July 6, 2005
Texas Attorney General Greg Abbott has filed suit against one of the largest drug companies in the nation for misrepresenting the safety of the painkilling prescription drug Vioxx.
According to the lawsuit, Merck & Co. falsely touted the safety of the drug, knowing it caused a higher risk of heart attack and cardiovascular problems and at the same time, pushed to place Vioxx on the states Medicaid list for approved medicines.
Abbott alleges Merck aggressively marketed the drug to the medical community, and in doing so, willfully misrepresented its own studies and the concerns of physicians suggesting the drug may increase the risk of heart problems.
The Texas Medicaid program reimbursed pharmacists $56 million for Vioxx prescriptions they filled for patients over a five-year period.
The Attorney General is invoking a provision in state law that allows for that amount to be automatically tripled to $168 million, which Merck would have to pay to the state of Texas for acts of fraud.
This is a prime example of a companys drive for profit steamrolling its duty to be safe, Abbott said. Drug companies have an ethical, legal and professional responsibility to conduct meticulous clinical studies to ensure the safety and effectiveness of drugs for human consumption.
Yet in this case, Abbott said, Merck took extreme measures to get this drug approved for widespread use, including for Medicaid patients, without the proper respect for good science and the concerns of peers.
Merck, which began marketing Vioxx in 1999 after brief clinical trials, finally conceded the health concerns and voluntarily withdrew the product in September 2004.
The Attorney Generals lawsuit claims Mercks costly promotional campaign aimed to convince consumers the drug was not only safe, but that they should demand it from their health care professionals for pain.
The company also allegedly tried to intimidate or threaten physicians and researchers who questioned the safety of Vioxx. The company even routinely misrepresented or concealed published evidence, including its own, showing possible harmful effects of the drug, the suit charges.
The Medicaid program reimbursed pharmacists for Vioxx prescriptions at the rate of about $1.94 per 25-milligram pill, the most commonly prescribed dosage. Pharmacists filled more than 700,000 prescriptions under the Medicaid program in these years, accounting for over 29 million pills.
If the facts about Vioxx had been known earlier, the Attorney General contends, physicians and their Medicaid patients would have chosen other nonsteroidal, anti-inflammatory agents like generic naproxen, which costs about $0.33 per daily equivalent dose.
According to the lawsuit, the companys repeated failure to disclose the adverse effects of Vioxx, while offering it to the states Medicaid program as a safe painkiller, directly violates the Texas Medicaid Fraud Prevention Act.
The Attorney General requests restitution to the state of Texas, plus interest, for all Medicaid payments made to the company for Vioxx prescriptions, as well as civil penalties of up to $10,000 per violation of this law.
