Lawsuits totaling approximately $15 million have been filed in state and federal court in Oregon on behalf of four people who claim they suffered serious health problems after taking the drug Baycol to lower their cholesterol.
The lawsuits, filed Tuesday, assert that German pharmaceutical company Bayer AG pushed the drug onto the U.S. market without adequate warning to doctors or federal regulators about potential side effects, such as kidney or lung failure.
“They rammed it through the FDA (news – web sites) when in fact the medicine was never tested on a long-term basis,” said Diane Craine, one of the lawyers representing the four plaintiffs.
Officials at Bayer Corp., the drug company’s U.S. subsidiary in Pittsburgh, did not immediately return phone calls.
Bayer voluntarily removed Baycol from the market last August after the U.S. Food and Drug Administration linked it to 31 deaths.
Baycol, like other anti-cholesterol drugs called “statins,” has been linked to rare reports of rhabdomyolysis — the destruction of muscle cells which are released into the bloodstream, causing severe muscle pain and leading to potential organ failure and death.
Craine said Baycol has accounted for 42 percent of the deaths linked to statins when it has just 2 percent of the market for the drug.
“Bayer wanted a piece of big, financially rewarding market so they brought in this high potency drug and promoted it,” Craine said.
One of the Oregon plaintiffs, Kathryn McKewen, 70, a former nurse, said she took Baycol after returning from medical missionary work in Russia and her doctor initially told her it had significantly lowered her cholesterol.
But then McKewen and her doctor became alarmed at the gradual onset of symptoms, including severe pain and swelling in her legs that since have confined her to a wheelchair.
Three of the lawsuits were filed Tuesday in Multnomah County Circuit Court while the fourth was filed in U.S. District Court in Oregon. The federal lawsuit did not list any doctors as defendants, unlike the complaints filed in state court, attorneys said.