Adding to a growing list of complaints, over 50 injured parties have filed a multi-plaintiff lawsuit against Bayer, a German multinational pharmaceutical company who has been the target of ongoing legal battles regarding its female birth control device, Essure. The device has been known to leave women severely injured, moving internally and damaging the uterus in the process. The recent complaints join over 1,500 claims filed all over the country. Despite the mounting discontent, Bayer maintains its innocence in the matter.
The plaintiffs, who filed in the U.S. District Court for the Eastern District of Pennsylvania, claim that Bayer knew about the potential side-effects but skewed its reports during the FDA approval process to cover up the potentially harmful effects of Essure. “[Bayer] manipulated their reports to the FDA and presented false and misleading information, which, in turn, resulted in plaintiffs’ consent to implant not being informed because critical facts regarding the nature and quality of side effects from Essure were concealed from plaintiffs and their physicians,” plaintiffs alleged. Claims include negligence but extend to other allegations as well.
The stories have been accruing over the last 15 years, since the device was introduced to the market. Take the case of Keisha Carney, who after having eight children with her partner RW Carney, decided to put a stop to her pregnancies by getting her tubes tied. But when she arrived at the obstetrician-gynecologist’s office, he suggested using another method because “[it’s] the most effective method of permanent birth control available.” A brochure given to Ms. Carney used comforting descriptors like “soft”, “gentle” and “non-surgical.” On paper the device sounds great. Instead of using hormones, it is supposed to “naturally” generate extra tissue near the opening of the fallopian tubes, effectively obstructing the entrance. In many cases, it has been anything but “natural” or “gentle.”
One day, Ms. Carney’s hair started falling out in clumps. She woke up with a terrible toothache even though she had never had issues with her teeth. She even started experience allergic reactions to nickel – to the point where she could only wear a nickel necklace for a few days before it began to bother her. She gained weight, missed her period, experienced unusual cramps at strange times, and was extraordinarily tired. All these symptoms, she began to realize, were probably related to Essure.
It’s perhaps no surprise that her OB/GYN recommended the device. A complaint filed in California within the past few years alleged that Essure’s manufacturer had organized meet and greets between doctors and OB/GYNs who had pushed the device. In effect, according to the complaint, specialists were rewarded with referrals for doing the company a kindness.
With 750,000 devices on the market – and the numbers are only growing – it’s no wonder there have been over 16,000 adverse events reported to the FDA. One need only look at this Facebook group devoted to Essure-related injuries to understand the impact of Bayer’s negligence. But, still, the company refuses to acknowledge any culpability in the matter.
Women have reported a number of symptoms and associated issues. These include: chronic pain, perforated uteri, internal bleeding and some of the issues experienced by Carney. Another less reported event is fetal death. Though the FDA has only reported single digits, an independent group known as Device Events has discovered over 300 cases of fetal death related to the birth control device.
Last year, on November 15th, the FDA issued a direct warning, suggesting that women consider the risks before choosing Essure. Around the same time, several lawsuits were being rounded up in a multi-district litigation in California. Prior to that, the agency had already issued a boxed warning and patient decision checklist, meant to inform women of the device’s potential side-effects.
In its November 15th announcement, the FDA asks “women to read the information brochure, understand Essure’s benefits and risks, and discuss the information with their doctor before making an informed decision.” It also specifies that “[a]fter three months, women must undergo an X-ray test so their doctor can verify if the device is placed correctly.”
In Carney’s case, she simply didn’t have the funds to go to her follow up appointment. Is Carney to be punished for simply not having the right insurance? Or enough money? Hopefully, Carney and many women like her receive the remuneration they deserve.