Mealey's Drugs & Devices
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September 05, 2025
4th Circuit: Gardasil Cases Found Untimely In Vaccine Court Properly Dismissed
RICHMOND, Va. — The addition of the Gardasil vaccine to the Vaccine Injury Table is not unconstitutional, and “timely participation in the Vaccine Act compensation program is a prerequisite to bringing a tort suit,” the Fourth Circuit U.S. Court of Appeals held Sept. 4 in affirming a district court’s ruling that dismissed a group of women’s claims from a multidistrict litigation.
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September 04, 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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September 04, 2025
Generic Drug Maker Agrees To $200 Million Settlement With End Payers In MDL
PHILADELPHIA — End-payer plaintiffs (EPPs) in the generic drug pricing antitrust multidistrict litigation pending in a Pennsylvania federal court on Sept. 3 moved for preliminary approval of a settlement for up to $200 million with two manufacturers who allegedly conspired with others to artificially inflate the cost of prescription medications.
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September 03, 2025
Conn. City Sues Drug Makers, PBMs Over Alleged Scheme To Inflate Drug Prices
NEW HAVEN, Conn. — A Connecticut city has sued drug manufacturers and pharmacy benefit managers (PBMs) in a Connecticut federal court, alleging that the companies worked together to artificially raise the price of insulin and other medications to treat diabetes, including glucagon-like peptide-1 receptor agonist (GLP-1) drugs that help control insulin levels.
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September 03, 2025
Judge Sets Trial Date For Case Alleging Sickle Cell Medication Was Ineffective
SAN FRANCISCO — A California federal judge set an August 2027 trial date for a case filed by seven individuals who allege that Oxbryta (voxelotor), a prescription medication used for the treatment of sickle cell disease (SCD), was ineffective and will hear arguments on whether class certification is warranted in June 2026.
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September 03, 2025
Gardasil Maker: Court Properly Dismissed Claims For Adverse Reaction To Vaccine
RICHMOND, Va. — The maker of the Gardasil human papillomavirus vaccine urged the Fourth Circuit U.S. Court of Appeals to uphold a series of rulings that led to a North Carolina federal judge entering final judgment against the plaintiffs in a multidistrict litigation involving claims that the vaccine caused postural orthostatic tachycardia syndrome (POTS) and primary ovarian insufficiency (POI).
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September 03, 2025
Preemption Laws Doom Potential Cochlear Implant Class Action In Calif. Federal Court
LOS ANGELES — A California federal judge on Sept. 2 dismissed a putative class action against the manufacturer of a cochlear implant system after finding that claims raised by a parent that his son’s implant failed to perform as expected are preempted by federal law.
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September 02, 2025
9th Circuit Refuses To Rehear Arguments In Decision That Remanded Opioid Case
SAN FRANCISCO — A panel of judges in the Ninth Circuit U.S. Court of Appeals on Aug. 29 denied a petition filed by a group of pharmacy benefits managers (PBMs) facing allegations of contributing to the opioid epidemic for rehearing or rehearing en banc of the court’s ruling that the U.S. Supreme Court’s holding in Coinbase, Inc. v. Bielski does not extend to an automatic stay in the federal officer removal context.
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August 29, 2025
Opioid MDL Judge Denies Ex Parte Communications Ban After Misdirected Email
CLEVELAND — The Ohio federal judge overseeing the opioid multidistrict litigation on Aug. 28 denied a motion filed by a pharmacy benefit manager (PBM) to bar ex parte communications between the appointed special master in the case and the court, finding that such communication is expressly permitted by a court order and Federal Rule of Civil Procedure 53.
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August 29, 2025
Putative Class Action Against Ankle Monitor Maker Filed In Colo. Federal Court
DENVER — A man who claims that he developed chronic pressure injuries as a result of wearing a court-ordered alcohol monitoring ankle bracelet sued the device manufacturer on Aug. 28 in a Colorado federal court and seeks to represent a nationwide class of individuals alleging similar injuries.
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August 29, 2025
Judge Dismisses FCA Suit Against Publix Super Markets For Opioid Prescriptions
TAMPA, Fla. — A Florida federal judge dismissed with prejudice a second amended complaint filed by two former Publix Super Market pharmacists who allege that the grocery chain violated the False Claims Act by knowingly filling prescriptions for opioids and other controlled substances that it knew were improper.
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August 29, 2025
Clinics Move To Dismiss Case Saying Its Embryo Tests Were Faulty, Misleading
DENVER — The allegations in a class action filed by three women in a Colorado federal court “fundamentally mischaracterize the purpose and limits of preimplantation genetic testing for aneuploidy (‘PGT-A’),” a group of physician-owned fertility clinics argue in a motion to dismiss.
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August 29, 2025
2nd Circuit Says Marketing, Sales Claims In Rapid Release Tylenol Class Preempted
NEW YORK — A federal court properly found that the marketing and pricing claims alleging that Johnson & Johnson Consumer Inc. (JJCI) improperly advertised that its Tylenol Rapid Release Gelcaps worked faster than cheaper tablet alternatives are preempted by federal law, the Second Circuit U.S. Court of Appeals held.
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August 28, 2025
Cook County, Ill., Jury Gives Defense Another Win In Zantac Injury Case
CHICAGO — An Illinois jury on Aug. 27 rejected arguments from a man who claimed that his colorectal cancer was caused by ingesting over-the-counter Zantac and returned a verdict for Boehringer Ingelheim Pharmaceuticals Inc., according to the court docket.
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August 28, 2025
Boston Scientific Secures Summary Judgment In Defective Medical Device Case
NEW YORK — The manufacturer of a medical device used to treat urinary incontinence was awarded summary judgment by a New York federal judge, who found that claims brought by a man who contends that the device repeatedly failed are preempted by federal law.
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August 26, 2025
Lilly, Medical Centers Agree To Settle Diet Drugs Trademark Case In Federal Court
SEATTLE — Eli Lilly and Co., two medical centers and two of their physicians who prescribe patients compounded versions of tirzepatide, a Food and Drug Administration-approved drug for diabetes and weight loss, told a Washington federal judge that they have reached an agreement to end a trademark case filed by Lilly.
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August 20, 2025
COMMENTARY: A Survey Of State Laws Regulating Third-Party Litigation Funding
By Mark A. Behrens and Christopher E. Appel
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August 25, 2025
Texas, Florida Ask To Intervene In Mifepristone Case To Protect States’ Interests
AMARILLO, Texas — Texas and Florida say the three states that intervened in a case originated by a group of antiabortion advocates challenging the U.S. Food and Drug Administration’s approval of the abortion drug mifepristone can no longer represent their interests and on Aug. 22 moved in a Texas federal court for permission to intervene.
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August 22, 2025
Compounding Pharmacies: Judge Erred In Allowing Drug’s Removal From Shortage List
NEW ORLEANS — Upholding a Texas federal judge’s “wayward view” in granting summary judgment to the U.S. Food and Drug Administration and Eli Lilly and Co. in a dispute over whether the agency properly determined that the shortage of tirzepatide, a drug for diabetes and weight loss, would “end judicial review of agency action as it has existed for generations,” companies representing the interests of drug compounders tell the Fifth Circuit U.S. Court of Appeals in an opening brief made public on Aug. 21.
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August 21, 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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August 21, 2025
More States Tell FDA That Mifepristone Restrictions Are Unneeded, Should Be Removed
A coalition of states on Aug. 20 submitted a citizen petition to the U.S. Food and Drug Administration urging the agency to remove the Risk Evaluation and Mitigation Strategy (REMS) restrictions on mifepristone, one of the two drugs prescribed for medication abortions, joining four other states that filed a similar petition in June.
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August 21, 2025
N.Y. Federal Judge Finds Claims In Defective Heart Device Case Are Preempted
NEW YORK — A New York federal judge granted a motion to dismiss a lawsuit filed by the estate of a woman who allegedly died as a result of heart defibrillator device failing to function as intended after finding that the claims are preempted by federal law.
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August 21, 2025
Hologic Loses Bid For Summary Judgment In Bellwether BioZorb Cases
BOSTON — The federal judge in Massachusetts 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 denied a motion for summary judgment filed by the device manufacturer, which argued that two bellwether plaintiffs failed to prove causation.
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August 20, 2025
COMMENTARY: Pharmaceutical Ad Proposals Target Wrong Malady
By Mark A. Behrens and Cary Silverman
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August 20, 2025
Express Scripts: Order In W.Va. Opioid Case Violates Constitutional Rights
WHEELING, W.Va. — A pharmacy benefits manager facing allegations that its actions contributed to an “oversupply” of prescription opioids throughout West Virigina asks a federal court in the state to reconsider its order to expedite a two-phase bench trial on public nuisance liability.