SACRAMENTO (CN) – Bayer kept selling its permanent contraceptive device Essure despite 16,000 customer complaints about its safety, and it concealed incidents of bowel perforation, three women claimed in court Tuesday.
Christina Barreiros et al. claim they were misled into having Essure coils implanted, and that shortly after the procedure they began suffering severe bleeding and cramping due to the device. The U.S. Food and Drug Administration approved the device in 2002.
Dozens of similar lawsuits have been filed against Bayer and its subsidiary Conceptus.
Barreiros says that after having two Essure coils implanted in 2013, she suffered pain and bleeding that her doctors initially associated with misbalanced hormones. She says that hormone pills didn’t help and she eventually underwent a total vaginal hysterectomy.
Plaintiffs Maria Johnson and Jaqueline Davis also say they suffered persistent abdominal and pelvic pain and “unnatural menstrual cycles” because of the defective contraceptive device.
The device consists of two metal coils made from a nickel-titanium alloy, placed by a doctor in a woman’s fallopian tubes. Patients are tested three months after the procedure to make sure the inserts were properly implanted.
In its advertisements, Bayer calls Essure “surgery-free” and “quick and easy,” according to the 60-page complaint.
The women say Bayer intentionally concealed allegations from post-marketing reports about the dangers of Essure, including cases of bowel perforation and coils migrating out of fallopian tubes.
“Defendants had notice of 168 perforations but only disclosed 22 to the FDA,” the complaint states.
Due to the controversy surrounding Bayer’s product, which it acquired from Conceptus in 2013, the FDA held a meeting with Essure users last fall. While Bayer claims the device is 99 percent effective in preventing pregnancy, 631 women reported to the FDA that they became pregnant while using the device.
The FDA issued a “black box” warning to Bayer in February, forcing it to inform doctors and patients of the adverse reports, and have patients sign a 5-page checklist on the benefits and risks of Essure. The FDA also ordered Bayer to conduct a new post-market study and report on any issues new patients experience over a minimum of three years.
Congressman Mike Fitzpatrick, R-Pa., bashed the FDA for allowing Essure to remain on the market while the study is being conducted.
“Frankly, I’d contend that the 25,000 women harmed by Essure are the post-market study that FDA is ordering. It’s been done. The evidence is all there: Tens of thousands of injured women and hundreds of fetal deaths,” Fitzpatrick said in a statement.
Last week a federal judge tossed several counts in a similar lawsuit against Bayer while allowing two claims to stand. U.S. District Judge John R. Padova of the Eastern District of Pennsylvania allowed negligent misrepresentation and negligent failure-to-warn claims relating to Essure stand but dismissed the five plaintiffs’ fraudulent misrepresentation claim, among others.
Padova’s ruling allows the plaintiffs to amend several of the tossed claims.
Bayer did not respond to an email request for comment on the lawsuit Wednesday.
Barreiros, Johnson and Davis seek compensatory and punitive damages for breach of warranty, fraudulent concealment, negligent misrepresentation, product liability, failure to warn and other charges. They also want Bayer ordered to disgorge its profits.
They are represented by Martin Schmidt with Schmidt National Law Group, in San Diego.
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