
Home » CLASS-ACTION LAWSUIT CHALLENGING NEXIUM MARKETING IS DISMISSED
CLASS-ACTION LAWSUIT CHALLENGING NEXIUM MARKETING IS DISMISSED
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
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