State sues Merck for deceptive marketing of Vioxx

South Florida Business Journal- Wednesday, October 1, 2008 - 11:49 AM EDT

Florida Attorney General Bill McCollum has filed suit again Merck & Co. for alleged deceptive marketing and promotion of the prescription drug Vioxx.

The lawsuit claims that Merck repeatedly failed to disclose the drug’s adverse effects while offering it to the state’s Medicaid program as a safe painkiller, in direct violation of Florida’s Deceptive and Unfair Trade Practices Act.

Vioxx was used to treat joint pain until it was removed from the market in 2004 after studies suggested those taking it had an increased risk of heart attack and stroke associated with long-term use.

The lawsuit follows a three-year investigation of Merck’s promotional practices and alleges that, due to the company’s marketing practices, numerous state agencies approved the inclusion of Vioxx as a covered or approved drug, and agreed to pay for the prescription or reimburse its expense.

In a prepared statement, Merck said it acted responsibly and intends to defend the complaint, which is similar to those filed by eight other states and pending in federal and state courts.

“The medicine was labeled appropriately under the direction of the FDA according to evolving science available at the time it was on the market,” the company stated in a news release.

Vioxx purchases by the Florida Medicaid program alone exceeded $80 million between 1999 and 2004.

The suit also alleges that Merck tried to intimidate physicians and researchers who questioned the safety of Vioxx, and may have misrepresented or concealed published evidence, including its own, showing possible harmful effects.

The lawsuit demands restitution to the state plus interest, for all state program payments – including Medicaid reimbursements – made for Vioxx prescriptions. It also seeks civil penalties of up to $10,000 per violation.

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Well, Don't say I didn't tell you so!

In one of my recent newsletters from September 21, 2008, Top-Selling Prescription Drug Mismarketed to Women?, I wrote , "I hope I am wrong, but this article from the Journal of Empirical Legal Studies may be a trial balloon for legal trouble for the pharmaceutical industry. We may soon see health insurers, Medicare and State Medicaid filing lawsuits worth billions of dollars to recover money spent on alleged false claims for Lipitor."

Fortunately or unfortunately it seems that the state of Florida is making my prediction ring true by filing suit against Merck Pharmaceuticals Vioxx medication. Vioxx is in a class of drugs called non-steroidal anti-inflammatory drugs (NSAIDs). Vioxx worked by reducing substances that cause inflammation, pain, and fever in the body. The manufacturer of Vioxx, in 2004, announced a voluntary withdrawal of the drug from the U.S. and worldwide market. This withdrawal was due to safety concerns of an increased risk of cardiovascular events (including heart attack and stroke) in patients taking Vioxx.

What the true risks of Vioxx were will probably never be known. In my practice, Vioxx worked very well and caused very few and minor side effects. It was removed from the market not due to lack of efficacy, but due to the economic potential of future lawsuits. It was a sad day for the 99%+ of patients who used the drug safely and effectively. But it was a sadder day for the patients who were potentially injured by the drug.

This all could have been avoided if Merck marketed the medication properly and did not allegedly attempt to hide data that showed possible complications from using the drug. If Merck had been prudent and shared this knowledge beforehand, Vioxx would still be on the market, helping millions of patients with Arthritis and other inflammatory conditions. It would have a big black-box warning attached to it warning of the dangers in a select population, but it would still be in use today.

Motto of the story: Big Pharma needs to work on their business and marketing practices and once again put patients health and well being ahead of profits. Until that time, do not expect the pharmaceutical industry to be trusted or respected as it had in the past.

If you have any questions on your medical care and the medications you take, call the office, make an appointment and discuss your options. My motto has always been to use the least amount of medication possible and only when necessary.

Steven Horvitz, D.O.

Board Certified Family Medicine

Founder of The Institute for Medical Wellness