South Dakota Widow Sues Bayer Over Recalled DrugNov 22, 2002 | AP
A Rapid City woman has sued the makers of a cholesterol-lowering drug that was recalled four days after her husband died of complications consistent with its use.
Pamela Sutterfield's federal court lawsuit seeks unspecified damages against Bayer Corp., GlaxoSmithKline and other parent companies on behalf of her late husband, John Sutterfield.
He died Aug. 4, 2001, from complications from the prescription drug Baycol, according to the lawsuit.
"This was a case where he died of a heart attack and he'd been healthy before that, had recently undergone physical evaluation, and it was shortly after he was started on the Baycol medication that he died unexpectedly," said Mark Connot, Sutterfield's Rapid City lawyer.
Bayer's lawyer did not immediately return a telephone call Friday.
Baycol, a type of drug called a statin, lowers cholesterol levels and reduces the risk of heart disease.
In June 1997, the U.S. Food and Drug Administration let Bayer market Baycol in lower doses. It allowed higher doses in May 1999.
But at least by early 1998, Bayer and GlaxoSmithKline learned that Baycol was linked to a death caused by muscle deterioration. Since then, 52 deaths have been reported that are associated with Baycol. Other patients have suffered muscle damage, the lawsuit states.
Still, Baycol's makers asked the FDA for increased dosages, it states.
They "knew or should have known that Baycol created significant risks of serious injuries or disorders, including damage to kidneys, liver and heart" and did not warn doctors or patients, the lawsuit said.
On Aug. 8, 2001, Bayer announced it was withdrawing Baycol from the market and "finally revealed the dangers associated with Baycol" by sending a letter to doctors, according to the court filing.
For John Sutterfield, it was too late.
He died four days earlier, just a month after starting to use Baycol.
Sutterfield had a physical exam in April 2001. Though it showed his risk of heart problems to be low, he had high cholesterol.
His physician, Dr. David Johnson, prescribed Baycol and also gave Sutterfield some free samples.
Sutterfield started taking Baycol in early July 2001 and immediately developed back and leg muscle pain and cramping, dark-colored urine, fatigue and tiredness all symptoms of muscle deterioration caused by Baycol, the lawsuit states.
He was found dead in his yard.
"The death was directly related to Baycol," the lawsuit states. It "had an adverse effect upon the liver, kidneys, heart and other organs, contributing to and causing the death of John Howard Sutterfield."
Specifically, the lawsuit says Baycol was defective, more dangerous than other statin drugs, not adequately tested and not accompanied with warnings to doctors or patients about its risk of damage to muscle tissue, kidneys, liver and heart or death.
The lawsuit says Baycol's parent companies knew about the risks but ignored them.
Before it was recalled, Baycol had 5 percent of the market for such drugs and was used by more than 700,000 patients, the lawsuit states.
Bayer and GlaxoSmithKline "falsely and deceptively misrepresented or omitted a number of material facts concerning Baycol, including but not limited to, adverse health effects caused by Baycol," the lawsuit states.