Mealey's Drugs & Devices

  • July 02, 2024

    Ohio Federal Judge Partially Dismisses Defective Chemotherapy Port Device Case

    CLEVELAND — A federal judge in Ohio partially granted a motion to dismiss filed by a medical device maker facing charges from a woman who claims that a defective SmartPort device caused her to develop an infection.

  • July 02, 2024

    Hernia Mesh MDL Judge Refuses To Seal Motion On Possible Settlement Terms

    COLUMBUS, Ohio — The Ohio federal judge overseeing the Davol hernia mesh multidistrict litigation on July 1 said defendants and counsel representing a group of plaintiffs cannot file under seal a motion to establish a qualified settlement fund.

  • July 02, 2024

    Court: Defective Screw Case Properly Dismissed On Statute Of Limitations Grounds

    FORT WORTH, Texas — Because a woman was aware that defective screws were possibly used in medical procedures on both of her feet more than two years before she filed suit, a Texas trial court was correct in granting summary judgment, a Texas appeals court held.

  • July 01, 2024

    CPAP Judge Gives Preliminary Approval To Medical Monitoring Claims Settlement

    PITTSBURGH — The federal judge overseeing the multidistrict litigation involving the recall of approximately 10.8 million continuous positive air pressure (CPAP) sleep apnea devices granted preliminary approval to $25 million settlement to resolve medical monitoring claims in the MDL.

  • July 01, 2024

    Convicted Executives Say Case Presents ‘Ideal Vehicle’ For High Court Review

    WASHINGTON, D.C. — Two former Acclarent Inc. executives convicted of distributing and misbranding medical devices sold in interstate commerce who say the U.S. Food and Drug Administration’s “intended use” regulations violate their constitutional rights argue in a July 1 reply brief in the U.S. Supreme Court that the case is “an ideal vehicle to review enormously important and contested constitutional questions.”

  • July 01, 2024

    Purdue Pharma Asks District Court Handling Bankruptcy For Status Conference

    NEW YORK — A lawyer representing Purdue Pharma LP and its affiliated debtors on June 28 wrote to the New York federal judge overseeing its bankruptcy case on how to proceed after the U.S. Supreme Court ruled that the Second Circuit U.S. Court of Appeals erred in finding that the U.S. Bankruptcy Code allows a liability release for members of the formerly controlling Sackler family in a multibillion-dollar opioid bankruptcy settlement reached by Purdue Pharma.

  • July 01, 2024

    California High Court Answers Question On Role Of Stronger Warning In Causation

    SAN FRANCISCO — A plaintiff in a medical device case can establish causation by showing that had a physician communicated a stronger warning to the patient, a prudent person in the patient’s position may have declined the treatment regardless of the physician’s continued recommendation, the California Supreme Court held, answering a certified question from the Ninth Circuit U.S. Court of Appeals.

  • June 28, 2024

    OptumRx Reaches $20M Settlement Agreement For Opioid Prescription Practices

    WASHINGTON, D.C. — OptumRx Inc. has agreed to pay $20 million to resolve claims that the prescription drug benefit provider improperly filled opioid prescriptions in violation of the Controlled Substances Act, the U.S. Department of Justice announced June 27.

  • June 28, 2024

    MDL Judge Rejects Argument That Vaccine Act Does Not Apply To Gardasil Cases

    STATESVILLE, N.C. — Applying the National Childhood Vaccine Injury Act of 1986 to personal injury claims related to the Gardasil vaccine does not violate the presentment clause of the U.S. Constitution, the federal judge overseeing the Gardasil multidistrict litigation ruled June 27.

  • June 28, 2024

    High Court Overrules Chevron Deference, Changes Standard For Regulatory Review

    WASHINGTON, D.C. — The U.S. Supreme Court on June 28 voted 6-3 to overrule the doctrine of Chevron deference as incompatible with the Administrative Procedure Act (APA) in two cases arising out of federal fishing regulations, changing governing precedent for federal courts reviewing agencies’ regulatory actions.

  • June 28, 2024

    Appeals Court: Woman’s Pelvic Mesh Claims Were Not Untimely; Verdict Upheld

    ATLANTA — The 11th Circuit U.S. Court of Appeals rejected arguments from a pelvic mesh device maker that a woman’s claims were time-barred under Florida’s four-year statute of limitations and affirmed a $2.5 million jury verdict.

  • June 27, 2024

    Arkansas Sues Pharmacy Benefit Managers, Says Their Role Furthered Opioid Crisis

    LITTLE ROCK, Ark. — Arkansas Attorney General Tim Griffin on behalf of the state filed suit in a state court against a group of pharmacy benefit managers (PBMs) for their role “in causing and furthering the worst man-made epidemic in modern medical history:  the misuse, abuse, diversion, and over-prescription of opioids.”

  • June 27, 2024

    Bankruptcy Code Does Not Permit Release Of Sackler Family, High Court Rules

    WASHINGTON, D.C. — The U.S. Supreme Court in a 5-4 decision on June 27 held that the Second Circuit U.S. Court of Appeals erred in approving a multibillion-dollar opioid bankruptcy settlement reached by Purdue Pharma L.P. that included a liability release for members of the formerly controlling Sackler family because the U.S. Bankruptcy Code does not authorize such a release.

  • June 27, 2024

    Motley Rice, 4 Other Firms Appeal Opioid MDL Attorney Fees Recommendations

    CLEVELAND — Five law firms filed separate notices of appeal in the opioid multidistrict litigation centralized in the U.S. District Court for the Northern District of Ohio over final recommendations made by a fee panel to allocate $2.13 billion in attorney fees in connection with various settlements reached by the parties.

  • June 27, 2024

    Suboxone MDL Judge Rejects Proposal By Defense For Phased Discovery

    CLEVELAND — The judge overseeing the Suboxone film multidistrict litigation rejected a proposal by a defendant to phase discovery, finding “that general causation is not so clear or cleanly divisible from other general or case-specific discovery that bifurcation would materially expedite and simplify the proceedings in this MDL.”

  • June 27, 2024

    Woman Says Contaminated Eye Drops Led To Vision Injury In New Jersey Federal Suit

    NEWARK, N.J. — A California woman’s use of artificial tears eye drops that were contaminated with bacteria led to potentially permanent eye and vision damage, she alleges in a complaint filed in a New Jersey federal court on June 26.

  • June 24, 2024

    High Court Again Extends Response Deadline In Review Of 9th Circuit FCA Reversal

    WASHINGTON, D.C. — The U.S. Supreme Court on June 21 granted a district court qui tam plaintiff’s second request for additional time to respond to pharmaceutical companies’ petition that seeks review of the Ninth Circuit U.S. Court of Appeals’ ruling reversing the district court’s dismissal of a suit accusing the companies of violating the False Claims Act (FCA) by artificially inflating drug prices.

  • June 20, 2024

    Parties Debate Allowing New Causation Expert In ASD-ADHD MDL

    NEW YORK — Defendants facing lawsuits by parents in the acetaminophen autism spectrum disorder-attention deficit hyperactivity disorder (ASD-ADHD) multidistrict litigation who allege that prenatal exposure to acetaminophen causes autism or ADHD say the parents’ arguments for allowing a new expert to testify are misplaced.

  • June 20, 2024

    9th Circuit Hears Arguments In Holmes, Balwani Appeals

    SAN FRANCISCO — The Ninth Circuit U.S. Court of Appeals heard oral arguments by Theranos Inc. founder Elizabeth Holmes and former Theranos Chief Operating Officer Ramesh “Sunny” Balwani, who are separately appealing their convictions and sentences.

  • June 20, 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 19, 2024

    JPMDL To Mull Consolidation Of Cases Alleging Benzene In Acne Products

    WASHINGTON, D.C.  — The U.S. Judicial Panel on Multidistrict Litigation (JPMDL) will meet in Portland, Maine, on July 25 to decide whether to consolidate for pretrial purposes cases that allege that users of benzoyl peroxide (BPO) products for the treatment of acne vulgaris, including creams, washes, scrubs and bars, were inadequately warned about the presence of benzene.

  • June 19, 2024

    Missouri Appeals Court Upholds Defense Verdict In Bair Hugger Case

    KANSAS CITY, Mo. — A Missouri appeals court on June 18 affirmed a defense verdict in a case alleging that 3M Co.’s Bair Hugger patient warming system was defectively designed and caused a postoperative infection after finding that trial court did not err in multiple evidentiary rulings or abuse its discretion in limiting expert testimony.

  • June 18, 2024

    Judge Dismisses Claims Against Insys As Deferred Prosecution Agreement Ends

    BOSTON — A Massachusetts federal judge on June 17 signed off on the dismissal of five counts of mail fraud against a subsidiary of opioid manufacturer Insys Therapeutics Inc. as part of the deferred prosecution agreement (DPA) that the parties reached in June 2019.

  • June 18, 2024

    Janssen Violated FCA, State Laws In HIV Drug Promotions, N.J. Federal Jury Says

    NEWARK, N.J. — A New Jersey federal jury found that Janssen Products LP violated federal and various state false claims laws in its promotion of HIV drugs Prezista and Intelence and ordered it to pay $150 million in damages.

  • 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.

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