Mealey's Drugs & Devices

  • August 16, 2022

    New Trial In Testosterone Heart Attack Trial Denied By MDL Judge

    CHICAGO — An Illinois federal judge overseeing the testosterone replacement therapy multidistrict litigation on Aug. 6 denied a plaintiff’s motion for a new trial, finding that defendant Actavis Inc. did not impermissibly introduce a warning label for a different drug or hold back a relevant Food and Drug Administration letter.

  • August 16, 2022

    California State Court Judge: Janssen’s Opioid Settlement Bars $1.3B Bill Of Costs

    SANTA ANA, Calif. — A California state court judge on Aug. 4 confirmed a tentative ruling denying Janssen Global Services LLC’s motion for $1.3 million in costs in California’s opioid lawsuit against the drug maker, finding that due to a settlement, California is the prevailing party and Janssen is due no costs.

  • August 16, 2022

    Montana High Court Upholds Injunction Against New Abortion Drug Restrictions

    HELENA, Mont. — A unanimous panel of the Montana Supreme Court on Aug. 8 affirmed a trial court’s preliminary injunction against three state laws that restrict abortions, including medication abortions, and on Aug. 9 separately said the impact of the U.S. Supreme Court’s post-argument abortion ruling in Dobbs v. Jackson Women’s Health Organization can be aired in the trial court.

  • August 15, 2022

    CVS Has Not Shown ‘Overwhelming Hardship’ To Warrant Dismissal Of Insurers’ Suits

    WILMINGTON, Del. — A Delaware judge on Aug. 12 denied CVS Health Corp.’s motion to dismiss its insurers’ lawsuits disputing coverage for underlying opioid litigation, finding that CVS has failed to satisfy the “overwhelming hardship” standard that governs its motion to dismiss under forum non conveniens.

  • August 12, 2022

    West Virginia:  Rite Aid Opioid Settlement May Add ‘Up To $30M’

    CHARLESTON, W.Va. — The West Virginia Attorney General’s Office on Aug. 11 issued a press release announcing an opioid settlement with pharmacy chain Rite Aid Corp. that “may add up to $30 million.”

  • August 12, 2022

    5th Circuit: IVC Filter Warned Of Complications Plaintiff Suffered

    NEW ORLEANS — The Fifth Circuit U.S. Court of Appeals on Aug. 10 affirmed summary judgment for C.R. Bard Inc. in an inferior vena cava (IVC) filter case, agreeing with a district court that the device warning label warned of the complications the plaintiff claims to have suffered and that state law did not require the manufacturer to list the comparative risk of the device.

  • August 11, 2022

    9th Circuit Reverses Summary Judgment In Wound Device Whistleblower Case

    SAN FRANCISCO — The Ninth Circuit U.S. Court of Appeals on Aug. 9 reversed summary judgment in a False Claims Act lawsuit involving billing for a wound-healing medical device, saying there are triable issues of materiality and scienter that should be decided by a jury.

  • August 11, 2022

    2nd Circuit Affirms Symptoms Triggered Time Bar For Pelvic Mesh Claim

    NEW YORK — The Second Circuit U.S. Court of Appeals on Aug. 8 affirmed summary judgment in a pelvic mesh case, agreeing with a district court that under New York state law, the plaintiff’s three-year statute of limitations began to run when she first noticed symptoms and not when she learned that alleged cause of her injuries.

  • August 11, 2022

    Judge:  Walgreen Opioid Policy Created Public Nuisance In San Francisco

    SAN FRANCISCO — Following a two-month bench trial, a California federal judge on Aug. 10 issued findings of fact and conclusions of law that pharmacy chain Walgreen Co. is liable for creating a public nuisance in San Francisco by failing, for 15 years, to resolve “red flags” for suspicious opioid prescriptions, resulting in an opioid epidemic that the city had to deal with.

  • August 10, 2022

    Drug/Device Maker Endo Says Bankruptcy Likely Due To Opioid Litigation

    DUBLIN, Ireland — Drug and medical device maker and opioid defendant Endo International PLC on Aug. 9 said in a regulatory filing that as a result of not being able to settle “thousands” of opioid lawsuits, it expects that negotiations with first-lien creditors and other parties “will likely result in a pre-arranged filing under Chapter 11 of the U.S. Bankruptcy Code . . . which could occur imminently.”

  • August 05, 2022

    Jury Finds Eli Lilly Liable For $61.2M In Medicare Drug Rebate False Claims Trial

    CHICAGO — An Illinois federal jury on Aug. 3 found Eli Lilly & Co. liable for $61.22 million in a trial in which a whistleblower alleged that the drug company underpaid Medicare drug rebates to the federal government.

  • August 04, 2022

    ‘Unprecedented’ MDL Created For 40 Gardasil Injury Cases

    WASHINGTON, D.C. — The Judicial Panel on Multidistrict Litigation on Aug 4 ordered that 40 federal lawsuits involving the Gardasil human papillomavirus (HPV) vaccine be centralized, a move that manufacturing defendant Merck Sharp & Dohme LLC had told the court would be “unprecedented” in the history of the National Childhood Vaccine Injury Act (the Vaccine Act).

  • August 03, 2022

    Mass Tort Cases For Drugs, Medical Devices

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

  • August 02, 2022

    ‘Big 3’ Opioid Distributors To Pay $400M To Settle West Virginia Claims

    CHARLESTON, W.Va. — Drug distributors AmerisourceBergen Drug Co., Cardinal Health Inc. and McKesson Corp. have reached a tentative agreement to pay $400 million to settle opioid claims by West Virginia cities and counties, according to Aug. 1 statements by the state attorney general and the state’s outside counsel.

  • August 02, 2022

    Mifepristone Maker: Opioid, Ruling, Constitution Trump Mississippi Abortion Law

    JACKSON, Miss. — A company that makes a generic version of the abortifacient mifepristone on July 21 moved to file an amended complaint arguing that Mississippi’s near-total ban of the abortion drug is constitutionally illegal and barred by a 2014 federal court ruling involving another state’s attempted ban of one opioid drug.

  • August 02, 2022

    All But 1 False Claim Survives Summary Judgment In Exactech False Claims Case

    TUSCALOOSA, Ala. — An Alabama federal judge on July 25 denied summary judgment on all but one claim by three whistleblowers who allege that orthopedic device maker Exactech Inc. caused false claims to be submitted to government health care programs when the defendant failed to recall a problematic knee implant or to tell the Food and Drug Administration or doctors about the problem.

  • August 02, 2022

    2nd Circuit: HHS Didn’t Need To Show ‘Corrupt’ Intent To Disallow Drug Co-Pays

    NEW YORK — The Second Circuit U.S. Court of Appeals on July 25 affirmed a trial court ruling that the U.S. Department of Health and Human Services did not have to find “corrupt” intent before finding that a co-pay assistance program for an expensive heart drug made by Pfizer Inc. violated the Anti-Kickback Statute (AKS) because the manufacturer payment would practically eliminate the statutory requirement that Medicare patients contribute toward the price of their drugs.

  • August 02, 2022

    10th Circuit:  EpiPen Competitor Lacks Evidence Mylan Harmed Consumers

    DENVER — The 10th Circuit U.S. Court of Appeals on July 29 affirmed a decision by the EpiPen multidistrict litigation court that Sanofi-Aventis U.S. LLC (Sanofi) could not show that Mylan Inc. monopolized the epinephrine autoinjector market without evidence of actual or threatened consumer harm.

  • August 01, 2022

    Judge Who Entered Opioid Default Judgment Is Suspended For Misconduct

    NASHVILLE, Tenn. — A Tennessee state court judge who had his default judgment against opioid maker Endo Pharmaceuticals Inc. overturned for judicial misconduct on July 26 was suspended by the Tennessee Board of Judicial Conduct for his actions in that case and in an adoption case.

  • August 01, 2022

    Insured Appeals Ruling In Favor Of Insurers In Suit Arising From Opioid Epidemic

    SAN FRANCISCO — A prescription drug distributor insured on July 27 filed a notice of appeal in a federal California court asking the Ninth Circuit U.S. Court of Appeals to review the lower court’s ruling that underlying lawsuits prompted by the opioid epidemic fail to allege an “accident” under California law.