Wyeth Pharmaceuticals, Inc., a Pfizer Inc. subsidiary, agreed to a $409.9 million settlement with the U.S. Department of Justice last month to resolve civil and criminal allegations of abusing the marketing of off-label pharmaceuticals. The complaint alleged that Wyeth, acquired by Pfizer in 2009, illegally marketed its immune-suppressant drug, Rapamune, which is intended to help kidney patients accept their transplanted organs, from 1998 through 2009.
It was alleged that Wyeth instructed sales representatives to promote the drug for unapproved uses in order to boost sales.
The U.S. Food and Drug Administration’s (FDA) job is to ensure drugs go through an approval process to guarantee their products are safe and effective for consumer’s use. The office of the Acting Assistant Attorney General for the civil division commented that they would hold accountable those who put patient’s health at risk in pursuit of financial gain.
Wyeth pleaded guilty to criminal misbranding under the Federal Food, Drug and Cosmetic Act and will pay a criminal fine of $157 million and forfeit $76 million. A $257.4 million civil settlement will go to the federal government, as well as Arkansas, California, Delaware, Florida, Hawaii, Illinois, Indiana, Louisiana, Massachusetts, Nevada, New Hampshire, New Mexico, Tennessee, Texas, Utah, Virginia and the District of Columbia.
The complaint, filed in 2005 by whistle-blowers Marlene Sandler and Scott Paris, two former sales representatives, accused Wyeth of hyping Rapamune for use in transplants of organs other than kidneys and in place of, or in combination with, other immune-suppressants.
Just one year ago, Abbott Laboratories paid $1.5 billion after pleading guilty to a criminal misdemeanor for misbranding Depakote. Abbot admitted that they maintained a specialized sales force trained to market Depakote in nursing homes to help control aggressive behavior in elderly dementia patients, even though no studies were conducted and no evidence supported their claims that it was safe and effective for that use. They also marketed Depakote for the treatment of schizophrenia, even after their clinical trials failed to demonstrate the drug to be effective.
This settlement was the second largest payment by a drug company, including criminal fine and forfeiture, totaling $700 million and civil settlements with the federal government and the states totaling $800 million.
Abbott’s settlement demonstrated the continued scrutiny of the sales and marketing practices of pharmaceutical companies that put profits before the safety and health of consumers.
This resolution is part of the government’s emphasis on fighting health care fraud and another step for the Health Care Fraud Prevention and Enforcement Action Team (HEAT) initiative, which was announced in May 2009 by Attorney General Eric Holder and Kathleen Sebelius, Secretary of HHS.
Hopefully, the big Pharma’s will realize that the government will hold accountable anyone who puts profits before the safety of the American consumers. For more information, contact one of our Gacovino Lake attorneys at 1-800-246-HURT (4878).