Court Rules in Favor of Essure Contraceptive Device Maker

Jefferson City, MOA St. Louis Circuit Judge in 2016 ruled that an Essure lawsuit filed by 92 women against Bayer could proceed in Missouri, but now that may not be the case. All the plaintiffs claimed they suffered injuries after having the permanent birth control device implanted, and they contended that Bayer is subject to jurisdiction in this state because it does business, generates revenue and conducts marketing for Essure in Missouri.

Bayer’s Two Reasons to Dismiss Essure Lawsuit

Bayer argued that only seven of the 92 plaintiffs are from Missouri—the others having no connection to the state. It wants individual claims by non-Missouri plaintiffs transferred to “appropriate venues”, according to court documents. Bayer’s attorneys pointed out that its claim is consistent with legislation Republicans introduced in the state legislature last year, whereby bills in the House and Senate were intended to reduce the number of cases filed in Missouri courts by plaintiffs with no connection to the stat.

The giant chemical company’s second reason is that all claims are preempted by federal law, which means that they are immune from the lawsuits because the FDA, a federal agency, approved the medical devise.

On December 19, the Associated Press reported that a unanimous ruling by Supreme Court judges said the lower court was wrong to deny Bayer's motion to dismiss out-of-state claims in the lawsuit and they “agreed that the case doesn't seem to fit in Missouri”. The case has gone back to the St. Louis Circuit Court with an amended petition (which the judges have allowed): Now, plaintiffs assert that their lawsuit still belongs in Missouri because clinical trials were conducted in this state and Bayer based its national marketing campaign here. The Supreme Court judges have allowed the lower court to consider plaintiffs’ amended petition.

This move has been the only good news for Bayer in some time. According to its January 2018 Healthcare report, the inventor of Aspirin has cut thousands of jobs, both in Germany and abroad, in response to difficult operating conditions. It stopped selling Essure in all countries except the U.S. by last September and it faces increasing controversy over the device. In its financial statement a year ago, Bayer reported it was facing about 3,700 lawsuits. One year later that number has more than doubled: more than 10,000 lawsuits have been filed from US Essure victims claiming the device caused serious injury.

Essure and the FDA

Bayer still asserts that Essure is safe, but the FDA has forced the company to put a “black box warning” on its packaging listing side effects. The FDA has not gone so far as to ask the company to stop selling the medical device in the United States – yet. Three members of Congress sent a letter to FDA Commissioner Scott Gottlieb last November to request a meeting to address the agency's inaction on the numerous reports of adverse events associated with Essure, In the letter they said Essure is "a prime example of systemic medical device oversight shortfalls and insufficient enforcement to ensure the safety and efficacy of medical devices.”