WASHINGTON, D.C. — Major drug distributor McKesson Corp. has agreed to pay a $1 million civil penalty to resolve federal allegations that the company violated recordkeeping requirements of the Controlled Substances Act, 21 U.S.C. § 801 et seq., the U.S. Justice Department announced March 14.
NEW YORK — A federal district court did not err in dismissing shareholder claims in a securities class action lawsuit against drug maker Bristol-Myers Squibb Co. and certain of its current and former senior executives stemming from alleged misstatements the defendants made regarding the design, outcome and risk of a clinical trial for the company’s new non-small cell cancer treatment drug, Opdivo, because the shareholders failed to sufficiently plead that the defendants made any material misstatements or omissions or scienter in pleading their federal securities law claims, a Second Circuit U.S. Court of Appeals panel ruled March 11 in affirming.
HARRISBURG, Pa. — The Pennsylvania Commonwealth Court on Feb. 4 said petitions by two county district attorneys (DAs) seeking to enjoin the state’s $21 billion settlement with opioid manufacturers and distributors is moot because the settlement agreement hasn’t been executed and become effective.
PITTSBURGH — The Pennsylvania federal judge overseeing the Philips CPAP multidistrict litigation on Feb. 15 appointed plaintiffs’ co-lead counsel, steering committee members and committee and subcommittee members.
PHOENIX — An Arizona federal judge on Feb. 2 dropped blood testing startup Theranos Inc. from a subclass in the Arizona Theranos litigation because Theranos is now defunct.
SILVER SPRING, Md. — Saying Philips Respironics’ consumer notification about its recall of continuous positive air pressure (CPAP) devices is inadequate, the Food and Drug Administration on March 10 took the unusual step of ordering the company to notify patients about the June 2021 recall due to the “unreasonable risk of substantial harm” from degraded sound insulation.
KANSAS CITY, Kan. — The Kansas federal judge overseeing the EpiPen multidistrict litigation on March 11 granted preliminary approval to a $264 million settlement with manufacturer-defendant Mylan N.V. and related entities.
CHICAGO — An Illinois appeals court on March 2 affirmed a trial court order that a hospital produce records and answer interrogatories before a plaintiff in a defective heart device case files a certificate of a valid medical malpractice claim.
WHITE PLAINS, N.Y. — While a New York federal bankruptcy judge on the morning of March 10 was hearing sometimes tearful, sometime angry statements by victims of opioid addiction, he entered an order authorizing and approving a settlement term sheet for OxyContin maker Purdue Pharma LP based on a hearing conducted March 9.
NEW ORLEANS — The Fifth Circuit U.S. Court of Appeals on March 9 affirmed dismissal and summary judgment in a Medtronic heart device case, saying the plaintiff’s product liability claims are preempted by federal law and that his breach of contract claims are unsupported.
PASADENA, Calif. — The Ninth Circuit U.S. Court of Appeals on March 9 affirmed a lower federal court’s summary judgment ruling in favor of a directors, officers and organization insurer in a breach of contract and bad faith lawsuit brought by the marketer of two prescription opioid pain relievers, finding that coverage is barred for the insured’s costs in complying with subpoenas in conjunction with an investigation of potential federal law violations by anyone who was illegally profiting from opioids.
WASHINGTON, D.C. — Mallinckrodt ARD LLC has agreed to pay $233.7 million to settle a False Claims Act lawsuit that it knowingly underpaid Medicaid rebates that resulted from large price increases for the drug H.P. Acthar Gel (Acthar), the U.S. Justice Department announced in a March 7 press release.
By Stacey Deere, Edd Gaus and EJ Odigwe
WHITE PLAINS, N.Y. — A federal bankruptcy judge on March 2 indefinitely extended her court appointment to mediate a new bankruptcy plan for opioid maker Purdue Pharma LP, saying she will file another report “at the appropriate time.”
WHITE PLAINS, N.Y. — Purdue Pharma on March 3 asked a New York federal bankruptcy court to approve a new bankruptcy plan settlement in which the company’s controlling Sackler family will contribute up to $6 billion of its money in exchange for a third-party release of liability in opioid litigation.
CROSSVILLE, Tenn. — A Tennessee state court judge on Feb. 28 issued a written order saying that he sanctioned opioid defendants Endo Health Solutions Inc. and Endo Pharmaceuticals Inc. (Endo) with a default judgment because the discovery abuse issues were included in a related state court case that also resulted in a default judgment.
OAKLAND, Calif. — A California federal judge on Feb. 22 denied a motion by pharmacy chain Walgreens and drug distributor ANDA Inc. to stay San Francisco’s April 25 opioid trial against the defendants, saying he was not persuaded that a defense ruling in a California state court opioid trial had a preclusive effect on San Francisco’s claims against the two defendants in the federal case.
WASHINGTON, D.C. — The Judicial Panel on Multidistrict Litigation (JPMDL) on Feb. 14 listed for its March 31 hearing a motion to centralize four federal lawsuits alleging injury from the Atrium ProLite and ProLoop hernia mesh devices.
WASHINGTON, D.C. — On a 50-46 vote, the U.S. Senate on Feb. 15 confirmed Robert Califf, M.D., as Food and Drug Administration commissioner, according to White House press secretary Jen Psaki.
BROOKLYN, N.Y. — A New York federal judge on Feb. 23 granted a motion by the Securities and Exchange Commission to permanently bar Martin Shkreli from serving as an officer or director for any public company and imposed a $1.39 million civil penalty for various securities violations.