Aug 19, 2008 5:08 pm US/Central
NJ Court Hears Suit Over Muscular Dystrophy Drug
NEWARK, N.J. (AP) ―
Attorneys for a Minnesota family suing to gain access to an experimental muscular dystrophy drug for their 16-year-old son argued on Tuesday that a drug company led them to believe they could participate in a clinical trial but then went back on their word.
Jacob Gunvalson and his parents want PTC Therapeutics of South Plainfield to provide him with the drug, PTC124. Jacob suffers from Duchenne muscular dystrophy, a rare and deadly condition that mainly strikes young boys and causes steady deterioration of muscle tissue.
Typically, those who suffer from it die in their 20s because of weakness in their heart and lung muscles.
The dispute centers around a clinical trial of PTC124 that included a 28-day preliminary phase in 2005 and a 96-week phase that is about to begin.
Gunvalson's parents, John and Cheri, claim that PTC employees -- including a woman who once hosted them at her house overnight -- assured them that Jacob would have access to the drug even though the medication he was taking at the time excluded him from taking part in the preliminary trial.
Later, they discovered that Jacob could not participate in the 96-week trial because he hadn't participated in the preliminary trial.
"There is not a shred of evidence that he doesn't qualify" for the second trial other than the fact he didn't take part in the first trial, attorney Marc Wolin told U.S. District Judge James J. Martini.
Attorneys representing PTC contended that no promises were made to the Gunvalsons and that Jacob was excluded from the initial trial for medical reasons and not due to any statements made by PTC employees.
In a statement, the company said giving the Gunvalsons access to the clinical trial "would harm all companies developing experimental drugs by providing a precedent for using the courts to gain special treatment instead of participating in controlled clinical trials."
Martini pressed PTC attorneys on the relationship between the Gunvalsons and Claudia Hirawat, a senior vice president at PTC who hosted the family at her home last year.
"It suggests to me a pretty close relationship," Martini said. "It could have given them some reason to believe that when the time came, she would be able to get them into a program."
Martini is expected to rule on the matter Wednesday.
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