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

Mealey's Drugs & Devices

March 11, 2025
Judge Allows Case Alleging Violations Of Diet Drugs’ Trademarks To Move Forward

SEATTLE — A Washington federal judge agreed that state law claims filed against medical centers and two physicians who prescribe patients compounded versions of tirzepatide, an FDA-approved drug for diabetes and weight loss, are preempted by federal law but otherwise denied a motion to dismiss.
March 10, 2025
GLP-1 Compounding Pharmacies Lose Bid To Stay Removal Of Drug From Shortage List

FORT WORTH, Texas — A Texas federal judge refused to grant a preliminary injunction and stay on the U.S. Food and Drug Administration’s decision to remove an FDA-approved drug for diabetes and weight loss from the agency’s drug shortage list, finding in an order unsealed March 7 that companies representing the interests of drug compounders failed to show a likelihood of “success on the merits of their claims, which is the most important (and usually decisive) factor.”
March 06, 2025
Mass Tort Cases For Drugs, Medical Devices

New developments in the following mass tort drug and device cases are marked in boldface type.
March 06, 2025
CooperSurgical: Consolidated Destroyed Embryo Cases Require Separate Trials

WATERBURY, Conn. — The manufacturer of a solution used during fertility-related treatments that women allege was toxic and destroyed developing embryos agrees that cases filed in a Connecticut state court should be transferred to the state’s complex litigation docket for pretrial purposes but argues that the cases should remain separate for trial.
March 06, 2025
N.Y. Appeals Court: Device Maker Not Liable For Burns Caused By Ice On Bare Skin

NEW YORK — Because ice packs were not necessary for a medical device to function and because the manufacturer’s duty to warn extended to the provider and not the patient, a New York state court erred in denying the manufacturer’s motion for summary judgment, a state appeals court held, reversing and ordering the complaint dismissed.
March 05, 2025
Woman’s Claims Alleging Tubal Ligation Clip Injuries Are Preempted By Federal Law

KANSAS CITY, Mo. — Claims filed by a woman who alleges that she was injured by a migrated tubal ligation clip are preempted by federal law, a Missouri federal judge ruled March 4, awarding summary judgment to four defendants named in the suit.
March 05, 2025
Final Approval Of $40M Settlement Granted In Securities Fraud Class Action

BALTIMORE — A federal judge in Maryland granted final approval of a $40 million settlement in a securities fraud class action brought by investors against a COVID-19 vaccine contractor that experienced contamination issues at its Bayview, Md., manufacturing facility and several of its executives.
March 04, 2025
5th Circuit Affirms Dismissal Of Taxotere Case For Late Serving Of Complaint

NEW ORLEANS — The Fifth Circuit U.S. Court of Appeals affirmed the dismissal of a case involving a woman who took nearly five years before serving a complaint on the manufacturer of a chemotherapy drug that she alleges caused her permanent hair loss.
March 04, 2025
Md. Federal Judge Rejects Challenge To State Statute In Case Involving HeLa Cells

BALTIMORE — A Maryland statute requiring a foreign corporation that does intrastate business in Maryland to register with the state or otherwise forfeit its ability to assert a statute of limitations defense is constitutional, a Maryland federal judge held March 3, rejecting a pharmaceutical company’s motion for judgment on the pleadings in a case filed by the family of Henrietta Lacks, a Black woman whose medical tissue was taken without her consent in 1951 to create the first immortalized human cell line that has been used in various medical developments.
March 03, 2025
Putative Class Action Filed In Colorado Federal Court For Contaminated Eye Drops

DENVER — A woman who alleges that she purchased over-the-counter eye drops that were later recalled after the company discovered that certain products were contaminated with fungus sued the manufacturer in a Colorado federal court, seeking to represent a class of consumers.
March 03, 2025
Companies Move To Dismiss Case Alleging Medication Caused Stroke, Injuries

SAN FRANCISCO — An April hearing will be held in a California federal court to consider a motion filed by two drug manufacturers to dismiss a complaint alleging that Oxbryta (voxelotor), a prescription medication used for the treatment of sickle cell disease (SCD), caused a man to experience an increased rate of vaso-occlusive crises (VOCs) and to suffer a stroke.
February 28, 2025
Woman’s Claims On Defective Birth Control Device Fail On Preemption Grounds

COLUMBUS, Ohio — An Ohio federal judge granted summary judgment to the manufacturer, distributor and parent company of birth control device that a woman claimed detached and migrated through her body after finding that her remaining claim is preempted by federal law.
February 27, 2025
Compounding Pharmacies Sue FDA For Removal Of Semaglutide From Drug Shortage List

FORT WORTH, Texas — The U.S. Food and Drug Administration, in “a reckless and arbitrary decision,” removed semaglutide, an FDA-approved drug for diabetes and weight loss, from the agency’s drug shortage list in violation of the Administrative Procedure Act (APA), a drug compounder and an association representing the interests of drug compounders allege in a complaint filed in a Texas federal court.
February 27, 2025
Judge Partially Dismisses Hip Replacement Patient’s Suit Over Defective Implant

SAN FRANCISCO — A California federal judge found that a man’s third amended complaint failed to cure deficiencies in his claims that a defective prosthetic hip replacement released toxic metals into his body, granting the manufacturer’s partial motion to dismiss.
February 27, 2025
Generic Mifepristone Maker Moves To Intervene In States Case Against FDA

AMARILLO, Texas — GenBioPro Inc., the maker of generic mifepristone, one of two drugs used to induce early termination of pregnancy, moved to intervene in a case challenging the U.S. Food and Drug Administration’s approval of the abortion drug, a case that eventually reached the U.S. Supreme Court, which found that the plaintiffs lacked standing and in which the original plaintiffs have now voluntarily dismissed all of their claims but that has been kept alive by a Texas federal judge’s decision to allow intervening states Missouri, Kansas and Idaho to file an amended complaint.
February 27, 2025
Woman, Manufacturers Agree To Dismiss Appeal Of Case Alleging Drug Risk

PHILADELPHIA — A woman who claims that she was misled into purchasing a weight loss medication that was associated with a known cancer risk and the drug manufacturers filed a joint stipulation to dismissal of the woman’s appeal in the Third Circuit U.S. Court of Appeals.
February 26, 2025
Newly Named MDL Judge Selects 5 Pilot Cases For Depo-Provera Litigation

PENSACOLA, Fla.— The Florida federal judge who in early February was appointed to oversee a multidistrict litigation of cases alleging that a long-lasting injectable contraceptive caused women to develop intracranial meningiomas, a type of brain tumor, said in a case management order that she has selected five pilot cases “to proceed through discovery and trial.”
February 26, 2025
Cook County, Ill., Jury Returns Defense Verdict In Zantac Injury Retrials

CHICAGO — A Cook County Circuit Court jury returned a verdict for Boehringer Ingelheim Pharmaceuticals Inc. in a retrial for two men who alleged that their prostate cancer was caused by ingesting over-the-counter Zantac.
February 26, 2025
Couple, Manufacturer Agree To End Case Over Loss Of Embryos During IVF Procedure

CHARLOTTE, N.C. — A manufacturer of sterile mineral oil and a couple who allege that the solution was toxic and led to the destruction of their embryos filed a joint stipulation to the dismissal of the case with prejudice in a North Carolina federal court.
February 25, 2025
FDA: Preliminary Injunction Not Needed In GLP-1 Compounding Pharmacies’ Suit

FORT WORTH, Texas — The U.S. Food and Drug Administration opposed a motion for a preliminary injunction filed by companies representing the interests of drug compounders that challenge the U.S. Food and Drug Administration’s decision to remove two FDA-approved drugs for diabetes and weight loss from the agency’s drug shortage list, arguing that the companies are unlikely to succeed in its suit against the agency.
February 25, 2025
9th Circuit Finds No Error In Convictions, Sentencing Of Theranos’ Holmes, Balwani

SAN FRANCISCO — The Ninth Circuit U.S. Court of Appeals on Feb. 24 affirmed the convictions, sentences and restitution orders against Theranos Inc. founder Elizabeth Holmes and former Theranos Chief Operating Officer Ramesh “Sunny” Balwani, finding no error in multiple decisions by the trial court that the pair raised as arguments on appeal.
February 20, 2025
Singapore Court Freezes Bioscience Company’s Assets Pending $830M Arbitration

SINGAPORE — A judge of the Singapore International Commercial Court granted an ex parte application by a Danish company brought against a Singaporean bioscience company and its founder for a worldwide asset freeze pending arbitration in New York regarding an $830 million dispute over a drug for hypertension and kidney disease.
February 20, 2025
Mass Tort Cases For Drugs, Medical Devices

New developments in the following mass tort drug and device cases are marked in boldface type.
February 20, 2025
Company, Owner Agree To $1M Fine For Selling Altered Products Purchased Overseas

CHICAGO — An Illinois medical device company and its owner will pay a $1 million fine to end a federal criminal investigation into allegations that the company purchased products overseas and concealed that information when reselling the products (United States v. Advanced Inventory Management, Inc., et al., No. 25-18, N.D. Ill.).
February 19, 2025
1st Circuit Affirms Ruling In DOJ ‘First Impression’ FCA Suit Against Regeneron

BOSTON — The First Circuit U.S. Court of Appeals on Feb. 18 affirmed a lower court ruling granting summary judgment to Regeneron Pharmaceuticals in a U.S. Department of Justice (DOJ) suit alleging violations of the federal False Claims Act (FCA) and the Anti-Kickback Statute (AKS) regarding purported improper funding of the Chronic Disease Fund (CDF) to subsidize patient copays for a Regeneron macular degeneration drug, finding that in this case of “first impression” regarding a 2010 amendment to the AKS, to show falsity under the amendment, the government must prove “that an illicit kickback was the but-for cause of a submitted claim.”