 Article
Feeds
|
FDA Regulatory Action Does Not Establish Causation -- FDA Borrows A Page From The Parlodel® Litigation |
August 15, 2004
Previously published on October 7, 2003
It has become an increasingly familiar pattern. After receiving anecdotal reports of adverse events,
FDA makes a precautionary decision to add warning language to a drug label or to withdraw the
drug's approval. Plaintiffs' attorneys respond with immediate advertisements over the print and
broadcast media and the Internet for potential plaintiffs who had similar adverse events while
taking the drug. For the product liability plaintiff bar, this is a pre-packaged litigation. The FDA
has "determined" causation, so all they need to do is find the plaintiffs and start filing lawsuits.
This phenomena was recently addressed by FDA Commissioner Mark McClellen:
|
The views expressed in this article are solely the views of the author and not Martindale-Hubbell. This article is intended for informational purposes only and is not legal advice or a substitute for consultation with a licensed legal professional in a particular case or circumstance. |
|
|
RSS | Blogs | Site Map | Contact Us