lawgavel_sm Thousands of women from all over the country are falling victim to dangerous complications and side effects from Essure birth control implants, according to a growing number of FDA patient reports. Essure, which consists of metal coils that close off the fallopian tubes by causing scar tissue growth, is often presented to patients as a safe, effective sterilization option.  However, injured users, concerned medical professionals, and consumer advocates say that the device poses a significant public health threat and should be banned.  

As the debate over Essure rages on and the FDA deliberates on possible regulatory action, women who have suffered grave injuries from receiving Essure implants are taking legal action against Bayer, the device’s manufacturer. Although Essure’s “FDA-approved” status may shield Bayer against common product liability allegations such as unsafe device design and failure to warn patients of risks, some plaintiffs are seeking to overturn this legal protection by calling the validity of Essure’s approval into question. Do victims and their families have a chance at securing rightful compensation through Essure lawsuits? 

Life-Shattering Side Effects Are Driving Victims To File Essure Lawsuits

Many women harmed by adverse Essure effects blame Bayer, accusing the manufacturer of purposely concealing or downplaying risks to make its new device seem more appealing to potential users. These patients declare that if they had been informed about the possible consequences before they were implanted, they would have never chosen Essure.

Indeed, the Essure system is typically pitched in Bayer promotional materials as a simple, “carefree” method of female sterilization, performed via a quick in-office procedure that allows patients to immediately return to their busy lives. But many women instead find themselves constantly suffering from severe side effects of the device and facing long-term health deterioration from chronic diseases, internal damage from placement procedure errors, or permanent disability due to unexplained pain and fatigue. Some patients even end up losing their lives to Essure-related complications.

When A “Surgery-Free” Procedure Leads To Multiple Operations

Though the possibility of avoiding surgery is a commonly-cited advantage of Essure, the device is in fact implanted through hysteroscopy, which is classified as a surgical procedure.

Furthermore, those who experience complications may require multiple surgeries to fix placement mishaps or other errors.  Dr. Art Sedrakyan, lead researcher on a recent study that found Essure patients 10 times more likely to require re-operation than those who get their tubes tied, points out that trying to avoid surgery by receiving Essure may instead lead to patients to undergoing correction surgeries more invasive and riskier than the laparoscopic tubal ligation they could’ve had in the first place.

And yet adverse effects often occur even when implants are properly placed. Patients who suffer intensely from side effects and need to have the implants removed promptly may be forced to go as far as undergoing hysterectomy, unless they happen to live near one of the few doctors trained in proper removal of Essure coils or have the resources to travel for the operation. During the September 2015 FDA panel meeting regarding Essure effectiveness and safety, multiple speakers showed dismay and disapproval at how Bayer does not ensure that patients will have the option to have their implants safely removed if necessary.

Furthermore, though for some patients adverse Essure effects are alleviated after device removal or hysterectomy, for others, the nightmare continues.  Especially because of the scarring response that the coils are designed to elicit, it can be next to impossible to retrieve lost coils or broken fragments, and these objects can continue to exert deleterious effects on the patient. Some women develop autoimmune disorders such as eczema, lupus, and celiac disease, which may plague them for life.

Were Patients Sufficiently Warned Of Potential Complications?

Victims of Essure often describe being utterly unprepared for the physical, mental, and emotional trauma they experienced after implantation and say that side effects of the device were minimized or not even discussed before their operation. Many feel that Bayer and even the FDA are jeopardizing patient safety by failing to ensure that women will have the chance to make an informed choice about the Essure procedure, especially considering the device is meant to be permanently implanted in the body.

For example, labeling for Essure mentions that patients may experience pain during or shortly after device placement. Yet many patient complaints report  “excruciating” levels of pain and discomfort that persist long after the procedure, either from chronic soreness / aching in the abdomen, pelvis, or lower back, or from recurring migraine headaches.

Is Bayer Responsible For Ruined Lives?

Essure patient distressed over side effectsSuch extreme adverse effects frequently wreak havoc on patient health and well-being at every level. Victims often find themselves unable to work or care for their families as even simple tasks become impossible. 

Patients filing lawsuits against Bayer say the life-altering problems they faced should have been avoided.  Evidence is mounting that Bayer deliberately tweaked or misrepresented the data they provided for Essure’s pre-approval, making the device seem more effective and complication-free than it really was. Some women are alleging that Bayer is manipulating post-approval data through various means as well.

Medical device manufacturers are obligated to safeguard patient health by ensuring that their products are reasonably safe and by properly informing doctors and patients of risks. If Bayer is failing to uphold these responsibilities by distorting data and hiding risks as Essure plaintiffs claim along with other allegations, then harmed patients may be entitled to compensation for any pain, suffering, health damage, and financial loss inflicted upon them by Bayer’s actions.

Essure Litigation Made Difficult By FDA Approval

However, the FDA’s stamp of approval, which Essure has held since 2002, affords Bayer considerable legal protection. Due to an explicit clause in legislation governing medical device regulation, FDA approval orders outrank any state laws for consumer protection, which form the basis for most product liability lawsuits. Thus, claims of manufacturer negligence, defective design, failure to warn, etc. are automatically “preempted” by FDA approval, which means courts can’t even give them a chance in trial.

FDA Gained Increased Authority From Medical Device Amendments

Congress originally granted the FDA authority to act as a gatekeeper for the medical device market through the Medical Device Amendments of 1976 (also called the Medical Device Regulation Act), a set of amendments to the Federal Food, Drug, and Cosmetic Act. These amendments established 3 classes of medical devices (Classes I – III, in order of increasing potential threat to patient safety) with specific protocols for regulating each class. Class III devices like Essure, which are defined as devices designed to sustain human life or that may pose a “unreasonable risk of illness or injury,” must be thoroughly reviewed by the FDA for Pre-Market Approval (PMA) before they can be released on the market.

Once approval is granted, the manufacturer is protected from any “non-Federal regulation” by a preemption clause that says only the FDA or another federal entity is allowed to impose requirements on the approved device.

Regulation Of Devices Saves Lives – But What If The FDA Makes A Mistake?

Prior to May 1976, the FDA was allowed to police medical devices that it deemed unreasonably dangerous, but there weren’t any concrete application / approval processes in place, so manufacturers were free to release new devices without performing pre-market safety testing or research on safety and efficacy. Now, in order to introduce any new, high-risk devices, manufacturers must submit extensive research supporting the safety and purported benefits of the proposed product and pass a rigorous review from the FDA. This increased regulation allows the FDA to catch potential health threats, preventing them from ever reaching consumers, and has likely saved many, many lives.

But sometimes, the FDA slips up and approves devices that pose overwhelming health risks. A recent example is the FDA handling of Menaflex knee implants, an implantable device for healing knee cartilage that frequently failed and required revision surgery. The FDA approved Menaflex in 2010 despite knowing of research pointing to its considerable risks, but about 3 years later,  the agency admitted that “the science does not support a decision to clear the device,” and ended up retracting its approval.

Plaintiffs Argue Bayer Invalidated Essure’s Approval

Many injured patients are hoping that the same will come to pass for Essure—that the FDA will conclude its latest safety review by revoking its approval. If that happens, “federal preemption” will no longer apply and the courts will be able to give product liability allegations a fair look.

But some victims are filing Essure lawsuits saying that the device’s FDA approval has already been lost, due to federal violations allegedly committed by Bayer that violate terms set forth in the original approval order. At least 9 such lawsuits have already been filed:

  1. Helen McLaughlin (filed in Dec. 2014)
  2. Ruth Ruble (filed in Dec. 2014)
  3. Melda Strimel (filed in Dec. 2014)
  4. Susan Stelzer (filed in Dec. 2014)
  5. Heather Walsh (filed in Jan. 2015)
  6. Tanya de la Paz (filed in Sept. 2015)
  7. Monica O’Neal (filed in Oct. 2015)
  8. Danielle Patterson (filed in Nov. 2015)
  9. Christine Barreiros (filed in Dec. 2015)

Although the specific details of these cases vary—for example, the exact list of symptoms and complications suffered by each woman are different—these plaintiffs all believe that Essure’s PMA should be considered invalid. To better understand how this argument can be made, let’s take a closer look at one of the cases.

Walsh Lawsuit: Hysterectomy, 5 Hospitalizations From An “Adulterated” Device

On January 26, 2015, Heather Walsh filed one of the very first Essure lawsuits. She asks for over $50,000 in compensation for damages from Essure device migration that resulted in 5 hospitalizations, a hysterectomy, and a number of lasting health conditions. Her lawsuit says that Essure is an “adulterated” device, as Bayer and Essure’s original manufacturer (Conceptus, Inc., which was later acquired by Bayer) committed multiple violations invalidating the FDA’s Pre-Market Approval order, and thus should have never been implanted into her.

Violations Of Approval Order Acknowledged By FDA And Dept. Of Health

Under the FDA’s protocol for Pre-Market Approval, a Class III device can be denied approval, granted outright approval, or granted a Conditional Pre-Market Approval (CMPA).  The approval order issued by the FDA for Essure granted CMPA and specifically stated: “Failure to comply with conditions of approval invalidates this approval order.”  Walsh claims that Conceptus, Inc. and Bayer committed 3 types of  violations:

  1. Failure to meet regular reporting requirements. The FDA didn’t receive timely status reports for Essure at 6 months, 1 year, 18-months, and 2 years post-approval as requested in the approval order.
  2. Failure to report known hazards to the FDA. The FDA clearly specified in the CMPA that any evidence of Essure-related injuries or adverse reactions should be promptly reported. Yet Bayer was found to have “actively concealed” 8 incidents of Essure perforation, and also failed to report complaints of device migration and over 100 more perforation incidents. The FDA even uncovered an internal spreadsheet containing 16,047 undisclosed Essure complaints.
  3. Failure to comply with federal marketing and distribution laws.  Bayer promotes Essure through sales teams from the manufacturers of Essure implanting equipment, third parties that are not “adequately trained nor have sufficient knowledge regarding Essure.” Furthermore, Bayer allegedly offers “bait” by giving out expensive hysteroscopic equipment to physicians who agree to purchase 2 Essure kits every month, even if these kits end up unsold and / or unused. Walsh points out that sales tactic puts pressure on doctors to “push” Essure on patients to make use of the kits.

The lawsuit also says that Bayer’s “unreasonably dangerous distribution plan” includes numerous manufacturing violations, such as using an unlicensed facility to manufacture Essure, employing non-conforming material for manufacturing Essure , failing to use pre-sterile and post-sterile cages, and manufacturing Essure for 3 years without the required licence.

Walsh asserts that the violations she mentions are more than allegations, pointing out that the FDA and the Department of Health officially cited Bayer for most of them, issuing violation notices, and the lawsuit included copies of these notices as evidence.

Aside From Invalid PMA, Walsh Accuses Bayer Of Negligent Training, Broken Warranties

Walsh’s lawsuit includes over 10 separate “causes of action” (arguments describing how her rights were violated and supporting her request for compensation), and only 2 of these — strict liability and negligent design— are reliant on an invalid PMA. Thus, even if the courts decide that Essure’s PMA is not invalid, Heather Walsh’s case may still stand in trial based on her other arguments, such as:

Negligent Training, Entrustment And Distribution.  Since Walsh’s injuries occurred because of a migrated Essure device and a mistakenly-placed extraneous implant, Walsh blames Bayer for failing to properly train her implanting physician. She says Bayer knew that her physician was not sufficiently trained in placing the Essure inserts, but still entrusted him with the “sophisticated hysteroscopic equipment” used for implanting Essure in order to sell more products. These arguments are not related to the question of an invalid PMA because they’re not based on the device itself, but rather on Bayer’s duty to train, entrust equipment, and distribute in a reasonably safe manner—duties that are not part of the PMA.

Breach Of Express Warranties And Other Misrepresentations.  If Bayer hadn’t “actively concealed” potential risks of the device, Walsh believes she would have refused Essure and avoided the injuries and loss she suffered as a result of the implants. After all, in making her decision to undergo implantation, Walsh relied upon information about Essure from the official website, brochures, booklets, TV commercials and other advertising materials.  Through these outlets, she says Bayer misrepresented the product with numerous false or misleading statements.

For example, the website claims that after a confirmed implantation, patients “never have to worry about unplanned pregnancy” and that zero pregnancies were detected in the clinical trials for Essure. However, there were actually 4 pregnancies during the clinical trials, and adverse reports revealed at least 64 unexpected pregnancies between 1997 and 2005. Also, a recent study found that Essure users are 10 times more likely to become pregnant after one year than women who had their tubes tied.  Another questionable claim: “Correct placement…is performed easily.” Bayer says this despite admitting that Essure placement requires a “skilled approach” and that for 1 in 7 clinical trial participants, even experts in hysteroscopy were unable to correctly place the implants.

These arguments may prove to be among the strongest in the lawsuit, and in Pennsylvania, where Walsh filed the case, claims regarding breach of express warranty (i.e. breaking explicitly-stated promises) are not preempted by FDA approval.

Should Essure Plaintiffs Consider Class Action?

With such large volumes of Essure complaints constantly submitted to the FDA, the legal community anticipates that the number of Essure lawsuits will grow sharply in the near future.  High numbers of similar lawsuits open up the possibility of using group litigation methods such as class action to streamline the necessary legal processes.

However, the experienced attorneys at Banville Law believe that joining a class action could put Essure victims at a disadvantage, for several major reasons:

  • Lack of influence in class action. In class action, a lead plaintiff files a single lawsuit that’s meant to represent a number of other similar claims, past and future. Only lead plaintiffs provide input for the lawsuit, participate in trial, and negotiate settlement agreements. All other claimants have no say in how the class action will proceed.
  • Risk of inadequate representation. Class action works best when the constituent cases are very similar to one another, so that the lead plaintiff can more easily serve as a good representative. Yet Essure cases are expected to vary widely—every woman’s story is different, and important details such as the severity of injuries suffered can bear heavily on the appropriate amount of compensation. For example, a lead plaintiff who experienced relatively minor symptoms might be willing to accept a small settlement, and thus would be a poor representative for claimants who suffered from life-threatening injuries.
  • Compensation is shared between claimants. Even if a class action suit receives a hefty settlement or court award, individual claimants may end up receiving very little. This is because most compensation is typically awarded to the lead plaintiff, and the rest is divided up between the remaining claimants. Some claimants may receive nothing at all.
  • Loss of rights. Class action usually requires participants to sign away their right to any further legal action. This means that if you ended up dissatisfied with the outcome of the class action, you wouldn’t be able to seek additional compensation with your own individual lawsuit afterward.

Individual personal injury lawsuits, on the other hand, don’t hold any of these drawbacks—you retain control over and rights to your claim, and you receive the full amount of any compensation awarded.

How Can I Start Filing A Lawsuit?

As we have seen, forming an Essure lawsuit is a complex and challenging process. If you think you may have a case, the best way to start exploring your legal options is to meet with an experienced lawyer.

Even if you’re drowning in expenses such as medical bills and have no money on hand, you can still get the help you need. Banville Law is currently offering free case evaluations to patients harmed by Essure. Our firm has extensive experience with litigation against large companies such as medical device manufacturers and our team is compassionate and highly dedicated to client success. If you have a viable case, our lawyers will work for you on a contingency-fee basis—you won’t pay any fees until we secure a court award or settlement in your favor. Call today to get all your questions answered.