Merck & Co. Inc. has settled another legal issue involving Vioxx, the pain reliever it withdrew from the market in 2004.
The Whitehouse Station, N.J. drug maker will pay $58 million over deceptive advertising related to the drug in a settlement with 29 states and the District of Columbia.
Pennsylvania will receive more than $2.9 million. New Jersey will get $1.8 million.
Merck had already taken a pre-tax charge of $55 million to cover the cost of the settlement. In a statement, the company said:
We believe that Merck acted in good faith and that the Company's activities in support of VIOXX were intended to fully comply with relevant regulations.
Pennsylvania Attorney General Tom Corbett clearly disagrees with that characterization. In a statement, Corbett said:
Using Merck's Vioxx, which was prescription pain relieving drug, carried an increased risk of having a heart attack or another serious cardiovascular side effect. Merck allegedly knew about this, but continued to misrepresent the safety of their product in their advertisements until they finally admitted that Vioxx caused serious side effects and pulled the product from the market in 2004.
The marketing effort of Merck's Vioxx was handled from the pharmaceutical company's huge West Point complex in Montgomery County. After the withdrawal, more than 25,000 lawsuits were filed by people who had taken the drug and felt they were harmed by it. Merck agreed to pay $4.85 billion last November to settlement thousands of those lawsuits.
Corbett was one of nine attorneys general on the executive committee that hammered out the settlement with Merck.
And he said the multi-state settlement will lead to changes:
This settlement addresses all of our concerns and will restrict Merck's ability to deceptively promote any of their products.
Corbett said Merck agreed to halt the practice of ghostwriting positive articles and studies, refrain from using scientific data deceptively when marketing to doctors, delay any direct-to-consumer TV advertising for a pain medication if the FDA recommends it, and submit all TV ads to the FDA for review before airing them.
In its statement, Merck says those actions are nothing new:
The agreement also includes compliance measures that supplement policies and procedures previously established by the Company.
Plus, keep in mind that the FDA has already admitted it's been unable to review and sign off on TV ad campaigns. It hadn't committed enough staffing to do that.