Should You File an Essure Lawsuit?
Essure is a controversial birth control device touted as a “safe” alternative to tubal ligation. Since Essure entered the birth control market, more than 10,000 women have filed official complaints, claiming they’ve experience serious and painful side effects because of the device. Last September, the FDA had a panel hearing at which women who had the Essure device implanted testified about the serious complications they experienced as a result. They include, but are not limited to, the following:
- Ectopic pregnancies
- Pelvic and abdominal pain
- Uterine perforation
- Severe bleeding and cramping
- Fecal incontinence
The FDA announced last month that Essure must carry a black box warning, indicating the device has significant risks for both serious and life-threatening complications — the agency’s most stringent warning. Also, Bayer is now under orders to carry out more research on the safety of the birth control device.
Cover-ups and kickbacks?
One U.S. congressman from Pennsylvania accused the FDA of under-reporting incidents of fetal death due to women’s use of Essure. According to Republican Congressman Mike Fitzpatrick, a report produced independently of the federal agency links 303 fetal deaths to Essure. This is a significant departure from the five Essure-related fetal deaths listed on the public database for the FDA.
The representative also stated that plaintiffs involved in federal litigation against the company marketing the controversial birth control device, Bayer Healthcare, allege the manufacturer “provided illegal kickbacks in the form of free medical equipment valued at $20,000.” Bayer Healthcare is the parent company of Conceptus, the manufacturer of Essure.
These issues, together with the 25,000-plus women reportedly suffering from severe complications, were the impetus behind Fitzpatrick’s introduction of a bill known as the “E-Free Act.” Should it pass, The FDA will be forced to remove Essure from the marketplace.
How Essure works
According to its website, Essure is designed to prevent pregnancy permanently. Inserts are placed into a woman’s Fallopian tubes “to form a natural barrier” that prevents sperm from fertilizing the woman’s eggs. The “natural barrier” is actually scar tissue that eventually encapsulates the foreign bodies, and it can take up to three months to build up enough to form an effective barrier. During that time, women are told to use other forms of birth control.
How it allegedly fails
There are many ways that women have experienced problems from their use of Essure. The coiled metal device has allegedly:
- Slit open other organs
- Migrated to other areas of the body
- Caused reproductive organs to fuse with organs in the digestive system
A further complication is that use of Essure has caused some women to have to undergo complete hysterectomies, forcing them immediately into surgical menopause.
It should be noted that Bayer staunchly refuted the congressman’s allegations, as well as disputing the legitimacy of the number of members of a Facebook page devoted to discussions of adverse effects from the use of the Essure device. Bayer’s response reads, in part:
“It would be irresponsible to suggest that Essure causes fetal deaths when, after an unsuccessful Essure procedure, an undesired pregnancy cannot be carried to term. In the post-market data, there is no data showing any increased risk of miscarriage and other complications compared to pregnancies in similar-age populations.
Bayer is also aware . . . of a private Facebook group. It is unreliable to cite that number of group members as if it were the number of Essure patients experiencing adverse events from the device . . . [or] confirm how many members of the page are Essure patients . . . [with] confirm[ed] health complaints, if any.”
Positioning for maximum deniability
It is not uncommon for a company to initially robustly defend a product that is under attack for alleged problems it causes to consumers. The reason is two-pronged. For one, a company can sincerely believe in the efficacy of its product and stand behind the pre-market trials and tests it underwent to obtain coveted FDA approval. Relying on their own statistics and research data that fly in the face of actual consumers’ experiences is a type of denial that many companies initially go through.
The second, however, is far more insidious, and is related to the enormous amount of money that is involved. The design, manufacturing and marketing of a drug or device is exorbitantly expensive for any company. When claims from consumers start to mount and individual and class-action lawsuits begin to be filed, the potential cost of the liabilities is incalculable. This causes companies to throw up every possible roadblock between them and those accusing them of negligence for introducing unsafe products to United States consumers.
Do you have grounds to file an Essure lawsuit?
It is possible that if you are a woman who was implanted with the Essure birth control device and you experienced adverse reactions and/or a worsened condition, that you might have a legitimate cause of action to file litigation in either state or federal court against the device’s manufacturers and parent company.
The best way to determine the legitimacy of an Essure claim is by a thorough examination of the medical records of the claimant to determine a causative link between the implantation of the device and the subsequent occurrence of complications. If you feel that you possibly have a claim, it would be wise to arrange a consultation with an attorney who handles those types of product liability claims.
Here at Shrader & Associates, our attorneys have experience taking on the pharmaceutical industry. We have proven track records of success in winning substantial settlements and judgments for our clients. Contact us today for a free, confidential consultation around the clock.