Mealey's Drugs & Devices

  • October 14, 2020

    FDA Requires Black Box Update For Risks Of Benzodiazepines

    SILVER SPRING, Md. — The Food and Drug Administration on Sept. 23 issued a Drug Safety Communication that it is requiring manufacturers of benzodiazepines to update the black box warnings for that class of drugs for their risk of abuse, misuse, addiction, physical dependence and withdrawal reactions.

  • October 14, 2020

    FDA Warns Of Mercury Dental Fillings Risks For Certain Patients

    SILVER SPRING, Md. — The Food and Drug Administration on Sept. 24 said certain patients may be at a higher risk of adverse health effects of mercury from metal dental fillings (amalgam).

  • October 14, 2020

    Black Box Warning For Breast Implants Recommended By FDA

    SILVER SPRING, Md. — The Food and Drug Administration on Sept. 19 recommended that breast implant manufacturers include a black box warning on product labels about the risks of the devices.

  • October 14, 2020

    Johnson & Johnson Appeals Opioid Public Nuisance Verdict, $465M Order

    OKLAHOMA CITY — Johnson & Johnson on Oct. 8 told the Oklahoma Supreme Court that it should reverse a trial court’s public nuisance verdict and its order to pay $465 million to fund the first year of a remediation plan (Oklahoma v. Johnson & Johnson, et al., No. 118,484, Okla. Sup.).

  • October 13, 2020

    Mass Tort Cases For Drugs, Medical Devices

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

  • October 13, 2020

    Summary Judgment Granted In Pradaxa Bleeding Death Case On Preemption Grounds

    ATLANTA — A Georgia federal judge on Sept. 29 granted preemption summary judgment in a Pradaxa bleeding death case after finding that there was no new evidence that the Food and Drug Administration should have considered to strengthen the drug’s warnings about bleeding risks (Kimberly A. Lyons, et al. v. Boehringer Ingelheim Pharmaceuticals, Inc., No. 18-4624, N.D. Georgia, Atlanta Div., 2020 U.S. Dist. LEXIS 184234).

  • October 13, 2020

    Florida Appeals Panel Affirms Defense Verdict In Medical Device Death Case

    WEST PALM BEACH, Fla. — In a 2-1 decision, a Florida state appeals panel on Oct. 7 affirmed a defense verdict in a wrongful death case involving a surgical suction device even though the trial judge erred in allowing the defendant to exercise a peremptory strike against the first alternate juror when one original juror left (Lisa Cavanaugh, et al. v. Stryker Corporation, et al., No. 4D19-523, Fla. App., 4th Dist., 2020 Fla. App. LEXIS 14345).

  • October 13, 2020

    Texas Supreme Court Reverses Appeals Court In Fen-Phen Fee Case

    AUSTIN, Texas — The Texas Supreme Court on Oct. 9 reversed an appeals court ruling reversing summary judgment for a plaintiff law firm in a fen-phen fee dispute and remanded the case to the appellate court to consider the law firm’s other arguments in the case (George Fleming, et al. v. Rebecca Wilson, et al., No. 19-0230, Texas Sup., 2020 Tex. LEXIS 931).

  • October 12, 2020

    Drug Maker Mallinckrodt Goes Bankrupt, Settles Opioid Cases For $1.6B Cash, Stock

    DUBLIN, Ireland — Mallinckrodt PLC on Oct. 12 announced an agreement in principle of a proposed settlement to resolve opioids-related claims for $1.6 billion, according to a company press release.

  • October 12, 2020

    6th Circuit: No Mandamus Order To Block Additional Drug Data Discovery

    CINCINNATI — The Sixth Circuit U.S. Court of Appeals on Oct. 8 denied a mandamus petition by the Ohio Board of Pharmacy (OBOP) to order the opioids multidistrict litigation court to rescind its order to provide the names and addresses of opioid prescribers and dispensers to retail pharmacies in an upcoming bellwether trial (In Re:  National Prescription Opiate Litigation [In Re:  State of Ohio Board of Pharmacy], No. 20-3875, 6th Cir.).

  • October 09, 2020

    FDA To Withdraw Approval Of Controversial Preterm Pregnancy Drug Makena

    SILVER SPRING, Md. — The Food and Drug Administration on Oct. 5 notified AMAG Pharma USA Inc. and five other drug companies that the agency is proposing to withdraw approval of Makena-brand hydroxyprogesterone caproate because a post-marketing clinical trial failed to verify that the drug has a clinical benefit and because the drug is not shown to be effective under its conditions for use.

  • October 09, 2020

    Drug Company Warned To Stop Marketing Budesonide Nasal Spray To Treat COVID-19

    SILVER SPRING, Md. — The Food and Drug Administration on Sept. 22 warned Nephron Pharmaceuticals Corp. to stop unapproved advertising that budesonide nasal asthma spray treats respiratory symptoms of COVID-19 infections.

  • October 09, 2020

    U.S. Supreme Court Defers Stay Of Injunction Allowing Mailing Of Abortifacient

    WASHINGTON, D.C. — The U.S. Supreme Court on Oct. 8 held in abeyance for 40 days an application by the Food and Drug Administration to stay a district court preliminary injunction permitting the mailing of an abortion pill due to the COVID-19 pandemic (Food and Drug Administration, et al. v. American College of Obstetricians and Gynecologists, et al., No. 20A34, U.S. Sup., 2020 U.S. LEXIS 4833).

  • October 08, 2020

    U.S. High Court Won’t Review Dismissal Of Defective Opioids Pump Lawsuit

    WASHINGTON, D.C. — The U.S. Supreme Court on Oct. 5 denied review of an implantable opioids pump case, letting stand a circuit court ruling that the plaintiff failed to show that any of three explanted devices were defective and that defendant Medtronic Inc. had a duty to analyze adverse event reports (Rebecca Lawrence v. Medtronic, No. 19-8689, U.S. Sup.).

  • October 08, 2020

    U.S. High Court Lets Reversal Of Avandia Preemption Ruling By 3rd Circuit Stand

    WASHINGTON, D.C. — The U.S. Supreme Court on Oct. 5 denied a certiorari petition by GlaxoSmithKline LLC (GSK) to reverse a preemption ruling involving the diabetes drug Avandia based on an interpretation by the Third Circuit U.S. Court of Appeals of a 2019 Supreme Court preemption decision (GlaxoSmithKline LLC v. United Food and Commercial Workers Local 1776, et al., No. 19-1444, U.S. Sup.).

  • October 08, 2020

    U.S. Supreme Court Won’t Review 6th Circuit’s Drug Preemption Ruling

    WASHINGTON, D.C. — The U.S. Supreme Court on Oct. 5 denied review of lower court rulings that a drug plaintiff’s state law failure-to-warn claim is “impliedly preempted” by federal law (Rita McDaniel, et al. v. Upsher-Smith Laboratories, Inc., No. 19-1246, U.S. Sup.).

  • October 01, 2020

    In AndroGel Patent Row, Panel Reinstates Reverse Payment Antitrust Claim

    PHILADELPHIA — In a Sept. 30 holding, the Third Circuit U.S. Court of Appeals tossed a $448 million disgorged profits award against the owners of a patent covering AndroGel but found that a Pennsylvania federal judge erred when he dismissed antitrust allegations by the Federal Trade Commission against the testosterone drug makers to the extent that those allegations relied on a reverse payment theory (Federal Trade Commission v. AbbVie Inc., et al., Nos. 18-2621,-2748, -2758, 3rd Cir., 2020 U.S. App. LEXIS 31048).

  • September 30, 2020

    Motion Filed For Elmiron Eye Injury MDL

    WASHINGTON, D.C. — Two plaintiffs on July 23 filed a motion asking the Judicial Panel on Multidistrict Litigation (JPMDL) to centralize 63 cases in which plaintiffs allege that the bladder drug Elmiron causes serious eye injury that patients have not been warned about (In Re:  Elmiron [Pentosan Polysulfate Sodium] Products Liability Litigation, MLD Docket No. 2973, JPMDL).

  • September 30, 2020

    Mass Tort Cases For Drugs, Medical Devices

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

  • September 30, 2020

    Opioid MDL Judge Won't Reconsider Dismissal, Certify Appeals For Bellwether Trial

    CLEVELAND — The Ohio federal judge overseeing the opioid multidistrict litigation on Sept. 22 denied a motion by pharmacy defendants to reconsider his earlier denial of two of their dismissal motions or to certify questions to the Sixth Circuit U.S. Court of Appeals and the Ohio Supreme Court (In Re:  National Prescription Opiate Litigation, MDL Docket No. 2804, No. 17-md-2804, N.D. Ohio, E. Div.,

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