We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Accept
  • SKIP TO CONTENT
  • SKIP NAVIGATION
  • Drug News
    • Trending
    • Commercial Operations
    • GMPs
    • FDA Enforcement Actions
    • Inspections and Audits
    • Postmarket Safety
    • Quality
    • Regulatory Affairs
    • Research and Development
    • Submissions and Approvals
    • FDAnews Drug Weekly
    • FDAnews
  • Device News
    • Trending
    • Commercial Operations
    • FDA Enforcement Actions
    • Inspections and Audits
    • Postmarket Safety
    • Quality
    • Regulatory Affairs
    • Research and Development
    • Submissions and Approvals
    • FDAnews Device Weekly
    • FDAnews
  • Books
    • FDAnews Books Library
    • Drug Books
    • Device Books
  • Training/Events
    • Webinar Training Pass
    • Events
  • Resources
    • Form 483s Database
    • FDA Approved Drugs
    • White Papers
  • CenterWatch
  • About Us
    • The Company
    • FDAnews Editorial Board
    • Contact Us
  • Advertising
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » CLASS-ACTION LAWSUIT CHALLENGING NEXIUM MARKETING IS DISMISSED

CLASS-ACTION LAWSUIT CHALLENGING NEXIUM MARKETING IS DISMISSED

November 11, 2005

A class-action lawsuit accusing AstraZeneca of waging a misleading promotional campaign to deceive patients into buying its heartburn drug Nexium was dismissed last week in a Delaware federal court.

Judge Sue Robinson of the U.S. District Court for the District of Delaware ruled that the plaintiffs, which included consumers, advocacy groups and state employee benefit funds, failed to prove that AstraZeneca used deceptive marketing to boost sales of Nexium (esomeprazol).

The lawsuit, filed in May, alleged that AstraZeneca violated Delaware false advertising laws by using misleading information to convince consumers that Nexium was significantly better than the company's older proton pump inhibitor (PPI) Prilosec (omeprazole). The $500-million marketing campaign was designed solely to shift patients from Prilosec — which was set to go off patent in 2001 — to Nexium to prevent the erosion of the firm's brand presence in the PPI market, the lawsuit claimed.

The plaintiffs argued that the Nexium ads "either implicitly or expressly represented" that Nexium was superior to Prilosec, and in doing so, AstraZeneca suppressed or omitted information demonstrating the drugs were equally effective at equivalent doses. The misleading advertising campaign resulted in "billions of dollars of unnecessary drug expenditures by third-party payors," the plaintiffs said.

However, Judge Robinson concluded that the Delaware Consumer Fraud Act (DCFA) doesn't apply to pharmaceutical advertising if the ad claims are within the bounds of the drug's FDA-approved labeling. "If the FDA labeling supports the statements made in advertising for an FDA-approved drug, the statements are not actionable," Robinson writes in her order.

The court's review of AstraZeneca's ad campaign found that the Nexium claims complied with the approved product labeling, Robinson added. The court also found that AstraZeneca did not make any "explicit statements that Nexium was 'superior' to Prilosec."

Even if AstraZeneca implicitly claimed that Nexium was superior to Prilosec, the plaintiffs would still have had to prove that the approved dosage of Nexium was not superior to the approved dosage of Prilosec — an argument that Robinson said isn't suited for the courts. "The issue of whether one drug is more effective than another drug is clearly within the expertise of the FDA and should not be resolved in a court of law through the adversarial system," Robinson writes. "The court concludes, therefore, that plaintiffs have not stated a claim upon which relief can be granted by this court."


KEYWORDS FDAnews Drug Daily Bulletin

    Upcoming Events

    • 28Sep

      The Cost of Counterfeiting: Why You Need a Plan to Secure Your Medical Device Supply Chain

    • 28Sep

      Calculating Sample Size to Satisfy FDA Expectations

    • 11Oct

      GMP Quality Management vSummit 2023: Where Quality Meets Risk

    • 16Oct

      MAGI@home Clinical Research Conference 2023

    • 26Oct

      FDA in 2024: What to Expect in an Election Year

    • 08Nov

      18th Annual FDA Inspections vSummit

    Featured Products

    • FDA, FTC and DOJ Enforcement of Medical Device Regulations

      FDA, FTC and DOJ Enforcement of Medical Device Regulations

    • Using Real-World Evidence in Drug and Device Submissions

      Using Real-World Evidence in Drug and Device Submissions

    Featured Stories

    • Manufacturing Cost is Key Issue Facing Gene Therapy Products, Marks Says

    • Artificial Womb Technology Not Yet Ready for Human Trials Adcomm Says

    • Top Concern for CBER is Marketing of Unapproved Biologics, Says FDA Official

    • FDA Deems Medline Industries’ Saline Solution Vial Recall as Class 1

    The Revised ICH E8: A Guide to New Clinical Trial Requirements

    Learn More
    • Drug Products
      • Quality
      • Regulatory Affairs
      • GMPs
      • Inspections and Audits
      • Postmarket Safety
      • Submissions and Approvals
      • Research and Development
      • Commercial Operations
    • Device Products
      • Quality
      • Regulatory Affairs
      • QSR
      • Inspections and Audits
      • Postmarket Safety
      • Submissions and Approvals
      • Research and Development
      • Commercial Operations
    • Clinical Products
      • Trial Design
      • Data Integrity
      • GCP
      • Inspections and Audits
      • Transparency
    • Privacy Policy
    • Do Not Sell or Share My Data
    Footer Logo

    300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

    Phone 703.538.7600 – Toll free 888.838.5578

    Copyright © 2023. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing