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Mealey's Drugs & Devices

  • May 20, 2019

    Pennsylvania State Court Jury Awards $80M In Ethicon Pelvic Mesh Trial

    PHILADELPHIA — A Pennsylvania state court jury on May 17 returned an $80.02 million verdict against Johnson & Johnson and Ethicon Inc. in the 10th trial in the state’s pelvic mesh complex litigation docket (Patricia Mesigian, et al. v. Ethicon Women’s Health and Urology, et al., No. 140200399, Pa. Comm. Pls., Philadelphia Co.).

  • May 20, 2019

    U.S. Supreme Court:  ‘Clear Evidence’ Standard Is For Judge, Not Jury To Decide

    WASHINGTON, D.C. — The U.S. Supreme Court on May 20 ruled that a judge and not a jury should decide if the Food and Drug Administration would have rejected a warning about the risk of femur fractures from the osteoporosis drug Fosamax (Merck Sharp & Dohme Corp. v. Doris Albrecht, et al., No. 17-290, U.S. Sup.).

  • May 20, 2019

    Pradaxa Maker Denied JMOL, New Trial In $1.7M Bleeding Injury Trial

    HUNTINGDON, W.Va. — A West Virginia federal judge on May 15 denied judgment as a matter of law (JMOL) or a new trial to drug maker Boehringer Ingelheim Pharmaceuticals Inc. in a Pradaxa anticoagulant case, preserving a $1.7 million verdict that included punitive damages (Claude R. Knight, et al. ex rel. Betty Erelene Knight v. Boehringer Ingelheim Pharmaceuticals, Inc., No. 15-6424, S.D. W.Va., Huntington Div., 2019 U.S. Dist. LEXIS 81728).

  • May 17, 2019

    3rd Circuit Reverses Sealing Of Documents In Avandia Summary Judgment Appeal

    PHILADELPHIA — In a split ruling, the Third Circuit U.S. Court of Appeals on May 15 reversed a district court’s denial of a motion to unseal underlying documents created by GlaxoSmithKline LLC (GKS) in the Avandia multidistrict litigation and remanded for application of the common-law right of access and for a document-by-document review (In Re: Avandia Marketing, Sales Practices and Products Liability Litigation [United Food and Commercial Workers Local 1776, et al.], Nos. 18-2259 and 18-2656, 3rd Cir., 2019 U.S. App. LEXIS 14470).

  • May 17, 2019

    Most Plaintiff Claims Survive Dismissal In Insys Opioid Addiction Lawsuit

    CONCORD, N.H. — A New Hampshire judge on May 16 dismissed a fraud count against opioid maker Insys Therapeutics Inc. but allowed the remainder of the plaintiff’s claims that the company paid a physician assistant to prescribe the fentanyl-based pain drug Subsys, resulting in her addiction and withdrawal (Pamela Langlois v. Insys Therapeutics, Inc., No. 19-192, D. N.H., 2019 U.S. Dist. LEXIS 82622).

  • May 17, 2019

    South Carolina Judge Denies Dismissal Of Co-Pay False Claims Case Against MiMedx

    FLORENCE, S.C. — A South Carolina federal judge on May 15 denied dismissal of a whistleblower lawsuit alleging that MiMedx Group Inc. paid kickbacks and caused submission of false claims to government health care programs through hidden payments to a foundation that covered patient co-pays (United States of America, ex rel. Jon Vitale v. MiMedx Group, Inc., No. 17-166, D. S.C., Columbia Div., 2019 U.S. Dist. LEXIS 81632).

  • May 14, 2019

    Johnson & Johnson, Teva Denied Summary Judgment In Oklahoma Opioid Case

    NORMAN, Okla. — An Oklahoma state court judge on May 13 denied motions by Johnson & Johnson and Teva Pharmaceuticals USA Inc. for summary judgment on Oklahoma’s opioid public nuisance lawsuit (Oklahoma, et al. v. Purdue Pharma L.P., et al., No. CJ-2017-816, Okla. Dist., Cleveland Co.).

  • May 13, 2019

    Insys, Maker Of Subsys Opioid, Says It May Have To File For Chapter 11 Bankruptcy

    CHANDLER, Ariz. — Opioid maker Insys Therapeutics Inc. on May 10 and 13 said in a press release and a regulatory filing that in the face of falling sales, litigation expenses, a federal drug settlement and a lack of liquid assets, it may be necessary for it to file a voluntary petition for reorganization under Chapter 11 of the U.S. Bankruptcy Code, 11 U.S. Code.

  • May 9, 2019

    Risperdal Gynecomastia Punitives-Only Trial Settles On Day Of Trial

    PHILADELPHIA — A Pennsylvania state court Risperdal gynecomastia case that was set for trial on May 6 on the issue of punitive damages only was settled on that day, according to court docket entries (Timothy Stange v. Janssen Pharmaceuticals, Inc., No. 1304-01984, Pa. Comm. Pls., Philadelphia Co.).

  • May 8, 2019

    Partial Summary Judgment Granted In C.R. Bard Pelvic Mesh Case

    MADISON, Wis. — A Wisconsin federal judge on April 16 granted partial summary judgment in a C.R. Bard Inc. pelvic mesh case for pleading deficiencies but denied dismissal of the plaintiffs other claims (Delinda Karnes, et al. v. C.R. Bard, Inc., No. 18-931, W.D. Wis., 2019 U.S. Dist. LEXIS 65115).

  • May 8, 2019

    Public Citizen Sues FDA To Force Action On Black Box For Dopamine Agonists

    WASHINGTON, D.C. — Public Citizen on April 29 sued the Food and Drug Administration to force it to respond to a citizen petition seeking a black box warning for dopamine agonist drugs about compulsive behavior side effects (Public Citizen v. Food and Drug Administration, No. 19-1229, D. D.C.).

  • May 8, 2019

    ASR Hip Case Dismissed On Forum Non Conveniens By MDL Judge

    CLEVELAND — The judge overseeing the ASR hip multidistrict litigation on May 1 dismissed the complaint of a British couple living in Spain on the basis of forum non conveniens (William A. Stephenson, et al. v. DePuy Orthopaedics, Inc., et al., No. 12-dp-21438, N.D. Ohio, Western Div., 2019 U.S. Dist. LEXIS 73547).

  • May 8, 2019

    Mass Tort Cases For Drugs, Medical Devices

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

  • May 8, 2019

    United States Backs NECC Pharmacist’s Conviction, Wants Bigger Sentence

    BOSTON — The U.S. Justice Department on May 1 told the First Circuit U.S. Court of Appeals that there was “ample evidence” to support a jury’s racketeering verdict against former lead pharmacist Glenn A. Chin of the New England Compounding Center (NECC) and argued that the trial court’s sentence failed to penalize the defendant for the health risk he created, how much he should forfeit and for restitution due to persons injured by NECC’s contaminated compounded drugs (United States v. Glenn A. Chin, Nos. 18-1263, 18-1310 and 18-1500, 1st Cir.).

  • May 8, 2019

    4th Bard IVC Filter MDL Bellwether Trial To Begin May 13

    PHOENIX — The Arizona federal judge overseeing the C.R. Bard inferior vena cava (IVC) filter multidistrict litigation on April 29 confirmed that the fourth bellwether trial will begin May 13 (Debra Tinlin, et al. v. C.R. Bard, Inc., No. 16-263, D. Ariz.).

  • May 8, 2019

    FDA Orders Black Box Warning On 3 Insomnia Drugs After 66 Adverse Events

    SILVER SPRING, Md. — The Food and Drug Administration on April 30 announced that it is requiring black box warnings on three insomnia drugs after receiving 66 adverse event reports that included nonfatal injuries and 20 deaths.

  • May 8, 2019

    No Limits On Opioid Expert, But Plaintiffs Face $100,000 Sanction For Depositions

    CLEVELAND — The Ohio federal judge overseeing the opioid multidistrict litigation on April 26 took off a magistrate judge’s restrictions on the use of a plaintiffs’ expert but ordered the plaintiffs to pay defendants no more than $100,000 for additional depositions of the expert who went from being an opioid “opinion leader” and defendant to a plaintiff expert (In Re:  National Prescription Opiate Litigation, MDL Docket No. 2804, No. 17-md-2804, N.D. Ohio, Eastern Div.).

  • May 8, 2019

    FDA To End Nonpublic Medical Device Adverse Event Reporting Program

    SILVER SPRING, Md. — The Food and Drug Administration on May 2 said it is ending its 22-year-old alternative summary reporting program for all medical devices, a program that allowed medical device manufacturers to submit summary reports of adverse events that were not publicly available on the agency’s Manufacturer and User Facility Device Experience (MAUDE) database.

  • May 7, 2019

    NECC Pharmacist Gets 1 Year Probation For FDCA Violation

    BOSTON — A former New England Compounding Center (NECC) pharmacist on May 3 was sentenced to one year of probation for her conviction on misdemeanor violations of the Food, Drug and Cosmetic Act (FDCA), 21 U.S. Code § 301 et seq. (United States v. Alla Stepanets, No. 14-10363, D. Mass.).

  • May 7, 2019

    Divided Federal Circuit Affirms: Painkiller Patent Is Not Invalid

    WASHINGTON, D.C. — In a May 3 divided ruling, the Federal Circuit U.S. Court of Appeals affirmed a Delaware federal judge’s findings that assertions of patent invalidity raised by two generic drug makers in connection with the painkiller Opana fail (Endo Pharmaceuticals Inc., et al. v. Actavis LLC, et al., No. 18-1054, Fed. Cir., 2019 U.S. App. LEXIS 13348).