1.1                          A bill for an act 
  1.2             relating to civil actions; limiting punitive damages 
  1.3             in cases involving products or devices approved by the 
  1.4             FDA; amending Minnesota Statutes 1994, section 549.20, 
  1.5             by adding a subdivision. 
  1.6   BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA: 
  1.7      Section 1.  Minnesota Statutes 1994, section 549.20, is 
  1.8   amended by adding a subdivision to read: 
  1.9      Subd. 6.  [LIMITATION ON PUNITIVE DAMAGES.] (a) Punitive 
  1.10  damages may not be awarded against the manufacturer or seller of 
  1.11  a product or device that caused the harm claimed by the 
  1.12  plaintiff if: 
  1.13     (1) the product or device was subject to approval under 
  1.14  United States Code, title 21, section 355, or premarket approval 
  1.15  under United States Code, title 21, section 360e, by the Food 
  1.16  and Drug Administration with respect to the safety of 
  1.17  formulation or performance of the aspect of the product or 
  1.18  device that caused the harm, or by the adequacy of the packaging 
  1.19  or labeling of the product or device; and 
  1.20     (2) the product or device was approved by the Food and Drug 
  1.21  Administration.  
  1.22     (b) Paragraph (a) does not apply in a case in which it is 
  1.23  determined on the basis of clear and convincing evidence that 
  1.24  the defendant:  
  1.25     (1) withheld from or misrepresented to the Food and Drug 
  2.1   Administration information concerning the product or device that 
  2.2   is required to be submitted under the federal Food, Drug and 
  2.3   Cosmetic Act that is material and relevant to the harm suffered 
  2.4   by the claimant; 
  2.5      (2) made an illegal payment to an official of the Food and 
  2.6   Drug Administration for the purpose of securing approval of the 
  2.7   product or device; or 
  2.8      (3) failed to use reasonable care to comply with Food and 
  2.9   Drug Administration regulations concerning the manufacture of, 
  2.10  or the investigation and correction of defects in design or 
  2.11  manufacture of, a medical device, and the failure to comply has 
  2.12  caused the harm suffered by the plaintiff.