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Mealey's Drugs & Devices

  • February 20, 2025

    Singapore Court Freezes Bioscience Company’s Assets Pending $830M Arbitration

    SINGAPORE — A judge of the Singapore International Commercial Court granted an ex parte application by a Danish company brought against a Singaporean bioscience company and its founder for a worldwide asset freeze pending arbitration in New York regarding an $830 million dispute over a drug for hypertension and kidney disease.

  • February 20, 2025

    Mass Tort Cases For Drugs, Medical Devices

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

  • February 20, 2025

    Company, Owner Agree To $1M Fine For Selling Altered Products Purchased Overseas

    CHICAGO — An Illinois medical device company and its owner will pay a $1 million fine to end a federal criminal investigation into allegations that the company purchased products overseas and concealed that information when reselling the products (United States v. Advanced Inventory Management, Inc., et al., No. 25-18, N.D. Ill.).

  • February 19, 2025

    1st Circuit Affirms Ruling In DOJ ‘First Impression’ FCA Suit Against Regeneron

    BOSTON — The First Circuit U.S. Court of Appeals on Feb. 18 affirmed a lower court ruling granting summary judgment to Regeneron Pharmaceuticals in a U.S. Department of Justice (DOJ) suit alleging violations of the federal False Claims Act (FCA) and the Anti-Kickback Statute (AKS) regarding purported improper funding of the Chronic Disease Fund (CDF) to subsidize patient copays for a Regeneron macular degeneration drug, finding that in this case of “first impression” regarding a 2010 amendment to the AKS, to show falsity under the amendment, the government must prove “that an illicit kickback was the but-for cause of a submitted claim.”

  • February 19, 2025

    D.C. Federal Judge Finds FDA Did Not Violate Law In Approving Generic Drug

    WASHINGTON, D.C. — A federal judge in the District of Columbia was unconvinced that the U.S. Food and Drug Administration violated the Administrative Procedure Act (APA) when it granted approval to a generic drug, denying a motion for summary judgment filed by a drug manufacturer and granting cross-motions filed by the FDA and the generic drug maker.

  • February 19, 2025

    Judge Dismisses Bellwether Plaintiff’s Failure-To-Warn Claim In BioZorb Case

    BOSTON — Testimony from the treating surgeon for a woman who alleges that an implanted radiographic marker used to mark soft tissue sites during cancer treatment was defective and caused injuries “cannot carry her burden at summary judgment, as it says nothing about the critical question on the issue of causation:  that is, what [the surgeon] would have done if she had known of those risks,” a Massachusetts federal judge ruled.

  • February 18, 2025

    United Appeals $300M Settlement Of Third-Party Payers’ Claims In Opioid MDL

    CLEVELAND — United HealthCare Services Inc. has appealed to the Sixth Circuit U.S. Court of Appeals the final approval of a $300 million settlement that third-party payers (TPP) reached with three drug manufacturers to end claims that the opioid industry’s practices caused them to pay more for prescription opioids instead of safer, less addictive alternatives, and for the cost of funding opioid addiction-related treatments.

  • February 18, 2025

    Mass. Federal Judge Dismisses Wrongful Death Suit, Finds Claims Are Preempted

    BOSTON — A Massachusetts federal judge recognized that a mother “suffered an immeasurable loss” in the death of her son but found that her claims against the manufacturer of an injectable medication that was used to treat his migraines are preempted by federal law, dismissing without leave to amend her wrongful death lawsuit.

  • February 14, 2025

    Massachusetts Federal Judge Dismisses Boston’s Opioid Suit Against PBMs As Untimely

    BOSTON — A Massachusetts federal judge granted two pharmacy benefit managers’ motion to dismiss a complaint filed against them by Boston for their role in contributing to the opioid epidemic after finding that the asserted claims are time-barred and that the city lacks standing.

  • February 14, 2025

    MDL Judge Partially Grants Motion To Dismiss Certain Paragard IUD Cases

    ATLANTA — The judge overseeing the Paragard intrauterine device (IUD) multidistrict litigation in the U.S. District Court for the Northern District of Georgia agreed to dismiss multiple pending cases as time-barred under various states’ statutes of limitations.

  • February 13, 2025

    Tepezza MDL Judge Selects First 4 Bellwether Plaintiffs To Head To Trial

    CHICAGO — The Illinois federal judge overseeing the Tepezza hearing loss multidistrict litigation has named the first four cases that will proceed as the initial bellwether cases and instructed the parties to confer to decide on the order in which the cases will be tried.

  • February 13, 2025

    Judge Dismisses Claims Against Novo Nordisk Over Allegedly Defective Insulin Pens

    NEW HAVEN, Conn. — A Connecticut federal judge partially granted a motion to dismiss a complaint filed by a hospital system alleging that insulin pens were defective and subjected the hospital to a class action of patients who may have been exposed to blood-borne illnesses.

  • February 12, 2025

    PBMs Say Michigan’s Suit Over Role In Opioid Crisis Belongs In Federal Court

    DETROIT — Two of the nation’s largest pharmacy benefit managers (PBMs) that were sued by the attorney general for Michigan for violations of the state’s public nuisance laws and other claims that allege that the PBMs contributed to the oversupply of opioids in Michigan filed an opposition to the state’s motion to remand the case and argue that removal to federal court was proper based on the federal officer removal statute.

  • February 11, 2025

    Cartiva Faces Allegation That Toe Cartilage Implant Device Failed, Caused Pain

    CHICAGO — An Illinois man sued the manufacturer of a synthetic cartilage implant (SCI) device used to treat arthritis in a toe joint in an Illinois federal court, alleging that the device was defective and that it caused pain and had to be surgically removed.

  • February 11, 2025

    Maine Hospitals Lose Appeal Of Dismissal Of Complaint Against Opioid Defendants

    PORTLAND, Maine — The Maine Supreme Judicial Court affirmed the dismissal of a case filed by a group of hospitals in the state that sued various businesses and individuals involved in marketing and distributing prescription opioids for negligence and found no error in the lower court’s refusing to allow the hospitals to amend the complaint.

  • February 11, 2025

    Plaintiffs Push To Move Suboxone MDL Toward Bellwether Case Selection

    CLEVELAND — Plaintiffs in the Suboxone film multidistrict litigation submitted a proposed case management order on how to select cases to be worked up and tried as bellwether cases, contending “that a pool of 100 Plaintiffs is more than adequate to achieve statistical significance as to the cohort of Plaintiffs in this MDL” and that the defendants are unnecessarily delaying the process of the litigation.

  • February 10, 2025

    Cases Alleging Depo-Provera Caused Tumors Centralized In Fla.’s Northern District

    WASHINGTON, D.C. — The U.S. Judicial Panel on Multidistrict Litigation on Feb. 8 agreed to centralize cases alleging that a long-lasting injectable contraceptive caused women to develop intracranial meningiomas, a type of brain tumor, in the U.S. District Court for the Northern District of Florida.

  • February 10, 2025

    Woman Seeks To Represent Nationwide Class Against Toxic Embryo Solution Maker

    NEW HAVEN, Conn. — A woman who alleges that her developing embryos were destroyed by a toxic solution used during fertility-related treatments that was later recalled filed a putative nationwide class action in a Connecticut federal court against the manufacturer of the solution.

  • February 06, 2025

    Federal Judge Cites Royal Canin In Allowing Post-Removal Amendment In Opioid Case

    NASHVILLE, Tenn. — A group of plaintiffs representing the interests of babies born addicted to opioids may amend their complaint in an effort to remand the case to state court, a Tennessee federal judge ruled, noting that a recent U.S. Supreme Court decision held that “post-removal amendments removing federal law claims can defeat jurisdiction.”

  • February 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.

  • February 05, 2025

    Learned-Intermediary Doctrine Dooms Failure To Warn Claim In BioZorb Case

    BOSTON — A woman who was selected as a bellwether plaintiff in a group of cases alleging that an implanted radiographic marker used to mark soft tissue sites during cancer treatment was defective and caused injuries was unable to show that her doctor would have acted differently if there was an adequate warning on the device, a Massachusetts federal judge said and granted summary judgment to the device manufacturer on her negligence for failure to warn claim based on the learned-intermediary doctrine.

  • February 05, 2025

    Danco: Intervening States Cannot Pursue Mifepristone Case In Texas Federal Court

    AMARILLO, Texas — Danco Laboratories LLC, the maker of Mifeprex brand of mifepristone, told a Texas federal court that “[m]ultiple independent grounds compel dismissal” of an amended complaint filed by Missouri, Kansas and Idaho in a case originated by a group of antiabortion advocates challenging the Food and Drug Administration’s approval of the abortion drug, a case that eventually reached the U.S. Supreme Court, which found that the group lacked standing and in which the original plaintiffs have now voluntarily dismissed all of their claims.

  • February 05, 2025

    Drug Manufacturers Move To Dismiss ‘Extraneous’ Claims In GLP-1 MDL

    PHILADELPHIA — The manufacturers of diabetes and diet drugs that consumers allege cause gastrointestinal and other injuries moved to dismiss certain claims from a master long-form complaint against the drug manufacturers in the multidistrict litigation that they allege “are extraneous to the core issues in the litigation, inadequately pleaded, or plainly foreclosed.”

  • February 05, 2025

    6th Circuit Vacates $650M Judgment After Ohio High Court Finds OPLA Bars Claims

    CINCINNATI — The Sixth Circuit U.S. Court of Appeals vacated a $650 million judgment awarded to two Ohio counties that alleged that Walgreens, CVS and Walmart helped fuel the nationwide opioid epidemic after the Ohio Supreme Court ruled that public nuisance claims are abrogated under the Ohio Product Liability Act (OPLA) in answering a certified question from the appellate court.

  • February 04, 2025

    Federal Judge Awards Some Costs To Mylan In EpiPen Misrepresentation Suit

    NEW YORK — A federal judge in New York issued a memorandum and order awarding some costs to drugmaker Mylan N.V. and certain of its current and former executives after previously granting summary judgment to Mylan and against stockholders who filed a class action suit against it alleging that the drugmaker made misrepresentations regarding its classification of the EpiPen and concealed its involvement in an anticompetitive rebate scheme that allowed Mylan to inflate the price of EpiPen.