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Mealey's Drugs & Devices

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.”
June 27, 2024
Bankruptcy Code Does Not Permit Release Of Sackler Family, High Court Rules

WASHINGTON, D.C. — The U.S. Supreme Court in a 5-4 decision on June 27 held that the Second Circuit U.S. Court of Appeals erred in approving a multibillion-dollar opioid bankruptcy settlement reached by Purdue Pharma L.P. that included a liability release for members of the formerly controlling Sackler family because the U.S. Bankruptcy Code does not authorize such a release.
June 27, 2024
Motley Rice, 4 Other Firms Appeal Opioid MDL Attorney Fees Recommendations

CLEVELAND — Five law firms filed separate notices of appeal in the opioid multidistrict litigation centralized in the U.S. District Court for the Northern District of Ohio over final recommendations made by a fee panel to allocate $2.13 billion in attorney fees in connection with various settlements reached by the parties.
June 27, 2024
Suboxone MDL Judge Rejects Proposal By Defense For Phased Discovery

CLEVELAND — The judge overseeing the Suboxone film multidistrict litigation rejected a proposal by a defendant to phase discovery, finding “that general causation is not so clear or cleanly divisible from other general or case-specific discovery that bifurcation would materially expedite and simplify the proceedings in this MDL.”
June 27, 2024
Woman Says Contaminated Eye Drops Led To Vision Injury In New Jersey Federal Suit

NEWARK, N.J. — A California woman’s use of artificial tears eye drops that were contaminated with bacteria led to potentially permanent eye and vision damage, she alleges in a complaint filed in a New Jersey federal court on June 26.
June 24, 2024
High Court Again Extends Response Deadline In Review Of 9th Circuit FCA Reversal

WASHINGTON, D.C. — The U.S. Supreme Court on June 21 granted a district court qui tam plaintiff’s second request for additional time to respond to pharmaceutical companies’ petition that seeks review of the Ninth Circuit U.S. Court of Appeals’ ruling reversing the district court’s dismissal of a suit accusing the companies of violating the False Claims Act (FCA) by artificially inflating drug prices.
June 20, 2024
Parties Debate Allowing New Causation Expert In ASD-ADHD MDL

NEW YORK — Defendants facing lawsuits by parents in the acetaminophen autism spectrum disorder-attention deficit hyperactivity disorder (ASD-ADHD) multidistrict litigation who allege that prenatal exposure to acetaminophen causes autism or ADHD say the parents’ arguments for allowing a new expert to testify are misplaced.
June 20, 2024
9th Circuit Hears Arguments In Holmes, Balwani Appeals

SAN FRANCISCO — The Ninth Circuit U.S. Court of Appeals heard oral arguments by Theranos Inc. founder Elizabeth Holmes and former Theranos Chief Operating Officer Ramesh “Sunny” Balwani, who are separately appealing their convictions and sentences.
June 20, 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 19, 2024
JPMDL To Mull Consolidation Of Cases Alleging Benzene In Acne Products

WASHINGTON, D.C. — The U.S. Judicial Panel on Multidistrict Litigation (JPMDL) will meet in Portland, Maine, on July 25 to decide whether to consolidate for pretrial purposes cases that allege that users of benzoyl peroxide (BPO) products for the treatment of acne vulgaris, including creams, washes, scrubs and bars, were inadequately warned about the presence of benzene.
June 19, 2024
Missouri Appeals Court Upholds Defense Verdict In Bair Hugger Case

KANSAS CITY, Mo. — A Missouri appeals court on June 18 affirmed a defense verdict in a case alleging that 3M Co.’s Bair Hugger patient warming system was defectively designed and caused a postoperative infection after finding that trial court did not err in multiple evidentiary rulings or abuse its discretion in limiting expert testimony.
June 18, 2024
Judge Dismisses Claims Against Insys As Deferred Prosecution Agreement Ends

BOSTON — A Massachusetts federal judge on June 17 signed off on the dismissal of five counts of mail fraud against a subsidiary of opioid manufacturer Insys Therapeutics Inc. as part of the deferred prosecution agreement (DPA) that the parties reached in June 2019.
June 18, 2024
Janssen Violated FCA, State Laws In HIV Drug Promotions, N.J. Federal Jury Says

NEWARK, N.J. — A New Jersey federal jury found that Janssen Products LP violated federal and various state false claims laws in its promotion of HIV drugs Prezista and Intelence and ordered it to pay $150 million in damages.
June 17, 2024
Government Urges High Court To Reject Review Of Off-Label Marketing Conviction

WASHINGTON, D.C. — The United States in a June 14 opposition brief urged the U.S. Supreme Court to reject a petition for a writ of certiorari filed by two former Acclarent Inc. executives convicted of distributing and misbranding medical devices sold in interstate commerce because the First Circuit U.S. Court of Appeals properly rejected their First Amendment challenge and affirmed the convictions based on overwhelming evidence of their guilt.
June 14, 2024
Suboxone MDL Judge Sets Guidelines For Common Fee Awards

CLEVELAND — The judge overseeing the Suboxone film multidistrict litigation filed a case management order setting guidelines and procedures for attorneys to submit claims for fees and expenses that are incurred for the common benefit of all plaintiffs.
June 14, 2024
Relator Seeks High Court Review Of Ruling Affirming Dismissal Of FCA Claims

WASHINGTON, D.C. — A qui tam relator filed a petition for writ of certiorari in the U.S. Supreme Court, seeking review of the Second Circuit U.S. Court of Appeals ruling affirming a district court’s dismissal of his claim filed against a pharmaceutical and medical supplier pursuant to the federal False Claims Act (FCA) for violations of the Anti-Kickback Statute (AKS), asserting that review is needed to resolve the split between circuit courts regarding whether knowledge that a party’s conduct violates the law is required to show willfulness pursuant to the AKS.
June 13, 2024
High Court Finds Challengers To Abortion Drug Mifepristone Access Lack Standing

WASHINGTON, D.C. — The U.S. Supreme Court in a unanimous decision on June 13 rejected a challenge to the expanded access to the abortion drug mifepristone, finding that a group of anti-abortion advocates lack standing in the case because they had no injury.
June 12, 2024
Motley Rice To Receive Largest Percentage Of Opioid MDL Attorney Fees, Panel Says

CLEVELAND — The fee panel appointed in the opioid multidistrict litigation centralized in the U.S. District Court for the Northern District of Ohio has made its final recommendations to allocate $2.13 billion in attorney fees in connection with various settlements reached by the parties; the judge overseeing the MDL said parties have until June 21 to file an appeal.
June 12, 2024
Judge Announces 12 Bellwether Discovery Plaintiffs In Tepezza MDL

CHICAGO — The federal judge overseeing the Tepezza hearing loss multidistrict litigation announced that 12 cases have been selected as the initial bellwether discovery cases.
June 12, 2024
Baltimore, Drug Manufacturer Agree To $45 Million Deal To End Opioid Litigation

BALTIMORE — Allergan Finance LLC will pay $45 million to Baltimore in a lump sum payment within 30 days to end litigation stemming from claims that the drug manufacturer contributed to the opioid epidemic, the city announced in a press release.
June 11, 2024
Publix To 6th Circuit: Order Questions Certified To Ga. High Court In Opioid MDL

CINCINNATI — Publix Super Markets Inc. filed a petition for a writ of mandamus in the Sixth Circuit U.S. Court of Appeals to order a series of questions certified to the Georgia Supreme Court for the high court to determine how the state’s public nuisance law applies in a nationwide opioid multidistrict litigation.