Mealey's Drugs & Devices

  • March 03, 2020

    Sandoz To Pay $195M Penalty For 4 Antitrust Violations In Generic Drug Trade

    PHILADELPHIA — Generic drug manufacturer Sandoz Inc. on March 2 agreed to a three-year deferred prosecution agreement for four antitrust violations in a Pennsylvania federal court and agreed to pay a $195 million penalty (United States v. Sandoz Inc., No. 20-cr-111, E.D. Pa.).

  • March 03, 2020

    Justice Alito Stays Discovery Order In Generic Drug Price-Fixing MDL

    WASHINGTON, D.C. — On Feb. 28, Justice Samuel A. Alito Jr. granted an application by a group of pharmaceutical firm defendants to stay a portion of a trial court’s discovery order in a multidistrict price-fixing litigation to allow for the U.S. Supreme Court’s resolution of the firms’ petition for certiorari, in which they argue that the order improperly requires them to produce materials before they have the opportunity to object on the basis of relevance or responsiveness in violation of Federal Rule of Civil Procedure 26(b)(1) (Actavis Holdco Inc., et al. v. Connecticut, et al., No. 19-1010, U.S. Sup., 2020 U.S. LEXIS 1369).

  • March 03, 2020

    Allergen Wants Biocell Breast Implant Plaintiffs To Identify Themselves

    NEWARK, N.J. — Allergan Inc. on Feb. 28 asked the Biocell breast implant multidistrict litigation court to prohibit plaintiffs from filing anonymous pleadings under names such as “Jane Doe” and initials (In Re:  Allergen Biocell Textures Breast Implant Product Liability Litigation, MDL Docket No. 2921, No. 19-mn-2921, D. N.J.).

  • March 02, 2020

    EpiPen MDL Judge Certifies National RICO, State Antitrust Classes, Seals Opinion

    KANSAS CITY, Kan. — The Kansas federal judge overseeing the EpiPen multidistrict litigation on Feb. 27 said he has signed a sealed memorandum and order that certifies a national racketeering class and a state antitrust class (In Re:  EpiPen [Epinephrine Injection, USP] Marketing, Sales Practices and Antitrust Litigation, MLD Docket No. 1785, No. 17-md-2785, D. Kan.).

  • March 02, 2020

    Drug Maker Sanofi To Pay $11.85M To Resolve Co-Pay Whistleblower Suit

    BOSTON — Drug manufacturer Sanofi-Aventis US LLC has agreed to pay $11.85 million to resolve a whistleblower lawsuit that it paid kickbacks to Medicare patients through a charity that put up co-pays for an expensive multiple sclerosis (MS) drug, the parties announced Feb. 28 (United States, et al., ex rel. Lemtrada/Aubagio Litigation Partnership, LLP v. Sanofi-Aventis U.S. L.L.C., et al., No. 17-10378, D. Mass.).

  • February 25, 2020

    Opioid Maker Mallinckrodt Says It’s Agreed To $1.6B Global Settlement

    STAINES-UPON-THAMES, England — Opioid manufacturer defendant Mallinckrodt PLC on Feb. 25 announced an agreement-in-principle for a $1.6 billion global settlement with 46 states, the District of Columbia and the Plaintiffs’ Executive Committee in the opioid multidistrict litigation.

  • February 19, 2020

    Mass Tort Cases For Drugs, Medical Devices

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

  • February 19, 2020

    Taxotere MDL Judge Denies New Trial In 1st Bellwether Case Based On Defense Expert

    NEW ORLEANS — A Louisiana federal judge overseeing the Taxotere hair loss multidistrict litigation on Feb. 14 denied a motion for a new trial in the first bellwether trial because of how a defense expert used a defendant’s analysis (In Re:  Taxotere [Docetaxel] Products Liability Litigation, MDL Docket No. 2740, No. 16-2740, E.D. La., 2020 U.S. Dist. LEXIS 26509).

  • February 19, 2020

    Generic Drug Executive Pleads Guilty To Restraint Of Trade

    PHILADELPHIA — A senior executive for a New Jersey generic drug manufacturer on Feb. 14 pleaded guilty to one count of conspiracy to restrain trade for allegedly trying to rig the generic drug market (United States v. Hector Armando Kellum, No. 20-cr-65, E.D. Pa.).

  • February 19, 2020

    New Jersey High Court Asked To Centralize Biocell Breast Implant Cancer Cases

    TRENTON, N.J. — The New Jersey Supreme Court on Feb. 13 published a notice that it has received an application to create a multicounty litigation (MCL) for state court lawsuits alleging injuries from Allergan Biocell Textured Breast Implants.

  • February 19, 2020

    New Jersey Prolene Hernia Mesh Cases Sent To Multicounty Litigation In Atlantic City

    ATLANTIC CITY, N.J. — The New Jersey Supreme Court on Jan. 15 created a multicounty litigation (MCL) for state court cases involving alleged injuries from Prolene hernia mesh and assigned it to Judge John C. Porto of the Atlantic County Superior Court (In Re:  Prolene Hernia System Mesh Litigation, MCL Case No. 633, N.J. Super., Atlantic Co.).

  • February 19, 2020

    New Jersey Supreme Court Denies Creation Of Tritanium Hip Multicounty Litigation

    TRENTON, N.J. — The New Jersey Supreme Court on Jan. 31 denied an application to create a multicounty litigation for state court cases alleging injuries as a result of the Stryker Tritanium Acetabular Shell due to the limited number of cases.

  • February 19, 2020

    MDL Panel Won’t Vacate Remand Of Cherokee, City Opioid Cases

    WASHINGTON, D.C. — The Judicial Panel on Multidistrict Litigation (JPMDL) on Feb. 5 denied a motion by 30 opioid defendants to vacate the panel’s remand of two opioid cases brought by the Cherokee Nation and San Francisco (In Re:  National Prescription Opiate Litigation, MDL Docket No. 2804, JPMDL).

  • February 18, 2020

    7 Insys Execs Ordered To Pay $56.6M In Restitution For Subsys Opioid Scheme

    BOSTON — A Massachusetts federal judge on Feb. 14 ordered seven former high-ranking employees of opioid maker Insys Therapeutics Inc. to pay at least $56.68 million in restitution to Medicare, six health insurers and five individual victims of the defendants’ scheme to get insurers to pay for prescriptions of Subsys spray fentanyl for use by non-cancer patients (United States v. Michael L. Babich, et al., No. 16-cr-10343, D. Mass., 2020 U.S. Dist. LEXIS 25952).

  • February 14, 2020

    6th Circuit Stays Some Opioid MDL Discovery, Will Hear Mandamus Arguments

    CINCINNATI — The Sixth Circuit U.S. Court of Appeals on Feb. 12 stayed the production of some opioid prescribing data by pharmacy chain defendants in the opioid multidistrict litigation and invited the opioid MDL court to respond to the pharmacies’ motion for a writ of mandamus against the production of dispensing information for an October trial (In Re:  National Prescription Opiate Litigation [In Re:  CVS Pharmacy, Inc., et al., No. 20-3075, 6th Cir.).

  • February 14, 2020

    FDA:  Withdraw Belviq Weight-Loss Drug Due To Increased Cancer In Study Subjects

    SILVER SPRING, Md. — The Food and Drug Administration on Feb. 13 said it has asked Eisai Co. Ltd. to voluntarily withdraw the company’s Belviq and Belviq XR prescription weight loss drug from the U.S. market because the company’s safety clinical trial showed an increased occurrence of cancer, including pancreatic, colorectal and lung cancer.

  • February 14, 2020

    Panel Affirms Dismissal Of UCL, Negligence Claims Against Lexapro Manufacturers

    PASADENA, Calif. — The Ninth Circuit U.S. Court of Appeals on Feb. 11 affirmed a lower federal court’s dismissal of California unfair competition law (UCL) and negligence claims against manufacturers of the antidepressant drug Lexapro, finding that “the drug's packaging contained clear warning labels about a heightened risk of suicidality for adolescents” (Stephanie Patton, et al. v. Forest Laboratories Inc., et al., No. 18-56336, 9th Cir., 2020 U.S. App. LEXIS 4520).

  • February 13, 2020

    Judge Dismisses Some Counts Against Theranos Executives In Fraud Case

    SAN JOSE, Calif. — A California federal judge on Feb. 11 granted a motion by Theranos Inc. founder Elizabeth A. Holmes and president Ramesh “Sunny” Balwani to dismiss fraud claims that relate to nonpaying patients and doctors, but denied dismissal of all other allegations related to the now-defunct blood-testing startup (United States v. Elizabeth A. Holmes, et al., No. 18-cr-258, N.D. Calif., San Jose Div., 2020 U.S. Dist. LEXIS 24551).

  • February 07, 2020

    Federal Lawsuits Alleging Zantac NDMA Contamination Centralized In Florida Court

    WASHINGTON, D.C. — A federal judicial panel on Feb. 6 centralized in a Florida federal court 141 federal lawsuits alleging that the over-the-counter heartburn drug Zantac contains or metabolizes into N-nitrosodimethylamine (NDMA), an alleged carcinogen (In Re:  Zantac [Ranitidine] Products Liability Litigation, MDL Docket No. 2924, JPMDL, No. 20-md-2924, S.D. Fla., 2020 U.S. Dist. LEXIS 19881).

  • February 06, 2020

    Dispute Over Secondary Payer Payment Settlement Dismissed In Michigan

    DETROIT — A Michigan federal judge on Feb. 3 agreed with the Centers for Medicare & Medicaid Services (CMS) that a declaratory judgment action stemming from a 2012 fungal meningitis outbreak must be dismissed for lack of subject matter jurisdiction (David J. Mattila, et al. v. Centers for Medicare & Medicaid Services, No. 19-10446, E.D. Mich., 2020 U.S. Dist. LEXIS 16892).

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