Essure Lawsuit Against Bayer and Local Hospital Remanded Back to State Court

A federal judge has decided that a multi-plaintiff lawsuit filed by a group of three women who all experienced complications from Essure birth control, after the permanent sterilization device was implanted at the same Kentucky hospital, should be returned back to state court, where it was originally filed.

The complaint (PDF) was first filed in Pike Circuit Court in Kentucky in March 2017, involving claims for Frankie Newsome, Kimberly Howell and Stacey Varney.

All three women were residents of Kentucky at the time, and alleged that they had suffered similar injuries due to the design of the Essure permanent birth control implant, filing their complaint against the device manufacturer, as well as Pikeville Medical Center, where each of the plaintiffs underwent procedures to implant the Essure coils into their fallopian tubes to prevent conception.

In addition to claims for product liability, each of the plaintiffs included allegations that they suffered damages because Pikeville Medical Center failed to properly inform them about the potential risks associated with Essure sterilization, and failed to use reasonable care in implanting the device.

The manufacturer, Bayer, removed the case to the federal court system, arguing that federal question and diversity jurisdiction applied. However, the plaintiffs opposed the transfer and asked that the case be remanded back to state court.

In an order (PDF) issued on April 23, U.S. District Judge Karen Caldwell, of the U.S. District Court for the Eastern District of Kentucky, agreed with the plaintiffs, finding that the case belongs in the state court system where it was originally filed, since it does not raise any substantial issues of federal law and plaintiffs’ claims are non-diverse.

Although Bayer attempted to argue that the local medical provider was improperly included, since some of the claims were filed after Kentucky’s one-year statute of limitations for medical malpractice claims. However, Judge Caldwell determined that the Defendants had not met the necessary burden of proof, suggesting that cases may have been timely filed based on when they could have reasonably learned that problems with Essure caused their injuries.

“[I]n this case, the defendants have only pointed to inferences arising from facts that are disputed by plaintiffs,” wrote Judge Caldwell. “As such, the defendants have not carried the burden of proving that the Kentucky statute of limitations prevents the plaintiffs from having a colorable basis of recovery under Kentucky law.”

The case joins a growing number of Essure lawsuits pending in state and federal courts nationwide, each raising similar allegations. However, it is one of the few claims that also includes medical providers in the complaint.

Essure Problems

Essure is designed to provide permanent protection against pregnancy, involving an outpatient procedure where coils are placed in the uterus, which develop scar tissue that prevent pregnancy. However, lawsuits filed by hundreds of women nationwide indicate that the device caused painful and debilitating injuries after it migrated, perforated organs, caused allergic reactions or other complications.

Bayer announced it was halting sales of the Essure implant all over the world last year, except in the United States. The company claimed that the decision to stop selling Essure was a marketing decision and not related to the numerous complaints of adverse events.

Last month, the FDA added new restrictions to Essure procedures, indicating that both the doctor and the patient must sign off on a checklist of potential problems, to ensure that the patient is fully informed about the risks.

In November 2016, following controversial hearings in the U.S., where testimony was heard from large numbers of women and medical experts, the FDA decided not to recall Essure in the United States. However, the agency did require Essure black box warnings, which are the strongest that the FDA can require a medical device carry.

Approximately 750,000 women worldwide have been implanted with the device, and Bayer has previously estimated that 70% of those have been implanted in women in the U.S.

The manufacturer has reportedly spent about $413 million defending the Essure litigation over the last year, and may face substantially greater liability at trial if Essure settlements or another resolution for the cases is not reached.