Breaking News: Gelsinger family files suit against researchers, University

The family of Jesse Gelsinger today filed a long-expected lawsuit against the University for wrongful death, assault and battery and fraud, a year and a day after the 18-year-old young man died in a Penn gene therapy experiment.<P> Gelsinger died on September 17, 1999 while under the care of Penn's Institute for Human Gene Therapy. Since his death, the U.S. government has made multiple charges of wrongdoing against the Institute and its director, James M. Wilson. The incident has had widespread ramifications on the entire field of gene therapy.<P> In addition to the University as a whole, the <a href="http://www.sskrplaw.com/links/healthcare2.html">suit</a> names as defendants all three men who ran the experiment in which Gelsinger was enrolled -- Wilson, Mark Batshaw and Steven Raper. <P> It also names former Health System CEO William Kelley, who recruited Wilson to Penn and ran the Health System and Medical School at the time of Gelsinger's death; Arthur Caplan, the director of Penn's Center for Bioethics; Genovo Inc., the genetic research firm founded by Wilson and which until recently was a major source of funding for the IHGT; the Children's Hospital of Philadelphia; and the Children's National Medical Center in Washington.<P> In a statement released today, the University expressed its remorse over Gelsinger's death but continued to deny that its researchers are to blame.<P> "The complaint filed today, by its nature, tells only one version of a very complicated and painful story," the statement reads. "Throughout the last year Penn has readily acknowledged weaknesses in IHGT's monitoring and oversight of clinical trials. At the same time, the University continues to believe that these weaknesses did not contribute to Jesse's death."<P> The suit, filed today in Philadelphia Common Pleas Court, says that both Kelley and Wilson had financial ties to the IHGT's research that may have influenced their decisions.<P> The allegations in the suit are similar to ones made last winter by the U.S. Food and Drug Administration, which suspended all clinical trials at the IHGT last January. In May, the University announced that it would scale back the IHGT's scope, limiting it to just animal and cellular research.<P> The allegations include that researchers understated the risks of the experiment to Gelsinger, that they changed the research methodology without consulting the necessary regulatory boards, and that they failed to disclose Wilson's alleged conflict of interest.<P> <P> <P>

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