Justia Health Law Opinion Summaries

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

The dispute centers on allegations by a Minnesota-based health insurer that several related pharmaceutical companies carried out an unlawful scheme involving the distribution and sale of repackaged and adulterated oncology drugs. The scheme allegedly involved breaking sterile seals on medication vials, pooling overfill amounts—which were not intended for patient use—and creating pre-filled syringes that were then sold to healthcare providers. These syringes were ultimately administered to cancer patients, including many insured under programs operated by the plaintiff. The defendants did not themselves submit claims for reimbursement, but the plaintiff asserts it paid for treatments using these adulterated drugs, unaware of their compromised quality.Prior to this lawsuit, the scheme was the subject of other civil actions and federal investigations, including qui tam actions and a federal criminal prosecution. The defendants disclosed these investigations in annual reports filed with the Securities and Exchange Commission and the events received media attention beginning in 2012. In 2017, a related company pleaded guilty to federal charges, admitting to the repackaging scheme, and paid significant fines and settlements. The plaintiff filed suit in 2023, asserting claims for common-law fraud, unjust enrichment, and violations of several Minnesota consumer protection statutes. The United States District Court for the District of Minnesota dismissed the complaint, finding the claims were barred by the applicable six-year statute of limitations, and that the plaintiff had failed to sufficiently plead fraudulent concealment to toll the limitations period.The United States Court of Appeals for the Eighth Circuit reviewed the district court’s dismissal de novo. It concluded that publicly available disclosures and the plaintiff’s own allegations established that the plaintiff should have discovered its causes of action no later than 2016. Because the plaintiff did not file suit until 2023, its claims were untimely. The court affirmed the district court’s judgment, holding that all claims were barred by the statute of limitations. View "United HealthCare Services, Inc. v. AmerisourceBergen Corporation" on Justia Law

In 2024, Iowa enacted legislation (HF 2677) prohibiting the manufacture and sale of electronic nicotine delivery systems (ENDS) that had not received marketing authorization from the United States Food and Drug Administration (FDA). The law required manufacturers to certify their compliance with federal premarket approval requirements or demonstrate that their products were pending FDA review. Several manufacturers, retailers, and consumers challenged the law, contending it was preempted by federal law, specifically the Family Smoking Prevention and Tobacco Control Act, and that it violated constitutional equal protection guarantees.The United States District Court for the Southern District of Iowa granted a preliminary injunction, halting enforcement of the law. The district court found that at least one plaintiff had standing, was likely to succeed on the merits of the preemption claim, and was not required to post a security bond. It dismissed claims against the Iowa Department of Revenue based on Eleventh Amendment immunity but allowed the case to proceed against the Director in her official capacity. The Department voluntarily stayed enforcement while the litigation continued.The United States Court of Appeals for the Eighth Circuit reviewed the district court’s order. The Eighth Circuit held that at least one retailer plaintiff had Article III standing, as they plausibly alleged injury from the credible threat of enforcement. However, the appellate court concluded the plaintiffs were not likely to succeed on the merits of their preemption claim. The court determined that HF 2677 was not preempted by federal law, as it fell within the scope of the Tobacco Control Act’s savings clause, which permits state requirements relating to the sale and distribution of tobacco products. The Eighth Circuit vacated the preliminary injunction and remanded the case for further proceedings. View "Iowans for Alternatives v. Mosiman" on Justia Law

Buyers of over-the-counter nasal decongestants containing oral phenylephrine brought numerous class actions against drug manufacturers and retailers, alleging that for years these companies sold and advertised decongestant products they knew to be ineffective. The plaintiffs claimed that scientific studies, particularly since 2016, had shown oral phenylephrine to be no better than a placebo at relieving congestion, yet the companies continued to market their products as effective decongestants and complied with Food and Drug Administration (FDA) labeling requirements. The FDA, despite mounting evidence, did not remove oral phenylephrine’s designation as an effective decongestant under its regulations.The Judicial Panel on Multidistrict Litigation consolidated nearly one hundred class actions and transferred them to the United States District Court for the Eastern District of New York. Plaintiffs filed a complaint asserting New York statutory and common-law claims as well as a federal RICO claim. The district court granted the defendants’ motion to dismiss, holding that the Federal Food, Drug, and Cosmetic Act (FDCA) expressly preempted the state law claims because the drugs’ labels complied with FDA requirements, and that the plaintiffs lacked standing to bring the RICO claim. The court also dismissed a Lanham Act claim brought by one pharmacy plaintiff.On appeal, the United States Court of Appeals for the Second Circuit held that the FDCA expressly preempts most of the state law claims because the federal regime requires manufacturers to follow the FDA-approved labeling, but it vacated the dismissal for claims regarding “Maximum Strength” labeling and brand-name drugs approved via the New Drug Application process, remanding those for further proceedings. The court affirmed dismissal of the RICO claim, adopting the indirect purchaser rule, and upheld denial of the pharmacy’s motion for reconsideration regarding its Lanham Act claim. View "Yousefzadeh v. Johnson & Johnson Consumer Inc." on Justia Law