Justia Drugs & Biotech Opinion Summaries

The Food and Drug Administration (“FDA”) approved mifepristone to be marketed with the brand name Mifeprex under Subpart H (the “2000 Approval”). In January 2023, FDA approved a modified REMS for mifepristone, lifting the in-person dispensing requirement.  Plaintiffs (physicians and physician organizations) filed a suit against FDA, HHS, and a several agency heads in the official capacities. Plaintiffs challenged FDA’s 2000 Approval of the drug and also requested multiple grounds of alternative relief for FDA’s subsequent actions. Plaintiffs moved for a preliminary injunction ordering FDA to withdraw or suspend (1) FDA’s 2000 Approval and 2019 Generic Approval, (2) FDA’s 2016 Major REMS Changes, and (3) FDA’s 2021 Mail-Order Decision and its 2021 Petition Denial of the 2019 Citizen Petition. The district court entered an order staying the effective date of the 2000 Approval and each of the subsequent challenged actions.   The Fifth Circuit granted Defendants’ motions for a stay pending appeal. The court wrote that at this preliminary stage, and based on the court’s necessarily abbreviated review, it appears that the statute of limitations bars Plaintiffs’ challenges to the Food and Drug Administration’s approval of mifepristone in 2000. However, Plaintiffs brought a series of alternative arguments regarding FDA’s actions in 2016 and subsequent years. And the district court emphasized that its order separately applied to prohibit FDA’s actions in and after 2016 in accordance with Plaintiffs’ alternative arguments. As to those alternative arguments, Plaintiffs’ claims are timely. Defendants have not shown that Plaintiffs are unlikely to succeed on the merits of their timely challenges. For that reason, Defendants’ motions for a stay pending appeal are denied in part. View "Alliance Hippocratic Medicine v. FDA" on Justia Law

Petitioners Wages and White Lion Investments, LLC, d/b/a Triton Distribution (“Triton”) and Vapetasia, LLC (“Vapetasia”) sought to market flavored nicotine-containing e-liquids for use in open-system e-cigarette devices. Petitioners needed to submit premarket tobacco product applications as required by 21 U.S.C. Section 387j—which the Food and Drug Administration (“FDA”) deemed applicable to e-cigarette tobacco products. FDA denied the requested marketing authorizations, finding that Petitioners failed to offer reliable and robust evidence (such as randomized controlled trials or longitudinal studies) to overcome the risks of youth addiction and show a benefit to adult smokers. Petitioners sought review of those marketing denial orders (“MDOs”), and prior to the consolidation of the two cases. Petitioners argued that the FDA lacks the authority to impose a comparative efficacy requirement and that FDA acted arbitrarily and capriciously by “requiring” scientific studies.   The Eleventh Circuit denied the petitions for review. The court explained that Congress passed the Family Smoking Prevention and Tobacco Control Act (“TCA”) in an active effort to protect public health. Relevant here, the Deeming Rule subjected e-cigarette manufacturers to the TCA’s prior authorization requirement—manufacturers of “new tobacco product[s]” must submit premarket tobacco product applications (“PMTAs”). The court held that the FDA’s consideration of the lack of cessation as a risk and comparing that risk between new tobacco products and old tobacco products “fall[s] squarely within the ambit of the FDA’s expertise and merit[s] deference.”  As such, the court cannot say that FDA acted arbitrarily and capriciously by disagreeing with Petitioners as to the significance of the evidence they presented. View "Wages and White Lion Investmen v. FDA" on Justia Law

The 2009 Family Smoking Prevention and Tobacco Control Act, implemented through the FDA, 21 U.S.C. 387a(b), 393(d)(2), prohibits manufacturers from selling any “new tobacco product” without authorization. The FDA’s 2016, “Deeming Rule” classified electronic nicotine delivery systems (e-cigarettes) as a “new tobacco product.” To avoid an overnight shutdown of the e-cigarette industry, the FDA delayed enforcement of the Deeming Rule then required e-cigarette makers to submit premarket tobacco applications (PMTAs). Originally, the FDA required that all PMTAs be filed by 2018. The FDA later extended the PMTA deadline to 2022 but then moved the deadline to 2020. Initially, the FDA’s guidance stated that “in general, FDA does not expect that applicants will need to conduct long-term studies to support an application” but later changed course and required long-term studies of e-cigarettes.Triton had e-cigarette products on the market before the Deeming Rule. Triton (and others) submitted PMTAs for flavored e-cigarettes. In August 2021, the FDA announced that it would deny the PMTAs for 55,000 flavored e-cigarettes, stating it “likely” needed evidence from long-term studies." Less than a week later, Triton submitted a letter stating that it intended to conduct long-term studies of its products. About two weeks later, the FDA issued Triton a marketing denial order. The Fifth Circuit granted a temporary administrative stay and, later, a full stay, “to prevent the FDA from shutting down Triton’s business” pending disposition of Triton’s petition. View "Wages and White Lion Investments, L.L.C. v. United States Food and Drug Administration" on Justia Law

Plaintiffs, three women who suffered persistent hair loss after chemotherapy treatments, sued as a part of a multidistrict litigation (MDL) against distributors of the drug Taxotere (docetaxel) for permanent chemotherapy-induced hair loss, asserting a failure-to-warn claim.Louisiana law provides a one-year liberative prescription period for products-liability cases. Furthermore, under Louisiana law, there is a firmly rooted equitable-tolling doctrine known as contra non valentem agere non currit praescriptio, which means "[n]o prescription runs against a person unable to bring an action."The Fifth Circuit affirmed the district court's judgment in favor of Sanofi, agreeing with the district court that plaintiffs' claims are facially prescribed. The court interpreted Louisiana law to require that once hair loss persisted after six months, contra non valentem tolled the prescription period until the point when a prospective plaintiff through the exercise of reasonable diligence should have "considered [Taxotere] as a potential root cause of" her injury. In this case, the court concluded that plaintiffs did not act reasonably in light of their injuries and their causes of action were reasonably knowable in excess of one year prior to their filing suit. Therefore, Louisiana's equitable tolling doctrine of contra non valentem did not save plaintiffs' claims. View "Thibodeaux v. Sanofi U.S. Services, Inc." on Justia Law

The Fifth Circuit affirmed the district court's grant of summary judgment on plaintiff's failure-to-warn claim asserted against the manufacturers of Taxotere, a chemotherapy medication. Plaintiff argues that Taxotere's manufacturers failed to provide an adequate warning of potentially permanent hair loss, which caused her injuries.The court concluded that, under Louisiana law, plaintiff cannot establish causation where, on this record, it is beyond any genuine dispute that a warning of the risk of permanent hair loss—as opposed to temporary hair loss—would not have affected the prescribing physician's decision to prescribe Taxotere. Therefore, plaintiff's claim fails as a matter of law. View "Phillips v. Sanofi U.S. Services, Inc." on Justia Law

The Commission charged Impax Laboratories with antitrust violations for accepting payments ultimately worth more than $100 million to delay the entry of its generic drug for more than two years. The Commission conducted a rule-of-reason analysis and unanimously concluded that Impax violated antitrust law.The Fifth Circuit denied the petition for review, concluding that substantial evidence supports the Commission's finding that the reverse payment settlement threatened competition. In this case, Endo agreed to make large payments to the company that was allegedly infringing its patents; in exchange, Impax agreed to delay entry of its generic drug until two-and-a-half years after the FDA approved the drug; and neither the saved costs of forgoing a trial nor any services Endo received justified these payments. Furthermore, substantial evidence supports the Commission's conclusion that a less restrictive, no-payment settlement, alternative was feasible. Therefore, Impax agreed to an unreasonable restraint of trade because the reverse payment settlement was an agreement to preserve and split monopoly profits that was not necessary to allow generic competition before the expiration of Endo's patent. View "Impax Laboratories, Inc. v. Federal Trade Commission" on Justia Law

The Fifth Circuit affirmed the district court's dismissal of plaintiff's complaint alleging that she used defendants' prescription chemotherapy drug and now suffers from permanent hair loss. As a plaintiff in this multidistrict litigation (MDL), plaintiff was required to serve defendants with a completed fact sheet disclosing details of her personal and medical history soon after filing her short form complaint. She failed to do so in this case.The court applied the Deepwater Horizon two-factor test to the district court's dismissal of plaintiff's case and held that the district court was not required to make specific factual findings on each of the Deepwater Horizon prongs before dismissing plaintiff's case. The court explained that plaintiff exhibited a clear record of delay sufficient to meet the first prong in the Deepwater Horizon test, and lesser sanctions would not have served the best interests of justice. The court also held that the district court did not abuse its discretion in denying plaintiff's motion for reconsideration. View "Kuykendall v. Accord Healthcare, Inc." on Justia Law

The Fifth Circuit affirmed defendant's sentence for methamphetamine-related offenses. The court held that the district court did not clearly err by denying a mitigating-role adjustment under USSG 3B1.2 where defendant certainly understood that she was illegally transporting contraband into the United States and that she was being paid for her participation. The court also held that the district court did not impermissibly rely on her integral role to the exclusion of all else, and remand was not warranted where the district court need not weigh each USSG 3B1.2 factor on the record. View "United States v. Bello-Sanchez" on Justia Law

The Fifth Circuit affirmed the district court's grant of summary judgment to Solvay on relators' False Claims Act (FCA) claims. The court held that relators failed to produce sufficient evidence to survive summary judgment on any of their briefed claims where the public disclosure bar applied to relators' AndroGel claims; at bottom, the probative value of relators' off-label marketing causation evidence was primarily based on conjecture and speculation and was insufficient to create a genuine issue of material fact for trial; and summary judgment was appropriate as to relators' claim that Solvay unduly influenced P&T committees to place Solvay's drugs on preferred drug lists and as to relators' FCA retaliation claims. Finally, the court affirmed the district court's ruling that partly granted court costs to Solvay. View "King v. Solvay Pharmaceuticals, Inc." on Justia Law