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

Mealey's Drugs & Devices

April 17, 2024
FDA Recalls Heart Devices Linked To Injuries, Death

SILVER SPRING, Md. — The U.S. Food and Drug Administration has announced a recall of nearly 14,000 HeartMate II and HeartMate 3 Left Ventricular Assist System (LVAS), citing reports that buildup in components can obstruct the device and make it less effective in helping the heart pump blood.
April 17, 2024
Plaintiffs In ASD-ADHD MDL Appeal Judgment, Exclusion Of Experts To 2nd Circuit

NEW YORK — Plaintiffs in the acetaminophen autism spectrum disorder-attention deficit hyperactivity disorder (ASD-ADHD) multidistrict litigation who allege that prenatal exposure to acetaminophen causes autism or attention deficit hyperactivity disorder have appealed to the Second Circuit U.S. Court of Appeals a decision by the MDL judge to exclude their expert witnesses and to enter final judgment dismissing their cases.
April 17, 2024
Deadlines For 1st Bellwether Trials In Covidien Hernia Mesh MDL Pushed Back

BOSTON — The federal magistrate judge overseeing the multidistrict litigation involving Covidien hernia mesh agreed to extend dates in the current scheduling order by eight months after the plaintiffs cited “significant discovery deficiencies” on the part of the defendants.
April 16, 2024
High Court Declines Woman’s Request To Review Lactaid Labeling Claim Dismissal

WASHINGTON, D.C. — The U.S. Supreme Court on April 15 denied woman’s petition to review a First Circuit U.S. Court of Appeals ruling that her claims that she was misled into purchasing Lactaid products are preempted by the U.S. Food and Drug Administration’s statutory enforcement authority under the Food, Drug and Cosmetic Act (FDCA).
April 15, 2024
JPMDL Won’t Transfer Hawaii Drug Pricing Suit To Insulin Pricing MDL

WASHINGTON, D.C. — The Judicial Panel on Multidistrict Litigation (JPMDL) refused to transfer a case pending in a Hawaii federal court in which the state alleges “a scheme to inflate the list price of all ‘brand-name prescription drugs’ — a substantially larger universe of drugs, manufacturers, and business practices than those at issue in the MDL” that centralized federal insulin pricing lawsuits.
April 15, 2024
JPMDL: OTC Cold Medicine MDL Will Include Maximum Strength Label Cases

WASHINGTON, D.C. — The Judicial Panel on Multidistrict Litigation (JPMDL) agreed to transfer cases involving “Maximum Strength” labeling on over-the-counter cough and cold medications containing the active ingredient phenylephrine (PE) to the multidistrict litigation for cases alleging that the medications are ineffective at relieving nasal congestion.
April 12, 2024
West Viriginia: Mifepristone Maker Lacks Standing In 4th Circuit Appeal

RICHMOND, Va. — A West Virginia prosecutor and the state’s attorney general tell the Fourth Circuit U.S. Court of Appeals that it should reject arguments from an abortion drug manufacturer that a state law curtailing the use of the drug violated the U.S. Constitution.
April 12, 2024
Federal Judge Denies Man’s Summary Judgment Motion In Defective Hip Device Case

FRANKFORT, Ky. — A Kentucky federal judge found that “estoppel should not be applied offensively in the face of inconsistent judgments” and denied a man’s motion for partial summary judgment in a Pinnacle hip implant products liability case.
April 12, 2024
Judge In Exactech MDL Denies Request For In Camera Meeting To Discuss Settlement

BROOKLYN, N.Y. — The federal judge overseeing the Exactech orthopedic device multidistrict litigation denied a request filed by the device manufacturer for an in camera, off-the-record conference to discuss a potential global settlement.
April 12, 2024
Tepezza Hearing Loss MDL Judge Clarifies Discovery Order, OKs Bellwether Extension

CHICAGO — The judge overseeing the Tepezza hearing loss multidistrict litigation clarified an order he signed in March compelling Horizon Therapeutics USA Inc. to hand over certain information to reflect that the drug manufacturer disputes the relevance of data that was requested by the plaintiffs.
April 11, 2024
Alabama Federal Judge Grants Motions To Dismiss In 2 Taxotere Cases

MONTGOMERY, Ala. — An Alabama federal judge in nearly identical orders granted two motions to dismiss filed in a pair of cases that were remanded from the Taxotere hair loss multidistrict litigation after finding that certain claims are time-barred and the rest are inadequately pleaded.
April 11, 2024
Judge Grants Compounding Pharmacy’s Motion To Dismiss Case Filed By Lilly

MIAMI — A federal judge in Florida said he joins “colleagues around the country” in finding that Eli Lilly & Co.’s claims that a compounding pharmacy violated the Florida Drug and Cosmetic Act (Florida DCA) are preempted by federal law.
April 11, 2024
Publix Asks Opioid MDL Judge To Certify Questions To Georgia Supreme Court

CLEVELAND — Publix Super Markets Inc. has asked the Ohio federal judge overseeing the opioid multidistrict litigation to certify to the Georgia Supreme Court a series of questions for the high court to determine how the state’s public nuisance law applies in the litigation.
April 10, 2024
Consent Decree Entered; Philips Barred From Making, Selling CPAP Products

PITTSBURGH — A Pennsylvania federal judge on April 9 entered a consent decree of permanent injunction, prohibiting Philips Respironics from manufacturing or selling continuous positive air pressure (CPAP) sleep apnea devices and respirators in the United States until certain requirements are met.
April 10, 2024
Pharma Companies Seek High Court Review Of Ruling Reversing FCA Suit Dismissal

WASHINGTON, D.C. — Pharmaceutical companies accused of violating the False Claims Act (FCA) by artificially inflating drug prices filed a petition for writ of certiorari in the U.S. Supreme Court, seeking review of the Ninth Circuit U.S. Court of Appeals’ reversal of a district court’s dismissal of a qui tam suit against them, arguing, in part, that the panel “created a circuit split by holding that a relator can avoid the public disclosure bar by ‘stitching together’ public disclosures.”
April 09, 2024
McKinsey MDL Judge OKs $39.5M Settlement Agreement With Tribal Plaintiffs

SAN FRANCISCO — The California federal judge presiding over the McKinsey & Co. opioid promotion multidistrict litigation has signed off on a $39.5 million settlement reached between the consulting company and a group of Native American tribes.
April 09, 2024
2nd Circuit Agrees Statute Of Limitations Bars Defective Medical Device Suit

NEW YORK — The Second Circuit U.S. Court of Appeals agreed that a woman’s product liability and breach of warranty claims against two medical device companies were properly dismissed by a district court and denied the woman’s appeal of the summary judgment award.
April 04, 2024
Mass Tort Cases For Drugs, Medical Devices

New developments in the following mass tort drug and device cases are marked in boldface type.
April 04, 2024
Oral Arguments Set For Theranos’ Elizabeth Holmes Fraud Conviction Appeal

SAN FRANCISCO — The Ninth Circuit U.S. Court of Appeals will hear oral arguments on June 11 in Theranos Inc. founder Elizabeth Holmes’ appeal of her conviction; Holmes argues that there was insufficient evidence to convict her of defrauding investors in her blood testing startup and that she was prevented from presenting exculpatory evidence.
April 04, 2024
Dispute Over Attorney Fees In Benicar MDL Stays In Federal Court, Judge Says

CAMDEN, N.J. — A New Jersey federal judge refused to send a dispute involving the proper amount of attorney fees that should have been awarded to a law firm for its work in the Benicar multidistrict litigation back to state court, denying a motion to remand filed by a group of plaintiffs.
April 03, 2024
Alaska Judge Finds Public Nuisance Laws Don’t Apply In Opioid Suit

ANCHORAGE, Alaska — An Alaska Superior Court judge found that the state’s argument that the actions of various pharmacies in the sale and distribution of opioids created a public nuisance “is a bridge too far to take” and granted final judgment to dismiss the case.
April 03, 2024
Proposed Co-Lead Counsel Named For Diabetes And Diet Drug MDL; 1 Firm Objects

PHILADELPHIA — Attorneys involved “in the vast majority of complaints on file have reached agreement on a proposed leadership structure for the cases consolidated” in the multidistrict litigation involving diabetes and diet drugs that consumers allege caused gastrointestinal and other injuries, according to a motion filed in the U.S. District Court for the Eastern District of Pennsylvania.
April 03, 2024
Kentucky Federal Judge Allows Defective Hip Device Case To Move Forward

FRANKFORT, Ky. — A Kentucky federal judge denied a “metal-on-metal” hip replacement device maker’s motion to dismiss portions of a woman’s third amended complaint for failure to state a claim, allowing a case that has been transferred from the Pinnacle hip implant products liability multidistrict litigation pending in the Northern District of Texas to proceed.
April 02, 2024
Parties In Exactech MDL Debate Need For In Camera Meeting To Discuss Settlement

BROOKLYN, N.Y. — Counsel for plaintiffs in the Exactech orthopedic device multidistrict litigation said the parties “are nowhere close to reaching any proposed settlement” and urged the judge overseeing the cases to reject a request from the device manufacturer for an in camera, off-the-record conference.
April 01, 2024
La. Federal Judge Selects Bellwether Cases In Taxotere Eye Injury MDL

NEW ORLEANS — The judge overseeing multidistrict litigation for cases alleging that a chemotherapy drug caused eye injuries announced March 29 the six cases that will be included in the bellwether pool.