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Mealey's Drugs & Devices

July 09, 2025
Magistrate Judge Recommends Dismissal Of Case Alleging Weight Loss Drug Injuries

NASHVILLE, Tenn. — While recognizing that woman’s “pro se status affords her with some measure of leniency from the Court,” a Tennessee federal magistrate judge on July 8 recommended that a motion for summary judgment filed by employees of a compounding pharmacy be granted and that a complaint alleging injuries from medication taken for weight loss be dismissed.
July 09, 2025
Washington Federal Judge Rules That FDA’s Restrictions On Mifepristone Can Stand

YAKIMA, Wash. — The U.S. Food and Drug Administration’s decision to add Risk Evaluation and Mitigation Strategy (REMS) restrictions on mifepristone, one of the two drugs prescribed for medication abortions, was not arbitrary or capricious, a Washington federal judge found on July 8, rejecting a request by a coalition of states to grant summary judgment and remand the matter to the FDA for further consideration.
July 08, 2025
Illinois Appeals Court Affirms Dismissal Of Non-Brand Defendants In Zantac Case

CHICAGO — Claims against non-brand defendants in a woman’s case alleging that the heartburn drug Zantac and its generic equivalent, ranitidine, caused her to develop colon cancer were properly dismissed, an Illinois appeals court affirmed.
July 08, 2025
Prenatal Tests Maker To Settle Class Action Claims Of False Positives For $8.25M

OAKLAND, Calif. — The manufacturer of noninvasive prenatal tests will pay up to $8.25 million in a class action settlement to resolve claims that its tests returned false positive test results for some rare genetic conditions despite advertising its products as reliable and accurate, according to a motion for preliminary approval of class action settlement filed in a California federal court.
July 07, 2025
Applying Recent High Court Decision, Judge Grants Limited TRO For Iowa PBM Law

DES MOINES, Iowa — Noting “the Supreme Court’s recent narrowing of district courts’ ability to impose injunctive relief beyond that which is necessary to afford relief to named parties,” an Iowa federal judge imposed an ex parte temporary restraining order (TRO) barring enforcement of a new Iowa pharmacy benefit manager (PBM) law as to the plaintiffs and the members of one of those plaintiffs; the judge concluded that the plaintiffs sufficiently showed that the provisions “are unenforceable as preempted by [the Employee Retirement Income Security Act] and violative of the First Amendment.”
July 07, 2025
N.C. Appeals Court Affirms Summary Judgment, Says Decedent’s Acts Led To Death

RALEIGH, N.C. — A North Carolina trial court did not err in granting summary judgment to the manufacturer of an over-the-counter bronchodilator, a state appeals court said, finding that the contributory negligence of a woman who died after using the product barred her claims.
July 07, 2025
Faulty Bone Cement Failed, Woman Alleges In Complaint Filed In N.C. Federal Court

ASHEVILLE, N.C. — A defective bone cement used during a 2018 surgery failed to bond a woman’s knee prothesis to her bone, forcing her to undergo a third revision surgery to fix it, a woman alleges in a complaint filed in a North Carolina federal court.
July 07, 2025
Government Says Theranos’ Holmes Is Not Eligible For Sentence Reduction

SAN JOSE, Calif. — Elizabeth A. Holmes, the founder and former CEO of defunct biotechnology startup Theranos Inc., “is ineligible for a sentence reduction because she personally orchestrated a fraud scheme that caused dozens of investors to invest over $800 million in the company she founded . . . based on false misrepresentations,” the government said in opposition to her motion asking a California federal court to reduce her sentence pursuant to an amendment to sentencing guidelines.
July 03, 2025
Woman Alleges Sister’s Death Was Caused By Use Of Depo-Provera; Suit To Join MDL

PENSACOLA, Fla. — The sister of a woman who died from a hemorrhage caused by an intracranial meningioma filed a wrongful death suit in Florida federal court against the manufacturer of Depo-Provera, a long-lasting injectable contraceptive that she alleges caused the death.
July 03, 2025
Judge Says Ethicon’s Expert Can Testify On Conditions Of Pelvic Mesh Devices

LEXINGTON, Ky. — The Kentucky federal judge presiding over a long-running case against a pelvic mesh manufacturer denied a woman’s motion to exclude a female pelvic medicine and reconstructive surgery expert from testifying for Ethicon Inc., finding that the doctor’s testimony is reliable.
July 02, 2025
D.C. Circuit Upholds Approval Of Drug; Not ‘Same’ Under Orphan Drug Act

WASHINGTON, D.C. — The District of Columbia Circuit U.S. Court of Appeals found that the U.S. Food and Drug Administration’s approval of a drug to treat narcolepsy during Jazz Pharmaceuticals Inc.’s seven-year exclusivity period for a drug containing the same active ingredient approved for the same disease or condition did not violate the Administrative Procedure Act (APA).
July 02, 2025
Texas Counties Say State High Court Opinion Confirms That Counties Are Not Persons

AUSTIN, Texas — Counsel for two Texas counties that sued pharmacies for their role in the opioid epidemic sent a letter to the Texas Supreme Court contending that a recent decision by the court “confirms that arguments advanced by the Pharmacy Defendants are inapplicable where, as here, the plaintiffs are not patients.”
July 02, 2025
Man Says ‘Gas Station Heroin’ Mimics Opioids In Proposed Class Action Against Maker

ATLANTA — An Illinois man seeks to represent a class of consumers who purchased over-the-counter dietary supplements that contain tianeptine, a highly addictive substance that can mimic the effects of illicit substances such as marijuana, cocaine and opioids, according to a complaint filed in a Georgia federal court.
July 02, 2025
Judge In Biocell Breast Implant MDL Sets Deadlines In Advance Of 1st Trial

NEWARK, N.J. — The first surgical explant bellwether trial in the Biocell breast implant multidistrict litigation is slated to begin June 15, 2026, the New Jersey federal judge overseeing the MDL announced in a case management order.
July 01, 2025
Judge Amends Order In Semaglutide Spat With Drug Maker, Compounding Pharmacy

TAMPA, Fla. — A Florida federal judge on June 30 granted Novo Nordisk Inc.’s motion to amend the court’s order granting summary judgment in favor of a pharmaceutical company accused of selling unapproved compounded drugs containing semaglutide, ruling that the motion for summary judgment is moot and that the drug manufacturer’s complaint is dismissed without prejudice.
July 01, 2025
Medical Spa Urges Court To Toss Complaint Filed By Semaglutide Manufacturer

NEWARK, N.J. — Novo Nordisk’s opposition to a motion to dismiss “does nothing to change the fact that its causes of action remain insufficiently pled under” Ashcroft v. Iqbal and Bell Atlantic Corp. v. Twombly, an aesthetic medical practice facing allegation that it improperly markets and sells compounded drug products that purport to contain semaglutide says in its June 30 reply brief.
July 01, 2025
Zimmer, Biomet Answer Complaint Alleging Hip Implant Injuries

CHICAGO — Zimmer US Inc. and Biomet Orthopedics LLC answered a complaint filed in an Illinois federal court by a man alleging injuries caused by a metal-on-metal hip implant, denying the allegations and asserting 43 affirmative defenses.
June 30, 2025
Judge Trims Claims Against Manufacturer In Defective Defibrillator Lead Case

NEWARK, N.J. — A federal judge in New Jersey partially granted a motion to dismiss certain claims leveled against a defibrillator lead manufacturer, finding that some claims are preempted by federal law or are subsumed by the New Jersey Products Liability Act.
June 27, 2025
Parties Dismiss 1 Insurer In N.C. Coverage Suit Arising From Opioid Epidemic

WINSTON-SALEM, N.C. — Insureds and one insurer filed a joint stipulation asking a North Carolina court to dismiss the claims and counterclaims between them in a coverage dispute arising from the opioid epidemic.
June 27, 2025
Split U.S. High Court: Universal Injunctions ‘Likely Exceed’ Courts’ Authority

WASHINGTON, D.C. — Nationwide or universal injunctions “likely exceed the equitable authority that Congress has granted to federal courts,” a majority of the U.S. Supreme Court ruled June 27, partially staying nationwide injunctions issued in three cases challenging President Donald J. Trump’s Jan. 20 birthright citizenship executive order (EO),
June 26, 2025
Shareholder Sues Hims After Partnership That Allowed Compounded Semaglutide Ends

SAN FRANCISCO — Hims & Hers Health Inc., a telehealth company that touted a collaboration with Novo Nordisk Inc. that would allow it to sell compounded semaglutide products, was hit with a securities fraud class action on June 25 by a shareholder who alleges that the stock value plummeted when Novo Nordisk ended the partnership.
June 26, 2025
Compounding Pharmacy Says Summary Judgment Award In Semaglutide Spat Should Stand

TAMPA, Fla. — Novo Nordisk Inc. fails to “meet a high bar to alter or amend a judgment” under Federal Rule of Civil Procedure 59(e) for a Florida federal court to amend its order granting summary judgment in favor of a pharmaceutical company accused of selling unapproved compounded drugs containing semaglutide, the company says in an opposition brief.
June 24, 2025
Woman Seeks Certification For Defective Potassium Pill Economic Loss Class Action

NEWARK, N.J. — An Alabama woman on June 23 sued Glenmark Pharmaceuticals Inc. in a New Jersey federal court, seeking to represent a class of consumers from Alabama who purchased allegedly defective potassium chloride pills.
June 24, 2025
Arkansas Moves To Consolidate Cases Over Law Banning PBMs From Owning Pharmacies

LITTLE ROCK, Ark. — Arkansas moved to consolidate four cases that challenge the constitutionality of a recently signed law that bans pharmacy benefits managers (PBMs) from owning a pharmacy business in the state, contending that the cases share common questions of law and name the same defendants.
June 23, 2025
Amicus Briefs Urge Court To Grant Petition Over Whether Stem Cells Are Drugs

WASHINGTON, D.C. — The U.S. Food and Drug Administration’s “attempts to own people’s biological cells, akin to their own skin or hair, by unjustifiably classifying them as drugs under the FDA’s regulatory scheme” is an issue of national importance, the Association of American Physicians and Surgeons (AAPS) argues in a June 20 amicus curiae brief filed in the U.S. Supreme Court, urging the court to grant a petition filed by a stem cell clinic and its owners that contends that the Ninth Circuit U.S. Court of Appeals erred in finding that a stem cell mixture used by clinics is a drug under the Food, Drug and Cosmetic Act (FDCA).