Justia Drugs & Biotech Opinion Summaries

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 First Circuit affirmed the judgment of the district court granting summary judgment in favor of CVS Pharmacy, Inc. and dismissing this complaint involving a pharmacist's dispensation of a prescription that triggered the pharmacy's internal warning system, holding that the district court did not err.Plaintiff brought this action alleging that he sustained permanent ocular damages as a result of a medication dispensed by CVS. Plaintiff brought a claim for negligence, a claim under Mass. Gen. Laws ch. 93A, and a claim for product liability. The district court granted summary judgment for CVS. The First Circuit affirmed, holding that Plaintiff did not provide any adequate basis for reversing the district court's decisions. View "Carrozza v. CVS Pharmacy, Inc." on Justia Law

The Supreme Court granted in part and denied in part a petition for a writ of mandamus stemming from lawsuits brought against generic drug manufacturers for selling vials of propofol to ambulatory surgical centers despite an allegedly foreseeable risk that they would be used on multiple patients, holding that some of the claims were preempted.Plaintiffs alleged that Petitioners knew or should have known that selling 50 mL vials of propofol, as opposed to 20 mL vials, to ambulatory surgical centers with high patient turnover was unsafe due to the risk of contamination from multi-dosing. Petitioners filed a motion to dismiss, alleging that Plaintiff's claims conflicted with federal law. The district courts summarily denied the motions to dismiss. Petitioners then filed the instant writ petition. The Supreme Court granted the writ in part, holding (1) Plaintiffs' negligence cause of action and request for punitive damages survived; but (2) the remainder of Plaintiffs' causes of action were preempted. View "Teva Parenteral Medicines, Inc. v. Eighth Judicial District Court" on Justia Law

In this case involving claims of personal injury and product liability against the manufacturer of a medical device the Supreme Judicial Court reversed the decision of the superior court judge denying the manufacturer's motion to dismiss, holding that plaintiffs asserting parallel state law claims may do so with no greater degree of specificity than otherwise required under Iannacchino v. Ford Motor Co., 451 Mass. 623, 636 (2008).Plaintiff sued Genzyme Corporation, asserting that Synvisc-One, a class III medical device subject to premarket approval under the Medical Device Amendments (MDA), 21 U.S.C. 360c et seq., was negligently manufactured, designed, distributed, and sold by Genzyme. Genzyme filed a motion to dismiss on the grounds that the allegations were preempted by federal regulation. The trial judge denied the motion to dismiss. The Supreme Judicial Court reversed, holding that while all of Plaintiff's state law claims properly paralleled the federal requirements, none of them was sufficiently pleaded under Iannacchino to survive Genzyme's motion to dismiss. View "Dunn v. Genzyme Corp." on Justia Law

The Supreme Court made permanent a preliminary writ of prohibition preventing the circuit court from allowing Plaintiffs' claims against Janssen Pharmaceuticals, Johnson & Johnson, and Janssen Research & Development (collectively, Defendants) in the Circuit Court of the City of St. Louis, holding that the circuit court abused its discretion by refusing to transfer the claims of those injured outside of the City of St. Louis.Multiple plaintiffs filed this action stating various causes of action arising from the sale and use of Risperdal, a prescription drug. Defendants filed a motion to dismiss based on improper venue and forum non conveniens for all plaintiffs not injured in the City of St. Louis. The circuit court overruled the motion. Defendants then filed a petition for a writ of prohibition or mandamus asking that the claims of the plaintiffs whose injuries allegedly occurred in Missouri counties other than the City of St. Louis be transferred. The Supreme Court granted a writ of prohibition, holding (1) Mo. R. Civ. P. 52.05(a) cannot be used to confer venue in a forum that is otherwise improper, and newly enacted Mo. Rev. Stat. 508.013.1 did not alter the result on these facts; and (2) the circuit court's failure to transfer the claims of those injured outside of the City of St. Louis was an abuse of discretion. View "State ex rel. Janssen Pharmaceuticals, Inc. v. Honorable Michael Noble" on Justia Law

In 2012, 41-year-old Karen Hubbard suffered a catastrophic stroke caused by a blood clot to her brain--a venous sinus thrombosis, a type of venous thromboembolism (VTE). She had been taking Beyaz, a birth control pill manufactured by Bayer. While she first received a prescription for Beyaz on December 27, 2011, Karen had been taking similar Bayer birth control products since 2001. The pills are associated with an increased risk of blood clots. The Beyaz warning label in place at the time of Karen’s Beyaz prescription warned of a risk of VTEs and summarized studies.The Eleventh Circuit affirmed summary judgment in favor of Bayer. Georgia’s learned intermediary doctrine controls this diversity jurisdiction case. That doctrine imposes on prescription drug manufacturers a duty to adequately warn physicians, rather than patients, of the risks their products pose. A plaintiff claiming a manufacturer’s warning was inadequate bears the burden of establishing that an improved warning would have caused her doctor not to prescribe her the drug in question. The Hubbards have not met this burden. The prescribing physician testified unambiguously that even with the benefit of the most up-to-date risk information about Beyaz, he considers his decision to prescribe Beyaz to Karen to be sound and appropriate. View "Hubbard v. Bayer Healthcare Pharmaceuticals Inc." on Justia Law

The Supreme Court affirmed the judgment of the trial court in favor of Defendants, Boehringer Ingelheim Pharmaceuticals, Inc. and Boehringer Ingelheim International, GmbH, on claims brought by Plaintiff, the executrix of the decedent's estate, that an oral anticoagulant medication wrongfully caused the decedent's death, holding that the trial court did not err.Specifically, the Supreme Court held that the trial court did not improperly (1) preclude evidence and arguments related to spoliation; (2) prevent Plaintiff from using an excerpt from a particular deposition on rebuttal; (3) grant Defendants' motion for summary judgment on a design defect claim relating to the absence of a reversal agent; and (4) issue a curative instruction to the jury after closing arguments. View "Boone v. Boehringer Ingelheim Pharmaceuticals, Inc." on Justia Law

In this lawsuit brought against Johnson & Johnson, Inc. and other entities (collectively, Defendants) alleging state tort claims due to injuries caused by a Class III medical device the Supreme Court reversed the judgment of the trial court granting Defendants' motion for judgment on the pleadings based on federal preemption of all claims, holding that, under Kentucky's notice pleading standards, the motion for judgment on the pleadings should have been denied.In their complaint, Plaintiffs asserted claims for, inter alia, strict liability negligence, and lack of informed consent. Defendants moved for judgment on the pleadings based on federal preemption of all claims. The trial court granted the motion and dismissed all of Plaintiffs' claims. The court of appeals affirmed. The Supreme Court reversed, holding that, under Kentucky's notice pleading standard, Plaintiffs' complaint sufficiently put Defendants on notice of parallel claims under Kentucky law that may not be preempted. View "Russell v. Johnson & Johnson Inc." on Justia Law

Cottingham sought compensation under the National Vaccine Injury Compensation Program, 42 U.S.C. 300aa-10, alleging that a Gardasil® vaccination received by her minor daughter, K.C., in 2012, for the prevention of HPV, caused K.C. injuries. The claim was filed immediately before the limitations period ran out.The government stated argued that a "reasonable basis for bringing the case may not be present.” Cottingham’s counsel was granted additional time but was unable to submit an expert opinion supporting her claim. The Special Master denied compensation. Cottingham sought attorneys’ fees and litigation costs ($11,468.77), 42 U.S.C. 300aa-15(e)(1). The Master found no evidence to support the "vaguely asserted claims" that the vaccination caused K.C.’s headaches, fainting, or menstrual problems." While remand was pending the Federal Circuit held (Simmons) that although a looming statute of limitations deadline may impact the question of whether good faith existed to bring a claim, that deadline does not provide a reasonable basis for asserting a claim. The Master decided that Simmons did not impact his analysis, applied a “totality of the circumstances” standard, and awarded attorneys’ fees. The Claims Court vacated and affirmed the Special Master’s third decision, finding no reasonable basis for Cottingham’s claim.The Federal Circuit vacated, noting that there is no dispute that Cottingham filed her claim in good faith. Simmons did not abrogate the “totality of the circumstances inquiry.” K.C.’s medical records paired with the Gardasil® package insert constitute circumstantial, objective evidence supporting causation. View "Cottingham v. Secretary of Health and Human Services" on Justia Law