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Mealey's Drugs & Devices

  • September 17, 2025

    Weight Loss Company Loses Motion To Dismiss Trademark Infringement Cas

    SAN DIEGO — The manufacturer of Ozempic, Wegovy and Rybelsus, fended off a motion to dismiss after a California federal judge found that a weight loss company facing claims of trademark infringement and unfair competition did not show that its application of the trademarks was within the nominative fair use doctrine.

  • September 17, 2025

    Judge Dismisses Putative Class Over Alleged Faulty Genetic Testing For Embryos

    WILMINGTON, Del. — A Delaware federal judge found that a group of consumers alleging that they would not have purchased preimplantation genetic testing for aneuploidy (PGT-A) if they had known of its failure rates lacked standing for failing to state an injury and dismissed the putative class complaint without prejudice.

  • September 16, 2025

    Philips Recalls Batch Of Sleep Apnea Devices, Citing Software Issues

    SILVER SPRING, Md. — Philips Respironics has recalled certain continuous positive air pressure (CPAP) and bi-level positive air pressure (BiPAP) sleep apnea devices because of a software error, the U.S. Food and Drug Administration said.

  • September 16, 2025

    7th Circuit Affirms $193M Medicare Drug Rebate False Claims Judgment Against Lilly

    CHICAGO — The Seventh Circuit U.S. Court of Appeals affirmed a final judgment of $193 million against Eli Lilly & Co. stemming from a False Claims Act jury verdict for reporting falsely deflated drug prices to the government.

  • September 15, 2025

    Valsartan Special Master Won’t Exclude Expert Who Cited AI-Generated Sources

    CAMDEN, N.J. — The special master in the valsartan, losartan and irbesartan hypertension drugs multidistrict litigation pending in a New Jersey federal court denied a motion to exclude an expert retained by a bellwether plaintiff, finding that the expert’s citation to nonexistent sources due to his use of artificial intelligence did not warrant exclusion.

  • September 11, 2025

    Health Care Products Distributor Agrees To Settle Virginia Claims In Opioid MDL

    CLEVELAND — A distributor of health care products and services on Sept. 10 reached a settlement with a group of Virginia counties and cities to resolve claims that its practices contributed to the nationwide opioid epidemic; terms of the settlement were not disclosed.

  • September 11, 2025

    Compounding Pharmacies Urge Reversal Of Summary Judgment Award in Semaglutide Case

    NEW ORLEANS — Companies representing the interests of drug compounders tell the Fifth Circuit U.S. Court of Appeals in an opening brief that a Texas district court erred in awarding summary judgment to the U.S. Food and Drug Administration in a dispute over whether the agency violated the law when it removed semaglutide, an FDA-approved drug for diabetes and weight loss, from the agency’s drug shortage list.

  • September 11, 2025

    9th Circuit Affirms District Court Properly Remanded California’s Opioid Case

    SAN FRANCISCO — The Ninth Circuit U.S. Court of Appeals held that a California federal court properly remanded a public nuisance suit filed by California against a group of pharmacy benefit managers (PBMs) facing allegations of contributing to the opioid epidemic after finding that the federal officer removal statute does not apply.

  • September 10, 2025

    Illinois Federal Judge Finds Defective Filshie Clip Claims Are Preempted

    CHICAGO — A woman’s claims that a defective birth control device caused injuries are preempted by federal law, an Illinois federal judge held Sept. 9, granting the manufacturer, distributor and parent company of the device summary judgment and ordering the case closed.

  • September 09, 2025

    Wound Dressing Maker Removes Complaint Alleging Infection To N.C. Federal Court

    WINSTON-SALEM, N.C. — The manufacturer of a wound and burn dressing that was the subject of a voluntary recall has removed to a federal court in North Carolina a complaint filed by woman who alleges that her foot became severely infected after using the product.

  • September 09, 2025

    6th Circuit Won’t Force Opioid MDL Recusal From Case, Disclosure Of Communications

    CINCINNATI — The Sixth Circuit U.S. Court of Appeals refused to force a district court judge to recuse himself from all pending and future proceedings involving certain pharmacy benefits managers (PBMs) and to order the disclosure of ex parte communications, denying a writ of mandamus petition that was filed by the PBMs.

  • September 09, 2025

    Texas High Court Won’t Decide If Counties Are Claimants Under Law In Opioid Case

    AUSTIN, Texas — The Texas Supreme Court has denied the petition for review of two appellate cases in which a group of pharmacies sued by Texas counties for their role in the opioid epidemic argued that an appellate court erred in rejecting its arguments that the counties are claimants under the Texas Medical Liability Act (TMLA) and that their cases should be dismissed.

  • September 09, 2025

    6th Circuit Challenge To Ruling That PBM Is Partly Preempted Draws Amicus Input

    CINCINNATI — An appeal of a ruling that parts of a Tennessee law regarding pharmacy benefit managers (PBMs) are “preempted to the extent they purport to govern self-funded [Employee Retirement Income Security Act] plans” has drawn input from numerous advocacy organizations, with two amicus curiae briefs supporting the appellee in urging the Sixth Circuit U.S. Court of Appeals to affirm the decision.

  • September 05, 2025

    4th Circuit: Gardasil Cases Found Untimely In Vaccine Court Properly Dismissed

    RICHMOND, Va. — The addition of the Gardasil vaccine to the Vaccine Injury Table is not unconstitutional, and “timely participation in the Vaccine Act compensation program is a prerequisite to bringing a tort suit,” the Fourth Circuit U.S. Court of Appeals held Sept. 4 in affirming a district court’s ruling that dismissed a group of women’s claims from a multidistrict litigation.

  • September 04, 2025

    Mass Tort Cases For Drugs, Medical Devices

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

  • September 04, 2025

    Generic Drug Maker Agrees To $200 Million Settlement With End Payers In MDL

    PHILADELPHIA — End-payer plaintiffs (EPPs) in the generic drug pricing antitrust multidistrict litigation pending in a Pennsylvania federal court on Sept. 3 moved for preliminary approval of a settlement for up to $200 million with two manufacturers who allegedly conspired with others to artificially inflate the cost of prescription medications.

  • September 03, 2025

    Conn. City Sues Drug Makers, PBMs Over Alleged Scheme To Inflate Drug Prices

    NEW HAVEN, Conn. — A Connecticut city has sued drug manufacturers and pharmacy benefit managers (PBMs) in a Connecticut federal court, alleging that the companies worked together to artificially raise the price of insulin and other medications to treat diabetes, including glucagon-like peptide-1 receptor agonist (GLP-1) drugs that help control insulin levels.

  • September 03, 2025

    Judge Sets Trial Date For Case Alleging Sickle Cell Medication Was Ineffective

    SAN FRANCISCO — A California federal judge set an August 2027 trial date for a case filed by seven individuals who allege that Oxbryta (voxelotor), a prescription medication used for the treatment of sickle cell disease (SCD), was ineffective and will hear arguments on whether class certification is warranted in June 2026.

  • September 03, 2025

    Gardasil Maker: Court Properly Dismissed Claims For Adverse Reaction To Vaccine

    RICHMOND, Va. — The maker of the Gardasil human papillomavirus vaccine urged the Fourth Circuit U.S. Court of Appeals to uphold a series of rulings that led to a North Carolina federal judge entering final judgment against the plaintiffs in a multidistrict litigation involving claims that the vaccine caused postural orthostatic tachycardia syndrome (POTS) and primary ovarian insufficiency (POI).

  • September 03, 2025

    Preemption Laws Doom Potential Cochlear Implant Class Action In Calif. Federal Court

    LOS ANGELES — A California federal judge on Sept. 2 dismissed a putative class action against the manufacturer of a cochlear implant system after finding that claims raised by a parent that his son’s implant failed to perform as expected are preempted by federal law.

  • September 02, 2025

    9th Circuit Refuses To Rehear Arguments In Decision That Remanded Opioid Case

    SAN FRANCISCO — A panel of judges in the Ninth Circuit U.S. Court of Appeals on Aug. 29 denied a petition filed by a group of pharmacy benefits managers (PBMs) facing allegations of contributing to the opioid epidemic for rehearing or rehearing en banc of the court’s ruling that the U.S. Supreme Court’s holding in Coinbase, Inc. v. Bielski does not extend to an automatic stay in the federal officer removal context.

  • August 29, 2025

    Opioid MDL Judge Denies Ex Parte Communications Ban After Misdirected Email

    CLEVELAND — The Ohio federal judge overseeing the opioid multidistrict litigation on Aug. 28 denied a motion filed by a pharmacy benefit manager (PBM) to bar ex parte communications between the appointed special master in the case and the court, finding that such communication is expressly permitted by a court order and Federal Rule of Civil Procedure 53.

  • August 29, 2025

    Putative Class Action Against Ankle Monitor Maker Filed In Colo. Federal Court

    DENVER — A man who claims that he developed chronic pressure injuries as a result of wearing a court-ordered alcohol monitoring ankle bracelet sued the device manufacturer on Aug. 28 in a Colorado federal court and seeks to represent a nationwide class of individuals alleging similar injuries.

  • August 29, 2025

    Judge Dismisses FCA Suit Against Publix Super Markets For Opioid Prescriptions

    TAMPA, Fla. — A Florida federal judge dismissed with prejudice a second amended complaint filed by two former Publix Super Market pharmacists who allege that the grocery chain violated the False Claims Act by knowingly filling prescriptions for opioids and other controlled substances that it knew were improper.

  • August 29, 2025

    Clinics Move To Dismiss Case Saying Its Embryo Tests Were Faulty, Misleading

    DENVER — The allegations in a class action filed by three women in a Colorado federal court “fundamentally mischaracterize the purpose and limits of preimplantation genetic testing for aneuploidy (‘PGT-A’),” a group of physician-owned fertility clinics argue in a motion to dismiss.