On November 9, 2007, Merck announced that it was settling approximately 27,000 lawsuits arising from the sale and distribution of Vioxx. At the time it was approved by the FDA in May 1999, Vioxx, a Cox-2 inhibitor, was hailed as a breakthrough in pain management.
The data that indicated that Vioxx led to an increased chance of heart attack and stroke was evident from the start. As early as April 2000, the FDA expressed concern, and it pressed Merck to add warnings on its Vioxx dispensers.
Yet, despite the growing evidence of cardiovascular issues from the use of Vioxx, the drug was not removed from the market until September, 2004, after sales of Vioxx had reached over $2.5 billion in 2003.
I have been reading today that this was a great move and a great deal for Merck. In fact, some financial publications are calling it a monumental victory for Merck.
And, it probably is, considering the mess they got themselves into. It looks like they finally listened to me.
In the summer of 2005, Merck announced that it would aggressively fight any Vioxx suit. In an article published in Risk Management Magazine in November 2005 (To Settle or Not to Settle by Vassar, Rick), I stated the following:
‘…This case accentuates a philosophy that we in the risk management profession know can become a harbinger of bad things to come—when someone in upper management says those five dirty words: “Let the lawyers handle it.”
The issue is whether or not counsel should have the ability to dictate the strategy and direction of a claim, and whether that direction is in the best interest of the organization.The Vioxx case exemplifies exactly why the executive branch must weigh the concerns of risk management more heavily than the concerns of the legal team. The legal team’s place is to execute the will of the organization to determine the best possible economic outcome from the mess that has been made. The company holds the map; the lawyers drive the car…’