Justia Drugs & Biotech Opinion Summaries

Articles Posted in US Court of Appeals for the Fifth Circuit
by
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

by
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

by
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

by
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

by
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

by
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