Mealey's Drugs & Devices
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May 14, 2021
Purdue Pharma Bankruptcy Plan Confirmation Hearing Set For July 19
WHITE PLAINS, N.Y. — The New York federal bankruptcy judge overseeing the Purdue Pharma LP Chapter 11 bankruptcy on May 13 issued an order setting the date for the reorganization plan confirmation hearing for July 19.
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May 14, 2021
Incretin Mimetic Plaintiffs Taxed For $605,910 In Defense Costs; Objections Filed
SAN DIEGO — Eight days after a California federal court overseeing the incretin mimetic multidistrict litigation entered an order taxing the plaintiffs $605,910 for the defendants as the prevailing party, plaintiffs attorneys on May 12 filed a motion asking the court to vacate its order as flawed or to stay the order pending the outcome of the plaintiffs’ pending appeal.
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May 13, 2021
2nd Circuit Affirms Lipitor Diabetes Claims Are Preempted Or Untimely
NEW YORK — The Second Circuit U.S. Court of Appeals on May 12 affirmed dismissal of the Lipitor diabetes claims of 24 plaintiff-appellants as preempted or untimely.
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May 12, 2021
Walmart Appeals Dismissal Of Preemptive Suit To Block Federal Drug Lawsuit
NEW ORLEANS — Walmart Inc. on May 10 asked the Fifth Circuit U.S. Court of Appeals to reverse a district court’s dismissal of its preemptive declaratory judgment lawsuit the company brought against the U.S. Justice Department to prevent it from threatened litigation for alleged violations of the Controlled Substances Act.
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May 07, 2021
Massachusetts Sues Opioid Marketer Publicis Health For Role In Abuse Crisis
BOSTON — Massachusetts on May 6 sued marketing company Publicis Health LLC in state court for allegedly creating a public nuisance of opioid abuse through the defendant’s consulting work for OxyContin maker Purdue Pharma LP and other opioid manufacturers.
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May 06, 2021
Drug Maker Incyte Pays $12.6M To Resolve False Claims Suit For Drug Co-Pays
PHILADELPHIA — Drug manufacturer Incyte Corp. has agreed to pay $12.6 million to settle a false claims lawsuit alleging that it paid kickbacks in the form of patient drug co-pays in exchange for health care providers prescribing the company’s chemotherapy drug Jakafi, according to a May 4 press release by the U.S. Justice Department.
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May 04, 2021
COVID Vaccine Contractor Emergent BioSolutions Faces House Probe, FDA Report, Suit
Over a two-day period April 19 and 20, COVID-19 vaccine contractor Emergent BioSolutions Inc. became the subject of a House investigation, a critical Food and Drug Administration inspection report of a vaccine production facility and a shareholder lawsuit.
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May 04, 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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May 04, 2021
MDL Sought By Belviq Weight Loss Drug Patients Due To Cancer Risk
WASHINGTON, D.C. — Thirteen plaintiffs on April 12 filed a petition asking the Judicial Panel on Multidistrict Litigation (JPMDL) to centralize federal lawsuits of plaintiffs who allege that they developed cancer or are at risk of developing cancer after taking the now-withdrawn prescription weight-loss drug Belviq.
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May 04, 2021
4th Circuit Puts Abortion Pill Case On Hold After FDA Changes Position On Access
RICHMOND, Va. — The Fourth Circuit U.S. Court of Appeals on April 15 granted a joint motion to hold in abeyance the Food and Drug Administration’s appeal involving the remote prescribing of the abortion pill mifepristone during the COVID-19 pandemic after the agency on April 12 changed its position on the issue.
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May 04, 2021
Trial To Begin In U.S. Civil Case Against California Stem Cell Clinic
RIVERSIDE, Calif. — Trial is scheduled to begin May 4 in the United States’ civil case against a California stem cell clinic that the government says violates the Food, Drug and Cosmetic Act (FDCA) by processing patients’ stem cells to treat a variety of health conditions.
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May 04, 2021
Opioid Trial Begins For 3 Drug Distributors For Alleged Public Nuisance
CHARLESTON, W.Va. — A bench trial got under way May 3 in a West Virginia federal court for three national drug distributors accused by a West Virginia city and county of creating a public nuisance by allegedly failing to flag or stop suspicious orders of opioids.
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May 04, 2021
11th Circuit: Expert In Da Vinci Surgical Robot Case Doesn’t Have To Be A User
ATLANTA — An 11th Circuit U.S. Court of Appeals panel on April 22 reversed summary judgment in a da Vinci surgical robot case, finding that a trial judge erred in excluding the plaintiff’s sole expert as a nonuser of the device and remanding the case with instructions for the district court chief judge to reassign the case due to a conflict of interest with the original trial judge.
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May 03, 2021
Pennsylvania High Court Won’t Review Denial Of Heightened Duty To Warn For Drug
PHILADELPHIA — The Pennsylvania Supreme Court on April 27 denied review of a state Superior Court ruling affirming summary judgment in a metoclopramide neurological injury case and the lack of duty to send “dear doctor” labels about the drug’s updated warning label.
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May 03, 2021
U.S. Wants NECC CEO, Pharmacist Resentenced To 17.5 Years In Drug Compounding Case
BOSTON — The United States on April 30 recommended to a Massachusetts federal court that Barry J. Cadden and Glenn A. Chin each be resentenced to 17.5 years in federal prison for their racketeering, mail fraud and federal drug law convictions for their roles in the operation of the New England Compounding Center (NECC) compounding facility at the center of a 2012 fungal meningitis outbreak.
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April 30, 2021
Summary Judgment Denied For 3 Drug Distributors On County’s Opioid Nuisance Claim
CHARLESTON, W.Va. — A West Virginia federal judge on April 26 denied a motion by three drug distributors for summary judgment on a county’s public nuisance claim, rejecting defendants’ argument that the county cannot do anything to abate the opioid abuse crisis and that the public nuisance claim is disallowed by state law.
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April 30, 2021
3 Purdue Pharma Law Firms To Give Up $1M In Fees For Not Disclosing Sackler Link
NEW YORK — Three law firms representing opioid maker Purdue Pharma LP in its Chapter 11 bankruptcy on April 29 agreed to give up $1 million in fees and to more fully disclose a 2018 Common Interest Agreement in which they represent not only Purdue Pharma but also the company’s controlling Sackler family.
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April 29, 2021
Indivior Inks $300M Settlement With States For False Claims About Addiction Drug
NORTH CHESTERFIELD, Va. — Indivior Inc. on April 21 signed a $300 million settlement resolving claims by all 50 states, the District of Columbia and the Commonwealth of Puerto Rico that Indivior promoted the opioid withdrawal treatment drug Suboxone for off-label use, falsely claimed that Suboxone was less subject to diversion and falsely claimed that Suboxone tablets were discontinued for “safety concerns.”
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April 26, 2021
GlaxoSmithKline Wants MDL Court To Order Third-Party Avandia Plaintiffs To Proceed
PHILADELPHIA — Drug maker GlaxoSmithKline PLC (GSK) on April 23 asked the Avandia multidistrict litigation court to enter a case management order setting deadlines for remaining discovery in a third-party payer action, saying that since a federal appeals court remanded the case 14 months ago, the plaintiffs have refused to respond to discovery requests as premature until the court enters a scheduling order.
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April 26, 2021
CDC Committee Votes To Recommend Resumption Of Janssen COVID-19 Vaccine
A Centers for Disease Control (CDC) advisory committee on April 23 voted 10-4 with one abstention to recommend the Johnson & Johnson COVID-19 vaccine for adults over 18 under the Food and Drug Administration’s emergency use authorization (EUA).