By the end of 2015, legal experts were predicting a wave of litigation over Bayer’s permanent contraception implant Essure, a device that patients say can cause severe side effects.
That wave has come.
Suffering Alleged Essure Injuries, Women Come Together In Pennsylvania
Between April and July 2016, at least 488 women and their loved ones joined together in condemning Bayer’s birth control device, filing a series of sharply-worded lawsuits in the US District Court for the Eastern District of Pennsylvania.
Now, these women have asked the Judicial Panel of Multi-District Litigation (JPML) to consolidate their claims, according to a story from legal news source HarrisMartin. While the JPML has yet to announce a decision, the request could lead to major changes. If consolidated, the cases would progress through important pre-trial phases, like the evidence-gathering process called discovery, together.
Pennsylvania, Arizona Women Join In Essure Claim
On April 7, 2016, a group of 24 women joined in filing the same complaint against Bayer in the US District Court for the Eastern District of Pennsylvania. Of the Plaintiffs, nine are residents of Pennsylvania, twelve are from Arizona, two live in Mississippi and one hails from Colorado. But their allegations are spoken in a single voice.
Plaintiffs say Bayer hid numerous adverse event reports from the FDA. In part, this allegation has been substantiated by FDA investigations. In the words of these 24 women:
“on May 30, 2013, the FDA uncovered an internal excel spreadsheet with 16,047 entries for complaints which were not properly reported to the FDA. Defendant [Bayer] did not disclose to the FDA complaints where its product migrated outside of the fallopian tube. Defendants excuse was that those complaints were not reported because the patients were ‘not – at last contact – experiencing pain…and were mere trivial damage that does not rise to the level of a serious injury.’ Accordingly, the FDA again warned Defendants for violation of [Food, Drug & Cosmetic Act].”
Those apparent omissions, Plaintiffs argue, serve to invalidate Essure’s Conditional Premarket Approval – a type of approval that currently shields Bayer from civil liability.
Plaintiffs Claim Severe Pelvic Pain, Numerous Side Effects
Of course, the injuries alleged by these women are anything but universal. Each woman describes her symptoms and side effects in painstaking detail.
The most common side effect is undoubtedly severe pelvic pain, alleged by each of the 24 Plaintiffs. Pelvic pain is followed closely by extreme changes in menstruation, a symptom noted by 22 of the women. Five of the women say they experienced migraine headaches. Weight gain is mentioned by four patients and five patients say that their hair began falling out after receiving the implants. Nine patients mention tingling in the extremities and hands, while two refer to numbness. “Brain fog,” a decline in cognitive abilities, is claimed by five patients, and three make mention of fatigue.
Less-frequent side effects include:
- chronic infections
- extreme bloating
- blurred vision
- tooth decay and teeth falling out
- hives and rashes
- muscle spasms
- autoimmune disorders
- adenomyosis – a condition in which endometrial tissue, which is usually confined to the uterine lining, begins growing into the uterus’ muscle walls
Despite Essure’s role as a form of contraception, two of the Plaintiffs say they became pregnant with the device implanted. But perhaps most shockingly, all but one of the 24 women claim to have undergone hysterectomy, in an apparent attempt to reverse the adverse effects they attribute to Essure. Several say that doctors have been unable to locate their Essure coils, or that coils became embedded in other internal organs.
As of July 7, 2016, the last date for which court information is available, Plaintiffs are currently fending off a Motion To Dismiss filed by Bayer initially on May 24, 2016.
Banding Together To Fight Bayer
Similar lawsuits have also been filed in the Pennsylvania court. Two weeks after the women from Pennsylvania and Arizona filed suit, another group of 24 women – from 23 different states – submitted their own complaint, leveling nearly identical allegations against Bayer. Many of the women say they only thought to call an attorney after learning of the FDA’s recent black box warning for Essure.
Again, severe pelvic pain and extreme menstrual abnormalities feature prominently in the Plaintiffs’ allegations. Nearly every woman says she was forced to undergo hysterectomy as a result of the alleged side effects.
Husband Files Suit Alongside Wife
On May 5, 2016, a third joint complaint was filed, this time on behalf of 13 women from Colorado, Nevada and eight other states.
But in a break from the other Essure lawsuits, a fourteenth plaintiff, husband to one of the women, has added his name to this recent complaint. In his section of the lawsuit, the man says he “suffered a loss of consortium as a result of his wife’s injuries.”
Within weeks of his wife’s implantation procedure, the husband began to note “mood swings [and] severe pain.” He “initially believed these symptoms were a natural part of the healing process, however, the longer they persisted the more he grew concerned.” She became unable to help around the house, the man claims, and has become “emotionally detached.”
The husband’s biggest fear, however, is for his unborn child. Plaintiff’s wife is one of the many women who have become pregnant after receiving Essure. “Plaintiff […] and his wife are seriously concerned as to how her implanted Essure coils, which doctors have been unable to find, will affect her pregnancy and ultimately the delivery and health of the couple’s unborn child.”
Essure Lawsuits Pick Up Speed
An even larger Essure lawsuit was filed on June 29, 2016. In total, 99 Plaintiffs joined in this single complaint, which was logged under the case number 2:16-cv-03589-JLS in the US District Court for the Eastern District of Pennsylvania.
On July 8, the litigation quickly gained speed, with two new lawsuits, representing 90 and 94 Plaintiffs respectively. Four days later, another 92 women filed suit, followed by 52 more Plaintiffs on the same day.
Hundreds of women have now filed suit over Essure in the Pennsylvania federal court, joining two early lawsuits submitted at the end of 2014. With calls now for the consolidation of Essure lawsuits, other patients have been urged to contact an experienced attorney immediately.