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

Mealey's Drugs & Devices

July 31, 2024
Fla. Federal Judge Allows Woman To Amend Complaint In Transferred Bair Hugger Case

TAMPA, Fla. — Over a manufacturer’s objections, a Florida federal judge presiding over a case that was recently transferred from a multidistrict litigation ruled that a woman who alleges that a Bair Hugger Force Air Warming System caused contaminants to enter her open surgical wound may amend her complaint after finding that doing so would not be violation of any orders issued by the MDL court.
July 31, 2024
Judge Says Federal Law Preempts Hip Device Claims, Grants Dismissal Motions

BALTIMORE — A Maryland federal judge found that a man’s claims that he was injured by a defective metal-on-metal hip implant are preempted by federal law and granted separate motions to dismiss filed by the remaining defendants.
July 31, 2024
Judge OKs Further Discovery, Denies Motion For Summary Judgment In Device Case

LEXINGTON, Ky. — A motion for summary judgment in a product liability and personal injury suit involving a surgical implant is premature, a Kentucky federal judge ruled after finding that “additional discovery is necessary.”
July 30, 2024
4th Circuit Sets Oral Argument Date In Dispute Over W.Va.’s Law Banning Abortion

RICHMOND, Va. — The Fourth Circuit U.S. Court of Appeals on July 29 tentatively set oral arguments from Oct. 29 to Nov. 1 in a case debating whether the West Virginia Unborn Child Protection Act (UCPA), which bans abortion in almost all cases, is preempted under federal law.
July 30, 2024
Breast Cancer Survivors Sue Device Maker, Say Implanted Device Was Defective

BOSTON — A group of seven breast cancer survivors who allege that an implanted radiographic marker used to mark soft tissue sites during treatment was defective and caused injuries, resulting in a second surgery to remove the device, filed suit against the manufacturer, seeking compensatory and punitive damages.
July 29, 2024
D.C. Circuit Says Drug Maker Did Not Show Error In FDA’s Refusal To Reclassify

WASHINGTON, D.C. —The U.S. Food and Drug Administration did not violate the Administrative Procedure Act (APA) by refusing to reclassify a company’s drug as a biological product, which makes approval of a generic product more difficult, the District of Columbia Circuit U.S. Court of Appeals said in an opinion unsealed July 26, affirming a lower court’s summary judgment award in favor of the FDA and the drug company’s competitor.
July 29, 2024
Indivior To Pay $86M In Multistate Settlement For Its Role In Opioid Crisis

NEW YORK — Suboxone maker Indivior has agreed to a $86 million settlement with multiple states to settle allegations that its buprenorphine-based products that are used to treat opioid use disorder but can fuel addiction if misused helped spread “deadly opioid addictions across New York and the country,” the New York attorney general announced July 26 in a press release.
July 26, 2024
2nd Circuit Says Plaintiffs Must Show Intent To Trigger CAFA, Affirms Remand

NEW YORK — Citing the “consistent desire” of plaintiffs asserting personal injury claims stemming from their use of Zantac “to avoid federal jurisdiction,” the Second Circuit U.S. Court of Appeals agreed that a motion to consolidate did not trigger federal jurisdiction and affirmed a district court decision to remand nine cases to state court.
July 26, 2024
Judge Partially Grants Amazon’s Motion To Dismiss Contaminated Eye Drops Case

PHILADELPHIA — A federal judge in Pennsylvania agreed to dismiss certain claims against Amazon.com Inc. in a woman’s suit alleging that use of artificial tears that were contaminated with bacteria resulted in her eye being surgically removed.
July 25, 2024
9th Circuit: Other States Can’t Intervene In Suit Over Mifepristone Regulations

SAN FRANCISCO — The Ninth Circuit U.S. Court of Appeals on July 24 said it was “guided . . . by the Supreme Court's recent decision on standing and the FDA's regulation of mifepristone in FDA v Alliance for Hippocratic Medicine. 602 U.S. 367 (2024)” and denied a motion filed by Idaho and other anti-abortion states to intervene in a case involving federal regulations for the abortion drug mifepristone.
July 25, 2024
Judge Partly Dismisses Hip Replacement Patient’s Suit Over Defective Implant

SAN FRANCISCO — A California federal judge granted in part and denied in part a motion to dismiss filed by several companies involved in the manufacture and sale of a prosthetic hip replacement who are accused of causing a patient injuries and lost wages after his implant began releasing toxic metals into his body, finding that the patient’s claims, including for violation of California’s unfair competition law (UCL), are not preempted by federal authority.
July 23, 2024
4th Circuit Finds Lower Court Erred In Excluding Testimony In Pelvic Mesh Case

RICHMOND, Va. — The Fourth Circuit U.S. Court of Appeals on July 22 found that based on answers to questions certified to the West Virginia Supreme Court of Appeals, a district court erred in excluding testimony from a woman’s expert in a pelvic mesh case and vacated a judgment that found in favor of the device manufacturer.
July 22, 2024
Massachusetts Federal Judge Denies Barry Cadden’s Motion To Reduce His Sentence

BOSTON — A Massachusetts federal judge denied a request by New England Compounding Center (NECC) founder Barry J. Cadden to reduce his sentence of 174 months for his role in a fungal meningitis outbreak after finding that Cadden is not eligible for a sentence reduction under a recent amendment to the U.S. Sentencing Commission guidelines.
July 18, 2024
Mass Tort Cases For Drugs, Medical Devices

New developments in the following mass tort drug and device cases are marked in boldface type.
July 18, 2024
Judge Grants Approval To $50M Settlement To End Antitrust Claims Involving EpiPen

KANSAS CITY, Kan. — A Kansas federal judge has signed off on final approval to a settlement agreement in which Pfizer Inc. agreed to pay $50 million to settle claims that it conspired with others in an attempt to delay entry of generic competitors for the EpiPen epinephrine autoinjector (EAI) into the market.
July 18, 2024
CPAP MDL Judge Sets Date For Medical Monitoring Settlement Hearing

PITTSBURGH — The federal judge overseeing the multidistrict litigation involving the recall of approximately 10.8 million continuous positive air pressure (CPAP) sleep apnea devices will hold a final fairness hearing on Oct. 30 on a $25 million settlement to resolve medical monitoring claims in the MDL.
July 18, 2024
Arbitration Agreement Not Binding, But Judge Says Device Claims Preempted

LAKE CHARLES, La. — The legal screen used to set up an app to connect a medical device that detects blood glucose levels to a personal mobile device such as an iPhone did not clearly make a user aware that she was agreeing to arbitrate all claims, a Louisiana federal judge ruled, but he partially granted the manufacturer’s motion to dismiss claims as preempted by federal law.
July 18, 2024
Judge Overseeing Diabetes And Diet Drug MDL OKs Direct Filings Of New Complaints

PHILADELPHIA — The Pennsylvania federal judge newly appointed to oversee the multidistrict litigation involving diabetes and diet drugs that consumers allege caused gastrointestinal and other injuries signed five case management orders, including an order that directs any potential plaintiff to file directly into the MDL.
July 17, 2024
Lawsuit Alleging Injury From Fen-Phen Drugs Survives Motion To Dismiss

LOS ANGELES — A California federal judge on July 16 found that a woman’s complaint alleging that she was injured after ingesting fen-phen diet drugs “contains plausible failure-to-warn claims” and denied the drug manufacturer’s motion to dismiss.
July 17, 2024
3rd Circuit Affirms Dismissal Of 1,189 Shingles Cases For Failure to Prove Causation

PHILADELPHIA — A district court judge did not abuse his discretion in dismissing 1,189 cases in the Zostavax shingles vaccine multidistrict litigation after the plaintiffs failed to provide prima facie evidence that their shingles were caused by the Oka strain of the varicella-zoster virus (VZV) used to make the vaccine rather than the “wild-type” of the virus from childhood chickenpox infections, the Third Circuit U.S. Court of Appeals affirmed July 16.
July 17, 2024
N.J. Federal Judge Remands Case Alleging Injury From CoolSculpting Procedure

NEWARK, N.J. — AbbVie Inc., whose subsidiary manufactured a medical device that a woman claims caused an injury, “failed to carry its heavy burden” of showing that a defendant had been fraudulently joined, a New Jersey federal judge ruled, remanding the case to state court.
July 16, 2024
Georgia Federal Judge Consolidates Claims In Pelvic Mesh Design Defect Case

ATLANTA — A Georgia federal judge partially granted a motion by Johnson & Johnson to consolidate several of a woman’s claims that she was injured by the company’s pelvic mesh product and dismissed her manufacturing defect claims.
July 15, 2024
3M Moves To Dismiss Cases That Failed To Substitute Party After Notice Of Death

MINNEAPOLIS — Defendants in the Bair Hugger multidistrict litigation moved to dismiss five plaintiffs with prejudice because in each case, “the plaintiff passed away more than five years ago, and the deadline to move to substitute a new plaintiff has long-since passed.”
July 15, 2024
NECC Pharmacy Founder Barry Cadden Argues His Sentence Should Be Reduced

BOSTON — Former New England Compounding Center (NECC) founder Barry J. Cadden has asked a Massachusetts federal court to reduce his sentence of 174 months for his role in a fungal meningitis outbreak pursuant to a recent amendment to the U.S. Sentencing Commission guidelines.
July 12, 2024
Federal Judge Refuses To Dismiss Coverage Dispute Over False Advertising Claims

LOS ANGELES — A federal judge in California denied a professional liability insurer’s motion to dismiss insureds’ breach of contract and bad faith lawsuit seeking coverage for an underlying putative class action alleging that they falsely advertised a penis enlargement device, finding that the court is unable to determine as a matter of law that the insureds’ alleged statements and omissions fail to arise out of work performed by the insureds that involves “specialized training, knowledge and skill in the pursuit of urology, including surgery.”