Mealey's Drugs & Devices
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October 15, 2021
Pharmacist Pleads Guilty To Violating FDCA With Compounded Eye Injection
DALLAS — A former Texas pharmacist on Oct. 12 pleaded guilty to a misdemeanor count of violating the Food, Drug and Cosmetic Act (FDCA) for compounding an adulterated injectable eye drug that contained too much of an inactive ingredient.
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October 15, 2021
3 Elmiron Eye Injury MDL Bellwether Trials Set For 2023
NEWARK, N.J. — The federal judge overseeing the Elmiron multidistrict litigation on Oct. 6 issued an order that three bellwether cases will be tried in January, March and May 2023.
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October 15, 2021
Magistrate Judge: Journalist Should Be Excluded From Gag Rule In Holmes Trial
SAN JOSE, Calif. — A federal magistrate judge on Oct. 14 recommended that a judge exclude journalist John Carreyrou from the court’s gag order for fact witnesses in the fraud trial of Theranos founder Elizabeth Holmes, saying that that in reality, Carreyrou can only testify to secondary events and is more akin to an expert witness.
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October 15, 2021
2 Heater-Cooler Makers Exit Market In Lieu Of Protocols To Prevent Infections
SILVER SPRING, Md. — Two companies that manufacture heater-cooler devices dropped out of the market rather than develop a cleaning and disinfection protocol to address the risk of nontuberculous mycobacteria (NTM), the Food and Drug Administration said in an Oct. 13 update posted on the agency’s website.
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October 11, 2021
JPMDL Sends 114 Philips CPAP Cases To MDL In Western District Of Pennsylvania
WASHINGTON, D.C. — A federal judicial panel on Oct. 8 centralized 114 federal lawsuits alleging class and personal injuries from deteriorating sound insulation in Philips continuous positive airway pressure (CPAP) devices and assigned the multidistrict litigation to Senior U.S. Judge Joy Flowers Conti of the Western District of Pennsylvania.
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October 06, 2021
California State Judge Sanctions Endo For Late Disclosures In Opioid Trial
SANTA ANA, Calif. — A California state court judge on Oct. 5 granted in part a motion for sanctions against opioid defendant Endo Pharmaceuticals Inc. in four municipalities’ complaint against opioid manufacturers.
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October 05, 2021
U.S. Supreme Court Won’t Review New York’s Opioid Tax
WASHINGTON, D.C. — The U.S. Supreme Court on Oct. 4 denied a petition by drug distributors to overturn a federal circuit court ruling that New York’s “opioid tax” cannot be challenged in federal court.
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October 05, 2021
Wall Street Journal Reporter Wants Off Witness List, Gag Order At Holmes Trial
SAN JOSE, Calif. — The Wall Street Journal reporter who exposed blood testing startup Theranos Inc. on Oct. 1 asked a federal court to exempt him from defendant Elizabeth Holmes’ trial witness list and the court’s attendant witness gag order, saying the defendant is doing so to harass him and to infringe on his First Amendment right to report on Holmes’ ongoing criminal fraud trial.
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October 05, 2021
Ohio Counties’ Opioid Trial Against 4 Pharmacies Is Under Way In Ohio MDL
CLEVELAND — Opening arguments were given Oct. 4 in the first trial against pharmacy defendants in the opioid multidistrict litigation.
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October 05, 2021
Supreme Court Remands Gadolinium Cases On Basis Of Federal Officer Removal
WASHINGTON, D.C. — The U.S. Supreme Court on Oct. 4 remanded two gadolinium injury cases to the Ninth Circuit U.S. Court of Appeals in light of the high court’s federal officer removal statute decision in BP p.l.c. v. Mayor and City Counsel of Baltimore.
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October 05, 2021
Trustee Wants Direct Appeal To 2nd Circuit Of Purdue Pharma Bankruptcy Plan
WHITE PLAINS, N.Y. — A U.S. bankruptcy trustee on Oct. 5 filed an amended notice asking a bankruptcy court to expedite an order certifying a direct appeal of the Purdue Pharma LP bankruptcy plan to the Second Circuit U.S. Court of Appeals.
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October 05, 2021
Mass Tort Cases For Drugs, Medical Devices
New developments in the following mass tort drug and device cases are marked in boldface type.
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October 05, 2021
6th Circuit Won’t Reconsider Order Denying Stay Of Opioid Settlement Negotiations
CINCINNATI — The Sixth Circuit U.S. Court of Appeals on Sept. 17 said it will not reconsider its order denying a motion by six people to stay settlement negotiations in the opioid multidistrict litigation, saying the six failed to meet the standards for the appeals court to do so.
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October 05, 2021
Judge: 7 States Can Seek Disgorgement In All States Where Vyera Sold Daraprim
NEW YORK — A New York federal judge on Sept. 24 ruled that seven states may seek disgorgement of profits resulting from a Daraprim antitrust conspiracy from whatever states the drug was sold in.
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October 05, 2021
FDA Expands Recall Of Contaminated Ultrasound Gel Linked To 66 Infections
SILVER SPRING, Md. — The Food and Drug Administration on Sept. 27 announced that a recall of ultrasound gels made by Eco-Med Pharmaceuticals Inc. has been expanded due to the risk of bacterial infection and that the manufacturer has “shut down all operations and is no longer manufacturing or distributing any products.”
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October 01, 2021
Taro, Sandoz, Apotex Pay $447.2M In Civil Penalties For Generic Drug Price Fixes
WASHINGTON, D.C. — The U.S. Justice Department on Oct. 1 announced in a press release that Taro Pharmaceuticals USA Inc., Sandoz Inc. and Apotex Corp. have agreed to pay $447.2 million to resolve civil allegations that they conspired to fix prices of certain generic drugs.
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October 01, 2021
2nd Circuit: Late Removal Consent Can’t Be Cured By Unrelated, Later Filing
NEW YORK — The Second Circuit U.S. Court of Appeals on Sept. 30 vacated a lower court’s dismissal of a hernia mesh complaint and reversed its denial of remand to a state court because one of the served defendants failed, under current federal statutory law, to consent to remand within 30 days.
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September 30, 2021
Ex-Insys Sales Representative Pleads Guilty To Paying Kickbacks For Opioid Sales
COLUMBUS, Ohio — A former sales representative for opioid maker Insys Therapeutics Inc. on Sept. 27 pleaded guilty to paying kickbacks to a physician who “dramatically” increased his prescribing of the pain drug Subsys.
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September 29, 2021
Ex-Supermodel: CoolSculpting Fat-Freezing Device Made Me Unemployable As A Model
NEW YORK — Former 1990s supermodel Linda Evangelista on Sept. 21 filed a product liability lawsuit in federal court against the manufacturer of the CoolSculpting fat cell freezing device, alleging that the device left her permanently disfigured and unemployable as a model.
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September 29, 2021
8th Circuit Backs Dismissal Of Fluoroquinolone MDL Case For Lack Of Experts
ST. LOUIS — The Eighth Circuit U.S. Court of Appeals on Sept. 27 affirmed dismissal of a fluoroquinolone injury complaint, agreeing with a multidistrict litigation court that when two plaintiffs opted out of a master settlement, they failed to comply with a court order to provide general causation expert reports and couldn’t refer to reports submitted by the MDL’s lead counsel.