Healthcare manufacturer Bayer markets Essure, its female sterilization device, as a convenient “surgery-free” alternative to tubal ligation. But thousands of women have reported suffering serious side effects and complications from the device.
Over 10,000 complaints sent to the FDA prompted the agency to re-evaluate Essure’s safety profile and announce plans to update product labeling with an urgent “black box” warning. Now, hundreds of women across the country are filing Essure lawsuits.
Essure’s Appeal For Prospective Users
Though tubal ligation is still the most widely-used method of family planning in the U.S., Essure permanent birth control has become another popular option, with an estimated 750,000 women currently implanted with the device worldwide. As a permanent contraceptive that’s implanted without surgical incisions, Essure often appeals to those seeking less-invasive sterilization that doesn’t involve the use of hormones.
Early clinical trials boasted high patient satisfaction scores and estimated success rates of 99%. After hearing from their doctors and Bayer promotional materials that Essure is “safe and effective,” patients may start to consider Essure an obvious choice over tube-tying.
Devastated By Essure Side Effects, Complications?
Tragically, instead of the “worry-free” contraception they expected, many women instead report falling victim to acute adverse effects after being implanted, such as chronic abdominal / pelvic pain, severe bloating, constant fatigue, and distressing menstrual problems.
Hundreds of women have complained of Essure failing at its designed purpose by allowing them to get pregnant. Others may suffer potentially-fatal complications from Essure implants that are incorrectly placed, broken, or malfunctioning. Some patients have even described being inflicted with long-term or permanent damage from migrated Essure coils that pierced vital organs, or from developing chronic autoimmune disorders that Bayer admits Essure can cause.
Patients afflicted with such harsh side effects often find themselves unable to work, to care for their families, or in some cases even to look after themselves, resulting in lost wages, broken families, and disrupted lives that may never return to normal.
Essure Lawsuits Say Bayer Misled Doctors & Patients
These tragic experiences are leading women who say they were harmed by Essure to take legal action against Bayer.
According to recent lawsuits, the manufacturer failed to properly warn the medical community and the public of dangerous Essure side effects and complications, instead choosing to “misrepresent” the device to consumers.
Essure plaintiffs argue that because their injuries could have been easily prevented with accurate safety information, victims have the right to demand compensation from Bayer for medical expenses, financial loss and pain and suffering.
Preemption: A Major Obstacle In Essure Litigation
Though it may seem that Essure victims who suffered severe injuries should have a solid case against Bayer, their current legal situation is far from simple. Medical device cases are already known to be challenging due to their complexity, but claims involving “high-risk” FDA-approved devices, like Essure, come with another potential roadblock: “federal preemption.”
The FDA & Medical Devices
Since 1976, medical device manufacturers have been granted considerable legal protection from product liability lawsuits. This partial immunity comes from a set of changes to the Food, Drug, and Cosmetic Act called the Medical Device Amendments of 1976, which afford the FDA sole authority over the regulation of medical devices.
Before these amendments were passed, the manufacture of medical devices wasn’t federally regulated at all, meaning that manufacturers were virtually free to market new devices without running studies or tests to establish a reasonable level of safety for consumers.
At first, the proposed Medical Device Amendments were met with resistance from the healthcare industry. But then, a contraceptive device called the Dalkon Shield IUD landed thousands of women in the hospital from severe complications, resulting in major public controversy. Legislators and the medical community could no longer ignore the urgent need for standard regulation of medical devices.
When Is A Claim Considered Preempted?
However, the very amendments that were enacted to protect patients from potentially unscrupulous manufacturing practices also make it difficult for victims of medical device injuries to seek much-needed financial relief.
The amendments establish that since the FDA is a federal agency, the regulations that it creates almost invariably outrank any potentially-conflicting state laws. This presents a problem for plaintiffs, because many product liability arguments for compensation are based on state consumer protection laws.
Express & Implied Preemption
Claims for relief may be federally preempted in two ways:
- Express Preemption. The Medical Device Amendments explicitly say that manufacturers cannot be held liable for violating any requirements other than those put in place by the FDA. Thus, if a plaintiff accuses Bayer of breaking a state law that doesn’t match up with any specific FDA regulation, the claim may be considered preempted and therefore invalid. On the other hand, if a state law is judged to be essentially identical to an FDA requirement for “high risk” medical devices like Essure, then a legal claim based on that law may be judged “parallel” and therefore not subject to dismissal by preemption.
- Implied Preemption. Though demonstrating that Bayer violated rules “parallel” to FDA regulations is necessary in order to avoid dismissal, plaintiffs cannot claim a right to compensation solely based on a company’s conduct towards the FDA. That is, it’s implied that victims must also explain exactly how alleged FDA violations caused their injuries. Claims thought to have been raised only because a manufacturer failed to obey the FDA may be judged “impliedly” preempted.
Proposed Legislation Supports Victim Rights
Essure victim support and advocacy groups, the best-known example being Essure Problems, have been fighting for an Essure ban for years, not only to protect more women from potential harm, but also to help ease the litigation process for patients filing side effect lawsuits against Bayer.
In fact, a citizen petition organized by the group, which called for Essure’s Pre-Market Approval to be revoked, was one of the main reasons why the FDA decided to subject Essure to another safety evaluation starting in September 2015. Unfortunately, the FDA concluded its Essure investigation without recalling Essure, instead asking Bayer for more postmarket studies and making plans to add a new “black box” warning and “patient decision checklist” to Essure’s product label.
But at least the publicity surrounding the FDA investigation has raised awareness for Essure victims and other pressing issues regarding “high-risk” medical devices. Now, legislators are taking notice, and several congresspeople have proposed new bills that would remove the threat of federal preemption for Essure plaintiffs:
- The “E-Free” Act. Sponsored by Congressman Mike Fitzpatrick. This bill would require the FDA Commissioner to revoke Essure’s PMA within 60 days of enactment. Since its introduction, the bill has already gained several co-sponsors and received hundreds of positive letters from citizens.
- Ariel Grace’s Law. Sponsored by Mike Fitzpatrick along with Representative Louise Slaughter. This bill would amend the federal preemption clause from the Food, Drug, and Cosmetic Act, removing legal protection from manufacturers of FDA-approved medical devices. The proposed law is named after Ariel Grace, who was conceived even though her mother was supposedly sterilized by Essure, and ended up dying stillborn.
If either one of these bills is passed, then federal preemption will no longer be a concern for Essure plaintiffs. However, both of these bills were only introduced recently, and it may take years either can become law. In the meantime, injured Essure patients are stepping up to fight Bayer despite federal preemption, with some making encouraging progress.
First Essure Lawsuits Make It Past Preemption
The first U.S. Essure lawsuits were all filed from late December 2014 to the end of January 2015, by plaintiffs in Pennsylvania:
These five plaintiffs have been permitted by a federal judge to proceed with their cases, even though Bayer attempted to have their claims completely dismissed by federation preemption.
Lawsuits Consolidated For Ease Of Comparison
Judge John R. Padova from the Eastern District of Pennsylvania, the judge in charge of the pioneering Essure suits, decided to consolidate them for pre-trial proceedings.
After all, other than the sections where each woman describes her unique medical history with Essure and specific side effects and complications, the lawsuits are virtually identical, listing all of the same “causes for relief” — arguments for compensation from Bayer.
Because of this, Judge Padova decided it only makes sense to treat the lawsuits as one, at least for the purpose of comparing their shared arguments against Bayer with Bayer’s arguments for dismissing the lawsuits.
Judge Sustains Two Counts, Permits Amendments To Others
After carefully considering the consolidated lawsuits, as well as Bayer’s objections to them, Judge Padova filed a court order on March 23, 2016. In the document, he delved into his specific evaluations of each of the 11 original causes for relief put forth by the plaintiffs, often drawing upon his knowledge of earlier rulings for similar cases to aid him in making reasonable decisions for the situation.
Ultimately, Judge Padova only saw 2 of the 11 counts — ”negligent misrepresentation” and “failure to warn” — as suitable to proceed without further amendment. While Padova dismissed the remaining counts, he granted the plaintiffs permission to amend most of the dismissed counts, giving them the chance to strengthen their arguments according to his suggestions.
A Breakdown Of The PA Lawsuit Counts
To get a better picture of specific claims made in the Pennsylvania lawsuits, we’ll now consider the counts one-by-one, along with Judge Padova’s justifications for his rulings on them.
Negligent Training (Count I)
Decision: Not preempted but dismissed. Can amend.
Argument: According to the plaintiffs, Bayer didn’t train implanting physicians with the level of care that a reasonably competent and responsible manufacturer should adopt in order to protect consumers. This failure, the plaintiffs say, may have led to many unnecessary implantation procedure complications.
They also accuse Bayer of employing “irresponsible” marketing tactics when dealing with implanting physicians, such as enforcing a “2 kits per month” purchase rule to drive doctors to sell more Essure, and “bribing” hospitals and doctors with “gifts” of expensive hysteroscopic instruments.
Ruling: Judge Padova says this count, which draws support from a Pennsylvania state law that mirrors the FDA’s physician training requirements, is parallel to FDA regulations and therefore not preempted.
Negligent Entrustment (Count II)
Decision: Preempted and completely dismissed.
By entrusting physicians with limited experience in hysteroscopy to operate hysteroscopic equipment and implant Essure, Bayer negligently endangered patients, according to this count.
Ruling: Judge Padova points out that there are no regulations laid down by the FDA that prohibit non-specialists from using hysteroscopes. With no parallel in federal law, this state law-based argument is expressly preempted and therefore considered “futile.”
Pharmacovigilance / Negligent Distribution (Count III)
Decision: Completely dismissed
Argument: The plaintiffs take aim at a “dangerous and negligent” Essure distribution plan allegedly employed by Bayer
Ruling: Judge Padova dismissed this count for redundancy, because he felt it was simply an “amalgam” of several other counts. He says the components of the argument (such as poor manufacturing practices, “unscrupulous” conduct to entice doctors to sell more Essure, and concealment of vital information) were already discussed at length in other parts of the lawsuits.
Negligent Risk Management (Count IV)
Decision: Not preempted, but dismissed. Can amend.
Here, plaintiffs criticize Bayer’s alleged lack of proper risk management protocols. They provide examples of quality control problems and other possible manufacturing oversights that they believe put consumers at “unnecessary risk of injury.”
Ruling: Because proper risk management is a requirement enforced by the FDA, Judge Padova says this count is not preempted. Looking closely at the plaintiffs’ claims, he concludes that they aren’t trying to do anything more than “hold Bayer to federal risk management standards.”
However, he dismissed the count on plausibility grounds for lack of clarity. He says the plaintiffs gave a “laundry list” of federal requirements and alleged breaches, but didn’t clearly link each alleged breach to a corresponding federal requirement. Also, not all of the listed federal requirements seemed to be strongly related to risk management in his opinion. But most importantly, he thinks the plaintiffs didn’t sufficiently link their injuries to the alleged risk management breaches.
Breach Of Express Warranty (Count V)
Decision: Not preempted, but dismissed. Can amend.
Express warranties refer to explicitly-made promises. According to the plaintiffs, Bayer made a number of false promises about the Essure device itself, its implantation procedure, and relevant clinical trial results.
For example, the plaintiffs cite claims from Bayer saying that there were “zero pregnancies” in Essure clinical studies, when in fact there were at least 4 known pregnancies during the trials.
Ruling: Counts based on breach of warranty arguments are not preempted because they don’t refer to federal or state requirements for consumer protection. Instead, these counts are based on contract law, since Bayer’s public statements about Essure constitute voluntary contracts made by Bayer with its prospective users.
However, though the plaintiffs do provide a list of allegedly false statements made by Bayer, Judge Padova feels it’s crucial for patients to specify exactly where and how they encountered the example statements, and to explain how belief in these “untrue” statements could have led to their injuries
Unfair Trade Practices & Consumer Protection Law (Count VI)
Decision: Completely dismissed
This count is based upon the Unfair Trade Practices & Consumer Protection Law (UTPCPL), a Pennsylvania state law aimed at halting “deceptive” business practices. The plaintiffs argue that
Bayer is in violation of the UTPCPL due to “deceptive conduct” such as the “false warranties” outlined in count V.
Ruling : Judge Padova explains that under the UTPCPL, doctors are dubbed “learned intermediaries” that medical device manufacturers are required to thoroughly inform of risks and other crucial safety data. The doctors, in turn, are responsible for relaying the information they should have received from manufacturers. This established chain of command renders manufacturers free of any obligations to issue warnings directly to patients.
Because the plaintiffs claimed that they relied on statements from Bayer materials to make decisions about Essure rather than consulting with their doctors, this count is not valid under the UTPCPL, so Judge Padova considers it futile.
Fraudulent Concealment (Count VII)
Decision: Preempted. Cannot amend.
Plaintiffs cite multiple instances where Bayer was cited by FDA officers for failing to disclose vital safety information on Essure to the FDA, including an internal spreadsheet of hundreds of adverse incident reports.
Ruling: Since the FDA enforces strict reporting requirements for adverse events, this count only serves to hold Bayer to the FDA’s own standards, and thus is not explicitly preempted.
However, in Judge Padova’s opinion, the count is impliedly preempted because while he agrees it demonstrates that Bayer committed a violation against FDA policy, he doesn’t feel it’s sufficiently linked with the plaintiff’s injuries. Though the plaintiffs tried to argue that concealment of adverse events may have delayed FDA action such as side effect warnings that could have prevented injuries, Judge Padova wasn’t convinced, and so he completely dismissed this count.
Fraudulent & Negligent Misrepresentation (Counts VIII & IX)
Decision: Not preempted. Fraudulent Misrep is completely dismissed, but Negligent Misrep can proceed “as is”
Argument: The plaintiffs accuse Bayer of “misrepresenting” Essure in promotional and informative materials, which they say convinced them to undergo implantation under false pretenses, leading to their injuries.
Ruling: To understand Judge Padova’s decisions regarding these counts, it’s vital to note that there are important differences between “negligent” misrepresentation, in which the perpetrator may not be intentionally making false or misleading claims (for example, he or she may carelessly cite facts without checking their validity beforehand), and “fraudulent” misrepresentation, in which the perpetrator intends to mislead others with false claims, with the aim of enticing them into a contract.
Because fraudulent misrepresentation is considered a more serious offense, there are more rules for demonstrating a defendant guilty of it. However, in Judge Padova’s estimation, the counts for negligent and fraudulent misrepresentation were pretty much identical, and didn’t come close to meeting the requirements for fraudulent misrepresentation. Thus, he completely dismissed Count VIII.
However, he felt that the plaintiffs may have done an adequate job of pleading negligent misrepresentation, which is established under rules that are not as strict as those for fraud. So he allowed Count IX to stand without need for amendment.
Strict Liability (Count X)
Decision: Dismissed. Cannot amend.
Argument: According to the theory of strict liability, manufacturers can be held liable for injuries caused by their products regardless of manufacturer conduct or intent. That is, plaintiffs only have to demonstrate that a product plausibly caused injuries. It doesn’t matter if the manufacturer took every available precaution to make the product safe; the manufacturer is still liable for any injuries caused. In this count, the plaintiffs argue that Bayer should be held strictly liable for Essure-related injuries.
Order: After looking over previous verdicts in Pennsylvania cases, Judge Padova predicted that Essure would fall into the category of “unavoidably unsafe products,” which are considered exempt from strict liability requirements under “well-established” Pennsylvania law. He explains that legal precedents for this exemption came from prescription drug cases where it was argued that some products are “quite incapable of being made safe for their intended and ordinary use” and yet they are “not unreasonably dangerous” with proper preparation and adequate warnings.
Thus, since Judge Padova believes that Essure belongs in this category of products, he thinks that it should be exempt from strict liability, and so he completely dismissed the count.
Negligent Manufacturing (Count XI)
Decision: Not preempted, but dismissed. Can amend.
Argument: According to the plaintiffs, poor manufacturing practices from Bayer resulted in the creation of defective Essure units, which caused consumer injuries.
Ruling: Judge Padova refused to consider the count preempted despite Bayer’s requests, because he says the plaintiffs’ argument gives a long list of alleged incidences of negligent conduct along with a list of FDA manufacturing standards, but again didn’t clearly link items from the two lists together. Therefore, he’s currently unable to ascertain whether or not the alleged violations are parallel with federal requirements.
But again, he dismissed this count due to insufficient evidence of a plausible relationship between plaintiff injuries and the cited negligent practices.
Negligent Failure To Warn (Count XII)
Decision: Not preempted nor dismissed.
Argument: Plaintiffs say that though Bayer should have known about Essure risks from internal adverse event spreadsheets, clinical trials, and postmarket research, the manufacturer failed to pass on this vital information to medical professionals and patients, which could have prevented their injuries..
Ruling: Because notifying the FDA and the rest of the medical community of device risks is a prominent FDA requirement, this count is clearly not expressly preempted. And since Judge Padova sees a clear link between warning the public of risks and patients choosing to undergo potentially-injurious implantation, he doesn’t consider it preempted by implication either. Thus, because he considers the count sufficiently-developed for negligence claims, he allowed it to proceed without the need for amendment.
No Counts Preempted For CA Plaintiffs
For instance, less than five months after Judge Padova’s milestone order was filed in Pennsylvania, a group of 11 lawsuits initiated by plaintiffs in California were consolidated and allowed to move forward in a similar fashion. Represented in these lawsuits were 14 women claiming injuries from Essure, along with 6 spouses putting forth “loss of consortium” claims.
Judge Winifred Y. Smith from the Superior Court of California, County of Alameda, also rejected requests from Bayer to completely dismiss the Essure lawsuits on federal preemption grounds. But even better, after evaluating the individual counts, Judge Smith didn’t consider any of them preempted, and allowed the lawsuits to stand on counts of failure to warn (which can be suitably based on either negligent or strict liability according to her ruling), negligent misrepresentation and fraudulent misrepresentation, breach of express warranty and loss of consortium.. Judge Smith dismissed the plaintiffs’ negligent / strict liability manufacturing defect and negligent training counts, but permitted them to amend and re-submit both.
Bayer also tried to have the suits dismissed because they were filed more than two years after the time of the plaintiffs’ alleged injuries, which exceeds California’s statute of limitations. However, Judge Smith rejected this argument as well, pointing out that the plaintiffs couldn’t reasonably have connected their injuries to Essure before September 24, 2015, when the FDA held a panel meeting with its Obstetrics and Gynecology Devices Panel to discuss safety concerns about Essure, including many that weren’t mentioned on the product labeling at the time.
When plaintiffs’ had no way of knowing the likely cause of their injuries earlier than a date after the statute of limitations, they can invoke the discovery rule, which allows the statute of limitations to be extended.
Your Lawsuit May Proceed Differently – Consult An Attorney
Why was the ruling in California different from the one in Pennsylvania? It’s important to note that although judges will use previous verdicts to help them make sound decisions, they’re not always constrained to follow what other judges have done and generally have room to come to a different conclusion if they see fit.
Also, states have different standards for what’s considered a plausible claim under each type of legal theory, which judges have to take into account. Judge Smith was well aware that Judge Padova dismissed Essure plaintiffs’ fraudulent misrepresentation and breach of warranty claims, but he explained that these dismissals “would not be consistent with California’s pleading standards,” so he let them proceed.
As you can see, the differences between federal and state law, and even those between various states, are complex. Even subtle differences can have a huge impact on a plaintiff’s case. That’s why it’s best to contact an Essure attorney as soon as possible. Experienced legal counsel is invaluable in navigating the many complicated legal issues surrounding Esure and other high risk medical devices.