Pfizer settled with the federal government in 1994 for $20 million to resolve claims that it deceived to obtain regulatory approval for its mechanical heart valve, which killed hundreds or thousands of people.
The settlement provides $10.75 million to the Department of Justice and $9.25 million to monitor or remove the device from Veterans Administration patients. Pfizer has a shocking history of criminal activity and human experimentation.
This mechanical heart valve is the Bjork-Shiley convexo-concave valve. Pfizer bought Shiley Laboratories, which created and patented the valve. Pfizer obtained the valve patent. 86,000 Bjork-Shiley valves were implanted worldwide between 1979 and 1986. After years of fatal claims, the valve was removed from the market.
At least 300 Americans died from defective heart valves by 1992. The valve’s potential to crack raised the receiver’s fatality risk.
After the Pfizer-government arrangement, many more patients from around the world had to undergo valve replacement surgeries. Dozens, maybe hundreds, of these people died due to valve replacement issues or valve anomalies.
51,000 Bjork-Shiley valve recipients earned $215 million from Pfizer. Consumer groups slammed Pfizer’s government deal. They pressured the government to indict Big Pharma. Pfizer’s deal was slammed. They also lobbied the authorities to penalize the multibillion-dollar corporation more.
Despite these failures, Pfizer did more than pay $20 million. Pfizer was sued by 51,000 persons who got the faulty cardiac valve in 1992. Pfizer reached a federal settlement two years later. A Cincinnati federal court sided with the plaintiffs.
Pfizer suggested a $215 million settlement and associated perks. The court approved the settlement even though other class action attorneys urged him not to.
The settlement included $75 million to improve strategies for detecting heart valve patients at risk of fractures. This money would finance research to better identify heart valve recipients at risk of fractures. Heart valve recipients would get between $90 million and $140 million of the settlement for medical or mental therapy in addition to compensation for themselves and their spouses.
Each patient receives $2,500–$4,000. Each patient costs $5,310 to $8,496 in today’s dollars. In 1992, Ross, 68, called Pfizer’s prospective $4,000 payout “a drop in the bucket.”
“You never know what is going to happen,” she told the LA Times. “Despite your best efforts, you live in fear. I feel violated that they could put anything in my chest that didn’t meet their criteria.