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

Mealey's Drugs & Devices

August 06, 2025
Florida Companies Settle Claims That GLP-1 Drug Sales Violated Connecticut Law

HARTFORD, Conn. — Florida companies have settled allegations that they violated Connecticut law by selling research grade semaglutide and tirzepatide directly to consumers in the state as weight loss medications that can be purchased without a prescription.
August 05, 2025
Novo Nordisk Sues Ark. Clinic For Misleading Customers With Compounded Semaglutide

FAYETTEVILLE, Ark. — The manufacturer of Ozempic, Wegovy and Rybelsus says in a complaint filed in an Arkansas federal court on Aug. 4 that a company falsely claims or misleadingly suggests that the compounded drugs that it sells are the same as or equivalent to the manufacturer’s prescription diet and diabetes drugs.
August 05, 2025
PBMs, Calif. Debate If 9th Circuit Should Rehear Ruling That Remanded Opioid Case

SAN FRANCISCO — A group of pharmacy benefits managers (PBMs) facing allegations of contributing to the public nuisance of the opioid epidemic in California argues in a reply brief that the state’s opposition to its petition to the Ninth Circuit U.S. Court of Appeals for a rehearing “underscores why further review is warranted.”
August 05, 2025
Judge Denies Woman’s Second Try To Amend Dismissed Complaint Against Device Maker

BOSTON — A Massachusetts federal judge denied a second motion for leave to file an amended complaint from a woman who claims that she was injured when her heart device malfunctioned, finding that her proposed amendment does not show that the device manufacturer breached its duty to warn.
August 04, 2025
4th Circuit Combines Appeals From Gardasil Bellwether, Nonbellwether Plaintiffs

RICHMOND, Va. — The Fourth Circuit U.S. Court of Appeals has agreed to consolidate appeals filed by bellwether plaintiffs and nonbellwether plaintiffs in the Gardasil multidistrict litigation who have appealed a series of rulings that led to the North Carolina federal judge overseeing the MDL entering final judgment against the plaintiffs.
August 01, 2025
Case Alleging Faulty Bone Plate Ends In Summary Judgment For Manufacturer

NEW ORLEANS — An orthopedic device manufacturer was awarded summary judgment by a Louisiana federal judge, who found that a woman who claims that a bone plate implanted to fix a broken tibia failed did not adequately plead her claims under the Louisiana Products Liability Act (LPLA).
August 01, 2025
Judge: Tenn. Statute Of Limitations Dooms Injury Case Involving Implantable Device

CHICAGO — Tennessee law controls a products liability case filed by a man who alleges that an implantable device used to relieve chronic back pain failed, an Illinois federal judge ruled, finding that the claims are time-barred.
July 31, 2025
Ark. Federal Judge Says Law Banning PBMs From Owning Pharmacies Likely To Fail

LITTLE ROCK, Ark. — A recently signed law that bans pharmacy benefits managers (PBMs) from owning a pharmacy business in Arkansas likely violates the U.S. Constitution’s commerce clause and is likely preempted by federal law, an Arkansas federal judge ruled, granting motions for a preliminary injunction.
July 31, 2025
Judge Adopts Recommendation To Dismiss Case Alleging Weight Loss Drug Injuries

NASHVILLE, Tenn. — A Tennessee federal judge said a woman’s objections to a recommendation from a magistrate judge that a motion for summary judgment filed by employees of a compounding pharmacy be granted and that her complaint alleging injuries from medication taken for weight loss be dismissed “are impressive considering she is a pro se litigant with no readily apparent legal background” but ruled that the case should be dismissed.
July 31, 2025
Man Sues California Doctor For Mailing Abortion-Inducing Medication Into Texas

GALVESTON, Texas — A man filed a complaint in a Texas federal court accusing a California doctor of wrongful death for mailing his pregnant girlfriend abortion-inducing drugs in violation of state law and seeking an injunction that would prohibit the doctor from mailing abortion drugs into the state.
July 31, 2025
FDA Says Surgical Stapler Can Inadvertently Lock During Surgery

SILVER SPRINGS, Md. — The U.S. Food and Drug Administration warned in a correction for a disposable surgical stapler cartridge that the device can inadvertently lock during surgical procedures.
July 30, 2025
N.J. Multicounty Litigation Tracks Sought For Separate Injuries From GLP-1 Drugs

TRENTON, N.J. — The New Jersey Supreme Court has asked for comments on two applications to create separate multicounty litigation (MCL) designations for state court cases alleging that permanent vision loss and gastrointestinal injuries were caused by the use of glucagon-like peptide-I receptor agonist (GLP-1 RA) medications.
July 30, 2025
Judge Dismisses Counterclaims Filed Against Lilly In Diet Drugs’ Trademarks Case

SEATTLE — A Washington federal judge dismissed with prejudice an abuse of process counterclaim filed by medical centers and two physicians who prescribe patients compounded versions of tirzepatide, a Food and Drug Administration-approved drug for diabetes and weight loss, against Eli Lilly and Co., noting that “this is far from a close call.”
July 29, 2025
W.Va. Counties Ask 4th Circuit To Find Opioid Claims Constitute Public Nuisance

RICHMOND, Va. — Attorneys for the Cabell County Commission and Huntington, W.Va., who are suing drug distributors and others for their role in creating an opioid epidemic in the state, filed a notice of supplemental authority with the Fourth Circuit U.S. Court of Appeals, noting that a lower court has denied certain pharmacy benefit managers’ (PBMs) motion to dismiss for failure to state a claim following the state high court’s refusal to weigh in on whether the state’s public nuisance law applies to the sale and distribution of opioids.
July 29, 2025
Series Of Motions To Exclude Experts In Pelvic Mesh Case Denied By Ky. Federal Judge

LEXINGTON, Ky. — The Kentucky federal judge presiding over a long-running case against a pelvic mesh manufacturer denied four separate motions to exclude experts filed by the manufacturer and a woman who says she was injured by the mesh, most recently ruling that the woman’s expert can opine on whether Ethicon Inc. met industry standards.
July 28, 2025
Man Says Contaminated Saline Solution Led To Infection And Amputation

NEWARK, N.J. — A man alleges that contaminated saline solution caused gas gangrene and necrotizing fasciitis of his right foot, leading to continuous medical complications and a below-the-knee amputation, according to a complaint filed in a New Jersey federal court.
July 28, 2025
On Remand From 9th Circuit, Judge Dismisses FCA Suit Against Drugmakers

SAN FRANCISCO — On remand from the Ninth Circuit U.S. Court of Appeals and after the U.S. Supreme Court denied certiorari, a California federal judge dismissed without prejudice a qui tam suit accusing pharmaceutical companies of violating the False Claims Act (FCA) and related state laws by artificially inflating drug prices, finding that dismissal “is warranted” because the second amended complaint “lumps” the companies “together in an undifferentiated mass” regarding the alleged fraud.
July 28, 2025
Judge Gives Final Approval To $3.57M Similasan Eye Product Class Settlement

DENVER — A federal judge in Colorado has granted final approval to a $3.57 million settlement between the maker of nonprescription health care products and plaintiffs who claim that it sold products without approval from U.S. Food and Drug Administration, noting that nearly 100,000 claim forms have been filed.
July 24, 2025
Partial, Limited Preliminary Injunction Granted In Iowa PBM Law Challenge

DES MOINES, Iowa — Citing the First Amendment, the Employee Retirement Income Security Act and a recent U.S. Supreme Court ruling, an Iowa federal judge issued a preliminary injunction order enjoining Iowa state regulators from enforcing 11 provisions of a new state pharmacy benefit manager (PBM) law against the plaintiffs “and their contractors and agents who assist in the administration of their health benefit plans.”
July 21, 2025
8 Opioid Manufacturers Agree To $720 Million Nationwide Settlement

Eight drug manufacturers have reached a nationwide settlement agreement, pledging to pay $720 million to fund drug prevention and treatment services throughout the country to end legal claims stemming from their roles in the U.S. opioid epidemic.
July 18, 2025
Hims Shareholder Files Derivative Complaint Over Compounded Semaglutide

SAN FRANCISCO — A shareholder of Hims & Hers Health Inc. on July 17 filed a stockholder derivative action in a California federal court on behalf of the company, accusing the company’s board of directors and executives of misleading the shareholders about a collaboration with Novo Nordisk Inc. that would allow Hims to sell compounded semaglutide products.
July 18, 2025
6th Circuit Affirms Hip Implant Device Manufacturer’s Summary Judgment Award

CINCINNATI — A lower court properly granted a manufacturer of a hip implant device summary judgment after finding that a man’s expert witnesses to support his claim that the device was defective were properly excluded under Federal Rule of Evidence 702 and Daubert v. Merrell Dow Pharmaceuticals Inc., the Sixth Circuit U.S. Court of Appeals held.
July 17, 2025
Mass Tort Cases For Drugs, Medical Devices

New developments in the following mass tort drug and device cases are marked in boldface type.
July 16, 2025
Judge Dismisses Defective Medical Device Case After Man Doesn’t Amend Complaint

NEW ORLEANS — A Louisiana federal judge cited a man’s “admission on the record that his claims are preempted as currently pled and his failure to otherwise amend his petition” and dismissed with prejudice his complaint that an allegedly defective medical device that was implanted to control pain caused injuries.
July 16, 2025
Magistrate Judge: Off-Label Promotion Use Of Drug Case Belongs In Federal Court

WILMINGTON, Del. — A federal magistrate judge in Delaware recommended that the court deny a motion to remand a case filed by mothers who allege that a pharmaceutical manufacturer wrongfully promoted the off-label use of an asthma drug to treat preterm labor in pregnant women.