Merck, the maker of now banned arthritis drug Vioxx, is being sued by the State of Texas. The company, while recalling the drug voluntarily in September last year, continues to deny that it knew of dangers of Vioxx (despite overwhelming amount of evidence uncovered by media and attorneys) and has refused to settle any cases out of court. As many as 140,000 Americans alone have been injured, of which an estimated 50,000 are dead, according to FDA estimates. Merck is expected to face as many as 100,000 lawsuits by victims and/or the family members of the deceased and analysts expect Merck’s liabilities to be as high as $38 billion, driving the company potentially into bankruptcy. Merck, on the other hand, is so convinced about the safety of Vioxx, that it wants to sell it again in the US.
Texas Attorney General Greg Abbott accuses Merck of misrepresenting the safety of Vioxx. He said, “The company also falsely touted the safety of the drug, knowing it caused a higher risk of heart attack and cardiovascular problems. Despite those potential health hazards, the company still pushed to place Vioxx on the stateâ€™s Medicaid list for approved medicines.” The suit demands $168 million in damages for violating Medicaid fraud law to gain profits. Other experts have charged that both Merck and Pfizer ignored drug safety and focused on profits alone to get an edge in the highly lucrative market for Cox-2 inhibitor drugs. (Related article: Merck and Pfizer fought Coke-Pepsi style battle)
Abbott alleges that 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. Dr. David Graham of the FDA and Dr. Eric Topol of Cleveland Clinic, two world-famous experts on Cox-2 drugs and long time critics of Vioxx, Celebrex, Bextra, and other Cox-2 drugs, will definitely agree with everything that Texas AG is saying.
While most of the lawsuits filed so far against Merck have been by individual plaintiffs (or as class action lawsuits), the Texas Attorney General is not the first state to sue Merck. The company was sued earlier by the New York State Attorney General for securities fraud. The company is also being investigated by the Department of Justice (DOJ), Securities & Exchange Commission (SEC), Congress, and others. Foreign governments are also suing Merck.
â€œThis is a prime example of a companyâ€™s drive for profit steamrolling its duty to be safe,â€ Attorney General Abbott said. â€œDrug 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, 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.â€
The Attorney Generalâ€™s lawsuit claims Merckâ€™s 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 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 Texas 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 companyâ€™s repeated failure to disclose the adverse effects of Vioxx, while offering it to the stateâ€™s 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.
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