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

Mealey's Drugs & Devices

March 29, 2024
FCA Suit Against Allergan Tossed, But Judge Allows ‘Last Opportunity’ To Amend

CHICAGO — An Illinois federal judge dismissed without prejudice relators’ third amended qui tam complaint against Allergan asserting violations of the federal False Claims Act (FCA) and numerous state false claims laws regarding allegations that Allergan paid unlawful kickbacks to physicians to prescribe opioid drugs for off-label uses, finding it “appropriate” to allow the relators “one chance to fix the deficiencies the Court has identified.”
March 28, 2024
MDL Judge Finds Some Claims In All Gardasil Cases Barred By Vaccine Act

STATESVILLE, N.C. — The federal judge overseeing the Gardasil multidistrict litigation partially granted the drug manufacturer’s motion for partial judgment on the pleadings for claims asserted by two women who claim injuries caused by the vaccine, also declaring that the ruling will apply to all cases in the MDL.
March 27, 2024
5th Circuit Affirms Dismissal Of Woman’s Defective Mesh Device Claims

NEW ORLEANS — The Fifth Circuit U.S. Court of Appeals on March 26 rejected a woman’s argument on appeal that a trial court erred in adopting a magistrate judge’s recommendation to grant summary judgment to a medical device manufacturer in an injury case, agreeing that she failed to assert the required facts to prove her claims.
March 26, 2024
Justices Hear Arguments On Restrictions To Access To Abortion Drug Mifepristone

WASHINGTON, D.C. — Oral arguments were held March 26 before the U.S. Supreme Court with the government arguing that a group of anti-abortion advocates lack standing in the case that challenges the U.S. Food and Drug Administration’s 2016 amendments to mifepristone’s approval and the agency’s 2021 decision not to enforce its regulations during the COVID-19 pandemic, and Justice Ketanji Brown Jackson questioning the “significant mismatch in this case between the claimed injury and the remedy that's being sought.”
March 26, 2024
California Woman Alleging Hair Loss From Cancer Drug Cannot Amend Complaint

SAN FRANCISCO — A woman whose case was remanded from the Taxotere hair loss multidistrict litigation cannot amend her complaint, a California federal judge ruled, finding that similar attempts have been unsuccessful in the MDL and other remanded cases.
March 25, 2024
4th Circuit Sends Certified Question To W.Va. High Court On Opioid Nuisance Claim

RICHMOND, Va. — The Fourth Circuit U.S. Court of Appeals has certified a question to the West Virginia Supreme Court of Appeals to address the dispute over whether the state’s public nuisance law applies to the sale and distribution of opioids.
March 25, 2024
Opioid MDL Rejects Calls To Disqualify Motley Rice Over Previous Government Work

CLEVELAND — The Ohio federal judge overseeing the opioid multidistrict litigation ruled “that disqualification of Motley Rice is unnecessary and inappropriate in the circumstances of this case,” rejecting calls from OptumRx that the law firm’s separate representation of other governmental investigations into the pharmacy benefits manager (PBM) means that it should be disqualified from representing parties in the MDL.
March 25, 2024
Executives Convicted Of Off-Label Marketing File Petition With High Court

WASHINGTON, D.C. — Two former Acclarent Inc. executives convicted of distributing and misbranding medical devices sold in interstate commerce filed a petition for a writ of certiorari with the U.S. Supreme Court asking it to review the First Circuit U.S. Court of Appeals’ decision that affirmed their convictions, arguing that the U.S. Food and Drug Administration’s “intended use” regulations violate their constitutional rights.
March 25, 2024
Suboxone MDL Judge Allows New Cases To Be Filed Directly In Ohio Federal Court

CLEVELAND — The judge overseeing the Suboxone film multidistrict litigation filed a case management order allowing users of the prescription drug that treats opioid use disorder who allege that the drug caused extensive dental decay to file directly in the U.S. District Court for the Northern District of Ohio for inclusion in the MDL.
March 18, 2024
Panel Refuses To Disturb No Coverage Ruling In Suit Arising From Opioid Epidemic

SAN FRANCISCO — A panel of the Ninth Circuit U.S. Court of Appeals unanimously voted to deny a prescription drug distributor insured’s petition seeking rehearing of the panel’s Jan. 26 ruling that there is no coverage owed for lawsuits prompted by the opioid epidemic because the underlying claims “describe exclusively deliberate conduct.”
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).