Essure lawsuit filings explode in California and across the country

On behalf of Dennis Reich at Reich & Binstock LLP

Thousands of women are filing suits for injury from the birth-control device.

Pharmaceutical giant Bayer is being sued in court after court for injuries allegedly caused by its permanent birth-control device Essure. Recent rulings by a California state judge have set the stage nationally for major legal issues in the matter.

Bayer's Essure sterilization device

Essure is marketed as a permanent birth-control device. It consists of two tiny metal coils that are inserted into the fallopian tubes to stimulate the growth of scar tissue that blocks the tubes, preventing sperm from entering. Insertion of the coils does not require an incision and can be performed on an outpatient basis.

Widespread allegations of unexpected consequences and serious injuries from Essure include:

  • Allergic reaction to the coil's metals
  • Headaches
  • Nausea
  • Colon, uterus or fallopian tube perforation
  • Migration of the coils to other areas of the body
  • Pregnancy, including ectopic
  • Miscarriage
  • Maternal and fetal death
  • Severe and persistent pain
  • Vaginal bleeding, including irregular or heavy menstruation
  • Joint pain
  • Fatigue
  • Weight fluctuation
  • Coil breakage
  • And more

The device is meant to remain permanently in the body, but when doctors have determined that the coils should be removed, there has been confusion and concern over the lack of guidance for how the removal should be performed. There have been reports of the coils breaking up upon surgical removal, after which pieces of metal have allegedly migrated throughout the abdominal area.

FDA treatment of Essure

The U.S. Food and Drug Administration approved Essure in 2002 on the condition that the manufacturer conduct post-approval studies. Unfortunately, since then the FDA has received thousands of complaints of injury and even death from Essure, according to Modern Healthcare.

In September 2015, the FDA convened a panel to consider evidence of Essure adverse outcomes, including public comments. After this, the FDA felt some patients were not receiving meaningful warnings about Essure's risks.

Accordingly, the FDA in October 2016 issued a final guidance regarding a black-box warning to be added to the product label that would detail the potential adverse effects and advise doctors to discuss these with patients. The FDA also recommended that a patient decision checklist become part of the label to facilitate discussion about risks between women and their physicians.

Finally, the agency ordered Bayer to conduct a post-market surveillance study of clinical data. Bayer's study plan was approved in September 2016 and is presumably underway at the time of this writing in February 2017.

In 2015, Rep. Michael Fitzpatrick, R-Pennsylvania, introduced the E-Free Act that would have ordered the FDA to withdraw its approval of Essure. The bill did not pass, but its introduction illustrates the heightened concern of elected officials over the product's safety.

The California litigation

Modern Healthcare reports that "dozens" of cases against Bayer for Essure injuries filed in California state courts by "hundreds" of women from various states have been consolidated in Alameda County Superior Court.

Judge Winifred Smith issued orders in December 2016 to establish pretrial procedures in the coordinated lawsuits in anticipation of their trials. According to Modern Healthcare, new cases continue to be added to the coordinated suits.

In addition to the California consolidated litigation, thousands of other lawsuits have been filed against Bayer in state and federal courts throughout the country. Anyone who has experienced injury from Essure should speak with an attorney about potential legal remedies.

The lawyers at Reich & Binstock in Houston, Texas, represent clients injured by dangerous drugs in Texas and across the country, including those involved in multidistrict and class-action cases.