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Mealey's Drugs & Devices

  • November 16, 2018

    Abbott Opposes Cert For Rulings On Experts In Depakote Birth Defect Case

    WASHINGTON, D.C. — With no circuit split and a settled decision, the U.S. Supreme Court need not grant certiorari to review a Second Circuit U.S. Court of Appeals opinion affirming exclusion of a mother’s causation experts in her attempt to hold a drugmaker liable for her child’s birth defects, the company says in a Nov. 14 response brief (N.K. v. Abbott Laboratories, No. 18-327, U.S. Sup.).

  • November 14, 2018

    Mass Tort Cases For Drugs, Medical Devices

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

  • November 14, 2018

    12-Year-Old Baycol False Claims Suit Survives 3rd Round Of Dismissal

    MINNEAPOLIS — A Minnesota federal judge on Oct. 16 denied another motion by Bayer Healthcare Pharmaceuticals Inc. to dismiss a 12-year-old whistleblower lawsuit about the alleged fraudulent marketing of the statin drug Baycol (United States, ex rel. Laurie Simpson v. Bayer Healthcare, et al., No. 08-5758, D. Minn., 2018 U.S. Dist. LEXIS 178751).

  • November 14, 2018

    Opioid MDL Judge Denies As Untimely Distributors’ Bid For Interlocutory Appeal

    CLEVELAND — The Ohio federal judge overseeing the opioid multidistrict litigation on Nov. 13 denied as untimely a motion by three drug distributors to certify a magistrate judge’s report and recommendation to the Ohio Supreme Court (In Re:  National Prescription Opiate Litigation, MDL Docket No. 2804, No. 17-md-2804, N.D. Ohio, Eastern Div.).

  • November 14, 2018

    Pelvic Mesh MDL Attorneys Seek 5 Percent Common Benefit Fee, Now At $366.1M

    CHARLESTON, W. Va. — Plaintiff attorneys in the seven pelvic mesh multidistrict litigations in the U.S. District Court for the Southern District of West Virginia on Nov. 12 asked the court to award common benefit attorney fees of 5 percent of settlement amounts, which presently amounts to $366.1 million but is expected to go to $550 million (In Re:  C.R. Bard, Inc., Pelvic Repair System Products Liability Litigation, MDL No. 2187, In Re:  American Medical Systems, Inc. Pelvic Repair System Products Liability Litigation, MDL No. 2325, In Re: Boston Scientific, Corp., Pelvic Repair System Products Liability Litigation, MDL No. 2326, In Re:  Ethicon, Inc., Pelvic Repair System Products Liability Litigation, MDL No. 2327, In Re:  Coloplast Pelvic Repair System Products Liability Litigation, MDL No. 2387, In Re:  Cook Medical, Inc., Pelvic Repair System Products Liability Litigation, MDL No. 2440, In Re:  Neomedic Pelvic Repair System Products Liability Litigation, MDL No. 2511, S.D. W.Va.).

  • November 13, 2018

    FDA Warns Stem Cell Maker Its Products Are Unapproved, Manufacturing Substandard

    SILVER SPRING, Md. — The Food and Drug Administration on Oct. 31 issued a warning letter to stem cell maker StemGenex Biologic Laboratories LLC for illegally marketing unapproved biologic products and for manufacturing violations.

  • November 13, 2018

    Kentucky Appeals Court: Investigational Device Claims Are Preempted By Federal Law

    FRANKFORT, Ky. — A Kentucky state appeals court panel on Nov. 9 affirmed preemption dismissal of a heart catheter injury claim, saying the Food and Drug Administration’s approved of the then-experimental device preempts state law claims and that a subsequent recall of catheters did not apply to the one involved in the plaintiff’s case (Clifford Russell Jr., et al. v. Johnson & Johnson, Inc., et al., Nos. 2017-CA-000866 and 2018-CA-000195, Ky. App., 2018 Ky. App. LEXIS 268).

  • November 13, 2018

    Statute Of Limitations Dismissal Denied In Abilify Neurological Injury Case

    SAN FRANCISCO — A California federal judge on Nov. 6 denied a motion by the maker of Abilify to dismiss a tardive dyskinesia injury claim based on California’s two-year statute of limitations (Ina Ann Rodman v. Otsuka America Pharmaceutical, Inc., No. 18-3732, N.D. Calif., 2018 U.S. Dist. LEXIS 190052).

  • November 13, 2018

    Ohio County, City Oppose Interlocutory Appeal In Opioid MDL Litigation

    CLEVELAND — Two Ohio municipalities on Nov. 9 opposed a motion by three opioid distributor defendants for interlocutory appeal of the issue of liability under the Ohio Products Liability Act (OPLA), saying that a federal magistrate judge in the MDL and an Ohio state court judge have already ruled on the issue and that an appeal would disrupt the federal case management timetable (In Re:  National Prescription Opiate Litigation, MDL Docket No. 2804, No. 17-md-2804, N.D. Ohio, Eastern Div.).

  • November 13, 2018

    Olympus Duodenoscope Claim Dismissed Without Prejudice By Federal Magistrate

    DENVER — A Colorado federal magistrate judge on Oct. 30 dismissed without prejudice a plaintiff’s claim that she developed a drug-resistant infection as a result of an Olympus duodenoscope that cannot be adequately cleaned to prevent cross-contamination among patients (Kathleen Lynch v. Olympus America, Inc., et al., No. 18-512, D. Colo., 2018 U.S. Dist. LEXIS 185595).

  • November 12, 2018

    Mirena MDL Plaintiffs Want Interlocutory Appeal; Defense Wants Summary Judgment

    NEW YORK — Unable to agree on the future of the Mirena brain injury multidistrict litigation, plaintiffs on Nov. 9 told the court that it should certify its recent expert exclusion ruling for appeal while the defendant argued that the court should grant summary judgment and let the terminated litigation go to appeal afterward (In Re:  Mirena IUS Products Liability Litigation No. II, MDL Docket No. 2767, No. 17-mc-2767, S.D. N.Y.).

  • November 12, 2018

    Judge In Cook IVC MDL Says Implanting Doctor Doesn’t Have To Do Expert Report

    INDIANAPOLIS — A treating physician in a Cook Medical inferior vena cava (IVC) filter who is a nonretained expert for the defense does not have to submit an expert witness report, the Indiana federal judge overseeing a multidistrict litigation ruled Nov. 9 (In Re:  Cook Medical, Inc, IVC Filters, MDL Docket No. 2570, No. 14-ml-2570, Tonya Brand v. Cook Medical, Inc., No. 14-6018, S.D. Ind., Indianapolis Div.).

  • November 12, 2018

    Testosterone MDL Judge Denies Insurer’s Intervention In Settlement Allocation

    CHICAGO — The Illinois federal judge overseeing the testosterone replacement therapy multidistrict litigation on Nov. 8 denied a motion by insurer Gemini Insurance Co. to intervene in settlement allocation for its insured, Endo Pharmaceuticals Inc., and a subsidiary (In Re:  Testosterone Replacement Therapy Products Liability Litigation, MDL Docket No. 2545, No. 14-1748, N.D. Ill., Eastern Div., 2018 U.S. Dist. LEXIS 191521).

  • November 9, 2018

    Abilify MDL Judge Remands 21 Cases To California State Court

    PENSACOLA, Fla. — The Florida federal judge presiding over the Abilify multidistrict litigation on Nov. 8 remanded 21 cases to California state court, finding that the plaintiffs have made plausible claims against drug distributor McKesson Corp. and have evinced an intent to make valid claims against it (In Re:  Abilify [Aripiprazole] Products Liability Litigation, MDL Docket No. 2734, No. 16-md-2734, N.D. Fla., Pensacola Div.).

  • November 8, 2018

    Pennsylvania State Judge Orders New Trial In Ethicon Pelvic Mesh Case

    PHILADELPHIA — Saying a jury defense verdict in an Ethicon pelvic mesh trial was inadequate, a Pennsylvania state court judge on Nov. 6 ordered a new trial (In Re: Pelvic Mesh Litigation, Kimberly L. Adkins v. Ethicon, Inc., July Term 2013, No. 00919, No. 17062172, Pa. Comm. Pls., Philadelphia Co.).

  • November 8, 2018

    6 Claims Out In Wright Metal-On-Metal Hip Case In Utah Federal Court

    SALT LAKE CITY — A Utah federal judge on Nov. 5 dismissed six claims in a Wright Medical Technology Inc. metal-on-metal hip implant injury case but denied dismissal of the plaintiff’s punitive damages and prejudgment interest claims (Diane Jorgensen v. Wright Medical Group, Inc., et al., No. 18-366, D. Utah, 2018 U.S. Dist. LEXIS 189834).

  • November 8, 2018

    Kidney Clinic Operator Settles 3 GranuFlo Death Cases For $25.5M After Verdict

    DENVER — Kidney clinic operator DaVita Healthcare Partners Inc. on Nov. 7 disclosed that it has agreed to settle for $25.5 million three dialysate wrongful death cases that in June resulted in a $383.5 million combined verdict in the U.S. District Court for the District of Colorado (Kathleen White, et al. v. DaVita Healthcare Partners, Inc., No. 15-2106, D. Colo.).

  • November 7, 2018

    California Appeals Court Reverses Summary Judgment In Diabetes Drug Case

    LOS ANGELES — A California state appeals court on Nov. 6 reversed summary judgment for three drug makers in the state’s coordinated incretin mimetic diabetes drug litigation, saying the trial court misapplied U.S. Supreme Court preemption case law about whether the Food and Drug Administration considered new evidence of risk (Aida Rotondo, et al. v. Amylin Pharmaceuticals, Inc., et al., No. B275314, Calif. App., 2nd Dist., Div. 7, 2018 Cal. App. Unpub. LEXIS 7515).

  • November 6, 2018

    Drug Company Founder Fails In Attempt To Reverse Conviction At High Court

    WASHINGTON, D.C. — The U.S. Supreme Court on Nov. 5 denied review of InterMune Inc. founder W. Scott Harkonen’s motion for a writ of error coram nobis due to new exculpatory evidence (W. Scott Harkonen, M.D. v. United States of America, No. 18-417, U.S. Sup.).

  • November 1, 2018

    $2.5M Risperdal Gynecomastia Verdict Upheld By Pennsylvania State Appeals Court

    PHILADELPHIA — A Pennsylvania appeals court on Oct. 31 affirmed a $2.5 million Risperdal gynecomastia compensatory damages verdict and, citing earlier court opinions, said the trial court needs to analyze whether the plaintiffs can ask for punitive damages (Phillip Pledger, et al. v. Janssen Pharmaceuticals, Inc., et al., Nos. 2088 EDA 2016 and 2187 EDA 2016, Pa. Super., 2018 Pa. Super. LEXIS 1167).