Essure Lawsuit Remanded Back to State Court

A federal judge has foiled Bayer’s attempts to have a multi-plaintiff Essure lawsuit over debilitating injuries from the permanent birth control device tried at the federal level. The judge remanded the claim back to the state court where the three women originally filed the lawsuit.

Essure Lawsuit
Flickr/Bruno Kussler Marques

Frankie Newsome, Kimberly Howell, and Stacey Varney originally filed the complaint in Kentucky’s Pike Circuit Court in March 2017. In all regards, the lawsuit meets the criteria set forth in the Superior Court’s Bristol-Myers Squibb Plavix jurisdiction decision. All three women were Kentucky residents at the time of the filing and alleged similar injuries due to Essure’s dangerously defective design. However, the manufacturer, Bayer, intervened and tried to manipulate the system to get a more favorable trial in federal court. Bayer quickly removed the case to the federal court system, citing federal question and diversity jurisdiction. But, the plaintiffs fought back against the transfer, demanding the case be remanded back to Kentucky state court.

In her April 23 order, District Judge Karen Caldwell of the Eastern District of Kentucky agreed with the plaintiffs’ objections. Judge Caldwell found that the Essure lawsuit did not raise any substantial issues of federal law and that the plaintiffs’ claims were non-diverse. Consequently, she concluded that the case clearly belongs in the state court system where the women originally filed.

Essure Lawsuit Allegations Against Pikeville Medical Center

In addition to claims against Bayer for product liability, the lawsuit also named Pikeville Medical Center as a defendant. All three women underwent procedures at the facility to implant Essure coils into their fallopian tubes to prevent pregnancy. Each of the plaintiffs included allegations that Pikeville Medical Center failed to warn them about the substantial risks associated with Essure sterilization. Furthermore, facility physicians did not use reasonable care during the implantation procedure.

Some of these claims occurred beyond Kentucky’s one-year statute of limitations window for medical malpractice. Consequently, Bayer latched onto these concerns to argue that the lawsuit improperly included the local medical facility. However, Judge Caldwell determined that the global healthcare behemoth had not met the necessary burden of proof for this argument. Since the FDA did not begin issuing health alerts regarding Essure’s significant risk factors until late 2016, Judge Caldwell reasoned that the plaintiffs could not have reasonably learned that Essure defects caused their injuries until then, extending the statute of limitations.

“[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 Essure lawsuit joins a growing number of similar claims pending in federal and state courts across the country. While all these women raise similar allegations, this is one of the few claims that also includes medical providers.

Essure Lawsuit Filed Over Serious Risks

Conceptus originally designed Essure to provide permanent protection against pregnancy.  However, hundreds of women’s lawsuits indicate that the device caused painful and debilitating injuries. Thousands more have also experienced painful, life-altering repercussions after the device migrated and perforated organs, as well as causing allergic reactions and other substantial complications.

The FDA first approved Essure for sale as a method of permanent birth control in 2002. Bayer acquired the device in 2013 for $1.1 billion when it bought the original manufacturer, Conceptus.

The device consists of two metal coils that are implanted into a woman’s fallopian tubes. The coils cause scar tissue to form, blocking sperm from entering to fertilize eggs – hypothetically. However, there have been a large number of ectopic and unwanted pregnancies, as well as still births, reported.

Essure Restrictions Take Toll on Sales

Due to the staggering number of injury reports, the FDA took action against the device in November 2016. The agency required Essure carry the agency’s strongest warning label. The black box warning lists severe potential adverse effects for the product. The FDA further mandated that patients fill out patient checklists, acknowledging they understand Essure’s considerable risks. The FDA also ordered Bayer to conduct a rigorous safety study. Since then, the FDA estimates that there has been a 70 percent decline in U.S. sales.

In September 2017, Bayer removed Essure from every market in the world except for the U.S. The company claimed that it based the decision on commercial reasons rather than the global outcry regarding the product’s safety. However, injured women are calling foul and claim the FDA should step in to remove the product from the U.S. market as well.

Earlier this month, the FDA restricted Essure sales and distribution amid these escalating safety concerns.

“The FDA is taking this step after becoming aware that some women were not being adequately informed of Essure’s risks before getting the device implanted, despite previous significant efforts to educate patients and doctors about the risks associated with this device,” the agency stated in its April 9 news release.

Bayer spent about $413 on the Essure litigation over the past year and faces substantially greater liability if the company continues to refuse to negotiate settlements.