Lawsuits Over Essure Procedure Problems Allowed to Move Forward in California

A California judge has cleared the way for more than a dozen Essure procedure lawsuits to proceed in the state system, after a number of cases filed nationwide have been dismissed based on preemption laws. 

Superior Court Judge Winifred Y. Smith issued a ruling on August 2, indicating that 14 claims will proceed involving claims by women who allege they suffered injuries and complications due to problems following an Essure birth control procedure.

Essure is a medical device designed to provide permanent birth control, involving placement of coils that cause scar tissue to form and block a woman’s tubes.

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Although the device has been marketed by Bayer as a safe and effective means of preventing pregnancy, thousands of women have surfaced in recent years on Facebook, Twitter and other websites describing painful Essure problems, where the coils migrated, perforated the uterus, caused severe allergic reactions, infections, abdominal pain and other complications.

In his ruling, Smith rejected arguments by Bayer that it was immune from lawsuits over Essure because they were pre-empted under federal law. The manufacturer has maintained that because the device was approved by the FDA as a class III medical device, lawsuits involving state law claims should be barred. The ruling allows women in California to continue to pursue cases against Bayer based on failure to warn, breach of warranty, and misrepresentation claims.

The ruling may open the door for an increase in litigation over Essure procedures, as long as plaintiffs can show standing to file the cases in California.

Bayer faces a growing number of claims in federal courts as well. As of last month, Bayer faced at least 30 product liability lawsuits over Essure procedures filed on behalf of more than 1,000 plaintiffs across five different federal districts.

As Essure injury lawyers continue to review cases, it is expected that the size of the litigation will continue to grow over the coming months and years.

On July 22, a petition was filed with the U.S. Judicial Panel on Multidistrict Litigation seek to consolidate all federal Essure inury lawsuits before one judge for coordinated pretrial proceedings.

Each of the claims raise similar questions of fact and law, involving allegations that Bayer sold an unreasonably dangerous device and failed to adequately report problems with the device to the FDA, doctors or consumers. The motion filed with the U.S. JPML argues that consolidating the Essure litigation in the federal courts would prevent duplicative discovery and conflicting rulings by different judges, and would serve the convenience of witnesses, the court and both parties. The motion suggests that the cases be transferred to the Eastern District of Pennsylvania under U.S. District Judge Gerald McHugh.

Last year, the FDA held advisory panel meetings to review the safety of Essure. After considering recommendations from the panel of outside experts, the agency announced in late February 2016 that much stronger Essure warnings will be required to make sure doctors and women are informed of the potential risks. Bayer has also been ordered to conduct additional studies to better understand the safety of the implant, raising questions about why the manufacturer failed to take these steps years ago after receiving complaints.

An estimated 750,000 women worldwide have undergone Essure sterilization procedures since the device was introduced in 2002. Bayer purchased the Essure product from the original developer, Conceptus, for about $1.1 billion in 2013.


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