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Mealey's Drugs & Devices

  • October 20, 2020

    Pennsylvania Appeals Court: Drug Makers Don’t Have To Send ‘Dear Doctor’ Letters

    PHILADELPHIA — The Pennsylvania Superior Court on Oct. 19 affirmed summary judgment in a metoclopramide neurological injury case, agreeing with a mass tort court that the manufacturers’ duty to warn does not include sending “dear doctor” letters about the drug’s updated warning label (Janine Zitney, et al. v. Wyeth LLC, et al., No. 3369 EDA 2019, Pa. Super., 2020 Pa. Super. Unpub. LEXIS 3278).

  • October 20, 2020

    Ohio Appeals Court Reverses Dismissal Of Ortho Device Case; No Settlement Existed

    TOLEDO, Ohio — An Ohio state appeals panel on Oct. 16 reversed dismissal of an orthopedic device case, finding that the plaintiffs never agreed to a settlement and therefore did not renege on their alleged agreement (Frank Aceste, et al. v. Stryker Corporation, et al., No. L-19-1156, Ohio App., 6th Dist., Lucas Co., 2020 Ohio App. LEXIS 3783).

  • October 16, 2020

    Opioids MDL Judge Sanctions Teva, Allergan For Not Finding Drug Order Report

    CLEVELAND — The Ohio federal judge overseeing the opioids multidistrict litigation on Oct. 14 sanctioned defendants Allergan Finance LLC and Teva Pharmaceutical Industries Ltd. for discovery violations by failing to find a suspicious drug order report Allergan had commissioned before Teva bought the latter’s generic opioid business (In Re:  National Prescription Opiate Litigation, MLD Docket No. 2804, No. 17-md-2804, N.D. Ohio, Eastern Div.).

  • October 16, 2020

    Graft Maker Shareholder Derivative Suit Settlement Gains Preliminary Approval

    ATLANTA — A federal judge in Georgia on Oct. 8 granted preliminary approval of a proposed settlement agreement in a shareholder derivative lawsuit brought on behalf of tissue graft maker MiMedx Group Inc. against several of the biopharmaceutical company’s current and former executive officers and directors that alleged that the defendants breached their fiduciary duty by covering up whistleblower allegations of a massive “channel-stuffing” scheme (In re MiMedx Group Inc. Shareholder Derivative Litigation, No. 18-4486, N.D. Ga.).

  • October 15, 2020

    Medical Device Maker Merit Medical Pays $18M For 6-Year Kickback Scheme

    NEWARK, N.J. — Medical device maker Merit Medical Systems Inc. will pay $18 million to the United States and various state governments to resolve whistleblower allegations that the company caused the submission of false claims to federal health care programs by paying kickbacks to physicians and hospitals to induce the purchase of the company’s medical products, the U.S. Justice Department said in an Oct. 14 press release (United States, ex rel. Charles J. Wolf, M.D. v. Merit Medical Systems, Inc., No. 16-1855, D. N.J.).

  • October 14, 2020

    Johnson & Johnson Adds $1B To $4B Offer To Settle Current, Future Opioids Claims

    NEW BRUNSWICK, N.J. — Johnson & Johnson on Oct. 13 announced that it will contribute an additional $1 billion to what it calls its “all-in settlement amount,” previously announced for $4 billion, to resolve current and future opioids claims by states, cities, counties and Native American tribes.

  • 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.).