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Mealey's Drugs & Devices

August 22, 2024
Acetaminophen Autism/ADHD Judge Says Causation Not Proven, Grants Summary Judgment

NEW YORK — The New York federal judge overseeing the acetaminophen autism spectrum disorder-attention deficit hyperactivity disorder (ASD-ADHD) multidistrict litigation, who recently found an expert retained by parents who allege that prenatal exposure to acetaminophen causes ADHD to be inadmissible, awarded summary judgment to the defendants after rejecting the plaintiffs’ argument that statements made by the defendants’ expert could use to prove causation.
August 22, 2024
Suboxone MDL Judge Names Counsel To Leadership Committee

CLEVELAND — The judge overseeing the Suboxone film multidistrict litigation appointed attorneys to the leadership development committee, which he said is “intended to provide mentorship to attorneys committed to long-term involvement in mass-tort MDL practice with the goal of developing future MDL leaders.”
August 22, 2024
Novo Nordisk Survives Motion To Dismiss Filed By Competitor In Semaglutide Case

NASHVILLE, Tenn. — Novo Nordisk Inc., a drug manufacturer that says it’s the only company with approval from the U.S. Food and Drug Administration to produce medicine containing the molecule semaglutide, survived a motion to dismiss filed by a pharmacy that it sued for selling products that contain semaglutide, but the Tennessee federal judge granted permission for the pharmacy to raise its arguments again.
August 21, 2024
JPMDL To Hear Arguments On Whether Defective Port Cases Should Be Consolidated

WASHINGTON, D.C. — Counsel for a medical device maker and for users who say that their chemotherapy port was defective and caused a multitude of injuries will appear before the U.S.. Judicial Panel on Multidistrict Litigation on Sept. 26 to argue whether centralization of the cases is appropriate.
August 21, 2024
Federal Circuit Affirms Dismissal Of Vaccine Case On Causation Grounds

WASHINGTON, D.C. — The Federal Circuit U.S. Court of Appeals on Aug. 20 affirmed a lower court’s finding that parents failed to prove that their child’s injury was caused by a flu vaccine in a National Childhood Vaccine Injury Act case.
August 20, 2024
JPMDL To Mull Consolidating Cases Stemming From Alleged Toxic Embryo Solution

WASHINGTON, D.C. — The U.S. Judicial Panel on Multidistrict Litigation will hear oral arguments in September on a motion to centralize cases filed by couples who sued a manufacturer of a solution used during fertility-related treatments that they claim was toxic and destroyed their developing embryos.
August 20, 2024
2nd Circuit Agrees Claims On Alleged Mislabeled Supplement Are Preempted

NEW YORK — A woman’s claims that a dietary supplement was mislabeled because it contained a different formulation of the main ingredient than the one displayed on the side are preempted by federal law, a Second Circuit U.S. Court of Appeals held, affirming a district court’s award of summary judgment.
August 19, 2024
Judge: Amended Complaint Claims Related To Defective Device Are Still Preempted

PHOENIX — An Arizona federal judge found that a man alleging that he was injured by a defective medical device used during an ankle replacement failed to cure his initial complaint’s deficiencies in his amended complaint and granted a motion to dismiss after finding that the claims are preempted by federal law.
August 19, 2024
Firms Appeal Opioid MDL Attorney Fees Awards To 6th Circuit

CLEVELAND — Two law firms in the opioid multidistrict litigation centralized in the U.S. District Court for the Northern District of Ohio filed notice of an appeal to the Sixth Circuit U.S. Court of Appeals after the judge overseeing the MDL rejected their objections to the final recommendations made by a fee panel to allocate $2.13 billion in attorney fees in connection with various settlements reached by the parties.
August 19, 2024
Pharma Supplier: High Court Should Deny Cert In FCA, Anti-Kickback Violations Row

WASHINGTON, D.C. — A pharmaceutical wholesaler and related entities argue in their Aug. 16 U.S. Supreme Court brief that the court should not grant certiorari to review the Second Circuit U.S. Court of Appeals ruling affirming a district court’s dismissal of federal False Claims Act (FCA) suit alleging violations of the Anti-Kickback Statute (AKS), asserting the Second Circuit correctly held that the AKS is violated only when a defendant knows their conduct was unlawful.
August 19, 2024
Baltimore Reaches 2 Settlements In Suit For Contributions To Opioid Crisis

BALTIMORE — Cardinal Health will pay Baltimore $152.5 million to settle the city’s claims that the opioid distributor contributed to the opioid epidemic, the city announced in an Aug. 16 press release, adding that the company will pay the entire sum this year.
August 14, 2024
Patent Attorney Urges High Court To Decline Review Of 9th Circuit FCA Reversal

WASHINGTON, D.C. — A patent attorney who was a district court’s qui tam plaintiff in a suit accusing pharmaceutical companies of violating the False Claims Act (FCA) by artificially inflating drug prices urges the U.S. Supreme Court to decline review of the Ninth Circuit U.S. Court of Appeals’ ruling reversing the district court’s dismissal, arguing that the Ninth Circuit correctly “held that the public disclosures did not collectively disclose the fraud.”
August 09, 2024
Woman’s Claims That Taxotere Caused Hair Loss Tossed By N.C. Federal Judge

CHARLOTTE, N.C. — A woman’s claims that Taxotere, a chemotherapy treatment, caused her to suffer permanent hair loss are untimely under North Carolina’s statute of limitations and statute of repose, a federal judge in the state ruled, granting a manufacturer’s motion for judgment on the pleadings.
August 09, 2024
3rd Circuit Affirms Summary Judgment In Case Alleging Merck Misled Government

PHILADELPHIA — The Third Circuit U.S. Court of Appeals affirmed summary judgment in favor of Merck & Co. and said the district court correctly rejected former employees’ claims in a qui tam action that the company made false representations to the Centers for Disease Control and Prevention about the effectiveness of the MMR (mumps, measles and rubella) vaccine after finding that even assuming that the representations were false, the employees did not show that the statements were material to the agency’s decision to purchase the vaccines.
August 09, 2024
Judge Tosses Most Claims In Shareholder Derivative Suit Against Formula Maker

CHICAGO — A federal judge in Illinois dismissed without prejudice multiple claims brought by investors in a shareholder derivative complaint against a food company whose shutdown of a plant contributed to a national shortage of baby formula, holding that the investors failed to show that a presuit demand on the company’s board of directors would have been futile.
August 08, 2024
Mistrial Declared In 3rd Zantac Trial In Illinois State Court After 2 Defense Wins

CHICAGO — An Illinois state court judge on Aug. 7 declared a mistrial in a case alleging that a man’s use of Zantac caused him to develop prostate cancer in the third Zantac case to go to trial, with juries returning defense verdicts in the first two cases.
August 08, 2024
Family Of Woman Whose Tissue Was Used For Medical Advancements Sues Pharma Cos.

BALTIMORE — The family of Henrietta Lacks, a Black woman whose medical tissue was taken without her consent in 1951 to create the first immortalized human cell line that has been used in medical developments from the polio vaccine to in vitro fertilization, sued two pharmaceutical companies in a Maryland federal court for unjust enrichment.
August 07, 2024
GSK Secures Second Defense Verdict In Illinois Case Alleging Zantac Caused Cancer

CHICAGO — A Cook County, Ill., jury rejected a woman’s claims that her use of Zantac caused her to be diagnosed with colorectal cancer and returned a verdict in favor of GlaxoSmithKline LLC (GSK), handing the drug manufacturer back-to-back wins in the first two Zantac cases to go to trial.
August 05, 2024
Gardasil MDL Judge Dismisses 4 Cases On Jurisdictional Grounds

STATESVILLE, N.C. — The North Carolina federal judge overseeing the Gardasil multidistrict litigation granted motions to dismiss filed by Merck Sharp & Dohme LLC, agreeing that four plaintiffs failed to timely file a required petition in the Vaccine Court.
August 05, 2024
Judge Grants Final Approval Of Opioid Third-Party Payers’ Claims Settlement

SAN FRANCISCO — The California federal judge overseeing the opioid promotion multidistrict litigation court on Aug. 2 indicated in a docket entry that he will approve a $78 million settlement agreement from McKinsey & Co. Inc. to end third-party payers (TPP) claims.
August 02, 2024
JPMDL Denies Request To Centralize Cases Alleging Benzene In Acne Products

WASHINGTON, D.C. — The U.S. Judicial Panel on Multidistrict Litigation (JPMDL) on Aug. 1 declined to centralize 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 after finding that many allegations will be specific to the individual defendants.
August 02, 2024
Partial Dismissal Granted In FCA Suit Against Hospital Over Unread Test Billing

SYRACUSE, N.Y. — A New York federal judge granted in part dismissal motions filed by a physician, his practice and a hospital in a relator’s qui tam suit alleging violations of the federal False Claims Act (FCA) and New York false claims law for the defendants’ purported billing of federal insurers, including Medicaid, for testing that was not evaluated by a physician, finding the allegations insufficient for labor law violations against the hospital and for reverse false claims and conspiracy against all defendants.
August 01, 2024
Judge: Drug Distributor Failed To Establish Potential Coverage For Opioid Suits

SAN FRANCISCO — A federal judge in California held that a prescription drug distributor insured failed to establish that five insurance policies spanning 1999-2004 have any potential to cover underlying opioid lawsuits because the lawsuits fail to allege an accident that caused the purported bodily injury, denying the insured’s motion for partial summary judgment.
August 01, 2024
Mass Tort Cases For Drugs, Medical Devices

New developments in the following mass tort drug and device cases are marked in boldface type.
August 01, 2024
Sanofi-Aventis Agrees To Cap Insulin At $35 In Settlement With Minnesota

NEWARK, N.J. — Minnesota Attorney General Keith Ellison and Sanofi-Aventis U.S. LLC told a New Jersey federal court that they have reached a settlement under which the drug manufacturer has agreed to make its insulin products available to consumers in Minnesota for no more than $35 for a monthly subscription.