Last December, 87-year-old Lilbert Sparks of Oklahoma City began taking the statin drug Baycol. His family says that 6 weeks later, he died of cardiac arrest. Thirty-one deaths in America are attributed to the cholesterol-lowering drug, which the Bayer Corporation pulled from the market last week.
Sparks's son, Steven, has now filed what could be a multimillion-dollar class-action lawsuit against the drug maker, blaming Bayer for his father's death and possibly others.
The lawsuit charges the Bayer Corporation with product liability and negligence, blaming Bayer for not adequately informing doctors and patients of possible risks. About 700,000 Americans have taken Baycol.
Attorney Don Strong says there is strong evidence Baycol caused the death.
"My client's father was a former Golden Gloves boxer. He walked 1 to 4 miles every day. He was in excellent shape," Strong says.
At issue is a potentially deadly condition called rhabdomyolysis. It causes severe muscle aches that can lead to muscle breakdown and kidney failure and ultimately, death.
There are currently two lawsuits, including one in Florida. A spokesperson for the Bayer Corporation declined to comment, saying the company cannot talk about ongoing litigation.
Patients taking Baycol are reportedly ten times more likely to suffer from the condition than those on other statins, but all statin drugs, including top sellers Lipitor and Zocor, carry a risk of the condition.
Despite the controversy, Bayer's competitors are wasting no time trying to increase market share. Merck, which manufactures Zocor, has taken out full-page newspaper ads trumpeting its benefits. Bristol-Myers Squibb, the maker of Pravachol, has done the same, even including a coupon for a free 30-day supply of Pravachol to former Baycol users.
"I know this story is going to make a lot more people not want to take them," says Weill Cornell Medical Center cardiologist Holly Anderson, who is concerned patient fears may interfere with treatment. She maintains the benefits of statins other than Baycol clearly outweigh the risks.
"The medicines that have been around longer have been extraordinarily well studied and I still believe they are an extraordinarily safe class of medicines in people who are monitored," she says.
The advocacy group Public Citizen plans to file a petition with the FDA that urges the agency to require all statins to have black warning labels on the box and a medication guide, similar to the one for Accutane, the powerful acne drug.
If you take a statin drug, make sure you get regular blood tests to monitor muscle changes and liver enzymes. If you have any muscle pain, call your doctor right away.
©MMII CBS Worldwide Inc. All Rights Reserved. This material may not be published, broadcast, rewritten, or redistributed