Mealey's Drugs & Devices

  • July 30, 2021

    Closing Arguments Heard In Opioid Trial Against ‘Big 3’ National Drug Distributors

    CHARLESTON, W.Va. — Closing arguments were given July 28 in a 40-day bench trial of three national drug distributors accused by a West Virginia city and county of creating a public nuisance by allegedly failing to flag or stop suspicious orders of opioids.

  • July 29, 2021

    NECC Pharmacist To Appeal Resentence, $82M Restitution In Contaminated Drug Case

    BOSTON — The former supervisory pharmacist for New England Compounding Center (NECC) on July 28 filed a notice of appeal of his increased fraud and racketeering sentence and $82 million restitution order to the First Circuit U.S. Court of Appeals.

  • July 28, 2021

    EpiPen Antitrust MDL Judge Dismisses Pharmacy’s Class Claims Without Prejudice

    KANSAS CITY, Kan. — The Kansas federal judge overseeing the EpiPen antitrust multidistrict litigation on July 26 dismissed without prejudice a class action complaint filed by a pharmacy chain on behalf of direct purchasers, saying the plaintiff lacked standing under the Sherman Act and that a post-complaint assignment of claims agreement with a distributor cannot be applied to the claim that defendants Mylan N.V. and Pfizer Inc. blocked generic competition.

  • July 21, 2021

    Attorneys General Announce $26B Global Opioid Agreement Reached With 4 Companies

    North Carolina Attorney General Josh Stein and attorneys general in other states on July 21 announced a $26 billion agreement with opioid distributors Cardinal Health Inc., McKesson Corp. and AmerisourceBergen Corp. and opioid manufacturer and marketer Johnson & Johnson that will resolve investigations and litigation by state and local governments across the country over those companies’ alleged roles in the opioid epidemic.

  • July 20, 2021

    New York Attorney General Announces $1.1B Opioid Use Prevention Settlement

    NEW YORK — The New York attorney general on July 20 announced a $1.1 billion agreement between the state and two counties and three drug distributors that resolves claims regarding the companies’ alleged role in helping fuel the opioid epidemic and removes the companies from the ongoing opioid trial in New York court.

  • July 16, 2021

    Tennessee Appeals Court Won’t Hear Appeal Of Opioid Defendants’ Default Judgment

    KNOXVILLE, Tenn. — The Tennessee Court of Appeals on July 15 denied a motion by opioid defendant Endo Pharmaceuticals Inc. to review a lower court’s default judgment in a governmental opioid case, saying that because the lower court judge left undecided further discovery sanctions, the appellate court lacks jurisdiction.

  • July 15, 2021

    Pfizer Agrees To $345M Settlement Of Consumer, Third-Party EpiPen Claims

    KANSAS CITY, Kan. — Pfizer Inc. and two related defendants have agreed to a $345 million class settlement of claims by consumers and third-party payers that they overpriced the EpiPen epinephrine autoinjector and engaged in anti-competitive behavior, according to a settlement agreement and approval motion filed July 14 in Kansas federal court.

  • July 14, 2021

    Mass Tort Cases For Drugs, Medical Devices

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

  • July 14, 2021

    Ex-NECC Chief Gets 5-1/2 Years Added To Sentence After 1st Circuit Remand

    BOSTON — A Massachusetts federal judge on July 7 resentenced the former owner of the New England Compounding Center (NECC) to 14-1/2 years in prison and ordered him to pay $1.4 million and restitution of $82 million, according to the U.S. Attorney’s Office.

  • July 14, 2021

    5th Circuit: Blood Clotting Test Strip Case Triggered When Plaintiff Had Stroke

    NEW ORLEANS — The Fifth Circuit U.S. Court of Appeals on July 6 affirmed dismissal of a claim that a defective coagulation test trip resulted in a stroke, agreeing with a district court that the statute of limitations was triggered when the plaintiff’s stroke happened and not when the plaintiff was told by the defendant that the strips had been recalled.

  • July 14, 2021

    D.C. Circuit Court: FDA Ban On Electroshock Behavior Therapy Violates FDCA

    WASHINGTON, D.C. — In a 2-1 decision, the District of Columbia Circuit U.S. Court of Appeals on July 6 ruled that a Food and Drug Administration rule banning the use of electrical stimulation devices to treat aggressive or self-injurious behavior violates federal law prohibiting the FDA from regulating the practice of medicine.

  • July 14, 2021

    MDL Sought For Recalled Philips CPAP Devices

    WASHINGTON, D.C. — A plaintiff on July 7 asked the Judicial Panel on Multidistrict Litigation (JPMDL) to centralize 10 federal cases in which plaintiffs allege that they were exposed to toxic deteriorating insulation from Philips continuous positive airway pressure (CPAP) medical devices.

  • July 14, 2021

    5th Circuit: Knowledge Of Taxotere Hair Loss Risk Precludes Causation

    NEW ORLEANS — The Fifth Circuit U.S. Court of Appeals on July 1 affirmed dismissal of a Taxotere permanent hair loss appeal, concluding that because the plaintiff and her doctor were aware of the risk, the drug maker’s alleged failure to warn cannot be the proximate cause of the injury.

  • July 14, 2021

    U.S. High Court Asked By Breast Implant Plaintiffs To Resolve Preemption Split

    WASHINGTON, D.C. — Twenty-three silicone gel breast implant plaintiffs on July 6 petitioned the U.S. Supreme Court to resolve what they say is a split among federal circuit courts about preemption and the application of the high court’s rulings in Riegel and Buckman.

  • July 12, 2021

    9th Circuit:  Relator In Drug False Claims Suit Lacked Direct Knowledge Of Fraud

    SAN FRANCISCO — The Ninth Circuit U.S. Court of Appeals on July 9 affirmed dismissal of a whistle-blower’s claims against two drug companies for off-label promotion of two drugs, saying the relator failed to sufficiently allege that he had “direct and independent” knowledge of the defendants’ alleged fraud.

  • July 12, 2021

    FDA Commissioner Asks Inspector General To Review Agency’s Aduhelm Approval

    SILVER SPRING, Md. — Acting Food and Drug Administration Commissioner Janet W. Woodcock on July 9 ask the Department of Health and Human Services inspector general to conduct an independent review of interactions between drug maker Biogen and the FDA while the agency was considering whether to approve the Alzheimer’s drug Aduhelm.

  • July 12, 2021

    5th Circuit Affirms Dismissal Of 2 Drug Qui Tam Cases At United States’ Request

    NEW ORLEANS — The Fifth Circuit U.S. Circuit Court of Appeal on July 7 said a district court did not err in dismissing kickback qui tam lawsuits against two drug companies, agreeing that the United States controls such complaints and that the government showed during a hearing that the cost of the litigation would be burdensome in relation to the expected recovery even if the relator prosecuted the cases themself.

  • July 12, 2021

    St. Jude Pays $27M For False Claims Stemming From Defective Heart Devices

    WASHINGTON, D.C. — St. Jude Medical LLC has agreed to pay $27 million to resolve allegations that it caused false claims to be submitted to three federal health care programs by failing to disclose a deadly battery defect in implantable heart devices St. Jude used to make, according to a settlement agreement disclosed July 8 by the U.S. Justice Department.

  • July 08, 2021

    Medical Device Maker To Pay Nearly $39M To Settle False Claims Act Allegations

    WASHINGTON, D.C. — Medical device manufacturers Alere Inc. and Alere San Diego Inc. (collectively, Alere) will pay $38.75 million to settle claims with the U.S. Department of Justice alleging that Alere violated the False Claims Act (FCA) by billing, and causing customers to bill, Medicare for rapid point-of-care devices, known as INRatio blood coagulation monitors, that the companies knew were defective, the department announced in a press release on July 8.

  • July 08, 2021

    15 State Attorneys General Agree To $4.32B Settlement With Sackler Opioid Family

    WHITE PLAINS, N.Y. — The Sackler family that controls OxyContin maker Purdue Pharma LP has agreed to a $4.32 billion settlement with 15 state attorneys general that also includes the disclosure of millions more documents including attorney-client communications and having the family name removed from charitable institutions, according to a bankruptcy court mediator’s report filed July 7 and to July 8 announcements by three of the settling attorneys general.