Mealey's Drugs & Devices : Mealey's : Legal News & Analysis

Mealey's Drugs & Devices

March 18, 2024
High Court: FDA, Danco Can Divide Time For Oral Arguments In Abortion Drug Case

WASHINGTON, D.C. — The U.S. Supreme Court on March 15 granted a motion filed by the U.S. solicitor general to 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 arguments 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 15, 2024
Judge Won’t Strike ‘Allegedly Scandalous Material’ In FCA Suit Against Medtronic

KANSAS CITY, Kan. — A Kansas federal judge denied Medtronic’s request to strike purportedly false allegations in a qui tam suit alleging that Medtronic and its related company and a hospital violated the False Claims Act (FCA) by participating in a scheme to provide medically unnecessary treatment resulting in the submission of false claims for payment to federal health care programs, finding that “the court has no grounds to strike” “the allegedly scandalous material.”
March 14, 2024
Mass Tort Cases For Drugs, Medical Devices

New developments in the following mass tort drug and device cases are marked in boldface type.
March 14, 2024
Alaska Announces $10M Settlement With CVS For Its Role In Opioid Crisis

ANCHORAGE, Alaska — Alaska announced that it has reached a $10 million settlement with CVS Pharmacy Inc. for the chain’s role in the opioid epidemic in the state.
March 13, 2024
Suboxone MDL Judge Appoints Plaintiff Leadership

CLEVELAND — The judge overseeing the Suboxone film multidistrict litigation has appointed counsel to plaintiffs’ leadership positions.
March 13, 2024
Negligent Misrepresentation Claim Survives In Defective Pelvic Mesh Case

BOSTON — A couple’s claim for negligent misrepresentation in a suit alleging that a manufacturer’s pelvic mesh product caused injuries will move forward after a Massachusetts federal judge on March 12 denied a motion to dismiss.
March 12, 2024
Lilly Appeals $132,000 Award For Whistleblower’s Costs Following $193M Judgment

CHICAGO — Eli Lilly & Co. appealed a decision by an Illinois federal court to award a whistleblower $132,706.13 for costs incurred in his case alleging that the company underpaid Medicare drug rebates owed to the United States, which ended in a $193 million judgment.
March 12, 2024
New Co-Lead Counsel Appointed For Defense In Paragard MDL

ATLANTA — The Georgia federal judge overseeing the Paragard IUD (intrauterine device) multidistrict litigation agreed to revise the defense leadership structure after a request by the defendants.
March 12, 2024
Hernia Mesh MDL Judge Dismisses 94 Cases After Agreements Reached

ATLANTA — The federal judge overseeing the Ethicon Physiomesh hernia patch multidistrict litigation agreed to dismiss with prejudice 94 cases after the parties filed a joint motion alerting the court that they have settled all claims in those cases.
March 12, 2024
Judge Refuses To Fully Dismiss Complaint Against Walmart Alleging CSA Violations

WILMINGTON, Del. — Relying on “a case neither party cited in its briefing or at oral argument,” a federal judge in Delaware on March 11 found that Walmart Inc. could be held responsible for filling prescriptions that compliance team members knew to be invalid in violation of the Controlled Substances Act (CSA), partially denying the pharmacy giant’s motion to dismiss, but he agreed that two counts should be dismissed.
March 11, 2024
Bair Hugger MDL Magistrate Judge Sets 6 Bellwether Trials For March 2025

MINNEAPOLIS — Parties in the Bair Hugger multidistrict litigation should be ready to bring the six selected cases to trial in March 2025, the magistrate judge overseeing the cases said in a scheduling order.
March 08, 2024
Judge Rules For CGL Insurer In Coverage Dispute With Medical Product Manufacturer

CONCORD, N.H. — A federal judge in New Hampshire granted a commercial general liability insurer’s motion for summary judgment in its declaratory judgment lawsuit pertaining to 10 underlying class actions alleging that its insured manufactured and marketed medical devices used to clean positive airway pressure (CPAP) and bi-level positive airway pressure (biPAP) devices that were not safe or effective, finding that the damages alleged in the class actions fail to constitute “damages because of ‘bodily injury’ or ‘property damage’” to trigger coverage.
March 08, 2024
Missouri Panel: Forum Selection Clause Binds Parties To Litigate Claims Abroad

ST. LOUIS — A Missouri appeals panel held that a trust that was created in a bankruptcy proceeding for the benefit of individuals harmed by major producers of opioid pharmaceutical products failed to satisfy its “heavy burden” of demonstrating that the forum selection clause in the debtors’ insurance policies was unfair or unreasonable, affirming a lower court’s grant of the insurers’ motion to dismiss the trust’s coverage lawsuit because the parties are bound to litigate any disputes arising from the contracts in England or Wales.
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.