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

Mealey's Drugs & Devices

September 13, 2024
Laboratory, Trade Association Ask Court To Vacate FDA’s Final FDCA Regulation Rule

SHERMAN, Texas — A national trade association representing leading laboratories and two of its members asked a Texas federal court to grant them summary judgment in their suit against the U.S. Food and Drug Administration and others and to vacate an FDA final rule that laboratory-developed testing services can be regulated as medical devices under the Federal Food, Drug, and Cosmetic Act (FDCA).
September 11, 2024
Manufacturer Of Embryo Culture Media Wins Dismissal In Suit Over Loss Of Embryos

OAKLAND, Calif. — A California federal judge granted motions to dismiss filed by the manufacturer of embryo culture media and its subsidiary in a case in which a couple alleges that a defective solution that was used in the fertility procedure caused none of their fertilized eggs to survive to the blastocyst stage.
September 11, 2024
Calif. Federal Judge Awards Metal-On-Metal Hip Implant Maker Summary Judgment

OAKLAND, Calif. — A California federal judge on Sept. 10 granted summary judgment to defendants in a defective metal-on-metal hip implant case remanded from a multidistrict litigation after finding that the man who alleges that he was injured failed to prove causation or that his doctor relied on misrepresentations from the company.
September 11, 2024
Judge Agrees To Dismiss Certain Defendants From Suboxone Film MDL

CLEVELAND — The judge overseeing the Suboxone film multidistrict litigation on Sept. 10 dismissed Indivior PLC, Reckitt Benckiser LLC and Reckitt Benckiser Healthcare (UK) Ltd. as defendants in all cases.
September 11, 2024
Judge Dismisses FCA Case Against Sanofi In Insulin Drug Medicaid Rebate Dispute

LOS ANGELES — A California federal judge granted dismissal to pharmaceutical company Sanofi in a qui tam suit filed against it by a former Medicaid provider alleging that Sanofi committed fraud in violation of the federal False Claims Act (FCA) and similar state laws by reporting false pricing information to the Centers for Medicare and Medicaid Services (CMS) regarding insulin marketed under the brand name “Admelog,” finding that the provider failed to plead the complaint with the appropriate scienter.
September 10, 2024
Defective Chemotherapy Port Device Case In Florida Federal Court Partly Dismissed

ORLANDO, Fla. — A Florida federal judge on Sept. 9 partially granted a motion to dismiss filed by medical device makers that argued that a man who alleges that a defective chemotherapy port fractured after implantation and that a fragment traveled to his heart failed to state his claims.
September 09, 2024
Teva To Pay Baltimore $80M To Settle Claims Of Contributions To Opioid Crisis

BALTIMORE — Teva Pharmaceuticals will pay the city of Baltimore $80 million to settle the city’s claims that the opioid distributor contributed to the opioid epidemic, the city announced in a Sept. 9 press release, bringing the total amount of recoveries from opioid defendants to $322.5 million.
September 05, 2024
Ga. Supreme Court Upholds Verdict For Opioid Distributors In Drug Dealer Law Case

ATLANTA — The Georgia Supreme Court on Sept. 4 affirmed a defense verdict that found that drug wholesalers Cardinal Health Inc., McKesson Corp. and J.M. Smith Corp. did not violate Georgia’s drug dealer or racketeering laws by failing to monitor and stop suspicious opioid orders by in-state pharmacies, rejecting claims that the trial court erred in denying a new trial based on alleged evidence of a juror’s dishonesty during jury selection and deliberations.
September 05, 2024
Judge In Bair Hugger MDL Agrees To Dismiss Multiple Cases That Violated Pretrial Order

MINNEAPOLIS — The judge overseeing the Bair Hugger multidistrict litigation granted in large part a motion to dismiss 46 cases after finding that the plaintiffs failed to comply with a pretrial order requiring that the court be alerted when a plaintiff dies.
September 05, 2024
Mass Tort Cases For Drugs, Medical Devices

New developments in the following mass tort drug and device cases are marked in boldface type.
September 05, 2024
Teva USA Objects To Motion To Add Teva Ltd. To Paragard IUD MDL

ATLANTA — Teva Pharmaceuticals USA Inc. urged the court overseeing the Paragard IUD (intrauterine device) multidistrict litigation to reject a motion filed by the plaintiffs for leave to amend the master complaint to add Teva Pharmaceutical Industries Ltd. as a defendant.
September 04, 2024
Woman Says Defective Potassium Pill Caused Mother’s Fatal Cardiac Arrest

NEWARK, N.J. — A woman who alleges that her mother died after ingesting defective potassium chloride pills manufactured by Glenmark Pharmaceuticals Inc. filed suit in a New Jersey federal court, seeking to represent a class of consumers whose damages she says total more than $50 million.
September 04, 2024
Philips Argues For Discovery Consolidation In Related CPAP MDLs

PITTSBURGH — Koninklijke Philips N.V., Philips North America LLC and Philips RS North America LLC (collectively, Philips) asked the judge overseeing two related multidistrict litigations involving the recall of approximately 10.8 million Philips continuous positive air pressure (CPAP) sleep apnea devices and respirators to rule that documents produced in one MDL can be used in the other.
September 03, 2024
Children Who Were Born Addicted To Opioids Sue In McKinsey MDL

SAN FRANCISCO — Three children who were born addicted to opioids filed a complaint on Aug. 30 in the McKinsey & Co. opioid promotion multidistrict litigation alleging that the consulting firm’s actions helped fuel an epidemic in Tennessee and across the country, leading to their mother becoming addicted to prescription opioids and drugs she purchased on the street.
September 03, 2024
Drugmakers To Pay $300M To Settle Third-Party Payers’ Claims In Opioid MDL

CLEVELAND — Third-party payers (TPP) in the opioid multidistrict litigation moved on Aug. 30 for preliminary approval of a $300 million settlement reached with three drug manufacturers to end claims that the opioid industry’s practices caused them to pay more for prescription opioids instead of safer, less addictive alternatives and for the cost of funding opioid addiction-related treatments.
September 03, 2024
NECC Pharmacist Pleads No Contest In Michigan Involuntary Manslaughter Case

HOWELL, Mich. — Former New England Compounding Center (NECC) chief pharmacist Glenn A. Chin pleaded no contest in a Michigan state court to 11 counts of involuntary manslaughter in connection with a 2012 fungal meningitis outbreak traced to a contaminated drug compounded by the company.
August 30, 2024
Texas Appeals Court Affirms $135K For Attorney Fees In Hernia Mesh Arbitration

EASTLAND, Texas — A Texas appeals court affirmed $135,000 arbitrator’s final award in a decades-old dispute over the distribution of attorney fees in a hernia repair Kugel Mesh case, rejecting a law firm’s request for a $1 million award.
August 30, 2024
3 Women To Appeal Dismissal Of Gardasil Cases Tossed On Jurisdictional Grounds

STATESVILLE, N.C. — Three women whose cases were dismissed in the Gardasil multidistrict litigation for failing to timely file a required petition in the Vaccine Court told the North Carolina federal court overseeing the MDL that they will appeal the decision to the Fourth Circuit U.S. Court of Appeals.
August 29, 2024
Federal Judge: Rapid Release Tylenol Class Action Fails Under Preemption Grounds

NEW YORK — A New York federal judge granted a motion to dismiss a putative class action alleging that Johnson & Johnson Consumer Inc. improperly advertised that its Tylenol Rapid Release Gelcaps worked faster than the cheaper tablet alternatives after finding that a woman’s claims are preempted by federal law.
August 29, 2024
Magistrate: Man Failed To Fix Allegations That Defective Device Caused Injuries

NEW YORK — A magistrate judge in New York recommended that a motion to file an amended complaint be denied after finding that a man failed “to fix the deficiencies in his claims” that a defective medical device caused his injuries.
August 28, 2024
Federal Judge Partially OKs Expert Exclusion Case Remanded From Pelvic Mesh MDL

LEXINGTON, Ky. — A Kentucky federal judge on Aug. 27 partially granted a motion to exclude expert testimony in a long-running case against a pelvic mesh manufacturer after previously ruling that the expert was properly designated and granting the manufacturer permission to move to exclude his general causation opinions under Daubert v. Merrell Dow Pharmaceuticals Inc.
August 28, 2024
Dispute Over FCA Public Disclosure Bar Distributed For Conference In Supreme Court

WASHINGTON, D.C. — The U.S. Supreme Court on Aug. 28 distributed for conference a petition for certiorari filed by pharmaceutical companies seeking review of the Ninth Circuit U.S. Court of Appeals’ ruling that the public disclosure bar was not triggered in a case where it reversed a district court’s dismissal of a suit accusing the companies of violating the False Claims Act (FCA) by artificially inflating drug prices.
August 28, 2024
Couple Sues Sterile Oil Manufacturer For Loss Of Embryos During IVF Procedure

CHARLOTTE, N.C. — A North Carolina couple sued a manufacturer of sterile mineral oil that they say was toxic and led to the destruction of their embryos, asserting claims for breach of contract, negligence and wrongful death in a North Carolina federal court.
August 27, 2024
CPAP Plaintiffs’ Counsel Ask For $5M In Fees, Costs In Medical Monitoring Settlement

PITTSBURGH — Counsel representing plaintiffs in a multidistrict litigation involving the recall of approximately 10.8 million continuous positive air pressure (CPAP) sleep apnea devices on Aug. 26 filed a motion requesting $5 million for attorney fees, costs and service awards as part of a $25 million settlement to resolve medical monitoring claims.
August 26, 2024
Delaware Judge Rules For Insurers In Coverage Dispute Over 218 Opioid Suits

WILMINGTON, Del. — A Delaware judge denied CVS Health Corp.’s motion for partial summary judgment and granted its insurers’ motion for partial summary judgment in their lawsuit disputing coverage for underlying opioid litigation, finding that CVS has failed to demonstrate any genuine issue of material fact that the underlying actions do not assert damages because of “bodily injury or property damage.”