Ill. Judge Says Manufacturers Can Update Drug Labels Without FDA Approval



DOCUMENTS
  • Complaint
  • Memorandum Opinion
  • Pfizer’s Motion
  • Pfizer’s Reply
  • Zikis’ Opposition


CHICAGO - An Illinois judge denied on Nov. 8 Pfizer Inc.'s motion for reconsideration of his order denying the company summary judgment in an alleged Zoloft-induced suicide case, saying the manufacturer could have added an extra warning to the drug's label without the Food and Drug Administration's approval. Zikis v. Pfizer Inc. No. 04-8104 (N.D. Ill.).

Gail C. Zikis sued Pfizer in the U.S. District Court for the Northern District of Illinois in December 2004, alleging that its Zoloft (sertraline) antidepressant was responsible for the December 2002 suicide death of her husband, Donald. Zikis claims Pfizer has known about Zoloft's …






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