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Mealey's Drugs & Devices

  • November 14, 2025

    Separate N.J. Multicounty Litigation Tracks Created For Injuries From GLP-1 Drugs

    TRENTON, N.J. — The New Jersey Supreme Court will create separate multicounty litigation (MCL) designations for state court cases alleging that permanent vision loss and gastrointestinal injuries were caused by the use of glucagon-like peptide-1 receptor agonist (GLP-1 RA) medications, according to a notice to the bar.

  • November 13, 2025

    Amici Urge 7th Circuit To Rehear Medicare Drug Rebate False Claims Case

    CHICAGO — Four organizations filed separate amicus curiae briefs in the Seventh Circuit U.S. Court of Appeals, urging the court to grant Eli Lilly & Co.’s petition for rehearing of a decision in which the Seventh Circuit affirmed a final judgment of $193 million stemming from a False Claims Act jury verdict for reporting falsely deflated drug prices to the government.

  • November 13, 2025

    Appeal Of FCA Suit Against Publix Super Markets For Opioid Prescriptions Dismissed

    ATLANTA — The 11th Circuit U.S. Court of Appeals has ordered the dismissal of an appeal filed by an organization comprising two former Publix Super Markets pharmacists that alleges that the grocery chain violated the False Claims Act (FCA) by filling prescriptions for opioids and other controlled substances that it knew were improper after the parties filed a notice of stipulation of dismissal.

  • November 12, 2025

    FDA To Remove Warnings From Hormone Replacement Therapy Products

    SILVER SPRING, Md. — The U.S. Food and Drug Administration will begin to remove the “black box” warnings on hormone replacement therapy (HRT) products after recent studies showed that previous reports that the products can increase the risk of breast cancer were based on faulty data.

  • November 11, 2025

    Judgment Entered For Novo Nordisk In FCA Dispute Over Hemophilia Drug

    TACOMA, Wash. — A Washington federal court jury found in favor of Novo Nordisk Inc. (NNI) in a qui tam suit accusing it of violating the federal False Claims Act (FCA) and similar state and city laws by allegedly submitting fraudulent claims for payment to government insurers via a “scheme” to persuade patients to seek prescriptions for a Novo Nordisk drug to treat hemophilia rather than a less expensive drug manufactured by another pharmaceutical company.

  • November 11, 2025

    Valsartan MDL Judge Excludes Causation Expert, Dismisses 1st Bellwether Case

    CAMDEN, N.J. — The first bellwether case in the valsartan, losartan and irbesartan hypertension drugs multidistrict litigation was dismissed with prejudice on Nov. 10 after the New Jersey federal judge overseeing the MDL found that testimony from the plaintiff’s expert that ruled out other causes of a man’s liver cancer was “nothing more than speculative ipse dixit.”

  • November 11, 2025

    Florida Sues Planned Parenthood, Says Mifepristone Safety Statements Are Misleading

    MILTON, Fla. — Planned Parenthood misleads women in Florida by deceptively marketing mifepristone, one of two drugs used to induce early termination of pregnancy, as “safer than Tylenol,” the state’s attorney general says in a complaint filed in a state court.

  • November 11, 2025

    Texas Magistrate Judge Sends Faulty Birth Control Device Suit Back To State Court

    AMARILLO, Texas — The distributor of a birth control device that a woman alleges failed and caused her to become pregnant did not provide sufficient evidence on which to base citizenship, a Texas federal magistrate judge said in finding that the court lacks subject matter jurisdiction and remanding the case.

  • November 10, 2025

    Delaware Judge Signs Order Dismissing Excess Insurers’ Opioid Coverage Suit

    WILMINGTON, Del. — A Delaware judge signed an order granting a management consulting firm insured’s motion to dismiss a lawsuit brought by its excess commercial general liability insurers seeking a declaration that they have no duty to defend and indemnify against more than 260 underlying lawsuits seeking to hold the insured accountable for contributing to and profiting from the opioid epidemic.

  • November 07, 2025

    PBMs Granted Extension In Appeal Over Arkansas Law Limiting Who Can Own Pharmacies

    . LOUIS — Pharmacy benefits managers (PBMs) that convinced an Arkansas federal judge that a law that barred PBMs from owning a pharmacy business in the state likely violates the U.S. Constitution’s commerce clause and is likely preempted by federal law have until Dec. 29 to respond to an appellant brief filed by the state in the Eighth Circuit U.S. Court of Appeals contending that the judge erred in granting motions for a preliminary injunction.

  • November 06, 2025

    Mass Tort Cases For Drugs, Medical Devices

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

  • November 06, 2025

    6th Circuit Sets Argument For Challenge To Ruling That PBM Is Partly Preempted

    CINCINNATI — The Sixth Circuit U.S. Court of Appeals has scheduled oral argument for Dec. 10 in a challenge to a ruling that parts of a Tennessee law regarding pharmacy benefit managers (PBMs) are “preempted to the extent they purport to govern self-funded” health plans that are subject to the Employee Retirement Income Security Act; the appeal has drawn amicus curiae input from numerous advocacy organizations.

  • November 06, 2025

    GLP-1 MDL Judge Agrees Plaintiffs Not Entitled To Slides In Discovery Spat

    PHILADELPHIA — The Pennsylvania federal judge who oversees the multidistrict litigation involving diabetes and diet drugs that consumers allege cause gastrointestinal and other injuries overruled objections filed by plaintiffs who disagreed with a special master’s decision to not require the drug manufacturers to produce certain animal histopathology slides the plaintiffs contend are relevant to the U.S. Food and Drug Administration’s approval of the medications at issue.

  • November 06, 2025

    Abbott Removes Case Alleging Injuries From Defective Heart Valve To Federal Court

    LEXINGTON, Ky. — The manufacturer of an implantable medical device for the heart that a man alleges failed and required surgical removal and replacement removed the complaint to a district court in Kentucky based on complete diversity and because the amount in controversy exceeds $75,000.

  • November 06, 2025

    Philadelphia Sues PBMs For Role In Creating Opioid Crisis In City

    PHILADELPHIA — Three of the nation’s largest pharmacy benefit managers (PBMs) “aided and abetted the spread of the opioid epidemic” by ignoring data and failing “to rein in opioid access” that caused devastation throughout the country and in the city of Philadelphia, the city alleges in a complaint filed in a Pennsylvania federal court.

  • November 06, 2025

    Calif. Federal Judge Dismisses Lilly’s Suit Against Mochi For Compounded Drug

    SAN FRANCISCO — A California federal judge found that Eli Lilly and Co. failed to show that it was injured by a telehealth company selling a compounded version of tirzepatide, a Food and Drug Administration-approved drug for diabetes and weight loss, and dismissed the complaint with leave to amend.

  • November 05, 2025

    MDL Centralization Urged In Defective Toe Cartilage Implant Device Cases

    WASHINGTON, D.C. — Five people who allege that a synthetic cartilage implant device used to treat arthritis in a toe joint was defective asked the U.S. Judicial Panel on Multidistrict Litigation (JPMDL) to centralize all cases in a federal court in West Virginia.

  • November 04, 2025

    9th Circuit Holds California’s Opioid Case In Abeyance Pending High Court Case

    SAN FRANCISCO — The Ninth Circuit U.S. Court of Appeals will hold in abeyance a petition for a rehearing on a ruling that affirmed that the federal officer removal statute does not bar removal of a public nuisance suit filed by California against a group of pharmacy benefit managers (PBMs) for their role in contributing to the opioid epidemic pending the U.S. Supreme Court's decision in Chevron U.S.A., Inc., et al. v. Plaquemines Parish, et al.

  • November 04, 2025

    Plaintiffs File Motion For Economic Loss Settlement With Party In Valsartan MDL

    CAMDEN, N.J. — Plaintiffs in the valsartan, losartan and irbesartan hypertension drugs multidistrict litigation pending in a New Jersey federal court moved for a preliminary approval of a $2 million settlement agreement reached with certain defendants to end economic loss claims.

  • November 03, 2025

    Takeda Given More Time To File Certiorari Petition In TPP Class Certification Case

    WASHINGTON, D.C. — The U.S. Supreme Court granted the manufacturer of the diabetes drug Actos more time to file its petition for a writ of certiorari to challenge a Ninth Circuit U.S. Court of Appeals decision that found no error in the certification of a class of national third-party payers (TPPs).

  • October 30, 2025

    Delaware Court Tosses Excess Insurers’ Suit Disputing Coverage For Opioid Suits

    WILIMNGTON, Del. — A Delaware court granted a management consulting firm insured’s motion to dismiss a lawsuit brought by its excess commercial general liability insurers seeking a declaration that they have no duty to defend and indemnify against more than 260 underlying lawsuits seeking to hold the insured accountable for contributing to and profiting from the opioid epidemic.

  • October 29, 2025

    Texas Says Tylenol Maker Hid ASD/ADHD Link, Illegally Transferred Liabilities

    CARTHAGE, Texas — Texas has sued the maker of Tylenol and its related companies in a Texas state court for allegedly hiding information about the dangers of acetaminophen and its link to autism spectrum disorder (ASD) and attention-deficit hyperactivity disorder (ADHD) and for violating the state’s consumer protection law by deceptively marketing the drug as the only safe product for pain relief for pregnant women.

  • October 29, 2025

    4th Circuit Holds Opioid Claims Constitute Public Nuisance In West Virginia Case

    RICHMOND, Va. — The Fourth Circuit U.S. Court of Appeals on Oct. 28 held that under West Virginia law, “the conditions resulting from the over-distribution of opioids can constitute a public nuisance,” reversing a final judgment entered in favor of national drug distributors in an opioid multidistrict litigation bellwether case.

  • October 28, 2025

    Judge: Stay Request In Vaccine Harm Case Covered By Blanket Deadline Extensions

    WASHINGTON, D.C. — A District of Columbia federal judge on Oct. 27 denied as moot a stay sought by the U.S. Department of Health and Human Services in a lawsuit by a man seeking to force HHS to add the COVID-19 vaccine to the Vaccine Injury Table (VIT) so he can be compensated by the National Vaccine Injury Compensation Program (VICP), noting that the district’s chief judge had extended all filing deadlines in the district past the end of the funding appropriations lapse.

  • October 27, 2025

    Government Seeks Shutdown-Related Stay In Case By Man Hurt By COVID Vaccine

    WASHINGTON, D.C. — The federal government on Oct. 24 sought a stay from the U.S. District Court for the District of Columbia in a lawsuit by a man seeking to force the U.S. Department of Health and Human Services to add the COVID-19 vaccine to the Vaccine Injury Table (VIT) so he can be compensated by the National Vaccine Injury Compensation Program (VICP), citing the ongoing government shutdown due to lack of funding appropriations.