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Mealey's Drugs & Devices

  • April 18, 2019

    Pennsylvania State Jury: Pelvic Mesh Negligently Designed, But Not Injurious

    PHILADELPHIA — A Pennsylvania state court jury on April 17 found that a TVT-Secur pelvic mesh device made by Ethicon Inc. was negligently designed but was not a factual cause of a woman’s claimed injuries (Malgorzata Krolikowski v. Ethicon, Inc., et al., No. 140102704, Pa. Comm. Pls., Philadelphia Co.).

  • April 17, 2019

    Mass Tort Cases For Drugs, Medical Devices

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

  • April 17, 2019

    Minnesota High Court Denies Review Of Expert Exclusion In Bair Hugger Case

    ST. PAUL, Minn. — The Minnesota Supreme Court on March 27 denied review of an appeals court ruling excluding plaintiff experts in a Bair Hugger patient warming device case (In Re:  3M Bair Hugger Litigation, No. A18-0473, Minn. Sup., 2019 Minn. LEXIS 170).

  • April 17, 2019

    Judge Denies Government’s Dismissal Of Qui Tam Suit As Motivated By Animus

    EAST ST. LOUIS, Ill. — An Illinois federal judge on April 15 denied the United States’ motion to dismiss a false claims lawsuit allegedly brought by “professional relators” after the judge said “one could reasonably conclude that the proffered reasons for the decision to dismiss are pretextual and the Government’s true motivation is animus towards the relator” (United States, ex rel. CIMZHNCA, LLC v. UCB, Inc., et al., No. 17-765, S.D. Ill., 2019 U.S. Dist. LEXIS 64267).

  • April 17, 2019

    Spinal Cord Stimulator False Claims Suit Settled, Parties Tell Court

    NEWARK, N.J. — A New Jersey federal court on April 2 stayed a false claims case against Boston Scientific Corp. after it and the relators told the court that they reached an agreement in principal to settle the case pending approval by the United States and a written agreement (United States of America, ex rel. Wendy A. Bahnsen, et al. v. Boston Scientific Corporation, No. 11-1210, D. N.J.).

  • April 17, 2019

    Oklahoma Trims Opioid Claims To Keep May 28 State Court Trial On Track

    NORMAN, Okla. — In an effort to keep a May 28 trial against two major opioid manufacturers on track, the Oklahoma attorney general on April 4 voluntarily dismissed certain claims without prejudice (Oklahoma, et al. v. Purdue Pharma L.P., et al., No. CJ-2017-816, Okla. Dist., Cleveland Co.).

  • April 17, 2019

    FDA Orders Last 2 Makers Of Pelvic Mesh To Stop Selling The Devices For 1 Use

    SILVER SPRING, Md. — The Food and Drug Administration on April 16 ordered the last two manufacturers of pelvic mesh sold to treat pelvic organ prolapse to immediately stop selling their devices in the United States after the companies failed to demonstrate a reasonable assurance of safety and effectiveness.

  • April 17, 2019

    MDL Panel Won’t Vacate MDL Transfer Of 28 Municipal, Tribal Opioid Suits

    WASHINGTON, D.C. — The Judicial Panel on Multidistrict Litigation (JPMDL) on April 4 denied a motion by 28 municipalities and native American tribes to vacate the conditional transfer of their opioid lawsuits to the opioid multidistrict litigation (In Re:  National Prescription Opiate Litigation, MDL Docket No. 2804, JPMDL, 2019 U.S. Dist. LEXIS 58890).

  • April 16, 2019

    Pennsylvania Superior Court Affirms $13.75M Ethicon Pelvic Mesh Verdict

    PHILADELPHIA — The Pennsylvania Superior Court on April 11 affirmed a $13.75 million pelvic mesh verdict against the Ethicon Inc. subsidiary of Johnson & Johnson, rejecting the defendants’ various appeal issues along with the plaintiffs’ bid for delay damages for the $10 million punitive damage award (Sharon Carlino, et al. v. Ethicon, Inc., et al., No. 1129 EDA 2016, Pa., Super., 2019 PA Super 114).

  • April 16, 2019

    Texas Supreme Court: ID Of Execution Drug Providers Can Be Withheld For Safety

    AUSTIN, Texas — The Texas Supreme Court on April 12 said disclosing the source of execution drugs would create a substantial threat of physical harm to the source and its employees and need not be disclosed by the state government (Texas Department of Criminal Justice v. Maurie Levin, et al., No. 17-0552, Texas Sup., 2019 Tex. LEXIS 373).

  • April 16, 2019

    Compounding Pharmacy Owner Convicted Of Selling Adulterated Drugs

    INDIANAPOLIS — An Indiana federal jury on April 10 found the former owner of a compounding pharmacy guilty of felony and misdemeanor counts of shipping untested, under- or super-potent drugs, some of which caused narcotic overdoses in three infants (United States of America v. Paul J. Elmer, No. 17-cr-113, S.D. Ind., Indianapolis Div.).

  • April 15, 2019

    Judge: Relators Didn’t Make Case For Profit Data In HIV Drug False Claims Suit

    TRENTON, N.J. — A New Jersey federal judge on April 8 affirmed a magistrate judge’s ruling that plaintiffs in an HIV false claims lawsuit had not shown a right to know how the manufacturer profited from the drugs or that the information is relevant at this stage of the lawsuit (United States, ex rel. Jessica Penelow, et al. v. Johnson & Johnson, et al., No. 12-7758, D. N.J., 2019 U.S. Dist. LEXIS 60437).

  • April 15, 2019

    No Acquittals, New Trials For 2 Convicted NECC Pharmacy Employees

    BOSTON — A Massachusetts federal judge on April 12 denied acquittal or a new trial for two of five New England Compounding Center (NECC) defendants found guilty in December of criminal charges related to the compounding and shipment of contaminated drugs (United States of America v. Gene Svirskiy, and United States of America v. Christopher Leary, No. 15-cr-10363, D. Mass., 2019 U.S. Dist. LEXIS 63735 and 2019 U.S. Dist. LEXIS 63736).

  • April 15, 2019

    Judge Gives Entire Relator Share To 1 Person In Victoza False Claims Settlement

    WASHINGTON, D.C. — A South Carolina federal judge on April 8 awarded 15 percent of a $46.5 million false claims recovery to one relator and none to seven other relators who filed lawsuits about the same conduct by drug maker Novo Nordisk Inc. (United States, ex rel. Lesley Ferrara, et al. v. Novo Nordisk, Inc., et al., No. 11-74, D. D.C., 2019 U.S. Dist. LEXIS 59885).

  • April 11, 2019

    Pennsylvania Superior Court Reverses Jurisdiction Rulings In Duodenoscope Case

    PHILADELPHIA — The Pennsylvania Superior Court on April 10 reversed dismissal of a duodenoscope fatal infection case for lack of personal jurisdiction along with a forum non conveniens ruling in favor of three other defendants in the same case (Freeman Maurice Vaughan, Jr., et al. v. Olympus America, Inc., et al., No. 3010 EDA 2017, Pa. Super., 2019 Pa. Super. LEXIS 334).

  • April 11, 2019

    Judge In Insys Trial Says There’s No Evidence Of Government Misconduct

    BOSTON — A Massachusetts federal judge on April 10 denied a defense motion for a mistrial in the trial of five high-level Insys Therapeutics Inc. employees, finding that the prosecution did not introduce improper evidence and did not commit misconduct (United States v. Michael J. Gurry, et al., No. 16-cr-10343, D. Mass.).

  • April 11, 2019

    Maker Of Opioid Treatment Drug Suboxone Indicted For Wire, Mail, Health Care Fraud

    ABINGDON, Va. — A federal grand jury in Virginia on April 9 indicted Indivior Inc. and Indivior PLC (collectively Individor) on criminal charges of conspiracy to commit wire fraud, mail fraud and health care fraud for allegedly engaging in an illegal scheme to increase prescriptions of Suboxone Film, an opioid approved to treat patients for opioid addiction (United States v. Indivior Inc., et al., No. 1:19-cr-00016, W.D. Va., Abington Div.).

  • April 11, 2019

    Pennsylvania High Court Will Review Jurisdiction In Ethicon Pelvic Mesh Case

    PHILADELPHIA — The Pennsylvania Supreme Court on April 10 said it will hear an appeal by Ethicon Inc. and Johnson & Johnson about whether the U.S. Constitution and state law preclude state courts from asserting personal jurisdiction over the New Jersey companies in a case brought by an Indiana resident asserting claims under the Indiana Product Liability Act, Ind. Code, § 34-20-1-1 (Patricia L. Hammons, et al. v. Ethicon, Inc., et al., No. 458 EAL 2018, Pa. Sup., 2019 Pa. LEXIS 2084).

  • April 9, 2019

    Opioid MDL Judge Affirms Disqualification Of Endo Attorney, Law Firm

    CLEVELAND — The Ohio federal judge overseeing the opioid multidistrict litigation on April 8 affirmed his March 19 order disqualifying counsel for Endo Pharmaceuticals Inc. in two cases because an attorney had access to confidential, nonpublic information related to the opioid crisis while she was a U.S. attorney (In Re:  National Prescription Opiate Litigation, MDL Docket No. 2804, No. 17-md-2804, N.D. Ohio, Eastern Div., 2019 U.S. Dist. LEXIS 59822).

  • April 9, 2019

    Learned Intermediary Doctrine Bars Amiodarone Warning Claim, 4th Circuit Says

    RICHMOND, Va. — The Fourth Circuit U.S. Court of Appeals on April 8 said South Carolina’s learned intermediary doctrine bars a plaintiff’s claim that two amiodarone manufacturers failed to warn his father about the risk of cardiac toxicity that led to the father’s death (Latham Sean Bean, et al. v. Upsher-Smith Pharmaceuticals, Inc., et al., No. 17-2263, 4th Cir., 2019 U.S. App. LEXIS 10260).