Justia Health Law Opinion Summaries

A dispute arose concerning the payment rate for a surgical procedure performed at an out-of-network facility. The patient receiving the surgery was covered by an ERISA-governed health plan provided by the employer and administered by an insurance company. Prior to the surgery, the facility contacted the plan administrator to verify coverage and was told that the plan would reimburse at the usual, customary, and reasonable (“UCR”) rate, not the lower Medicare rate. Relying on this representation, the facility performed the surgery. However, the plan later paid only at the Medicare rate, far less than the full billed amount. The facility’s successor in interest, having obtained the rights to the claim, sought to recover the unpaid balance.The action was first brought in California state court, then removed to the United States District Court for the Central District of California. The plaintiff asserted both ERISA and state law claims. The district court dismissed the ERISA claim for lack of derivative standing, as the plaintiff was not properly assigned the right to sue under ERISA. The court also dismissed the state law claims for negligent misrepresentation and promissory estoppel, holding that these claims were preempted by ERISA because they related to an ERISA-covered plan.The United States Court of Appeals for the Ninth Circuit reviewed the case. It affirmed the district court’s dismissal of the promissory estoppel claim, holding that, under circuit precedent, such claims are preempted by ERISA. However, the Ninth Circuit reversed the dismissal of the negligent misrepresentation claim. The appellate court held that ERISA does not preempt a negligent misrepresentation claim by a provider’s successor in interest when the claim arises from representations made by the plan administrator during a pre-service verification call. The court concluded that such a claim does not sufficiently “relate to” an ERISA plan to trigger preemption, as it is not based on an ERISA-regulated relationship or enforceable under ERISA’s civil enforcement mechanism. The case was remanded for further proceedings on the negligent misrepresentation claim. View "HEALTHCARE ALLY MANAGEMENT OF CALIFORNIA, LLC V. WSP USA, INC." on Justia Law

A company that manufactures flavored e-liquids for use in electronic nicotine delivery systems (ENDS), including fruit and candy flavors, submitted premarket applications to the Food and Drug Administration (FDA) seeking authorization to sell 64 such products. The FDA’s regulatory authority under the Family Smoking Prevention and Tobacco Control Act (TCA) requires that new tobacco products be shown to be “appropriate for the protection of the public health” before they can be marketed. The FDA denied the company’s applications, citing the failure to provide robust comparative evidence demonstrating that its flavored products offer a public health benefit for adult smokers that outweighs the risks to youth, compared to tobacco-flavored ENDS.Following the FDA’s marketing denial order, the company petitioned for review in the United States Court of Appeals for the Ninth Circuit. The company argued that the FDA acted arbitrarily and capriciously by requiring comparative efficacy evidence, failed to adequately consider its marketing and sales restriction plans, and improperly denied authorization for “zero nicotine” products. It also argued that the FDA could only impose a comparative efficacy requirement through notice-and-comment rulemaking under the TCA and the Administrative Procedure Act (APA).The United States Court of Appeals for the Ninth Circuit denied the petition for review. The court held that the FDA’s denial based on the absence of comparative efficacy evidence was neither arbitrary nor capricious, especially since the applicant offered no evidence distinguishing its products’ youth risks from those of other flavored ENDS. The court also found that any error in declining to consider marketing or access restriction plans was harmless. Additionally, the court ruled that the FDA was not required to undertake notice-and-comment rulemaking before applying the comparative efficacy requirement, and the inclusion of “zero nicotine” products in the denial order was proper based on the company’s own representations. View "DRIP MORE LLC V. FDA" on Justia Law

A physician purchased a medical professional liability insurance policy that included a “limited regulatory defense” provision requiring the insurer to cover defense costs for administrative proceedings related to patient complaints about the physician’s professional activities. During the policy period, the husband of a former patient filed a complaint with the Board of Registration in Medicine, alleging both the physician’s criminal conduct unrelated to medical care and an allegation that the physician prescribed an addictive medication to the patient when her primary care physician would not, due to concerns about addiction.The insurer denied coverage for defense costs in the administrative proceedings, arguing that the proceeding did not arise from a “covered claim” or a patient complaint about the physician’s “professional activities” as required by the policy. The insurer maintained that the criminal conduct alleged was not related to the provision of professional medical services. In Superior Court, following a jury-waived trial on agreed facts, the judge sided with the insurer, concluding that the allegations did not arise from the physician’s professional services, but instead from unrelated criminal conduct, and entered judgment for the insurer.The Supreme Judicial Court of Massachusetts reviewed the case de novo. It held that, although most of the alleged criminal conduct was not covered as professional services, the allegation regarding prescribing an addictive medication when the patient’s primary care physician refused did constitute a “professional service” under the policy. The Court reasoned that prescribing medication is a professional act requiring specialized medical knowledge, and the allegations created at least a possibility of coverage. Because one covered allegation triggers the duty to defend all claims in the proceeding, the Court vacated the Superior Court order and remanded for further proceedings. View "O'Connor v. MAG Mutual Insurance Company" on Justia Law

A minor child suffering from a rare congenital condition required urgent medication, specifically Lupron Depot injections, to alleviate her symptoms. Her parents, after consulting with her physician, pursued this treatment and sought to fill the prescription through a specialty pharmacy owned by Walgreens. The process required prior authorization from the child’s health insurer, Blue Cross and Blue Shield of Oklahoma. Walgreens investigated coverage, communicated the need for prior authorization to the physician, and placed the prescription on hold pending approval. Although the physician eventually obtained and sent the authorization, Walgreens closed the prescription file, and neither party followed up for nearly a month. The child was hospitalized twice during that period. After renewed urgency from the physician, Walgreens reopened the file, filled the prescription, and delivered the medication.The parents and child brought a negligence claim against Walgreens in Oklahoma state court, alleging Walgreens had promised to timely deliver the medication and breached a duty by not doing so. Walgreens removed the case to the United States District Court for the Northern District of Oklahoma, which applied Oklahoma law. Walgreens moved for summary judgment, arguing it owed no duty to fill the prescription until it had taken affirmative action after July 13, and citing state statutes and regulations that do not impose a general duty to fill prescriptions within a certain timeframe. The plaintiffs argued Walgreens owed a duty throughout the period.The United States Court of Appeals for the Tenth Circuit reviewed the district court’s grant of summary judgment de novo. It held that, under Oklahoma law, Walgreens owed no duty to fill the prescription before July 13, 2020, either by statute, regulation, or common law, and found no evidence of a promise or undertaking by Walgreens to do so. The Tenth Circuit affirmed the district court’s judgment for Walgreens. View "Scholl v. Walgreens Specialty Pharmacy" on Justia Law

The case centers on the tragic death of a young woman who was murdered by her former romantic partner shortly after he was discharged from a psychiatric hospital. The partner had previously expressed homicidal ideations toward her, both to medical staff and law enforcement, and was involuntarily committed under Connecticut law for psychiatric disabilities and being a danger to others. After a brief stay, he was discharged from the psychiatric facility with no further supervision or warning provided to either the victim or law enforcement. The plaintiff, administratrix of the victim’s estate, sued the mental health care provider, alleging both ordinary negligence and medical malpractice for failing to protect the victim from a known risk.The Superior Court in the judicial district of Hartford granted the provider’s motion to strike, finding that all claims sounded in medical malpractice since the alleged negligence involved medical judgment relating to diagnosis and treatment. Relying on Jarmie v. Troncale, the court concluded that, under Connecticut law, medical malpractice actions can only be brought by patients, and since the victim was not a patient, the claims were barred. The court also determined that Connecticut does not recognize gross negligence as a separate cause of action.On appeal, the Supreme Court of Connecticut reviewed the trial court’s decision. The Supreme Court held that some allegations did implicate medical malpractice and were barred, but others, liberally construed, sounded in ordinary negligence. These included claims that the provider actually knew of a substantial risk of imminent harm to an identifiable third party and failed to take reasonable steps to protect or warn her. The Court, for the first time, recognized a limited duty: a mental health care provider who knows a patient poses a substantial risk of imminent harm to an identifiable third party must take reasonable steps to protect that party, which may include warning or controlling the patient. The judgment was reversed in part and remanded for further proceedings on the ordinary negligence claims. View "Ashworth v. Branford" on Justia Law

An executive at a group of medical device companies that sell products to the federal government raised internal concerns in early 2024 that the company was violating Food and Drug Administration (FDA) regulations related to product design, quality management, and testing. He believed that selling a particular product without addressing these regulatory deficiencies could result in misrepresenting data to the FDA to obtain approval. Over a two-week period, he communicated these concerns to multiple executives and suggested implementing changes to improve compliance. Shortly after these communications, his position was eliminated.Following his termination, the executive filed suit in the United States District Court for the Eastern District of Pennsylvania, alleging, among other claims, that his employer retaliated against him in violation of the False Claims Act (FCA)’s anti-retaliation provision. The District Court dismissed the FCA retaliation claim, holding that the complaint failed to allege a sufficient connection between the plaintiff’s concerns about FDA violations and the submission of false claims for payment to the federal government, and thus did not constitute protected conduct under the FCA.On appeal, the United States Court of Appeals for the Third Circuit reviewed two questions: whether FCA retaliation claims are subject to Rule 9(b)’s heightened pleading standard, and what constitutes protected conduct under the “other efforts” prong of the FCA’s anti-retaliation provision. The court held that FCA retaliation claims are not subject to Rule 9(b), but instead require only notice pleading under Rule 8(a). It further held that, to constitute protected conduct, a plaintiff’s actions must be motivated by an objectively reasonable belief that the employer is submitting or will submit false or fraudulent claims for payment to the government. Finding no such allegation in the complaint, the Third Circuit affirmed the District Court’s dismissal of the FCA retaliation claim. View "Lisenby v. Olympus Corporation of the Americas" on Justia Law

Several plaintiffs alleged that they suffered injuries, such as renal, bone, or tooth damage, from taking a drug manufactured by Gilead Sciences, Inc. known as tenofovir disoproxil fumarate (TDF). Plaintiffs conceded that TDF was not defective but claimed that Gilead had developed an alternative drug, tenofovir alafenamide fumarate (TAF), which was equally effective and less toxic. Plaintiffs argued that Gilead unreasonably delayed bringing TAF to market, allegedly to maximize profits, and that this delay deprived them of a safer drug option, causing their injuries.In the San Francisco City and County Superior Court, Gilead moved for summary judgment, asserting that negligence liability could not attach for injuries caused by a nondefective product. The trial court denied Gilead’s motion. Gilead then petitioned the Court of Appeal, First Appellate District, Division Four, which partially granted the petition. The Court of Appeal directed summary adjudication on the fraudulent concealment claim but allowed the negligence claim to proceed. It held that drug manufacturers may owe a duty of reasonable care to users of a nondefective drug in deciding whether and when to commercialize a safer alternative.The Supreme Court of California reviewed the case and reversed the Court of Appeal’s judgment. The court held that, even assuming drug manufacturers might owe a broader duty of care beyond marketing nondefective drugs, the factors set forth in Rowland v. Christian justify an exception in this context. Specifically, the court determined that a manufacturer’s decision to delay commercialization of a safer drug during early development stages is too remote and unforeseeable to establish a duty of care, and imposing such liability would unduly burden innovation and public health. The Supreme Court directed the trial court to grant summary judgment for Gilead on all claims. View "Tenofovir Cases" on Justia Law

A nurse practitioner was accused of orchestrating a large-scale Medicare fraud scheme beginning in 2018. The evidence showed that she signed prescriptions for durable medical equipment and genetic testing that were medically unnecessary, often without examining patients or verifying their needs. She worked with telemarketers who cold-called Medicare beneficiaries, fabricated records, and sold prescriptions to medical providers who then billed Medicare. The practitioner received significant kickbacks for her participation and later recruited others to help. When government investigations targeted similar schemes, she attempted to cover her tracks but continued fraudulent conduct by billing for nonexistent telemedicine appointments, at times claiming over twenty-four hours of appointments in a single day. Ultimately, she received more than $1.66 million from these activities, and law enforcement discovered a written confession during a search of her residence.A grand jury indicted her on conspiracy, health care fraud, and false statement charges. Pretrial, the United States District Court for the Southern District of Florida denied her motion to exclude her written statement, finding the attorney-client privilege was waived. During jury selection, her request to strike a potentially biased juror for cause was denied, forcing her to use a peremptory challenge. At trial, disputes arose over the introduction of her inculpatory statement, and the court allocated more time for the government’s closing argument than for her defense. The jury found her guilty, and she was sentenced based on intended loss, not just actual billed amounts, despite her objections.The United States Court of Appeals for the Eleventh Circuit reviewed her claims, including the unequal allocation of closing argument time, a misstatement in oral jury instructions, jury selection issues, the handling of her statement, and sentencing calculations. The court held that although the district court abused its discretion by giving the government more closing argument time based solely on its burden of proof, this error was harmless due to overwhelming evidence of guilt. The court found no reversible error on the other grounds and affirmed her conviction. View "USA v. Hernandez" on Justia Law

The defendant, a physician specializing in obstetrics and gynecology in Illinois, owned and operated a medical practice where she engaged in fraudulent billing to health care benefit programs, including Medicaid and Tricare, from February 2018 to April 2022. She submitted claims for procedures and services that were either not provided or not medically necessary, including telemedicine visits, office visits, and tests. Some of these fraudulent claims were for endometrial ablations, a procedure with significant consequences for patients’ reproductive health.Facing a thirteen-count indictment for health care fraud, the defendant pleaded guilty to two counts pursuant to a plea agreement. These counts specifically alleged the submission of fraudulent claims to Tricare for a telemedicine visit and lab testing. The United States District Court for the Northern District of Illinois, Eastern Division, held a sentencing hearing, during which it considered testimony from patients, expert witnesses, and victim impact statements. The court found that the defendant performed medically unnecessary procedures without informed consent, and that her statements during the plea hearing and subsequent professional regulation proceedings indicated a failure to accept responsibility.On appeal, the United States Court of Appeals for the Seventh Circuit reviewed three main issues: the district court’s denial of a reduction for acceptance of responsibility, application of a sentencing enhancement for reckless risk of serious bodily injury, and the substantive reasonableness of the 120-month sentence. The Seventh Circuit held that the district court did not clearly err in its factual findings, properly applied the sentence enhancement, and did not abuse its discretion in weighing aggravating and mitigating factors. The court affirmed the judgment of the district court, upholding the defendant’s sentence. View "USA v Ghosh" on Justia Law

After the death of their fourteen-year-old daughter Taylor Rose Sookra in December 2021, four months after she received Pfizer’s COVID-19 vaccine, Arthur Sookra and April Burch-Sookra filed a lawsuit. They alleged willful misconduct under the Public Readiness and Emergency Preparedness Act (PREP Act) against Pfizer, federal officials, the physician who administered the vaccine, and the pediatric practice. Their claims included both federal law claims and state-law tort claims.Initially, the case was filed in the United States District Court for the Eastern District of New York. When the Sookras added a PREP Act willful-misconduct claim, they requested and obtained a transfer to the United States District Court for the District of Columbia, as required by the statute. The defendants moved to dismiss, and the motions were referred to a magistrate judge who recommended dismissal of the claims against the federal government on sovereign immunity grounds and against Pfizer for failure to exhaust administrative remedies. The magistrate also recommended dismissal of Pfizer’s state-law claims based on immunity and advised that the court decline supplemental jurisdiction over the remaining state-law claims. The district court adopted these recommendations, dismissed the case, and denied as moot the plaintiffs’ later request for a three-judge court.On appeal, the United States Court of Appeals for the District of Columbia Circuit held that the district court erred by dismissing the complaint without first convening a three-judge court, as required by 42 U.S.C. § 247d-6d(e)(5) for willful-misconduct claims under the PREP Act. The appellate court vacated the district court’s judgment and remanded with instructions to initiate procedures for convening a three-judge court. The court did not address the other arguments raised by the parties. View "Sookra v. Pfizer Inc." on Justia Law