High-profile campaigns to ban Essure, a permanent birth control implant manufactured by Bayer, have stirred the hearts and consciences of women and men across the country. Patients from every walk of life say they chose Essure because it promised to safely, effectively prevent pregnancy, only to learn that the small metal implants may be the cause of severe side effects. But within this whirlwind of controversy, Bayer stands relatively unscathed.
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Denying every claim of wrongdoing, and maintaining that Essure is both safe and effective, the German company is currently shielded from legal responsibility. In fact, it remains unclear whether Bayer will ever face any legal consequences for selling the device, which many critics say threatens women’s lives.
Have Any Women Filed Essure Lawsuits?
Yes, but they face significant legal hurdles.
Several women have filed lawsuits against Bayer, the German pharmaceutical company and current manufacturer of Essure. Though their complaints contain damning allegations, many of which are at least partially supported by FDA reports, whether or not these lawsuits will ever see trial is still in doubt. Bayer is currently shielded from product liability lawsuits over Essure, because the device went through a special approval process designed for “high-risk” medical devices.
How Pre-Market Approval Is Protecting Essure
The approval process, known as “Pre-Market Approval,” is particularly “stringent,” according to the Food & Drug Administration. In part because the regulatory review is so rigorous, the Supreme Court believes device manufacturers, like Bayer, should be protected from liability in state courts. Lawsuits involving these high-risk medical products are “pre-empted,” effectively invalidated because an agency of the federal government found the devices to be safe and effective.
Those current restrictions are unfortunate, since filing an Essure lawsuit may be the only way for patients to recover compensation for their injuries. Women say the Essure implants can break or migrate to other parts of the body, causing severe chronic pain and in some cases, requiring emergency surgical intervention. Suffering from numerous alleged side effects, some patients have even been forced to undergo hysterectomy. But the government’s current stance on Pre-Market Approval prevents them from pursuing compensation.
Will Bayer Lose Its “Legal Shield”?
Women are fighting back, though. In their lawsuits, several patients have argued that Essure’s Pre-Market Approval (PMA) should be invalidated.
Heather Walsh, who says she had to undergo hysterectomy after the Essure implant migrated to her uterus, claims Bayer failed to submit numerous side effect reports to the US Food & Drug Administration. In her complaint, Walsh says Bayer received 144 reports of device perforation, in which an Essure device broke through an internal organ, but only sent 22 of those reports on to the FDA. The company also hid over 16,000 patient complaints from the agency, Walsh claims, in direct violation of the FDA’s guidelines for “high-risk” medical device approval.
Only time will tell whether these allegations stand up under scrutiny, but if they do, Bayer’s PMA could be thrown out. That would open the door for thousands of women who believe Essure caused them suffering to file their own suits.
Breaking Essure Lawsuit News
By Michael Monheit, Esq.
May 21, 2018 – Kentucky Judge Remands Three-Plaintiff Essure Lawsuit To State Court
A federal judge in Kentucky has sent one Essure lawsuit, representing the claims of three injured women, back to state court, ruling on April 23, 2018 that the cases don’t raise any substantial questions of federal law. In her court order, HarrisMartin reports, Chief Judge Karen Caldwell of the US District Court for Eastern Kentucky also ruled that the plaintiffs additional claims, many of which are leveled against their medical professionals, could move forwards.
April 10, 2018 – FDA Announces “Unique” Regulation On Essure, Limiting Sales To Doctors Who Disclose Risks
The FDA has announced unprecedented restrictions on the sale and distribution of Essure. Following up on the agency’s heightened warnings, doctors who hope to purchase and use the birth control implant will now be required, at risk of strict civil and criminal penalties, to inform potential patients of the device’s risks.
It’s now mandatory for physicians to review a packet of risk information with their patients before implanting the device – and Bayer has been left with the responsibility of ensuring that health care providers follow through on the new regulation. Agency Commissioner Scott Gottlieb, M.D., who held meetings with leaders from the Essure Problems movement in February, has called the restrictions “unique” in the FDA’s history. The agency generally shies away from telling individual doctors how to run their practices. To learn more about the regulations, read our in-depth post at this link.
March 8, 2018 – FDA Commissioner Reiterates Support For Essure In Personal Memo
One day before International Women’s Day, Dr. Scott Gottlieb, chief at the US Food & Drug Administration, issued a personal memo updating patients and health advocates of the federal agency’s Essure safety review. In his letter, Gottlieb notes that the FDA received nearly 12,000 new Essure side effect reports in 2017, 90% of which refer to the potential for invasive device removal procedures. At the same time, Gottlieb says that the agency’s position on Essure is unchanged. “The FDA continues to believe that Essure may be appropriate for some women based on our current information,” the FDA commissioner wrote. To find more on the story, click here.
February 1, 2018 – Disputed New Study Finds Mixed Results On Essure Safety, Efficacy
A controversial new study out of France has found mixed results on the safety of Essure. Comparing women who underwent hysteroscopic sterilization to those who received the traditional sterilization method of tubal ligation, researchers found an increase in gynecological complications (including sterilization failure) among Essure patients, but a lower risk for surgical problems. To learn more, read our post here.
January 5, 2018 – Essure Plaintiffs Lose Jurisdiction Battle In Missouri Supreme Court
The Supreme Court of Missouri has ruled against a group of Essure lawsuit patients, saying a lower court erred in allowing the cases of 85 out-of-state plaintiffs to proceed in St. Louis. According to a unanimous decision on December 19, 2017, the out-of-state patients will need to provide more evidence of Bayer’s business activities in Missouri to establish appropriate jurisdiction in the State. The multi-plaintiff case has been remanded to a lower court, where plaintiffs say they intend to introduce an amended complaint to buttress their arguments. For more on the story, click here.
December 11, 2017 – Missouri Essure Lawsuit Survives On Appeal
On December 5, 2017, the Missouri Court of Appeals for the Western District upheld the claims of a 33-year-old woman who says she underwent a hysterectomy after receiving Essure implants and experiencing severe pain. X-ray tests, the woman claims, found that one of her implants had broken apart and pierced her uterus. A lower State Court had ruled that the woman’s allegations of negligence and product liability were preempted by federal law. To find more on the woman’s lawsuit, follow this link.
November 8, 2017 – State Reps Say FDA Is Allowing Bayer To “Drag Its Feet” On Essure
In a new letter to the FDA Commissioner, three Democratic members of Congress question the federal agency’s response to Essure side effect reports. While FDA experts in 2016 ordered Bayer to conduct a long-term study on the contraceptive implant’s side effects, only 1 patient has been enrolled in the study to date, the State Representatives report. “It is unclear whether Bayer has acted with urgency,” they write, adding that “the FDA cannot continue to allow Bayer to drag its feet.” To learn more about this story, click here.
October 11, 2017 – Essure Distribution & Sales To End In All Countries, Except The US
In an announcement released on September 18, 2017, global health care conglomerate Bayer says Essure will no longer be available in every country, except for the United States. To find our full coverage of the story, follow this link.
September 6, 2017 – Australia Recalls Essure After Bayer Pulls Device Off Market
Australia’s Therapeutic Goods Administration has issued a full recall of Essure implants, saying “there will be no further implantations of Essure in Australia.” The recall comes fast on the heels of Bayer’s decision to discontinue Essure sales in the country, a move spurred, the company says, by “business reasons.” To learn more about the recall, click here.
August 8, 2017 – European Union Member States Recall Essure Implants For 3-Month Ban
Ireland’s top health regulator has allowed Essure’s commercial license to lapse, revoking Bayer’s right to distribute and sell the implants throughout the European Union for at least the next three months. Many of the Union’s 28 member states, including France and Ukraine, have already instructed Bayer to recall the contraceptive devices. The ban on Essure sales is scheduled to end on November 2, 2017, although new insights from Ireland’s investigation may change that.
July 20, 2017 – Brazil Allows Essure Sales & Distribution To Resume
The Brazilian government’s ban on Essure sales and distribution has been lifted, according to a report from MedicalXpress. Anvisa, Brazil’s national health agency, halted imports and distribution of the birth control implant in February, saying the device’s manufacturer, Bayer, had failed to provide the department with adequate safety data. Now, representatives at Anvisa have told reporters that Essure distribution will begin anew in Brazil, having received the results from a number of multi-year clinical trials.
June 12, 2017 – End To Essure Sales Looms In UK, Finland, Netherlands
Global healthcare giant Bayer intends to withdraw its contraceptive device Essure from three countries: Finland, the Netherlands and the United Kingdom. In less than a month, Essure implants will no longer be distributed or sold in these European markets:
- United Kingdom (England, Scotland, Northern Ireland and Wales) – September 1, 2017
- Finland – June 25, 2017
The date on which Bayer will discontinue Essure sales in the Netherlands has not yet been reported. The company blames the series of withdrawals on Essure’s market performance, not the growing public concern over the birth control implant’s link to severe side effects. Declining sales, rather than patient harm, seem to have forced Bayer’s hand, according to Legal Reader.
May 3, 2017 – FDA Sheds Light On New Essure Injury Statistics
In its ongoing effort to monitor the potential side effects of Essure, the US Food & Drug Administration has updated its official website with adverse event report statistics for 2016.
Through that year, the federal agency received 5,019 reports of side effects and complications associated with the birth control implants, a decrease of over 1,000 reports from the previous year. The reports remain consistent, the FDA says, with 10,746 filed in relation to pain and 5,377 filed for menstrual abnormalities. The update’s most shocking finding, however, pertains to the number of pregnancies experienced by women who rely on Essure as contraceptive. The agency has received notice of 1,113 pregnancies in patients with Essure, including at least 474 pregnancy losses.
At least 38 deaths have now been linked to the contraceptive implants, although 8 of these reports are being considered erroneous.
April 13, 2017 – Paired With Yasmin Birth Control Lawsuits, Essure Litigation Outstrips Bayer’s Insurance Coverage
Despite protests worldwide, healthcare giant Bayer has yet to remove its birth control implant Essure from the global market. One country – Brazil – has taken matters into its own hands, issuing an immediate suspension on sales, marketing and distribution of the controversial device. Bayer itself, on the other hand, has thus far dismissed the complaints of thousands of women, who blame the contraceptive implants for debilitating side effects.
Recent financial revelations, however, may ultimately sway the company’s decision-making process. According to Bayer’s 2016 Annual Report, litigation expenses and decreases in revenue tied directly to Essure lost the company around $413 million. Bayer’s insurance policies, maintained to protect against losses in civil product liability lawsuits, are also being strained by the growing Essure litigation. In fact, the company now says that legal disputes surrounding two contraceptive products – Essure and the birth control pills Yasmin and Yaz – have outstripped the company’s “available insurance coverage.”
March 17, 2017 – Illinois Essure Lawsuit Will Move Forward Now, Circuit Court Judge Rules
An Illinois state judge has rejected Bayer’s request for a stay of proceedings in an Essure lawsuit filed by more than eight women, according to the Madison – St. Clair Record. Madison County Circuit Judge Dennis Ruth denied the company’s motion on February 24, 2017.
In a January court filing, Bayer asked Judge Ruth to pause the legal proceedings, in anticipation of two pending court decisions: Bristol-Myers Squibb v. Superior Court of California, which the Supreme Court recently accepted for review, and Jeffs v. Ford Motor, a case pending in the Fifth District Appellate Court. Bayer’s defense attorneys argue that judgments in the two cases could have a major impact on whether the women’s lawsuit belongs in Wisconsin at all. The company has long held that, despite conducting substantial business in the State, Essure lawsuits should be transferred elsewhere.
February 15, 2017 – Dutch Women Wait For Essure Removal Procedures
Long waiting lists are beginning to form at hospitals in the Netherlands, Medisch Contact reports, as Dutch women wait to have their Essure permanent birth control implants removed.
In North Brabant, a province in the south of Netherlands, around 150 women have asked local surgeons to remove their implants. “This is a nationwide phenomenon,” a spokesperson for the Dutch Society of Obstetricians and Gynecologists said. “We heard from several hospitals [that] there is a wait.” An estimated 25,000 to 30,000 women in the Netherlands have chosen Essure as a contraceptive, but side effect complaints are mounting. Medisch Contact says that pain and “psychological symptoms” have been the most frequently-cited adverse reactions.
As we wrote in a previous article, similar bottlenecks in Essure removal have been reported in the United States, where only about 30 physicians have experience performing the complex procedures.
January 19, 2017 – Elizabeth Graham, Esq. Appointed To Leadership Role In California Essure Lawsuit Coordination
BirthControlProblems.com sponsor Elizabeth Graham has been appointed to a committee of lawyers that will guide the course of Essure lawsuits currently coordinated in a California State Court.
On December 21, 2016, Judge Winifred Y. Smith of the Alameda County Superior Court selected Ms. Graham, along with four other plaintiffs’ attorneys, to serve on the Plaintiffs’ Executive Committee for the Court’s proceeding 4887, in which dozens of women say the Essure implant caused severe side effects. “We’d like to see these trials get started within a year,” Ms. Graham told Modern Healthcare. She has also been appointed to serve as one of two co-liaison counsels, handling administrative matters for the Court.
December 5, 2016 – Trump Election Sparks Demand For Birth Control
In anticipation of possible changes to American healthcare policy under a President Donald Trump, woman around the country are flooding Planned Parenthood locations for birth control. Appointments scheduled at the reproductive health clinics increased substantially immediately after this year’s presidential election was called. Just three days after the election, appointments for intrauterine devices (IUD) jumped by 900% nationally, reporters at DNA Info say.
Many Planned Parenthood locations offer Essure implants, a controversial form of permanent birth control that has been linked to devastating side effects. No statistics have yet surfaced on whether or not interest in irreversible contraceptive methods has seen a similar spike in interest.
November 14, 2016 – New “Suggested” Black Box Warning For Essure
The US Food & Drug Administration has finalized a set of safety guidelines, including a “black box” warning, for the labeling and usage of Essure birth control implants. The federal agency published its new labeling guidance, which will cover all “permanent hysterescopically-placed tubal implants intended for sterilization,” on October 31, 2016. Included in the advisory document is “suggested” language for a boxed warning that will appear on Essure’s packaging, as well as a “recommended” outline for the patient decision checklist intended to inform and guide doctor-patient conversations about the device.
To learn more about the new Essure safety guidance, read our detailed blog post on the topic here.
October 7, 2016 – Essure Lawsuit Plaintiffs In California Win Coordination Approval
In a motion filed Friday, September 30, 2016, a California state judge has allowed 55 Essure lawsuits to be coordinated. The lawsuits, which represent an estimated 900 women, will soon be brought together in a single court. According to Fierce Biotech, the move will allow “attorneys for the plaintiffs in each case [to] pool their resources.”
This is just one favorable ruling that has come from Judge Winifred Y. Smith of the Superior Court in Alameda County. In August, Judge Smith allowed 11 Essure lawsuits, which had been consolidated themselves, to proceed despite Bayer’s arguments for dismissal.
Elizabeth Graham, an attorney at Grant & Eisenhofer and one of this site’s lead sponsors, hopes that the coordination will bring “a quicker, more efficient, cohesive resolution to all women’s cases in California.” Along with Fidelma Fitzpatrick of law firm Motley & Rice, Graham argued in support of consolidation before Judge Smith on September 30th.
“This is a very favorable development for these injured women,” Graham says. “Having these cases coordinated before a single judge will avoid inconsistent rulings and allow these women to prosecute their claims in a cohesive and unified manner.”
September 27, 2016 – As Essure Lawsuits Gain Speed, Bayer Wins Approval For New IUD
As women continue to file lawsuits over Essure, the controversial birth control implant’s manufacturer has decided once again to step into the contraception market. On September 19, 2016, German healthcare giant Bayer announced that the company’s new intrauterine device – Kyleena – had received FDA approval.
Like most IUDs, Kyleena is a T-shaped piece of plastic that can be inserted in the uterus. Once implanted, Kyleena releases a synthetic hormone known as levonergestrel, believed to thicken the uterine lining and thereby prevent pregnancy. The device is expected to remain effective for up to five years, according to Reuters.
September 19, 2016 – In Idaho, Federal Judge Allows Essure Lawsuit To Proceed
On August 30, 2016, a federal judge for the US District Court of Idaho allowed another Essure lawsuit to move forward.
Essure manufacturer Bayer has long argued that personal injury lawsuits filed over the birth control implant – which are usually based in tenets of state law – should be preempted entirely by federal law. But several recent court decisions have found otherwise. In the most recent ruling, Chief Judge B. Lynn Winmill held that an Essure lawsuit could proceed on allegations that Bayer withheld vital safety information from the US Food & Drug Administration.
In the lawsuit, a woman claims that she became pregnant with twins just one year after receiving the Essure implants, which are designed to prevent pregnancy altogether. To learn more about Judge Winmill’s ruling, click here.
September 7, 2016 – FDA Approves On-Going Essure Safety Study
In February, the US Food & Drug Administration ordered health care giant Bayer to add a “black box” warning to Essure. As an additional measure, the federal agency instructed Bayer to conduct a long-term study on Essure’s health risks – the details of which have now been approved, according to the Regulatory Affairs Professionals Society.
Bayer’s safety study will follow two groups of 1,400 women. One group will receive Essure implants, while the other will undergo laparoscopic tubal sterilization procedures. All of the subjects will be between 21 and 45 years old.
The study will focus on four primary health risks, all of which currently appear more likely among patients who receive Essure:
- chronic abdominal or pelvic pain
- abnormal bleeding
- allergic reactions
- surgical removals of Essure
As secondary endpoints, the study will review patients’ bloodwork, pathology and histology. The effectiveness of both birth control methods will also be assessed, with effectiveness defined as the ability to prevent pregnancy.
While the study won’t be complete until 2023, a six-month report is done in March 2017. One-year findings will be released in September 2017.
In recent years, Bayer’s controversial birth control implant has been linked to numerous severe side effects. Tens of thousands of women have spoken out about their experiences with the device, noting severe pelvic pain, menstrual abnormalities and migraine headaches. Now, hundreds of women have filed personal injury lawsuits against Bayer, accusing the company of hiding vital safety information from the FDA.
September 1, 2016 – California Judge Gives Green-Light To Essure Side Effect Lawsuits
Judge Winifred Y. Smith just gave the growing Essure litigation a boost, allowing 11 lawsuits filed in a California state court to proceed, according to ModernHealthcare.com.
The manufacturer behind Essure, Bayer, has long argued that women claiming the company’s birth control device causes severe side effects should be barred from court. Since the FDA, a federal agency, approved Essure as “safe and effective,” the company argues, women shouldn’t be allowed to file lawsuits based on state consumer protection laws.
Judge Smith, however, isn’t buying that logic wholesale. On August 2, 2016, the Judge allowed a slate of Essure lawsuits move forward on two counts:
- Bayer’s alleged failure to adequately warn the FDA, and thereby the public, of Essure’s potential side effects
- Bayer’s alleged misrepresentation of Essure’s safety and efficacy in advertising materials that were not approved by the FDA
Legal experts say the opinion could open doors for thousands of other women considering Essure lawsuits of their own. You can read more about the decision, and check out an infographic we made to explain Judge Smith’s reasoning, on our blog.
February 29, 2015 – FDA Wants To Put “Black Box” Warning On Essure
Following more than six months of review, the US Food & Drug Administration has decided on a path forward on Essure – although it’s not as strong a stance as some public health advocates would like.
Apparently published (too) early, an FDA press release says the agency will “recommend” a major labeling revision, by instructing Bayer Pharmaceutical to add a new “black box” warning to packages containing Essure implants. The new warning is expected to include major side effects reported by many women, including chronic pelvic pain, according to CNN.
The FDA has also recommended a “patient decision checklist,” a document intended to guide conversations between physicians and their patients. It will likely include info regarding side effects, and will ask patients to agree to a three-month follow-up appointment. The checklist is meant to be signed by both patients and doctors.
The agency has also instructed Bayer to conduct a new study investigating the device’s risks “in a real-world environment.” The FDA’s press release is no longer available on its website. It was taken down shortly after being published, but is expected to be released officially on March 1, 2016. You can learn more about the agency’s new warnings on our blog.
Raise Your Voice For Women’s Health
BirthControlProblems.com is sponsored by an alliance of experienced plaintiffs’ attorney devoted to protecting women’s rights. Led by Rob Jenner, Esq. and Elizabeth Graham, Esq., we believe that every Essure patient deserves to have their experiences honored. We’ve heard too many stories from women who were ignored by their own doctors, dismissed as irrational and left to suffer in silence.
We want to hear from you. If you received Essure and experienced severe side effects, we want to know about it. Call us today for a free, no obligation consultation and learn more about your rights and legal options.