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Mealey's Drugs & Devices

March 18, 2025
Mass. Federal Judge Allows Design Defect Claims To Move Forward In BioZorb Cases

BOSTON — A group of cases alleging that an implanted radiographic marker used to mark soft tissue sites during cancer treatment was defective and caused injuries survived a motion to dismiss filed by the device manufacturer, which argued that the plaintiffs failed to state a claim for defective design.
March 17, 2025
Fosamax Manufacturer Urges High Court Review Of ‘Outlier’ Preemption Ruling

WASHINGTON, D.C. — High court review is needed again in the long-running Fosamax femur fracture multidistrict litigation, the drug manufacturer says in a petition for certiorari, arguing that the Third Circuit U.S. Court of Appeals “defied” a 2019 U.S. Supreme Court ruling, “gutting drug preemption and rendering itself an outlier among the Circuits” when it found that state law claims are not preempted and reversed the decision that awarded the drug manufacturer summary judgment in 1,046 cases.
March 17, 2025
Boston Appeals Dismissal Of Opioid Suit Against PBMs; PBM Appeals Counsel Ruling

BOSTON — Boston has filed notice that it is appealing to the First Circuit U.S. Court of Appeals an order dismissing its case against two pharmacy benefit managers (PBMs) in which a Massachusetts federal judge found that the city’s claims against the PBMs for their role in contributing to the opioid epidemic are time-barred and that the city lacks standing; separately, one of the PMBs on March 14 filed a notice of cross-appeal, saying the judge erred in refusing to disqualify Motley Rice LLC from representing Boston and others in the suit.
March 14, 2025
Final Approval Hearing Set For $73M Settlement For EpiPen Antitrust Claims

KANSAS CITY, Kan. — A final approval hearing for a $73 million settlement reached with Mylan NV, Mylan Specialty LP and Mylan Pharmaceuticals Inc. (collectively, Mylan) to end claims that they conspired with others in an attempt to delay entry of generic competitors for the EpiPen epinephrine autoinjector (EAI) into the market is scheduled for May 9 in a Kansas federal court, the judge overseeing the case announced.
March 14, 2025
Case Alleging Injury From Defective Stapler Device Survives Motion To Dismiss

JACKSON, Miss. — A lawsuit in a Mississippi federal court alleging that a woman was injured by a defective surgical stapler will continue after a federal judge on March 13 found that the couple adequately pleaded their claims under the Mississippi Products Liability Act (MPLA).
March 14, 2025
Couple Files Amended Complaint, Says Drug Maker Hid Risk Of Stroke, Injuries

SAN FRANCISCO — A federal judge in California on March 13 denied as moot a motion filed by Global Blood Therapeutics Inc. (GBT) and Pfizer Inc. 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 after the couple filed an amended complaint.
March 13, 2025
Indiana Appeals Court Affirms Defective Hip Case Time-Barred By Statute Of Repose

INDIANAPOLIS — The latent disease exception to the Indiana Products Liability Act’s (IPLA) statute of repose does not apply to a case alleging that a defective metal-on-metal hip device caused injuries, the Indiana Court of Appeals ruled, affirming that a trial court properly granted summary judgment for the manufacturer and that the only exceptions to the law are for asbestos-related claims.
March 13, 2025
FTC, Nasal Spray Maker Stipulate To Dismissal In COVID Prevention Claims Case

SALT LAKE CITY — The Federal Trade Commission and a company that claims to make a nasal spray that provides protection against and treatment for COVID-19 filed a joint stipulation of dismissal with prejudice that states that each party is responsible for its own costs and that no party is responsible to any other party for fines, cost or penalties arising from the case.
March 12, 2025
‘Paucity Of Evidence’ Linking Disorders To Gardasil Vaccine Bars Preemption Defense

STATESVILLE, N.C. — The manufacturer of the Gardasil vaccine could not unilaterally add warnings to the vaccine’s label, the North Carolina federal judge overseeing the Gardasil multidistrict litigation ruled, finding that the bellwether plaintiffs’ sole remaining claim is preempted by federal law.
March 12, 2025
Pharmaceutical Company To Settle Claims In National Opiate MDL; Terms Undisclosed

CLEVELAND — Zydus Pharmaceuticals (USA) Inc. and Nesher Pharmaceuticals (USA) LLC (collectively, Zydus) agreed to settle claims against them in the nationwide opioid multidistrict litigation brought by various states, subdivisions and Native American tribes, according to two orders to establish confidential qualified settlement funds signed by the Ohio federal judge overseeing the MDL on March 11.
March 12, 2025
GLP-1 Compounding Pharmacies Appeal Ruling That Denied Stay In Suit Against FDA

FORT WORTH, Texas — Companies representing the interests of drug compounders appealed to the Fifth Circuit U.S. Court of Appeals a Texas federal judge’s ruling that denied 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.
March 11, 2025
Magellan CEO Pleads Guilty In Connection To Malfunctioning Blood Lead Test Kits

BOSTON — The former chief executive officer of Massachusetts medical device company Magellan Diagnostics Inc. on March 10 pleaded guilty in a Massachusetts federal court to one count of introducing misbranded medical devices into interstate commerce following two other plea deals reached with other Magellan executives who were accused of concealing that blood lead testing devices malfunctioned and produced inaccurately low lead levels.
March 11, 2025
Depo-Provera MDL Judge Schedules Hearings To Select Counsel For Leadership Roles

PENSACOLA, Fla. — The 75 attorneys seeking a leadership position in the multidistrict litigation for cases alleging that a long-lasting injectable contraceptive caused women to develop intracranial meningiomas, a type of brain tumor, should be prepared to offer oral arguments at a Florida federal court on March 13 and 14, the federal judge overseeing the MDL said in a pretrial order.
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.