Dec 072013

Finally there is flicker of light among the dark clouds. Just to go over the background, the FDA approved a new surgical device, a heat cautery called Alair(R) thermoplasty system, for surgery of severe asthmatic patients. On behalf of a non-profit, PIMR, I filed a lawsuit to get the FDA to revoke the approval given to the device.

The District Court dismissed my petition on the grounds that the PIMR did not suffer any injury from the FDA's actions, therefore PIMR did not have standing to sue. I appealed to the 9th Circuit Court of Appeal.

The Appellate Court has scheduled oral arguments on February 13, 2014 in Pasadena Courthouse. This is very unusual. Their web site clearly says that oral arguments are seldom granted, and to get oral argument you have to request it in your opening brief. Neither PIMR nor FDA asked for oral arguments. So the court ordered oral arguments on its own initiative.

I see it as a very encouraging sign. They are taking my appeal seriously But then it is a long war against the FDA, to stop them from approving unsafe drugs and devices. So far I have lost all of the battles 

Let us hope the lightning is the dark cloud is not a sign that my hopes are just as short lived !

 Posted by at 9:44 am

 Leave a Reply

You may use these HTML tags and attributes: <a href="" title=""> <abbr title=""> <acronym title=""> <b> <blockquote cite=""> <cite> <code> <del datetime=""> <em> <i> <q cite=""> <s> <strike> <strong>



Time limit is exhausted. Please reload the CAPTCHA.