AAJ Seeks Help to Fight FDA Rule Preempting Pregnant Womens' Claims

FDA Pregnancy and Lactation Labeling Rule

The FDA recently released a new system for labels to notify when certain prescription drugs could be harmful to women who are pregnant or breastfeeding.  In the preamble to this rule, the agency also claims that this new system will preempt any claims brought by women who are injured by these products or who claim they were not adequately warned about the dangers of these products.

AAJ will file comments.  It would be helpful to include examples of other instances where pregnant or lactating women sustained injuries caused by inadequate warnings on drugs, or examples where the FDA first said it was safe for pregnancy and later admitted that it was not.

If you have come across any such examples in your practice, please contact Gerie Voss, AAJ Director of Regulatory Affairs, at (202) 944-2847 or via email to Gerie.Voss@justice.org. 

LT