Mealey's Drugs & Devices
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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.
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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.”
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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.
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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.
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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.
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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.”
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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March 27, 2025
Mass. Federal Judge Appoints Leadership Positions For BioZorb Cases
BOSTON — A federal judge in Massachusetts who is overseeing a group of cases in which women allege that an implanted radiographic marker used to mark soft tissue sites during cancer treatment was defective and caused injuries has appointed counsel to leadership positions.
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March 25, 2025
Magistrate Judge: Motion To Dismiss Should Be Granted In Medical Device Case
SACRAMENTO, Calif. — A federal magistrate judge in California recommended that a motion to dismiss filed by a diabetes monitor manufacturer be granted for failure to state a claim and that a pro se plaintiff be allowed 30 days to amend his complaint for a second time.
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March 24, 2025
Judge: Medical Director Not Manufacturer, Seller Under Michigan Statutes
FLINT, Mich. — An employee who approved donor tissue or participated in quality control of that tissue is not a manufacturer or seller under Michigan’s product liability statutes, a Michigan federal judge said March 21, granting a partial motion to dismiss.
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March 24, 2025
11th Circuit Dismisses Complaint Accusing Depo-Provera MDL Judge Of Misconduct
ATLANTA — The chief judge of the 11th Circuit U.S. Court of Appeals found that the “voluntary corrective actions” by the judge overseeing the Depo-Provera multidistrict litigation who faced a complaint that her encouragement of women to apply for leadership positions in the MDL constituted impermissible bias and judicial misconduct “warrant the conclusion of this proceeding.”
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March 24, 2025
Washington Law Does Not Shield Walgreens From OTC Claims, State High Court Says
SEATTLE — A drug manufacturer labeling an over-the-counter cough medicine as nondrowsy does not fall within the statutory safe harbor of the Washington Consumer Protection Act (CPA), the state Supreme Court said in answering a certified question from a district court.
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March 20, 2025
Opioid MDL Judge Denies Albertsons’ Motion For Interlocutory Appeal
CLEVELAND — The Ohio federal judge overseeing the opioid multidistrict litigation on March 19 denied pharmacy defendant Albertsons’ motion for an interlocutory appeal of his ruling that denied its motion for summary judgment, “concluding that the motion is better presented to the transferor court on remand.”
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March 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.