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Judge Questions Arguments in Five Essure Lawsuits


January 18, 2016 — Five lawsuits involving women who were injured by Essure are being reviewed by U.S. District Judge John R. Padova, reports.

The cases have been located in Philadelphia since 2014 and were recently transferred to federal court, according to

Judge Padova asked attorneys to resubmit part of their case and repeatedly asked for more specifics on the charges against Bayer. He “provisionally” rejected the argument that Essure’s Pre-Market Approval (PMA) is invalid because the manufacturer did not comply with certain requirements.

The PMA process allows “high-risk” medical devices on the market and shields manufacturers from lawsuits, but the device must first go through a rigorous scientific review. In 2008, the Supreme Court decision Riegel v. Medtronic upheld the shield.

Attorneys for thousands of women who were injured by Essure say the PMA is invalid because the manufacturer falsified medical records and failed to report adverse events to the FDA. Last year, the agency said it had received over 5,000 reports of adverse events linked to Essure since its approval in 2002.

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