Bristol-Myers, Sanofi prevail in Plavix false claims case
- U.S. District Judge Freda Wolfson partially dismissed claims from a former Sanofi-Aventis sales rep alleging coercion to make false claims about Plavix (clopidogrel).
- The rep, Elisa Dickson, said she was instructed to promote the drug as more effective than aspirin for secondary prevention in stroke patients even though trial data showed the drug was not effective for that population.
- Dickson also alleged that Sanofi told her to focus on detailing physicians, whose patients were mainly covered by Medicare or Medicaid.
When the FDA approved the first generic version of Plavix in May 2012 it was hailed as the end of an era. Since 1997, when it was approved, Plavix had been a go-to treatment option for patients with high-risk cardiovascular (CVD) profiles at risk of CVD-related events, including heart attack and stroke. Plavix, which carried indications for primary and secondary prevention, generated $9 billion in sales at its peak in 2010.
However along with its widespread usage, Plavix was a source of controversy in terms of how it was marketed, going all the way back to 2003. In 2013, the Department of Justice vowed to investigate Plavix-related marketing practices to determine if there was a problem with false claims.
That's why, this latest decision is a such a coup of the Sanofi-Aventis Plavix marketing team. The judge noted that Dickson was unable to prove that Plavix had been used for anything but on-label uses by the physicians she called on. Moreover, the judge also said that there was no evidence to show that doctors who prescribed Plavix to patients who are covered by Medicare or Medicaid received false marketing information.