January 18, 2016 — A federal judge in Philadelphia is set to decide whether to allow five lawsuits involving Bayer’s Essure sterilization device to move forward.
Philly.com reports that U.S. District Judge John R. Padova asked attorneys representing the women to resubmit part of the case with more specifics.
Judge Padova said he was “provisionally” rejecting the plaintiffs’ argument that the Pre-Market Approval (PMA) for Essure should be automatically invalidated because Bayer failed to comply with federal requirements. Judge Padova also asked how Bayer’s actions were linked to the plaintiffs’ injuries.
Attorneys said their clients never would have chosen Essure if they had known about the risks. Lawsuits challenging the validity of Essure’s PMA say the manufacturer falsified medical records and hid adverse events from the FDA.
Between November 2002 and May 2015, the FDA received over 5,000 side effect reports involving uterine perforation infection, severe bleeding, chronic pain, and women who had hysterectomies to relieve problems.
Although thousands of women have been harmed, they have been generally unable to file lawsuits against Bayer. When the FDA approves a “high-risk” device through the PMA pathway, manufacturers must go through a rigorous scientific review. In exchange, manufacturers are automatically shielded from litigation. This shield was upheld by the Supreme Court in the 2008 decision, Riegel v. Medtronic.