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

Mealey's Drugs & Devices

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).
June 23, 2025
Company Says Petition To Enter Judgment Strays Outside Of Arbitral Award

WASHINGTON, D.C. — A Swiss pharmaceutical company on June 20 filed a brief in District of Columbia federal court arguing that a California company’s petition for entry of judgment confirming an International Chamber of Commerce (ICC) tribunal’s award against the Swiss company worth more than $17.8 million asks the court to improperly enter judgment on the petitioner’s “interpretation” of merits findings made by the tribunal.
June 19, 2025
Judge Clarifies Schedule In Petition To Enforce $17.8M Arbitral Award

WASHINGTON, D.C. — A District of Columbia federal judge in a June 18 docket entry explained that the court will treat a California pharmaceutical company’s petition to enforce an International Chamber of Commerce (ICC) tribunal’s award in its favor worth more than $17.8 million as a motion to enforce under the Federal Arbitration Act (FAA) and directed a Swiss company to respond by the end of the month.
June 19, 2025
Mass Tort Cases For Drugs, Medical Devices

New developments in the following mass tort drug and device cases are marked in boldface type.
June 18, 2025
CVS Asks Court To Halt Law Barring PBMs From Operating Pharmacies In Arkansas

LITTLE ROCK, Ark. — CVS Pharmacy Inc. and its subsidiaries urged an Arkansas federal court to put on hold an Arkansas law that “adopts an unprecedented prohibition on pharmacies that are affiliated with pharmacy benefit managers (commonly referred to as PBMs) continuing to operate in the State” while the companies challenge the law’s constitutionality.
June 18, 2025
9th Circuit Affirms RICO TPP Class Certification For Actos Cancer Risk

SAN FRANCISCO — The Ninth Circuit U.S. Court of Appeals ruled that a district court did not err in certifying a national third-party payer (TPP) class of entities that paid for the diabetes drug Actos, agreeing with the lower court that the predominance requirement for certification was satisfied.
June 17, 2025
New York Federal Judge Won’t Vacate Medical Device Suit Rulings On Recusal Grounds

NEW YORK — A woman who sued medical device manufacturers in 2018 for injuries stemming from a hip replacement surgery did not convince a New York federal judge that alleged financial conflicts warranted vacatur of orders from a magistrate judge, the trial judge or one of the appellate judges who affirmed the manufacturers’ summary judgment award or that the court should hold an evidentiary hearing.
June 17, 2025
50 States, Territories Sign Off On $7.4B Settlement With Purdue Pharma, Sacklers

NEW YORK — Purdue Pharma LP updated its 13th amended Chapter 11 reorganization plan in the U.S. Bankruptcy Court for the Southern District of New York on June 17, a day after all 50 states and the District of Columbia and U.S. territories agreed to a $7.4 billion agreement in principle with Purdue Pharma and its owners, the Sackler family that was first announced in January, to settle claims that they contributed to creating the opioid crisis.
June 16, 2025
U.S. Supreme Court Won’t Review Fosamax MDL Ruling On Preemption

WASHINGTON, D.C. — The U.S. Supreme Court on June 16 denied a drug manufacturer’s petition for certiorari in the long-running Fosamax femur fracture multidistrict litigation, letting stand a Third Circuit U.S. Court of Appeals decision that found that state law claims are not preempted and reversed a decision that awarded the drug manufacturer summary judgment in 1,046 cases.