Transvaginal mesh implants have seen lawsuits almost since they were introduced.
Hundreds upon thousands of women have submitted complaints to the Food and Drug Administration (FDA) about their experiences with pain, scarring, recurring prolapses, organ perforation and more. They joined together in massive multidistrict litigation cases, suing medical manufacturers for compensation. Many of these mesh lawsuits are still pending and can be joined by other harmed patients.
But will a transvaginal mesh lawsuit be worth it? What type of settlement or verdict could you receive in return?
By the summer of 2017, transvaginal mesh manufacturers had paid out billions in regard to allegations surrounding their products. The following are some of the major lawsuits that set legal precedent.
Ethicon was the only company that won a defense verdict, and their parent company, Johnson & Johnson, initially stated that they would not participate in transvaginal mesh lawsuit settlement talks because they were fighting “meritless claims.” In 2013, they had to pay $11.11 million to a woman named Linda Gross who had 18 corrective surgeries after being implanted with surgical mesh.
Linda Batiste never saw her transvaginal mesh settlement, as she died before being awarded $1.2 million against Ethicon. Parent company Johnson & Johnson worked hard to get the verdict overturned, and the family has to date received no compensation. However, Ms. Batiste was a pioneer in the fact that she went up against a giant and proved that their TVT-O vaginal mesh product was defective. This case was precedent-setting and helped countless other women who followed. She even achieved that in Texas court, where the burden of proof is higher for the plaintiff because she had to show that there were safer alternatives available to the implant used.
Jo Huskey is another TVT-O recipient and was part of the West Virginia MDL; she won $3.27 million against Ethicon in 2014. Johnson & Johnson has been appealing ever since. As of February 2018, J&J is trying to appeal to the U.S. Supreme Court.
Patricia Hammons, a Wal-Mart shelf stocker from Philadelphia, was awarded $12.5 million against Ethicon for her troubles from their Prolift product. Naturally, J&J is appealing, even though they pulled that device from the market in 2012 after receiving too many complaints.
Another Philly jury awarded $20 million to Peggy Engleman after she started experiencing mesh erosion from her TVT-Secur device (that was the one tested in sheep for a total of five weeks).
Finally, there was Elizabeth Hrymoc in New Jersey, who received $15 million in December 2017 after her Prolift device caused intense chronic pelvic pain.
Boston Scientific Corp., whose product was discussed by plastics expert Duane Priddy with 60 Minutes recently, lost an enormous trial against Martha Salazar when the jury said the company was grossly negligent. The jury awarded her $73.4 million for her experience with their Obtryx Sling.
Another verdict was upheld for four women against Boston Scientific for $19 million.
Deborah Barba received the single largest award ever for transvaginal mesh, an astonishing $100 million (though this was cut to $10 million on appeal). She had received both the Pinnacle and Advantage Fit implants for stress urinary incontinence and pelvic organ prolapse. She experienced recurring bladder infections and pelvic pain, and ended up requiring two additional surgeries.
Christine Scott, a California woman implanted with C.R. Bard’s Avaulta product for pelvic organ prolapse, was awarded $5.5 million by a jury, and her surgeon was actually found to be 40% at fault. The court’s opinion goes into why: Her surgeon went to a one-day seminar in which she implanted mesh into a cadaver, but was not instructed on how to remove it or to diagnose when it should be removed. Ms. Scott had eight corrective surgeries and no longer has control of her bowels. She also has excruciating nerve pain that precludes her from having intercourse.
Bard also lost to Donna Cisson of Georgia when a jury awarded her $2 million for her surgical mesh lawsuit. The jury awarded her $250,000 for compensatory damages and $1.75 million in punitive damages.
A settlement is an agreed-upon amount of compensation between the parties prior to a jury verdict. In exchange for ending the case, the defendant will offer some amount; the plaintiff (AKA the injured party) can choose to accept or refuse that number.
This will often be a case of back and forth until both parties are, at least, somewhat satisfied. The defendant’s lawyer will take into account how likeable you are as a plaintiff, the strength of the evidence, whether you are sympathetic, and what the outcomes have been for similar cases in that region before making any offer. The likelier you are to succeed at trial, the better chance you have of settling and not actually having to pursue a transvaginal mesh lawsuit in court.
A verdict is what the judge or jury finds for the plaintiff. They will perform calculations regarding damages (attaching numbers to nebulous ideas like “How much is her loss of enjoyment worth?” “What will be her medical bills going forward?” “How much is her loss of consortium worth?” (That’s another term for “marital relations.”) Once those calculations are performed, they will reach a number that represents total damages for the plaintiff. That number influences your transvaginal mesh verdict amount.
You nearly always have a chance to settle prior to a full-on court case, but you might not be happy with what you receive. The defendant might offer an insulting transvaginal mesh settlement number, something far below what you need to even begin to feel normal again. That is when you can refuse their offer and continue to court.
First you need to hire a lawyer and file a claim (lawsuit) for your transvaginal mesh device. When you file a case, the opportunity to reach a settlement will present itself after discovery has been mostly completed and both sides know how much the case is potentially worth. The defendant might offer a paltry sum to settle, or it might be a heftier amount based on your chances of winning at trial.
If you reject the offer to settle or the manufacturer does not offer a settlement for your transvaginal mesh case, both sides will proceed to a jury or bench trial (the latter being in front of a judge).
Many women believe that it makes sense to pursue both the surgeon and the medical device manufacturer when they receive a defective implant and experience physical symptoms. However, only in cases of gross negligence or medical malpractice would the surgeon or hospital be included in a lawsuit of this type. That would include a blatant violation of hospital protocol or indifference to a legal duty. So, if they literally botched up the surgical process and somehow caused the symptoms to occur, then they would be included in a claim.
It is far more likely that only the medical device manufacturer would be pursued for a transvaginal mesh settlement. They are the ones who created the defective product, and those defects are what caused your physical problems.
Before all the transvaginal mesh lawsuits began, there was a mad rush to create the first transvaginal mesh “kit” (i.e., the package that includes the implant and surgical tools specific to the procedure). Medical device companies made more than 100 different products, all of them offering women a speedy recovery. Each company tried to stand out from the others, though they were mostly based on the first transvaginal mesh implant to hit the market: the Protegen Sling. This resulted in the devices sharing common characteristics. This also likely led to many market withdrawals of faulty products.
At this time, C.R. Bard and Ethicon are out of the game and no longer make transvaginal mesh products, though others still manufacture them:
Mesh lawsuits center on the legal concept of defective products, which are products liability cases. The active lawsuits for transvaginal mesh are a series of products liability lawsuits, so if you want to join a case, it will have to be for those issues. See more about vaginal mesh complications and lawsuits.
When pursuing a products liability case, the court usually either follows a concept of negligence or strict liability, the latter meaning that the defendant’s intent did not matter, as long as the product was indeed defective. There are three possible categories for defective products:
In a lawsuit, a defective mesh implant would most likely fall under “manufacturing defect,” since the end product injured patients. However, an attorney could also include one or several “failure to warn” claims as well, if the manufacturer did not provide proper warnings or surgical instructions.
Products liability lawsuit settlements for transvaginal mesh can take a very long time. Many questions must be answered, such as exactly which companies produced the mesh, where in the supply chain things went wrong, who implanted it, and what health problems the product caused. This will result in a lot of discovery between the parties. That is why many women choose to join multidistrict litigation that is already in motion. MDLs are confused with class-action suits, but there are many differences.
MDLs are a federal litigation tool that consolidates similar cases for pretrial and discovery, and ensures there is no duplicative evidence presented. Many of the cases will present the same type of evidence and are against the same defendant. Plaintiffs can be from any state, though once discovery is complete (pretrial motions, depositions, etc.), the individual case will be sent back to its original court for the rest of the trial.
Let’s say you filed your case in the federal court closest to you. The Judicial Panel on Multidistrict Litigation (the JPML, seven appointed federal judges who oversee MDLs) might hand down a transfer order, instructing you to consolidate with thousands of other similar cases — just for pretrial purposes. Your attorney might also make the decision to join one without prompting from the JPML. The same judge will hear the evidence from all of the cases in the all-encompassing lawsuit, and then once pretrial proceedings are finished, your case — along with any rulings from the MDL judge — will go back to your local federal court for the rest of the trial.
There are no class-action lawsuits pending for transvaginal mesh implants.
There was a class-action in 2015, filed by Federal Insurance Company against Caldera Medical Inc., but the deadline for any individual plaintiff to join the lawsuit was May 2, 2016, and the total award proposed for plaintiffs was $11.75 million. Three dozen women in the class-action protested that amount, but a judge ended up approving a meager $12.5 million for 4,000 plaintiffs. Liability was estimated to be worth $100 million, but the company’s insurer had no income and a negative liquidation value.
While there are no class-action lawsuits, there are plenty of MDLs and lawsuits seeking settlements for transvaginal mesh implants.
In the claims against mesh manufacturers, women state that the companies “had a legal duty to ensure the safety and effectiveness of their pelvic mesh products,” but instead provided patients with “false and misleading information.”
Other allegations against manufacturers in vaginal mesh lawsuits include legal claims like:
There are many options for women pursuing a mesh lawsuit. See a list of current transvaginal mesh lawsuits.
The first thing you should do is speak with your surgeon if you are feeling pain or discomfort at your mesh implant site. There may be a possibility you can rectify the issue without surgical intervention. The imperative is to resolve your pain and make sure the implant is not eroding.
Second, find a transvaginal mesh attorney. Many women feel more comfortable with a female attorney, as these cases involve intimate areas.
You can also start with a Google search along the lines of “Florida vaginal mesh attorney,” where you substitute Florida for your state. You can also get a specific as your city, such as “Tampa vaginal mesh lawyer.” This will help to narrow down your results, since just Googling “mesh implant attorney” will require you to weed through too many.
How do you know if an attorney is good? Well, first read online reviews to weed out lawyers who don’t feel right to you. Then, once you have shortlisted 3-5 attorneys, talk with them in person. You can interview each one and decide if he or she is appropriate for your vaginal mesh lawsuit.
Remember, each state has a statute of limitations (the time window in which you can file your case). Once that window is closed, you can no longer file. A few states only offer one year for cases, so you should act fast. An attorney will be able to preserve your claim and help you bring a vaginal mesh lawsuit.
Products liability law is quite specialized. You need a lawyer who has years of experience and knows how to coordinate with pending multidistrict litigation cases. If you have not met with a transvaginal mesh lawyer yet, look through the Enjuris directory for someone in your state who can assist you in this complicated process.