Merck Agrees to Pay $4.85 Billion for Vioxx Claims

According to a news release on Merck's Corporate website, they have agreed to a settlement with the law firms of the executive committee of the Plaintiff's Steering Committee of the federal multi-district Vioxx litigation. Representatives of the plaintiff's counsel also approved this settlement. The agreement will resolve the claims against Merck concerning the drug Vioxx and the Myocardial infarctions (heart attacks) and ischemic strokes the drug is alleged to have caused. The settlement will also apply to the claims where the statute of limitations is tolled. According to Wikipedia, tolling "prevents the time for filing a suit from running while the condition exists".

Merck & Co, Incorporated is the manufacturer of the drug Vioxx. According to the FDA, Vioxx was approved in May 1999. Merck voluntarily recalled it on September 30, 2004. Merck states that they did so because safety concerns arose in some of the drug trials involving Vioxx. The FDA states that it did not recall the drug because it had not had time to review the data before Merck voluntarily recalled the drug. The New York Times and other news sources reported that the FDA was lax in their over-seeing of the issue and that they might have known earlier that the drug was questionable.

There are conditions for the settlement to be valid and all of the claims will still be evaluated on a case-by-case basis. The settlement is not the same as a class action settlement. It will apply only to claims that were filed as of November 8, 2007 or as stated above, those which have been tolled. The first condition of the settlement is three-fold. The claimants must have objective medical evidence of a myocardial infarction or ischemic stroke. They must prove that they received at least 30 pills and they must show that they received a sufficient number of the pills within 14 days of the infarction or stroke to satisfy the question of whether or not they could have taken the pills close to the time of the attack. Administrators for the resolution process will determine if the conditions are met. Part of the agreement specifies that Merck will not admit any fault.

The plaintiffs have until March 1, 2208 to enroll in the program and unless 85% in each of the categories enroll, Merck will not be obligated to go through with the settlement. Merck retains the right to extend the date. The settlement only applies to U.S. citizens or those who took the medication and had the heart attacks or ischemic strokes while in the United States. There are other conditions; all of them are detailed on the Merck web site.

According to Merck, payments could be initiated as early as August 2008. The agreement does give Merck the right to end the process at any time and to try the cases individually if all of the agreement's conditions are not met. Merck Senior Vice President Bruce N. Kuhlik states that he feels the agreement is a good one for Merck in that they have set aside approximately $1.9 billion to defend the Vioxx claims since 2004 and that Merck is aware that the litigation could last indefinitely. He also states that the statute of limitations have already expired in almost every state.

The website states that it was the judges in the case who requested that Merck enter into discussions with the plaintiff's representatives and also states that those claimants who do not agree to become part of the settlement will be required by court order to provide certified copies of medical and pharmacy records and the supporting expert opinions "in a timely fashion". According to Merck, it intends to "defend all claims that are not included in the resolution process".

Merck's figures state that as of October 9, 2007, they had been served or named as a defendant in approximately 26,600 lawsuits in the U.S. So far, Merck has won 12 suits and those filing Vioxx claims have won 5 times.

Sources used:

http://www.merck.com/newsroom/press_releases/corporate/2007_1109.html

http://www.fda.gov/bbs/topics/news/2004/NEW01122.html

http://www.freedomofchoiceinhealthcare.ca/Articles/FDA/FDAfailing.doc

http://en.wikipedia.org/wiki/Statute_of_limitations

http://www.fda.gov/cder/drug/infopage/vioxx/vioxxQA.htm