Justia Health Law Opinion Summaries

The case involves Amarin Pharma, Inc., Amarin Pharmaceuticals Ireland Limited, and Mochida Pharmaceutical Co., Ltd. (collectively, “Amarin”) and Hikma Pharmaceuticals USA Inc. and Hikma Pharmaceuticals PLC (collectively, “Hikma”). Amarin markets and sells icosapent ethyl, an ethyl ester of an omega-3 fatty acid commonly found in fish oils, under the brand name Vascepa®. In 2012, the U.S. Food and Drug Administration (“FDA”) approved Vascepa for the treatment of severe hypertriglyceridemia. In 2019, following additional research and clinical trials, the FDA approved Vascepa for a second use: as a treatment to reduce cardiovascular risk in patients having blood triglyceride levels of at least 150 mg/dL.In the United States District Court for the District of Delaware, Hikma moved to dismiss Amarin’s complaint for failure to state a claim. The court granted Hikma’s motion, concluding that Amarin’s allegations against Hikma did not plausibly state a claim for induced infringement.The United States Court of Appeals for the Federal Circuit reversed the decision of the district court. The court held that Amarin had plausibly pleaded that Hikma had induced infringement of the asserted patents. The court noted that the case was not a traditional Hatch-Waxman case or a section viii case, but rather a run-of-the-mill induced infringement case arising under 35 U.S.C. § 271(b). The court concluded that the totality of the allegations, taken as true, plausibly plead that Hikma “actively” induced healthcare providers’ direct infringement. View "AMARIN PHARMA, INC. v. HIKMA PHARMACEUTICALS USA INC. " on Justia Law

The case involves United Therapeutics Corporation (UTC), a biotechnology company, and the Commissioner of Internal Revenue. The dispute centers on the interpretation of a tax provision that coordinates two tax credits: the research credit and the orphan drug credit. The Commissioner claimed that UTC disregarded one of the provision’s two commands, improperly reducing its tax liability by over a million dollars. UTC argued that the relevant half of the coordination provision lost effect in 1989 and has been moribund since.The United States Tax Court disagreed with UTC's argument. The court interpreted the statute’s terms by reference to their ordinary meaning, giving effect to the full coordination provision. The court rejected UTC's argument that changes to the tax law since its enactment rendered part of the coordination provision ineffective. The court also disagreed with UTC's interpretation of two regulations it relied on for support.The United States Court of Appeals for the Fourth Circuit affirmed the tax court's decision. The appellate court agreed with the tax court's interpretation of the coordination provision according to its ordinary meaning. The court also found that the tax court correctly rejected UTC's arguments based on the interpretation of predecessor statutes and regulations. The court concluded that the tax court correctly resolved the case in favor of the Commissioner. View "United Therapeutics Corporation v. Commissioner of Internal Revenue" on Justia Law

The case involves Carl Fowler, an employee at Perdue, Inc., who contracted COVID-19 and sought compensation from his employer. Fowler worked at Perdue from January 2020 until late March 2020. In March 2020, Fowler developed COVID-19 symptoms and was later diagnosed with the virus. He was hospitalized for over two months and suffered severe health complications. Fowler claimed that he contracted the virus at work, specifically in the company's cafeteria, which he described as crowded and likened to a "sardine can."The Industrial Accident Board of the State of Delaware initially denied Fowler's claim, finding that he failed to present sufficient evidence that COVID-19 was a compensable occupational disease. The Superior Court affirmed this decision. Fowler then appealed to the Supreme Court of the State of Delaware.The Supreme Court affirmed the lower court's decision. The court found that while Fowler had established that the cafeteria at Perdue presented a hazard greater than that attending employment in general, he failed to show that the cafeteria was a hazard "distinct from" that attending employment in general. The court concluded that Fowler failed to establish the necessary relationship between his work environment at Perdue and COVID-19 as a "natural incident to" that employment. Therefore, the court held that Fowler's COVID-19 infection was not an occupational disease under these circumstances. View "Fowler v. Perdue, Inc." on Justia Law

The case involves Ryan Owen Frayo, a former employee of A&A Organic Farms Corporation (A&A), who was terminated for refusing to take a COVID-19 test. Frayo sued A&A and its owners, Andrew D. Martin and Aimee M. Raphael-Martin, alleging they violated the Confidentiality of Medical Information Act (CMIA). Frayo claimed that his termination was a result of his refusal to provide a COVID-19 test result, which he argued was equivalent to refusing to sign an authorization for the release of his medical information under the CMIA. He also claimed that A&A used his description of his symptoms, which he considered as medical information, to terminate his employment.The trial court sustained A&A’s demurrer to Frayo’s first amended complaint, finding that Frayo failed to state a claim under the CMIA. The court concluded that Frayo failed to state a claim under section 56.20(b) of the CMIA because the statute prohibits employer discrimination based on an employee’s refusal to sign an authorization to release his medical information, not refusal to take a COVID-19 test. The court also sustained the demurrer to Frayo’s second cause of action under section 56.20(c) because Frayo failed to allege A&A had possession of his medical information, as defined by the statute.The Court of Appeal of the State of California Sixth Appellate District affirmed the trial court's decision. The appellate court agreed with the trial court that Frayo did not state a cognizable CMIA claim under either section 56.20(b) or (c). The court found that Frayo's refusal to take and provide the results of a COVID-19 test was not equivalent to an "employee’s refusal to sign an authorization" under the CMIA. Furthermore, the court concluded that Frayo failed to allege that A&A was in possession of his medical information as defined under the CMIA. Therefore, the court affirmed the judgment of dismissal. View "Frayo v. Martin" on Justia Law

A group of individuals and businesses challenged the Affordable Care Act's requirement for private insurers to cover certain types of preventive care, including contraception, HPV vaccines, and drugs preventing HIV transmission. The plaintiffs argued that the mandates were unlawful because the agencies issuing them violated Article II of the Constitution, as their members were principal officers of the United States who had not been validly appointed under the Appointments Clause. The district court mostly agreed, vacating all agency actions taken to enforce the mandates and issuing both party-specific and universal injunctive relief.The United States Court of Appeals for the Fifth Circuit agreed that the United States Preventive Services Task Force, one of the challenged administrative bodies, was composed of principal officers who had not been validly appointed. However, the court found that the district court erred in vacating all agency actions taken to enforce the preventive-care mandates and in universally enjoining the defendants from enforcing them. The court also held that the Secretary of the Department of Health and Human Services had not validly cured the Task Force’s constitutional problems.The court affirmed in part, reversed in part, and remanded the case for further proceedings. The court did not rule on the plaintiffs' challenges against the other two administrative bodies involved in the case, the Advisory Committee on Immunization Practices and the Health Resources and Services Administration, reserving judgment on whether the Secretary had effectively ratified their recommendations and guidelines. View "Braidwood Mgmt v. Becerra" on Justia Law

The case involves the Iowaska Church of Healing (the "Church"), an organization whose religious practices involve the consumption of Ayahuasca, a tea containing the hallucinogenic drug dimethyltryptamine (DMT), which is regulated under the Controlled Substances Act (CSA). The Church had applied for tax-exempt status under 26 U.S.C. § 501(c)(3) but was denied by the Internal Revenue Service (IRS) on the grounds that the Church's religious use of Ayahuasca was illegal. The Church challenged this decision in the District Court, arguing that the IRS's determination was based on an incorrect assumption of illegality and that the denial of tax-exempt status violated the Religious Freedom Restoration Act of 1993 (RFRA).The District Court denied the Church's motion and granted the Government's motion for summary judgment. The court held that the Church lacked standing to assert its RFRA claim and that the lack of standing also undermined its tax-exemption claim. The court found that the Church's religious use of Ayahuasca was illegal without a CSA exemption, and the IRS had no authority to assess whether the Church's proposed Ayahuasca use warranted a religious exemption from the CSA.On appeal, the United States Court of Appeals for the District of Columbia Circuit affirmed the District Court's judgment. The Court of Appeals held that the Church lacked standing to assert its RFRA claim because the economic injury it claimed was neither an injury-in-fact nor redressable. Without a cognizable RFRA claim, the Church's tax-exemption claim also failed. The Court of Appeals found that the Church could not proffer evidence of a CSA exemption to show it passed the organizational and operational tests for tax-exempt status. View "Iowaska Church of Healing v. Werfel" on Justia Law

This case involves a dispute over the interpretation of a statute that regulates healthcare providers participating in the federal Medicaid program. The State of Texas, acting through the Attorney General, sought to enforce a statute that imposes penalties on a provider who submits a claim for payment and knowingly fails to indicate the type of professional license and the identification number of the person who actually provided the service. The defendant, a dentist, argued that the statute only applies if a claim fails to indicate both the license type and the identification number of the actual provider.Previously, the trial court granted the State's motion for partial summary judgment and denied the defendant's motion. The court rendered a final judgment awarding the State more than $16,500,000. The defendant appealed, and the court of appeals affirmed the trial court's judgment, except for the amount of attorney’s fees and expenses.The Supreme Court of Texas reversed the lower courts' decisions. The court agreed with the defendant's interpretation of the statute. The court held that the statute applies only if a claim fails to indicate both the license type and the identification number of the actual provider. The court found that the 1,842 claims at issue did indicate the actual providers’ license type, so they did not constitute an unlawful act under the statute. The court rendered judgment in the dentist’s favor. View "MALOUF v. THE STATE OF TEXAS EX RELS. ELLIS AND CASTILLO" on Justia Law

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