Justia Health Law Opinion Summaries

The case involves Image API, LLC, a company that provided services to the Texas Health and Human Services Commission (HHSC) from 2009 to 2015. Image's job was to manage a processing center for incoming mail related to Medicaid and other benefits programs. The agreement between the parties stated that HHSC would compensate Image using its “retrospective cost settlement model”. In 2016, HHSC notified Image that an independent external firm would conduct an audit of Image’s performance and billing for the years 2010 and 2011. The audit concluded that HHSC had overpaid Image approximately $440,000 in costs relating to bonuses, holiday pay, overtime, and other unauthorized labor expenses. HHSC then sought to recoup the overpayments by deducting from payments on Image’s invoices.The trial court granted HHSC’s motion for summary judgment and signed a final judgment for the commissioner. The court of appeals reversed the trial court’s judgment and dismissed Image’s entire suit for want of jurisdiction. Image sought review.The Supreme Court of Texas held that Image is a Medicaid contractor under Section 32.0705(a), and that the deadline in Section 32.0705(d) for auditing HHSC’s Medicaid contractors is mandatory. However, the court ruled that HHSC’s failure to meet the deadline does not preclude it from using the result of the audit or pursuing recoupment of overcharges found in the audit. The court affirmed the part of the court of appeals’ judgment dismissing Image’s claims arising from the 2016 audit for lack of jurisdiction, reversed the part of the judgment dismissing the remainder of Image’s suit, and remanded to the trial court for further proceedings. View "IMAGE API, LLC v. YOUNG" on Justia Law

This case involves a dispute over the interpretation of the "learned intermediary doctrine" in a product liability case involving a medical device. The plaintiff, Michelle Himes, sued the defendant, Somatics, LLC, alleging that the company failed to provide adequate warning about the risks associated with electroconvulsive therapy (ECT), a treatment she underwent for severe depression. Himes claimed that she was only warned about the possibility of short-term memory loss, and not about the potential for permanent brain damage, severe permanent retrograde and anterograde amnesia, and acute and/or chronic organic brain syndrome, which she alleges she suffered as a result of the treatment.The district court granted summary judgment in favor of Somatics, finding that Himes failed to present evidence showing that a more detailed warning would have changed her physician's decision to administer ECT. The Ninth Circuit Court of Appeals agreed with the district court's finding but noted a genuine dispute of material fact as to whether the physician would have communicated a stronger warning to Himes.The Supreme Court of California was asked to clarify the causation standard under the learned intermediary doctrine. The court held that a plaintiff is not required to show that a stronger warning would have altered the physician’s decision to prescribe the product to establish causation. Instead, a plaintiff may establish causation by showing that the physician would have communicated the stronger warning to the patient and an objectively prudent person in the patient’s position would have thereafter declined the treatment. The court emphasized that the causation analysis must take into consideration whether the physician would still recommend the prescription drug or medical device for the patient, even in the face of a more adequate warning. View "Himes v. Somatics, LLC" on Justia Law

The case involves Roland Black, who was convicted of attempting to possess with intent to distribute a controlled substance, specifically furanyl fentanyl. Law enforcement intercepted a package addressed to Black, believing it contained narcotics. After obtaining a warrant, they found the substance, replaced it with sham narcotics, and delivered the package to Black's residence. Black was arrested after the package was opened and he was found with luminescent powder from the sham narcotics on his hands.Prior to his trial, Black had unsuccessfully moved to dismiss the indictment and suppress all evidence derived from the seizure of the package. He argued that the officers lacked reasonable suspicion to seize the package and requested an evidentiary hearing to resolve related factual disputes. The district court denied these motions, ruling that the totality of the circumstances supported the officers' reasonable suspicion determination.In the United States Court of Appeals for the Seventh Circuit, Black appealed his conviction, raising four arguments. He contended that the officers lacked reasonable suspicion to seize the package, the jury instruction about his requisite mens rea was erroneous, the jury’s verdict was not supported by sufficient evidence, and the court erred in denying his motion to dismiss based on the court’s treatment of furanyl fentanyl as an analogue of fentanyl.The Court of Appeals affirmed the lower court's decision. It found that the officers had reasonable suspicion to seize the package, the jury instruction accurately stated the law, the jury’s verdict was supported by more than sufficient evidence, and Black's motion to dismiss argument was foreclosed by precedent. View "USA v. Black" on Justia Law

Insulet Corp. and EOFlow are medical device manufacturers that produce insulin pump patches. Insulet began developing its OmniPod product in the early 2000s, and EOFlow started developing its EOPatch product after its founding in 2011. Around the same time, four former Insulet employees joined EOFlow. In 2023, reports surfaced that Medtronic had started a process to acquire EOFlow. Soon after, Insulet sued EOFlow for violations of the Defend Trade Secrets Act (DTSA), seeking a temporary restraining order and a preliminary injunction to enjoin all technical communications between EOFlow and Medtronic in view of its trade secrets claims.The U.S. District Court for the District of Massachusetts temporarily restrained EOFlow from disclosing products or manufacturing technical information related to the EOPatch or OmniPod products. The court then granted Insulet’s request for a preliminary injunction, finding strong evidence that Insulet is likely to succeed on the merits of its trade secrets claim, strong evidence of misappropriation, and that irreparable harm to Insulet crystallized when EOFlow announced an intended acquisition by Medtronic. The injunction enjoined EOFlow from manufacturing, marketing, or selling any product that was designed, developed, or manufactured, in whole or in part, using or relying on alleged trade secrets of Insulet.The United States Court of Appeals for the Federal Circuit reversed the district court’s order. The court found that the district court had failed to address the statute of limitations, lacked a tailored analysis as to what specific information actually constituted a trade secret, and found it hard to tell what subset of that information was likely to have been misappropriated by EOFlow. The court also found that the district court had failed to meaningfully engage with the public interest prong. The court concluded that Insulet had not shown a likelihood of success on the merits and other factors for a preliminary injunction. The case was remanded for further proceedings consistent with the opinion. View "INSULET CORP. v. EOFLOW, CO. LTD. " on Justia Law

The case involves a dispute over the eligibility of a married individual, Costa Tingos, for Medicaid long-term care benefits. Costa and his wife, Mary, had been married for over 50 years, but had kept their finances largely separate due to Costa's history of gambling and financial mismanagement. When Costa moved into a nursing home, he applied for Medicaid benefits. However, Mary refused to provide information about her income and assets, which was necessary to determine Costa's eligibility. Costa argued that Mary's refusal to cooperate should not affect his eligibility.The case was initially heard by the Massachusetts Medicaid program, MassHealth, which denied Costa's application. Costa appealed to the MassHealth board of hearings, which also denied his appeal. Costa then sought judicial review in the Superior Court, which vacated the board's decision and remanded the case back to the board. After two more rounds of hearings and appeals, the Superior Court affirmed the board's decision to deny Costa's application.The Supreme Judicial Court of Massachusetts affirmed the decision of the Superior Court. The court held that the board's interpretation of the phrase "refuses to cooperate" in the relevant regulation was reasonable. The court found that Mary's refusal to disclose her financial information did not constitute a refusal to cooperate within the meaning of the regulation, given the couple's long history of cooperation in other aspects of their marriage. The court also rejected Costa's argument that the board's decision was arbitrary and capricious. View "Freiner v. Secretary of the Executive Office of Health and Human Services" on Justia Law

The case revolves around Tokvan Ly, a man suffering from severe mental illness, who was incarcerated in the Scott County Jail. The district court found Ly incompetent to face criminal proceedings and ordered him committed to the care of the appellant, Jodi Harpstead, the Commissioner of Human Services. The law requires that persons in Ly's position be prioritized for admission to state-operated treatment programs and be admitted within 48 hours. However, Ly was not admitted within this timeframe. Fifteen days after his commitment, Ly remained in jail and was not receiving the specialized treatment needed for his severe mental illness. Consequently, he filed a petition for writs of mandamus and habeas corpus, alleging that the Commissioner was failing to comply with a mandatory duty to admit him to treatment within 48 hours under the Priority Admission statute and seeking damages resulting from his delayed admission to treatment.The district court issued a peremptory writ of mandamus that determined the Commissioner’s liability solely on the facts as alleged in Ly’s petition, and set the issue of mandamus damages for a fact trial. The Commissioner appealed the district court’s order, contending that she could immediately appeal the order before entry of final judgment. The court of appeals disagreed and dismissed the appeal for lack of jurisdiction.The Minnesota Supreme Court concluded that the basis for appeal from an order issuing a peremptory writ of mandamus under Rule 103.03(g) has been extinguished, and that appeal must instead proceed from a final judgment under Minn. R. Civ. App. P. 103.03(a). The court further concluded that an order issuing a peremptory writ is not appealable under Rule 103.03(a) as a form of irregular judgment, and that the district court order currently on appeal does not satisfy the finality requirement of that rule. However, the court invoked its inherent authority and its authority under Minn. R. Civ. App. P. 102 to suspend the final judgment requirement of Rule 103.03(a), reverse the decision of the court of appeals, exercise jurisdiction over the Commissioner’s underlying appeal, and remand to the court of appeals to consider the merits of the appeal. View "Ly v. Harpstead" on Justia Law

In 2000, the Food and Drug Administration (FDA) approved the use of mifepristone tablets, marketed under the brand name Mifeprex, for terminating pregnancies up to seven weeks. The FDA imposed additional restrictions on the drug's use and distribution, including requiring doctors to prescribe or supervise the prescription of Mifeprex and requiring patients to have three in-person visits with the doctor to receive the drug. In 2016, the FDA relaxed some of these restrictions, and in 2021, it announced that it would no longer enforce the initial in-person visit requirement. Four pro-life medical associations and several individual doctors moved for a preliminary injunction that would require the FDA to either rescind approval of mifepristone or rescind the FDA’s 2016 and 2021 regulatory actions.The District Court agreed with the plaintiffs and effectively enjoined the FDA's approval of mifepristone, ordering it off the market. The FDA and Danco Laboratories, which sponsors Mifeprex, appealed and moved to stay the District Court’s order pending appeal. The Supreme Court ultimately stayed the District Court’s order pending the disposition of proceedings in the Fifth Circuit and the Supreme Court. On the merits, the Fifth Circuit held that plaintiffs had standing and concluded that plaintiffs were unlikely to succeed on their challenge to FDA’s 2000 and 2019 drug approvals, but were likely to succeed in showing that FDA’s 2016 and 2021 actions were unlawful. The Supreme Court granted certiorari with respect to the 2016 and 2021 FDA actions.The Supreme Court of the United States held that the plaintiffs lack Article III standing to challenge the FDA’s actions regarding the regulation of mifepristone. The Court found that the plaintiffs, who are pro-life and oppose elective abortion, have sincere legal, moral, ideological, and policy objections to mifepristone being prescribed and used by others. However, because the plaintiffs do not prescribe or use mifepristone, they are unregulated parties who seek to challenge the FDA’s regulation of others. The Court concluded that the plaintiffs' theories of causation were insufficient to establish Article III standing. The Court reversed the judgment of the Fifth Circuit and remanded the case for further proceedings consistent with its opinion. View "FDA v. Alliance for Hippocratic Medicine" on Justia Law

The case involves a lawsuit filed by Rosemary Lambert and Carolyn Hinzman, individually and as co-executors of the estate of Delmar P. Fields, against Eldercare of Jackson County, LLC, Community Health Association, and Dr. Irvin John Snyder. The plaintiffs allege that Mr. Fields contracted COVID-19 while a resident at Eldercare and died while under the care of Jackson General and Dr. Snyder. The defendants sought dismissal of the lawsuit, arguing that they were immune from liability under the COVID-19 Jobs Protection Act.The Circuit Court of Jackson County denied the defendants' motions to dismiss. The court interpreted the term "actual malice" in the COVID-19 Jobs Protection Act to mean that the defendant acted with the intent to injure or harm the plaintiff or decedent. The court found that the plaintiffs had alleged sufficient facts to survive a motion to dismiss.On appeal, the Supreme Court of Appeals of West Virginia affirmed the lower court's decision in part and reversed in part. The court held that the term "actual malice" in the COVID-19 Jobs Protection Act means that the defendant acted with the deliberate intent to commit an injury, as evidenced by external circumstances. The court found that the plaintiffs had alleged sufficient facts to show that Eldercare engaged in intentional conduct with actual malice. However, the court found that the allegations against Jackson General Hospital and Dr. Snyder were insufficient to establish that they engaged in intentional conduct with actual malice. The case was remanded for further proceedings. View "Eldercare of Jackson County, LLC v. Lambert" on Justia Law

The case involves Dr. Peter Bolos, who was convicted of mail fraud, conspiracy to commit healthcare fraud, and felony misbranding as part of a complex scheme. Bolos purchased an interest in Florida-based pharmacy Synergy Pharmacy Services in 2013 and became the managing partner. Synergy signed an agreement with HealthRight, a telemarketing firm, to generate business. HealthRight used social media advertisements and large phone banks to generate potential clients for Synergy. The information collected from potential clients was forwarded to a licensed doctor in the patient’s home state for review. Most of these decisions were made without the doctor ever seeing or speaking to the patient. The doctors then sent the prescriptions to Synergy for filling.The District Court for the Eastern District of Tennessee convicted Bolos on all counts after a four-week trial. Bolos appealed, arguing that his actions were not unlawful and that he was being unfairly held criminally culpable for contractual violations and others’ misconduct.The United States Court of Appeals for the Sixth Circuit disagreed with Bolos and affirmed the lower court's decision. The court found that Bolos and Synergy leadership knew of the deficiencies in their business practices and either actively facilitated and furthered them or turned a blind eye, all in an effort to induce Pharmacy Benefit Managers (PBMs) to pay Synergy. The court also held that the federal healthcare-fraud statute requires the government to prove that Bolos knowingly devised a scheme or artifice to defraud a health care benefit program in connection with the delivery of or payment for health care benefits, items, or services. The court found ample evidence in the record to support the jury’s finding that Bolos conspired to create a scheme with the intent to defraud the PBMs of their money. View "United States v. Bolos" on Justia Law

Nicole Costin, individually and on behalf of her minor son, filed a lawsuit against Glens Falls Hospital and several of its staff members. Costin alleged that the hospital discriminated against her due to her substance-abuse disorder, violating the Americans with Disabilities Act and the Rehabilitation Act. She also raised state-law claims. Costin's allegations included the hospital conducting drug tests without informed consent, reporting her to the New York State Child Abuse and Maltreatment Register based on a false positive drug test, withholding pain relief, accelerating her labor without consent, and refusing to correct their actions.The United States District Court for the Northern District of New York dismissed Costin’s action, concluding that she failed to plausibly allege that she was discriminated against due to her disability. The district court also declined to exercise supplemental jurisdiction over her state-law claims.The United States Court of Appeals for the Second Circuit affirmed in part, vacated in part, and remanded the case for further proceedings. The court agreed with the lower court's dismissal of Costin’s claims related to the denial of an epidural, acceleration of labor, and treatment of her newborn. However, the court disagreed with the dismissal of Costin’s claims related to the hospital's instigation of a Child Protective Services investigation and its administration of a drug test. The court found that Costin had plausibly alleged that these actions were based on discriminatory policies, not medical decisions. The court also vacated the lower court's decision to decline supplemental jurisdiction over Costin’s state-law claims. View "Costin v. Glens Falls Hospital" on Justia Law