Justia Drugs & Biotech Opinion Summaries

Carlos Esteras and Raphael Frias were convicted of fentanyl trafficking charges and appealed their sentences, arguing that the district court erred in calculating their respective Guidelines ranges. Esteras contended that the district court wrongly calculated his base offense level by applying a two-level increase for maintaining a premises for narcotics trafficking and declining to apply a two-level reduction for being a minor participant in the trafficking scheme. He also argued that the district court wrongly applied a two-point increase to his criminal history score after finding that he was on parole at the time of the offense. Frias argued that the district court erred in applying the two-level premises enhancement and a four-level increase for being an organizer or leader of the scheme, and failed to adequately consider his mitigating evidence in declining to vary downwards.The United States District Court for the Northern District of New York had sentenced Esteras to 84 months' imprisonment and Frias to 135 months' imprisonment. The court had applied several sentencing enhancements, including a two-level enhancement for maintaining a premises for narcotics trafficking and a four-level enhancement for being an organizer or leader of the scheme.The United States Court of Appeals for the Second Circuit affirmed each of the district court’s sentencing decisions except its application of the organizer or leader enhancement to Frias. The court affirmed Esteras’s sentence and vacated and remanded Frias’s sentence for further proceedings consistent with its opinion. The court found that Esteras's home qualified for the stash-house enhancement and that he was not a minor participant in the conspiracy. The court also found that Esteras was on parole when he committed his offenses, warranting a two-point increase to his criminal history score. However, the court found that Frias did not qualify as an organizer or leader under the Guidelines, warranting a remand for further proceedings. View "United States v. Frias" on Justia Law

The United States Court of Appeals for the Second Circuit heard a case initiated by Adam Hart, who filed a qui tam action under the False Claims Act (FCA) against pharmaceutical distributor McKesson. Hart alleged that McKesson provided business management tools to its customers for free in exchange for commitments to purchase drugs, which he claimed violated the federal anti-kickback statute (AKS) and several analogous state laws. The district court dismissed Hart's FCA claim, determining he failed to allege McKesson acted "willfully" as required by the AKS.On appeal, the Second Circuit held that to act "willfully" under the AKS, a defendant must knowingly act in a way that is unlawful. The court found that Hart failed to provide sufficient facts to meet this standard. However, the court disagreed with the district court's assertion that Hart's state claims were premised solely on a violation of the federal AKS. Consequently, the Second Circuit affirmed the dismissal of Hart’s federal FCA claim, vacated the dismissal of the remaining state claims, and remanded for further proceedings. View "United States, ex rel. Hart v. McKesson Corp." on Justia Law

The United States Court of Appeals for the Second Circuit upheld the life imprisonment sentence of Azibo Aquart, who was found guilty of multiple federal homicide and drug trafficking crimes. The court had previously affirmed his conviction but vacated his death sentence, remanding the case for a new penalty proceeding. On remand, the government decided not to pursue the death penalty, and Aquart was resentenced to life imprisonment. Aquart appealed, arguing that the district court erred in refusing to address new challenges to his conviction and in sentencing him for both drug-related murder and drug conspiracy, which he argued constituted double jeopardy. The Appeals Court rejected both arguments, ruling that the district court correctly applied the mandate rule and that Aquart's double jeopardy argument was without merit. View "United States v. Aquart" on Justia Law

After the district court granted summary judgment in favor of two government agencies and a pharmaceutical company in this Freedom of Information Act ("FOIA") case. Plaintiff, a science writer and journalism professor, sought records from the government agencies relating to the pharmaceutical company's successful application for accelerated approval of a drug for the treatment of a neuromuscular disease. The agencies produced over 45,000 pages of documents, some of which were redacted under Exemption 4 of FOIA. The district court granted summary judgment for the agencies and the pharmaceutical company on the basis that the redacted information fell within Exemption 4 and publication would either cause foreseeable harm to the interests protected by Exemption 4 or was prohibited by law.Plaintiff appealed and the Second Circuit affirmed the district court’s ruling. The court held that the interests protected by Exemption 4 are the submitter's commercial or financial interests in the information that is of a type held in confidence and not disclosed to any member of the public by the person to whom it belongs. Defendants' declarations show that the release of the information Plaintiff seeks would foreseeably harm the pharmaceutical company’s interests and Plaintiff does not raise a genuine dispute as to that showing. View "Seife v. FDA, et al." on Justia Law

Defendants in these tandem cases (collectively, "Takeda") are a brand pharmaceutical manufacturer and related entities that began producing and marketing the Type-2 diabetes drug ACTOS in 1999. Purchasers of ACTOS filed suit against Takeda for improperly describing its patents to the FDA, in effect extending the duration of its patent protection over ACTOS and delaying generic competition. The district court denied Takeda's motion to dismiss, concluding that the alleged patent descriptions were incorrect under the Hatch–Waxman Act and pertinent regulations.On this interlocutory appeal, the Second Circuit held that under the "Listing Requirement" of 21 U.S.C. 355(b)(1), a combination patent does not "claim" any of its component drug substances past their individual patent expiration dates. The court also held that the purchasers were not required to allege that Takeda's interpretation of the Listing Requirement was unreasonable in order to plead a monopolization claim under the Sherman Act. Accordingly, the court affirmed the district court's denial of Takeda's motion to dismiss and remanded for further proceedings. View "United Food & Commercial Workers Local 1776 v. Takeda Pharmaceutical Co." on Justia Law

Plaintiffs, who were prescribed a metered-dose inhaler manufactured by defendant and approved by the FDA to alleviate symptoms of chronic obstructive pulmonary disease, filed suit alleging violations of state law premised on defendant's allegedly deceptive labeling or defective design and manufacture of the metered-dose inhaler.The Second Circuit affirmed the district court's dismissal of the claims as preempted by federal law. The court explained that plaintiffs' state law design and manufacturing defect claims are preempted to the extent that they would require any change listed in 21 C.F.R. 314.70(b)(2). In this case, the modifications that plaintiffs' claims would require under state law constitute "major" changes, and therefore those claims are preempted by federal law. Finally, the complaint failed to state any non-preempted claim and plaintiffs' remaining arguments are without merit. View "Ignacuinos v. Boehringer Ingelheim Pharmaceuticals Inc." on Justia Law

The Second Circuit affirmed the district court's grant of summary judgment in favor of defendants and dismissal of plaintiffs' products liability claims after precluding, pursuant to Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993), the opinions of plaintiffs' expert witnesses as to general causation.The court concluded that, not only was it appropriate for the district court to take a hard look at plaintiffs' experts' reports, the court was required to do so to ensure reliability. Furthermore, plaintiffs' contention that the district court impermissibly focused on plaintiffs' experts' conclusions instead of their methodologies is similarly unavailing. Even assuming that the district court required experts to back their opinions with studies definitely supporting their conclusions, the district court did not err in doing so. Therefore, the district court appropriately undertook a rigorous review of each of plaintiffs' experts, and based on that review reasonably found that the experts' methods were not sufficiently reliable and that their conclusions were not otherwise supported by the scientific community.The court also concluded that the district court correctly granted summary judgment in favor of defendants where no reasonable juror could find that it was more likely than not that general causation had been established based on plaintiffs' admissible evidence. The court was not persuaded that the district court erred in holding that there is a general causation requirement across all states. Furthermore, the court rejected plaintiffs' contention that the district court prevented them from obtaining and presenting evidence of general causation. In this case, plaintiffs failed to explain how admitting portions of the expert reports would have established general causation; the district court did not abuse its broad discretion in excluding differential-diagnosis evidence; and the district court did not abuse its broad discretion in managing discovery. View "In Re: Mirena IUS Levonorgestrel-Related Products Liability Litigation" on Justia Law

Plaintiffs filed a class action under S.E.C. Rule 10b-5, 17 C.F.R. 240.10b-5, following the failure of NewLink's Phase 3 clinical trial for a novel pancreatic cancer drug and the resulting decline in the market value of NewLink shares.The Second Circuit held that defendants' statements about the efficacy of their pancreatic cancer drug were puffery, not material misrepresentations. However, the court held that plaintiffs plausibly pled material misrepresentation and loss causation for defendants' statements about the scientific literature and the design of their clinical trial. Therefore, the court affirmed the district court's dismissal in part regarding the 2013-2016 Assessments; vacated the dismissal in part regarding the September, March, and Enrollment statements; and remanded for further proceedings. View "Nguyen v. NewLink" on Justia Law

The Food Drug and Cosmetic Act's (FDCA) broad preemption clause, 21 U.S.C. 379s, bars plaintiffs from seeking to impose additional or different labeling requirements through their state-law claims, especially when Congress and the FDA already have provided for specific labeling requirements. Plaintiffs filed suit against L’Oréal, alleging common law claims for unjust enrichment and breach of the implied warranty of merchantability, as well as claims under eight state consumer protection statutes. Plaintiffs believed they were being deceived into buying more product, because a portion of each of the liquid cosmetics they purchased could not be extracted.The Second Circuit affirmed the district court's dismissal of the complaint, holding that plaintiffs' state law claims at issue are preempted by the FDCA. In this case, plaintiffs alleged that their injuries resulted from the fact that the labels of the various L’Oréal products omitted certain critical information—specifically, that the creams could not be fully dispensed from their respective containers. Plaintiffs also admit that the packages comply with federal labeling requirements. The court explained that, if plaintiffs were permitted to move forward with their claims, they would be using state law to impose labeling requirements on top of those already mandated in the FDCA and the regulations promulgated thereunder. View "Critcher v. L'Oreal USA, Inc." on Justia Law

In this multi-district litigation, plaintiffs brought a series of products liability actions against the makers of Eliquis for injuries they or their decedents suffered while taking the drug. In the multi-district litigation, the district court denied motions to remand many of the actions to state court and then dismissed 64 suits.The Second Circuit affirmed, holding that 28 U.S.C. 1441(b)(2) was no barrier to the removal of the transferred actions at issue. The court held that a home‐state defendant may in limited circumstances remove actions filed in state court on the basis of diversity of citizenship, was authorized by the text of Section 1441(b)(2), and was neither absurd nor fundamentally unfair. The court also affirmed the dismissal of plaintiffs' negligence and strict liability claims as preempted by the Food, Drug, and Cosmetics Act. In this case, plaintiffs' claims consisted of conclusory and vague allegations and did not plausibly allege the existence of newly acquired information. Therefore, plaintiffs' allegations were insufficient to state a claim that was not preempted. View "Gibbons v. Bristol-Myers Squibb Co." on Justia Law