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.
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.
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.
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.
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.
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.
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.
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.
CLEVELAND — Opening arguments were given Oct. 4 in the first trial against pharmacy defendants in the opioid multidistrict litigation.
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.
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.
New developments in the following mass tort drug and device cases are marked in boldface type.
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.
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.
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.”
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.
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.
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.
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.
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.