Product News and Recalls

Federal Essure Lawsuits Headed Back to Philadelphia Court

essure lawsuit goes back to state courtEssure will no longer be marketed in the United States in the near future – or anywhere else in the world for that matter – but that doesn’t mean that the lawsuits surrounding the device are going anywhere. And, in at least one situation, a federal court has ruled that, at least for now, it’s not a federal issue.

Bayer had initially requested the move to the federal bench under the argument that five of the plaintiffs did not live in Pennsylvania. The plaintiffs in the case, however, argued against the move and in the end U.S. District Court Judge John R. Padova agreed and sent the cases back to the state.

“Bayer has simply not established that there is an actual disagreement about an interpretation of federal law that is material to the claims issue,” the judge wrote. “Moreover, it has not established that the resolution of any dispute would have ramifications in federal cases outside of the Essure context or is otherwise important to the federal system as a whole. Indeed, we conclude that Bayer has failed to identify any federal issue that holds significance for anyone other than the parties.”

Bayer is facing more than 20,000 Essure lawsuits over claims that its female sterilization device caused immeasurable pain and suffering to patients and ultimately led to a litany of issues including hysterectomies, organ perforation, and difficulties with sex and urination, among others. Outcry over these unintended effects was swift and began shortly after the device was approved by the FDA. Social media helped amplify that outcry on a global scale and late last year Bayer announced that demand for the device had dropped so low that it was leaving every market except the United States.

The final nail in Essure’s coffin was hammered home just about a year later when Bayer announced Essure’s removal from the United States market; again, citing a drop in demand. No mention was made, however, of the calls for a ban on the device coming from the halls of Congress, nor the lengths the FDA was willing to go to keep from banning Essure themselves.

So while the device is nearly completely off the market the world over, it appears that the legal work has just begun.