Justia Health Law Opinion Summaries

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 third-party payors who covered prescriptions for Avandia, a diabetes medication manufactured by GlaxoSmithKline LLC, brought a putative class action alleging that the company misrepresented Avandia’s cardiovascular risks and benefits. They claimed these misrepresentations led health care providers to prescribe Avandia more frequently than less expensive alternatives, causing the payors to reimburse for prescriptions that otherwise would not have been issued. The plaintiffs sought class certification on behalf of entities that paid for Avandia prescriptions during a specified period.The United States District Court for the Eastern District of Pennsylvania previously reviewed this case. It denied GlaxoSmithKline’s motion to dismiss the plaintiffs’ Racketeer Influenced and Corrupt Organizations Act (RICO) claim, and the Third Circuit affirmed that denial. Later, the District Court granted summary judgment to GlaxoSmithKline on certain claims, but the Third Circuit reversed in part and remanded for further proceedings. Most recently, the District Court granted class certification, finding the class ascertainable and concluding that common issues would predominate regarding causation. It relied on evidence of a common scheme to deceive and statistical analyses showing marketing campaigns increased prescriptions.The United States Court of Appeals for the Third Circuit reviewed the District Court’s class certification. The Third Circuit held that while the class is ascertainable, the record does not yet demonstrate that common questions predominate on causation. The court clarified that plaintiffs in pharmaceutical fraud RICO class actions may use statistical evidence to prove causation, but such evidence must establish causation, not merely correlation. Because the plaintiffs’ statistical evidence failed to satisfy this standard, the Third Circuit vacated the District Court’s class certification and remanded for further fact-finding on predominance under the clarified standard. View "In re Avandia Marketing" on Justia Law

The case involves a dispute between two biopharmaceutical companies over the distribution of a biosimilar drug following the expiration of a key patent. After Janssen’s patent for the composition of its biologic drug expired, Samsung sought to introduce its biosimilar product. Janssen and Samsung had previously settled related patent litigation through an agreement that granted Samsung a limited license to enter the market at a set date and restricted Samsung’s ability to sublicense, except to certain commercialization partners. Samsung subsequently entered into agreements with both Sandoz and Quallent, a subsidiary of the Cigna Group, allowing Quallent to distribute the biosimilar under its own label. Janssen argued that the sublicense to Quallent violated the settlement agreement and would cause it irreparable harm by altering market dynamics, reducing its market share and negotiation leverage, and sought a preliminary injunction to prevent Samsung from supplying Quallent during the litigation.The United States District Court for the District of New Jersey denied Janssen’s motion for a preliminary injunction. The court found that while Janssen was likely to succeed on the merits of its breach-of-contract claim, it had not demonstrated irreparable harm because any injury could be measured and compensated by monetary damages. The court credited Samsung’s expert's view that harm to Janssen would be quantifiable, did not find persuasive evidence of brand loyalty or reputational harm, and concluded that Janssen’s asserted loss of negotiation leverage was too speculative.On appeal, the United States Court of Appeals for the Third Circuit reviewed the District Court’s denial for abuse of discretion and affirmed. The Court held that loss of market share in a complex market does not categorically constitute irreparable harm in contract cases, and that mere difficulty in calculating damages does not meet the threshold for irreparable harm. The Court concluded that Janssen had not shown the requisite irreparable harm to justify preliminary injunctive relief. View "Johnson & Johnson v. Samsung Bioepis Co Ltd" on Justia Law

A New Jersey physician wished to provide medical aid in dying to terminally ill patients, including nonresidents seeking this service under New Jersey’s law that permits doctor-assisted suicide. The relevant statute allows only New Jersey residents, with a prognosis of six months or fewer to live, to request and obtain a prescription for life-ending medication. Patients must demonstrate residency through various documents and satisfy several procedural safeguards. The plaintiff, a physician, challenged the law’s residency requirement after two terminally ill nonresidents who had joined the suit died during the course of litigation.The United States District Court for the District of New Jersey dismissed the complaint. The court reasoned that the right to receive medical aid in dying was neither a fundamental privilege nor a fundamental right requiring extension to nonresidents under the Privileges and Immunities Clause or the Equal Protection Clause. It further found the law was not economic protectionism and survived rational-basis review. The plaintiff appealed this decision.The United States Court of Appeals for the Third Circuit affirmed the District Court’s dismissal. It held that New Jersey’s restriction of doctor-assisted suicide to its own residents does not violate the Privileges and Immunities Clause because there is no longstanding tradition making such access a fundamental privilege, nor does it violate the Equal Protection Clause, as there is no fundamental right to assisted suicide or to interstate travel for this purpose. The Third Circuit also determined that the law does not offend the dormant Commerce Clause since it is a moral rather than commercial regulation and does not discriminate against out-of-state economic interests. The court concluded that New Jersey’s residency requirement is constitutionally permissible, justified by the state’s interests in protecting doctors, avoiding interstate friction, and safeguarding patients. View "Bryman v. Murphy" on Justia Law

An employee of a telecommunications company, who also served as a union representative, was charged with defrauding a pharmacy benefits management company by orchestrating the submission of fraudulent claims for compounded medications. The government alleged that he induced another individual to obtain medically unnecessary compounded drugs and arranged for a doctor to sign prescriptions without a medical examination or determination of necessity. The prescriptions were then used to submit claims to the company’s health plan, and the employee received a percentage of the reimbursement. The government further alleged that the employee paid the individual to participate in the scheme and later instructed him to lie to investigators.The United States District Court for the District of New Jersey granted the defendant’s motion to dismiss the superseding indictment. The court found that the indictment failed to allege any actionable misrepresentation or omission under 18 U.S.C. § 1347, did not specify how the fraudulent claims were submitted or by whom, and did not identify any false statements or omissions in the claims. The court also expressed concern about the use of the term “medically unnecessary,” finding it vague and undefined.On appeal, the United States Court of Appeals for the Third Circuit reviewed the sufficiency of the indictment de novo. The Third Circuit held that the indictment adequately alleged an implicit misrepresentation: that the prescriptions, incorporated into the claims, falsely implied medical necessity and a legitimate doctor-patient relationship. The court found that such implicit misrepresentations are actionable under the health care fraud statute. The court also determined that the indictment’s language was sufficiently clear to apprise the defendant of the charges. Accordingly, the Third Circuit reversed the District Court’s dismissal and remanded the case for further proceedings. View "USA v. Mattia" on Justia Law

Nita and Kirtish Patel operated two companies that provided mobile diagnostic medical services. To obtain Medicare reimbursement for neurological testing, they falsely represented that a licensed neurologist would supervise the tests. In reality, Kirtish, who lacked a medical license, wrote the reports, and Nita forged a physician’s signature. Their fraudulent scheme generated over $4 million, including substantial Medicare payments.In 2014, a former employee filed a sealed qui tam action in the United States District Court for the District of New Jersey, alleging healthcare fraud and asserting claims under the False Claims Act. The Patels were subsequently arrested and each pleaded guilty to one count of healthcare fraud. Their plea agreements did not address or preclude future civil or administrative actions. After their guilty pleas, the Government intervened in the qui tam action and obtained summary judgment against the Patels, relying on collateral estoppel from their criminal admissions. The District Court trebled the Medicare loss and imposed civil penalties, resulting in a judgment exceeding $7 million. Nita appealed, and the United States Court of Appeals for the Third Circuit affirmed her liability under the False Claims Act.Both Patels later moved to vacate their criminal sentences under 28 U.S.C. § 2255, arguing ineffective assistance of counsel because their attorneys did not advise them that their guilty pleas could have collateral estoppel effects in the civil qui tam action. The District Court denied their motions, finding that counsel’s performance was not objectively unreasonable and that the Patels were aware their plea agreements did not preclude civil actions.On appeal, the United States Court of Appeals for the Third Circuit held that the Sixth Amendment does not require criminal defense counsel to advise clients of collateral consequences such as civil liability under the False Claims Act. The court affirmed the District Court’s judgment, concluding that Padilla v. Kentucky’s holding is limited to deportation consequences and does not extend to civil liability. View "Patel v. USA" on Justia Law

Novo Nordisk, a pharmaceutical manufacturer, challenged the implementation of the Drug Price Negotiation Program established by the Inflation Reduction Act of 2022. The Program requires the Department of Health and Human Services, through the Centers for Medicare and Medicaid Services (CMS), to negotiate prices for certain high-expenditure drugs covered by Medicare. In the first round of selections, CMS grouped six of Novo Nordisk’s insulin aspart products as a single “negotiation-eligible drug” and selected them for price negotiation. Novo Nordisk signed the required agreements to participate but subsequently filed suit, arguing that CMS’s grouping of its products and the procedures used to implement the Program violated statutory and constitutional provisions.The United States District Court for the District of New Jersey granted summary judgment in favor of the government. The court found it lacked subject matter jurisdiction to review CMS’s decision to treat the six products as one drug due to a statutory bar on judicial review. It also held that Novo Nordisk lacked standing to challenge the identification of more than ten drugs for the initial pricing period. The court rejected Novo Nordisk’s claims under the unconstitutional conditions doctrine, the Due Process Clause, the nondelegation doctrine, and the First Amendment, concluding that the Program did not deprive the company of a protected property interest, that Congress provided an intelligible principle to guide CMS, and that the Program primarily regulated conduct rather than speech.On appeal, the United States Court of Appeals for the Third Circuit affirmed the District Court’s judgment. The Third Circuit held that the statutory bar on judicial review precluded consideration of Novo Nordisk’s challenge to the grouping of its products. The court also held that CMS was authorized to implement the Program through guidance for the initial years without notice and comment rulemaking, that the Act did not violate the nondelegation doctrine or the Due Process Clause, and that Novo Nordisk’s First Amendment claim was foreclosed by precedent. View "Novo Nordisk Inc. v. Secretary US Dept & Health and Human Services" on Justia Law

Natalya Shvets was convicted by a jury in 2014 for healthcare fraud and conspiracy to commit healthcare fraud, stemming from her role as a nurse at Home Care Hospice, Inc. (HCH). Evidence showed she and other employees created false records for high-priced “continuous care” services, resulting in fraudulent bills submitted to Medicare. Shvets was ordered to pay $253,196 in restitution, jointly and severally with eight other defendants, for her involvement in 52 false bills. The broader scheme allegedly caused $16.2 million in losses to Medicare, with seventeen individuals ordered to pay varying restitution amounts.After sentencing in the United States District Court for the Eastern District of Pennsylvania, Shvets moved for an accounting and to declare her restitution judgment satisfied, arguing that payments by herself and her jointly liable co-defendants had collectively exceeded $253,196. The District Court, relying on United States v. Sheets, held that Shvets’s judgment would not be satisfied until she personally paid the full amount or until all defendants collectively paid $16.2 million. The Clerk of Court, using a complex allocation method, also reported Shvets’s balance as outstanding, but the District Court did not resolve whether the Clerk’s method was correct.On appeal, the United States Court of Appeals for the Third Circuit affirmed in part, vacated in part, and remanded. The Court held that sentencing judges may issue “hybrid” restitution orders under the Mandatory Victim Restitution Act, combining joint and several liability with apportioned liability. The Court found the District Court erred by applying the Sheets rule, which conflicted with the language of Shvets’s judgment. The Third Circuit directed the District Court to determine whether the Clerk’s accounting method is fair and appropriate, and to decide if Shvets’s restitution judgment has been satisfied. View "United States v. Shvets" on Justia Law

A pharmaceutical company challenged provisions of the Inflation Reduction Act of 2022, which established a program requiring the Department of Health and Human Services, through the Centers for Medicare and Medicaid Services (CMS), to negotiate maximum fair prices for certain high-cost prescription drugs covered by Medicare. The company’s drug was selected for the program, and it signed the required agreements to participate. The program imposes significant penalties and an excise tax on manufacturers who do not comply, but allows manufacturers to exit Medicare and Medicaid programs to avoid the tax, a process the company argued was not a realistic option.After its drug was selected, the company filed suit in the United States District Court for the District of New Jersey, alleging that the program violated the Eighth Amendment’s Excessive Fines Clause, the Fifth Amendment’s Takings Clause, and the First Amendment’s Free Speech Clause. The District Court granted summary judgment for the government, holding that participation in the program is voluntary and that the program primarily regulates conduct, not speech. The court also found it lacked jurisdiction over the Eighth Amendment claim due to the Tax Anti-Injunction Act and the Declaratory Judgment Act.On appeal, the United States Court of Appeals for the Third Circuit affirmed. The court held that the company’s Eighth Amendment claim was barred by the Tax Anti-Injunction Act and the Declaratory Judgment Act, as the relief sought would restrain the assessment or collection of a federal tax. The court further held that the program does not violate the Takings Clause or the First Amendment, relying on its recent precedent. The judgment of the District Court was affirmed. View "Novartis Pharmaceuticals Corp v. Secretary Department of Health" on Justia Law

Two pharmaceutical companies challenged a federal program created by the Inflation Reduction Act of 2022, which directs the Centers for Medicare and Medicaid Services (CMS) to negotiate prices for certain high-expenditure prescription drugs lacking generic competition. Under this program, manufacturers of selected drugs must either negotiate a price with CMS or face steep excise taxes on all sales of those drugs, unless they withdraw all their products from specific Medicare and Medicaid programs. Both companies had drugs selected for negotiation and, while litigation was pending, agreed to participate and reached negotiated prices.The United States District Court for the District of New Jersey resolved the cases on cross-motions for summary judgment, as the parties agreed there were no material factual disputes. The District Court ruled in favor of the government, holding that the program did not violate the Takings Clause, the First Amendment, or the unconstitutional conditions doctrine. The companies appealed, and the United States Court of Appeals for the Third Circuit consolidated the appeals.The Third Circuit affirmed the District Court’s orders. It held that participation in Medicare and the negotiation program is voluntary, so there is no physical taking under the Fifth Amendment. The court found that economic incentives to participate do not amount to legal compulsion. It also held that the program’s requirements do not compel speech in violation of the First Amendment, as any speech involved is incidental to the regulation of conduct and participation is voluntary. Finally, the court concluded that the program does not impose unconstitutional conditions, as any compelled speech is limited to the contracts necessary to effectuate the program and does not restrict speech outside those contracts. The court affirmed summary judgment for the government. View "Bristol Myers Squibb Co v. Secretary United States Department of HHS" on Justia Law