Bayer Moves for Judgment On the Pleadings in Pennsylvania Essure Birth Control Actions

PHILADELPHIA — Bayer Corp. has moved for judgment on the pleadings in a number of Essure birth control device cases, arguing that the plaintiffs’ claims fail because the device was approved via the FDA’s premarket approval process and, as such, the plaintiffs’ claims are preempted by the Medical Device Amendments to the FDCA.

In a July 2 brief filed in the U.S. District Court for the Eastern District of Pennsylvania, Bayer asserted that “the courts cannot overrule FDA approval of a medical device” and that “the FDA has not taken any step to recall Essure or to invalidate its approval.”