Suits Mount over Bayer’s Birth Control Device “Essure”
By Lynn Shapiro, Staff Writer
As legal pressure mounts against Bayer Corporation’s nickel-coiled, permanent, birth control device,“Essure”, a female attorney, Elam Fitzpatrick, a partner at the Providence, R.I, office of Motely, Rice, has been named lead counsel of the California “Essure” litigation.
Fitzpatrick will be the first-chair attorney at the Alameda County Superior Court in California, where the California mass torts are being coordinated.
New Trend toward Female Attorneys in Leadership Positions
"We're seeing a new trend toward women looking for leadership positions and women being selected for leadership positions by courts," Fitzpatrick told the National Law Journal.
"It's important to have both men and women represented, but in a case like this where we're talking about birth control devices and women's health issues it's particularly important to have women represented,” Fitzpatrick said.
Essure's Pre-marketing Exemptions Overruled
Last March, 32 women in Missouri filed a joint complaint against Bayer in St. Louis Circuit Court, the St. Louis Post-Dispatch reported.
In their lawsuits, plaintiffs allege that “Essure’s” Pre-Market Approval immunity to lawsuits-- granted to companies that have developed one-of-a-kind drugs or devices that undergo rigorous, short-term testing, before being rushed to market-- should be invalidated, because the device’s previous manufacturer, Conceptus Inc., allegedly concealed the fact that the device was toxic to many more women than reported.
Plaintiffs allege Conceptus misled the FDA and the medical community, reporting only a few singular incidents of side effects that plaintiffs say have “ruined their lives.”
Samantha - Essure Victim from St. Louis
According to the St Louis Dispatch, one “Essure” victim, named Samantha, said that the device “ruined her life”, according to the St. Louis Post-Dispatch.
“I had this fatigue that I had never felt before. I had never felt my body give up and not want to do anything,” Samantha told the Dispatch.
After having the “Essure” coils removed from her fallopian tubes, she was herself again, she said.
Samantha was able to be what is known among a Facebook support group as “e-free” at the end of 2015,” as she had the “Essure” procedure reversed. (The reversal procedure is new.)
“It was unbelievable. She's happy. She was dancing the other day, the first time in a while,” Samantha’s husband, Sean, said.
Essure Complications Due to Nickel Alloys
“Essure”s nickel titanium alloys is a material known to cause allergic reactions, including dermatitis and hives.
More dangerous, once the “Ensure” inserts are placed in the body, they leech nickel into organs, including the reproductive tract.
Negative Reactions Include:
- abdominal pain
- Heavier or irregular menstruation
- Weight fluctuations
- Early menopause
- Migraine Headaches
Bayer Healthcare has now acknowledged that its device can cause serious complications.
Essure Black Box Warning
Marketed since 2002, the FDA has finally placed a black-box warning on the device.
And on November 15, the FDA released an article that suggested women consider other forms of birth control before using “Essure”. (http://www.usrecallnews.com/fda-updates-warnings-regarding essure/
Over 20,000 women have complained about the health risks of Bayer’s nickel-containing device.(http://www.usrecallnews.com/category/medical-devices/essure/
Meanwhile, a victims’ lobbying group originally founded on Facebook, is seeking to have the device recalled by the FDA.
How Essure Works
“Essure” is a permanent contraceptive device, in which coils are implanted into each of the two fallopian tubes. Within three months’ time, the coils form scar tissue that prevents a man’s sperm from penetrating a woman’s ova.
Another side effect of the device is ectopic pregnancies, those happening outside the uterus, which are not viable pregnancies, and may be deadly for the mother.
Essure for Women on Medicaid
‘Essure” is the only permanent birth control method besides tubal ligation.
However, tubal ligation requires surgery and is more expensive for the many women on Medicaid, who are offered “Essure”, as a less expensive and less invasive option than tubal ligation, otherwise known as having one’s “tube’s tied.”
“Essure is implanted in a doctor’s office within a few minutes. Plaintiffs say they were told of no other option but “Essure.”
As the suits proceed through the state courts, FDA has told Bayer to test “Essure” against the safety and efficacy of tubal ligation. The tests will take several years to complete.
When it comes to giant pharmaceutical and medical device companies, it’s all about cost, not women’s health and safety, plaintiffs’ attorneys say.
Attorneys must continue to fight for their clients, especially now that there’s no telling what a Trump FDA will do.