Justia U.S. 4th Circuit Court of Appeals Opinion Summaries
Articles Posted in Drugs & Biotech
United States v. Henderson
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
United Therapeutics Corporation v. Commissioner of Internal Revenue
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
City of Huntington v. Amerisourcebergen Drug Corporation
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
US v. Evans
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
Mayor and City Council of Baltimore v. Actelion Pharmaceuticals Ltd.
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
Knight v. Boehringer Ingelheim Pharmaceuticals, Inc.
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
Posted in:
Constitutional Law, Drugs & Biotech
Small v. Welldyne, Inc.
Plaintiff filed suit on behalf of his mother's estate against WellDyne and Exactus, asserting claims for negligence, negligence per se and breach of the implied warranty of fitness for a particular purpose against both defendants. Plaintiff also alleged Exactus was vicariously liable for the actions of WellDyne under agency and joint venture theories. In this case, plaintiff's mother died shortly after a hospital stay stemming from her ingestion of prescription medications that were erroneously mailed to her by WellDyne. The district court granted summary judgment in favor of WellDyne and Exactus as to all counts, finding that plaintiff's mother was contributorily negligent as a matter of law which completely barred her recovery in North Carolina.The court reversed the district court's judgment insofar as it granted summary judgment on the basis of contributory negligence and causation, remanding for the district judge to conduct a Daubert analysis of the expert opinions proffered by plaintiff to determine whether taking some of the misdirected medications was the cause of the mother's injuries and death. The court affirmed summary judgment to Exactus; affirmed summary judgment to WellDyne as to the claim for implied warranty of a particular purpose; and remanded. View "Small v. Welldyne, Inc." on Justia Law
Posted in:
Drugs & Biotech, Personal Injury
Plaintiffs Appealing Case Management Order 100 v. Pfizer, Inc.
Lipitor, a pharmaceutical drug, is prescribed to lower patients’ “bad” cholesterol and triglycerides. Plaintiffs, more than 3,000 women, claim that they developed diabetes as a result of taking Lipitor. The Judicial Panel on Multidistrict Litigation consolidated the lawsuits for pretrial proceedings. The parties agreed on four bellwether cases. Plaintiffs enlisted general experts, to testify that there was a causal association between Lipitor and diabetes; specific experts, to testify that Lipitor proximately caused the onset of diabetes in the bellwether plaintiffs; and an expert biostatistician, who concluded that taking Lipitor led to a statistically significant increased risk of diabetes. Plaintiffs also sought to introduce internal Pfizer emails, information from Lipitor's labeling, a statement in Lipitor's FDA New Drug Application, and information from the Lipitor website. Citing Federal Rule of Evidence 702, the court excluded the opinions of the statistician; the general causation expert, except relating to a specific dosage; and the specific causation opinions. The rulings left the plaintiffs without their bellwether cases, limited to a subset of patients who had taken an 80 mg dose. The court issued show-cause orders asking whether any plaintiff could submit evidence that would enable her claim to survive summary judgment given prior rulings. Some plaintiffs submitted evidence showing only that they were not diabetic before taking Lipitor, that they were diagnosed with diabetes after taking Lipitor, and that they lacked certain risk factors that might make them especially likely to develop the disease. After the court rejected the evidence, the plaintiffs unsuccessfully argued that the cases ought to be returned to their transferor district courts for individual resolution on the issue of specific causation. The Fourth Circuit affirmed summary judgment for the defendants. View "Plaintiffs Appealing Case Management Order 100 v. Pfizer, Inc." on Justia Law
Association for Accessible Medicine v. Frosh
In 2017, Maryland enacted “An Act concerning Public Health – Essential Off-Patent or Generic Drugs – Price Gouging – Prohibition.” The Act, Md. Code, Health–General 2-802(a), prohibits manufacturers or wholesale distributors from “engag[ing] in price gouging in the sale of an essential off-patent or generic drug,” defines “price gouging” as “an unconscionable increase in the price of a prescription drug,” and “unconscionable increase” as “excessive and not justified by the cost of producing the drug or the cost of appropriate expansion of access to the drug to promote public health” that results in consumers having no meaningful choice about whether to purchase the drug at an excessive price due to the drug’s importance to their health and insufficient competition. The “essential” medications are “made available for sale in [Maryland]” and either appear on the Model List of Essential Medicines most recently adopted by the World Health Organization or are “designated . . . as an essential medicine due to [their] efficacy in treating a life-threatening health condition or a chronic health condition that substantially impairs an individual’s ability to engage in activities of daily living.” The Fourth Circuit reversed the dismissal of a “dormant commerce clause” challenge to the Act, finding that it directly regulates the price of transactions that occur outside Maryland. View "Association for Accessible Medicine v. Frosh" on Justia Law
Belmora LLC v. Bayer Consumer Care AG
BBC, owner of the FLANAX trademark in Mexico, and its sister company, Bayer, filed suit against Belmora, owner of the FLANAX trademark in the United States, contending that Belmora used the FLANAX mark to deliberately deceive Mexican-American consumers into thinking they were purchasing BCC’s product. The court concluded that the Lanham Act’s, 15 U.S.C. 1125, plain language contains no unstated requirement that a section 43(a) plaintiff have used a U.S. trademark in U.S. commerce to bring a Lanham Act unfair competition claim; the Supreme Court’s guidance in Lexmark International, Inc. v. Static Control Components, Inc. does not allude to one, and the court's prior cases either only assumed or articulated as dicta that such a requirement existed; and therefore, the district court erred in imposing such a condition precedent upon Bayer’s claims. The court also concluded that BCC has adequately pled a section 43(a) false association claim for purposes of the zone of interests prong; BCC's allegations reflect the claim furthers the section 45 purpose of preventing the deceptive and misleading use of marks in commerce within the control of Congress; and BCC has also alleged injuries that are proximately caused by Belmora’s violations of the false association statute. Therefore, the court held that BCC has sufficiently pled a section 43(a) false association claim to survive Belmora’s Rule 12(b)(6) motion. Because these statements are linked to Belmora’s alleged deceptive use of the FLANAX mark, the court is satisfied that BCC’s false advertising claim, like its false association claim, comes within the Act’s zone of interests. The court inferred that the alleged advertisements contributed to the lost border sales pled by BCC, and that the claim also satisfies Lexmark’s proximate cause prong. Further, the court agreed with Bayer that the district court erred in overturning the TTAB’s section 14(3) decision because it read a use requirement into the section that is simply not there. Accordingly, the court vacated and remanded. View "Belmora LLC v. Bayer Consumer Care AG" on Justia Law
Posted in:
Drugs & Biotech, Trademark