New FDA citizen’s petition

On February 25, 2015, a citizen’s petition was filed by Koch Parafinczuk and Wolf, P.A. (“Petitioner”), with the FDA asking that the Commissioner issue various orders relating to the medical device known as Essure, and sold by Bayer.  In particular, Petitioner requests the Commissioner to issue an order (i) finding that the Pre-Market Approval Order for the medical device has been violated, (ii) requiring Bayer to disclose the violations to the public, (iii) finding that Essure is “adulterated” or “misbranded,” and (iv) requiring Bayer to withdraw and issue a notice of retraction of misleading representations.

By:  Jacqueline A. DiRamio

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