Mealey's Drugs & Devices

  • June 18, 2019

    Judge Orders Parties In $85M Teva Opioid Settlement To Reveal Pact, Clarify Terms

    NORMAN, Okla. — An Oklahoma state court judge on June 17 gave the state attorney general, Teva Pharmaceuticals USA Inc., the state’s top elected officials and eight state cities 15 days to come up with joint consent judgment that discloses terms of an $85 million opioid settlement and resolves questions about who will get the money and how it will be spent in accordance with a new state law (Oklahoma, ex rel. Mike Hunter, et al. v. Purdue Pharma L.P., et al., No. CJ-2017-816, Okla. Dist., Cleveland Co.).

  • June 18, 2019

    MiMedx Says Shareholders Back Their Board Candidates, Reject Former Chairman

    MARIETTA, Ga. — Surgical graft processor MiMedx Group Inc. said in a June 17 press release that a preliminary vote count shows that shareholders voted to elect three new directors backed by the current management and not to elect former Chairman and Chief Operating Officer Parker H. "Pete" Petit and his two board picks.

  • June 18, 2019

    Zofran Birth Defect Case Again Remanded Under Voluntary-Involuntary Doctrine

    BOSTON — A Massachusetts federal judge overseeing the Zofran birth defect multidistrict litigation on June 13 remanded a case for a second time after finding under the voluntary-involuntary doctrine that the plaintiffs did not voluntarily dismiss a local hospital and open the door for removal to a federal court (In Re:  Zofran [Ondansetron] Products Liability Litigation, [Thomas Brown, et al. v. GlaxoSmithKline LLC, No. 19-10647], No. 15-md-2657, D. Mass., 2019 U.S. Dist. LEXIS 99811).

  • June 18, 2019

    Opioid MDL Court Asked To Certify ‘Negotiation Class’ For Cities, Counties

    CLEVELAND — Plaintiff lawyers in the opioid multidistrict litigation on June 14 filed a motion to have the court certify an admittedly novel “negotiation class” consisting of cities and counties that will have a stake in any settlements with drug manufacturers, drug distributors and chain pharmacies (In Re:  National Prescription Opiate Litigation, MDL Docket No. 2804, No. 17-md-2804, N.D. Ohio, E. Div.).

  • June 18, 2019

    4th Circuit:  Law Firm Waived Appeal Of Pelvic Mesh MDL Common Benefit Fee Order

    RICHMOND, Va. — Plaintiffs’ law firm Kline & Specter of Philadelphia’s appeal of a $500 million attorney fee award in seven pelvic mesh multidistrict litigations was dismissed June 14 by the Fourth Circuit U.S. Court of Appeals after a panel agreed that Kline & Specter previously agreed to be bound by the MDL court’s fee determination (In Re:  Ethicon, Inc., Pelvic Repair System, No. 19-1224, 4th Cir.).

  • June 18, 2019

    Judge OKs Settlement Of Spinal Cord Stimulator Whistleblower Lawsuit

    NEWARK, N.J. — A New Jersey federal judge on May 23 approved a stipulated dismissal of a whistleblower lawsuit alleging that Boston Scientific Neuromodulation Corp. submitted false claims to federal health care programs for the company’s Precision Plus Spinal Cord Stimulation implantable electronic stimulator (United States, et rel. Wendy A. Bahnsen, et al. v. Boston Scientific Neuromodulation Corporation, No. 11-1210, D. N.J.).

  • June 18, 2019

    Nasdaq Will Delist Insys Stock Due To Voluntary Bankruptcy Filing

    NEW YORK — The Nasdaq Stock Market on June 10 told Insys Therapeutics Inc. that because of its bankruptcy petition the day before, it will be delisted from the over-the-counter stock market as of June 19.

  • June 18, 2019

    Arizona Appeals Court Affirms Dismissal Of Knee Implant Product Defect/Medmal Case

    PHOENIX — An Arizona state appeals court on June 11 affirmed defense judgment in a knee prosthesis case, saying the failure of the plaintiff’s claim of res ipsa loquitor acted to contradict the plaintiff’s product liability and medical malpractice claims (Gerald Cook, et al. v. Richard Hawkins, et al., No. 1 CA-CV 18-0399, Ariz. App., Div. 1, 2019 Ariz. App. Unpub. LEXIS 689).

  • June 18, 2019

    Manufacturing Defect Claim Out, Warnings Claims In In IVC Injury Case

    SAN JOSE, Calif. — A California federal judge on May 13 dismissed a manufacturing defect claim with prejudice in an inferior vena cava (IVC) filter case but said the plaintiff’s failure-to-warn claim survives dismissal (Sandra Broge v. ALN International, Inc., No. 17-7131, N.D. Calif., San Jose Div., 2019 U.S. Dist. LEXIS 80507).

  • June 14, 2019

    Opioid MDL Judge OKs Tribes’ Claims Except For Negligence Per Se

    CLEVELAND — The Ohio federal judge overseeing the opioid multidistrict litigation on June 13 adopted almost all of a magistrate judge’s recommendations preserving the right of two Native American tribes to sue manufacturers, distributors and pharmacies (In Re:  National Prescription Opioid Litigation, [Muscogee (Creek) Nation v. Purdue Pharma L.P., et al., No. 18-op-45749, and The Blackfeet Tribe of the Blackfeet Indian Reservation v. AmerisourceBergen Drug Corporation, et al., No. 18-op-45749], MDL Docket No. 2804, No. 17-md-2804, N.D. Ohio, Eastern Div.).

  • June 14, 2019

    Florida Objects To Certain Insys Payments Listed In Bankruptcy Petition

    WILMINGTON, Del. — The state of Florida on June 11 filed limited objections in the Insys Therapeutics Inc. Chapter 11 bankruptcy case and asked the court to require the opioid maker to provide a more detailed analysis of payments the company wants the court to approve (In Re:  Insys Therapeutics, Inc., et al., No. 19-11292, U.S. Bkcy., Del.).

  • June 14, 2019

    Judge In Mirena Brain Injury MDL Grants Summary Judgment For Lack Of Causation

    NEW YORK — The New York federal judge overseeing the Mirena brain injury multidistrict litigation on June 11 granted summary judgment to defendant Bayer Corp. after he rejected the plaintiffs’ argument that they can still prove causation even after the court excluded their experts (In Re:  Mirena IUS Levonorgestrel-Related Products Liability Litigation [No. II], Nos. 17-md-2767, S.D. N.Y., 2019 U.S. Dist. LEXIS 97904).

  • June 14, 2019

    Connecticut Opioid Appeals Go To State High Court; Settlement Talks ‘Ongoing’

    HARTFORD, Conn. — The appeal by two Connecticut cities of a trial court’s dismissal of their lawsuits against several opioid makers and drug distributors was transferred June 11 from the state’s Appellate Court to the Connecticut Supreme Court (New Haven, et al. v. Purdue Pharma L.P., et al., No. S.C. 20313, Conn. Sup.).

  • June 13, 2019

    Medical Device Maker Pleads Guilty To ‘Silent Recall,’ Pays $15M In Settlements

    BALTIMORE — Medical device maker ACell Inc. on June 11 pleaded guilty to a federal misdemeanor charge of failing to report a device recall and agreed to pay $15 million in criminal and civil penalties (United States v. ACell, Inc., No. 19-cr-282, United States, ex rel. John J. Murtaugh v. ACell, Inc., No. 13-1820, D. Md.).

  • June 11, 2019

    Minnesota Appeals Court Affirms Preemption Summary Judgment In Heart Device Case

    ST. PAUL, Minn. — The Minnesota Court of Appeals on June 10 affirmed preemption summary judgment in a Medtronic Inc. heart device case and the exclusion of a plaintiff expert’s testimony about whether the manufacturer complied with requirements of the Food and Drug Administration (Donna Delfino v. Medtronic, Inc., No. A18-1462, Minn. App., 2019 Minn. App. Unpub. LEXIS 530).

  • June 10, 2019

    2 NECC Defendants Acquitted: Unclear FDA Regulation Created Legal Impossibility

    BOSTON — The Massachusetts federal judge presiding in the New England Compounding Center (NECC) criminal case on June 7 acquitted two previously convicted defendants because “unclear” regulation of the compounding drug company by the Food and Drug Administration at the time of the defendants’ alleged offenses was a “legal impossibility” (United States v. Gregory Conigliaro, et al., No. 14-cr-10363, D. Mass., 2019 U.S. Dist. LEXIS 96453).

  • June 10, 2019

    Opioid Maker Insys Files Voluntary Chapter 11 Bankruptcy Petition

    WILMINGTON, Del. — Opioid maker Subsys Therapeutics Inc. on June 10 filed a voluntary petition for bankruptcy reorganization and said it intends to sell “substantially all” of the company’s assets and address its “legacy legal liabilities,” including $243 million owed to the United States and millions owed to 21 law firms that make up most of its top 30 unsecured creditors (In Re:  Insys Therapeutics, Inc., No. 19-11292, D.Del. Bkcy., Del.).

  • June 07, 2019

    Federal Circuit Reverses Denial Of Gardasil HPV Vaccine Injury Petition

    WASHINGTON, D.C. — The Federal Circuit U.S. Court of Appeals on June 5 reversed and remanded a vaccine court denial of a claim that a girl was injured by the Gardasil human papillomavirus (HPV) vaccine, finding that dismissal was an abuse of discretion by a special master (Patrice Moczek, et al. v. Secretary of Health and Human Services, No. 18-2341, Fed. Cir., 2019 U.S. App. LEXIS 16902).

  • June 06, 2019

    On Same Day Mallinckrodt Settles For $15.4M, United States Sues Over Drug Co-Pays

    On the same day Mallinckrodt plc said it reached a $15.4 million agreement-in-principal to settle a U.S. Justice Department investigation into improper sales and marketing by subsidiary Questcor Pharmaceuticals Inc., the Justice Department on June 5 filed a federal complaint alleging that Mallinckrodt contributed to a drug co-pay program at the same time it increased a drug’s price from double to quintuple digits (United States of America, ex rel. Charles Strunck, et al., No. 12-175, E.D. Pa.).

  • June 06, 2019

    Opioid Maker Insys Pleads Guilty, Pays $225M In Fines, False Claims Settlement

    BOSTON — A subsidiary of opioid manufacturer Insys Therapeutics Inc. on June 5 pleaded guilty to mail fraud and the parent company agreed to pay $225 million in fines, forfeiture and civil settlement of five whistleblower lawsuits alleging that the company paid kickbacks to doctors to prescribe the fentanyl-based pain drug Subsys (United States of America v. Insys Therapeutics, Inc., et al., No. 19-cr-10191, D. Mass.).

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