When drug giant Pfizer acquired Wyeth Pharmaceuticals in 2009, they also acquired a very large criminal and civil liability. According to the U.S. Department of Justice, Wyeth improperly marketed and mis-branded their drug Rapamune, approved in 2009 by the U.S. Food and Drug Administration for use by kidney transplant patients in Ohio and across the nation.
The FDA accused Wyeth of training and giving financial incentives to sales reps to push physicians and hospitals to buy the drug for non-approved uses. As of July 31, both civil and criminal cases have been resolved.
Pfizer pleaded guilty to mis-branding Rapamune under the Federal Food, Drug and Cosmetic Act and received a fine of $157.58 million, and the recent plea deal with the Department of Justice also requires the forfeiture of assets worth $76 million. The civil liability stemmed from allegations that Wyeth violated the False Claims Act from 1998 through 2009 by submitting claims to Medicare, Medicaid and other federal health care programs for unapproved uses of Rapamune. The pharmaceutical company will pay approximately $230.1 million to the federal government and $27.3 million to the states to compensate for the civil liability.
If a patient believes that he or she were harmed by a drug that they used “off-label,” an attorney may research which conditions and diseases the pharmaceutical product is approved for and if there is a record of adverse reactions for those patients who have been prescribed the drug for other, non-approved uses. As this particular case suggests, in some cases, the drug manufacturer may share in the liability along with, possibly, the prescribing physician. An attorney may try to find other cases of patients involved in similar pharmaceutical litigation, and the patient could join in on a class action if possible or have his or her case litigated separately.
Source: Daily Finance, “Pfizer Resolves Federal Marketing Allegations for $491 Million”, Keith Speights, July 31, 2013