Mealey's Drugs & Devices

  • July 15, 2020

    Generic Drug Maker Glenmark Charged With Conspiring To Rig Drug Prices, Bids

    PHILADELPHIA — Glenmark Pharmaceuticals Inc. USA on June 30 was charged by the United States with one count of conspiring with other generic drug manufacturers to restrain trade in violation of the Sherman Act, 15 U.S. Code § 1 (United States v. Glenmark Pharmaceuticals Inc., USA, No. 20-cr-200, E.D. Pa.).

  • July 14, 2020

    Mass Tort Cases For Drugs, Medical Devices

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

  • July 14, 2020

    California Appeals Court Reverses Preemption Ruling In Breast Implant Case

    LOS ANGELES — A California state appeals court on July 2 reversed preemption summary judgment in a silicone breast implant case, saying across the board that the plaintiffs made their case and escape preemption (Rexina Mize, et al. v. Mentor Worldwide LLC, No. B295829, Calif. App., 2nd Dist., Div. 6, 2020 Cal. App. LEXIS 618).

  • July 14, 2020

    FDA Announces 7 More Recalls Of Extended Release Metformin Over NDMA Contamination

    SILVER SPRING, Md. — The Food and Drug Administration on July 13 announced seven additional voluntary recalls of extended-release metformin made by six drug companies due to the possibility that they contain N-nitrosodimethylamine (NDMA) above the acceptable limit.

  • July 14, 2020

    FDA Enjoined From Enforcing Ban On Shipping Abortion Drugs During Pandemic

    GREENBELT, Md. — A Maryland federal judge on July 13 enjoined the Food and Drug Administration from enforcing requirements that abortion drugs be dispensed in person until after the COVID-19 public health emergency is declared over (American College of Obstetricians and Gynecologists, et al. v. U.S. Food and Drug Administration, et al., No. 20-1320, D. Md.).

  • July 14, 2020

    Responding Plaintiffs Oppose Covidien Hernia Mesh As Premature, Delaying

    WASHINGTON, D.C. — A motion to create a Covidien hernia mesh multidistrict litigation was opposed June 30 and July 2 by two sets of plaintiffs and one plaintiff law firm (In Re:  Covidien Hernia Mesh Products Liability Litigation, MDL Docket No. 2953, JPMDL).

  • July 14, 2020

    Federal Circuit Vacates Denial Of Claim Vaccine Aggravated Seizure Disorder

    WASHINGTON, D.C. — The Federal Circuit U.S. Court of Appeals on July 1 reversed denial of an off-table claim that a child’s vaccinations significantly aggravated her genetic mutation and remanded the claim to the vaccine special masters’ office for further proceedings (Heidi Sharpe, et al. v. Secretary, Health and Human Services, No. 19-1951, Fed. Cir., 2020 U.S. App. LEXIS 20506).

  • July 13, 2020

    2 Ohio Counties Tell Circuit Court Opioid MDL Mandamus, New Judge Unneeded

    CINCINNATI — Two Ohio counties on July 10 told the Sixth Circuit U.S. Court of Appeals that a “motion to enforce mandamus” filed by five pharmacy chains against the opioids multidistrict litigation judge should be dismissed because the judge “fully complied” with the appeals court’s earlier order involving two other Ohio counties (In Re:  CVS Pharmacy, Inc., et al., No. 20-3075, 6th Cir.).

  • 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 07, 2020

    Drug Maker To Pay Over $21M To Settle Foreign Corruption Practices Violations

    WASHINGTON, D.C. — A pharmaceutical company will pay more than $21 million to settle claims brought by the Securities and Exchange Commission that allege that the defendant violated provisions of the Foreign Corrupt Practices Act of 1977 (FCPA) when its Russian and Turkish subsidiaries engaged in schemes to pay government officials in those countries for favorable treatment for the company’s primary drug, Soliris, according to a cease-and-desist order filed by the SEC on July 2 (In the Matter of Alexion Pharmaceuticals Inc., No. 3-19852, SEC).

  • 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).