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

Mealey's Drugs & Devices

September 29, 2023
Ankle Replacement Device Case Dismissed, Preempted By Federal Law, Judge Says

PHOENIX — An Arizona federal judge on Sept. 28 found that claims that a medical device used during an ankle replacement was defective are preempted by the Medical Device Amendments (MDA) to the Food, Drug and Cosmetic Act (FDCA) and granted the manufacturer’s motion to dismiss.
September 28, 2023
Defective Medical Device Case Moves Forward In Illinois Federal Court

CHICAGO — An Illinois federal judge on Sept. 27 largely denied a manufacturer’s motion to dismiss a lawsuit alleging that a medical device implanted into a woman’s spine collapsed, requiring additional surgery to remove.
September 28, 2023
Lawsuit Claiming Target’s ‘Non-Drowsy’ Medicine Label Is Misleading Moves Forward

MINNEAPOLIS — Claims by consumers who allege that Target Corp. misled its customers by labeling its cold medicine as non-drowsy survived the retailer’s motion for dismissal when a Minnesota federal judge ruled that the claims are not preempted by the Food, Drug and Cosmetic Act (FDCA).
September 28, 2023
Certification Request Denied In FCA Suit Over Defective Knee Replacement Devices

TUSCALOOSA, Ala. — An Alabama federal judge denied a motion by an orthopedic device manufacturer to certify for appeal an order denying summary judgment in relators’ suit asserting that the manufacturer violated the federal False Claims Act (FCA) by submitting for reimbursement to government health care programs claims for knee replacement devices it knew were defective, finding that the motion is untimely and will not likely shorten the litigation.
September 27, 2023
Pa. Federal Judge Dismisses FCA Retaliation Claims By Fired Sleep Study Workers

PHILADELPHIA — While a Pennsylvania federal judge said it was “very unfortunate” that two longtime employees of Abington Memorial Hospital were terminated for “minor infractions” or possible retaliation for reporting that the hospital’s sleep center was using recalled continuous positive air pressure (CPAP) sleep apnea devices and respirators on its patients, the complaint failed to plead that the use could have defrauded the federal government, dooming their False Claims Act (FCA) retaliation claim.
September 27, 2023
Decongestant Makers, Retailers Face Class Claims For Selling Ineffective Products

SAN FRANCISCO — Two new putative class lawsuits filed in California federal court accuse multiple defendants of violating California’s unfair competition law (UCL) and other laws by selling decongestant products to millions of consumers that contained an active ingredient that a Food Drug and Administration advisory panel recently agreed is not effective as advertised
September 26, 2023
Woman’s Claims Against Birth Control Device Companies Survive Motions To Dismiss

CHICAGO — A woman’s claim that a defective birth control device can detach and migrate through the body on Sept. 25 survived three motions for summary judgment filed by the manufacturer, distributor and parent company of the device in an Illinois federal court.
September 22, 2023
Experts Out, Summary Judgment Granted In Multivitamin Lead Poisoning Case

CHICAGO — Testimony of causation experts retained by a man who alleges that he developed peripheral neuropathy after taking a multivitamin is inadmissible, and without the testimony, his claims fail, an Illinois federal judge ruled and granted summary judgment to the manufacturer.
September 22, 2023
Insured Failed To Provide Timely Notice Of Opioid Suits, 11th Circuit Affirms

ATLANTA — The 11th Circuit U.S. Court of Appeals on Sept. 21 affirmed a lower federal court’s ruling that an excess insurer has no duty to defend an opioid manufacturer insured against underlying lawsuits arising from the insured’s sale of prescription opioid medications, finding that the insured failed to provide timely notice of the underlying actions.
September 22, 2023
MDL Special Master Pledges Impartiality, Won’t Recuse After Replying All To Email

CLEVELAND — The special master whom two pharmacy benefit managers (PBM) moved to disqualify from the opioid multidistrict litigation responded Sept. 21 in an affidavit declaring that he does “not now have, and [has] never had, any disqualifying personal bias or prejudice toward them (or any other party in the Opioid MDL).”
September 20, 2023
Woman Sues Drug Manufacturers, Says OTC Cold Medicine Not Effective

KANSAS CITY, Mo. — A woman filed a putative class action in a Missouri federal court, alleging that she and others similarly situated purchased over-the-counter (OTC) decongestant products containing phenylephrine (PE) that were ineffective.
September 19, 2023
1st Circuit Says Lactaid Labeling Claims Are Preempted, Affirms Dismissal

BOSTON — The First Circuit U.S. Court of Appeals on Sept. 18 affirmed dismissal of a woman’s claim that she was misled into purchasing Lactaid products, with the appeals court finding that her claims are preempted by the U.S. Food and Drug Administration’s statutory enforcement authority under the Food, Drug and Cosmetic Act (FDCA)
September 18, 2023
Government Urges High Court To Uphold ‘Bedrock Principle’ Of Chevron Deference

WASHINGTON, D.C. — The U.S. secretary of Commerce, two National Oceanic and Atmospheric Administration (NOAA) officials and the National Marine Fisheries Service (NMFS) (collectively, the government) urge the U.S. Supreme Court in a Sept. 15 brief to not overrule the doctrine of Chevron deference in a challenge to fishery regulations that were upheld by the District of Columbia Circuit U.S. Court of Appeals, writing that doing so could “cause disruption” to complex federal regulatory schemes.
September 18, 2023
Expert In Alleged Faulty Knee Implant Case Can Testify, Wash. Federal Judge Rules

SEATTLE — A federal magistrate judge in Washington on Sept. 15 found that an expert retained by a patient who is suing a medical device manufacturer after a failed knee implant can base his conclusions on the notes of the surgeon and denied the manufacturer’s motion to exclude his testimony.
September 14, 2023
Leadership Team For Plaintiffs In Bard Port Catheter MDL Proposed

PHOENIX — Attorneys representing claimants alleging injury from C.R. Bard Inc.’s implanted port catheter device in the newly formed multidistrict litigation moved for the appointment of the plaintiffs’ co-lead counsel and other leadership posts.
September 14, 2023
Mass Tort Cases For Drugs, Medical Devices

New developments in the following mass tort drug and device cases are marked in boldface type.
September 14, 2023
Securities Fraud Claims Trimmed In Class Suit Against COVID Vaccine Contractor

BALTIMORE — A federal judge in Maryland has partially granted and partially denied a motion to dismiss securities fraud claims leveled against a COVID-19 vaccine contractor that experienced contamination issues at its Bayview, Md., manufacturing facility and several of its executives, dismissing reported-results fraud and internal-controls fraud claims under Section 10(b) of the Securities Exchange Act of 1934 but allowing business operations fraud claims under Section 10(b) to survive for alleged material misstatements made between July 6, 2020, and May 19, 2021.
September 13, 2023
6th Circuit Certifies Question To Ohio Supreme Court In Opioid Verdict Appeal

CINCINNATI — The Sixth Circuit U.S. Court of Appeals certified a question to the Ohio Supreme Court regarding whether a common-law public nuisance claim is permitted under the Ohio Product Liability Act in an appeal of a $650 million verdict awarded to two counties filed by a trio of pharmacies.
September 13, 2023
Judge Asked To Dismiss 129 Cases In Bair Hugger MDL For Pretrial Order Violations

MINNEAPOLIS — Defendants in the Bair Hugger multidistrict litigation filed a 10th motion to dismiss, asking a federal judge to toss 129 cases for failure to comply with a pretrial order or for lack of standing.
September 12, 2023
1st Bellwether Trial Date Set For Paragard IUD MDL

ATLANTA — The first bellwether case for the Paragard IUD multidistrict litigation centered in a Georgia federal court will be held in October 2024, a federal judge announced in an amended scheduling order.
September 12, 2023
Government Declines To Intervene In Acetaminophen Autism/ADHD MDL

NEW YORK — The New York federal judge overseeing the acetaminophen autism spectrum disorder-attention deficit hyperactivity disorder (ASD-ADHD) multidistrict litigation on Sept. 11 denied a request for a status conference, days after being told by the U.S. government that it was declining the court’s invitation to submit a response in the case.
September 11, 2023
Trial Dates Set For Next 2 Davol/Bard Hernia Patch Bellwether Cases

COLUMBUS, Ohio — A case management conference was held in an Ohio federal court, setting the stage for the third and fourth Davol/C.R. Bard hernia mesh multidistrict litigation bellwether trials.
September 11, 2023
Testimony In Metal-On-Metal Hip Replacement Device Case Limited In Federal Court

PHOENIX — An Arizona federal judge agreed to limit expert testimony offered by a man alleging that a defective “metal-on-metal” hip replacement device caused an injury and barred another expert who previously served as a consultant for the device manufacturer from testifying.
September 11, 2023
Judge Dismisses Claims Over Contaminated Laxatives On Preemption Grounds

WHITE PLAINS, N.Y. — A New York federal judge has dismissed claims filed by two women who allege that they were injured by deceptive labeling of certain laxative products that allegedly were contaminated with a bacterium after finding the claims preempted by the federal Food, Drug and Cosmetic Act (FDCA).
September 11, 2023
Man Alleges Defective Ankle-Monitoring Device Causes Skin Injuries

DENVER — A South Carolina man has filed a proposed class action in a Colorado federal court against a manufacturer of an ankle-monitoring device, alleging that the device causes rashes and skin infections.