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

Mealey's Drugs & Devices

May 23, 2025
Stem Cells Are Not Drugs Under FDCA, Clinic Tells High Court In Urging Review

WASHINGTON, D.C. — The Ninth Circuit U.S. Court of Appeals erred in finding that a stem cell mixture used by clinics is a drug under the U.S. Federal Food, Drug, and Cosmetic Act (FDCA), a stem cell clinic and its owners tell the U.S. Supreme Court in a petition for a writ of certiorari.
May 23, 2025
Depo-Provera MDL Judge Says Complaints Must Identify Requisite Injury And Product

PENSACOLA, Fla. — The Florida federal judge overseeing the Depo-Provera multidistrict litigation, a group of cases alleging that a long-lasting injectable contraceptive caused women to develop intracranial meningiomas, a type of brain tumor, outlined what complaints must contain to be included in the MDL and identified potential deficiencies in complaints that have been filed.
May 22, 2025
Judge Dismisses Complaint Alleging That Medication Contained Benzene As Preempted

CHICAGO — A group of consumers who allege that over-the-counter medicine sold by Walgreens Inc. contained benzene have standing to sue, an Illinois federal judge found, but he agreed to dismiss the complaint after finding that federal law prohibited Walgreens from changing the drug’s label.
May 22, 2025
Judge Signs Off On Final Approval Of $73M Settlement For EpiPen Antitrust Claims

KANSAS CITY, Kan. — A Kansas federal judge on May 21 granted final approval to 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.
May 21, 2025
Woman’s Taxotere Case Tossed For Failing To Timely Name Proper Defendants

NEW ORLEANS — The judge overseeing multidistrict litigation for cases alleging that a chemotherapy drug caused permanent hair loss granted a motion to dismiss a Florida woman’s complaint, finding that her claims are time-barred under Florida law.
May 21, 2025
Women Say Implantable BioZorb Marker Device Was Defective, Sue Manufacturer

BOSTON — Six women who allege that an implanted radiographic marker used to mark soft tissue sites during cancer treatment was defective and caused injuries filed a combined complaint against the manufacturer in a Massachusetts federal court.
May 20, 2025
Man Sues Medtronic, FDA For Injuries Caused By Defective Spinal Cord Device

MINNEAPOLIS — A man who claims in a Minnesota federal court that two spinal cord stimulation (SCS) devices manufactured by Medtronic Inc. failed and caused pain sued the manufacturer and the U.S. Food and Drug Administration, alleging that the agency violated federal law in approving the devices.
May 20, 2025
Hernia Mesh MDL Judge OKs Dismissal Of 5 Cases After Agreements Reached

ATLANTA — The judge overseeing the Ethicon Physiomesh hernia patch multidistrict litigation signed off on the dismissal of another five cases after the parties told the court in a joint motion that they have settled all claims in those cases.
May 16, 2025
CEO Of Spinal Device Company To Plead Guilty To Unlawfully Paying Surgeons

BOSTON — The founder and CEO of a spinal medical device company on May 15 agreed to plead guilty to one count stemming from charges that he paid consulting fees to induce doctors to use the company’s products in surgeries that were reimbursed by federal health care programs.
May 15, 2025
Drugmakers Move To Dismiss Case Claiming Sickle Cell Medication Was Ineffective

SAN FRANCISCO — An amended complaint filed by seven individuals who allege that Oxbryta (voxelotor), a prescription medication used for the treatment of sickle cell disease (SCD), was ineffective should be dismissed because the claims are either preempted for fail as a matter of law, Global Blood Therapeutics Inc. (GBT) and Pfizer Inc. tell a California federal court.
May 15, 2025
Acetaminophen Makers Win Summary Judgment In Calif. Case Linking Drug To Autism

OAKLAND, Calif. — A California judge granted the manufacturers of acetaminophen summary judgment in a case brought by a mother who alleges that prenatal ingestion of the over-the-counter drug led to her child developing autism, finding that her claims based on failure-to-warn fail as a matter of law.
May 15, 2025
Mass Tort Cases For Drugs, Medical Devices

New developments in the following mass tort drug and device cases are marked in boldface type.
May 14, 2025
FDA, Diet Drug Maker Win Summary Judgment In Case Against Compounding Pharmacies

FORT WORTH, Texas — A Texas federal judge on May 13 made public his ruling that granted summary judgment to the U.S. Food and Drug Administration and to Eli Lilly and Co. in a dispute filed by companies representing the interests of drug compounders over whether the agency properly determined that the shortage of tirzepatide, a drug for diabetes and weight loss, had ended when it removed the drug from the agency’s drug shortage list.
May 14, 2025
Federal Judge Grants Compounding Pharmacy Summary Judgment In Semaglutide Spat

TAMPA, Fla. — A Florida federal judge on May 13 entered judgment in favor of a pharmaceutical company accused of selling unapproved compounded drugs containing semaglutide after finding that the sole claim raised by Novo Nordisk Inc. “is moot, impliedly preempted, and fails on the merits for failure to show consumer injury.”
May 13, 2025
West Virginia High Court Refuses To Weigh In On Public Nuisance Law For Opioids

CHARLESTON, W.Va. — The West Virginia Supreme Court of Appeals on May 12 declined to answer a certified question from the Fourth Circuit U.S. Court of Appeals to address the dispute over whether the state’s public nuisance law applies to the sale and distribution of opioids.
May 13, 2025
Theranos’ Balwani Says 9th Circuit’s ‘Serious Error’ Makes Rehearing Necessary

SAN FRANCISCO — Former Theranos Chief Operating Officer Ramesh “Sunny” Balwani tells the Ninth Circuit U.S. Court of Appeals that it should grant a rehearing or a rehearing en banc to reconsider its ruling that the government’s failure to correct false testimony during his criminal trial does not warrant a new trial.
May 13, 2025
Fosamax MDL Plaintiffs Reject Need For High Court Review Of Preemption Ruling

WASHINGTON, D.C. — The U.S. Supreme Court should deny a petition for certiorari in the long-running Fosamax femur fracture multidistrict litigation because the Third Circuit U.S. Court of Appeals “faithfully” applied precedent from the high court “to the facts of this case to find that federal law did not preempt state-law claims” when it reversed a decision that awarded a drug manufacturer summary judgment in 1,046 cases, the plaintiffs say in a May 12 brief.
May 09, 2025
Pharmacies Say Appeals Court Erred In Finding Counties Not Persons Under Texas Law

AUSTIN, Texas — A group of pharmacies tells the Texas Supreme Court that a Texas appellate court erred in rejecting its arguments that Texas counties suing pharmacies in two cases for their role in the opioid epidemic are claimants under the Texas Medical Liability Act (TMLA) and that their cases should be dismissed.
May 09, 2025
3rd Circuit Won’t Rehear Ruling Affirming Dismissal Of FCA Suit Over Antibiotics

PHILADELPHIA — The Third Circuit U.S. Court of Appeals denied a petition for rehearing and rehearing en banc of its ruling affirming a lower court’s dismissal of a qui tam relator’s suit against Bayer Corp., Johnson & Johnson, Merck & Co. and other pharmaceutical companies, alleging that “hiding” side effects of their antibiotics from the U.S. Food and Drug Administration “caused fraudulent claims to be submitted to Medicaid and Medicare.”
May 08, 2025
Parties Respond To Request To Name Bellwether Cases In Bard Port Catheter MDL

PHOENIX — The parties involved in the multidistrict litigation involving C.R. Bard Inc.’s implanted port catheter (IPC) device pending in an Arizona federal court over claims that the defective devices caused various injuries, including death, on May 7 filed a joint motion to seal their responses to an order from the judge overseeing the case to weigh in on bellwether case selections.
May 08, 2025
Compounding Pharmacies Appeal Removal Of Tirzepatide From Shortage List Spat Ruling

FORT WORTH, Texas — Companies representing the interests of drug compounders on May 7 filed a notice of interlocutory appeal to the Fifth Circuit U.S. Court of Appeals immediately after a Texas federal judge in an order under seal granted two motions for summary judgment in a dispute over whether the agency properly determined that the shortage of tirzepatide, a drug for diabetes and weight loss, had ended when it removed the drug from the agency’s drug shortage list.
May 07, 2025
Bayer Moves To Dismiss Complaint Alleging Injuries From Birth Control Device

SEATTLE — “Perforation and migration to the abdominal cavity is an adverse event that is expressly and repeatedly warned of in the official labeling and patient information materials” of the Mirena intrauterine contraceptive device (IUD), its manufacturer argues in a May 6 motion in Washington federal court to dismiss a woman’s claim that she was injured by the allegedly defective device.
May 06, 2025
Woman Claims Spinal Cord Device Caused Injuries, Sues Manufacturer And FDA

CHICAGO — A woman on May 5 filed a complaint in an Illinois federal court against Abbott Laboratories and the U.S. Food and Drug Administration alleging that she was injured by an implanted spinal cord stimulator (SCS) device and that the device had “been fundamentally altered” since its initial approval by the FDA.
May 06, 2025
Trump Administration Says States Cannot Establish Venue In Mifepristone Case

AMARILLO, Texas — The U.S. Food and Drug Administration urges a Texas federal court to dismiss an amended complaint filed by Missouri, Kansas and Idaho in a case originated by a group of antiabortion advocates challenging the FDA’s approval of the abortion drug mifepristone, a case that eventually reached the U.S. Supreme Court, which found that the original plaintiffs lacked standing, with the Trump administration now taking the same position as its predecessor and arguing in a reply brief filed May 5 that the intervening states cannot satisfy venue requirements to continue in the Texas court.
May 05, 2025
Implantable Port Maker Denies Claims That It Concealed Defects In Device

MINNEAPOLIS — A manufacturer of an implantable port system that is accused of concealing that the system was defective and unsafe on May 2 answered an amended complaint filed in a Minnesota federal court, arguing that the claims are time-barred and preempted by the Medical Device Amendments (MDA) to the Food, Drug and Cosmetic Act (FDCA), among other defenses.