Widower Sues Over Wife's Death During Trial for Biogen DrugJun 21, 2005 | AP A Colorado widower whose wife died after participating in a clinical trial for one of Biogen Idec's multiple sclerosis drugs has sued the company, saying his wife "didn't have to die."
The wrongful death suit filed Wednesday on behalf of Walter Smith, of Colorado Springs, also named Cambridge-based Biogen Idec's partner, Elan Pharmaceuticals of Ireland.
Smith's wife, Anita, 46, died of the rare brain disease progressive multifocal leukoencephalopathy after taking part in a clinical trial of the drug, Tysabri.
She was one of two patients who died from the disease, prompting the two companies to pull Tysabri from the market earlier this year.
During the trial, Tysabri and Biogen Idec's other MS drug, Avonex, were taken together. The suit, first reported in The Boston Globe, alleges the companies knew or should have known that when Tysabri and Avonex are combined, they reduce body's ability to defend itself against infection.
"My wife didn't have to die," Walter Smith said in a statement released by his lawyer. "If we had all the information we should have had, she'd be with us today."
The suit asks for punitive damages and compensation for Anita Smith's pain and suffering, but doesn't specify a dollar amount.
Attorney Jerrold Parker, who represents Walter Smith, said in a statement that the Avonex-Tysabri combination therapy may have been a way to extend Avonex's market life after the introduction of the newer drug.
"It certainly appears that combination therapy was proposed to maintain the relevance of Avonex in the marketplace following Tysabri's introduction," Parker said.
A spokesman for Biogen Idec, Jose Juves, declined to comment Thursday on the lawsuit, but noted that the clinical trial was designed to determine the drug's safety and effectiveness.
He noted that the company pulled Tysabri from the market and halted the trial four days after Smith's death in late February and began an extensive safety evaluation.
"Throughout this process, our first and only consideration has been the safety and well being of the patients concerned," he said
Davia Temin, a spokeswoman for Elan, told the Globe the company does not comment on litigation.
"However, we do believe we've taken and are taking all appropriate actions to ensure patient safety," she said.
Tysabri was initially developed by a firm that was later acquired by Elan, Ireland's biggest drug company. Since Smith's death, the companies have attributed a second death to the brain disease. They have declined to comment on additional suspected cases until a full safety review is completed later this summer.
Smith, a mother of two, received her first dose of Tysabri in April 2002. In November 2004, she began experiencing problems with speech, mental perception and hand-eye coordination.
In February, she was diagnosed with PML. She died at a hospice on Feb. 24 "after enduring intractable pain and suffering," according to the complaint.