Mich Ct App holds that absolute FDA approval defense in product l liability lawsuits is an unconstitutional delegation

[Richards, Edward P.]

This is construing a state law that limited failure to warn and product defect cases for drugs approved by the FDA.  There are certain opt outs if the plaintiff can show that the drug company withheld critical info from the FDA, but it is otherwise a strong regulatory compliance defense.  While the opinion is silent on the genesis of the law, it looks to track some of the provision suggested in the Restatement of Torts 3rd.
 
Ed
 
Edward P. Richards
Executive Director - Center for Public Health Law
The Ruby M. Hulen/UMKC Professor of Law
University of Missouri Kansas City
(816)235-2370 Fax (816)235-5276
richardse at umkc.edu
http://biotech.law.umkc.edu 

-----Original Message-----
From: Volokh, Eugene [mailto:VOLOKH at mail.law.ucla.edu]
Sent: Wednesday, February 20, 2002 1:22 PM
To: CONLAWPROF at listserv.ucla.edu
Subject: Mich Ct App holds that absolute FDA approval defense in product l iability lawsuits is an unconstitutional delegation



        A Michigan Court of Appeal panel held that absolute FDA approval defense in product liability lawsuits is an unconstitutional delegation of state law definition power to a federal agency.  Taylor v. Gate Pharmaceuticals, 2001 WL 1526395 (Mich. App. Nov. 30).

        Eugene 

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