Mealey's Drugs & Devices

  • October 10, 2024

    GSK To Pay $$2.2 Billion To Settle Majority Of Zantac Cases In United States

    LONDON — GSK PLC announced Oct. 9 that it has reached settlement agreements to end approximately 80,000 Zantac (ranitidine) state court product liability cases pending against the pharmaceutical company in the United States.

  • October 10, 2024

    Janssen, Bayer Say It Is Time To End Fluoroquinolone MDL

    MINNEAPOLIS — The Janssen and Bayer defendants named in the fluoroquinolone multidistrict litigation asked the court to terminate the MDL, arguing that the MDL “has fulfilled its original purpose and that maintaining the MDL no longer promotes the just and efficient conduct of litigation.”

  • October 10, 2024

    Alabama Federal Judge Grants Summary Judgment To Birth Control Device Companies

    MONTGOMERY, Ala. — An Alabama federal judge granted two motions for summary judgment filed by the manufacturer, distributor and parent company of an allegedly defective birth control device after finding that a couple’s claims are barred by the state’s statute of limitations and preempted by federal law.

  • October 09, 2024

    FDA: District Court Should Dismiss Mifepristone Case; Intervening States Say No

    AMARILLO, Texas — Parties in a lawsuit challenging the U.S. Food and Drug Administration’s approval of abortion drug mifepristone offered the district court varying opinions on how to proceed in light of the U.S. Supreme Court’s finding that a group of anti-abortion advocates lacked standing in its challenge to the approval because they had no injury.

  • October 07, 2024

    JPMDL Won’t Centralize Cases Stemming From Alleged Toxic Embryo Solution

    WASHINGTON, D.C. — The U.S. Judicial Panel on Multidistrict Litigation on Oct. 4 denied a motion to centralize cases filed by couples who sued a manufacturer of a solution used during fertility-related treatments that they claim was toxic and destroyed their developing embryos.

  • October 07, 2024

    JPMDL Centralizes Defective Port Cases In California’s Southern District

    WASHINGTON, D.C. — The U.S. Judicial Panel on Multidistrict Litigation agreed to centralize cases alleging that chemotherapy ports were defective and caused a multitude of injuries, assigning the litigation to U.S. Judge Jinsook Ohta of the Southern District of California.

  • October 07, 2024

    U.S. Supreme Court Denies Cert In FCA, Anti-Kickback Violations Row

    WASHINGTON, D.C. — The U.S. Supreme Court on Oct. 7 denied certiorari of a qui tam relator’s petition seeking review of a Second Circuit U.S. Court of Appeals ruling affirming a district court’s dismissal of federal False Claims Act (FCA) suit alleging violations of the Anti-Kickback Statute (AKS), where the relator argued for review to resolve the split between circuit courts regarding whether knowledge that a party’s conduct violates the law is required to show willfulness pursuant to the AKS.

  • October 07, 2024

    U.S. Supreme Court Denies Certiorari In FCA Public Disclosure Bar Dispute

    WASHINGTON, D.C. — The U.S. Supreme Court on Oct. 7 denied a petition for certiorari filed by pharmaceutical companies seeking review of the Ninth Circuit U.S. Court of Appeals’ ruling that the public disclosure bar was not triggered in a case where it reversed a district court’s dismissal of a suit accusing the companies of violating the False Claims Act (FCA) by artificially inflating drug prices.

  • October 02, 2024

    Mass Tort Cases For Drugs, Medical Devices

    New developments in the following mass tort drug and device cases are marked in boldface type.

  • October 02, 2024

    Federal Judge Allows Nondrowsy Label Dispute To Move Forward But Limits Claims

    CHICAGO — An Illinois federal judge ruled that a woman “overslept on her rights” to pursue breach of warranty claims against the maker of a nondrowsy cold medicine but also found that her claims are not preempted by federal law and that she can, for the time being, represent a nationwide class of purchasers.

  • October 02, 2024

    Pa. Federal Judge Adopts Dismissal Recommendations In Surgical Mesh Injury Case

    SCRANTON, Pa. — A federal judge in Pennsylvania has adopted a magistrate judge’s report and recommendation and partially granted a motion to dismiss filed by a surgical mesh manufacturer and its distributor facing claims that a man was injured after the product was used during surgery.

  • October 02, 2024

    Stem Cell Company Owner Sentenced For Violating FDCA In Marketing, Sale Of Product

    LOS ANGELES — The founder and CEO of a company that manufactured and distributed injectable stem cell products made from human umbilical cord blood was sentenced in a California federal court to 36 months in prison after he pleaded guilty to violating the federal Food, Drug and Cosmetic Act (FDCA).

  • October 02, 2024

    Manufacturer Largely Loses Bid To Toss 4 Cases Alleging Defective Device Injuries

    BOSTON — A federal judge in Massachusetts denied three motions for summary judgment filed by a device manufacturer in cases in which women allege that an implanted radiographic marker used to mark soft tissue sites during cancer treatment was defective and caused injuries but partially granted a fourth motion, finding that the woman failed to identify a genuine dispute of material fact as to causation on her failure-to-warn claim under Florida law.

  • October 02, 2024

    Ky. Federal Judge Rules Claims In Defective Heart Device Case Are Preempted

    LOUISVILLE, Ky. — A Kentucky federal judge granted a motion to dismiss a case alleging that a defective heart device caused injuries after finding that each claim is preempted by federal law and that “mere reference to past recalls is not enough to properly plead a parallel claim.”

  • October 02, 2024

    3rd Circuit Remands Cases In Fosamax Femur MDL, Finds Claims Not Preempted

    PHILADELPHIA — The Third Circuit U.S. Court of Appeals found that a district court erred in finding that state law claims in the Fosamax femur fracture multidistrict litigation are preempted and reversed the decision that awarded a drug manufacturer summary judgment in 1,046 cases.

  • October 02, 2024

    9th Circuit Finds Stem Cells Are Drugs Under FDCA, Reverses Lower Court

    SAN FRANCISCO — A stem cell mixture used by clinics is a drug under the U.S. Federal Food, Drug, and Cosmetic Act (FDCA), the Ninth Circuit U.S. Court of Appeals ruled in reversing a lower court, also finding that the “same surgical procedure” exception does not apply, though the judges differed on why they reached that conclusion.

  • October 01, 2024

    Suboxone Plaintiffs Cite More Cases To Strengthen Argument Against Preemption

    CLEVELAND — Lead counsel for the plaintiffs in the Suboxone film multidistrict litigation filed a notice of supplemental authority to further argue its position that state law claims are not preempted by directing the court to recent decisions that reflect the impact of Loper Bright Enters. v. Raimondo.

  • September 30, 2024

    Judge Approves $3M Securities Settlement For Misleading COVID-19 Treatment Claims

    NEWARK, N.J. — A New Jersey federal judge granted final approval of a $3 million settlement including $750,000 in attorney fees to resolve a securities class action against a pharmaceutical company for deceiving shareholders by making misleading statements about the prospects of its product for the successful treatment of COVID-19.

  • September 27, 2024

    Settlement In Principle Reached In Walgreens Lidocaine Labeling Class Suit

    CHICAGO — A status hearing in a putative class complaint by consumers who accuse Walgreen Co., doing business as Walgreens, of misleading labeling on certain lidocaine products was delayed via a docket entry by a clerk in a federal court in Illinois on Sept. 26 after the parties stated that they reached a settlement in principle.

  • September 27, 2024

    Cook County, Ill., Jury Deadlocks In Zantac Injury Case

    CHICAGO — A Cook County Circuit Court judge declared a mistrial in a case in which a man alleges that his prostate cancer was caused by ingesting over-the-counter Zantac after a jury deadlocked on whether the manufacturer was responsible for his illness.

  • September 27, 2024

    Judge: Manufacturing Defect Claims Survive Preemption In Heart Device Case

    ST. LOUIS — A man’s claims relating to an allegedly defective implantable cardioverter defibrillator (ICD) that “are rooted in manufacturing defects are not preempted” by federal law, a Missouri federal judge ruled, but partially granted the manufacturer’s motion to dismiss as to the failure to warn claims.

  • September 26, 2024

    Judge Dismisses Remaining Claim In Defective Device Case, Finds It Preempted

    LAKE CHARLES, La. — A woman who alleges that she was injured in a car accident when a device failed to alert her that her blood glucose levels were at dangerously low levels failed in her amended complaint to show that her sole remaining claim was not preempted by federal law, a Louisiana federal judge held Sept. 24 in dismissing the claim.

  • September 25, 2024

    Judge Adopts Magistrate’s Report To Dismiss In Part Medical Device Injury Suit

    SCRANTON, Pa. — A Florida federal judge largely adopted a magistrate judge’s report and recommendation to dismiss a case filed by a man who alleges that he was injured when his pacemaker failed, finding that the claims are expressly preempted by federal law.

  • September 25, 2024

    5th Circuit Remands Mifepristone Case To District Court After High Court Ruling

    NEW ORLEANS — The Fifth Circuit U.S. Court of Appeals vacated its stay of a district court order in a case challenging expanded access to the abortion drug mifepristone and remanded the case to the U.S. District Court for the Northern District of Texas after the U.S. Supreme Court found that the plaintiffs lacked standing, but one judge filed a concurrence stating that the high “[c]ourt reversed because the [g]overnment reversed.”

  • September 23, 2024

    FTC Sues PBMs For Policies That Led To Inflated Insulin Costs

    WASHINGTON, D.C. — The Federal Trade Commission on Sept. 20 filed an administrative complaint against three prescription drug benefit managers (PBMs) accusing them of creating “a perverse drug rebate system that prioritizes high rebates from drug manufacturers, leading to artificially inflated insulin list prices,” according to a press release from the commission.

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