Mealey's Drugs & Devices

  • September 16, 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 16, 2020

    Medical Group Asks 6th Circuit To Enjoin FDA From 'Withholding' Hydrochloroquine

    CINCINNATI — A conservative physician's group on Aug. 21 filed an emergency motion asking the Sixth Circuit U.S. Court of Appeals for an injunction against the Food and Drug Administration for it withdrawal of emergency use authorization (EUA) for hydrochloroquine to treat COVID-19 (Association of American Physicians & Surgeons v. Food & Drug Administration, et al., No. 20-1784, 6th Cir.).

  • September 16, 2020

    Top 2 NECC Execs Ordered Held For Trial For Murder By Michigan State Judge

    LANSING, Mich. — A Michigan state court judge on Aug. 19 found that there is sufficient evidence to hold the former president and chief pharmacist of the New England Compounding Center (NECC) for trial on 11 counts of second-degree murder in the deaths of 10 patients who died after getting injected with contaminated steroid made by NECC, according to an Aug. 20 press release by the Michigan Attorney General’s Office.

  • September 16, 2020

    Ohio Pharmacy Board Asks 6th Circuit To Block Disclosure Of State's Drug Database

    CINCINNATI — The Ohio pharmacy board on Aug. 20 petitioned the Sixth Circuit U.S. Court of Appeals for a writ of mandamus and stay blocking the opioid multidistrict litigation court’s decision to require the board to disclose information from the Ohio Automated Rx Reporting System (OARRS) (In Re:  State of Ohio Board of Pharmacy, No. 20-3875, 6th Cir.).

  • September 16, 2020

    9th Circuit Won't Rehear, Grant En Banc Rehearing In Surgical Gown Case

    SAN FRANCISCO — The Ninth Circuit U.S. Court of Appeals on Sept. 9 denied a plaintiff’s motion to reconsider the court’s reversal of a $24 million damages award against a surgical gown maker and the plaintiff’s motion for an en banc rehearing of the appeal (Bahamas Surgery Center, LLC, et al. v. Kimberly-Clark Corporation, et al., Nos. 18-55478,18-55484 and 18-55558, 9th Cir.).

  • September 15, 2020

    Judge Denies Acquittal, New Trial For 2 Execs Convicted Of Off-Label Marketing

    BOSTON — A Massachusetts federal judge on Sept. 14 said that while it is not entirely clear that Congress intended to criminalize off-label marketing, the facts presented in a trial involving off-label marketing of a sinus device bar a judgment of acquittal and a new trial for two men convicted in 2016 of misdemeanors (United States v. William Facteau, et al., No. 15-cr-10076, D. Mass., 2020 U.S. Dist. LEXIS 167169).

  • September 15, 2020

    2nd Circuit Reinstates New York's Opioid Tax As A Federally Defined Levy

    NEW YORK — The Second Circuit U.S. Court of Appeals on Sept. 14 reinstated New York's statutory requirement that opioid manufacturers and distributors make annual payments to a state opioid services fund, finding that it is a federally defined tax that a district court should have severed from a disputed provision preventing payers from passing the tax along to consumers (Association for Accessible Medicines, et al. v. Letitia James, et al., Nos. 19-183, 19-199 and 19-201, 2nd Cir., 2020 U.S. App. LEXIS 29016).

  • September 15, 2020

    Founder Of Opioid Maker Asks 1st Circuit For New Trial On Health Insurance Fraud

    BOSTON — The founder of bankrupt opioid maker Insys Therapeutics Inc. on Sept. 10 told the First Circuit U.S. Court of Appeals that since a trial judge vacated a jury conviction for honest services fraud and for violating the Controlled Substances Act (CSA), 21 U.S.C. § 801 et seq., the appeals court should order a retrial solely on health insurance fraud to avoid tainting by the vacated conviction (United States v. John Kapoor, et al., No. 20-1368, et al., 1st Cir.).

  • September 15, 2020

    Judge Won't Stay Thalidomide Suit Against Law Firm For 3rd Circuit Appeal

    PHILADELPHIA — A Pennsylvania federal judge on Sept. 11denied an emergency motion by a plaintiff law firm to stay a former plaintiff's lawsuit alleging breach of fiduciary duty, saying that given the past history of related litigation, the motion was intended to frustrate a discovery process that "has already revealed gross misconduct by the Firm" (Carolyn Sampson v. Hagens Berman Sobol Shapiro, LLP, et al., No. 20-2232, E.D. Pa.).

  • September 14, 2020

    Judge Says Superseding Information Naming Theranos Execs Survives, But Is Limited

    SAN JOSE, Calif. — A California federal judge on Sept. 11 denied a motion by former Theranos Inc. founder and CEO Elizabeth A. Holmes and the company's former president to dismiss a superseding criminal information filed against them by the United States, even though the judge agreed that because the information did not come from a grand jury, the government may not prosecute any of the new claims (United States v. Elizabeth A. Holmes, et al., No. 19-cr-258, N.D. Calif., San Jose Div.).

  • September 11, 2020

    Theranos CEO Holmes To Get Government Psych Exam After Citing Her Mental Health

    SAN JOSE, Calif. — A California federal judge on Sept. 9 ordered former Theranos Inc. founder and CEO Elizabeth A. Holmes to sit for a two-day psychological and psychiatric evaluation by government experts after she told a California federal court that she intended to introduce expert evidence "relating to a mental disease or defect or any other mental condition" in her criminal conspiracy case (United States v. Elizabeth A. Holmes, No. 19-cr-258, N.D. Calif., San Jose Div.).

  • September 11, 2020

    Off-Label Claims For Spinal Device Not Preempted; Other Claims Can Be Refiled

    SACRAMENTO, Calif. — A California federal judge on Sept. 8 denied dismissal of a plaintiff's fear-of-injury claim involving a spinal device allegedly used off-label and dismissed other parts of her claims without prejudice and with leave to file an amended complaint (Christina Bird, et al. v. Globus Medical, Inc., No. 19-1024, E.D. Calif., 2020 U.S. Dist. LEXIS 164480).

  • September 09, 2020

    Federal Circuit Court Affirms Woman Didn't Prove Injury, Causation By Flu Vaccine

    WASHINGTON, D.C. — The Federal Circuit U.S. Court of Appeals on Sept. 8 affirmed rulings that a woman failed to prove that she developed polyarthritis or Guillain-Barre syndrome (GBS) from an influenza vaccine (Kathleen Wyatt v. Secretary of Health and Human Services, No. 19-2234, Fed. Cir., 2020 U.S. App. LEXIS 28403).

  • September 09, 2020

    Judge Unseals Expert Reports Over GSK's Objections In Avandia MDL

    PHILADELPHIA — Citing the common-law presumption of public access, the Pennsylvania federal judge presiding over the Avandia multidistrict litigation on Sept. 3 mostly denied a motion by GlaxoSmithKline LLC (GSK) to continue sealing expert reports that were subject to a 2008 discovery protective order in the long-running litigation, finding that the pharmaceutical firm did not establish that any injury would result in the documents being unsealed (In re:  Avandia Marketing, Sales Practices and Products Liability Litigation, No. 07-1871, E.D. Pa., 2020 U.S. Dist. LEXIS 161614).

  • September 04, 2020

    Shareholder Claims In AbbVie Kickback Lawsuit Survive Dismissal Bid

    CHICAGO — A federal judge in Illinois on Sept. 1 ruled that shareholders in a securities class action lawsuit against AbbVie Inc. and two of its senior executives have sufficiently pleaded the necessary elements of their federal securities laws claims in alleging that the defendants misrepresented the biopharmaceutical company's growth and success of its rheumatoid arthritis prescription medication, Humira, and their alleged failure to disclose their involvement in a kickback scheme with physicians (Mayuko Holwill v. AbbVie Inc., et al., No. 18-6790, N.D. Ill., 2020 U.S. Dist. LEXIS 159885).

  • September 02, 2020

    3rd Circuit: False Claims Act First-To-File Rule Doesn't Bar Relators From Subbing

    PHILADELPHIA — The first-to-file bar in the False Claims Act (FCA) does not prevent relators in a Plavix whistleblower lawsuit from replacing one of the partners who filed the original complaint, the Third Circuit U.S. Court of Appeals ruled Sept. 1 (In Re:  Plavix Liability Litigation [United States, ex rel. JKJ Partnership 2011 LP v. Sanofi-Aventis U.S. LLC, et al.], No. 18-2472, 3rd Cir., 2020 U.S. App. LEXIS 27777).

  • September 02, 2020

    Connecticut State Court Judge: Pradaxa GI Bleed Claim Preempted; FDA Knew Risk

    HARTFORD, Conn. — A Connecticut state court judge on Aug. 25 granted summary judgment in a Pradaxa gastrointestinal (GI) bleed death case, finding that the plaintiff’s claims that defendant Boehringer Ingelheim Pharmaceuticals Inc. failed to warn about the risk of GI bleeds in patients who had gastroesophageal reflux disease (GERD) are preempted by federal law (Tamra Lea Kearns Estep, et al. v. Boehringer Ingelheim Pharmaceuticals, Inc., et al., NoX03 HHD CV17-6075319S, Conn. Super., Hartford Dist.).

  • September 01, 2020

    Seller Of Misbranded Medical Devices, 85, Denied Early Release From Federal Prison

    PIERRE, S.D. — A South Dakota federal judge on Aug. 12 denied a motion to apply a 2018 sentence-reduction law and grant compassionate release to an 85-year-old man serving a seven-year sentence for selling misbranded medical devices (United States v. Robert Larry Lytle, et al., No. 17-cr-50020, D. S.C, Western Div., 2020 U.S. Dist. LEXIS 147466).

  • September 01, 2020

    7th Circuit Tells Lower Court To Dismiss Qui Tam Suit On Government's Motion

    CHICAGO — The Seventh Circuit U.S. Court of Appeals on Aug. 17 said a district court erred in not granting the United States’ motion to dismiss a false claims lawsuit against a drug company because the government felt the case was not worth the expense and was against the public interest (United States ex rel. Cimznhca, LLC v. UCB Inc., et al., No. 19-2273, 7th Cir., 2020 U.S. App. LEXIS 25954).

  • September 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.