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Mealey's Drugs & Devices

  • 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.

  • April 29, 2025

    Walgreens Opposes Consolidation Of ‘Non-Drowsy’ OTC Medication Labeling Cases

    CHICAGO — Walgreens Boots Alliance Inc. and Walgreen Co. (collectively, Walgreens) oppose consolidating two pending cases in Illinois federal court alleging that Walgreens’ generic antitussives are mislabeled because they contain the phrase “non-drowsy” when dextromethorphan hydrobromide (DXM), the active ingredient in the antitussives, can make users drowsy.

  • April 29, 2025

    Judge Says Some OPLA Claims Fail But Allows Case Against Device Maker To Proceed

    CLEVELAND — A woman who sued the manufacturer of an endotracheal tube (ETT) alleging that the device failed and caused a man’s death failed to adequately plead to certain claims for violation of Ohio product liability statutes, a federal judge in Ohio found, but the judge allowed the manufacturing defect and defective device clams to move forward.

  • April 29, 2025

    Magistrate: Relator Must Provide All Alleged False Claims In FCA Kickback Suit

    SAN DIEGO — A California federal magistrate judge granted Abbott Laboratories’ motion to compel discovery into all the alleged false claims it purportedly submitted to the government in a suit alleging Abbott violated the False Claims Act (FCA) and state false claim laws regarding Abbott’s purported kickback scheme to induce hospitals and physicians to use an Abbott cardiac medical device, finding that Abbott is “entitled to know the specific false claims” against it.

  • April 28, 2025

    Judge Dismisses Defective Implant Case, Finds Amended Complaint Still Fails

    TOLEDO, Ohio — An Ohio federal judge agreed to dismiss an amended complaint alleging that a woman suffered injuries due to a defective spinal implant after finding that there were no substantial changes made to the amended complaint after the judge dismissed the original with leave to amend.

  • April 28, 2025

    Weight Loss Center Settles False Advertising, Trademark Claims With Ozempic Maker

    ATLANTA — A weight loss center in Georgia that sells and promotes compounded drug products that purport to contain semaglutide has reached a confidential settlement agreement with the manufacturer of Ozempic, Wegovy and Rybelsus, according to an April 25 joint notice filed in a Georgia federal court.

  • April 25, 2025

    Suboxone MDL Judge Names Cases For Bellwether Discovery

    CLEVELAND — The judge overseeing the Suboxone film multidistrict litigation has identified the 500 cases that were randomly selected for case-specific discovery.

  • April 24, 2025

    Lilly Sues 4 Telehealth Companies For Selling Compounded Weight Loss Drugs

    SAN FRANCISCO — Eli Lilly and Co. on April 23 sued four telehealth companies in a federal court alleging that they violated California’s unfair competition and false advertising laws by selling “knockoff compounded tirzepatide drugs,” FDA-approved drugs for diabetes and weight loss.

  • April 24, 2025

    Drug Makers Move To Dismiss Complaint Saying Sickle Cell Medication Caused Stroke

    SAN FRANCISCO — Global Blood Therapeutics Inc. (GBT) and Pfizer Inc. tell a California federal court in an April 23 motion that an amended complaint alleging that Oxbryta (voxelotor), a prescription medication used for the treatment of sickle cell disease (SCD), caused a man to experience an increased rate of vaso-occlusive crises (VOCs) and to suffer a stroke should be dismissed for failure to state a claim.

  • April 23, 2025

    Woman Claims Ozempic Caused Permanent Vision Loss In New Jersey Federal Complaint

    NEWARK, N.J. — A woman’s use of Ozempic led to an irreversible condition that caused sudden and permanent vision loss, she alleges in a complaint filed in a New Jersey federal court against the manufacturer of the diabetes and diet drug.