Mealey's Drugs & Devices

  • November 21, 2019

    Mass Tort Cases For Drugs, Medical Devices

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

  • November 21, 2019

    3rd Circuit:  Jury Must Decide If Discovery Rule Saves Plaintiff’s Hip Case

    PHILADELPHIA — In a 2-1 opinion, the Third Circuit U.S. Court of Appeals reversed summary judgment in a Zimmer metal-on-metal hip case, saying that under Pennsylvania law, whether Pennsylvania’s discovery rule applies is a question of fact for a jury (Marilyn Adams v. Zimmer US Inc. et al., No. 18-3011, 3rd Cir., 2019 U.S. App. LEXIS 34513).

  • November 21, 2019

    Pennsylvania High Court: Trial Court Must Revisit Risperdal Accrual Date Issue

    PHILADELPHIA — The Pennsylvania Supreme Court on Nov. 20 vacated summary judgment in two Risperdal gynecomastia cases as being time-barred, ruling that the state Superior Court erred in determining if there was enough publicity about a cause and effect to put the plaintiffs on notice (In Re:  Risperdal Litigation [Jonathan Saksek v. Janssen Pharmaceuticals, Inc., et al., No. 22 EAP 2018; Joshua Winter v. Janssen Pharmaceuticals, Inc., et al., No. 23 EAP 2018, Pa. Sup., 2019 Pa. LEXIS 6480).

  • November 21, 2019

    Pennsylvania State Judge Won’t Recuse Himself From Risperdal Gynecomastia Case

    PHILADELPHIA — A Pennsylvania state court judge on Oct. 30 denied without comment a Johnson & Johnson motion for him to recuse himself from a Risperdal gynecomastia case for allegedly celebrating an $8 billion punitive damages verdict with some members of the jury (Nicholas Murray v. Janssen Pharmaceuticals, Inc., et al., No. 13040199000495, Pa. Comm. Pls., Philadelphia Co.).

  • November 21, 2019

    Class Action Sought For Pre-Term Drug Makena As Ineffective, Overpriced

    SYRACUSE, N.Y. — Two women on Nov. 12 filed a New York state class action complaint against the manufacturer of the pre-term pregnancy prevention drug Makena, arguing that the injectable drug is ineffective and overpriced (Teresa Faughnan, et al. v. AMAG, Inc., No. 19-1394, N.D. N.Y.).

  • November 21, 2019

    6th Circuit Rejects Appeal Of Denial Of Injunction Involving Opioid Babies

    CINCINNATI — On a 2-1 vote with a lengthy dissent, the Sixth Circuit U.S. Court of Appeals on Nov. 18 dismissed an appeal by two women who sought to enjoin opioid manufacturers from dispensing their drugs to women without a negative pregnancy test (Amanda Hanlon, et al. v. Purdue Pharma L.P., et al., No. 19-3398, 6th Cir., U.S. App. LEXIS 34350).

  • November 21, 2019

    Gilead False Claims Case Dismissed On Motion By United States

    SAN FRANCISCO — A California federal judge on Nov. 5 granted a motion by the United States to dismiss a whistleblower lawsuit alleging that drug maker Gilead Sciences Inc. caused false claims to be submitted to Medicare and Medicaid by using drug ingredients supplied by an unregistered Chinese supplier (United States, ex rel. Jeff Campie, et al. v. Gilead Sciences, Inc., et al., No. 11-941, N.D. Calif., 2019 U.S. Dist. LEXIS 193147).

  • November 20, 2019

    Zofran Birth Defect Defendant Files FDA Citizen Petition As Part Of Preemption Bid

    BOSTON — GlaxoSmithKline LLC (GSK) on Nov. 1 filed a citizen petition asking the Food and Drug Administration for an opinion about Zofran’s birth defect warnings, a move that plaintiffs in the multidistrict litigation in a Nov. 13 brief say is designed to delay an upcoming bellwether trial but that GSK says in its own Nov. 13 brief will help the court decided whether the plaintiff’s claims are preempted (In Re:  Zofran [Ondansetron] Products Liability Litigation, MDL Docket No. 2657, No. 15-md-2657, D. Mass.).

  • November 19, 2019

    Centralization Of Stryker Tritanium Hip Cases Sought In New Jersey

    TRENTON, N.J. — The New Jersey Supreme Court on Nov. 4 solicited comments on a motion to create a multicounty litigation for state court lawsuits alleging early failure of the Stryker Tritanium acetabular shell, a hip prosthesis component.

  • November 19, 2019

    Hip Defendant:  MDL Plaintiffs Skewing Bellwether Pool With Lexecon Opt-Outs

    NEW YORK — Counsel for Zimmer Inc. on Nov. 15 asked a New York federal judge overseeing the M/L Taper hip multidistrict litigation to restore protections under Lexecon because of the plaintiffs’ alleged “mass use” of the U.S. Supreme Court jurisdictional rule to remove cases from bellwether consideration and thus “skew” the bellwether pool (In Re:  Zimmer M/L Taper Hip Prothesis Products Liability Litigation, MDL Docket No. 2859, No. 10-md-2859, S.D. N.Y.).

  • November 18, 2019

    Opioid Maker Insys Files Amended Bankruptcy Plan

    WILMINGTON, Del. — Opioid maker Insys Therapeutics Inc. on Nov. 14 filed an amended liquidation plan with a federal bankruptcy court that addresses the company’s settlement with the United States and addresses payments for personal injury claimants and state, municipal and tribal claims (In Re:  Insys Therapeutics, Inc., et al., No. 19-11292, Bkcy. Del.).

  • November 18, 2019

    Jury Orders Biogen To Pay $5.9M For Retaliation, Sex Discrimination Claims

    SEATTLE — A Washington federal jury on Nov. 11 found that drug maker Biogen Inc. retaliated against a saleswoman in violation of the federal False Claims Act, 31 U.S. Code § 3729, and wrongfully terminated her in violation of public policy (Danita Erickson v. Biogen, Inc., No. 18-1029, W.D. Wash., Seattle).

  • November 15, 2019

    Oklahoma Judge Orders Johnson & Johnson To Pay $465M For Opioid Abatement

    NORMAN, Okla. — An Oklahoma state court judge on Nov. 15 ordered Johnson & Johnson and subsidiary Janssen Pharmaceuticals Inc. to pay the state $465.02 million for the first year of a state-run opioid abuse public nuisance abatement program (Oklahoma v. Purdue Pharma L.P., et al., No. CJ-2017-816, Okla. Dist., Cleveland Co.).

  • November 14, 2019

    ‘Scattershot Approach’ To Pleading Securities Claims Against Drug Maker Rejected

    NEWARK, N.J. — A federal judge in New Jersey on Nov. 12 ruled that lead plaintiffs in a securities class action lawsuit brought against a biopharmaceutical company that develops hematology and oncology therapeutics and certain of its current and former executive officers regarding their marketing and sale of the company’s fentanyl-based cancer treatment drug have failed to plead any actionable misrepresentations in making their federal securities law claims (In re Galena Biopharma Inc. Securities Litigation, No. 17-929, D. N.J., 2019 U.S. Dist. LEXIS 196297).

  • November 14, 2019

    7th Circuit Affirms Summary Judgment On Insurer’s RICO Case In Testosterone MDL

    CHICAGO — The Seventh Circuit U.S. Court of Appeals on Nov. 12 affirmed summary judgment against a health insurer’s racketeering lawsuit against five testosterone replacement drug manufacturers, agreeing that a jury couldn’t find that the insurer or pharmacy benefits managers relied on allegedly misleading statements by the defendants (Medical Mutual of Ohio v. AbbVie Inc., et al., No. 14-8857, 7th Cir., 2019 U.S. App. LEXIS 33702).

  • November 11, 2019

    Spine Company, 2 Top Execs Settle Kickback, False Claims Suit For $5.9M

    NEW YORK — Orthopedic device maker Life Spine Inc., its founder and a vice president will pay $5.9 million to settle a false claims lawsuit that they paid kickbacks to surgeons to use Life Spine products, the U.S. attorney for the Southern District of New York announced Nov. 7 (United States, et al., ex rel. BNHT LLC v. Life Spine Inc., et al., No. 18-1311, S.D. N.Y.).

  • November 11, 2019

    Federal Circuit Upholds Denial Of Award For Vaccine SIDS Death Claim

    WASHINGTON, D.C. — A majority of a Federal Circuit U.S. Court of Appeals panel on Nov. 7 affirmed a trial court’s reversal of compensation for parents who say their infant died from vaccinations that caused his sudden crib death, with a dissenting judge saying the ruling goes against the purpose of the National Childhood Vaccine Injury Act (Chase Boatmon, et al. v. Secretary of Health and Human Services, No. 18-2333, Fed. Cir., 2019 U.S. App. LEXIS 33295).

  • November 08, 2019

    Pharmacy Ingredient Supplier Pays $22M For Reporting Inflated Wholesale Prices

    WASHINGTON, D.C. — The U.S. Justice Department on Nov. 7 announced that Fagron Holding USA LLC agreed to pay $22.05 million to resolve allegations that subsidiary Freedom Pharmaceuticals Inc. reported inflated average wholesale prices (AWPs) for active pharmaceutical ingredients used for compounded drugs.

  • November 08, 2019

    Zantac MDL Creation Sought By Plaintiffs Seeking Refunds, Cancer Compensation

    WASHINGTON, D.C. — Plaintiffs in six federal lawsuits on Nov. 4 filed a motion asking a judicial panel to centralize their Zantac cancer and refund claims into a multidistrict litigation in the U.S. District Court for the District of New Jersey (In Re:  Zantac (Ranitidine) Products Liability Litigation, MDL Docket No. 2924, JPMDL).

  • November 07, 2019

    Government Sues Gilead For Patent Infringement In Delaware Federal Court

    WILMINGTON, Del. — In a Nov. 6 complaint filed in the U.S. District Court for the District of Delaware, the U.S. Department of Health and Human Services (HHS) accuses a drug maker of infringing four patents relating to the treatment of human immunodeficiency virus (HIV) (The United States v. Gilead Sciences Inc., et al., No. 19-2103, D. Del.).