Mealey's Drugs & Devices

  • May 22, 2018

    U.S. Supreme Court Won’t Review 3rd Circuit’s Eyedrop Class Reversal

    WASHINGTON, D.C. — The U.S. Supreme Court on May 21 denied review of a prescription eyedrop case, sending the purported class action back to a New Jersey federal court for further proceedings (Alcon Laboratories, Inc., et al. v. Leonard Cottrell, et al., No. 17-1337, U.S. Sup.).

  • May 22, 2018

    FDA Warns Of Possible Birth Defects From Dolutegravir HIV Drug

    SILVER SPRING, Md. — The Food and Drug Administration on May 18 issued a drug safety communication that the HIV drug dolutegravir, sold as Tivicay, Juluca and Trimeq, has been associated with neural tube birth defects in an African observational study.

  • May 22, 2018

    U.S. Supreme Court Won’t Take Up When Relator Is An Original Source In Solvay Case

    WASHINGTON, D.C. — The U.S. Supreme Court on May 21 denied review of a case by two whistleblowers who claimed that the former Solvay Pharmaceuticals engaged in off-label marketing of three drugs, including AndroGel, and caused the submission of false claims to federal health care programs (United States, ex rel. John King, et al. v. Solvay Pharmaceuticals, Incorporated, No. 17-1370, U.S. Sup.).

  • May 18, 2018

    Nebraska Supreme Court Affirms Exclusion Of Accutane Causation Expert

    LINCOLN, Neb. — The Nebraska Supreme Court on May 18 affirmed the exclusion of a plaintiff’s sole causation expert in an Accutane bowel injury case, saying the expert’s methodology failed to meet case law standards (Aimee Freeman v. Hoffman-La Roche Inc., et al., No. 300 Neb. 47, Neb. Sup.).

  • May 17, 2018

    Defense Verdict Returned In 4th AndroGel MDL Bellwether Trial

    CHICAGO — An Illinois federal jury on May 15 returned a defense verdict in the fourth AndroGel multidistrict litigation bellwether trial (Arthur Myers, et al. v. Abbvie Inc., et al., No. 15-1085, N.D. Ill.).

  • May 16, 2018

    Pennsylvania Superior Court Affirms That Opioid Death Complaint Is Preempted

    PHILADELPHIA — The Pennsylvania Superior Court on May 9 affirmed dismissal of an opioid death complaint because the complaint was premised on violation of federal drug law and is preempted (Joseph A. Caltagirone, et al. v. Cephalon, Inc., No. 1303 EDA 2017, Pa. Super., 2018 Pa. Super. Unpub LEXIS 1504).

  • May 16, 2018

    West Virginia High Court: Zoloft Liability Can’t Be Shown Without Experts

    CHARLESTON, W.Va. — The West Virginia Supreme Court of Appeals on May 15 said the state’s Zoloft mass tort court correctly granted summary judgment in two cases after the plaintiffs’ experts could not testify and said the plaintiffs cannot rely on documents or the testimony of opposing experts to prove inadequate warning (J.C., et al. v. Pfizer, Inc., et al., No. 17-0282, W.Va. Sup., 2018 W. Va. LEXIS 402).

  • May 16, 2018

    Mass Tort Cases For Drugs, Medical Devices

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

  • May 16, 2018

    7th Circuit Vacates $1M Opioid Defamation Verdict, Orders New Trial

    CHICAGO — The Seventh Circuit U.S. Court of Appeals on May 9 reversed a $1 million verdict for a doctor who says CVS Pharmacy defamed him when it refused to fill his patients’ opioid prescriptions (Anthony Mimms v. CVS Pharmacy, Inc., No. 17-1918, 7th Cir., 2018 U.S. App. LEXIS 12179).

  • May 15, 2018

    1st Bair Hugger Infection MDL Bellwether Trial Under Way In Minnesota Court

    MINNEAPOLIS — The first bellwether trial in the Bair Hugger multidistrict litigation got under way on May 14 in Minnesota federal court (Louis Gareis, et al. v. 3M Company, et al., No. 16-4187, D. Minn.).

  • May 15, 2018

    After United States Intervenes, Judge Unseals 5 Opioid Whistleblower Complaints

    LOS ANGELES — A California federal judge on May 11 unsealed five whistle-blower lawsuits alleging that Insys Therapeutics paid kickbacks for doctors to prescribe its opioid drug Subsys (United States of America, et al., ex rel. Maria Guzman v. Insys Therapeutics, Inc., et al., No. 13-5861, United States of America, et al., ex rel. John Doe, et al., No. 14-34888, United States of America, ex rel. Allison Erickson, et al. v. Insys Therapeutics, Inc., No. 16-2956, United States of America, ex rel. Jane Doe, et al. v. Insys Therapeutics, Inc., No. 16-7937, C.D. Calif., Western Div.).

  • May 15, 2018

    California Federal Judge Again Finds No ‘Joint Trial’ Intent In State Lipitor Cases

    SANTA ANA, Calif. — A California federal judge on May 10 remanded the cases of 4,321 Lipitor diabetes plaintiffs to state court, finding that nothing that was said or done by either the plaintiffs or California state judges in connection with a state coordinated Lipitor litigation meant that the plaintiffs intend to have a joint trial (In Re:  Lipitor, No. 18-1725, C.D. California, 2017 U.S. Dist. LEXIS 80284).

  • May 14, 2018

    Summary Judgment Denied In Lyrica Case Based On State Of Doctor’s Knowledge

    NEW YORK — A New York state court justice on April 25 denied summary judgment in a Lyrica injury case, finding that the prescribing physician may not have been aware of the current risks listed on the drug’s label at the time she prescribed the drug and the extent of the plaintiff’s injuries (Evelyn Karambelas v. Pfizer, Inc., No. 150334/16, N.Y. Sup., New York Co., 2018 N.Y. Misc. LEXIS 1507).

  • May 14, 2018

    West Virginia High Court: Levaquin Maker Not Liable For Injury By Generic Drug

    CHARLESTON, W.Va. — The West Virginia Supreme Court of Appeals on May 11 ruled that state statutory law, case law, public policy and legal precedent do not allow the manufacturer of the antibiotic Levaquin to be sued for injuries allegedly caused by the drug’s generic version, levofloxacin (Kimmy McNair, et al. v. Johnson & Johnson, et al., No. 17-0519, W.Va. Sup. Ct. App., 2018 W.Va. LEXIS 344).

  • May 14, 2018

    Declaratory Judgment Standing Lacking In Dispute Over Generic AIDS Drugs

    WASHINGTON, D.C. — A California federal judge did not err in finding that a nationwide provider of health care services for patients with AIDS lacks declaratory judgment standing to maintain an action against the brand name manufacturer of drugs containing tenofir alafenamide fumarate (TAF), the Federal Circuit U.S. Court of Appeals ruled May 11 (AIDS Healthcare Foundation Inc. v. Gilead Sciences Inc., et al., No. 16-2475, Fed. Cir.).

  • May 14, 2018

    Too Soon To Decide Who’ll Pay Costs In Thalidomide Case Misconduct, Judge Says

    PHILADELPHIA — A Pennsylvania federal judge on May 8 denied a motion by GlaxoSmithKline PLC (GSK) to make a plaintiff law firm pay all the special master fees and costs incurred after the plaintiffs’ firm admitted to falsifying an expert report in an attempt to get a plaintiff to voluntarily withdraw her thalidomide birth defect case (Glenda Johnson, et al. v. SmithKline Beecham Corporation, et al., No. 11-5782, E.D. Pa., 2018 U.S. Dist. LEXIS 77223).

  • May 14, 2018

    Opioid MDL Judge Orders DEA To Share Data About All States And Territories

    CLEVELAND — Saying that the data has helped with litigation in six states, the Ohio federal judge overseeing the opioid multidistrict litigation on May 7 ordered the U.S. Drug Enforcement Administration (DEA) to provide opioid monitoring data for the entire United States (In Re:  National Prescription Opiate Litigation, MDL Docket No. 2804, No. 17-md-2804, N.D. Ohio, Eastern Div.).

  • May 10, 2018

    3 VA Health Care Employees Indicted For Conspiracy, Graft Related To Allografts

    GREENVILLE, S.C. — Three federal Veterans Affairs health clinic employees were indicted May 8 in the U.S. District Court for the District of South Carolina for conspiracy and graft for allegedly taking money and gifts from allograft maker MiMedx Group Inc. in exchange for buying or recommending the company’s products (United States of America v. Donna Becker, et al., No. 18-cr-481, D. S.C.).

  • May 10, 2018

    Tribe’s Suit Against Big Pharma Moved To Opioid MDL Docket

    CLEVELAND — Another lawsuit filed by a Native American tribe seeking to hold drug manufacturers and distributors accountable for the national opioid crisis is among the latest batch of suits transferred May 8 to a multidistrict litigation docket in Ohio federal court that now contains nearly 700 cases (In Re:  National Prescription Opiate Litigation, MDL No. 2804, N.D. Ohio, 2018 U.S. Dist. LEXIS 78022).

  • May 9, 2018

    6 NECC Defendants Won’t Have Deaths, Injuries Used Against Them In Bad Drug Trial

    BOSTON — The Massachusetts federal judge overseeing the New England Compounding Center (NECC) criminal case on May 7 granted a motion by six of the nine remaining defendants to exclude evidence from their Oct. 4 trial about patient deaths and injuries from contaminated methylprednisolone acetate (MPA) made by the drug compounding pharmacy (United States v.  Barry J. Cadden, et al., No. 14-10363, D. Mass., 2018 U.S. Dist. LEXIS 76613).