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Mealey's Drugs & Devices

  • May 20, 2025

    Man Sues Medtronic, FDA For Injuries Caused By Defective Spinal Cord Device

    MINNEAPOLIS — A man who claims in a Minnesota federal court that two spinal cord stimulation (SCS) devices manufactured by Medtronic Inc. failed and caused pain sued the manufacturer and the U.S. Food and Drug Administration, alleging that the agency violated federal law in approving the devices.

  • May 20, 2025

    Hernia Mesh MDL Judge OKs Dismissal Of 5 Cases After Agreements Reached

    ATLANTA — The judge overseeing the Ethicon Physiomesh hernia patch multidistrict litigation signed off on the dismissal of another five cases after the parties told the court in a joint motion that they have settled all claims in those cases.

  • May 16, 2025

    CEO Of Spinal Device Company To Plead Guilty To Unlawfully Paying Surgeons

    BOSTON — The founder and CEO of a spinal medical device company on May 15 agreed to plead guilty to one count stemming from charges that he paid consulting fees to induce doctors to use the company’s products in surgeries that were reimbursed by federal health care programs.

  • May 15, 2025

    Drugmakers Move To Dismiss Case Claiming Sickle Cell Medication Was Ineffective

    SAN FRANCISCO — An amended complaint filed by seven individuals who allege that Oxbryta (voxelotor), a prescription medication used for the treatment of sickle cell disease (SCD), was ineffective should be dismissed because the claims are either preempted for fail as a matter of law, Global Blood Therapeutics Inc. (GBT) and Pfizer Inc. tell a California federal court.

  • May 15, 2025

    Acetaminophen Makers Win Summary Judgment In Calif. Case Linking Drug To Autism

    OAKLAND, Calif. — A California judge granted the manufacturers of acetaminophen summary judgment in a case brought by a mother who alleges that prenatal ingestion of the over-the-counter drug led to her child developing autism, finding that her claims based on failure-to-warn fail as a matter of law.

  • May 15, 2025

    Mass Tort Cases For Drugs, Medical Devices

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

  • May 14, 2025

    FDA, Diet Drug Maker Win Summary Judgment In Case Against Compounding Pharmacies

    FORT WORTH, Texas — A Texas federal judge on May 13 made public his ruling that granted summary judgment to the U.S. Food and Drug Administration and to Eli Lilly and Co. in a dispute filed by companies representing the interests of drug compounders over whether the agency properly determined that the shortage of tirzepatide, a drug for diabetes and weight loss, had ended when it removed the drug from the agency’s drug shortage list.

  • May 14, 2025

    Federal Judge Grants Compounding Pharmacy Summary Judgment In Semaglutide Spat

    TAMPA, Fla. — A Florida federal judge on May 13 entered judgment in favor of a pharmaceutical company accused of selling unapproved compounded drugs containing semaglutide after finding that the sole claim raised by Novo Nordisk Inc. “is moot, impliedly preempted, and fails on the merits for failure to show consumer injury.”

  • May 13, 2025

    West Virginia High Court Refuses To Weigh In On Public Nuisance Law For Opioids

    CHARLESTON, W.Va. — The West Virginia Supreme Court of Appeals on May 12 declined to answer a certified question from the Fourth Circuit U.S. Court of Appeals to address the dispute over whether the state’s public nuisance law applies to the sale and distribution of opioids. 

  • May 13, 2025

    Theranos’ Balwani Says 9th Circuit’s ‘Serious Error’ Makes Rehearing Necessary

    SAN FRANCISCO — Former Theranos Chief Operating Officer Ramesh “Sunny” Balwani tells the Ninth Circuit U.S. Court of Appeals that it should grant a rehearing or a rehearing en banc to reconsider its ruling that the government’s failure to correct false testimony during his criminal trial does not warrant a new trial.

  • May 13, 2025

    Fosamax MDL Plaintiffs Reject Need For High Court Review Of Preemption Ruling

    WASHINGTON, D.C. — The U.S. Supreme Court should deny a petition for certiorari in the long-running Fosamax femur fracture multidistrict litigation because the Third Circuit U.S. Court of Appeals “faithfully” applied precedent from the high court “to the facts of this case to find that federal law did not preempt state-law claims” when it reversed a decision that awarded a drug manufacturer summary judgment in 1,046 cases, the plaintiffs say in a May 12 brief.

  • May 09, 2025

    Pharmacies Say Appeals Court Erred In Finding Counties Not Persons Under Texas Law

    AUSTIN, Texas — A group of pharmacies tells the Texas Supreme Court that a Texas appellate court erred in rejecting its arguments that Texas counties suing pharmacies in two cases for their role in the opioid epidemic are claimants under the Texas Medical Liability Act (TMLA) and that their cases should be dismissed.

  • May 09, 2025

    3rd Circuit Won’t Rehear Ruling Affirming Dismissal Of FCA Suit Over Antibiotics

    PHILADELPHIA — The Third Circuit U.S. Court of Appeals denied a petition for rehearing and rehearing en banc of its ruling affirming a lower court’s dismissal of a qui tam relator’s suit against Bayer Corp., Johnson & Johnson, Merck & Co. and other pharmaceutical companies, alleging that “hiding” side effects of their antibiotics from the U.S. Food and Drug Administration “caused fraudulent claims to be submitted to Medicaid and Medicare.”

  • May 08, 2025

    Parties Respond To Request To Name Bellwether Cases In Bard Port Catheter MDL

    PHOENIX — The parties involved in the multidistrict litigation involving C.R. Bard Inc.’s implanted port catheter (IPC) device pending in an Arizona federal court over claims that the defective devices caused various injuries, including death, on May 7 filed a joint motion to seal their responses to an order from the judge overseeing the case to weigh in on bellwether case selections.

  • May 08, 2025

    Compounding Pharmacies Appeal Removal Of Tirzepatide From Shortage List Spat Ruling

    FORT WORTH, Texas — Companies representing the interests of drug compounders on May 7 filed a notice of interlocutory appeal to the Fifth Circuit U.S. Court of Appeals immediately after a Texas federal judge in an order under seal granted two motions for summary judgment in a dispute over whether the agency properly determined that the shortage of tirzepatide, a drug for diabetes and weight loss, had ended when it removed the drug from the agency’s drug shortage list.

  • May 07, 2025

    Bayer Moves To Dismiss Complaint Alleging Injuries From Birth Control Device

    SEATTLE — “Perforation and migration to the abdominal cavity is an adverse event that is expressly and repeatedly warned of in the official labeling and patient information materials” of the Mirena intrauterine contraceptive device (IUD), its manufacturer argues in a May 6 motion in Washington federal court to dismiss a woman’s claim that she was injured by the allegedly defective device.

  • May 06, 2025

    Woman Claims Spinal Cord Device Caused Injuries, Sues Manufacturer And FDA

    CHICAGO — A woman on May 5 filed a complaint in an Illinois federal court against Abbott Laboratories and the U.S. Food and Drug Administration alleging that she was injured by an implanted spinal cord stimulator (SCS) device and that the device had “been fundamentally altered” since its initial approval by the FDA.

  • May 06, 2025

    Trump Administration Says States Cannot Establish Venue In Mifepristone Case

    AMARILLO, Texas — The U.S. Food and Drug Administration urges a Texas federal court to dismiss an amended complaint filed by Missouri, Kansas and Idaho in a case originated by a group of antiabortion advocates challenging the FDA’s approval of the abortion drug mifepristone, a case that eventually reached the U.S. Supreme Court, which found that the original plaintiffs lacked standing, with the Trump administration now taking the same position as its predecessor and arguing in a reply brief filed May 5 that the intervening states cannot satisfy venue requirements to continue in the Texas court.

  • May 05, 2025

    Implantable Port Maker Denies Claims That It Concealed Defects In Device

    MINNEAPOLIS — A manufacturer of an implantable port system that is accused of concealing that the system was defective and unsafe on May 2 answered an amended complaint filed in a Minnesota federal court, arguing that the claims are time-barred and preempted by the Medical Device Amendments (MDA) to the Food, Drug and Cosmetic Act (FDCA), among other defenses.

  • May 05, 2025

    Taxotere MDL Judge Says Generic Drugmakers Had No Requirement To Change Label

    NEW ORLEANS — The Louisiana federal judge overseeing the Taxotere hair loss multidistrict litigation granted summary judgment to two generic drug manufacturers after finding on remand from the Fifth Circuit U.S. Court of Appeals that one abstract presented at a December 2013 conference did not constitute newly acquired risk information that could have been added to the label of a chemotherapy drug that allegedly caused permanent chemotherapy-induced alopecia (PCIA) in cancer patients.

  • May 02, 2025

    11th Circuit: Defective Pelvic Mesh Claims Time-Barred; Summary Judgment Upheld

    ATLANTA — A woman who sued a pelvic mesh manufacturer “repeatedly inquired whether the mesh was causing her injuries and insisted on having the mesh removed despite her doctor’s uncertainty,” the 11th Circuit U.S. Court of Appeals said May 1 in upholding summary judgment for Johnson & Johnson and its subsidiary Ethicon Inc. and affirming that the woman’s claims were time-barred.

  • May 01, 2025

    Mass Tort Cases For Drugs, Medical Devices

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

  • April 30, 2025

    Judge Denies Stay Of Semaglutide’s Removal From FDA’s Drug Shortage List

    FORT WORTH, Texas — A Texas federal judge on April 29 set a briefing schedule for motions for summary judgment in a dispute over the U.S. Food and Drug Administration’s removal of semaglutide, an FDA-approved drug for diabetes and weight loss, from the agency’s drug shortage list after the judge denied a motion for a preliminary injunction and a stay filed by a drug compounder and an association representing the interests of drug compounders.

  • April 30, 2025

    Opioid MDL Judge Won’t Recuse Over Ex Parte Communication Allegations

    CLEVELAND — The Ohio federal judge overseeing the opioid multidistrict litigation on April 29 refused to recuse himself from the case, denying a request by pharmacy benefit managers (PBMs) that argued that recusal was necessary because of reports that an attorney regularly communicates ex parte with the court to get “inside information.”

  • April 29, 2025

    Generic Mifepristone Maker Allowed To Intervene In States Case Against FDA

    AMARILLO, Texas — A Texas federal judge on April 28 granted a motion by GenBioPro Inc., the maker of generic mifepristone, one of two drugs used to induce early termination of pregnancy, to intervene in a case challenging the U.S. Food and Drug Administration’s approval of the abortion drug, finding that an amended complaint by intervening states Missouri, Kansas and Idaho directly challenges the generic approval.