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Mealey's Drugs & Devices

March 07, 2024
5th Circuit Mulls Whether Generic Drugmakers Can Change Label Under FDA Rules

NEW ORLEANS — The Fifth Circuit U.S. Court of Appeals held oral arguments on March 6 in an interlocutory appeal of the Taxotere hair loss multidistrict litigation court’s ruling that three generic drug manufacturers are not protected by preemption because newly acquired risk information could have been added to the drug label.
March 07, 2024
Drug Manufacturer Pleads Guilty To Selling Adulterated Drugs, Agrees To Fines

PHILADELPHIA — KVK Research Inc., a generic drug manufacturer, on March 6 pleaded guilty in a Pennsylvania federal court to two misdemeanor counts of introducing adulterated drugs into interstate commerce and agreed to fines totaling $3.5 million for violations of the federal Food, Drug and Cosmetic Act (FDCA) and the False Claims Act (FCA).
March 07, 2024
Alabama Reaches $220M Settlement With 2 Drugmakers For Role In Opioid Crisis

MONTGOMERY, Ala. — Alabama Attorney General Steve Marshall announced a $220 million settlement with Cardinal Health and Cencora, formerly AmerisourceBergen, to resolve litigation for their role in the opioid crisis in Alabama.
March 06, 2024
NECC Pharmacy Founder Barry Cadden Pleads No Contest To Involuntary Manslaughter

LANSING, Mich. — Former New England Compounding Center (NECC) founder Barry J. Cadden pleaded no contest to 11 counts of involuntary manslaughter in a Michigan state court in connection with a 2012 fungal meningitis outbreak traced to a contaminated drug compounded by his company, Michigan Attorney General Dana Nessel announced March 5.
March 06, 2024
GSK Counsel Recovers $450,000 In Fees For Zofran MDL Defense Costs

BOSTON — The Massachusetts federal judge for the Zofran birth defect multidistrict litigation will allow GlaxoSmithKline LLC (GSK) and its counsel to recover $453,989.18 in costs incurred before a federal appeals court affirmed summary judgment in all cases.
March 06, 2024
Amicus Curiae Argues In Support Of Drug Distributor In Opioid Coverage Dispute

SAN FRANCISCO — United Policyholders (UP) filed an amicus curiae brief in support of a prescription drug distributor insured asking the Ninth Circuit U.S. Court of Appeals to reconsider its ruling that there is no coverage owed for lawsuits prompted by the opioid epidemic because the underlying claims “describe exclusively deliberate conduct,” arguing that the ruling “deviates from every other court in the United States that has considered whether the allegations against opioid distributors constitute an ‘occurrence’ or ‘accident’ under the terms of insurance policies like those at issue here.”
March 05, 2024
Judge Dismisses Elizabeth Holmes From Arizona Theranos Case After Settlement

PHOENIX — Theranos Inc. founder and CEO Elizabeth Holmes, who was convicted of defrauding Theranos investors out of an estimated $140 million and sentenced to 11 years in prison, has been dismissed from a class action that ended in a $44 million settlement with pharmacy chain Walgreens to resolve class claims involving tests conducted in Arizona and California pharmacies by Holmes’ now-defunct blood testing company.
March 05, 2024
Tepezza Hearing Loss MDL Plaintiffs Select 4 Bellwether Cases

CHICAGO — Plaintiffs in the Tepezza hearing loss multidistrict litigation have submitted four cases to be considered as bellwether cases.
March 04, 2024
Divided Time For FDA, Danco Requested Ahead Of High Court Oral Arguments

WASHINGTON, D.C. — The U.S. solicitor general asked that the U.S. Supreme Court allow counsel for the U.S. Food and Drug Administration and Danco Laboratories LLC, the manufacturer of Mifeprex-brand mifepristone, to divide time for oral argument in a case on whether the Fifth Circuit U.S. Court of Appeals erred in upholding a district court’s stay of the FDA’s 2016 amendments to mifepristone’s approval and the agency’s 2021 decision not to enforce its regulations during the COVID-19 pandemic.
March 04, 2024
CVS, Walgreens To Start Dispensing Mifepristone At Select Pharmacies

CVS and Walgreens on March 1 announced that they have completed the U.S. Food and Drug Administration’s certification process to dispense mifepristone, one of two drugs used to induce early termination of pregnancy, and will begin in select states in the coming weeks.
March 04, 2024
Endo Agrees To $464 Million Settlement To Resolve Claims Related To Opioid Drug

NEW YORK — Endo Health Solutions Inc. (EHSI) has agreed to pay $464.9 million to resolve criminal and civil investigations related to its opioid drug Opana ER with INTAC (Opana ER) and to plead guilty to a misdemeanor charge.
February 29, 2024
3rd Circuit Denies Drug Manufacturer’s Petition To Rehear D&O Coverage Dispute

PHILADELPHIA — The Third Circuit U.S. Court of Appeals on Feb. 28 denied a pharmaceutical drug manufacturer insured’s petition for panel rehearing and rehearing en banc, refusing to disturb its finding that an excess directors and officers liability insurer has no duty to pay the insured’s settlement and defense costs arising from an underlying shareholder class action alleging that it artificially inflated its stock when it misrepresented the results of a clinical drug study.
February 29, 2024
Drugmaker, Woman Square Off On ACA’s Impact On Mirena Class Action

SAN JOSE, Calif. — The Patient Protection and Affordable Care Act (ACA) mandates that insurers cover contraceptive drugs at no out-of-pocket cost, so a woman’s lawyers should have known that she couldn’t have suffered an economic injury sufficient for standing to pursue her claims that she wouldn’t have paid for the drug had she known about its cancer risks, the manufacturer says in seeking sanctions and opposing her motion to amend. But in reply, the woman says all the evidence in the case suggests that she does have an injury and that adding named plaintiffs who can more readily produce evidence of their own injury won’t prejudice the company.
February 29, 2024
Mass Tort Cases For Drugs, Medical Devices

New developments in the following mass tort drug and device cases are marked in boldface type.
February 26, 2024
Anti-Abortion Advocates Tell Court Changes To Abortion Drug Access Caused Harm

[This story has been updated to reflect the addition of amicus curiae briefs filed in support of the respondent.]
February 29, 2024
MDL Judge Orders Taxotere Plaintiffs To Show Proof Of Diagnosis In Lone Pine Order

NEW ORLEANS — Plaintiffs in the Taxotere hair loss multidistrict litigation who are eligible for remand must show proof of a diagnosis of permanent chemotherapy-induced alopecia (PCIA), the MDL judge ruled.
February 29, 2024
Couple Sue Manufacturer Of Embryo Culture Media For Loss Of Embryos

OAKLAND, Calif. — A couple sued the manufacturer of embryo culture media in a California federal court alleging that none of their fertilized eggs survived to the blastocysts stage due to a defective solution that was used in the procedure and seek compensatory and punitive damages.
February 29, 2024
Amici Urge 4th Circuit To Reverse District Court Ruling Limiting Abortion Drug

RICHMOND, Va. — “Mifepristone, when used as part of a two-drug medication abortion regimen, is one safe and common course of treatment that is used with pregnancy loss or obstetrical complications leading to fetal demise. Medication abortion, including the use of mifepristone, thus is an important part of reproductive care,” groups of obstetricians, gynecologists and clinicians tell the Fourth Circuit U.S. Court of Appeals in an amicus curiae brief.
February 29, 2024
CPAP MDL Judge Rejects Special Master Report On Medical Monitoring Claims

PITTSBURGH — The federal judge overseeing the multidistrict litigation involving the recall of approximately 10.8 million Philips continuous positive air pressure (CPAP) sleep apnea devices and respirators declined to adopt a special master’s report and recommendation to partially grant a motion to dismiss plaintiffs’ second amended medical monitoring complaint.
February 28, 2024
Hospitals Allege Harm From Opioid Epidemic Caused By Drugmakers, Distributors

CLEVELAND — A group of hospitals filed a complaint in a federal court in Ohio against drug manufacturers and distributors alleging that the hospitals have been “directly and monetarily damaged by the opioid epidemic.”
February 28, 2024
ASD-ADHD MDL Judge Sets Deadlines To Object To Causation Experts, Tosses Cases

NEW YORK — The New York federal judge overseeing the acetaminophen autism spectrum disorder-attention deficit hyperactivity disorder (ASD-ADHD) multidistrict litigation on Feb. 27 ordered that any objections on whether testimony by a newly named causation expert is admissible under Federal Rule of Evidence 702 be filed by July 1.
February 27, 2024
FDA Withdraws Pepaxto Approval After Low Survival Rate In Myeloma Patients

SILVER SPRING, Md. — The U.S. Food and Drug Administration has withdrawn its approval of Pepaxto-brand melphalan flufenamide, a drug approved in February 2021 under an accelerated approval process to treat patients with multiple myeloma.
February 27, 2024
MDL Suboxone Judge Sets Deadlines For Lead Counsel Applications

WASHINGTON, D.C. — The judge overseeing the Suboxone film multidistrict litigation ordered counsel interested in a leadership position in the MDL to submit an application by March 1 in preparation for an initial status conference that is scheduled for March 7.
February 27, 2024
Judge: PREP Act Applies To Class Action Alleging Injuries From COVID-19 Drug

LOS ANGELES — Patients and their family members who allege injuries after being prescribed and ingesting an antiviral drug used to treat severe COVID-19 symptoms saw their putative class action dismissed by a California federal judge who found that the manufacturer has immunity under the Public Readiness and Emergency Preparedness Act (PREP Act).
February 27, 2024
Diabetes And Diet Drug MDL To Meet To Discuss Lead Counsel, Division Of Cases

PHILADELPHIA — The federal judge overseeing the multidistrict litigation involving diabetes and diet drugs that consumers allege caused gastrointestinal and other injuries announced plans for an initial in-court conference to discuss, among other topics, plans to appoint lead counsel.