how the issue of tolling may affect Rodriguez's entitlement to any relief. View "Rodriguez v. Super. Ct." on Justia Law

In the case concerning the estate of Frances R. Mason, the Supreme Judicial Court of Massachusetts ruled on two key issues. First, it considered whether the Massachusetts Medicaid program, MassHealth, could enforce a lien (known as a TEFRA lien) against a member's property after the member's death. The Court concluded that, under Massachusetts law, MassHealth can only enforce such a lien if the property is sold during the member's lifetime. Therefore, MassHealth could not enforce its lien against Mason's property, which was not sold until after her death. This ruling is a restriction on MassHealth's ability to recover Medicaid benefits paid.Second, the Court addressed the timing of MassHealth's claim for recovery of Medicaid benefits paid on Mason's behalf. The Court concluded that the three-year statute of repose of the Massachusetts Uniform Probate Code (MUPC) does not apply retroactively to bar MassHealth's claim against the estate of a member who died prior to the effective date of the MUPC. Accordingly, MassHealth's claim against Mason's estate, which was filed nearly nine years after her death, was not barred by the MUPC's three-year statute of repose.The facts of the case were as follows: Frances R. Mason was a recipient of Medicaid benefits from MassHealth. From January to August 2008, MassHealth paid for her care in a residential nursing facility. In May 2008, MassHealth imposed a TEFRA lien against Mason's home, as she was expected to be permanently institutionalized in the facility. Mason died in August 2008 without the property having been sold. MassHealth filed a claim to recover the Medicaid benefits paid for Mason's care in August 2018, after the executor of Mason's will had opened formal probate proceedings in June 2017.The disposition by the Court was to affirm the order of the Probate and Family Court judge insofar as it struck MassHealth's lien against Mason's home, and to reverse the order insofar as it dismissed MassHealth's claim against her estate. The case was remanded for further proceedings consistent with the Court's opinion. View "In re Estate of Mason" on Justia Law

In 2017, Donald Winkler received a Tdap vaccination after stepping on rusted metal. Soon after, he developed symptoms of Guillain-Barré Syndrome (GBS), a type of acute monophasic peripheral neuropathy. Winkler filed a petition for relief under the National Vaccine Injury Compensation Program, asserting the Tdap vaccine caused his GBS. However, the Special Master denied his claim, and this decision was upheld by the United States Court of Federal Claims. Winkler appealed to the United States Court of Appeals for the Federal Circuit.The appellate court affirmed the lower court's decision. The court noted that GBS is not listed as a covered condition for Tdap vaccines, so Winkler had to prove that his GBS was actually caused by the Tdap vaccination. The court applied the three-prong test set forth in Althen v. Secretary of Health and Human Services, requiring Winkler to show a medical theory causally connecting the vaccination and the injury, a logical sequence of cause and effect showing that the vaccination was the reason for the injury, and a proximate temporal relationship between vaccination and injury.The Special Master found that Winkler had not established the second Althen prong, as he failed to provide preponderant evidence of a logical sequence of cause and effect. The court disagreed with Winkler's argument that the Special Master erred by requiring him to disprove that he suffered from a Campylobacter jejuni infection, a known trigger for GBS, stating that Winkler mischaracterized his burden of proof. The court further stated that Winkler failed to establish a prima facie case of causation of his GBS by the Tdap vaccine, not that he failed to disprove evidence of an infection. Therefore, the court affirmed the Special Master's holding that Winkler failed to prove causation of GBS by the Tdap vaccine by preponderant evidence. View "WINKLER v. HHS " on Justia Law

In this case handled by the Supreme Court of Texas, the parents of two children, Kate Cox and Justin Cox, along with their doctor, Dr. Damla Karsan, filed a suit to challenge the enforcement of Texas laws that prohibit abortion. Mrs. Cox was about 20 weeks pregnant with a baby diagnosed with trisomy 18, a serious genetic disorder. The suit sought to apply a medical-necessity exception provided in the Texas law, which allows an abortion if a woman's life is threatened or she faces a serious risk of substantial impairment of a major bodily function due to her pregnancy.The court, in its decision, clarified that the exception to the abortion prohibition is based on the reasonable medical judgment of a doctor, not a court. It was noted that Dr. Karsan presented a "good faith belief" that Mrs. Cox meets the exception's requirements but did not assert that her belief meets the objective standard of "reasonable medical judgment."The court held that judges lack the authority to broaden the statutory exception by interpreting it and held the trial court erred in applying a different, lower standard instead of requiring reasonable medical judgment. The court emphasized that the exception requires a doctor's decision whether a pregnant woman’s complications pose the required risks.The court conditionally granted relief and directed the trial court to vacate the temporary restraining order that had restrained the Attorney General from enforcing the abortion laws against Dr. Karsan and others related to the case, based solely on the verified pleading. The court also noted that nothing in their opinion prevents a physician from acting if, in that physician’s reasonable medical judgment, they determine that the pregnant woman has a life-threatening physical condition. View "IN RE STATE OF TEXAS" on Justia Law

In this case heard before the United States Court of Appeals for the Fourth Circuit, the plaintiff, Daniella Easterbrook, appealed the denial of her application for disability benefits by the Social Security Administration. Easterbrook, who has suffered from persistent back pain since 2011, argued that the Administrative Law Judge (ALJ) failed to provide a "good reason," supported by substantial evidence, for not giving adequate weight to the opinions of her treating physician, Dr. John Kim.The court agreed with Easterbrook, stating that the ALJ erred in not applying the "treating source rule" to Dr. Kim's opinions and not providing a sufficient justification for giving his opinions less weight. The court noted that Dr. Kim's opinions were well-supported by medically acceptable clinical and laboratory diagnostic techniques and were consistent with the substantial evidence in the record.The court also found that the ALJ's reasons for discounting Dr. Kim's opinions, such as Easterbrook's decision not to undergo certain treatments, were inappropriate and did not constitute "good reasons." The court stated that a patient's refusal to pursue a specific type of medical treatment does not automatically call into question the severity of her pain.As a result, the court reversed the Commissioner's decision and remanded the case for a determination consistent with its opinion. View "Easterbrook v. Kijakazi" on Justia Law

The Minnesota Supreme Court ruled that an individual can bring a private action under the Minnesota private attorney general statute to compel a healthcare provider to disclose that individual’s medical records as required by the Minnesota Health Records Act. This decision was based on the interpretation of the private attorney general statute, which the court concluded applies to laws regarding unfair, discriminatory, and other unlawful practices in business, commerce, or trade. The court found that the Minnesota Health Records Act, which mandates the timely disclosure of health records to patients, falls within this category. However, the court also held that an individual does not have a private right of action under the Minnesota Health Care Bill of Rights to compel a healthcare provider to disclose an individual’s medical records. The ruling affirmed in part, reversed in part, and remanded the case to the district court for further proceedings. View "Findling vs. Group Health Plan, Inc." on Justia Law

In this case before the United States Court of Appeals for the Eighth Circuit, the defendant, Bradley Ready, appealed his sentence following his guilty plea for possession with intent to distribute methamphetamine and possession of a firearm as an unlawful user of a controlled substance. The court affirmed the district court's decision.During a search of Ready's residence, law enforcement officers found drug paraphernalia, scales, a loaded hunting rifle, and three bags of methamphetamine. Ready was subsequently charged and pleaded guilty to both counts. At sentencing, the U.S. Probation Office recommended grouping the drug and gun counts together and applying a two-level enhancement due to the possession of a dangerous weapon. Ready objected to this enhancement, but the district court overruled this objection.On appeal, Ready argued that the district court erred in applying the enhancement for possession of a dangerous weapon and applied the wrong standard in determining his eligibility for safety valve relief. The appellate court found no error in the district court's conclusions.The appellate court held that the district court did not err in applying the enhancement for possession of a dangerous weapon, as it was not "clearly improbable" that the rifle found in Ready's bedroom was connected to the distribution of methamphetamine from his home. The court also held that the district court did not err in its application of the standard for determining Ready's eligibility for safety valve relief. Therefore, the district court's judgment was affirmed. View "United States v. Ready" on Justia Law

In this case, the United States Court of Appeals for the Eighth Circuit evaluated a decision by the Western District Court of Missouri, which had denied Robin M. Sims's motion for compassionate release from prison under 18 U.S.C. § 3582(c)(1)(A)(i). In 2015, Sims was convicted of drug trafficking and firearm offenses and was sentenced to 360 months in prison. In 2022, he filed a motion for compassionate release, citing changes to the Armed Career Criminal Act since his sentencing and his medical conditions as extraordinary and compelling reasons for a reduction in sentence. The district court denied the motion, stating that Sims's arguments did not constitute extraordinary and compelling reasons warranting a sentence reduction.The Court of Appeals found that the district court had misunderstood Sims's arguments and the government's position. Instead of arguing for compassionate release due to an increased risk of contracting COVID-19, Sims had argued that he had contracted COVID-19 in custody, was experiencing ongoing medical complications, and was receiving inadequate medical care. The government had conceded that Sims had established "extraordinary and compelling" reasons under § 3582(c)(1)(A)(i), but the district court mistakenly stated that the government had opposed Sims's motion on the basis that he had failed to do so.The Court of Appeals remanded the case back to the district court, instructing it to consider the full scope of Sims's argument in support of "extraordinary and compelling" reasons, and if such reasons were found, to consider the factors set forth in 18 U.S.C. § 3553(a) in light of these reasons. The court emphasized the need for an individualized inquiry in motions for compassionate release. View "United States v. Sims" on Justia Law