Mealey's Drugs & Devices

  • April 02, 2020

    Ex-Theranos CEO Seeks Orders Allowing Her To Prepare For Securities Fraud Trial

    SAN JOSE, Calif. — Arguing that preparation for her trial on criminal charges in connection with an alleged securities fraud scheme has been hindered by state and federal government orders put in place in response to the novel coronavirus pandemic, former Theranos Inc. CEO Elizabeth Holmes asked a federal judge in California on March 30 to issue a pair of orders that would consider her attorneys essential workers and allow them to continue to prepare for her upcoming trial (United States of America v. Elizabeth Holmes, et al., No. 18-cr-258. N.D. Calif.).

  • April 01, 2020

    FDA Asks Makers Of Zantac, Generics To Withdraw Drugs Due To High NDMA Levels

    SILVER SPRING, Md. — The Food and Drug Administration on April 1 said it has asked all manufacturers to withdraw prescription and nonprescription ranitidine drugs from the market due to them developing high levels of N-nitrosodimethylamine (NDMA) contamination during storage.

  • April 01, 2020

    United States Appeals 2 Conviction Reversals In NECC Criminal Trial

    BOSTON — The United States on Feb. 20 asked the First Circuit U.S. Court of Appeals to overturn a district court judge’s reversal of two convictions in the New England Compounding Center (NECC) criminal case (United States v. Sharon P. Carter & Gregory Conigliaro, Nos. 19-1644 and 19-1645, 1st Cir.).

  • April 01, 2020

    2 Plaintiff Firms Want Bard IVC MDL Fee Request Unsealed, A Seat At The Table

    PHOENIX — Two plaintiff law firms on March 30 asked an Arizona federal court overseeing the C.R. Bard inferior vena cava (IVC) filter multidistrict litigation to deny a motion by the Plaintiffs’ Executive Committee (PEC) to seal its motion for common benefit fees or to appoint one of their attorneys to the Common Benefit Fee and Cost Committee (In Re:  C.R. Bard IVC Filters Products Liability Litigation, MDL Docket No. 2641, No. 15-md-2641, D. Ariz.).

  • April 01, 2020

    Mass Tort Cases For Drugs, Medical Devices

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

  • March 31, 2020

    Insys Founder Kapoor Must Begin 66-Month Sentence Pending Opioid Fraud Appeal

    BOSTON — John Kapoor, the founder of opioid drug maker Insys Therapeutics Inc., was ordered March 30 to report to federal prison on May 19 to begin serving his 66-month sentence for paying kickbacks to doctors to prescribe the company’s fentanyl-based drug Subsys (United States v. John Kapoor, No. 16-cr-10343, D. Mass.).

  • March 31, 2020

    National, State Class Action Sought For Buyers Of Weight Loss Drug Belviq

    NEW YORK — A woman on March 27 filed a class action complaint in New York federal court seeking reimbursement for Belviq, a prescription weight loss drug that the Food and Drug Administration in February ordered off the market due to the increased risk of cancer (Barbara Zottola, et al. v. Eisai Inc., et al., No. 20-2600, S.D. N.Y.).

  • March 31, 2020

    6th Circuit: ASR Hip MDL Lacked Jurisdiction In 12 Foreign Cases

    CINCINNATI — The Sixth Circuit U.S. Court of Appeals on March 27 denied a motion by foreign nationals in 12 cases to file amended complaints alleging injuries from the DePuy Orthopaedics ASR hip implant and remanded the cases to the multidistrict litigation court for dismissal because it said the lower court lacked jurisdiction from the very beginning (In Re:  DePuy Orthopaedics, Inc., ASR Hip Litigation [Linda Boal v. DePuy Orthopaedics, Inc., et al.], No. 19-3494, et al., 6th Cir., 2020 U.S. App. LEXIS 9630).

  • March 31, 2020

    9th Circuit: Court Must Say Why FDA Can Withhold Ebola Drug Documents

    SAN FRANCISCO — The Ninth Circuit U.S. Court of Appeals on March 24 reversed summary judgment that denied access to Food and Drug Administration records about ZMapp, an experimental drug to treat the Ebola virus (Goldwater Institute v. U.S. Department of Health and Human Services, No. 19-15615, 9th Cir., 2020 U.S. App. LEXIS 9126).

  • March 30, 2020

    $3.75M In Common Benefit Fees Sought For $225M Sorin3T MDL Settlement

    HARRISBURG, Pa. — Plaintiff attorneys in the Sorin 3T Heater-Cooler multidistrict litigation on March 27 asked the court to award them $3.75 million in common benefit fees and $441,260 in common benefit expenses from the $225 million master settlement of infection claims (In Re:  Sorin 3T Heater-Cooler System Products Liability Litigation [No. II], MDL Docket No. 2816, No. 18-md-2816, M.D. Pa.).

  • March 27, 2020

    3rd Circuit Affirms Dismissal Of Zostavax Vaccine Case As Being Untimely Filed

    PHILADELPHIA — The Third Circuit U.S. Court of Appeals on March 26 affirmed dismissal of a Zostavax shingles vaccine injury case, agreeing that a plaintiff lawyer’s failure to conduct discovery did not justify post-judgment relief from a statute-of-limitations ruling (Chris Juday, et al. v. Merck & Co. Inc., et al., No. 19-1144, 3rd Cir., 2020 U.S. App. LEXIS 9450).

  • March 27, 2020

    3 Insys Employees Must Report To Federal Prison By May 19

    BOSTON — A Massachusetts federal judge on March 24 ordered three former top Insys Therapeutics Inc. employees to report to federal prison on May 19 following his denial of their motions to stay their sentences pending appeal to the First Circuit U.S. Court of Appeals (United States v. Michael J. Gurry, No. 16-cr-10363, United States v. Richard Simon, No. 16-cr-10343, United States v. Sunrise Lee, No. 16-cr-10343, D. Mass.).

  • March 23, 2020

    U.S. Supreme Court Won’t Review Summary Judgment In Silicone Implant Case

    WASHINGTON, D.C. — The U.S. Supreme Court on March 23 denied review of summary judgment in a silicone breast implant case in which the plaintiff wanted the court to recognize the doctrine of res ipsa loquitor and to resolve a purported circuit split about whether the alleged manufacturing defect violated federal current good manufacturing practices (CGMPs) (Nicole Weber v. Allergan, Inc., No. 19-869, U.S. Sup.).

  • March 17, 2020

    Judge Unseals EpiPen Class Certification Opinion, Won’t Keep ‘2-Pack’ Logic Sealed

    KANSAS CITY, Kan. — The Kansas federal judge overseeing the EpiPen multidistrict litigation on March 10 denied a motion by defendant Mylan Specialty L.P. to keep sealed a portion of his class certification ruling dealing with the defendants’ decision to package its epinephrine autoinjector in twin rather than single packs, saying the information is more than 10 years old and isn’t a competitive secret (In Re:  EpiPen Marketing, Sales Practices and Antitrust Litigation, MDL Docket No. 2785, No. 17-md-2785, D. Kan.).

  • March 17, 2020

    Mass Tort Cases For Drugs, Medical Devices

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

  • March 17, 2020

    New Jersey Appeals Court: Market Share Liability Out In Hernia Mesh Case

    JERSEY CITY, N.J. — A New Jersey state appellate court on March 6 agreed that a plaintiff who claims that she was injured by unidentified hernia mesh cannot use market share liability to pursue her case against a manufacturer she suspects made her mesh (Deborah Kline, et al. v. Johnson & Johnson, et al., No. A-4355-17T1, N.J. Super., App. Div., 2020 N.J. Super. Unpub. LEXIS 481).

  • March 17, 2020

    New York Opioid Trial Postponed Due To Coronavirus Pandemic

    CENTRAL ISLIP, N.Y. — A New York state court judge on March 10 postponed the March 20 trial of the state attorney general’s lawsuit against opioid manufacturers and distributors, according to a press release from the Attorney General’s Office (In Re Opioid Litigation, No. 400000/2017, N.Y. Sup., Suffolk Co.).

  • March 17, 2020

    HHS Secretary Invokes Liability Immunity Law For COVID-19 Countermeasures

    WASHINGTON, D.C. — U.S. Health and Human Services Secretary Alex Azar on March 12 issued a declaration invoking the liability immunity and injury compensation provisions of the Public Health Services Act, 42 U.S. Code, § 247d-6e.

  • March 17, 2020

    Half Of Plaintiff Claims In IVC Filter Case Dismissed With Prejudice

    UTICA, N.Y. — A New York federal judge on March 9 accepted a magistrate judge’s recommendation to dismiss with prejudice half of a plaintiff’s claims against the makers of an inferior vena cava (IVC) filter but to allow the other claims to proceed (Kevin O’Neil v. Argon Medical Devices Inc., et al., No. 17-640, N.D. N.Y., 2002 U.S. Dist. LEXIS 15043).

  • March 17, 2020

    Insurer Humana’s Monopoly Claims Involving MS Drug Mostly Survive Dismissal

    LOS ANGELES — A federal lawsuit by health insurer Humana Inc. alleging that drug manufacturer Mallinckrodt ARD LLC and its predecessor created a monopoly for the multiple sclerosis (MS) drug Acthar mostly survived dismissal March 9 by a California federal judge who granted the insurer leave to amend its complaint (Humana Inc. v. Mallinckrodt ARD LLC, et al., No. 19-6926, C.D. Calif.).