Mealey's Drugs & Devices

  • July 10, 2020

    1st Circuit OKs Convictions Of 2 NECC Defendants But Sends Terms, Forfeiture Back

    BOSTON — The First Circuit U.S. Court of Appeals on July 9 affirmed the convictions of the two top employees of the former New England Compounding Center (NECC) but remanded both for possible recalculation for longer prison sentences and higher forfeitures (United States v. Barry J. Cadden, Nos. 17-1694, 17-1712 and 17-2062, 2020 U.S. App. LEXIS 21317; U.S. v. Glenn A. Chin, Nos. 18-1263, 18-1310 and 18-1500, 1st Cir., 2020 U.S. App. LEXIS 21318).

  • July 10, 2020

    3rd Circuit Says Expert Testimony Properly Admitted At Doctor’s Opioid Trial

    PHILADELPHIA — The Third Circuit U.S. Court of Appeals on July 9 affirmed the conviction and 27-year prison sentence of a Pennsylvania doctor for illegally prescribing narcotics, finding in part that the trial court properly allowed a medical expert to testify for the prosecution (United States v. Fuhai Li, No. 19-1875, 3rd Cir., 2020 U.S. App. LEXIS 21283).

  • July 02, 2020

    COVID-19, But Not 1st Circuit, Keeps Opioid Execs From Starting Jail For 83 Days

    BOSTON — The First Circuit U.S. Court of Appeals on July 1 denied a motion by five former top employees of opioids maker Insys Therapeutics Inc. to delay the start of their sentences pending their appeals, but on July 2 the sentencing judge in the U.S. District Court for the District of Massachusetts granted the defendants’ assented motion for an 83-day reprieve due to the COVID-19 pandemic (United States v. John Kapoor, No. 1325, United States v. Sunrise Lee, No. 1326, United States v. Richard M. Simon, No. 20-1335, United States v. Michael J. Gurry, No. 20-1335, United States v. Joseph A. Rowan, No. 20-1336, 1st Cir., United States v. Michael L. Babich, et al., No. 16-cr-10343, D. Mass.).

  • July 02, 2020

    Novartis Pays $678M For Sham Speaker Programs, Drug Co-Pay Kickbacks

    Swiss drug maker Novartis Pharmaceuticals Corp. will pay $678 million to settle a false claims lawsuit alleging that it paid kickbacks through sham speaker programs and three drug co-pay charities, according to press releases by the U.S. Justice Department and Novartis (United States ex rel. Oswald Bilotta v. Novartis Pharmaceuticals Corporation, No. 11-71, S.D. N.Y.).

  • July 01, 2020

    Drug Company CEO Pleads Guilty To Misbranding Opioid Suboxone To State Formulary

    ABINGDON, Va. — The former CEO of drug maker Indivior PLC on June 30 pleaded guilty in a Virginia federal court to one misdemeanor count of violating the Food, Drug and Cosmetic Act (FDCA), 21 U.S. Code § 301 et seq., by causing the distribution of misbranded Suboxone Film, a drug prescribed to recovering opioids addicts (United States v. Shaun Thaxter, No. 20-cr-24, W.D. Va., Abingdon Div.).

  • July 01, 2020

    Avandia MDL Judge Chides, But Won’t Sanction 2 Plaintiff Attorneys For Bad Faith

    PHILADELPHIA — The Pennsylvania federal judge overseeing the Avandia multidistrict litigation on June 26 said that while there are bases for criticizing the conduct of counsel for a third-party payer plaintiff, defendant GlaxoSmithKline PLC (GSK) did not prove by clear and convincing evidence that the payer’s two attorneys acted in bad faith so as to justify sanctions against them (Allied Services Division Welfare Fund v. GlaxoSmithKline, No. 09-730, E.D. Pa.).

  • July 01, 2020

    Pfizer Asks Federal Court To Declare That Drug Co-Pays Aren’t Illegal Kickbacks

    NEW YORK — Drug maker Pfizer Inc. on June 26 sued the U.S. Department of Health and Human Services and its inspector general, seeking a declaratory judgment by a New York federal court that a proposed drug co-pay program does not violate federal kickback and inducement restrictions (Pfizer Inc. v. U.S. Department of Health and Human Services, et al., No. 20-4920, S.D. N.Y.).

  • July 01, 2020

    Mass Tort Cases For Drugs, Medical Devices

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

  • June 30, 2020

    Motion For Profemur Hip MDL To Be Heard Remotely July 30 By Federal Judicial Panel

    WASHINGTON, D.C. — The Judicial Panel on Multidistrict Litigation (JPMDL) on June 26 scheduled a hearing for July 30 on a motion by plaintiffs to centralize in a multidistrict litigation 41 federal lawsuits alleging that Profemur hip prostheses are defective and subject to fretting and corrosion that causes injury to recipients of the device (In Re:  Profemur Hip Implant Products Liability Litigation, MDL Docket No. 2949, JPMDL).

  • June 30, 2020

    New Jersey Federal Judge Denies Preemption In Gadolinium Injury Case

    CAMDEN, N.J. — A New Jersey federal judge on June 29 denied motions by six defendants to dismiss as preempted a plaintiff’s claims that she was injured by gadolinium-based contrast agents (GBCAs) (Kimberly Gremo v. Bayer Corporation, et al., No. 19-13432, D. N.J.).

  • June 30, 2020

    Covidien Wants Hernia Mesh MDL To Deal With ‘Copy-Cat’ Lawsuits; Hearing July 30

    WASHINGTON, D.C. — A federal judicial panel on June 26 scheduled a July 30 hearing on a motion by medical device maker Covidien LP to create a multidistrict litigation for what it called 12 “copy-cat” federal lawsuits alleging complications from the defendant’s hernia mesh products (In Re:  Covidien Hernia Mesh Products Liability Litigation, MDL Docket No. 2953, JPMDL).

  • June 30, 2020

    United States Cuts Insys Restitution From $308M To $59.7M, Expects Only $10M

    BOSTON — The United States on June 16 agreed to reduce its restitution request from opioids maker Insys Therapeutics Inc. from $308 million to $59.75 million, although it said that with the coming liquidation of the company in bankruptcy, the government “will recover, if anything, no more than $10 million in restitution from the bankruptcy estate” (United States of America v. Insys Therapeutics, Inc., et al., No. 19-10191, D. Mass.).

  • June 29, 2020

    Novartis, Former Subsidiary To Pay $345M In 3 Foreign Bribery, Securities Cases

    Novartis AG and a former subsidiary on June 25 agreed to pay $345 million in criminal penalties and disgorgement to resolve criminal and administrative charges that they violated the Foreign Corrupt Practices Act (FCPA) and the Securities and Exchange Act of 1934, 15 U.S. Code § 78m, by paying bribes to health care employees in Greece and Vietnam to buy the companies’ drugs and failing to report those transactions (United States v. Novartis Hellas S.A.C.I., No. 20-538, United States v. Alcon Pte. Ltd., No. 20-539, D. N.J., In the Matter of Novartis AG, Admin. Proc. 3-29835, SEC).

  • June 25, 2020

    Ohio Panel Reverses, Remands No Coverage Ruling In Dispute Over Opioid Epidemic

    CINCINNATI — An Ohio appeals court on June 24 reversed and remanded a lower court’s summary judgment ruling in favor of a commercial general liability insurer, finding that some of the underlying losses claimed by governmental entities against a pharmaceutical distributor insured arising from the opioid epidemic are arguably “because of” bodily injury to trigger coverage under the policy (Acuity v. Masters Pharmaceutical, Inc., No. C-190176, Ohio App., 1st Dist., 2020 Ohio App. LEXaIS 2381).

  • June 25, 2020

    United States Sues Regeneron For Using Charity To Drive Sales Of Costly Eye Drug

    BOSTON — The United States on June 24 filed a false claims and kickback civil complaint alleging that Regeneron Pharmaceuticals Inc. funneled “tens of millions of dollars” into a patient-assistance charity so patients could avoid paying a required co-pay for the expensive macular degeneration drug Eylea (United States v. Regeneron Pharmaceuticals, Inc., No. 20-11217, D. Mass.).

  • June 24, 2020

    Summary Judgment Denied In Da Vinci Surgical Robot Internal Burn Lawsuit

    SAN JOSE, Calif. — A California federal judge on June 12 denied summary judgment on a plaintiff’s manufacturing defect, design defect and failure-to-warn claims involving a da Vinci surgical robot that burned her during a hysterectomy (Candy Trump v. Intuitive Surgical, Inc., No. 19-6413, N.D. Calif., 2020 U.S. Dist. LEXIS 104476).

  • June 22, 2020

    Manufacturing, Design Defect Claims In Knee Prosthesis Case Survive Dismissal

    NEW HAVEN, Conn. — A Connecticut federal judge on June 17 denied dismissal of manufacturing and design defect claims involving a Smith & Nephew Inc. knee prosthesis but granted dismissal of warning, negligence and misrepresentation claims (Peter Mals v. Smith & Nephew, Inc., No. 19-1770, D. Conn., 2020 U.S. Dist. LEXIS 106362).

  • June 19, 2020

    Drugstore Chain Must Mediate EpiPen Antitrust Claim 1st, MDL Judge Rules

    KANSAS CITY, Kan. — The Kansas federal judge overseeing the EpiPen multidistrict litigation on June 18 said that a Core Distribution Services Agreement required a retail pharmacy chain to mediate its antitrust claim against EpiPen manufacturer Mylan N.V. before it presses an antitrust lawsuit (KPH Healthcare Services, Inc., et al. v. Mylan N.V., et al., No. 20-2065, D. Kan., 2020 U.S. Dist. LEXIS 106808).

  • June 16, 2020

    Mallinckrodt To Take $650M Charge After Appeals Court Denies Medicare Injunction

    WASHINGTON, D.C. — The District of Columbia Circuit U.S. Court of Appeals on June 15 denied an emergency motion blocking a Medicare drug rebate calculation for Acthar Gel, a move that defendant Mallinckrodt ARD LLC said resulted in an immediate $650 million charge for back rebates and that puts the company’s opioid settlement in danger (Mallinckrodt ARD LLC, et al. v. Seema Verma, et al., No. 19-1471, D.C. Cir.).

  • June 16, 2020

    Cancer Drug Maker Wants 10th Circuit Panel Or En Banc Court To Rehear Preemption

    DENVER — Genentech Inc. on June 12 petitioned the 10th Circuit U.S. Court of Appeals to rehear or rehear en banc arguments that claims about the company underfilling vials of the breast cancer drug Herceptin are preempted by federal law (In re:  Genentech, Inc., Herceptin [Trastuzumab] Marketing and Sales Practices Litigation, No. 19-5035, 10th Cir.).