HOME  |  CONTACT US  |  SUBSCRIBE  |  SUPPORT WLF

Case Detail


In re Sheila Engdahl
On July 31, 2009, FDA denied an appeal filed by WLF on behalf of a client who is suffering from a life-threatening disease and is seeking FDA access to a promising drug for the treatment of her disease. WLF’s client – Sheila Engdahl of Hull, Massachusetts – is suffering from ALS (a/k/a “Lou Gehrig’s Disease”), a life-threatening neurological disease for which there is no known cure. The drug in question is Iplex. FDA has denied Engdahl access to Iplex, despite the fact that both the manufacturer and her personal physician believe that Iplex might provide her with significant benefits. Iplex has not yet been approved by FDA for treatment of ALS, but has been determined by FDA to be safe and effective in treating other medical conditions. Iplex is now being administered to a handful of ALS patients in the U.S. and Europe on a compassionate use basis – with promising results. In denying WLF’s appeal, FDA announced that it will approve no more applications for compassionate-use access.
Case Status:
Loss. WLF is contemplating litigation against FDA.
More Information and Downloads:
6/17/2009: Download the Brief

  • Welcome to the Washington Legal Foundation
  • 2009 Massachusetts Ave., NW
    Washington, DC 20036
  • info@wlf.org  |  ph. 202-588-0302
    ©2017 WLF All Rights Reserved