Mealey's Drugs & Devices

  • April 29, 2020

    Insys Founder Kapoor Gets Extra 2 Months To Report To Prison In Opioid Case

    BOSTON — The founder of opioid maker Insys Therapeutics Inc. on April 27 got an extra two months of freedom before having to report to prison to serve his 66-month sentence for his fraud conviction in an opioid kickback trial (United States v. John Kapoor, No. 16-cr-10343, D. Mass.).

  • April 29, 2020

    EpiPen MDL Judge Won’t Take In New Expiration Date Class Complaint

    KANSAS CITY, Kan. — The Kansas federal judge overseeing the EpiPen multidistrict litigation on April 27 denied a motion to take in a racketeering class action alleging that defendant Mylan N.V. manipulated expiration dates to force patients to refill their prescriptions more often than they needed to (In Re:  EpiPen Marketing, Sales Practices and Antitrust Litigation, MDL Docket No. 2785, No. 17-md-2785 [Troy Gott v. Mylan N.V., et al., No. 20-2099], D. Kan., 2020 U.S. Dist. LEXIS 73242).

  • April 29, 2020

    Most Expert Testimony Admitted In Suit Alleging Injury From Faulty Surgical Device

    SAN JOSE, Calif. — A federal judge in California on April 24 allowed two experts to opine that a surgical device was faulty and that the defect caused a hysterectomy patient’s injuries, though the judge limited one expert’s testimony when opining on what part of the device is defective (Candy Trump v. Intuitive Surgical Inc., No. 5:18-cv-06413, N.D. Calif., 2020 U.S. Dist. LEXIS 73781).

  • April 28, 2020

    6th Surgeon Settles Federal Allegations Of Taking Spine Company’s Kickbacks

    BOSTON — A Virginia orthopedic surgeon on April 24 agreed to pay $1.75 million to resolve  federal allegations that he accepted kickbacks in the form of sham consulting fees originating from a medical device manufacturer in exchange for using the company’s devices, according to an April 24 settlement agreement.

  • April 27, 2020

    United States: Insys Founder Kapoor Is A Flight Risk, Should Start Prison Sentence

    BOSTON — The United States in an April 24 opposition brief tells a Massachusetts federal court that it opposes continuing the May 19 prison surrender date for former Insys Therapeutics Inc. owner John Kapoor because he remains a flight risk (United States v. John Kapoor, No. 16-cr-10343, D. Mass.).

  • April 27, 2020

    3rd Circuit Vacates Class Certification In Reverse Payments Case

    PHILADELPHIA — The Third Circuit U.S. Court of Appeals on April 23 remanded class certification in an antitrust dispute upon finding that a New Jersey federal judge’s order failed to resolve “key factual disputes, assess competing evidence, and weigh conflicting expert testimony” (In re:  Lamictal Direct Purchaser Antitrust Litigation, No. 19-1655, 3rd Cir., 2020 U.S. App. LEXIS 12899).

  • April 24, 2020

    FDA Warns Against Unsupervised Use Of Malaria Drugs To Treat COVID-19

    SILVER SPRING, Md. — The Food and Drug Administration on April 24 cautioned that hydroxychloroquine or chloroquine should not be used outside of a hospital setting or clinical trial due to the risk of serious heart rhythm problems.

  • April 23, 2020

    $175M Shareholder Derivative Settlement With Opioid Seller Gains Final Approval

    OAKLAND, Calif. — A federal judge in California on April 22 granted final approval to a $175 million shareholder derivative settlement with opioid drug distributor McKesson Corp. stemming from allegations that several of the company’s current and former senior officers and directors failed to conduct the necessary oversight of opioid drug sales, even after the company twice had been hit with fines for previous compliance failures, finding the proposed deal to be fair, reasonable and adequate (In re McKesson Corp. Derivative Litigation, No. 17-1850, N.D. Calif.).

  • April 21, 2020

    Opioid MDL Judge: Discovery In Remanded Cases Should Be Limited, Specific

    CLEVELAND — In response to a motion by the U.S. Drug Enforcement Agency for a clarification of discovery on remand of two West Virginia cases, the Ohio federal judge overseeing the opioid multidistrict litigation on April 17 said he believed that only “limited, jurisdiction-specific discovery” should be necessary (In Re:  National Prescription Opiate Litigation, MDL Docket No. 17-md-2804, N.D. Ohio, Eastern Div.).

  • April 21, 2020

    Full, Partial Summary Judgment Granted In 50 Essure Birth Control Cases

    PHILADELPHIA — A Pennsylvania federal judge on April 15 dismissed 34 Essure birth control device cases and granted partial summary judgment in others to defendant Bayer Essure Inc. (Helen McLaughlin v. Bayer Essure, Inc., et al., No. 14-7315, E.D. Pa., 2020 U.S. Dist. LEXIS 57872).

  • April 21, 2020

    Case Watch

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

  • April 21, 2020

    Judge: Drug Maker Should Have Done Materiality Discovery Sooner In Claims Case

    PHILADELPHIA — A Pennsylvania federal judge on April 16 said she denied a motion in February to compel discovery in an 18-year-old false claims lawsuit, saying defendant Sanofi U.S. Services Inc. (also known as Sanofi Aventis) misrepresented that it was not aware until the day before discovery closed that materiality was an important consideration in the case (United States ex rel. Yoash Gohil v. Sanofi U.S. Services Inc., et al., No. 02-2964, E.D. Pa., 2020 U.S. Dist. LEXIS 66869).

  • April 21, 2020

    U.S. Supreme Court Denies 2nd Common Benefit Appeal In Pelvic Mesh MDL Cases

    WASHINGTON, D.C. — The U.S. Supreme Court on April 20 denied certiorari to a plaintiff law firm that challenged how $550 million in pelvic mesh multidistrict litigation common benefit fees and costs were decided and whether plaintiff firms waived their right to appeal (Mazie, Slater, Katz & Freeman, LLC v. Common Benefit Fee and Cost Committee, No. 19-984, U.S. Sup.).

  • April 21, 2020

    Justice Won’t Dismiss New York’s Opioid Public Nuisance Suit Against Drug Makers

    RIVERHEAD, N.Y. — A New York state court justice on April 16 denied without prejudice a motion by six opioid manufacturers to dismiss New York State’s public nuisance lawsuit (In Re Opioid Litigation, Index No. 400000/2017, N.Y. Supreme, Suffolk Co.).

  • April 20, 2020

    After Mandamus Writ, Opioid MDL Judge Trims Pharmacy Claims But Wants A 2nd Case

    CLEVELAND — The day after the Sixth Circuit U.S. Court of Appeals trimmed dispensing claims from two opioid cases against seven pharmacy chains, the Ohio federal judge overseeing the underlying opioid multidistrict litigation on April 16 said trial on the surviving claims will still take place in November and he also ordered the parties to select another pharmacy case on all claims for an additional bellwether trial (In Re:  National Prescription Opiate Litigation, MDL Docket No. 17-md-2804, N.D. Ohio, Eastern Div.).

  • April 20, 2020

    Pentax Pays $43M For Not Filing Device Reports, Shipping Outdated Instructions

    CAMDEN, N.J. — Medical device maker Pentax Medical Co. on April 1 agreed to pay $43 million in a criminal fine and forfeiture for shipping duodenoscopes to health care providers without approved cleaning instructions and for failing to timely report adverse events associated with its devices, according to a deferred prosecution agreement (DPA) with the U.S. attorney for the District of New Jersey (United States v. Pentax of America, Inc., et al., No. 20-mj-2054, D. N.J.).

  • April 17, 2020

    Tissue Graft Maker MiMedx Settles False Claims Pricing Suit For $6.5M

    MINNEAPOLIS — Biopharmaceutical company MiMedx Group Inc. has agreed to pay $6.5 million to settle a false claims lawsuit that it charged inflated prices to the Department of Veterans Affairs (VA) for tissue graft products, according to an April 6 stipulation and to announcements by the U.S. Justice Department and the company (United States ex rel. Jess Kruchoski, et al. v. MiMedx Group, Inc., No. 17-187, D. Minn.).

  • April 17, 2020

    Novartis Whistleblower Suit Over MS Drug Dismissed With Leave To Amend

    NEW YORK — A New York federal judge on March 24 dismissed with leave to amend a false claims complaint alleging that Novartis Pharmaceuticals Corp. used a sham speaker program to pay kickbacks to doctors to prescribe the multiple sclerosis drug Gilenya (United States, ex rel. Steven M. Camburn v. Novartis Pharmaceuticals Corporation, No. 13-3700, S.D. N.Y., 2020 U.S. Dist. LEXIS 52914).

  • April 17, 2020

    Xarelto MDL Judge OKs $93M In Common Benefit Fees For $775M Settlement

    NEW ORLEANS — The Louisiana federal judge overseeing the Xarelto multidistrict litigation on March 23 awarded plaintiff attorneys a common benefit fee of $93 million and common benefit costs of 2.7 percent for the $775 million settlement affecting about 30,000 cases (In Re:  Xarelto [Rivaroxaban] Products Liability Litigation, MDL Docket No. 2592, No. 14-md-2592, E.D. La., 2020 U.S. Dist. LEXIS 50440).

  • April 16, 2020

    6th Circuit:  Opioid MDL Judge Erred By Allowing Late Claims Against Pharmacies

    CINCINNATI — The Sixth Circuit U.S. Court of Appeals on April 15 granted a writ of mandamus to seven pharmacy chains in the opioid multidistrict litigation, ruling that the MDL judge erred in allowing two counties to file amended claims against them long after deadlines had passed (In Re:  National Prescription Opiate Litigation [In Re:  CVS Pharmacy, Inc., et al.], No. 20-3075, 6th Cir., 2020 U.S. App. LEXIS 11923).

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