Mealey's Drugs & Devices

  • July 11, 2019

    GlaxoSmithKline Says Albrecht Doesn’t Allow Paxil Suicide Verdict To Be Reinstated

    CHICAGO — GlaxoSmithKline (GSK) in a July 8 brief tells an Illinois federal court that the U.S. Supreme Court’s recent ruling on the “clear evidence” standard for drug warning label cases is not a change in law that warrants overturning the reversal of a $3 million Paxil suicide verdict (Wendy B. Dolin, et al. v. SmithKlineBeecham Corporation, et al., No. 12-6403, N.D. Ill.).

  • July 09, 2019

    United States Says 2 Insys Execs Are Helping In At Least 8 Other Probes

    BOSTON — The United States on July 8 asked a Massachusetts federal judge to continue the sentencing of two former Insys Therapeutics Inc. executives because they are cooperating with federal investigation in at least eight other federal districts (United States v. Michael L. Babich, et al., No. 16-cr-10343, D. Mass.).

  • July 09, 2019

    Directed Judgment Denied For Johnson & Johnson In Oklahoma Opioid Case

    NORMAN, Okla. — An Oklahoma state court judge on July 8 denied a motion by Johnson & Johnson for a directed judgment in the state’s opioid public nuisance lawsuit against the manufacturer defendant, according to a press statement by the state attorney general (Oklahoma, et al. v. Purdue Pharma L.P., et al., No. CJ-2017-816, Okla. Dist., Cleveland Co.).

  • July 02, 2019

    Mass Tort Cases For Drugs, Medical Devices

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

  • July 02, 2019

    New York State Court Judge Denies Motion To Dismiss Sackler Family In Opioid Case

    RIVERHEAD, N.Y. — A New York state court judge on June 21 denied a motion by eight members of Purdue Pharma L.P.’s controlling Sackler family to dismiss them from a consolidated opioid lawsuit filed by 36 counties (In Re Opioid Litigation, No. 400000/2017, N.Y. Sup., Suffolk Co., 2019 N.Y. Misc. LEXIS 3324).

  • July 02, 2019

    4th Circuit Stays Pelvic Mesh MDL Common Benefit Order Pending Rehearing

    RICHMOND, Va. — The Fourth Circuit U.S. Court of Appeals on June 28 stayed its mandate dismissing a common benefit fee appeal in seven pelvic mesh multidistrict litigations after the plaintiffs’ law firm filed a petition for rehearing or a rehearing en banc (In Re:  Ethicon, Inc., Pelvic Repair System Products Liability Litigation, No. 19-1224, 4th Cir.).

  • July 02, 2019

    Bankrupt Opioid Maker, Opioid Plaintiffs Propose Plan To Manage Litigation Claims

    WILMINGTON, Del. — Opioid maker Insys Therapeutics Inc., its bankruptcy creditors committee and various entities filing opioid litigation on June 30 filed a proposed case management protocol with the U.S. Bankruptcy Court for the District of Delaware that will seek to quantify claims and come up with a way to allocate the debtor’s assets (In Re:  Insys Therapeutics, Inc., et al., No. 19-11292, D. Del. Bkcy.).

  • July 02, 2019

    Partial Summary Judgment Granted in Yasmin Birth Control Pill Stroke Case

    SAN FRANCISCO — A California federal judge on June 28 granted partial summary judgment in a Yasmin birth control pill stroke case and denied defendant Bayer Corp.’s motion to exclude plaintiffs’ expert witnesses (Susan Galinis, et al. v. Bayer Corporation, et al., No. 09-4980, N.D. Calif., 2019 U.S. Dist. LEXIS 108952).

  • July 02, 2019

    Widow: Albrecht Warrants Reinstatement Of $3M Paxil Suicide Verdict

    CHICAGO — A widow who had a $3 million Paxil suicide verdict reversed on appeal for preemption on June 27 asked the trial court for relief from judgment in light of the U.S Supreme Court’s intervening ruling in Merck Sharp & Dohme v. Albrecht, 139 S.C. 1668 (2019), about whether the Food and Drug Administration would find “clear evidence” that a drug label needs to warn of an unrecognized risk (Wendy Dolin, et al. v. SmithKline Beecham Corporation, et al., No. 12-6403, N.D. Ill., Eastern Div.).

  • July 02, 2019

    2nd New York Doctor Pleads Guilty To Taking Kickbacks To Prescribe Opioid

    NEW YORK — A New York physician on June 26 pleaded guilty to taking kickbacks from drug maker Insys Therapeutics Inc. in exchange for prescribing the company’s opioid Subsys (United States v. Todd Schlifstein, No. 18-cr-217, S.D. N.Y.).

  • July 02, 2019

    Judge Rejects Plaintiff’s Albrecht Citation In Gadolinium Retention Case

    BROOKLYN, N.Y. — A New York federal judge on June 24 dismissed a gadolinium exposure case because the plaintiff did not adequately plead that the possible retention of the radiographic contrast agent in her body caused her alleged injuries (Denise McGrath v. Bayer Healthcare Pharmaceuticals Inc., et al., No. 18-2134, E.D. N.Y., 2019 U.S. Dist. LEXIS 105164).

  • July 02, 2019

    United States Appeals 2 Acquittals In NECC Drug Compounding Criminal Case

    BOSTON — The United States on June 24 appealed the acquittal by a Massachusetts federal judge of two former employees of the New England Compounding Center (NECC) following their convictions of conspiracy to defraud the Food and Drug Administration (United States v. Sharon P. Carter, et al., No. 15-cr-10363, D. Mass.; United States v. Gregory A. Conigliaro, No. 19-1645, and United States v. Sharon P. Carter, No. 19-1644, 1st Cir.).

  • June 28, 2019

    Medtronic MiniMed Insulin Pumps Recalled Due To Cybersecurity Vulnerability

    SILVER SPRING, Md. — The Food and Drug Administration on June 27 said Medtronic Inc. is recalling 11 MiniMed insulin pumps because of a cybersecurity risk that cannot be fixed by the manufacturer.

  • June 28, 2019

    3rd Circuit Asked If Pennsylvania Allows Strict Liability In Pelvic Mesh Case

    PHILADELPHIA — A Pennsylvania federal judge presiding in a pelvic mesh case on June 25 predicted that the state Supreme Court would not recognize a strict liability claim for manufacturing defect of a prescription medical device, but “given the growing debate among federal courts,” he certified the question to the Third Circuit U.S. Court of Appeals (Sarah Rosenberg v. C.R. Bard, Inc., No. 18-4767, E.D. Pa., 2019 U.S. Dist. LEXIS 105785).

  • June 28, 2019

    Judge In Actos Case Finds Jurisdiction Over 2 Takeda Entities, But Not Another

    PHILADELPHIA — A Pennsylvania federal judge on June 26 issued a split ruling on personal jurisdiction in an Actos bladder cancer lawsuit, finding for entities of defendant Takeda Pharmaceuticals America Inc. that were registered in Pennsylvania but not for another entity that did not do so (Jeffrey R. Williams, et al. v. Takeda Pharmaceuticals America, Inc., et al., No. 18-4778, E.D. Pa., 2019 U.S. Dist. LEXIS 107093).

  • June 27, 2019

    Stem Cell Treatment Class Action Certified Based On Website Marketing Claims

    SAN DIEGO — Although he said he sees “dangers down the road,” a California federal judge on June 24 certified a national class of plaintiffs who paid at least $14,900 to a stem cell clinic after viewing information on the firm’s website about the effectiveness of stem cell treatment or getting an email from the defendant about patient satisfaction with the company’s services (Selena Moorer v. Stemgenex Medical Group, Inc., et al., No. 16-2816, S.D. Calif., 2019 U.S. Dist. LEXIS 106328).

  • June 26, 2019

    New York Appellate Court Won’t Dismiss Suit Alleging Pain Killer Overprescription

    NEW YORK — A New York appellate court on June 13 affirmed a lower court’s refusal to dismiss claims that a doctor’s overprescription of opioids led to a woman’s death.  It concluded that a jury should decide whether the doctor’s failure to obtain the decedent’s medical records or contact her treating orthopedist contributed to her overdose (Patricia Halloran v. Ajay N. Kiri, M.D., et al., No. 21037/15E, N.Y. Sup., App. Div., 1st Dept., 2019 N.Y. App. Div. LEXIS 4755).

  • June 25, 2019

    Motion For Opioid MDL Negotiating Class To Be Revised; New Hearing Aug. 6

    CLEVELAND — The Ohio federal judge overseeing the opioid multidistrict litigation on June 25 adjourned a hearing on a motion to certify a novel “negotiation class” so that the moving plaintiffs can get input from state attorneys general and counties and incorporate them into a revised motion (In Re:  National Prescription Opiate Litigation, MDL Docket No. 2804, No. 17-md-2804, N.D. Ohio, Eastern Div.).

  • June 25, 2019

    $85M Teva Opioid Settlement In Oklahoma OK’d After State Parties Clarify Terms

    NORMAN, Okla. — An Oklahoma state court judge on June 24 approved the state’s $85 million opioid settlement with manufacturer Teva Pharmaceuticals USA Inc. after the parties met with a special master to clarify the agreement’s terms and agreed that the consent agreement does not preclude separate lawsuits by state counties and cities (Oklahoma, ex rel. Mike Hunter, et al. v. Purdue Pharma L.P., et al., No. CJ-2017-816, Okla. Dist., Cleveland Co.).

  • 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.).

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