Justia Drugs & Biotech Opinion SummariesArticles Posted in US Court of Appeals for the Fourth Circuit
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
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
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