Joseph Randone suffered a horrible death because pharmaceutical giant Bayer Corp. hid the lethal side effects of its highly profitable heart-surgery drug, a new suit alleges.
The Long Island travel agent, 52, died Aug. 8, 2006, after an agonizing eight months in Stony Brook University Hospital after his kidneys failed following heart surgery.
On dialysis, his legs amputated, Randone was hooked up to breathing and feeding tubes.
“It was a living hell that no other family should go through, ” said his widow, Josephine.
Ten days after Randone’s bypass, his surgeon showed Josephine a news story on a study linking the drug Trasylol – used to control bleeding during surgery – to kidney disease, strokes, congestive heart failure and dozens of deaths.
Bayer later admitted it “mistakenly” hid similar results of its own clinical studies from the Food and Drug Administration.
“My jaw dropped. I couldn’t believe this drug was allowed on the market,” Josephine said.
She has filed an $80 million suit in Suffolk County accusing Bayer of peddling a defective product, fraud and failure to warn.
Bayer faces at least 19 suits nationwide. “We plan to defend ourselves against them,” said spokeswoman Staci Grouveia.
Randone was healthy except for a minor heart murmur, his widow said. He checked into Stony Brook for a valve repair and bypass on Jan. 16, 2006. The surgery was a success, but his kidneys shut down. His legs had to be amputated to stop gangrene.
Dr. Todd Rosengart, Randone’s surgeon and Stony Brook’s chief of cardiothoracic surgery, filed a report with the FDA and stopped administering Trasylol.
“I haven’t used it on any patients since,” he said.
Randone’s lawyer, Marc Bern, said Trasylol may become the next Vioxx – a painkiller that Merck & Co. recalled in 2004 after users started dying of heart attacks. “This is another example of a drug company putting profits over safety,” Bern alleged.
Bayer raked in $291 million from Trasylol in 2005, but sales dropped to $193 million last year.
The FDA has let Bayer keep it on the market.