Two former sales reps of Wyeth Pharmaceuticals, purchased by Pfizer Inc. last year, brought a whistleblower lawsuit against Wyeth in 2005 under the qui tam provisions of the False Claims Act. The reps alleged that Wyeth targeted organ-transplant centers used predominantly by African-Americans to illegally promote the off-label use of the drug Rapamune and to experiment on African-American patients without their knowledge.
It is certainly an explosive allegation, and the pharmaceutical blog Pharmalot states that it has growing force now that the federal government and 19 states have asked to join the suit. "The feds do not intervene in every whistleblower lawsuit," notes Pharmalot, adding that the intervention strengthens the case against Pfizer.
By joining, the federal and state governments would share in any settlement, along with the sales representatives.
Pfizer is already reeling from a series of previous suits that resulted last year in a $2-plus billion settlement. Its present business operations are being conducted under a Corporate Integrity Agreement that could result in its losing the ability to sell its products to the government if allegations of marketing fraud are established. Its likely defense will be that any irregularities in the present case occurred during Wyeth's reign, prior to that company being purchased by Pfizer.
Among other things, the lawsuit alleges that Wyeth offered kickbacks to hospitals and paid doctors to endorse Rapamune's off-label use.
Related Resource: www.theday.com "Feds and 19 states seek status in suit against Pfizer" September 23, 2010