Justia U.S. 9th Circuit Court of Appeals Opinion Summaries

Oregon enacted a law requiring prescription drug manufacturers to report detailed information about certain drugs, including pricing, costs, and factors contributing to price increases, to the state’s Department of Consumer and Business Services. The law also directs the agency to post most of this information online, but prohibits public disclosure of information designated as a trade secret unless the agency determines that disclosure is in the public interest. Since the law’s enactment, manufacturers have claimed thousands of trade secrets, but the agency has not publicly disclosed any such information.A trade association representing pharmaceutical manufacturers sued the director of the Oregon agency in the United States District Court for the District of Oregon, raising several facial constitutional challenges. The district court granted summary judgment for the association on two claims: that the reporting requirement violated the First Amendment by compelling speech, and that any use of the public-interest exception to disclose trade secrets would constitute an uncompensated taking under the Fifth Amendment. The court declared the entire reporting requirement unconstitutional and held that any disclosure of trade secrets under the public-interest exception would violate the Takings Clause unless just compensation was provided.The United States Court of Appeals for the Ninth Circuit reviewed the case. It reversed the district court’s summary judgment for the association on both the First and Fifth Amendment claims. The Ninth Circuit held that the reporting requirement compels commercial speech and survives intermediate scrutiny under the First Amendment, as it directly advances substantial state interests in transparency and market efficiency and is not more extensive than necessary. On the takings claim, the court found the association’s challenge justiciable but concluded that, under the Penn Central regulatory takings framework, none of the factors supported a facial claim that every disclosure under the public-interest exception would constitute a taking. The court remanded with instructions to enter summary judgment for the state on these claims. View "Pharmaceutical Research and Manufacturers of America v. Stolfi" on Justia Law

A pharmaceutical company developed a sublingual opioid painkiller, DSUVIA, which could only be administered in medically supervised settings due to safety concerns and was subject to a strict FDA Risk Evaluation and Mitigation Strategy (REMS). The company marketed DSUVIA with the slogan “Tongue and Done” at investor conferences, accompanied by additional disclosures about the drug’s limitations and REMS requirements. After the FDA issued a warning letter objecting to the slogan as potentially misleading under the Federal Food, Drug, and Cosmetic Act, several shareholders filed suit, alleging that the slogan misled investors about the complexity of administering DSUVIA and the drug’s limited market potential.The United States District Court for the Northern District of California dismissed the shareholders’ complaint, finding that the plaintiffs failed to adequately plead facts supporting a strong inference of scienter, but did not rule on whether the statements were false or misleading. The plaintiffs were given two opportunities to amend their complaint, but the court ultimately dismissed the case with prejudice.On appeal, the United States Court of Appeals for the Ninth Circuit reviewed the dismissal de novo. The Ninth Circuit held that the plaintiffs failed to adequately plead falsity because a reasonable investor would not interpret the “Tongue and Done” slogan in isolation, but would consider the context provided by accompanying disclosures and other available information. The court also held that the FDA’s warning letter did not establish falsity under securities law, as the standards and intended audiences differ. Additionally, the court found that the plaintiffs did not plead a strong inference of scienter, as the facts suggested the company’s officers acted in good faith. The Ninth Circuit affirmed the district court’s dismissal. View "Sneed v. Talphera, Inc." on Justia Law

Dionne Marie Nadon applied for disability insurance benefits and supplemental security income in April 2015 and May 2016, respectively, citing conditions such as fibromyalgia, spinal abnormalities, depression, and anxiety. The administrative law judge (ALJ) initially denied her applications in January 2017, finding she could return to her past work as a cashier/checker. On appeal, the case was remanded because the ALJ had not adequately addressed Nadon’s post-traumatic stress disorder (PTSD). On remand, the ALJ again determined that Nadon was not disabled, following the five-step sequential analysis for determining disabilities.The ALJ found that Nadon had engaged in substantial gainful activity as a personal care attendant from July 2021 through 2022 but continued the analysis due to a continuous period of at least twelve months during which Nadon did not engage in substantial gainful activity. The ALJ found that Nadon had severe impairments but did not have an impairment or combination of impairments that met or equaled the severity of a listed impairment. The ALJ determined that Nadon’s residual functional capacity allowed her to perform light work with certain limitations and found that she could perform her past relevant work as a personal care attendant and other work as a housekeeper, marker, or small products assembler.The district court affirmed the ALJ’s decision. The United States Court of Appeals for the Ninth Circuit reviewed the case de novo and affirmed the district court’s decision. The court held that the ALJ did not err by considering Nadon’s work as a personal care attendant, as an ALJ is permitted to consider any work done by a claimant when evaluating a disability claim. The court also found that the ALJ provided several reasons for discounting Nadon’s testimony and the opinions of several healthcare professionals, beyond her work as a personal care attendant. The court rejected Nadon’s argument that the ALJ erred by relying on the vocational expert’s testimony, as it relied on the rejected premise that the ALJ erred in discounting the healthcare professionals’ opinions. View "Nadon v. Bisignano" on Justia Law

Mark Schena operated Arrayit, a medical testing laboratory in Northern California, which focused on blood tests for allergies. Schena marketed these tests as superior to skin tests, despite their limitations, and billed insurance providers up to $10,000 per test. To maintain a steady flow of patient samples, Schena paid marketers a percentage of the revenue they generated by pitching Arrayit’s services to medical professionals, often misleading them about the tests' efficacy. During the COVID-19 pandemic, Schena transitioned to COVID testing, using similar deceptive marketing practices to bundle allergy tests with COVID tests.The United States District Court for the Northern District of California denied Schena’s motion to dismiss the EKRA counts, arguing that his conduct did not violate the statute as a matter of law. The jury convicted Schena on all counts, including conspiracy to commit healthcare fraud, healthcare fraud, conspiracy to violate EKRA, EKRA violations, and securities fraud. The district court sentenced Schena to 96 months in prison and ordered him to pay over $24 million in restitution.The United States Court of Appeals for the Ninth Circuit reviewed the case and affirmed Schena’s convictions. The court held that 18 U.S.C. § 220(a)(2)(A) of EKRA covers payments to marketing intermediaries who interface with those who do the referrals, and there is no requirement that the payments be made to a person who interfaces directly with patients. The court also concluded that a percentage-based compensation structure for marketing agents does not violate EKRA per se, but the evidence showed wrongful inducement when Schena paid marketers to unduly influence doctors’ referrals through false or fraudulent representations. The court affirmed Schena’s EKRA and other convictions, vacated in part the restitution order, and remanded in part. View "United States v. Schena" on Justia Law

Thomas Keller, a physician specializing in pain management, was convicted of prescribing controlled substances outside the scope of professional practice. Keller was known for prescribing large quantities of opioids, which led to a federal investigation. During the investigation, agents seized a journal from Keller's residence, which contained patient information and medical notes. Keller was subsequently indicted on federal charges, including unlawfully dispensing controlled substances and health care fraud. He was convicted on four counts of distributing controlled substances outside the scope of professional practice.The United States District Court for the Northern District of California denied Keller's motion to suppress the journal, finding it fell within the scope of the search warrant and was supported by probable cause. The court also declined to hold an evidentiary hearing on the suppression motion, ruling that Keller's allegations did not establish contested issues of fact. Additionally, the court rejected Keller's argument that the charges violated the nondelegation doctrine, holding that the Attorney General's regulations were within the scope of authority delegated by Congress. Keller was sentenced to 30 months in prison and 3 years of supervised release.The United States Court of Appeals for the Ninth Circuit affirmed Keller's conviction and sentence. The court held that the district court did not err in denying the motion to suppress the journal, as it was properly seized under the search warrant. The court also found no abuse of discretion in the district court's decision not to hold an evidentiary hearing. The court upheld the constitutionality of the nondelegation doctrine as applied to Keller's charges. Finally, the court ruled that the district court correctly calculated Keller's sentencing range using the drug conversion ratio found in the Sentencing Guidelines commentary, as it was properly incorporated into the Guidelines. View "United States v. Keller" on Justia Law

Juan Carlos Enriquez, a pharmacy technician, was involved in a scheme to refer Medicare and Medi-Cal beneficiaries to pharmacies owned by his alleged co-conspirator, Irina Sadovsky, in exchange for kickbacks. Enriquez was indicted for conspiracy to receive healthcare kickbacks in violation of 18 U.S.C. § 371 and for receiving prohibited payments in violation of the Anti-Kickback Statute (AKS). He moved to dismiss the indictment, arguing it failed to state an offense and lacked specificity because it did not negate the statutory safe harbor for a bona fide employment relationship under 42 U.S.C. § 1320a-7b(b)(3)(B).The United States District Court for the Central District of California denied Enriquez’s motion to dismiss. Enriquez then entered a conditional guilty plea, reserving the right to appeal the denial of his pretrial motion. The district court sentenced him to one day of imprisonment, followed by two years of supervised release, and ordered him to pay $121,115 in restitution.The United States Court of Appeals for the Ninth Circuit reviewed the case. Enriquez argued that the principles from Ruan v. United States, which required the government to prove beyond a reasonable doubt that a defendant knew they were acting in an unauthorized manner under the Controlled Substances Act, should apply to the AKS. He contended that the AKS bona fide employment safe harbor should be treated as a "quasi-element" for pleading purposes. The Ninth Circuit declined to extend Ruan’s reasoning to the AKS or to pleading requirements, affirming that indictments need not allege affirmative defenses. The court held that the indictment provided sufficient detail to inform Enriquez of the charges and enable him to prepare his defense. The district court’s denial of Enriquez’s motion to dismiss was affirmed. View "USA V. ENRIQUEZ" on Justia Law

Elizabeth Holmes and Ramesh "Sunny" Balwani, founders of Theranos, were convicted of defrauding investors about the capabilities of their company's blood-testing technology. Theranos claimed it could run accurate tests with just a drop of blood, attracting significant investments. However, the technology was unreliable, and the company misled investors about its financial health, partnerships, and the validation of its technology by pharmaceutical companies.The United States District Court for the Northern District of California severed their trials due to Holmes's allegations of abuse by Balwani. Holmes was convicted on four counts related to investor fraud, while Balwani was convicted on all counts, including conspiracy to commit wire fraud against investors and patients. Holmes was sentenced to 135 months, and Balwani to 155 months in prison. The district court also ordered them to pay $452 million in restitution.The United States Court of Appeals for the Ninth Circuit reviewed the case. The court affirmed the convictions, sentences, and restitution order. It held that the district court did not abuse its discretion in admitting testimony from former Theranos employees, even if some of it veered into expert territory. The court found any errors in admitting this testimony to be harmless due to the weight of other evidence against the defendants.The Ninth Circuit also upheld the district court's decision to admit a report from the Center for Medicare and Medicaid Services, finding it relevant to Holmes's knowledge and intent. The court rejected Holmes's argument that the district court violated her Confrontation Clause rights by limiting cross-examination of a former Theranos lab director. Additionally, the court found no merit in Balwani's claims of constructive amendment of the indictment and Napue violations. The court concluded that the district court's factual findings on loss causation and the number of victims were not clearly erroneous and affirmed the restitution order. View "USA V. HOLMES" on Justia Law

A medical institute and its co-director sought to provide patients with psilocybin, a schedule I controlled substance, for therapeutic use. They requested the Drug Enforcement Administration (DEA) to exempt the co-director from registration under the Controlled Substances Act (CSA) or to waive the registration requirement. The DEA declined both requests, leading the petitioners to seek judicial review.Previously, the petitioners had asked the DEA for guidance on accommodating the Right to Try Act (RTT Act) for psilocybin use. The DEA responded that the RTT Act did not waive CSA requirements, and the petitioners' initial judicial review was dismissed for lack of jurisdiction. The petitioners then made a concrete request to the DEA for exemption or waiver, which the DEA again denied, prompting the current appeal.The United States Court of Appeals for the Ninth Circuit reviewed the case. The court held that it had jurisdiction under 21 U.S.C. § 877 to review the DEA's final decision. The court found that the DEA's denial was not arbitrary and capricious. The DEA provided a reasonable explanation, stating that the RTT Act did not exempt the CSA's requirements and that the proposed use of psilocybin was inconsistent with public health and safety. The DEA also noted that the petitioners did not provide sufficient details for the proposed regulation. The court denied the petition for review, affirming the DEA's decision. View "ADVANCED INTEGRATIVE MEDICAL SCIENCE INSTITUTE, PLLC V. UNITED STATES DRUG ENFORCEMENT ADMIN" on Justia Law

Julian Omidi and his business, Surgery Center Management, LLC (SCM), were involved in a fraudulent scheme called "Get Thin," which promised weight loss through Lap-Band surgery and other medical procedures. Omidi and SCM defrauded insurance companies by submitting false claims for reimbursement, including fabricated patient data and misrepresented physician involvement. The scheme recruited patients through a call center, pushing them towards expensive medical tests and procedures regardless of medical necessity.A grand jury indicted Omidi and SCM for mail fraud, wire fraud, money laundering, and related charges. After extensive pretrial litigation and a lengthy jury trial, both were convicted on all charges. The district court sentenced Omidi to 84 months in prison and fined SCM over $22 million. The government sought forfeiture of nearly $100 million, arguing that all proceeds from the Get Thin scheme were derived from fraud. The district court agreed, finding that even proceeds from legitimate procedures were indirectly the result of the fraudulent scheme.The United States Court of Appeals for the Ninth Circuit reviewed the case. The court affirmed the district court's forfeiture judgment, holding that under 18 U.S.C. § 981(a)(1)(C), all proceeds directly or indirectly derived from a health care fraud scheme must be forfeited. The court rejected the argument that only proceeds from fraudulent transactions should be forfeited, noting that the entire business was permeated with fraud. The court concluded that there is no "100% Fraud Rule" in forfeiture cases seeking proceeds of a fraud scheme, and all proceeds from the Get Thin scheme were subject to forfeiture. View "United States V. Surgery Center Management, LLC" on Justia Law

A group of 53 California hospitals challenged the Secretary of Health and Human Services' (HHS) 2020 low-wage-index policy, which adjusted Medicare payment rates by inflating the rates for the lowest quartile of hospitals and reducing payments to all hospitals by a small percentage. The hospitals argued that the policy violated statutory provisions, was arbitrary and capricious, resulted from a faulty administrative procedure, and was unsupported by evidence.The United States District Court for the Central District of California denied HHS's motion for summary judgment, granted the hospitals' motion for summary judgment, and remanded the matter to the Secretary without vacating the policy. The court held that HHS lacked authority to implement the low-wage-index policy under either the Wage Index Provision or the Exceptions and Adjustments Provision and found procedural defects in the policy's implementation.The United States Court of Appeals for the Ninth Circuit affirmed the district court's holding that the Secretary exceeded his statutory authority in establishing the 2020 wage index. The court held that the low-wage-index policy did not "reflect" area differences in hospital wage levels as required by the statute and that the Exceptions and Adjustments Provision could not independently authorize the policy. The court also vacated the district court's decision to remand the case without vacating the policy, stating that when an agency cannot issue the challenged policy in another way, the only appropriate remedy is vacatur. Judge Nguyen dissented, arguing that the low-wage-index policy was consistent with the statutory text and that the majority's decision would have negative repercussions for vulnerable communities. View "Kaweah Delta Health Care District v. Becerra" on Justia Law