Justia Drugs & Biotech Opinion Summaries

The case involves four plaintiffs who took docetaxel, a chemotherapy drug, as part of their treatment for early-stage breast cancer and subsequently suffered permanent chemotherapy-induced alopecia (PCIA). The plaintiffs allege that the manufacturers of the drug, Hospira, Inc., Hospira Worldwide, LLC, and Accord Healthcare, Inc., violated state law by failing to warn them that docetaxel could cause PCIA.The case was initially heard in the United States District Court for the Eastern District of Louisiana, where the defendants moved for summary judgment on the basis that the plaintiffs' state law failure-to-warn claims were preempted by federal law. The district court denied the motion, and the defendants appealed.The United States Court of Appeals for the Fifth Circuit was tasked with determining whether federal law preempts the plaintiffs' state law failure-to-warn claims against the defendant drug manufacturers. The court found that the district court had erred in its interpretation of what constitutes "newly acquired information" under the changes-being-effected (CBE) regulation, which allows manufacturers to file a supplemental application with the FDA and simultaneously implement a labeling change before obtaining FDA approval. The court held that the district court failed to enforce the requirement that newly acquired information must "reveal risks of a different type or greater severity or frequency than previously included in submissions to FDA."The court vacated the district court's judgment on the plaintiffs' failure-to-warn claims and remanded the case for further consideration of one outstanding issue: whether the Bertrand Abstract, a scientific study, constituted "newly acquired information" that revealed a greater risk of PCIA than previously known. If the Bertrand Abstract does not meet this standard, the court held that the defendants would not be liable to the plaintiffs on their state law failure-to-warn claims. View "Hickey v. Hospira" on Justia Law

The case revolves around a dispute over a medical marijuana cultivation license issued by the Arkansas Medical Marijuana Commission to Bennett Scott “Storm” Nolan II. 2600 Holdings, LLC, an unsuccessful applicant for the same license, filed a lawsuit against the Commission and other state entities, alleging that Nolan's application did not meet the minimum merit selection criteria and that the Commission violated its own rules and the Arkansas Constitution in awarding the license to Nolan. Nolan was not initially named as a defendant or joined as a party in the lawsuit.The Pulaski County Circuit Court denied Nolan's multiple motions to join the lawsuit as an indispensable party under Rule 19(a) of the Arkansas Rules of Civil Procedure and granted summary judgment in favor of 2600 Holdings. The court ruled that the Commission had exceeded its discretion and violated the Arkansas Constitution and its own rules in awarding the license to Nolan.On appeal, the Supreme Court of Arkansas reversed the lower court's decision, finding that Nolan was indeed an indispensable party under Rule 19(a)(2). The court held that the lower court erred in not joining Nolan as an indispensable party to the litigation. As a result, the court vacated the order granting summary judgment to 2600 Holdings and remanded the case for further proceedings. The court did not address Nolan's remaining issues as they were deemed moot due to the reversal and remand. View "Nolan v. 2600 Holdings, LLC" 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

A group of individuals filed a lawsuit against Genzyme Corporation, a drug manufacturer, for injuries allegedly caused by the company's mishandling of a prescription drug shortage between 2009 and 2012. The lawsuit was filed several years after the events in question occurred and would typically have been considered too late under the applicable statutory limitations periods. However, the plaintiffs argued that previous class actions, a savings statute, and a tolling agreement between the parties allowed the lawsuit to proceed. The district court partially agreed and rejected Genzyme's argument that the delay in filing required dismissal of the lawsuit. However, it dismissed the claims of all but four plaintiffs for lack of standing, and dismissed the remaining claims on the merits.On appeal, the United States Court of Appeals for the First Circuit found that all plaintiffs have standing and the court has jurisdiction to proceed with the case, at least with respect to the plaintiffs' individual claims. However, it concluded that four plaintiffs waited too long before filing this lawsuit, and their claims are time-barred. For the remaining plaintiffs, the court vacated the judgment dismissing their claims and remanded the case to the district court for further proceedings. View "Wilkins v. Genzyme Corporation" on Justia Law

In a multi-district litigation involving diabetes drug saxagliptin, the plaintiffs claimed that the drug caused their heart failure. They presented a single expert to show the drug could cause heart failure. After a Daubert hearing and expert motions, the United States Court of Appeals for the Sixth Circuit found that the expert's testimony was unreliable due to methodological flaws and therefore excluded it. Subsequently, the district court granted summary judgment for the defendants, rejecting the plaintiffs' claim that other evidence created a genuine issue of material fact. The court also refused the plaintiffs' request for ninety days to find a replacement expert. On appeal, the plaintiffs challenged the district court's exclusion of their expert, its grant of summary judgment, and its refusal to give them more time to find another expert witness. The Court of Appeals affirmed the district court's decisions, stating that the plaintiffs' claims lacked merit. The court found that the expert's reliance on one study to the exclusion of all others was unreliable, that his use of animal data was unreliable due to his admitted lack of qualifications to analyze such studies, and that he did not reliably apply the Bradford Hill criteria - a scientific framework used to analyze whether an association between two variables is causal. The court also found that all jurisdictions require expert testimony to show general causation in complex medical cases such as this one. As the plaintiffs failed to identify a reliable general causation expert, the court granted summary judgment for the defendants. The court also found no good cause to grant the plaintiffs more time to find a replacement expert. View "In re Onglyza (Saxagliptin) and Kombiglyze (Saxagliptin and Metformin) Products Liability Litigation" on Justia Law

In this case, Virginia Cora Ward, as the administratrix of the estate of Edmund Edward Ward, brought a case against AlphaCore Pharma, LLC (ACP) and Bruce Auerbach. The decedent, Edmund Ward, was a participant in a clinical trial for a drug known as ACP-501, which was developed by ACP and administered by the National Institutes of Health (NIH). The trial took place in Maryland, where Ward traveled from his home in Massachusetts to receive treatment. Ward later withdrew from the trial due to deteriorating kidney function.In 2016, Ward filed a complaint against ACP, Auerbach, and several others, alleging fraudulent inducement to participate in the clinical trial. ACP and Auerbach moved to dismiss the case for lack of personal jurisdiction, arguing that they lacked sufficient contacts with Massachusetts. The United States District Court for the District of Massachusetts agreed with them and dismissed the case. Ward appealed to the United States Court of Appeals for the First Circuit.The First Circuit affirmed the district court's decision. The court held that neither ACP nor Auerbach had sufficient related and purposeful contacts in and with Massachusetts to establish personal jurisdiction. The court rejected Ward's claims that ACP and Auerbach had contacts with Massachusetts through their interactions with Ward's Massachusetts-based doctor, their alleged shipment of the drug to Massachusetts, their involvement in drafting the clinical trial protocol, and their alleged reimbursement of Ward's travel expenses. The court found that these claims were either unsupported by evidence or were not sufficient to establish personal jurisdiction. As a result, the court affirmed the district court's dismissal of the case against ACP and Auerbach for lack of personal jurisdiction. View "Ward v. Schaefer" on Justia Law

The First Circuit affirmed the judgment of the district court dismissing Plaintiff's putative class action against McNeil Nutritionals, LLC and Johnson & Johnson Consumer, Inc. challenging certain statements on the packaging of Lactaid products, holding that the district court correctly dismissed the complaint.Plaintiff brought this action claiming that Lactaid's labels violated federal labeling requirements, leading Plaintiff to have been mislead into purchasing Lactaid products, which she claimed were more expensive than other lactase supplements. The district court granted Defendants' second motion to dismiss. The First Circuit affirmed, holding that Plaintiff's claims were impliedly preempted by the statutory enforcement authority of the Food and Drug Administration. View "DiCroce v. McNeil Nutritionals, LLC" on Justia Law

A group consisting primarily of union health and welfare insurance plans claims that Abbvie, the manufacturer of the drug Niaspan, paid off a potential manufacturer of a generic version of the drug to delay the generic’s launch. This putative class action was brought to recover damages based on the allegedly inflated prices charged by Abbvie in violation of state antitrust and consumer protection laws. The district court denied a motion for class certification, finding that the class was not ascertainable.The Third Circuit affirmed, declining to reconsider its “ascertainability” requirement. The court rejected an argument that the district court’s factual findings were clearly erroneous because the court misunderstood their proposed methodology, overstated the prevalence of intermediaries in the pharmacy benefit managers’ data, and failed to consider the use of affidavits as a means of identifying class members. The court further noted that the new suggestion concerning affidavits was not properly put before the district court. The district court properly concluded that the proposed data matching technique is unreliable. View "In Re: Niaspan Antitrust Litigation" on Justia Law

The Butter! Spray is a butter-flavored vegetable oil dispensed in pump-action squirt bottles with a spray mechanism. The front label on the product states that the Butter! Spray has 0 calories and 0 grams of fat per serving. Plaintiffs are a class of consumers who brought their lawsuit against the then-manufacturer, Unilever United States, Inc., contending that the product’s label makes misrepresentations about fat and calorie content based on artificially low serving sizes. The district court found that Plaintiffs failed to plausibly allege that Butter! Spray was not a “spray type” fat or oil under Food and Drug Administration (FDA) regulations. The district court further held that the FDCA preempted plaintiffs’ serving size claims.   The Ninth Circuit affirmed the district court’s Fed. R. Civ. P. 12(b)(6) dismissal. The panel held that, as a matter of legal classification, Butter! Spray was a “spray.” In common parlance, a “spray” refers to liquid dispensed in the form of droplets, emitted from a mechanism that allows the product to be applied in that manner. In addition, the notion that Butter! Spray could be housed under the FDA’s legal classification for “butter” is implausible. The panel also rejected Plaintiffs’ argument that Butter! Spray is a “butter substitute” based on how it is marketed so it should be treated as “butter” for serving size purposes, too. The court explained that because Plaintiffs’ challenge to the Butter! Spray serving sizes would “directly or indirectly establish” a requirement for food labeling that is “not identical” to federal requirements, the FDCA preempts their serving size claims. View "KYM PARDINI, ET AL V. UNILEVER UNITED STATES, INC." on Justia Law

This appeal arose from an Idaho district court decision affirming a declaratory ruling issued by Respondent Dave Jeppesen (the Director) in his capacity as Director of the Idaho Department of Health and Welfare (the Department). Appellant Grace at Twin Falls, LLC (Grace), a residential assisted living and memory care facility, partnered with a preferred pharmacy to offset costs associated with a software system that coordinated the tracking and delivery of residents’ prescription medications. Because residents who failed to choose the preferred pharmacy did not receive the offset, Grace sought to charge those residents an additional $10.00 each month to cover the difference. Grace brought a petition for declaratory ruling to the Department, asking the Director to declare that Idaho Code section 39-3316(12)(b) and IDAPA 16.03.22.550.12.b did not prohibit Grace from charging the $10.00 fee to those residents who did not choose the preferred pharmacy. The Director denied the petition, declaring that Grace would not “be permitted to assess a non-preferred-pharmacy fee as such fee violates residents’ right to choose their pharmacy or pharmacist . . . .” Grace sought judicial review before the district court, which affirmed the Director’s declaratory ruling. Grace then appealed to the Idaho Supreme Court. Finding no reversible error, the Supreme Court affirmed the district court. View "Grace at Twin Falls, LLC v. Jeppesen" on Justia Law