Mealey's Drugs & Devices
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April 17, 2025
PBMs Lose Bid To Dismiss County’s Suit Against Them For Role In Opioid Crisis
SEATTLE — A Washington federal judge rejected arguments from two pharmacy benefits managers (PBMs) that a county in the state failed to state a claim in its suit alleging that the PBMs helped create and perpetuate the opioid epidemic and denied a motion to dismiss.
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April 17, 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 16, 2025
Philips Objects To Special Master’s Report That Says Summary Judgment Motion Fails
PITTSBURGH —The manufacturer of recalled continuous positive air pressure (CPAP) sleep apnea devices and respirators facing a false claims lawsuit filed by SoClean Inc., which makes equipment that uses ozone to clean and disinfect CPAP devices, objected to a special master’s recommendation that its motion for summary judgment be denied, arguing that “black-letter federal law” dictates that SoClean lacks standing because it never had preapproval from the U.S. Food and Drug Administration to sell those products.
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April 15, 2025
Gardasil Bellwether Plaintiffs Appeal Multiple Adverse Rulings To 4th Circuit
RICHMOND, Va. — The bellwether plaintiffs in the Gardasil multidistrict litigation have appealed to the Fourth Circuit U.S. Court of Appeals a series of rulings that led to the North Carolina federal judge overseeing the MDL entering final judgment against the plaintiffs.
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April 14, 2025
Theranos’ Holmes Says 9th Circuit En Banc Review, Rehearing Needed
SAN FRANCISCO — Theranos Inc. founder and CEO Elizabeth Holmes argues that the Ninth Circuit U.S. Court of Appeals erred in affirming her conviction, sentence and restitution order and the “panel’s flawed opinion calls out for en banc review.”
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April 14, 2025
Organizations Tell High Court It Must Review Preemption Ruling In Fosamax Case
WASHINGTON, D.C. — Three amicus curiae briefs were filed April 11 in support of the U.S. Supreme Court granting a petition for certiorari to correct an alleged erroneous application of preemption law by the Third Circuit U.S. Court of Appeals when it reversed a district court’s decision that awarded a drug manufacturer summary judgment in 1,046 cases in the long-running Fosamax femur fracture multidistrict litigation.
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April 14, 2025
Insured Appeals No Coverage Ruling In Dispute Arising From Opioid Epidemic
TAMPA, Fla. — An insured told Florida federal court that it is asking the 11th Circuit U.S. Court of Appeals to review the court’s judgment in favor of insurers in its lawsuit seeking coverage for underlying actions arising from the opioid epidemic, challenging the court’s finding that the insurers have no duty to defend or indemnify because the opioid lawsuits fail to allege damages “for bodily injury” or “because of bodily injury.”
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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.
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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.
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April 11, 2025
Women 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 appealed the judge’s refusal to reconsider her order to the 11th Circuit U.S. Court of Appeals.
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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.
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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.”
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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.
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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.
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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.