Mealey's Drugs & Devices
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October 02, 2024
Mass Tort Cases For Drugs, Medical Devices
New developments in the following mass tort drug and device cases are marked in boldface type.
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October 02, 2024
Federal Judge Allows Nondrowsy Label Dispute To Move Forward But Limits Claims
CHICAGO — An Illinois federal judge ruled that a woman “overslept on her rights” to pursue breach of warranty claims against the maker of a nondrowsy cold medicine but also found that her claims are not preempted by federal law and that she can, for the time being, represent a nationwide class of purchasers (Nancy Calchi v. TopCo Associates, LLC, No. 22-747, N.D. Ill.).
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October 02, 2024
Pa. Federal Judge Adopts Dismissal Recommendations In Surgical Mesh Injury Case
SCRANTON, Pa. — A federal judge in Pennsylvania has adopted a magistrate judge’s report and recommendation and partially granted a motion to dismiss filed by a surgical mesh manufacturer and its distributor facing claims that a man was injured after the product was used during surgery.
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October 02, 2024
Stem Cell Company Owner Sentenced For Violating FDCA In Marketing, Sale Of Product
LOS ANGELES — The founder and CEO of a company that manufactured and distributed injectable stem cell products made from human umbilical cord blood was sentenced in a California federal court to 36 months in prison after he pleaded guilty to violating the federal Food, Drug and Cosmetic Act (FDCA).
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October 02, 2024
Manufacturer Largely Loses Bid To Toss 4 Cases Alleging Defective Device Injuries
BOSTON — A federal judge in Massachusetts denied three motions for summary judgment filed by a device manufacturer in cases in which women allege that an implanted radiographic marker used to mark soft tissue sites during cancer treatment was defective and caused injuries but partially granted a fourth motion, finding that the woman failed to identify a genuine dispute of material fact as to causation on her failure-to-warn claim under Florida law.
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October 02, 2024
Ky. Federal Judge Rules Claims In Defective Heart Device Case Are Preempted
LOUISVILLE, Ky. — A Kentucky federal judge granted a motion to dismiss a case alleging that a defective heart device caused injuries after finding that each claim is preempted by federal law and that “mere reference to past recalls is not enough to properly plead a parallel claim.”
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October 02, 2024
3rd Circuit Remands Cases In Fosamax Femur MDL, Finds Claims Not Preempted
PHILADELPHIA — The Third Circuit U.S. Court of Appeals found that a district court erred in finding that state law claims in the Fosamax femur fracture multidistrict litigation are preempted and reversed the decision that awarded a drug manufacturer summary judgment in 1,046 cases.
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October 02, 2024
9th Circuit Finds Stem Cells Are Drugs Under FDCA, Reverses Lower Court
SAN FRANCISCO — A stem cell mixture used by clinics is a drug under the U.S. Federal Food, Drug, and Cosmetic Act (FDCA), the Ninth Circuit U.S. Court of Appeals ruled in reversing a lower court, also finding that the “same surgical procedure” exception does not apply, though the judges differed on why they reached that conclusion.
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October 01, 2024
Suboxone Plaintiffs Cite More Cases To Strengthen Argument Against Preemption
CLEVELAND — Lead counsel for the plaintiffs in the Suboxone film multidistrict litigation filed a notice of supplemental authority to further argue its position that state law claims are not preempted by directing the court to recent decisions that reflect the impact of Loper Bright Enters. v. Raimondo.
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September 30, 2024
Judge Approves $3M Securities Settlement For Misleading COVID-19 Treatment Claims
NEWARK, N.J. — A New Jersey federal judge granted final approval of a $3 million settlement including $750,000 in attorney fees to resolve a securities class action against a pharmaceutical company for deceiving shareholders by making misleading statements about the prospects of its product for the successful treatment of COVID-19.
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September 27, 2024
Settlement In Principle Reached In Walgreens Lidocaine Labeling Class Suit
CHICAGO — A status hearing in a putative class complaint by consumers who accuse Walgreen Co., doing business as Walgreens, of misleading labeling on certain lidocaine products was delayed via a docket entry by a clerk in a federal court in Illinois on Sept. 26 after the parties stated that they reached a settlement in principle.
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September 27, 2024
Cook County, Ill., Jury Deadlocks In Zantac Injury Case
CHICAGO — A Cook County Circuit Court judge declared a mistrial in a case in which a man alleges that his prostate cancer was caused by ingesting over-the-counter Zantac after a jury deadlocked on whether the manufacturer was responsible for his illness.
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September 27, 2024
Judge: Manufacturing Defect Claims Survive Preemption In Heart Device Case
ST. LOUIS — A man’s claims relating to an allegedly defective implantable cardioverter defibrillator (ICD) that “are rooted in manufacturing defects are not preempted” by federal law, a Missouri federal judge ruled, but partially granted the manufacturer’s motion to dismiss as to the failure to warn claims.
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September 26, 2024
Judge Dismisses Remaining Claim In Defective Device Case, Finds It Preempted
LAKE CHARLES, La. — A woman who alleges that she was injured in a car accident when a device failed to alert her that her blood glucose levels were at dangerously low levels failed in her amended complaint to show that her sole remaining claim was not preempted by federal law, a Louisiana federal judge held Sept. 24 in dismissing the claim.
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September 25, 2024
Judge Adopts Magistrate’s Report To Dismiss In Part Medical Device Injury Suit
SCRANTON, Pa. — A Florida federal judge largely adopted a magistrate judge’s report and recommendation to dismiss a case filed by a man who alleges that he was injured when his pacemaker failed, finding that the claims are expressly preempted by federal law.
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September 25, 2024
5th Circuit Remands Mifepristone Case To District Court After High Court Ruling
NEW ORLEANS — The Fifth Circuit U.S. Court of Appeals vacated its stay of a district court order in a case challenging expanded access to the abortion drug mifepristone and remanded the case to the U.S. District Court for the Northern District of Texas after the U.S. Supreme Court found that the plaintiffs lacked standing, but one judge filed a concurrence stating that the high “[c]ourt reversed because the [g]overnment reversed.”
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September 23, 2024
FTC Sues PBMs For Policies That Led To Inflated Insulin Costs
WASHINGTON, D.C. — The Federal Trade Commission on Sept. 20 filed an administrative complaint against three prescription drug benefit managers (PBMs) accusing them of creating “a perverse drug rebate system that prioritizes high rebates from drug manufacturers, leading to artificially inflated insulin list prices,” according to a press release from the commission.
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September 20, 2024
Preliminary Approval Of $40M Settlement Sought In Securities Fraud Class Suit
BALTIMORE — Lead plaintiffs in a securities fraud class suit filed against a COVID-19 vaccine contractor that experienced contamination issues at its Bayview, Md., manufacturing facility and several of its executives seek preliminary approval of a $40 million settlement reached between the parties.
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September 19, 2024
Mass Tort Cases For Drugs, Medical Devices
New developments in the following mass tort drug and device cases are marked in boldface type.
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September 19, 2024
Parties Ask Court For Summary Judgment In Defective Birth Control Device Case
CHICAGO — A woman who claims that she was injured by a defective birth control device and the manufacturer, distributor and parent company of that device filed competing motions seeking to exclude experts and asking for summary judgment in an Illinois federal court.
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September 19, 2024
D.C. Federal Judge Punts Challenge To Generic Drug Approval Until FDA Ruling
WASHINGTON, D.C. — A District of Columbia federal judge partially granted a motion to dismiss a suit filed by a pharmaceutical company against the U.S. Food and Drug Administration challenging the agency’s “bioequivalence determination” of a competitor’s generic drug by ruling that the FDA must first rule on the drugmaker’s citizen petition.
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September 18, 2024
Parents Appeal Exclusion Of Causation Experts, Case Dismissal To 2nd Circuit
NEW YORK — Six parents who allege that prenatal exposure to acetaminophen causes autism or attention deficit hyperactivity disorder (ADHD) but saw their claims dismissed after a New York federal judge excluded their causation experts have filed an appeal in the Second Circuit U.S. Court of Appeals.
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September 17, 2024
Federal Circuit: Judge Erred When Finding Patent Claims Mutually Exclusive
WASHINGTON, D.C. — A federal judge in Minnesota incorrectly held that that varying claims about the location of an opening in a catheter were mutually exclusive, which forced the judge “into a later conclusion of indefiniteness, which it did not have to do” in a patent dispute over the catheter, a panel of the Federal Circuit U.S. Court of Appeals held Sept. 16.
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September 16, 2024
Sanofi-Aventis Agrees To Cap Insulin Costs At $35 In Minn. Settlement Agreement
NEWARK, N.J. — A New Jersey federal judge signed off on an agreement to dismiss with prejudice all claims levied by Minnesota against Sanofi-Aventis U.S. LLC after the company agreed to make its insulin products available to consumers in Minnesota for no more than $35 for a monthly subscription.
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September 16, 2024
Company Agrees To Drop References To Lilly Drugs In Compound Medication Ads
DENVER — Eli Lilly and Co. and HydraMed IV LLC have reached a settlement to end a trademark infringement dispute, with the mobile IV treatment company HydraMed agreeing to a permanent injunction barring the company from advertising or selling compounded medications that lead consumers to believe that they are generic versions of Lilly’s weight loss medications.