Does the Seventh Amendment change the requirements for surgery claims?
Yes. The existing Settlement Agreement provides Matrix Level III benefits for a Class Member who took the Diet Drugs and had heart-valve repair or replacement surgery on a valve that had been diagnosed between the commencement of Diet Drug use and the end of the Screening Period as having FDA Positive or mild mitral regurgitation. The Settlement Agreement also provides Matrix Level III benefits under certain circumstances for a Class Member who took the Diet Drugs and needed-but did not have - heart-valve surgery on a valve with severe regurgitation, if he or she submits supporting medical records. The Seventh Amendment provides Matrix Level III benefits for people who actually have surgery within specified deadlines, but it does not provide these benefits for people who did not have surgery. However, the Seventh Amendment does permit a person needing surgery, but whose doctor has advised against it, to make certain claims at Matrix Levels IV and V.