NEW ORLEANS – Dozens of women across the country are standing up to the giant international pharmaceutical company Bayer, Corp., and claiming its birth control device, Essure, has caused irreparable and life-threatening injuries.
Louisiana-based firms Unglesby + Williams and Baggett, McCall, Burgess, Watson & Gaughan, along with St. Louis attorney Eric Holland, filed a lawsuit Thursday in the Circuit Court of St. Louis, MO, against Bayer Corp. and its subsidiaries on behalf of 32 women who have suffered serious and permanent injuries as a result of using the alleged dangerous and defective medical device Essure.
Essure, which is currently still on the market, is advertised, sold and issued as a permanent birth control device that consists of two metal coils implanted into a woman's fallopian tubes.
Since entering the marketplace in 2002, thousands of women have complained to the manufacturer about serious complications related to the device, and it has recently been the subject of major controversy. In February 2016, an analysis conducted by independent consultancy Device Events found hundreds of fetal deaths were linked to Essure—a number that was previously underreported by Bayer. The lawsuit now contends that Bayer and Essure’s original developer, Conceptus Inc., knew about the device’s severe risks and intentionally misreported and concealed facts and findings in order to keep Essure on the market.
“Bayer purposefully deceived not only the FDA, but our nation’s physicians and ultimately their patients who entrusted their lives, health and well-being on the promise of a safe, effective product,” said Lance Unglesby, partner at Unglesby + Williams. “Not only do these women—our friends, wives, coworkers and neighbors—deserve to have their voices heard and receive justice, but Essure should also be taken off the market to protect women worldwide.”
“Our team has uncovered disturbing trends in Bayer's reports to the FDA,” Unglesby said. “Bayer has misrepresented and grossly underestimated the true numbers of device breakage.”
Essure has been issued to about 750,000 women globally, according to Bayer. Bayer purchased Conceptus in 2013 for about $1.1 billion. However, by then, thousands of women harmed by the Essure device had been reporting complaints directly to Conceptus and eventually formed a support group named “Essure Problems” on Facebook. Today, the group has more than 28,000 members.
As the lawsuit maintains, the Essure Problems group “demanded that the FDA take meaningful action to investigate and evaluate the building scientific knowledge concerning Essure.”
In early March, the FDA announced that it would require a detailed “black box warning” for the Essure device. The FDA uses these warnings for “serious or life-threatening risks,” according to its website. Additionally, the FDA will require every potential Essure patient to receive and sign a detailed checklist specifically tailored to the risks now associated with the device. In total, patients must initial or sign the document 15 times before undergoing the procedure.
Congress has also joined the effort to remove Essure from the market. Pennsylvania Rep. Mike Fitzpatrick introduced the E-Free Act (H.R. 3920) in November 2015, which would ban sales of the Essure device.
“Despite thousands of formal complaints, tens of thousands of women in the ‘Essure Problems’ group, the warning from the FDA, and opposition from Congress, Bayer maintains its product Essure is safe and should remain on the market,” Unglesby said. “We hope that by taking legal action, the women harmed by Essure will receive the justice they deserve as a result of Bayer’s negligence and deceit. Furthermore, we hope this action assists in the swift removal of Essure from the market so that no one else is hurt as a result of using the product.”
