Justia Health Law Opinion Summaries

The Association for Accessible Medicines (AAM), representing generic drug manufacturers, challenged a Minnesota law regulating drug prices, Minn. Stat. § 62J.842, arguing it violated the dormant Commerce Clause. The law prohibits manufacturers from imposing excessive price increases on generic or off-patent drugs sold in Minnesota. The district court granted AAM's motion for a preliminary injunction, finding the law likely violated the dormant Commerce Clause.The United States District Court for the District of Minnesota concluded that AAM was likely to succeed on the merits of its claim, faced a threat of irreparable harm, and that the balance of harms and public interest factors were neutral. Minnesota appealed, contesting the likelihood of success on the merits and the balance of harms/public interest.The United States Court of Appeals for the Eighth Circuit reviewed the district court’s ruling for abuse of discretion and its legal conclusions de novo. The court found that the Minnesota law had the impermissible extraterritorial effect of controlling prices outside the state, similar to laws previously struck down by the Supreme Court. The court rejected Minnesota's argument that the law did not control out-of-state prices, noting that it effectively regulated out-of-state transactions if the drugs ended up in Minnesota.The Eighth Circuit affirmed the district court’s decision, agreeing that AAM was likely to succeed on the merits of its dormant Commerce Clause claim. The court also found no abuse of discretion in the district court’s assessment of the balance of harms and public interest, noting that protecting constitutional rights is always in the public interest. The preliminary injunction against the Minnesota law was upheld. View "Ass'n for Accessible Medicines v. Ellison" on Justia Law

SWT Global Supply, Inc. (SWT Global), a Missouri-based manufacturer of electronic nicotine delivery system (ENDS) vaping products, sought review of the U.S. Food and Drug Administration's (FDA) denial of market authorization for its menthol-flavored ENDS products. The FDA denied the premarket tobacco product applications (PMTAs) submitted by SWT Global, citing insufficient evidence that the products would benefit adult users enough to outweigh the risks to youth.The FDA's decision was based on the Family Smoking Prevention and Tobacco Control Act of 2009, which requires new tobacco products to receive FDA authorization before being sold. The FDA determined that SWT Global's PMTAs lacked product-specific evidence demonstrating that the menthol-flavored ENDS products would attract adults away from combustible cigarettes and reduce overall harm. The FDA also found SWT Global's marketing plan insufficient to prevent youth access to the products.The United States Court of Appeals for the Eighth Circuit reviewed the case. SWT Global argued that the FDA's denial was arbitrary and capricious, claiming the FDA changed its position on the required scientific evidence and failed to justify its finding that the marketing plan was insufficient. The court referenced the Supreme Court's decision in Food & Drug Administration v. Wages & White Lion Investments, L.L.C., which held that the FDA's denial of PMTAs for flavored ENDS products was consistent with its guidance and did not violate the change-in-position doctrine.The Eighth Circuit found that the FDA did not change its position regarding the scientific evidence required for PMTAs and provided a satisfactory explanation for its decision. The court also determined that the FDA's treatment of menthol-flavored ENDS products was reasonable and consistent with its approach to other non-tobacco-flavored ENDS products. Consequently, the court denied SWT Global's petition for review. View "SWT Global Supply, Inc. v. U.S. Food & Drug Administration" on Justia Law

On March 15, 2022, law enforcement responded to a drug overdose in Rapid City, South Dakota, where they found K.S. conscious but sluggish after receiving Narcan. Officers suspected two individuals, including a woman with purple hair, of distributing fentanyl to K.S. Surveillance at a hotel led to a traffic stop of a red Ford Fiesta, where officers found Anthony Ward in the backseat. Ward was arrested for false impersonation after providing false names. A search of the vehicle revealed drugs, a stolen gun, and cash. Ward was charged with distribution of a controlled substance resulting in serious bodily injury and conspiracy to distribute fentanyl.The United States District Court for the District of South Dakota denied Ward's motions to suppress evidence from the traffic stop and to dismiss the indictment for failure to preserve evidence. After a five-day trial, the jury convicted Ward on both counts, and the court imposed concurrent 360-month sentences. Ward appealed the district court's decisions.The United States Court of Appeals for the Eighth Circuit reviewed the case. The court upheld the district court's denial of Ward's motions to suppress and dismiss, finding no unreasonable extension of the traffic stop and no bad faith in the handling of evidence. The court also found sufficient evidence to support Ward's convictions. The court concluded that the evidence showed Ward distributed fentanyl that caused K.S.'s serious bodily injury and that Ward was involved in a conspiracy to distribute fentanyl. The judgment of the district court was affirmed. View "United States v. Ward" on Justia Law

Evan Brown Bull was convicted by a jury of conspiracy to distribute 500 or more grams of methamphetamine. The government presented evidence from thirteen witnesses and various forms of documentation, including videos and Facebook messages, detailing Brown Bull's drug dealings from 2016 to 2023. The Probation Office's Presentence Investigation Report (PSR) recommended a base offense level of 32, with adjustments that increased the total offense level to 40, resulting in an advisory guidelines sentencing range of 360 months to life imprisonment. Brown Bull objected to the PSR's findings and requested a downward variance to 180 months.The United States District Court for the District of South Dakota overruled Brown Bull's objections and applied three sentencing enhancements: a two-level increase for obstruction of justice, a four-level increase for being an organizer or leader of a criminal activity involving five or more participants, and a two-level increase for committing the offense as part of a pattern of criminal conduct engaged in as a livelihood. The court ultimately sentenced Brown Bull to 400 months imprisonment and five years of supervised release.The United States Court of Appeals for the Eighth Circuit reviewed the case and affirmed the district court's decision. The appellate court found no clear error in the district court's application of the sentencing enhancements. The court held that Brown Bull's pretrial jail messages and Facebook post constituted obstruction of justice, that he was an organizer or leader of the drug conspiracy, and that his criminal conduct was part of his livelihood. The court concluded that the district court's findings were supported by the evidence and upheld the 400-month sentence. View "United States v. Bull" on Justia Law

Paul Cropper applied for disability insurance benefits and supplemental security income in February 2020, citing various impairments such as anxiety, depression, ADHD, insomnia, and COPD. His application was denied initially and upon reconsideration by the Social Security Administration. Cropper then requested a hearing before an administrative law judge (ALJ), where he presented opinions from his medical providers indicating severe limitations. The ALJ conducted a five-step analysis and denied the application, finding that while Cropper had severe impairments, he could still perform certain jobs available in the national economy. The ALJ found the opinions of Cropper’s primary care provider and psychiatrist unpersuasive.Cropper sought judicial review in the United States District Court for the District of Minnesota, arguing that the ALJ improperly evaluated the evidence, leading to an incorrect residual functional capacity determination. The district court granted summary judgment in favor of the Commissioner, concluding that substantial evidence supported the ALJ’s decision to find the medical opinions unpersuasive.The United States Court of Appeals for the Eighth Circuit reviewed the case de novo and affirmed the district court’s decision. The court held that the ALJ adequately considered the supportability and consistency of the medical opinions as required by the revised regulations. The court emphasized that the ALJ’s findings were supported by substantial evidence, including the conservative course of treatment and the lack of significant outpatient therapy. The court also noted that the ALJ’s reasoning was sufficiently clear to allow for appropriate judicial review. View "Cropper v. Dudek" on Justia Law

Joe May was indicted for conspiracy to commit wire fraud, mail fraud, and violations of the Anti-Kickback statute, among other charges, related to defrauding TRICARE. May, a medical doctor, was recruited to sign prescriptions for compounded drugs without evaluating patients. He signed 226 prescriptions, mostly without determining medical necessity. May received cash payments for his participation. When investigated, May created false medical records and lied to the FBI.The United States District Court for the Eastern District of Arkansas convicted May on all counts and sentenced him to 102 months imprisonment, ordering restitution of over $4.6 million. May appealed, challenging the admission of business records, limitations on cross-examination, jury instructions, the government's closing argument, and the sufficiency of evidence for certain charges.The United States Court of Appeals for the Eighth Circuit reviewed the case. The court found no abuse of discretion in admitting business records or limiting cross-examination. The court upheld the jury instructions and found no error in the government's closing argument. The court determined there was sufficient evidence for the conspiracy, mail fraud, and kickback charges. However, the court found plain error in one count of aggravated identity theft related to Perry Patterson, as the jury was not instructed on the correct underlying offense.The Eighth Circuit reversed the conviction on the aggravated identity theft count related to Patterson, remanded to vacate the special assessment for that count, and affirmed all other aspects of the case. View "United States v. May" on Justia Law

John Doe filed a putative class action against SSM Health Care Corporation in Missouri state court, alleging that SSM shared private health information with third-party marketing services without authorization, violating Missouri law. Doe claimed that SSM's MyChart patient portal transmitted personal health data to third-party websites like Facebook. The lawsuit included nine state law claims, such as violations of the Missouri Wiretap Statute and the Computer Tampering Act.SSM removed the case to federal court, citing the federal officer removal statute and the Class Action Fairness Act (CAFA). Doe moved to remand the case to state court. The United States District Court for the Eastern District of Missouri rejected SSM's arguments, ruling that SSM was not "acting under" a federal officer and that Doe's proposed class was limited to Missouri citizens, thus lacking the minimal diversity required under CAFA. The district court remanded the case to state court.The United States Court of Appeals for the Eighth Circuit reviewed the case de novo. The court affirmed the district court's decision, holding that SSM did not meet the criteria for federal officer removal because it was not acting under the direction of a federal officer. The court also held that the proposed class was limited to Missouri citizens, which destroyed the minimal diversity necessary for CAFA jurisdiction. Consequently, the Eighth Circuit affirmed the district court's remand order. View "Doe v. SSM Health Care Corporation" on Justia Law

After plaintiff's son was denied coverage related to gender reassignment services and surgery, plaintiff filed suit against Essentia and the health insurance plan's third party administrator for sex based discrimination in violation of Title VII of the Civil Rights Act of 1964, the Minnesota Human Rights Act (MHRA), and the Affordable Care Act (ACA). The Eighth Circuit held that plaintiff was not discriminated against on the basis of her own sex, and the protections of Title VII and the MHRA do not extend to discrimination based on her son's sex. Therefore, the court affirmed as to this issue. The court reversed the district court's dismissal of plaintiff's ACA claim based on lack of Article III standing, holding that plaintiff has alleged an injury cognizable under Article III because she contends that defendants' discriminatory conduct denied her the benefits of her insurance policy and forced her to pay out of pocket for some of her son's prescribed medication. View "Tovar v. Essentia Health" on Justia Law

Relator filed a qui tam action under the False Claims Act (FCA), 31 U.S.C. 3729-33, alleging that his former employer, AAKC, violated the FCA by submitting claims for Medicare reimbursement of anesthesia services at the “Medical Direction” rate. Relator alleged that, because AAKC anesthesiologists were not present in the operating room during patients’ “emergence” from anesthesia, and therefore AAKC did not comply with the Medicare conditions of payment for submitting such claims. The district court granted AAKC summary judgment. The court granted the United States leave to appear as amicus curiae supporting neither party. The court concluded that, because the agency had not clarified an obvious ambiguity in its Step Three regulation for decades, AAKC’s failure to obtain a legal opinion or prior CMS approval cannot support a finding of recklessness. The court also concluded that the district court did not abuse its discretion in refusing to consider a new theory first articulated in relator's summary judgment papers. Finally, the court rejected relator's claim that AAKC violated 42 C.F.R. 415.110(b). Accordingly, the court affirmed the judgment. View "Donegan v. Anesthesia Assoc." on Justia Law

SEARK, operator of two hospice-care facilities, voluntarily entered into a provider agreement with the Secretary of Health and Human Services to receive Medicare reimbursement pursuant to the Medicare Act, 42 U.S.C. 1395c, 1395f(a)(7), 1395cc. The Act annually caps Medicare reimbursement. SEARK filed suit after the Secretary sent it seven demands for repayment, arguing that the cap violates the Takings Clause of the Fifth Amendment. The district court concluded that SEARK’s voluntary participation in the Medicare program precludes a takings claim. The court concluded that SEARK has not met its burden to prove the demands for repayment based on the statutory cap are a taking where the reimbursement cap allocates the government's capacity to subsidize healthcare; SEARK presented no evidence to suggest the cap makes it impossible to profitably engage in their business; and SEARK voluntarily chose to participate in the Medicare hospice program. Accordingly, the court affirmed the judgment. View "Southeast Arkansas Hospice v. Burwell" on Justia Law