Vioxx® Lawyer

SSEM successfully investigated and prosecuted individual claims for its clients who were injured as a consequence of taking the prescription drug Vioxx® (rofecoxib). In November 2007, Merck established a $4.85 billion fund to settle most of the Vioxx® suits.  That fund was divided into two funds:  a $4 billion fund for people who claimed that they suffered heart attacks as a result of Vioxx® use; and an $850 million fund for those who suffered ischemic strokes.

On March 2, 2010, Merck & Co. announced that it had made a final $4.1 billion payment to its Vioxx® settlement fund and that it anticipated that the final payouts to former Vioxx® users or their survivors should be made by the end of June 2010.

Summary

On September 30, 2004, Merck & Company announced that it was withdrawing its arthritis drug Vioxx® from the market worldwide. The reason given was that “a clinical trial found an increased risk of heart attack and stroke.” This was a big step for Merck because Vioxx was one of its most important drugs, with sales in 2003 of $2.5 billion.

Vioxx® FAQs

Vioxx® Press Release (from Merck & Co.)

What Merck did not say was that the findings were nothing that should have surprised it since researchers have been warning about a connection between Vioxx and an increased risk of heart attack and stroke for years. Until September 2004, Merck brushed those studies aside, saying they were inconclusive because they lacked the rigor of a placebo-controlled clinical trial.

Merck knew for some time that Vioxx presented a problem. On September 17, 2001, the Food and Drug Administration sent Chief Executive Gilmartin an eight-page warning letter*, wherein the FDA said that Merck engaged “in a promotional campaign for Vioxx that minimizes the potentially serious cardiovascular findings that were observed” in a clinical trial comparing Vioxx® to naproxen, a less-expensive painkiller. “Your promotional campaign discounts the fact” that in the trial, “patients on Vioxx® were observed to have a four- to five-fold increase” in heart attacks, compared with patients on naproxen, the letter said.

* FDA Letter to Merck (PDF Download)

Attorney John Evans (who manages the firm’s pharmaceutical practice) noted that the FDA approved the use of Vioxx® for infants over the weight of 22 pounds only two weeks prior to the worldwide withdrawal. The information Merck provided to the FDA in seeking this approval in the face of data showed a high correlation between Vioxx® and heart attack/stroke.