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Mealey's Drugs & Devices

  • December 20, 2024

    CPAP MDL Judge Dismisses Actions Against SoClean, Says Not Appropriately Filed

    PITTSBURGH — A Pennsylvania federal judge who oversees the two related multidistrict litigations involving the recall of approximately 10.8 million continuous positive air pressure (CPAP) sleep apnea devices dismissed a third-party complaint filed in one of the MDLs by the manufacturer of recalled CPAP machines, which asked that the manufacturer of equipment that uses ozone to clean and disinfect the machines be forced to contribute to settlement agreements and ruled that a putative class action against the same party “is an entirely new lawsuit” and dismissed it from the MDL docket.

  • December 20, 2024

    Government Intervenes In Suit Alleging CVS’s Opioid Distribution Violated Law

    PROVIDENCE, R.I. — CVS Pharmacy Inc. and its subsidiaries violated the False Claims Act (FCA) and the Controlled Substances Act (CSA) by filling “prescriptions for controlled substances that lacked a legitimate medical purpose, were not valid, and/or were not issued in the usual course of professional practice,” the government alleges in a complaint that was ordered to be unsealed by a Rhode Island federal judge.

  • December 19, 2024

    Mass Tort Cases For Drugs, Medical Devices

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

  • December 19, 2024

    Ala. Federal Judge Dismisses Suit Alleging Woman Was Killed By Faulty Heart Device

    BIRMINGHAM, Ala. — Because a wrongful death complaint failed to “mention any federal requirement that was allegedly violated” by the manufacturer of a heart defibrillator, an Alabama federal judge granted Boston Scientific’s motion to dismiss based on federal preemption.

  • December 19, 2024

    Denial Of Drug’s Fast Track Application Was Not An Error, D.C. Circuit Affirms

    WASHINGTON, D.C. — The U.S. Food and Drug Administration’s denial of a pharmaceutical company’s application for a fast-track approval of its new drug was not arbitrary and capricious, the District of Columbia Circuit U.S. Court of Appeals held, affirming a summary judgment award to the FDA.

  • December 19, 2024

    Parties Debate Whether Mifepristone Case Can Continue With Intervening States

    AMARILLO, Texas — Missouri, Kansas and Idaho “have no plausible connection” to the federal court in Texas in which a lawsuit filed by a group of antiabortion advocates challenging the U.S. Food and Drug Administration’s approval of abortion drug mifepristone originated, a case that eventually reached the U.S. Supreme Court, which found that the group lacked standing, the FDA argued in a reply brief supporting its motion to dismiss.

  • December 19, 2024

    Federal Judge: Bair Hugger Bellwether Plaintiff Can Partially Amend Complaint

    CLEVELAND — A woman whose case was selected as a bellwether action in the Bair Hugger multidistrict litigation can partially amend her complaint to add claims under Ohio laws, but amending the complaint to add claims under Minnesota law is futile, a federal judge in Ohio ruled.

  • December 18, 2024

    JPMDL Hearing Set To Mull Centralizing Cases Alleging Depo-Provera Caused Tumors

    WASHINGTON, D.C. — The U.S. Judicial Panel on Multidistrict Litigation will hear arguments in January on whether to centralize cases filed by women who allege that they developed intracranial meningiomas, a type of brain tumor, from their use of Depo-Provera, a long-lasting injectable contraceptive.

  • December 18, 2024

    OTC Cold Medicine MDL Judge Won’t Reconsider Dismissal Of Lanham Act Claims

    BROOKLYN, N.Y. — A pharmacy’s argument “misses the mark” in contending that its Lanham Act claim should be reinstated because the claim was not in the initial streamlined complaint filed in multidistrict litigation stemming from allegations that over-the-counter cough and cold medications containing the active ingredient phenylephrine (PE) are ineffective at relieving nasal congestion, the judge overseeing the MDL said.

  • December 17, 2024

    Hernia Mesh MDL Judge Issues Case Management Order After Settlement Announced

    COLUMBUS, Ohio — The Ohio federal judge overseeing the Davol hernia mesh multidistrict litigation on Dec. 16 issued case management orders to establish a qualified settlement fund and an order to protect identifiable health information after the device maker announced that it has reached a settlement to resolve the majority of the claims in the MDL and similar cases consolidated in a Rhode Island state court.

  • December 17, 2024

    Oral Arguments Heard On Indivior’s Motion To Dismiss Suboxone Case

    CLEVELAND — Parties in the Suboxone film multidistrict litigation on Dec. 16 presented oral arguments on whether the MDL judge should grant a motion to dismiss filed by the drug’s manufacturer.

  • December 16, 2024

    McKinsey To Pay $650M To Resolve Purdue Investigation; Executive To Plead Guilty

    ABINGDON, Va. — A former McKinsey & Co. Inc. senior partner who worked on matters involving Purdue Pharma L.P. is expected to plead guilty next month to obstruction of justice for allegedly deleting folders, documents and emails from his McKinsey-issued laptop, the government said in court filings on Dec. 13, separately announcing that the company has agreed to a $650 million settlement to resolve criminal and civil investigation into the firm’s consulting work with Purdue.

  • December 12, 2024

    CPAP Judge Gives Final OK To Medical Monitoring Settlement, Attorney Fees Awards

    PITTSBURGH — The federal judge overseeing the multidistrict litigation involving the recall of approximately 10.8 million continuous positive air pressure (CPAP) sleep apnea devices has given final approval to a $25 million settlement to resolve medical monitoring claims and awarded $4.8 million for attorney fees and costs.

  • December 12, 2024

    Oral Arguments On Indivior’s Motion To Dismiss Suboxone Case Set For Dec. 16

    CLEVELAND — Counsel for plaintiffs in the Suboxone film multidistrict litigation as well as counsel for the drug’s manufacturer filed a joint notice with the court on Dec. 12, agreeing that the only topic to be discussed at a Dec. 16 hearing will be a pending motion to dismiss filed by the manufacturer.

  • December 10, 2024

    Ohio Product Liability Act Bars Public Nuisance Claims, State High Court Rules

    COLUMBUS, Ohio — The Ohio Supreme Court on Dec. 10 ruled that public nuisance claims are abrogated under the Ohio Product Liability Act (OPLA), answering a certified question from the Sixth Circuit U.S. Court of Appeals, which is hearing an appeal of a $650.6 million judgment awarded to two Ohio counties that allege that Walgreens, CVS and Walmart helped fuel the nationwide opioid epidemic.

  • December 10, 2024

    2nd Circuit Says Appeals On Exclusion Of Causation Experts To ‘Be Heard In Tandem’

    NEW YORK — The Second Circuit U.S. Court of Appeals ruled that four appeals filed by parents who allege that prenatal exposure to acetaminophen causes autism or attention deficit hyperactivity disorder (ADHD) but saw their claims dismissed after a New York federal judge in two separate orders excluded their causation experts “be heard in tandem by the same panel.”

  • December 06, 2024

    Senators Reintroduce Bill Barring Texas 2-Step Restructurings, Nondebtor Releases

    WASHINGTON, D.C. — Three U.S. senators reintroduced a bill on Dec. 5 that would force courts to dismiss any Chapter 11 case where a company has used the Texas Two-Step to place all of its liabilities, usually from asbestos personal injury claims, with a spinoff company that then files for bankruptcy protection.  The measure would also prohibit the use of nonconsensual, nondebtor releases of third parties in bankruptcy cases, which the U.S. Supreme Court recently held are illegal.

  • December 06, 2024

    Jury Hands Medical Device Company A Win In Ethylene Oxide Wrongful Death Case

    PHILADELPHIA — A Pennsylvania state court jury on Dec. 6 handed down a verdict in favor of a medical device company in a lawsuit brought by a widow who contended that the company’s use of ethylene oxide (EtO) at a facility where it sterilizes medical instruments caused her husband’s wrongful death.

  • December 05, 2024

    Mass Tort Cases For Drugs, Medical Devices

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

  • December 05, 2024

    West Virginia Woman Says Toe Cartilage Implant Failed; Company Issues Recall

    CHARLESTON, W.Va. — A woman sued the manufacturers of a synthetic cartilage implant (SCI) device used to treat arthritis in a toe joint, alleging that the device failed and caused considerable pain and future surgeries.

  • December 04, 2024

    Artificial Tears Maker, Seller Lose Bid To Toss Injury Case In N.J. Federal Court

    NEWARK, N.J. — A woman’s complaint against the makers and sellers of an artificial tears product that she claims caused an eye infection largely survived two motions to dismiss filed in a New Jersey federal court.

  • December 04, 2024

    Plaintiffs File Amended Master Complaint In Bard Port Catheter MDL

    PHOENIX — Co-lead counsel for the plaintiffs in the multidistrict litigation involving C.R. Bard Inc.’s implanted port catheter (IPC) device on Dec. 3 filed a second amended master long-form complaint and jury trial demand in an Arizona federal court over claims that the defective devices caused various injuries, including death.

  • December 04, 2024

    PBMs File Objection To Special Master’s Discovery Ruling In Opioid MDL

    CLEVELAND — Two pharmacy benefit managers (PBM) in the opioid multidistrict litigation filed an objection to a special master’s ruling that 14 documents prepared by a legal department as part of an internal investigation are not privileged.

  • December 03, 2024

    MDL Sought For Cases Alleging Depo-Provera Caused Development Of Brain Tumor

    WASHINGTON, D.C. — Women who allege that they developed intracranial meningiomas, a type of brain tumor, from their use of Depo-Provera, a long-lasting injectable contraceptive, have asked the U.S. Judicial Panel on Multidistrict Litigation to transfer all currently filed and any subsequently filed cases and centralize them in the U.S. District Court for the Northern District of California.

  • December 02, 2024

    Misleading ‘Non-Drowsy’ Medicine Label Case Against CVS Survives Dismissal Motion

    ST. LOUIS — A woman’s lawsuit that she was misled into purchasing over-the-counter (OTC) CVS-branded medicines that were labeled non-drowsy when in fact they cause drowsiness survived a motion to dismiss filed by CVS Pharmacy Inc. after a federal judge in Missouri ruled that her claims are not pre-empted by the Food, Drug and Cosmetic Act.