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Mealey's Drugs & Devices

  • October 07, 2025

    Woman Says Dupixent Caused T-Cell Lymphoma, Death Of Her Mother, Sues Drugmakers

    NASHVILLE — A daughter has sued the manufacturers of Dupixent, a prescription medication used for the treatment of asthma and inflammatory skin conditions, in a Tennessee federal court, alleging that her mother died of T-cell lymphoma that was caused by the injection of the drug and that the drugmakers failed to warn about the risk.

  • October 03, 2025

    Texas Federal Judge Sends Mifepristone Case To Missouri Federal Court

    AMARILLO, Texas — Because the U.S. Supreme Court ruled that the original plaintiffs in a case challenging the U.S. Food and Drug Administration’s approval of mifepristone, one of two drugs used to induce early termination of pregnancy, lacked standing, a Texas federal judge found that Missouri, Idaho and Kansas did not intervene in a jurisdictionally valid case and that transfer of the case to a Missouri federal court is proper.

  • October 02, 2025

    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, 2025

    Depo-Provera MDL Judge Rejects Woman’s Remand Motion, Dismisses Pharmacy

    PENSACOLA, Fla. — Illinois law does not extend a duty to warn to dispensing pharmacies, the federal judge in Florida who is overseeing the Depo-Provera multidistrict litigation ruled, rejecting a woman’s argument to remand her case to an Illinois state court after it was transferred to the MDL.

  • October 02, 2025

    Relator Appeals Dismissal Of FCA Suit Against Publix Super Markets

    TAMPA, Fla. — An organization comprising two former Publix Super Markets pharmacists that alleges that the grocery chain violated the False Claims Act (FCA) by knowingly filling prescriptions for opioids and other controlled substances that it knew were improper is appealing to the 11th Circuit U.S. Court of Appeals a decision by a Florida federal judge that dismissed its second amended complaint with prejudice.

  • October 01, 2025

    Defective Medical Device Case Heads Back To Missouri State Court After Remand Win

    ST. LOUIS — A medical device manufacturer did not show that its sales representative was fraudulently joined in a design defect case filed in a Missouri state court and removed to federal court, a federal judge in the state ruled Sept. 30, granting a couple’s motion to remand.

  • October 01, 2025

    Depo-Provera MDL Judge Hears Arguments On Whether Preemption Laws Bar Cases

    PENSACOLA, Fla. — The Florida federal judge overseeing the Depo-Provera multidistrict litigation, a group of cases alleging that a long-lasting injectable contraceptive caused women to develop intracranial meningiomas, a type of brain tumor, heard oral arguments on whether the claims are preempted by federal law.

  • October 01, 2025

    Calif. Federal Judge Agrees To Trim Claims Against Telehealth Company Sued By Lilly

    SAN FRANCISCO — A California federal judge partially granted a motion to dismiss filed by an online telehealth platform that sells compounded versions of U.S. Food and Drug Administration-approved medications, finding that a manufacturer failed to state a claim based on allegations that the compounded drugs are not “safe and effective.”

  • October 01, 2025

    Tribe Voluntarily Dismisses Complaint Alleging Insulin Pricing Scheme

    NEWARK, N.J. — The Miccosukee Tribe in Florida will stop pursuing claims that drug manufacturers and pharmacy benefit managers (PBMs) conspired to increase the costs of insulin and other medications to treat diabetes, including glucagon-like peptide-1 receptor agonist (GLP-1) drugs that help control insulin levels, according to a notice of voluntary dismissal filed in a New Jersey federal court.

  • September 30, 2025

    N.J. Federal Judge Denies Motion For Reconsideration In Insulin Pricing Dispute

    NEWARK, N.J. — A New Jersey federal judge refused to reconsider his order that dismissed certain claims in a case alleging that three drug manufacturers engaged in an unfair and unconscionable pricing scheme for their analog insulin products, finding that the “extraordinary remedy” is unwarranted.

  • September 29, 2025

    Oral Arguments Postponed In Appeal Of Autism-ADHD MDL Expert Exclusion

    NEW YORK — The Second Circuit U.S. Court of Appeals has rescheduled oral arguments in an appeal over whether a district court erred in excluding testimony from experts retained by parents who allege that prenatal exposure to acetaminophen causes autism or attention deficit hyperactivity disorder (ADHD) after receiving letters from the parties in the wake of the U.S. Food and Drug Administration recently announcing a possible link between the use of the drug and the disorders.

  • September 29, 2025

    D.C. Circuit Upholds FDA’s Summary Judgment In Generic Drug Approval Case

    WASHINGTON, D.C. — Novartis Pharmaceuticals Corp.’s arguments on appeal, disputing a district court judge’s denial of its motion for summary judgment in a case contesting the U.S. Food and Drug Administration’s approval of a generic version of its heart failure drug Entresto, gave the District of Columbia Circuit U.S. Court of Appeals “no reason to question the FDA’s expert judgment regarding these scientific issues,” the court said in a Sept. 26 opinion.

  • September 26, 2025

    HHS, FDA To Conduct Review Of Abortion Drug Mifepristone Safety, REMS Requirements

    The secretary of the U.S. Department of Health and Human Services and the commissioner of the U.S. Food and Drug Administration told attorneys general from 22 states that the government will be “conducting its own review of the evidence, including real-world outcomes and evidence, relating to the safety and efficacy of” mifepristone, one of the two drugs prescribed for medication abortions.

  • September 25, 2025

    Manufacturer Of Embryo Culture Media Loses Bid To Dismiss Case Brought By Couple

    ALBUQUERQUE, N.M. — A lawsuit against the manufacturer of an embryo culture media that a couple alleges was defective and led to the failure of their in vitro fertilization (IVF) procedure can move forward, a New Mexico federal judge ruled, denying the manufacturer’s motion to dismiss but holding that the couple failed to plead the claims against its parent company.

  • September 25, 2025

    Pharmacies Urge 2nd Look By Texas Supreme Court In Counties’ Opioid Suit

    AUSTIN, Texas — The misreading of a Texas Supreme Court decision by Texas counties that sued a group of pharmacies for their role in the opioid epidemic will leave those counties “emboldened to find another set of businesses to target” and “could cause serious harm to people across this State,” the pharmacies argue in asking for a rehearing of their denied petition for review.

  • September 24, 2025

    Judge Tosses FCA Suit Related To Drug Patent Pursuant To Public Disclosure Bar

    BOSTON — A Massachusetts federal judge on Sept. 23 dismissed a qui tam relator’s suit alleging violations of the federal False Claims Act (FCA) and related state laws regarding pharmaceutical companies’ purported fraudulently obtained patents for the drug Xyrem resulting in government health insurers reimbursing Xyrem prescriptions “at inflated prices,” finding that facts in the complaint were previously disclosed and that the public disclosure bar applies.

  • September 24, 2025

    Pfizer Agrees To End 2 Groups’ Zantac Claims In Connecticut State Court

    WATERBURY, Conn. — Pfizer Inc. has reached a settlement to end claims brought by two groups who allege injuries from ingestion of generic ranitidine products, according to notices of settlement filed in a Connecticut state court.

  • September 24, 2025

    Lilly, Medical Centers’ Trademark Dispute Settlement Halted By Federal Judge

    SEATTLE — A Washington federal judge refused to sign off on a joint motion filed by Eli Lilly and Co., two medical centers and two of their physicians who prescribe patients compounded versions of tirzepatide, a Food and Drug Administration-approved drug for diabetes and weight loss, for a consent judgment and permanent injunction to end a trademark case, finding that the motion “suffers from numerous defects.”

  • September 24, 2025

    FDA Warns About Possible Link Between Acetaminophen And Autism, ADHD

    SILVER SPRING, Md. — The U.S. Food and Drug Administration has begun the process to change the warning label for acetaminophen “to reflect evidence suggesting that the use of acetaminophen by pregnant women may be associated with an increased risk of neurological conditions such as autism and ADHD in children,” the agency said in a press release and issued a letter to physicians.

  • September 23, 2025

    Depo-Provera MDL Parties Debate Whether Federal Preemption Laws Bar Cases

    PENSACOLA, Fla. — Plaintiffs in the Depo-Provera multidistrict litigation, a group of cases alleging that a long-lasting injectable contraceptive caused women to develop intracranial meningiomas, a type of brain tumor, urged the Florida federal judge overseeing the MDL to reject the drug manufacturers’ argument that the claims are preempted by federal law.

  • September 23, 2025

    PBMs Want Expediated Review Of Certiorari Petition In Remanded Opioid Case

    WASHINGTON, D.C. — Pharmacy benefit managers (PBMs) facing allegations of contributing to a public nuisance in California for their role in the opioid epidemic asked the U.S. Supreme Court to expedite its consideration of their petition for a writ of certiorari, which argues that the Ninth Circuit U.S. Court of Appeal erred in finding that a remand order is not subject to an automatic stay under the federal officer removal statute.

  • September 18, 2025

    Del. Federal Judge Won’t Order Permanent Injunction Barring Bid For FDA Approval

    WILMINGTON, Del. — A pharmaceutical company that sought “equitable relief that is unprecedented under” federal law “has not established that its story warrants such relief,” a Delaware federal judge said, denying a motion that sought to bar a competitor from seeking approval from the U.S. Food and Drug Administration for a drug to treat narcolepsy.

  • September 18, 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 17, 2025

    Weight Loss Company Loses Motion To Dismiss Trademark Infringement Case

    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.