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

Mealey's Drugs & Devices

July 12, 2024
Acetaminophen Autism/ADHD MDL Judge Rejects Admissibility Of New Causation Expert

NEW YORK — A New York federal judge has granted a motion to exclude testimony from an expert opining that prenatal exposure to acetaminophen causes attention deficit hyperactivity disorder (ADHD); the expert was retained after the judge overseeing the multidistrict litigation in December found that previously named experts were inadmissible.
July 11, 2024
Rite Aid Agrees To Settle FCA And CSA Claims Stemming From Opioid Prescriptions

WASHINGTON, D.C. — The U.S. Department of Justice on July 10 reached an agreement with Rite Aid Corp. and 10 subsidiaries and affiliates to settle violations of the False Claims Act (FCA) and Controlled Substances Act (CSA), with the pharmacy chain paying $7.5 million and granting the government an unsubordinated, general unsecured claim of $401.8 million in Rite Aid’s bankruptcy case that is pending in the District of New Jersey.
July 11, 2024
Taxotere Eye Injury MDL Judge Denies Accord’s Motion To Dismiss For Untimely Service

NEW ORLEANS — The judge overseeing multidistrict litigation for cases alleging that a chemotherapy drug caused eye injuries denied a motion filed by a drug manufacturer to dismiss a complaint that was included in the bellwether pool for untimely service of process.
July 11, 2024
MDL Sought For Cases Alleging Injuries Stemming From Toxic Embryo Solution

WASHINGTON, D.C. — Plaintiffs who sued a manufacturer of a solution used during fertility-related treatments that they claim was toxic and destroyed their developing embryos have asked the U.S. Judicial Panel on Multidistrict Litigation to centralize the cases for pretrial purposes.
July 09, 2024
Hernia Mesh MDL Judge Orders Stay Of All Cases Pending Possible Settlement

COLUMBUS, Ohio — The Ohio federal judge overseeing the Davol hernia mesh multidistrict litigation issued a limited stay at the request of C.R. Bard Inc. and Davol Inc. and the Plaintiffs’ Steering Committee (PSC) as they work toward a settlement agreement.
July 09, 2024
Purdue Pharma’s Unsecured Creditors Ask For Permission To Sue Sackler Family

NEW YORK — The Official Committee of Unsecured Creditors on July 8 asked the New York federal bankruptcy judge overseeing Purdue Pharma LP’s bankruptcy case to grant it sole derivative standing so it can sue Purdue Pharma’s owners — members of the Sackler family and their trusts and affiliates — after the U.S. Supreme Court ruled that the Second Circuit U.S. Court of Appeals erred in finding that the U.S. Bankruptcy Code allows a liability release for members of the family in a multibillion-dollar opioid bankruptcy settlement reached by Purdue Pharma.
July 09, 2024
Medical Journal Finds Possible Link Between GLP-1 Drugs, Blindness

BOSTON — A recent study published in the JAMA Ophthalmology found a potential link between semaglutide, a glucagon-like peptide 1 receptor agonist (GLP-1 RA), and an increased risk of a significant cause of blindness among adults.
July 08, 2024
Federal Magistrate Judge Recommends Reduced Attorney Fees In CoolSculpting Case

ORLANDO, Fla. — A federal magistrate judge in Florida recommended that attorney fees for counsel who successfully defended a company in a design defect case be reduced from the counsel’s request after finding “that employing 15 attorneys and four paralegals for this matter, and requesting over $1 million in fees for a 13-month period, to be excessive on its face.”
July 08, 2024
Merck Says 3 Gardasil Cases Must Be Dismissed On Jurisdictional Grounds

STATESVILLE, N.C. — Merck Sharp & Dohme LLC tells the court overseeing the Gardasil multidistrict litigation that plaintiffs opposing its motion to dismiss “yet again ask this Court to interpret the Vaccine Act in a way that, so far as Merck is aware, no court ever has.”
July 05, 2024
PBMs Lose Battle To Keep County’s Opioid Suit In New York Federal Court

NEW YORK — A New York federal judge on July 4 granted Nassau County’s motion to remand its suit against various companies for their roles in the opioid crisis, saying two pharmacy benefits managers failed to persuade her that she should retain jurisdiction.
July 03, 2024
Mass Tort Cases For Drugs, Medical Devices

New developments in the following mass tort drug and device cases are marked in boldface type.
June 28, 2024
COMMENTARY: Courts Must, As Recently Reminded, Follow The Law In Rule 702 Expert Testimony Determinations

By Erin Sheley
July 02, 2024
Parties Debate How Alliance Changes Right Of States To Intervene In Related Case

SAN FRANCISCO — Parties in an appeal pending in the Ninth Circuit U.S. Court of Appeals on whether a lower court erred in refusing to allow a group of anti-abortion states to intervene in a case filed by other states and the District of Columbia that sued the U.S. Food and Drug Administration to block any changes to the FDA’s approval of mifepristone and subsequent changes to its prescribing practices filed supplemental briefs to opine on how a recent U.S. Supreme Court decision impacts their arguments.
July 02, 2024
Ohio Federal Judge Partially Dismisses Defective Chemotherapy Port Device Case

CLEVELAND — A federal judge in Ohio partially granted a motion to dismiss filed by a medical device maker facing charges from a woman who claims that a defective SmartPort device caused her to develop an infection.
July 02, 2024
Hernia Mesh MDL Judge Refuses To Seal Motion On Possible Settlement Terms

COLUMBUS, Ohio — The Ohio federal judge overseeing the Davol hernia mesh multidistrict litigation on July 1 said defendants and counsel representing a group of plaintiffs cannot file under seal a motion to establish a qualified settlement fund.
July 02, 2024
Court: Defective Screw Case Properly Dismissed On Statute Of Limitations Grounds

FORT WORTH, Texas — Because a woman was aware that defective screws were possibly used in medical procedures on both of her feet more than two years before she filed suit, a Texas trial court was correct in granting summary judgment, a Texas appeals court held.
July 01, 2024
CPAP Judge Gives Preliminary Approval To Medical Monitoring Claims Settlement

PITTSBURGH — The federal judge overseeing the multidistrict litigation involving the recall of approximately 10.8 million continuous positive air pressure (CPAP) sleep apnea devices granted preliminary approval to $25 million settlement to resolve medical monitoring claims in the MDL.
July 01, 2024
Convicted Executives Say Case Presents ‘Ideal Vehicle’ For High Court Review

WASHINGTON, D.C. — Two former Acclarent Inc. executives convicted of distributing and misbranding medical devices sold in interstate commerce who say the U.S. Food and Drug Administration’s “intended use” regulations violate their constitutional rights argue in a July 1 reply brief in the U.S. Supreme Court that the case is “an ideal vehicle to review enormously important and contested constitutional questions.”
July 01, 2024
Purdue Pharma Asks District Court Handling Bankruptcy For Status Conference

NEW YORK — A lawyer representing Purdue Pharma LP and its affiliated debtors on June 28 wrote to the New York federal judge overseeing its bankruptcy case on how to proceed after the U.S. Supreme Court ruled that the Second Circuit U.S. Court of Appeals erred in finding that the U.S. Bankruptcy Code allows a liability release for members of the formerly controlling Sackler family in a multibillion-dollar opioid bankruptcy settlement reached by Purdue Pharma.
July 01, 2024
California High Court Answers Question On Role Of Stronger Warning In Causation

SAN FRANCISCO — A plaintiff in a medical device case can establish causation by showing that had a physician communicated a stronger warning to the patient, a prudent person in the patient’s position may have declined the treatment regardless of the physician’s continued recommendation, the California Supreme Court held, answering a certified question from the Ninth Circuit U.S. Court of Appeals.
June 28, 2024
OptumRx Reaches $20M Settlement Agreement For Opioid Prescription Practices

WASHINGTON, D.C. — OptumRx Inc. has agreed to pay $20 million to resolve claims that the prescription drug benefit provider improperly filled opioid prescriptions in violation of the Controlled Substances Act, the U.S. Department of Justice announced June 27.
June 28, 2024
MDL Judge Rejects Argument That Vaccine Act Does Not Apply To Gardasil Cases

STATESVILLE, N.C. — Applying the National Childhood Vaccine Injury Act of 1986 to personal injury claims related to the Gardasil vaccine does not violate the presentment clause of the U.S. Constitution, the federal judge overseeing the Gardasil multidistrict litigation ruled June 27.
June 28, 2024
High Court Overrules Chevron Deference, Changes Standard For Regulatory Review

WASHINGTON, D.C. — The U.S. Supreme Court on June 28 voted 6-3 to overrule the doctrine of Chevron deference as incompatible with the Administrative Procedure Act (APA) in two cases arising out of federal fishing regulations, changing governing precedent for federal courts reviewing agencies’ regulatory actions.
June 28, 2024
Appeals Court: Woman’s Pelvic Mesh Claims Were Not Untimely; Verdict Upheld

ATLANTA — The 11th Circuit U.S. Court of Appeals rejected arguments from a pelvic mesh device maker that a woman’s claims were time-barred under Florida’s four-year statute of limitations and affirmed a $2.5 million jury verdict.
June 27, 2024
Arkansas Sues Pharmacy Benefit Managers, Says Their Role Furthered Opioid Crisis

LITTLE ROCK, Ark. — Arkansas Attorney General Tim Griffin on behalf of the state filed suit in a state court against a group of pharmacy benefit managers (PBMs) for their role “in causing and furthering the worst man-made epidemic in modern medical history: the misuse, abuse, diversion, and over-prescription of opioids.”