PFIZER VOLUNTARILY SETTLES UNLAWFUL MARKETING SUIT FOR $490 MILLION
Written By: Rheingold, Valet, Rheingold, Ruffo & Giuffra LLP
by Kelda Doherty
One of the world's largest Pharmaceutical Company, Pfizer, has recently reached a $490 million dollar settlement with US District Judge Vicki Miles-La Grange in Oklahoma City after being accused of illegal marketing. The settlement includes a $157 million criminal fine and $76 million forfeiture of assets as well as $257.4 million with the federal government, all 50 states and the District of Columbia.
Pfizer/Wyeth entered a guilty plea to the charge of misbranding a drug
under the Food, Drug and Cosmetic Act. The drug involved in the controversy
is the prescription medication Rapamune (sirolimus), an immunosuppressive
therapy a drug approved by the FDA for use by kidney transplant patients.
However, the Justice Department found Pfizer to be marketing the drug
on an unapproved basis for other types of organ transplants and to be
training its sales force to promote Rapamune for off-label purposes, offering
bonuses and other sales incentives for doing so.
Not only did they fail to comply with the FDA usage approval, but in doing so Pfizer put profits first, putting consumers' health and safety in jeopardy. The unlawful marketing also led to multiple false Medicaid and Medicare claims. The action was brought by two former Rapamune Sales representatives the Justice Department said.