Mealey's Drugs & Devices
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March 15, 2022
McKesson Pays $1M For Controlled Substances Recordkeeping Violations
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.
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March 15, 2022
Dismissal Of Investor Claims In Bristol-Myers Securities Suit Affirmed On Appeal
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.
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March 15, 2022
Pennsylvania Appeals Court: DAs’ Challenges To State Opioid Settlement Is Premature
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.
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March 15, 2022
Plaintiffs’ Leadership Named In Philips CPAP MDL
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.
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March 15, 2022
Defunct Theranos Dropped From Subclass In Blood Testing Class Action
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.
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March 14, 2022
FDA Says Philips CPAP Recall Notice Is Inadequate, Orders Company To Do More
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.
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March 14, 2022
EpiPen MDL Judge Preliminarily Approves $264M Class Settlement
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.
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March 14, 2022
Illinois Appeals Court Affirms Discovery Order For Hospital In Heart Device Case
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.
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March 11, 2022
Bankruptcy Judge Approves Revised Purdue Pharma Bankruptcy Settlement
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.
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March 10, 2022
Summary Judgment, Dismissal Affirmed By 5th Circuit In Medtronic Heart Device Case
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.
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March 10, 2022
Panel Affirms No Coverage For Opioid Marketer’s Costs For Complying With Subpoenas
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.
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March 08, 2022
Mallinckrodt To Pay $233.7M To Settle Acthar Medicaid Rebate False Claims Act Suit
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.
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March 04, 2022
COMMENTARY: Public Nuisance, COVID-19, And The Re-Emergence Of The “Super Tort”
By Stacey Deere, Edd Gaus and EJ Odigwe
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March 03, 2022
Bankruptcy Judge Indefinitely Extends Mediation In Purdue Pharma Bankruptcy
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.”
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March 03, 2022
New Purdue Pharma Bankruptcy Plan Set With Up To $6B From Regretful Sacklers
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.
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March 01, 2022
Tennessee State Judge Says Endo Opioid Default Judgment Stemmed From Other Case
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.
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March 01, 2022
Judge Won’t Stay California Opioid Trial Against Walgreens, Drug Distributor
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.
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March 01, 2022
Judicial Panel To Weigh MDL For Atrium ProLite, ProLoop Hernia Mesh Patches
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.
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March 01, 2022
Dr. Robert Califf Confirmed To 2nd Term As Commissioner Of FDA On 50-46 Vote
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.
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March 01, 2022
Shkreli Gets Lifetime Ban, $1.39M Penalty For Civil Securities Violations
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.