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Mealey's Drugs & Devices

  • June 24, 2019

    Theranos Top Executives, United States Agree On 2020 Criminal Trial

    SAN JOSE, Calif. — Former Theranos Inc. top executives Elizabeth Holmes and Ramesh “Sunny” Balwani could face a three-month trial in September 2020 on federal wire fraud charges, according to a June 21 joint stipulation filed by the parties in the U.S. District Court for the Northern District of California (United States v. Elizabeth Holmes, et al., No. 18-cr-258, N.D. Calif.).

  • June 21, 2019

    6th Circuit Vacates Opioid MDL Protective Order For DEA’s ARCOS Drug Database

    CINCINNATI — In a 2-1 decision, the Sixth Circuit U.S. Court of Appeals on June 20 vacated a protective order by the opioid multidistrict litigation court blocking public access to drug distribution data collected by the U.S. Drug Enforcement Administration (DEA) and produced under subpoena in the MDL (In Re:  National Prescription Opiate Litigation [HD Media Company, LLC, et al. v. United States Department of Justice, et al.], Nos. 18-3839 and 18-3860, 4th Cir., 2019 U.S. App. LEXIS 18502).

  • June 19, 2019

    Justice Department Denied Stay Of Theranos Defendant’s SEC Case

    SAN JOSE, Calif. — A California federal judge on June 14 allowed the U.S. Justice Department to intervene in a civil Securities and Exchange Commission lawsuit against former Theranos Corp. President Ramesh “Sunny” Balwani but denied the government’s motion to stay the securities case while Balwani is prosecuted in a separate criminal case (Securities and Exchange Commission v. Ramesh “Sunny” Balwani, No. 18-cv-1603, N.D. Calif., San Jose Div., 2019 U.S. Dist. LEXIS 100335).

  • June 19, 2019

    Mass Tort Cases For Drugs, Medical Devices

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

  • June 19, 2019

    United States Says Pharmacy Added Abilify To Boost Federal Reimbursements

    JACKSONVILLE, Fla. — The United States on June 13 filed a complaint-in-intervention against a Florida drug compounder, alleging that it mixed crushed antipsychotic Abilify tablets into topical pain cream to boost reimbursement by federal health care programs (United States, et al., ex rel. Amy Sanchez v. Smart Pharmacy, Inc., et al., No. 14-1453, United States, ex rel. Ashok Kohli v. Smart Pharmacy, Inc., et al., No. 16-387, M.D. Fla., Jacksonville Div.).

  • June 19, 2019

    New Jersey Pelvic Mesh Plaintiff Sues Lawyers, Firms Over Attorney Fees, Costs

    HACKENSACK, N.J. — A New Jersey state court judge on June 10 ordered six plaintiff attorneys and their seven law firms to show cause why the court should not order them to provide an accounting of their New Jersey state court pelvic mesh cases, any settlements, retainer agreements and attorney fees and expenses, to disclose cross-firm agreements and to deposit their fees and expenses with the court clerk (Debbie Gore, et al. v. Bruce H. Nagel, et al., No. BER-L-4381-19, N.J. Super., Bergen Co.).

  • 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.).