Mealey's Drugs & Devices

  • June 17, 2024

    Government Urges High Court To Reject Review Of Off-Label Marketing Conviction

    WASHINGTON, D.C. — The United States in a June 14 opposition brief urged the U.S. Supreme Court to reject a petition for a writ of certiorari filed by two former Acclarent Inc. executives convicted of distributing and misbranding medical devices sold in interstate commerce because the First Circuit U.S. Court of Appeals properly rejected their First Amendment challenge and affirmed the convictions based on overwhelming evidence of their guilt.

  • June 14, 2024

    Suboxone MDL Judge Sets Guidelines For Common Fee Awards

    CLEVELAND — The judge overseeing the Suboxone film multidistrict litigation filed a case management order setting guidelines and procedures for attorneys to submit claims for fees and expenses that are incurred for the common benefit of all plaintiffs.

  • June 14, 2024

    Relator Seeks High Court Review Of Ruling Affirming Dismissal Of FCA Claims

    WASHINGTON, D.C. — A qui tam relator filed a petition for writ of certiorari in the U.S. Supreme Court, seeking review of the Second Circuit U.S. Court of Appeals ruling affirming a district court’s dismissal of his claim filed against a pharmaceutical and medical supplier pursuant to the federal False Claims Act (FCA) for violations of the Anti-Kickback Statute (AKS), asserting that review is needed to resolve the split between circuit courts regarding whether knowledge that a party’s conduct violates the law is required to show willfulness pursuant to the AKS.

  • June 13, 2024

    High Court Finds Challengers To Abortion Drug Mifepristone Access Lack Standing

    WASHINGTON, D.C. — The U.S. Supreme Court in a unanimous decision on June 13 rejected a challenge to the expanded access to the abortion drug mifepristone, finding that a group of anti-abortion advocates lack standing in the case because they had no injury.

  • June 12, 2024

    Motley Rice To Receive Largest Percentage Of Opioid MDL Attorney Fees, Panel Says

    CLEVELAND — The fee panel appointed in the opioid multidistrict litigation centralized in the U.S. District Court for the Northern District of Ohio has made its final recommendations to allocate $2.13 billion in attorney fees in connection with various settlements reached by the parties; the judge overseeing the MDL said parties have until June 21 to file an appeal.

  • June 12, 2024

    Judge Announces 12 Bellwether Discovery Plaintiffs In Tepezza MDL

    CHICAGO — The federal judge overseeing the Tepezza hearing loss multidistrict litigation announced that 12 cases have been selected as the initial bellwether discovery cases.

  • June 12, 2024

    Baltimore, Drug Manufacturer Agree To $45 Million Deal To End Opioid Litigation

    BALTIMORE — Allergan Finance LLC will pay $45 million to Baltimore in a lump sum payment within 30 days to end litigation stemming from claims that the drug manufacturer contributed to the opioid epidemic, the city announced in a press release.

  • June 11, 2024

    Publix To 6th Circuit: Order Questions Certified To Ga. High Court In Opioid MDL

    CINCINNATI — Publix Super Markets Inc. filed a petition for a writ of mandamus in the Sixth Circuit U.S. Court of Appeals to order a series of questions certified to the Georgia Supreme Court for the high court to determine how the state’s public nuisance law applies in a nationwide opioid multidistrict litigation.

  • June 11, 2024

    Gilead Agrees To Pay $40M To Settle Claims It Held Back Safer HIV Drug

    OAKLAND, Calif. — Gilead Sciences Inc. has agreed to pay up to $40 million to settle the claims of more than 2,600 plaintiffs who allege that they suffered injuries to their kidneys and bones while the company withheld a safer alternative to an HIV medication, the company announced.

  • June 11, 2024

    Texas Court: AI Surgery Tool Maker Need Not Submit To Presuit Deposition

    FORT WORTH, Texas — Even assuming counsel’s arguments during a hearing constitute evidence in a dispute involving an artificial intelligence-assisted surgery tool manufacturer, the company need not produce a corporate representative because the statements fall short of the requirements for a presuit deposition under Texas law, an appeals court in the state said, granting mandamus relief and vacating a ruling to the contrary.

  • June 10, 2024

    New Pennsylvania Federal Judge Appointed To Oversee Diabetes And Diet Drug MDL

    PHILADELPHIA — The Pennsylvania federal judge newly appointed to oversee the multidistrict litigation involving diabetes and diet drugs that consumers allege caused gastrointestinal and other injuries ordered the parties to appear in her courtroom on June 10 for a status conference.

  • June 07, 2024

    Experts In Metal-On-Metal Hip Implant Case Can Testify, Judge Says

    OAKLAND, Calif. — A California federal judge denied requests by defendants in a defective metal-on-metal hip implant case remanded from a multidistrict litigation to exclude testimony from two experts witnesses and grant them summary judgment.

  • June 06, 2024

    Mass Tort Cases For Drugs, Medical Devices

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

  • June 06, 2024

    Judge Limits Testimony In Design Defect Case, Grants Partial Summary Judgment

    BOSTON — A Massachusetts federal judge partially dismissed a woman’s suit against a surgical stapler device manufacturer after finding that certain testimony from expert witnesses is inadmissible under the standards of Federal Rule of Evidence 702 and Daubert v. Merrell Dow Pharmaceuticals Inc.

  • June 06, 2024

    Laboratory, Trade Association Challenge FDA’s Final FDCA Regulation Rule

    SHERMAN, Texas — A national trade association representing leading laboratories and two of its members sued the U.S. Food and Drug Administration and others in a Texas federal court challenging a recently published final rule that laboratory-developed tests will be regulated as medical devices under the federal Food, Drug and Cosmetic Act (FDCA).

  • June 06, 2024

    Pharmacy Benefit Managers Lose Motion To Dismiss Alaska’s Opioid Charges

    ANCHORAGE, Alaska — A group of pharmacy benefits managers (PBMs) lost in large part a bid to dismiss charges that they helped fuel the opioid epidemic in Alaska when a federal judge there ruled that the public nuisance and violation of the Alaska Unfair Trade Practices and Consumer Protection Act (CPA) claims can continue.

  • June 05, 2024

    Federal Judge OKs Walgreens Settlement With San Francisco For Opioid Crisis

    SAN FRANCISCO — A California federal judge on June 4 granted final approval to a $229,610,002 settlement between San Francisco and Walgreen Co. to end claims that the pharmacy chain contributed to the public nuisance that fueled the opioid epidemic in the city.

  • June 05, 2024

    U.S. High Court Extends Response Deadline In Review Of 9th Circuit FCA Suit Ruling

    WASHINGTON, D.C. — The U.S. Supreme Court on June 3 granted a 30-day extension for the qui tam plaintiff in a district court decision to respond to pharmaceutical companies’ petition seeking review of the Ninth Circuit U.S. Court of Appeals’ reversal of a district court’s dismissal of a suit accusing them violating the False Claims Act (FCA) by artificially inflating drug prices, arguing in part that the Ninth Circuit “created a circuit split by holding that a relator can avoid the public disclosure bar by ‘stitching together’ public disclosures.”

  • June 05, 2024

    Innovasis, Executives Agree To Settle FCA Violation Claims For $12 Million

    DALLAS — A spinal device manufacturer and two of its executives have agreed to pay $12 million to settle allegations that they paid kickback to surgeons to use their devices in violation of the False Claims Act (FCA), according to an unsealed settlement agreement filed in a Texas federal court.

  • June 04, 2024

    Valsartan MDL Judge Orders Parties To Finalize Settlement Terms With Drugmaker

    CAMDEN, N.J. — The New Jersey federal judge presiding over the valsartan/losartan/irbesartan hypertension drugs multidistrict litigation ordered the plaintiffs and the maker of the valsartan and losartan medications to finalize the terms of the valsartan settlement of personal injury, economic loss and medical monitoring claims by June 30 and to meet with a magistrate judge to continue settlement negotiations to resolve the losartan economic loss claim.

  • June 04, 2024

    Judge Won’t Reconsider Order That Taxotere Plaintiffs Show Proof Of Diagnosis

    NEW ORLEANS — The federal judge overseeing the Taxotere hair loss multidistrict litigation rejected a request to vacate her order that plaintiffs must show proof of a diagnosis of permanent chemotherapy-induced alopecia (PCIA).

  • June 03, 2024

    Hernia Mesh MDL Judge Grants Dismissal Of 14 Cases After Agreements Reached

    ATLANTA — Another 14 cases in the Ethicon Physiomesh hernia patch multidistrict litigation have been dismissed with prejudice after the parties told the court in a joint motion that they have settled all claims in those cases.

  • May 29, 2024

    COMMENTARY: Review Of Expert Causation Testimony Under Federal Rule Of Evidence 702: An Early Assessment Of The 2023 Amended Rule

    By William L. Anderson and Mark A. Behrens

  • June 03, 2024

    4th Bellwether Plaintiff Selected For Exactech MDL

    BROOKLYN, N.Y. — The federal judge overseeing the Exactech orthopedic device multidistrict litigation announced the name of the fourth bellwether plaintiff after the parties conferred to select a consensus pick.

  • May 31, 2024

    Novo Nordisk Sues Pharmacy For Selling Compounded Drugs Containing Semaglutide

    HOUSTON — Novo Nordisk Inc. on May 30 filed a complaint in a Texas federal court, asking that a pharmacy be enjoined from “selling misbranded injectable, non-FDA approved drugs that claim to contain semaglutide.”

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