Mealey's Drugs & Devices

  • November 03, 2020

    Mass Tort Cases For Drugs, Medical Devices

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

  • November 03, 2020

    Illinois Appeals Court: Learned Intermediary Doesn’t Apply To Unapproved Device

    ELGIN, Ill. — An Illinois state appeals court on Oct. 30 reversed dismissal of a medical device eye injury case, saying the state’s learned intermediary doesn’t protect Johnson & Johnson and a company sales representative who told a doctor that a new device was approved when it was actually an unapproved prototype taken by the representative and an associate (Nancy E. Plass v. Dekalb Eye Consultants, LLC, et al., No. 2-19-0403, Ill. App., 2nd Dist., 2020 Ill. App. Unpub. LEXIS 1845).

  • November 03, 2020

    Clinical Study Coordinator Pleads Guilty To Falsifying Patients In GSK Drug Study

    MIAMI — A former clinical study coordinator on Oct. 30 pleaded guilty in a Florida federal court to one count of conspiracy to commit wire fraud for her role in fabricating participants in a clinical study of a GlaxoSmithKline asthma drug for pediatric patients (United States v. Lisett Raventos, No. 20-cr-20190, S.D. Fla.).

  • November 02, 2020

    Kentucky High Court: State’s Pleading Standard Bars Preemption Of Catheter Claim

    FRANKFORT, Ky. — The Kentucky Supreme Court on Oct. 29 reversed a preemption judgment in a medical device case, ruling that under Kentucky’s lenient pleading standards, the motion for summary judgment should have been denied since the plaintiff asserted a state law claim that paralleled federal regulations (Clifford Russell, Sr. et al. v. Johnson & Johnson, et al., No. 2019-DC-0118, Ky. Sup., 2020 Ky. LEXIS 391).

  • October 30, 2020

    9th Circuit: Hawaii’s Plavix Consumer Lawsuit Is State Enforcement Proceeding

    SAN FRANCISCO — The Ninth Circuit U.S. Court of Appeals on Oct. 29 affirmed dismissal of a preemptive federal lawsuit by the marketers of Palvix over a state court consumer case brought by the Hawaii attorney general, agreeing that the underlying litigation is a quasi-criminal enforcement proceeding and that a U.S. Supreme Court ruling bars federal courts from interfering with the state court proceeding (Bristol-Myers Squibb Company, et al. v. Clare E. Connors, et al., No. 20-15515, 9th Cir., 2020 U.S. App. LEXIS 34142).

  • October 30, 2020

    Medtronic Pays $9.21M For Using Doctor’s Restaurant To Funnel Drug Pump Kickbacks

    RAPID CITY, S.D. — Medtronic USA Inc. on Oct. 29 agreed to pay $9.21 million to the United States for violating the False Claims Act and the Open Records Program by paying kickbacks for nine years to a South Dakota neurosurgeon’s restaurant in exchange for the doctor’s use of the Medtronic SynchroMed II intrathecal infusion pump, according to a settlement agreement released by the U.S. Justice Department.

  • October 27, 2020

    Janssen Unopposed To MDL For Elmiron Eye Injuries But Wants Cases Reined In

    WASHINGTON, D.C. — Janssen Pharmaceuticals Inc. on Oct. 15 told a judicial panel it does not oppose creation of a multidistrict litigation for Elmiron eye injury cases but suggested assigning the docket to Judge Brian Martinotti of the U.S. District Court for the District of New Jersey to “rein in” meritless claims (In Re:  Elmiron Products Liability Litigation, MDL Docket No. 2973, JPMDL).

  • October 26, 2020

    Ex-Opioids CEO Sentenced To 6 Months For Misbranding Addiction Drug

    ABINGDON, Va. — The former chief executive officer of opioids maker Indivior PLC was sentenced by a Virginia federal judge on Oct. 22 to six months in federal prison and ordered to forfeit $500,000 and pay a fine of $100,000 after pleading guilty to a misdemeanor for misbranding the opioid treatment drug Suboxone Film (United States v. Shaun Thaxter, No. 20-cr-24, W.D. Va.).

  • October 26, 2020

    Johnson & Johnson Says It Faces 53,900 Medical Device, Drug Claims

    NEW BRUNSWICK, N.J. — Johnson & Johnson on Oct. 23 told shareholders that as of Sept. 27, it is facing 53,900 product liability cases involving four of its current or former medical devices and three of its prescription drugs.

  • October 23, 2020

    Paragard IUD MDL Motion To Be Heard Dec. 3

    WASHINGTON, D.C. — The Judicial Panel on Multidistrict Litigation on Oct. 22 said it will hear arguments at its Dec. 3 hearing on the centralization of 55 federal lawsuits alleging injury from the Paragard intrauterine device (IUD) (In Re:  Paragard IUD Products Liability Litigation, MDL Docket No. 2974, JPMDL).

  • October 23, 2020

    3 State Attorneys General: Purdue Pharma Settlement Lets Sackler Family Off The Hook

    Three state attorneys general on Oct. 21 criticized the federal government’s $8.56 billion settlement with opioids maker Purdue Pharma LP, saying the company’s controlling Sackler family should face criminal charges and that the company should not be turned into a public trust.

  • October 22, 2020

    Pennsylvania Supreme Court Backs Personal Jurisdiction In 1st Pelvic Mesh Trial

    PHILADELPHIA — In a 6-1 ruling, the Pennsylvania Supreme Court on Oct. 21 said a trial court’s finding of personal jurisdiction in the state’s first pelvic mesh mass tort case to go to trial meets constitutional and statutory requirements (Patricia L. Hammons v. Ethicon, Inc., et al., No. 7 EAP 2019, Pa. Sup., 2020 Pa. LEXIS 5542).

  • October 21, 2020

    OxyContin Maker Purdue Pharma Pleads Guilty, Pays $8.56B In Federal Settlements

    WASHINGTON, D.C. — OxyContin maker Purdue Pharma LP has agreed to plead guilty to federal conspiracy charges and to pay a combined $8.56 billion in fines and penalties to resolve allegations that its marketing of opioids resulted in the submission of false claims to federal health care programs, the U.S. Justice Department said Oct. 21 in a press release.

  • October 20, 2020

    COMMENTARY: Conducting A Civil Jury Trial In COVID-19 Times

    By John P. Katerndahl

  • October 20, 2020

    Pennsylvania Appeals Court: Drug Makers Don’t Have To Send ‘Dear Doctor’ Letters

    PHILADELPHIA — The Pennsylvania Superior Court on Oct. 19 affirmed summary judgment in a metoclopramide neurological injury case, agreeing with a mass tort court that the manufacturers’ duty to warn does not include sending “dear doctor” letters about the drug’s updated warning label (Janine Zitney, et al. v. Wyeth LLC, et al., No. 3369 EDA 2019, Pa. Super., 2020 Pa. Super. Unpub. LEXIS 3278).

  • October 20, 2020

    Ohio Appeals Court Reverses Dismissal Of Ortho Device Case; No Settlement Existed

    TOLEDO, Ohio — An Ohio state appeals panel on Oct. 16 reversed dismissal of an orthopedic device case, finding that the plaintiffs never agreed to a settlement and therefore did not renege on their alleged agreement (Frank Aceste, et al. v. Stryker Corporation, et al., No. L-19-1156, Ohio App., 6th Dist., Lucas Co., 2020 Ohio App. LEXIS 3783).

  • October 16, 2020

    Opioids MDL Judge Sanctions Teva, Allergan For Not Finding Drug Order Report

    CLEVELAND — The Ohio federal judge overseeing the opioids multidistrict litigation on Oct. 14 sanctioned defendants Allergan Finance LLC and Teva Pharmaceutical Industries Ltd. for discovery violations by failing to find a suspicious drug order report Allergan had commissioned before Teva bought the latter’s generic opioid business (In Re:  National Prescription Opiate Litigation, MLD Docket No. 2804, No. 17-md-2804, N.D. Ohio, Eastern Div.).

  • October 16, 2020

    Graft Maker Shareholder Derivative Suit Settlement Gains Preliminary Approval

    ATLANTA — A federal judge in Georgia on Oct. 8 granted preliminary approval of a proposed settlement agreement in a shareholder derivative lawsuit brought on behalf of tissue graft maker MiMedx Group Inc. against several of the biopharmaceutical company’s current and former executive officers and directors that alleged that the defendants breached their fiduciary duty by covering up whistleblower allegations of a massive “channel-stuffing” scheme (In re MiMedx Group Inc. Shareholder Derivative Litigation, No. 18-4486, N.D. Ga.).

  • October 15, 2020

    Medical Device Maker Merit Medical Pays $18M For 6-Year Kickback Scheme

    NEWARK, N.J. — Medical device maker Merit Medical Systems Inc. will pay $18 million to the United States and various state governments to resolve whistleblower allegations that the company caused the submission of false claims to federal health care programs by paying kickbacks to physicians and hospitals to induce the purchase of the company’s medical products, the U.S. Justice Department said in an Oct. 14 press release (United States, ex rel. Charles J. Wolf, M.D. v. Merit Medical Systems, Inc., No. 16-1855, D. N.J.).

  • October 14, 2020

    Johnson & Johnson Adds $1B To $4B Offer To Settle Current, Future Opioids Claims

    NEW BRUNSWICK, N.J. — Johnson & Johnson on Oct. 13 announced that it will contribute an additional $1 billion to what it calls its “all-in settlement amount,” previously announced for $4 billion, to resolve current and future opioids claims by states, cities, counties and Native American tribes.

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