Justia U.S. 4th Circuit Court of Appeals Opinion Summaries

A group of pharmaceutical manufacturers that participate in the federal 340B drug pricing program challenged a new West Virginia law, S.B. 325, which imposed restrictions and penalties on manufacturers regarding the delivery of discounted drugs to contract pharmacies. The 340B program is a federal scheme where drug manufacturers provide discounts to designated health care providers (“covered entities”) in exchange for access to the Medicaid market. Dissatisfied with the federal program’s scope, West Virginia enacted S.B. 325, which specifically barred manufacturers from restricting delivery of 340B drugs to any location authorized by a covered entity (including contract pharmacies), and from requiring data submission as a condition for delivery, with significant penalties for violations.The manufacturers sued in the United States District Court for the Southern District of West Virginia seeking to enjoin enforcement of S.B. 325, arguing that it was preempted by federal law. The district court found that the manufacturers were likely to succeed on the merits of their preemption claim, that they faced irreparable harm, and that the balance of equities and public interest favored injunctive relief. The court granted a preliminary injunction against enforcement of the statute.On appeal, the United States Court of Appeals for the Fourth Circuit addressed whether S.B. 325 was preempted by federal law. The Fourth Circuit held that S.B. 325 likely interferes with the federal 340B program by imposing additional conditions on manufacturers solely because of their participation in a federal program, thereby intruding into a domain reserved for federal regulation. The court found that Congress had struck a careful bargain in the 340B program and that West Virginia’s law sought to alter that bargain in a way that conflicted with federal objectives and the enforcement scheme administered by the Department of Health and Human Services. The Fourth Circuit affirmed the district court’s preliminary injunction, barring enforcement of S.B. 325. View "Pharmaceutical Research & Manufacturers of America v. McCuskey" on Justia Law

A former employee of a pharmaceutical manufacturer brought a qui tam lawsuit under the False Claims Act, alleging that the company improperly calculated and reported its “Best Price” for certain drugs to the Centers for Medicare and Medicaid Services (CMS), as required under the Medicaid Rebate Statute. The plaintiff claimed that, during a period from 2005 to 2014, the company failed to aggregate multiple rebates and discounts given to different entities on the same drug, resulting in inflated “Best Price” reports and underpayment of rebates owed to Medicaid. The complaint asserted that the company was subjectively aware that CMS interpreted the statute to require aggregation of all such discounts, especially after the company’s communications with CMS during a 2006–2007 rulemaking process and the company’s subsequent internal audit.After the government and several states declined to intervene, the United States District Court for the District of Maryland dismissed the amended complaint, finding that, even under the subjective scienter standard established in United States ex rel. Schutte v. SuperValu Inc., the plaintiff had not plausibly alleged that the company acted with actual knowledge, deliberate ignorance, or reckless disregard as to the truth or falsity of its reports. The district court also suggested that ambiguity in the statute precluded a finding of falsity.On appeal, the United States Court of Appeals for the Fourth Circuit reviewed the dismissal de novo. The Fourth Circuit held that the plaintiff’s allegations—including the company’s awareness of CMS’s interpretation of the rule, its targeted audit and compliance efforts, and its continued use of non-aggregated reporting—plausibly alleged the requisite subjective scienter under the False Claims Act. The court clarified that statutory ambiguity does not, at the pleading stage, negate scienter or falsity, and remanded for the district court to address other elements, including falsity, in the first instance. The Fourth Circuit reversed the dismissal and remanded for further proceedings. View "United States ex rel. Sheldon v. Allergan Sales, LLC" on Justia Law

Dr. Timothy Baxter, while working for Indivior, a pharmaceutical company, distributed misleading information to Massachusetts’s Medicaid program about the safety of new opioid drugs. This led to his conviction for misdemeanor drug misbranding. Following his conviction, the Secretary of Health and Human Services banned him from participating in federal healthcare programs for five years. Baxter challenged this exclusion, arguing that his crime did not categorically relate to the delivery of an item or service under a state healthcare program.The United States District Court for the Eastern District of Virginia granted summary judgment in favor of the Secretary, rejecting Baxter’s claims. Baxter then appealed to the United States Court of Appeals for the Fourth Circuit.The Fourth Circuit reviewed the case and held that the exclusion statute, 42 U.S.C. § 1320a-7(a), does not require a categorical approach. Instead, it employs a circumstance-specific approach, meaning it looks at the actual conduct of the individual rather than the elements of the statute of conviction. The court found that Baxter’s conduct—misbranding drugs to influence MassHealth’s coverage decisions—was related to the delivery of an item under a state healthcare program. Therefore, his exclusion was mandatory under the statute.The Fourth Circuit affirmed the district court’s decision, upholding Baxter’s exclusion from federal healthcare programs. View "Baxter v. Kennedy" on Justia Law

A father, Scott Williams, and his son, Taeyan Williams, were convicted by a federal jury of various drug-related offenses, including conspiracy to distribute and possess with intent to distribute marijuana and cocaine. The case stemmed from an investigation into the disappearance of a drug dealer, Noah Smothers, who supplied drugs to Scott and Taeyan. A search of Scott's home revealed large quantities of drugs, firearms, and cash. Both Scott and Taeyan were found guilty of conspiracy and possession with intent to distribute, while Scott was also convicted of additional charges related to methamphetamine and evidence destruction.The United States District Court for the District of Maryland denied Scott's motion to suppress evidence obtained from the search, despite his claim that law enforcement failed to knock and announce before entering. The court held that suppression was not the appropriate remedy. Scott and Taeyan were sentenced to 276 months and 150 months in prison, respectively, followed by five years of supervised release. Both appealed their convictions and sentences.The United States Court of Appeals for the Fourth Circuit reviewed the case. The court affirmed Taeyan's conviction, finding sufficient evidence to support his possession with intent to distribute charges, based on his connection to the drugs found in Scott's home. The court also upheld the district court's denial of Scott's motion to suppress, citing exigent circumstances that justified the no-knock entry. Additionally, the court rejected Scott's request for a sentence reduction under the newly promulgated U.S.S.G. § 4C1.1, advising him to seek relief through a motion under 18 U.S.C. § 3582. Finally, the court found no improper delegation of judicial authority in the conditions of Scott's supervised release, affirming the district court's judgments in their entirety. View "United States v. Williams" on Justia Law

The case involves Jamie Christopher Henderson, who was convicted and sentenced following a jury trial for conspiracy to distribute cocaine and cocaine base, possession with intent to distribute cocaine base, and possession of firearms in furtherance of his drug trafficking crimes. Henderson appealed his convictions and sentence, arguing that the evidence was insufficient to support these convictions, and that his sentence is procedurally and substantively unreasonable.The case originated from an incident on April 30, 2019, when law enforcement officers executed a search warrant at Henderson’s residence. They witnessed Henderson toss items underneath a vehicle, including a gun. The officers recovered a loaded handgun, a plastic bag with cocaine and crack cocaine, a cigarette lighter, and a glass crack pipe from underneath the vehicle. Henderson was arrested. Inside the trailer, police found a loaded rifle, a loaded handgun, cocaine powder and crack cocaine in a toilet tank, and a second loaded handgun in a kitchen trash can. They also seized three digital scales and a digital video recorder containing footage from security cameras showing Henderson and other men, armed with multiple handguns and a rifle, standing in the front yard of the residence as cars and people would approach it.Henderson was charged with conspiracy to distribute cocaine and cocaine base, possession of a firearm in furtherance of the drug-distribution conspiracy, possession with intent to distribute cocaine and cocaine base, possession of a firearm in furtherance of the possession-with-intent offense, and possession of a firearm as a felon. He pleaded not guilty. At trial, the Government presented the testimony of the law enforcement officers, Henderson’s videotaped confession, the security footage from the trailer, and a letter Henderson had written to his brother. Henderson presented the testimony of his mother and daughter who claimed that Henderson was a drug user, thief, and liar—but not a drug dealer. The jury convicted Henderson on all counts.The United States Court of Appeals for the Fourth Circuit affirmed the convictions and sentence. The court found that there was substantial evidence to support the conviction and that the sentence was not procedurally or substantively unreasonable. The court noted that Henderson faced a heavy burden in challenging the sufficiency of the evidence and that the court's role was limited to considering whether there was substantial evidence to support the conviction. The court found that there was abundant independent evidence that Henderson was engaged in a large-scale drug trade, which supported the trustworthiness of his confessions. The court also found that the district court did not err in calculating the quantity of drugs attributable to Henderson for sentencing purposes. The court concluded that Henderson's sentence was substantively reasonable and that he failed to overcome the presumption of reasonableness that applies to a below-Guidelines sentence. View "United States v. Henderson" on Justia Law

The case involves United Therapeutics Corporation (UTC), a biotechnology company, and the Commissioner of Internal Revenue. The dispute centers on the interpretation of a tax provision that coordinates two tax credits: the research credit and the orphan drug credit. The Commissioner claimed that UTC disregarded one of the provision’s two commands, improperly reducing its tax liability by over a million dollars. UTC argued that the relevant half of the coordination provision lost effect in 1989 and has been moribund since.The United States Tax Court disagreed with UTC's argument. The court interpreted the statute’s terms by reference to their ordinary meaning, giving effect to the full coordination provision. The court rejected UTC's argument that changes to the tax law since its enactment rendered part of the coordination provision ineffective. The court also disagreed with UTC's interpretation of two regulations it relied on for support.The United States Court of Appeals for the Fourth Circuit affirmed the tax court's decision. The appellate court agreed with the tax court's interpretation of the coordination provision according to its ordinary meaning. The court also found that the tax court correctly rejected UTC's arguments based on the interpretation of predecessor statutes and regulations. The court concluded that the tax court correctly resolved the case in favor of the Commissioner. View "United Therapeutics Corporation v. Commissioner of Internal Revenue" on Justia Law

This case was before the United States Court of Appeals for the Fourth Circuit where the City of Huntington and Cabell County Commission (plaintiffs) brought a suit against AmerisourceBergen Drug Corporation, Cardinal Health, Inc., and McKesson Corporation (defendants), three distributors of opioids. The plaintiffs alleged that these companies perpetuated the opioid epidemic by repeatedly shipping excessive quantities of opioids to pharmacies, thus creating a public nuisance under West Virginia common law. The district court ruled in favor of the distributors, holding that West Virginia’s common law of public nuisance did not cover the plaintiffs’ claims.After a bench trial in 2021, the district court held that the common law of public nuisance in West Virginia did not extend to the sale, distribution, and manufacture of opioids. The court found that the application of public nuisance law to the sale, marketing, and distribution of products would invite litigation against any product with a known risk of harm, regardless of the benefits conferred on the public from proper use of the product. The court also rejected the plaintiffs’ proposed remedy, a 15-year “Abatement Plan” developed by an expert in opioid abatement intervention. The court held that this relief did not qualify as an abatement as it did not restrict the defendants' conduct or their distribution of opioids but generally proposed programs and services to address the harms caused by opioid abuse and addiction.The plaintiffs appealed the decision to the United States Court of Appeals for the Fourth Circuit, which certified the following question to the Supreme Court of Appeals of West Virginia: Under West Virginia’s common law, can conditions caused by the distribution of a controlled substance constitute a public nuisance and, if so, what are the elements of such a public nuisance claim? View "City of Huntington v. Amerisourcebergen Drug Corporation" on Justia Law

The defendant, Rodriquies Evans, was convicted of four criminal offenses related to his involvement in a multistate conspiracy to transport and distribute methamphetamine and other controlled substances. The district court sentenced him to the statutory maximum of 80 years in prison. The Fourth Circuit United States Court of Appeals found that the district court had erred in calculating Evans’s Sentencing Guidelines range and vacated his sentence, remanding the case for resentencing. The court determined that the district court had incorrectly attributed nearly three kilograms of crystal methamphetamine seized from a co-conspirator to Evans. The court held that for sentencing purposes under the Sentencing Guidelines, only acts that fall within the scope of the criminal activity the defendant agreed to jointly undertake can be considered relevant conduct. The district court had attributed the drugs based on the broader standard of substantive liability under Pinkerton, which allows a defendant to be held liable for the acts of co-conspirators if they are within the scope of the overall conspiracy and reasonably foreseeable to the defendant. The court also found that the district court had erred in applying a threat enhancement in calculating Evans's Sentencing Guidelines range, as the possession of a firearm enhancement could not by itself be the basis for a threat enhancement. View "US v. Evans" on Justia Law

Plaintiffs filed an antitrust class action against Actelion, alleging that Actelion extended its patent monopoly for its branded drug Tracleer — a drug to treat pulmonary artery hypertension — beyond the patent's expiration date. Plaintiffs claimed that Actelion did so "through illegitimate means" with the intent of precluding competition from generic drug manufacturers and charging supracompetitive prices for Tracleer, in violation of federal and state antitrust laws. Plaintiffs further claimed that, as a result of Actelion's illegal monopolization, they were injured by having to pay supracompetitive prices for Tracleer for some three years after Actelion's patent for Tracleer expired.The Fourth Circuit vacated the district court's limitations ruling and concluded that plaintiffs' antitrust claims did not accrue until they were injured by paying supracompetitive prices for Tracleer after the patent expired in November 2015. Therefore, plaintiffs action commenced in November 2018 was timely. The court also concluded that, even if the February 2014 date, when Actelion entered into agreements settling the generic manufacturers' antitrust claims, marked the last anticompetitive act, damages could not then have been recovered by plaintiffs because their claims would not have been ripe for judicial resolution in view of the speculative nature of future conduct that might have thereafter occurred. Therefore, limitations would not begin to run until the claims became ripe. In any event, the court explained that because plaintiffs alleged that Actelion continued with anticompetitive acts after November 2015 in selling Tracleer at supracompetitive prices, new limitations periods began to run from each sale that caused plaintiffs damages. The court largely agreed with the district court's standing, but concluded that the allegations asserting violations of the laws in states where plaintiffs did not purchase Tracleer may yet be considered when determining whether plaintiffs can, based on a Rule 23 analysis, represent class members who purchased Tracleer in those States, and if they can, then whether plaintiffs can include those claims. View "Mayor and City Council of Baltimore v. Actelion Pharmaceuticals Ltd." on Justia Law

After Boehringer developed a drug called Pradaxa to help reduce the risk of stroke, the FDA approved the drug and its label. Betty Knight suffered complications from taking the drug and eventually died. Betty's children filed suit against Boehringer asserting a variety of state-law claims alleging Boehringer failed to adequately warn about the risks associated with taking Pradaxa. Boehringer argued that federal law preempted the claims, the district court agreed with plaintiffs, and then the jury returned a mixed verdict. Boehringer appealed, claiming that plaintiffs' fraud claim based on the physician label was preempted.The Fourth Circuit reversed the district court's order denying Boehringer's post-trial motion for judgment as a matter of law. The court held that there is no bright-line, one-size-fits-all line marking the moment when an analysis reveals new information. A careful review of the record is needed to determine whether a conclusion has been reached. Applying careful review here, the court concluded that Boehringer did not have "newly acquired information" regarding an optimal Pradaxa blood concentration level which would have warranted a unilateral change to the physician label. Therefore, the state-law fraud claim is preempted. View "Knight v. Boehringer Ingelheim Pharmaceuticals, Inc." on Justia Law