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

Mealey's Drugs & Devices

April 11, 2025
3rd Circuit Affirms Dismissal Of FCA Suit Over ‘Hiding’ Antibiotics’ Side Effects

PHILADELPHIA — The Third Circuit U.S. Court of Appeals on April 10 affirmed 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,” finding that the relator failed to satisfy the essential elements of a False Claims Act (FCA) violation.
April 11, 2025
Judge Says Man’s Defective Hip Implant Case Time-Barred Under New York Law

ROCHESTER, N.Y. — A man’s claims that his hip implant fractured and caused injuries are time-barred, a New York federal judge ruled April 10, granting the manufacturers’ motion for summary judgment.
April 11, 2025
Women To Appeal Dismissal Of Cases From Paragard MDL

ATLANTA — A group of women who saw their cases in the Paragard intrauterine device (IUD) multidistrict litigation dismissed with prejudice for failure to follow a court’s order will appeal the judge’s refusal to reconsider her order to the 11th Circuit U.S. Court of Appeals.
April 10, 2025
FDA: Compounding Pharmacies’ Arguments That Agency’s Actions Violated Law Fail

FORT WORTH, Texas — The U.S. Food and Drug Administration properly determined that the shortage of tirzepatide, an FDA-approved drug for diabetes and weight loss, had ended when it removed the drug from the agency’s drug shortage list, and its order was consistent with the requirements of the Administrative Procedure Act (APA), the agency tells a Texas federal court in a motion for summary judgment.
April 10, 2025
Widow Sues Medical Device Manufacturers, Alleges Defect Caused Husband’s Death

JACKSON, Miss. — A widow sued the manufacturers of a device used during a heart catheterization procedure for wrongful death and other claims in a Mississippi federal court, alleging that the manufacturer knew that the device “had safety issues relative to preventing or detecting an air embolus.”
April 09, 2025
4th Circuit: District Court Did Not Err In Remanding Opioid Case Filed In 2018

RICHMOND, Va. — The Fourth Circuit U.S. Court of Appeals on April 8 affirmed in an unpublished per curiam opinion that a Viriginia federal judge properly remanded a case alleging that multiple companies contributed to a city’s opioid epidemic after finding that the pharmacy benefit managers waived their rights to removal.
April 09, 2025
Valsartan MDL Judge Says Full Refund Not Required, Expert On Damages Excluded

CAMDEN, N.J. — An expert retained by the third-party payer (TPP) trial plaintiffs in the valsartan/losartan/irbesartan hypertension drugs multidistrict litigation is barred from testifying on damages, the MDL judge said, also finding that the plaintiffs are not entitled a full refund as a matter of law.
April 08, 2025
Lilly Says Weight Loss Company Infringed Trademarks With Altered Products

INDIANAPOLIS — Eli Lilly and Co., which manufactures diet drugs Mounjaro and Zepbound, sued an Indiana weight loss clinic for trademark infringement on April 7, alleging in Indiana federal court that the company represents on its website and in advertising material that it sells unaltered, Food and Drug Administration-approved Lilly medicines when it does not.
April 08, 2025
Manufacturers Say Multiple Defective Port Cases Are Untimely, Urge Dismissal

SAN DIEGO — The manufacturers of chemotherapy ports that plaintiffs in a multidistrict litigation allege were defective and caused a multitude of injuries tell a California federal court that a series of complaints were not filed within the applicable statute of limitations period and that none of the plaintiffs’ arguments in opposition “saves their untimely claims from dismissal.”
April 08, 2025
Mylan To Pay $335 Million To Multiple States To Settle Opioid Claims

Mylan Inc. on April 7 agreed to pay up to $335 million in a multistate settlement agreement to end claims that the pharmaceutical company contributed to the opioid epidemic by manufacturing and selling various opioid products since 2005, including generic fentanyl patches, oxycodone, hydrocodone and buprenorphine products.
April 07, 2025
Minnesota Federal Judge Asks JPMDL To End Fluoroquinolone MDL

MINNEAPOLIS — The federal judge overseeing the fluoroquinolone multidistrict litigation pending in the U.S. District Court for the District of Minnesota on April 4 requested that the Judicial Panel on Multidistrict Litigation (JPMDL) terminate the MDL.
April 07, 2025
Magistrate Judge Rules On Discovery Dispute In Toe Cartilage Implant Device Case

CHARLESTON, W.Va. — A West Virginia federal magistrate judge granted in part a man’s motion to compel the manufacturer of a synthetic cartilage implant (SCI) device used to treat arthritis in a toe joint to compel discovery of documents relating to similar incidents.
April 04, 2025
PBMs Ask Opioid MDL Judge To Recuse Over Ex Parte Communication Allegations

CLEVELAND — Pharmacy benefit managers (PBMs) say “they have no choice but to seek” the recusal of the Ohio federal judge overseeing the opioid multidistrict litigation because of reports that an attorney regularly communicates ex parte with the court to get “inside information.”
April 04, 2025
Compounding Pharmacies Say Removing Tirzepatide From Shortage List Was An Error

FORT WORTH, Texas — The U.S. Food and Drug Administration violated federal law when it “abruptly declared the shortage” of tirzepatide, an FDA-approved drug for diabetes and weight loss, over and removed the drug from the agency’s drug shortage list, companies representing the interests of drug compounders tell a Texas federal court in an April 3 motion, moving for summary judgment on its claims against the FDA.
April 03, 2025
Mass Tort Cases For Drugs, Medical Devices

New developments in the following mass tort drug and device cases are marked in boldface type.
April 03, 2025
CVS: ‘Novel’ FCA, CSA Claims Against It For Unlawful Opioid Prescriptions Fail

PROVIDENCE, R.I. — CVS Pharmacy Inc. and its subsidiaries moved to dismiss a majority of the claims filed in a Rhode Island federal court alleging that the pharmacy chain violated the False Claims Act (FCA) and the Controlled Substances Act (CSA) by unlawfully filling prescriptions for opioids and other controlled substances.
April 03, 2025
Judge In Biocell Breast Implant MDL Upholds Magistrate Judge’s Discovery Orders

NEWARK, N.J. —The New Jersey federal judge overseeing the Biocell breast implant multidistrict litigation denied the appeal of two case management orders relating to the shifting of costs to the plaintiffs for certain manufacturing batch record (MBRs) and the scope of a deposition of a corporate representative.
April 01, 2025
Texas Federal Judge Vacates FDA’s Final FDCA Regulation Rule On Lab Test Services

SHERMAN, Texas — A final rule by the U.S. Food and Drug Administration that laboratory-developed testing services can be regulated as medical devices under the Federal Food, Drug, and Cosmetic Act (FDCA) exceeds the agency’s statutory authority, a Texas federal judge held March 31 and vacated the rule.
April 01, 2025
Minn. Ends Claims Against Novo Nordisk After It Agrees To Cap Insulin Costs At $35

NEWARK, N.J. — Minnesota on March 31 moved to dismiss, with prejudice, all of its claims against Novo Nordisk Inc. after a drugmaker signed a settlement agreement, release and order and agreed to make its insulin products available to consumers in Minnesota for no more than $35 for a monthly prescription.
March 31, 2025
Woman Suing Heart Device Manufacturer Seeks Leave To Amend Dismissed Complaint

BOSTON — A woman who claims she was injured when her heart device malfunctioned filed a second motion for leave to file an amended complaint on March 30, days after a Massachusetts federal judge ruled that her first attempt “omitted any cause as to why the motion should be allowed” in response to the judge’s ruling granting the device manufacturer’s motion to dismiss.
March 31, 2025
Women Tell 4th Circuit Gardasil Claims Not Untimely; Merck Urges Court To Affirm

RICHMOND, Va. — Three women whose cases were dismissed in the Gardasil multidistrict litigation for failing to timely file a required petition in the Vaccine Court tell the Fourth Circuit U.S. Court of Appeals that the act’s timing requirement is not jurisdictional; oral arguments are scheduled for May 15.
March 31, 2025
Judge: Taxotere Plaintiffs Failed To Timely Identify Correct Manufacturer

NEW ORLEANS — The Louisiana federal judge overseeing the Taxotere hair loss multidistrict litigation granted two motions to dismiss, finding that the women in those cases failed to properly file their complaints against the proper manufacturers within the applicable statute of limitations.
March 28, 2025
CooperSurgical Says Other Companies Are Responsible For Destroyed Embryos

WATERBURY, Conn. — The manufacturer of a solution used during fertility-related treatments that women allege was toxic and destroyed developing embryos filed an apportionment complaint in a Connecticut court against two companies that it alleges are liable to the women for failure to adequately test the solution.
March 27, 2025
Judge Refuses GLP-1 Compounding Pharmacies’ Request For Injunction Pending Appeal

FORT WORTH, Texas — A Texas federal judge on March 26 said he “is increasingly exasperated by” the attempts of companies representing the interests of drug compounders “to dictate to the undersigned how to manage this case” and denied a motion for an injunction pending their appeal of the judge’s refusal to convert his preliminary injunction order into a final judgment.
March 27, 2025
Federal Judge Agrees With Magistrate Judge That Filshie Clip Claims Are Preempted

HOUSTON — A Texas federal judge adopted a report and recommendation from a federal magistrate judge and agreed that state law claims that a migrated tubal ligation clip caused injuries are federally preempted and ordered the complaint dismissed with prejudice.