Justia Drugs & Biotech Opinion Summaries

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

A man was convicted by a Michigan state jury for delivering oxycodone to a friend, resulting in her death from a drug overdose. The evidence showed that the man and the deceased had a longstanding relationship, and after her release from jail, he purchased 40 Percocet pills—containing oxycodone and acetaminophen—and spent time with her at a hotel where she died. Medical experts found oxycodone in her blood and acetaminophen in her urine, both components of Percocet, and testified that oxycodone was a substantial factor in causing her death.After his conviction, the defendant sought a new trial in the Michigan courts, arguing that his trial counsel was ineffective for two reasons: failing to investigate an “acetaminophen-based” defense (that the absence of acetaminophen in the blood meant the deceased had not consumed Percocet), and failing to call an expert witness to challenge the prosecution’s case on causation. The trial court held a hearing and ultimately rejected these claims. The Michigan Court of Appeals affirmed, and the Michigan Supreme Court denied further review.The United States District Court for the Eastern District of Michigan then denied the defendant’s petition for habeas corpus, and the case was appealed to the United States Court of Appeals for the Sixth Circuit. The Sixth Circuit held that, under the highly deferential standards of the Antiterrorism and Effective Death Penalty Act (AEDPA), the state courts did not unreasonably apply clearly established Supreme Court law or make unreasonable determinations of fact in rejecting the ineffective assistance claims. The court further held that counsel’s strategic decisions were not objectively unreasonable and that the alleged failures did not prejudice the outcome of the trial. The Sixth Circuit affirmed the denial of habeas relief. View "DeBruyn v. Douglas" on Justia Law

During a contentious divorce and custody dispute, Amanda Hovanec, who had returned to Ohio from South Africa with her children, conspired with Anthony Theodorou, her romantic partner, to kill her husband, T.H. After failed attempts to hire hitmen in South Africa, Theodorou, at Hovanec’s direction, obtained and shipped etorphine, a dangerous animal tranquilizer, to the United States. Hovanec ultimately used the drug to fatally inject T.H. at her mother Anita Green’s home. Green assisted after the murder by helping to select a burial site, driving the others to dig a grave, and later transporting them and the body for burial. The group also undertook efforts to conceal the crime, including disposing of T.H.’s belongings and misleading authorities. All three were arrested after an investigation revealed dashcam footage of the crime.In the United States District Court for the Northern District of Ohio, Hovanec pleaded guilty to multiple controlled-substance offenses resulting in death, and Green pleaded guilty to being an accessory after the fact. Hovanec received a 480-month sentence; Green received 121 months and was ordered to pay restitution for psychological care for T.H.’s and Hovanec’s children. Both defendants appealed their sentences and, in Green’s case, the restitution order.The United States Court of Appeals for the Sixth Circuit affirmed the sentences for both Hovanec and Green. The appellate court upheld the denial of a sentencing reduction for Green based on her lack of candor regarding knowledge of the murder plan. The court also affirmed the sentencing enhancements for Hovanec’s leadership role and obstruction of justice. However, the court reversed the restitution order against Green, holding that under federal law, restitution for psychological care requires evidence of bodily injury, defined as physical harm or physical manifestations of psychological harm, and remanded for further factual findings on this issue. View "United States v. Green" on Justia Law

A medical device company that manufactures spinal devices was indicted, along with its CEO and CFO, for allegedly paying bribes to surgeons through a sham consulting program in violation of the Anti-Kickback Statute. The indictment claimed the surgeons did not provide bona fide consulting services, but were paid to use and order the company’s devices in surgeries covered by federal health care programs. The company’s CFO, who is not a shareholder but is one of only two officers, allegedly calculated these payments based on the volume and value of surgeries performed with the company’s devices. During the development of the consulting program, the company retained outside counsel to provide legal opinions on the agreements’ compliance with health care law, and those opinions were distributed to the surgeons.After the grand jury returned the indictment, the United States District Court for the District of Massachusetts addressed whether the CFO’s plan to argue at trial that the involvement of outside counsel negated his criminal intent would effect an implied waiver of the company’s attorney-client privilege. The district court initially found that if the CFO or CEO invoked an “involvement-of-counsel” defense, it would waive the corporation’s privilege over communications with counsel. Following dismissal of charges against the company, the district court focused on whether the officers collectively could waive the privilege, concluded they could, and ruled that the CFO’s planned defense would constitute an implied waiver, allowing disclosure of certain privileged communications to the government. The district court stayed its order pending appeal.The United States Court of Appeals for the First Circuit vacated the district court’s waiver order and remanded. The Court of Appeals held that (1) the record was insufficient to determine whether the CFO alone had authority to waive the company’s privilege, and (2) not every involvement-of-counsel defense necessitates a waiver. The appellate court directed the district court to reassess the issue in light of changed circumstances and to consider less intrusive remedies before finding an implied waiver. View "United States v. SpineFrontier, Inc." on Justia Law

An attorney based in Oklahoma developed a business model to help out-of-state clients enter the state’s medical marijuana industry, which is governed by strict residency and disclosure requirements. He created a two-entity structure: one company, with nominal Oklahoma-resident owners, obtained the necessary state licenses, while a second company, owned and operated by out-of-state clients, ran the actual marijuana operations. The attorney did not disclose the true ownership structure to state authorities, and in some cases, marijuana was grown before the required state registrations were obtained. State authorities began investigating after noticing irregularities, such as multiple licenses listing the same address and repeated use of the same Oklahoma residents as owners, many of whom had little or no involvement in the businesses.Oklahoma state prosecutors charged the attorney with multiple felonies related to his business practices, including conspiracy and submitting false documents. While those charges were pending, a federal grand jury indicted him for drug conspiracy and maintaining drug-involved premises, based on the same conduct. In the United States District Court for the Western District of Oklahoma, the attorney moved to enjoin his federal prosecution, arguing that a congressional appropriations rider barred the Department of Justice from spending funds to prosecute individuals complying with state medical marijuana laws. The district court held an evidentiary hearing and denied the motion, finding that the attorney had not substantially complied with Oklahoma law, particularly due to nondisclosure of ownership interests and failure to obtain required registrations.On appeal, the United States Court of Appeals for the Tenth Circuit affirmed. The court held that the appropriations rider does bar the Department of Justice from spending funds to prosecute private individuals who comply with state medical marijuana laws. However, the court found that the attorney failed to substantially comply with Oklahoma’s requirements, so the rider did not protect him. The court concluded that the district court did not abuse its discretion in denying the injunction. View "United States v. Stacy" on Justia Law

A licensed veterinarian developed and manufactured undetectable performance enhancing drugs (PEDs) for use in professional horse racing, selling them to trainers who administered them to horses to gain a competitive edge. His salesperson assisted in these activities, operating a company that distributed the drugs without prescriptions or FDA approval. The drugs were misbranded or adulterated, and the operation involved deceptive practices such as misleading labeling and falsified customs forms. The PEDs were credited by trainers for their horses’ successes, and evidence showed the drugs could be harmful if misused.The United States District Court for the Southern District of New York presided over two separate trials, resulting in convictions for both the veterinarian and his salesperson for conspiracy to manufacture and distribute misbranded or adulterated drugs with intent to defraud or mislead, in violation of the Food, Drug, and Cosmetic Act. The district court denied motions to dismiss the indictment, admitted evidence from a prior state investigation, and imposed sentences including imprisonment, restitution, and forfeiture. The court calculated loss for sentencing based on the veterinarian’s gains and ordered restitution to racetracks based on winnings by a coconspirator’s doped horses.On appeal, the United States Court of Appeals for the Second Circuit held that the statute’s “intent to defraud or mislead” element is not limited to particular categories of victims; it is sufficient if the intent relates to the underlying violation. The court found no error in the admission of evidence from the 2011 investigation or in the use of gain as a proxy for loss in sentencing. However, it vacated the restitution order to racetracks, finding no evidence they suffered pecuniary loss, and vacated the forfeiture order, holding that the relevant statute is not a civil forfeiture statute subject to criminal forfeiture procedures. The convictions and sentence were otherwise affirmed. View "United States v. Fishman" on Justia Law

A pharmaceutical company participated in a federal program that required it to report the average price it received for drugs sold to wholesalers, which in turn affected the rebates it owed the government under Medicaid. From 2005 to 2017, the company sold drugs to wholesalers at an initial price, but if it raised the price before the wholesaler resold the drugs to pharmacies, it required the wholesaler to pay the difference. The company reported only the initial price as the average manufacturer price (AMP), excluding the subsequent price increases, which resulted in lower reported AMPs and thus lower rebate payments to the government. The company justified this exclusion by categorizing the price increases as part of a bona fide service fee to wholesalers, even though the increased value was ultimately paid by pharmacies.The United States District Court for the Northern District of Illinois reviewed the case after a qui tam action was filed by a relator, who alleged that the company’s AMP calculations were false and violated the False Claims Act (FCA). The district court granted summary judgment to the relator on the issue of falsity, finding the AMP calculations and related certifications were factually and legally false. The issues of scienter (knowledge) and materiality were tried before a jury, which found in favor of the relator and awarded substantial damages. The company appealed, challenging the findings on falsity, scienter, and materiality, while the relator cross-appealed on the calculation of the number of FCA violations.The United States Court of Appeals for the Seventh Circuit affirmed the district court’s judgment. The court held that the company’s exclusion of price increase values from AMP was unreasonable and contradicted the plain language and purpose of the relevant statutes, regulations, and agreements. The court also held that the jury reasonably found the company acted knowingly and that the false AMPs were material to the government’s payment decisions. The court rejected the cross-appeal on damages, finding the issue was not properly preserved for appeal. View "Streck v Eli Lilly and Company" on Justia Law

Robert Kennedy was convicted of possessing a firearm as a convicted felon, possessing heroin with the intent to distribute, and possessing a firearm in furtherance of a drug trafficking crime. The convictions were based on evidence found during a search of his apartment, including drugs, scales, and a firearm. Kennedy's prior convictions for burglary and drug offenses led to his classification as an armed career criminal and a career offender, resulting in a guidelines range of 420 months to life imprisonment. He received a below-guidelines sentence of 360 months.The United States District Court for the Middle District of Georgia admitted text messages and expert testimony over Kennedy's objections and found sufficient evidence to support his convictions. The court also determined that Kennedy's prior convictions qualified him for the ACCA and career offender enhancements, despite his arguments to the contrary.The United States Court of Appeals for the Eleventh Circuit reviewed the case and affirmed the district court's decisions. The appellate court held that the text messages were admissible as they were directly related to the charged offense and not subject to Rule 404(b). The expert testimony was also deemed appropriate as it did not violate Rule 704(b). The court found sufficient evidence to support Kennedy's convictions, including testimony linking him to the drugs and firearm.The appellate court also upheld the ACCA enhancement, finding that Kennedy's prior burglary convictions qualified as predicate offenses. The court rejected Kennedy's arguments against the career offender enhancement, affirming that his prior drug convictions met the criteria. Finally, the court found Kennedy's sentence to be both procedurally and substantively reasonable, given the circumstances and the guidelines range. The sentence was affirmed. View "United States v. Kennedy" on Justia Law

Frederick Brewer was convicted by a jury of distributing fentanyl, possessing with intent to distribute fentanyl, and participating in a conspiracy to distribute fentanyl. The jury, however, found that the government did not prove beyond a reasonable doubt that Brewer's conspiracy and possession convictions involved at least 40 grams of fentanyl. Brewer moved for acquittal twice, arguing insufficient evidence, but the district court denied both motions. Brewer appealed, contending that the evidence was insufficient to support his convictions and that the district court erred in calculating the drug quantity for sentencing.The United States District Court for the Eastern District of Wisconsin initially denied Brewer's motions for acquittal. The court found sufficient evidence to establish that Brewer and his co-defendant, Don James, Jr., were engaged in a conspiracy to distribute fentanyl, rather than a simple buyer-seller relationship. The court also rejected Brewer's argument that the jury's finding regarding the drug quantity undermined the guilty verdicts. At sentencing, the district court attributed 1.2 to 4 kilograms of fentanyl to Brewer, resulting in a higher base offense level and a sentence of 144 months in prison followed by 120 months of supervised release.The United States Court of Appeals for the Seventh Circuit reviewed the case and affirmed the district court's decisions. The appellate court held that the evidence was sufficient to support Brewer's convictions for conspiracy, possession, and distribution of fentanyl. The court also upheld the district court's drug quantity determination for sentencing purposes, noting that the sentencing court could consider conduct underlying acquitted charges if proven by a preponderance of the evidence. Brewer's conviction and sentence were affirmed. View "United States v. Brewer" 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