Merck & Company said on Monday that the Justice Department has launched a criminal investigation related to the Company’s research, marketing and selling activities with respect to Vioxx, the arthritis drug that it pulled from all worldwide markets on September 30, 2004 after a study confirmed that Vioxx increased the risk of heart attacks and strokes in patients who took it for more than 18 months. In addition, Merck said the Securities and Exchange Commission informed it that it has begun an informal inquiry over Vioxx.
In a public filing with the SEC (10-Q Filing), Merck said it’s cooperating with both the Justice Department and the SEC.
Merck warned that a potential civil disposition from the SEC, and potential civil or criminal dispositions from the Justice Department could have a material-adverse effect on the its financial position, liquidity and results of operations.
Merck said it expects one or more of the Vioxx Personal Injury Lawsuits filed against it may go to trial in the first half of 2005. The company said it will vigorously defend against them.
As of October 31, 2004, Merck said it has been named as a defendant in approximately 375 lawsuits, which include 1,000 plaintiff groups alleging personal injuries resulting from the use of Vioxx. Certain of these lawsuits include allegations regarding gastrointestinal bleeding, cardiovascular events and kidney damage, Merck said.
Merck said it has also been named as a defendant in several putative class actions seeking medical monitoring as a result of the putative class members’ use of Vioxx. In addition, certain state court actions seek various remedies under state consumer fraud and fair business practice statutes, including recovering the cost of Vioxx purchased by individuals and third-party payers such as union health plans (all of the actions discussed in this paragraph are collectively referred to as the “Vioxx Personal Injury Lawsuits”).
In addition to the lawsuits discussed above, the Merck has been named as a defendant in actions in various countries in Europe, Canada, Brazil and Israel related to Vioxx.
The Company said it has product liability insurance for claims brought in the Vioxx Personal Injury Lawsuits of up to approximately $630 million after deductibles and co-insurance.
Based on media reports and other sources, Merck anticipates that additional Vioxx Lawsuits will be filed against it and several of its current and former officers and directors in the future.
In addition, Merck said it has at $190 million in insurance to cover its directors and officers for Vioxx Securities Lawsuits and Vioxx Derivative Lawsuits, and at least approximately $275 million of insurance coverage for the Vioxx ERISA Lawsuits.
But Merck said it’s unable to determine if the company’s insurance coverage with respect to the Vioxx Personal Injury Lawsuits and the Vioxx Shareholder Lawsuits will be adequate to cover its defense costs and losses, if any.
(via Merck)
2 responses so far ↓
Dodge // Mar 31, 2005 at 10:22 am
All I here about the vioxx is that it can give you a heart attack, what about the other side effects? I have been having attacks, but the doctors did not call them heart related attacks, actually they didn’t know what they were, but my attacks were very violent and very real and started with indigestion and sweats and loss of body functions, and a stay in the hospital. Are there other people out there that are having other side effects, too?
Edith Abrams // Jun 1, 2005 at 7:06 pm
I had mycardial infarction at the age of 50, was feeling fine then one morning I was going about my daily routine and bam, the sudden chest pain and squeezing started, I had been taking vioxx for some time, and I relly do believe this is the culprit of my ever lasting health problems, I was aworking 2 jobs with an active lifestyle, so don’t blame it on me,something had to be wrong somewhere, something casued this sudden invsion of my body and I will never be the same, I will beieve till this day it was vioxx, oh yes it did relieve my pain, but what a price to pay.
You must log in to post a comment.