·  Legal News, Analysis, & Commentary


Did Bayer Violate FDA Rules Regarding Essure?

— January 26, 2016

Over 25,000 women (and many men, too!) around the U.S. are holding their collective breath waiting for a federal judge in Philadelphia to decide whether five suits against Big Pharma giant Bayer will proceed. The focus of the cases: did Bayer violate FDA rules regarding Essure? If the cases move forward and the plaintiffs win, Bayer could lose the pre-market approval (PMA) status that is currently protecting it from lawsuits over injuries caused by its “permanent” birth control device.

It didn’t look good on Monday, January 11 though, when U.S. District Judge John R. Padova reviewed the cases. Judge Padova told Marcus Susen, lead attorney, to resubmit sections of the case by Friday, January 15 with more specifics.


Judge Padova said, “In 23 years, I can’t remember a case where I had to start by asking plaintiffs what the count [charge] is all about.”

The five cases in front of Judge Padova started in 2014 with one plaintiff claiming her Essure coils migrated from her fallopian tubes to her uterus. She was hospitalized several times and ultimately need a hysterectomy. Currently, the issue at hand is whether Bayer invalidated its PMA protections by negligent behavior (inadequate training for doctors) and intentional fraud (misleading advertising and withholding data from the FDA).

Bayer, of course, denies all the allegations.

Judge Padova “provisionally” rejected one of the plaintiff’s claims, that “failure to comply with various federal requirements automatically invalidates a premarket approval”. He said, “We were unable to find any cases that support plaintiffs’ theory of self-invalidation.”

Judge Padova dismissed the plaintiffs’ strict liability and negligent design claims, citing the U.S. Supreme Court case, Riegel v. Medtronic. The Supreme Court ruled in Riegel that manufacturers of medical devices cannot be sued for product liability if they complete FDA’s approval process (the PMA).

The dismissal order was issued on January 14. The judge is still deciding whether to dismiss breach of warranty claims. His decision will be made based on the additional information he requested from Marcus Susen. That information was provided on January 15 in a joint submission. Plaintiffs gave a long list of Bayer’s actions, including falsified documents and dishonest advertising.

And so, we wait.


Federal judge weighing Essure lawsuits

Essure Injury Lawsuits Filed in Philadelphia Hang On Federal Judge’s Decision

Join the conversation!