Protonix is a proton pump inhibitor (PPI) that was used by physicians to treat various forms of gastro-esophageal reflux disease (GERD). The Food and Drug Administration (FDA) approved Protonix for short-term treatment of erosive esophagitis, a condition associated with GERD that can only be diagnosed with an invasive endoscopy.
The government alleged that Wyeth engaged in a “multifaceted” campaign to promote Protonix for all forms of GERD, including symptomatic GERD, which was far more common and could be diagnosed without an endoscopy. These other uses were not approved by the FDA.
Under the Federal Food Drug and Cosmetic Act, manufacturers must obtain FDA approval for any indication for use for which a manufacturer intends to market a drug. A prescription drug that is intentionally marketed for unapproved off-label uses is considered “misbranded.”
The government alleged that Wyeth intentionally engaged in the following conduct to promote Protonix for off-label use:
- training its sales force to promote Protonix for all forms of GERD;
- promoting Protonix to physicians for unapproved uses;
- promoting Protonix as the “best PPI for nighttime heartburn,” even though there was no clinical evidence that Protonix was more effective than any other PPI for nighttime heartburn;
- retaining an outside market research firm to ensure that sales representatives delivered that misleading superiority message;
- using continuing medical education (CME) programs to promote Protonix for unapproved uses.
Pfizer denied the allegations, and the settlement resolves the case without a finding of guilt or innocence.
While the Pfizer case was brought by the government directly, many off-label promotion cases are brought by whistleblowers. Under the qui tam provisions of the False Claims Act, whistleblowers are entitled to a reward of up to 30% of the amount of money the government recovers. In some cases, the rewards in pharmaceutical cases have reached millions of dollars.
If you have information that a pharmaceutical company is promoting its drugs for off-label uses, then you should consult with an experienced False Claims Act attorney immediately. To schedule a free and confidential consultation by telephone or in person, call my office today at (917) 652-6504 or click here to communicate with me via email.
John Howley, Esq.
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