Justia U.S. 8th Circuit Court of Appeals Opinion Summaries
Articles Posted in Health Law
Ass’n for Accessible Medicines v. Ellison
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. v. U.S. Food & Drug Administration
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
Posted in:
Government & Administrative Law, Health Law
United States v. Ward
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
United States v. Bull
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
Cropper v. Dudek
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
Posted in:
Health Law, Public Benefits
United States v. May
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
Doe v. SSM Health Care Corporation
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
United States v. Wiley
Kathan Daniel Wiley was convicted of conspiracy to distribute fentanyl and possession with intent to distribute fentanyl resulting in serious bodily injury. On October 30, 2021, Wiley's 18-month-old child ingested fentanyl pills, leading to severe health issues but ultimately surviving. Wiley had been distributing fentanyl pills for months, and evidence showed he obtained the pills shortly before the incident. The jury found him guilty on both counts, and the district court sentenced him to 240 months for the conspiracy charge and 324 months for possession with intent to distribute, to be served concurrently.The United States District Court for the Southern District of Iowa denied Wiley's motion for judgment of acquittal. Wiley appealed, arguing insufficient evidence for the conspiracy charge, claiming his possession was to support his addiction rather than for distribution. He also contended that the evidence did not support the conviction for possession with intent to distribute resulting in serious bodily injury, asserting the fentanyl ingested by his child was intended for personal use.The United States Court of Appeals for the Eighth Circuit reviewed the sufficiency of the evidence de novo, affirming the district court's decision. The court held that the evidence, including Facebook messages and testimony, supported the jury's finding of a conspiracy and intent to distribute. The court also upheld the district court's application of a four-level enhancement under U.S.S.G. § 2D1.1(b)(13) for misrepresenting the substance as another drug. Additionally, the court found no abuse of discretion in the district court's consideration of the § 3553(a) factors, affirming the 324-month sentence as substantively reasonable. The judgment was affirmed. View "United States v. Wiley" on Justia Law
United States v. Driskill
Ethan Driskill and Marchello Oliver were charged with multiple drug-related offenses, including distribution of fentanyl and possession of firearms. Driskill was charged with distribution resulting in death, among other counts, while Oliver faced charges including possession with intent to distribute fentanyl and cocaine. Both defendants entered plea agreements; Oliver pleaded guilty to possession with intent to distribute fentanyl, and Driskill pleaded guilty to distribution resulting in death.The United States District Court for the Western District of Arkansas sentenced Oliver to 168 months, an above-guidelines sentence, and Driskill to 456 months, a within-guidelines sentence. Both defendants appealed, arguing their sentences were substantively unreasonable.The United States Court of Appeals for the Eighth Circuit reviewed the sentences for procedural errors and substantive reasonableness. For Oliver, the court found no procedural errors in the district court's application of an upward departure under USSG § 5K2.1, which was based on the finding that Oliver's distribution of fentanyl resulted in a death. The court also found the sentence substantively reasonable, noting that the district court had appropriately considered the relevant factors and the extent of the departure.For Driskill, the court noted that his within-guidelines sentence was presumed reasonable. The court found that the district court had properly considered mitigating factors and the significant differences between Driskill and Oliver, including their criminal histories and the specific charges to which they pleaded guilty. The court concluded that the district court did not abuse its discretion in sentencing Driskill.The Eighth Circuit affirmed the sentences imposed on both Oliver and Driskill. View "United States v. Driskill" on Justia Law
United States ex rel. Holt v. Medicare Medicaid Advisors
Elizabeth Holt, a former insurance agent for Medicare Medicaid Advisors, Inc. (MMA), alleged that MMA and several insurance carriers (Aetna, Humana, and UnitedHealthcare) violated the False Claims Act (FCA). Holt claimed that MMA engaged in fraudulent practices, including falsifying agent certifications and violating Medicare marketing regulations, which led to the submission of false claims to the Centers for Medicare and Medicaid Services (CMS).The United States District Court for the Western District of Missouri dismissed Holt's complaint. The court found that no claims were submitted to the government, the alleged regulatory violations were not material to CMS’s contract with the carriers, and the complaint did not meet the particularity standard required by Federal Rule of Civil Procedure 9(b). The court also denied Holt's motion for reconsideration, which introduced a fraudulent inducement theory and requested leave to amend the complaint.The United States Court of Appeals for the Eighth Circuit reviewed the case. The court affirmed the district court's dismissal, agreeing that Holt's allegations did not meet the materiality requirement under the FCA. The court applied the materiality standard from Universal Health Services, Inc. v. United States ex rel. Escobar, considering factors such as whether the government designated compliance as a condition of payment, whether the violations were minor or substantial, and whether the government continued to pay claims despite knowing of the violations. The court found that the alleged violations did not go to the essence of CMS’s contract with the carriers and were not material to the government's payment decisions.The Eighth Circuit also upheld the district court's denial of Holt's motion for reconsideration and request to amend the complaint, concluding that adding a fraudulent inducement claim would be futile given the immateriality of the alleged violations. View "United States ex rel. Holt v. Medicare Medicaid Advisors" on Justia Law