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Bayer’s Essure, an implantable “high-risk” device used for permanent female birth control, has become the target of widespread public outrage after reportedly causing thousands of women to suffer from severe side effects and complications.
Hundreds of victims have already filed Essure sterilization lawsuits against Bayer, alleging that the manufacturer failed to warn patients of risks and used misleading advertising that presented the device as safe and “worry-free.”
Though plaintiffs face daunting legal challenges due to Essure’s protected status as an FDA-approved device, their fight for justice is far from hopeless. Recent positive developments in Essure litigation, as well as several newly-introduced bills in Congress, appear promising for victims fighting to hold Bayer responsible for the pain, suffering, and damage to health they say was caused by Essure.
According to over 10,000 complaints sent to the FDA, along with a wave of victim comments and interviews from news outlets and social media, Essure can cause a host of serious adverse effects with a considerable negative impact on patient health and quality of life. These include device or procedure-related complications, such as damage from migrated or misplaced implants puncturing the uterus and surrounding organs, as well as recurring symptoms like:
Many women describe being utterly destroyed by Essure side effects and complications. Intractable pain, uncontrolled menstrual bleeding, loss of control over bodily functions, and chronic fatigue often leave patients unable to work or care for their families. Some women have even been rendered disabled or lost their lives from complications blamed on Essure.
Patients say they had no way to expect these horrible side effects and that they weren’t properly informed of all their options. Essure was presented as safe and effective, they claim, but it fails a lot more than the 99% effectiveness statement Bayer would have one believe, frequently causing a host of side effects in the process.
Recent studies show that Essure patients are 3 times more likely to get pregnant than those who had their tubes tied, and 10 times more likely to need re-operation. Some experts, such as medical researcher Dr. Art Sedrakyan, believe that Essure removal surgery can prove to be far more dangerous than the minimally-invasive laparoscopic surgery typically performed in tubal ligation—and thus women may be better off getting their tubes tied rather than taking their chances with "surgery-free" Essure.
But patients aren't just filing lawsuits against Bayer. Women are now calling for a total ban on Essure, not only because they believe the device is unreasonably dangerous, but because Essure's “FDA-approved” status gives Bayer considerable legal protection against patient lawsuits.
The company's legal protection comes from the Medical Device Amendments of 1976, the very legislation that originally granted the FDA authority to regulate the medical device market. Before these laws were passed, there weren’t any official regulatory processes that manufacturers had to go through before releasing medical devices. In order to protect consumers from potentially-dangerous new devices, the FDA was given the sole authority to evaluate and approve medical devices, overriding many state consumer protection laws.
Normally, the FDA carefully reviews new applications, requiring manufacturers to run clinical trials, extensive testing and other important measures to demonstrate that a new device is reasonably safe.
There are 3 different safety tiers for medical devices, from I to III, with class III, the class that Essure belongs to, being the “high-risk” category. Class III devices are defined as ones designed to sustain human life (such as pacemakers) or that pose a considerable safety threat in some way. Typically, devices that are implanted in the body are put into Class III.
But sometimes, the FDA makes exceptions. In the case of Essure, the agency afforded Bayer an “Investigational Device Exemption” (IDE) which allowed the company to submit Essure without the usual rigorous level of safety data. IDE’s are given out in cases where a new device is thought to be especially promising in saving or improving patients’ lives. But as many Essure victims point out, the risks aren't likely to outweigh the potential benefits in this case. Is it worth subjecting women to the risk of enduring years of pain, discomfort, and permanent damage just to investigate a new birth control procedure?
The FDA, for that matter, isn't immune to making mistakes. A recent example is the Meniflex Knee Implant controversy. Politics surrounding the device pressured the FDA into approving the implants despite how the FDA's own researchers considered them "unworthy of approval." A few years later, the agency admitted that based on research provided in the application, the implants should never have been approved, and the device was pulled from the market after harming many consumers.
The doctrine of federal preemption says that the authority of the FDA, a federal entity, overrides most state law requirements. Thus, because many product liability lawsuits draw support from state laws, it can be very challenging to file a lawsuit involving an FDA-approved device such as Essure.
But if Essure was banned by the FDA, the device would lose its stamp of FDA approval, leaving Bayer vulnerable to state law-based justifications for patient compensation. Though there’s growing support for an Essure ban, it’s still unclear whether or not such a ban will actually take place, much less any time soon.
So far, there have been two proposed laws calling for the FDA to retract its approval of Essure, but both proposals still have far to go in the legislative process before they become law. This is why many plaintiffs are choosing to take legal action now rather than waiting for Essure to be banned.
In Pennsylvania, 5 federal Essure sterilization lawsuits—the very first Essure cases—were filed between December 2014 and January 2015. Later, the cases were consolidated for pre-trial proceedings. Each lawsuit, with Plaintiff Heather Walsh's being the most recent of the 5, contain virtually identical allegations presented in over 10 "counts" against Bayer. Individually, each Plaintiff requests over $75,000 in damages. Predictably, Bayer responded by filing a motion requesting for the outright dismissal of these claims based on federal preemption and other legal justifications.
However, instead of dismissing the lawsuits, Judge John R. Padova of the Eastern District of Pennsylvania chose instead to allow the Plaintiffs to proceed after carefully reviewing each argument they presented against Bayer. On March 23, 2016, Judge Padova filed an order permitting 2 of the Plaintiffs’ arguments to stand “as is,” while dismissing the rest.
More encouraging yet, the judge is allowing the plaintiffs to amend and re-submit most of the claims that he dismissed.
To get an understanding of the specific allegations these plaintiffs are leveling against Bayer, and to identify which claims for relief (i.e. justifications for requesting compensation) are currently most promising for victims of Essure, let’s look at each count along with a summary of Judge Padova’s comments on them:
Status: Not preempted, but dismissed on plausibility grounds. Plaintiffs can amend and re-submit.
Plaintiffs say Bayer didn’t exercise proper care in training physicians to implant Essure, an oversight they believe led to patients being injured by insufficiently-trained implanting physicians. They also allege that Bayer “bribed” doctors by offering them “expensive” hysteroscopic equipment in return for selling Essure. The plaintiffs believe that Bayer’s requirement that hospitals purchase at least 2 Essure kits per month created pressure for doctors to push Essure on patients, to recover their monthly investment in the device.
Order: According to Judge Padova, this count is not preempted because it’s based on a Pennsylvania state law that imposes the same requirements as the FDA regarding training, rendering it "parallel" to federal law. However, he feels the plaintiffs weren’t specific enough in pointing out exactly what federal requirements on proper training were violated. Also, he pointed out that the plaintiffs need to more clearly demonstrate how the alleged negligent training actually led to their injuries. The judge dismissed this count but permitted the plaintiffs to strengthen their argument with more detail and later re-submit.
Status: Preempted and considered “futile,” so plaintiffs are not allowed to amend this count.
The plaintiffs alleged that Bayer was negligent in allowing physicians who are not sufficiently experienced in hysteroscopy to implant Essure.
Order: Judge Padova says this count is preempted because there isn’t a federal law that requires that only specialist hysteroscopists can perform procedures with a hysteroscope. Thus, this argument attempts to impose a state law requirement with no parallel in federal law, which is explicitly prohibited by the Medical Device Amendments of 1976.
Status: Not preempted, but dismissed on plausibility grounds. Plaintiffs can amend and re-submit.
Plaintiffs claim that Bayer didn’t perform proper risk management, endangering patients in the process.
Order: Judge Padova believes this count is not preempted because proper risk management is definitely a component of the FDA’s requirements for approval. He points out that the "plaintiffs only seek to hold Bayer to federal risk management standards," and are not trying to impose any additional standards than what the FDA expects. But he dismissed the count for being “insufficiently pled” because the plaintiffs didn’t point out any particular risk management requirements that Bayer violated, and also didn’t strongly link the alleged failures to their injuries.
Status: Not preempted but dismissed on plausibility grounds. Plaintiffs can amend and re-submit.
The plaintiffs allege that Bayer made multiple untrue claims about Essure that led to their injuries. For example, they cited Bayer promising that Essure was “worry-free” contraception and that patients would never have to fear getting pregnant after a successful confirmation test. This promise was proven false, the plaintiffs assert, as both adverse FDA reports and medical studies have shown that many women have gotten pregnant on Essure.
Order: Judge Padova says that this count is not preempted because it’s not based on any state or federal requirement, but rather on an alleged contract that Bayer voluntarily made with patients by making public statements about Essure. However, the judge didn’t feel that the plaintiffs were specific enough as to when exactly they encountered the alleged promises made by Bayer and to what extent believing these statements caused their injuries.
Status: Preempted. Plaintiffs are not allowed to amend this count.
Plaintiffs accuse Bayer of concealing important safety information about Essure from the FDA. For example, they present a letter from the FDA citing Bayer for failing to show the FDA an internal spreadsheet containing hundreds of adverse Essure incidents, which the agency later discovered.
Order: While this count isn’t explicitly preempted since it’s based on the federal requirement to disclose crucial safety data to the FDA, Judge Padova considers it “impliedly preempted.” That is, he says that the count only tries to show that Bayer committed fraud against the FDA, which is not a valid cause for action in connection with the plaintiffs’ injuries. Plaintiffs cannot take legal action against a company solely because it violated FDA regulations—the violations must have actually plausibly caused injury to the plaintiffs to be considered valid.
Status: Neither count is preempted. Fraudulent misrepresentation is dismissed as plaintiffs failed to demonstrate fraud, but negligent misrepresentation is allowed to proceed "as is."
The plaintiffs say that Bayer is guilty of using misleading advertising to promote Essure, which led to their injuries. Fraudulent and negligent misrepresentation are two separate “tiers” of misrepresentation:
Order: These counts were judged as not preempted because misrepresentation requirements are in line with the FDA’s standards of drug / device advertising. However, in Judge Padova’s opinion, the plaintiffs’ fraudulent and negligent misrepresentation claims were practically identical and did not include the necessary elements for demonstrating fraudulent conduct. However, since the rules for proving negligence are not as strict, he felt that the count might indeed be sufficient to plausibly demonstrate negligent misrepresentation. So he dismissed the fraudulent misrepresentation count as futile but allowed the negligent misrepresentation count to remain.
Status: Dismissed. Plaintiffs are not permitted to amend.
This count cites the Pennsylvania Unfair Trade Practices & Consumer Protection Law (UTPCPL), which defines and prohibits “deceptive” business practices. The plaintiffs say that Bayer violated this law through making allegedly false statements about Essure.
Order: Citing previous relevant cases involving the UTPCPL, Judge Padova explained that medical device manufacturers are required to warn doctors and other medical professionals about risks and other important product information, but they’re not obligated to warn patients directly. By this law, doctors are considered “learned intermediaries” that are responsible for notifying patients of risks that manufacturers are required to educate them on. The plaintiffs, however, admitted that they relied on direct statements from Bayer rather than on their doctors’ counsel, which invalidates their claim based on the UTPCPL. The Judge completely dismissed this count.
Status: Dismissed. Plaintiffs are not allowed to amend.
Strict liability is a legal theory that holds manufacturers responsible for injuries caused by their products, even if the manufacturer in question didn’t intend to cause injuries and took every measure to prevent causing injuries. In other words, the manufacturer is liable as long as it can be demonstrated that its product indeed caused an injury. The plaintiffs attempted to hold Bayer strictly liable for harm they claim to have suffered from using Essure.
Order: Unfortunately for the Essure victims, Judge Padova considers this count invalid under Pennsylvania law, referring to previous verdicts in which certain drugs were considered too “inherently dangerous” to make reasonably safe for human consumption. Due to this supposed inherent risk in the nature of the product, these drugs were considered exempt from strict liability. Judge Padova predicted that a medical device like Essure would likely also be judged exempt and thus dismissed the count as futile.
Status: Not preempted, but dismissed on plausibility grounds. Plaintiffs can amend and re-submit.
The plaintiffs say that errors and oversights in the manufacturing of Essure caused defects leading to patient injury.
Order: Judge Padova considers this claim parallel to FDA requirements and thus not dismissible on preemption grounds. But he says the plaintiffs failed to clearly demonstrate exactly how manufacturing errors led to their injuries.
Status: Allowed to proceed "as is"
Plaintiffs say Bayer didn’t sufficiently warn doctors and patients of Essure’s risks, which it should have known based on adverse reports and postmarket research.
Order: Judge Padova considers this count parallel to FDA regulations and thus not expressly preempted. He believes it’s not impliedly preempted either, because the matter of warning the FDA of side effects and complications does potentially relate to the plaintiffs’ injuries, as the FDA is obligated to warn patients of serious problems with medical devices. Thus, if it’s demonstrated that Bayer failed to warn the FDA of risks, the company can be held responsible for injuries that occurred due to patients not knowing about risks that they should have been warned of.
Status: Dismissed. Plaintiffs are not allowed to amend.
The plaintiffs accuse Bayer of implementing an “unreasonably dangerous and negligent” distribution plan for Essure.
Order: Judge Padova dismissed this count completely because, according to him, it was redundant—simply an "amalgamation of several other counts" in the lawsuit, again mentioning manufacturing oversights, “scheming” to induce doctors to sell more Essure by forcing them to purchase a minimum of 2 kits per month, and repeated failure to report adverse effects of the device.
As we've seen, despite the formidable challenges posed by federal preemption, victims of Essure may end up succeeding in obtaining rightful compensation from Bayer for their injuries. Following the trail blazed by the first Essure sterilization lawsuits, more women are now taking legal action against Bayer for Essure injuries. Today, over 25 lawsuits, filed on behalf of hundreds of women, are currently pending in courts throughout the country.
Though it's much too soon to predict the future of Essure litigation, it appears that for now, all of these plaintiffs as well as other victims who have yet to file their own legal claims still have a fighting chance in court.
