Zetia and Vytorin Class Action Lawsuits are filed as investigations are launched
Following the release of damaging data about their blockbuster cholesterol drugs, Merck and Schering-Plough now face Zetia and Vytorin class action lawsuits from users who claim that the drugs carry no medical benefits over cheaper, generic alternatives. In addition, the FDA issued an early communication late Friday indicating that they will be reviewing a final analysis of the data and the New York Attorney General has launched a probe into the drug makers’ actions surrounding the release of the study.
>>PRIOR POST (1/15/2008): Concerns about Zetia and Vytorin Side Effects
Vytorin is a cholesterol drug which combines Zetia and Zocor. On January 14, 2008, preliminary data was released from a clinical trial which was conducted to look at the effect of Vytorin on the build of cholesterol plaque in the neck arteries when compared to users taking Zocor alone, which is available as a generic.
Preliminary data from the clinical trial indicated that Vytorin does lower cholesterol levels, but there was no significant difference in the reduction of plaque which can develop on the inner walls of the arteries. The build up of this plaque could potentially lead to an increased risk of a heart attack or stroke.
ZETIA AND VYTORIN INVESTIGATIONS
Concerns surrounding the study were initially fueled by an announcement in November 2007 that Merck and Schering-Plough were going to change the trial’s primary measure of effectiveness, even though the collection of data had concluded a year and a half earlier. Many considered this to be a violation of scientific protocol, and a congressional committee announced in December that they were going to investigate whether the drug makers were attempting to manipulate the data.
On Friday, the FDA released an “Early Communication” which indicated that they will be evaluating the complete analysis of the study’s data, which they anticipate will take about six months. Early communications usually indicate that the FDA is looking at the safety of a product, and whether risks associated with it may outweigh the benefits provided by the treatment. While this communication did not identify any specific health risks, many people in the medical community have expressed concern that Vytorin and Zetia may expose users to an unnecessary increased risk of heart attacks and strokes.
On Saturday, it was reported that another investigation has been launched by the New York Attorney General, who will be looking into the actions of Merck and Schering-Plough. The Attorney General will be looking at the drug makers’ continued marketing of the Vytorin even after they were aware of the results of the study which concluded in April 2006. The sale of stock by company insiders just before the bad results of the study were disclosed will also be investigated.
In a statement released by Andrew Cuomo, the New York Attorney General, he said:
Drug companies are on notice that concealing critical information about life-saving prescription drugs, profiting at the expense of patients’ health, and wasting taxpayer dollars, is simply unacceptable.
ZETIA AND VYTORIN CLASS ACTION LAWSUITS
Zetia and Vytorin class action suits have been filed in at least four different states on behalf of patients and medical insurers who paid for the drug which apparently had no positive medical benefits. The lawsuits allege that the drug makers pursued profits, without concern for whether the drug would have an impact on the health of users.
The Zetia and Vytorin class action suits are seeking reimbursement for the cost of the prescription or for the difference between the cost of the prescription and what the generic would have cost. The lawyers at Saiontz & Kirk, P.A. are also evaluating the potential for individual Vytorin lawsuits for users of the drugs who suffered a heart attack or stroke. Since the drug does not provide any medical benefit, even a minimal increase in the risk of a heart attack or stroke would be an unacceptable risk.
If you, a friend or family member have suffered a heart attack or stroke while taking Vytorin or Zetia, you can have the circumstances surrounding your injury reviewed as part of our law firm’s evaluation of whether Zetia and Vytorin lawsuits will be pursued. Request a free consultation.