Most people are skeptical about their ability to be compensated by a medical device manufacturer should a medical procedure they’ve undergone cause them significant physical and mental anguish. On March 12, 2018, an Indiana woman accomplished just that. The jury presiding over the case awarded her a combined verdict of 35M in compensation, with $10M in actual damages and $25M in punitive damages. After further time in court, the punitive damages were reduced by $15 M so the judgment was for $20M. This medical procedure was the implantation of a transvaginal mesh. These damages are to be paid by the medical device manufacturer Johnson & Johnson and their subsidiary Ethicon.
To better understand all of the ins and outs of this landmark decision, let’s go through the entirety of this case from beginning to end.
What’s a Transvaginal Mesh?
A transvaginal mesh is a synthetic netting implanted in the pelvis to regulate urinary incontinence, and manage vaginal prolapse. Primarily, a transvaginal mesh works to maintain the overall shape and function of the vagina should the current form not be conducive to proper functioning.
Having a transvaginal mesh implanted requires a surgeon to perform a procedure in which the pelvic mesh is embedded into the body, and then the patient will be stitched back up. Before any patient has a pelvic mesh procedure, a doctor does everything in their power to inform the patient as to what the procedure will entail, possible complications of the process itself, and what life will be like once the procedure is completed.
Why Are Women Around America Suing Ethicon Over Transvaginal Meshes?
A company controlled by Johnson & Johnson that goes by the name of Ethicon offers around a dozen different transvaginal mesh options to women. They’re now finding themselves on the business end of several lawsuits around the country since women are dealing with complications they weren’t informed of before agreeing to the procedure.
The first transvaginal mesh product came about in 2002 as a class II moderate-risk device, according to the FDA. Most products for medical use go through rigorous testing by the FDA. Still, there exists a clearance method known as the 501(k) clearance method that allows for products that use similar principles of already approved devices to skirt the rigorous testing process usually required. Ethicon used this very same 501(k) clearance method to get their pelvic meshes approved without having to have them tested at the same standards as a new product.
Most medical supply companies protect themselves from being sued over their products by explaining to doctors the entirety of their product’s scope, and the possible complications. These potential complications are then weighed by the doctor to determine whether they should perform the procedure. The surgeon is expected to pass on to the patient what they have learned from the medical device manufacturer about complications. Then the woman can make a fully informed decision about what is in her best interests.
As the court case has developed, it has been determined that Ethicon aggressively marketed its pelvic mesh products to doctors without fully explaining the possible ramifications of the procedure and obfuscating the rate at which these products were causing issues. This prompted doctors not to give a clear picture to their patients as to what to expect after being implanted with an Ethicon product.
The implication is that had Ethicon chosen to explain their product and its risks to doctors adequately those doctors could then inform their patients of these risks so they could make a more informed choice as to whether or not they should proceed. Doctors reassured patients that a transvaginal mesh was a relatively safe procedure with little risk for long-term harm. In the end, many women have dealt with constant pain and sexual after having the mesh implanted. Had these women known of these possible issues, they may not have agreed to the surgical procedure.
Indiana Court Case Against Ethicon
A resident of Indiana named Barbara Kaiser first filed her suit in 2012, alleging that the Gynecare Prolift mesh produced by Ethicon and implanted inside of her in 2009 had a much higher rate of failure and complications than the information provided to the medical community had suggested.
The device was implanted inside of Kaiser in 2009. By 2011, she was suffering from constant lower pelvic pain for some time after her doctor connected the pelvic implant. By 2012, she had sued Ethicon based on their deceptive marketing practices, with a decision made by March 2018 with the jury awarding Kaiser $35M in total damages. The trial court judge, however, felt that the $35M decision was excessive and unreasonable and cut the verdict to be awarded to $20M. Despite Ethicon’s efforts to appeal the decision, as of January 2020, the Seventh Circuit Court of Appeals in Chicago has upheld the decision they should pay $20M in damages.
This is one of several jury verdicts for women implanted with Prolift but the amount of this verdict was, as the Seventh Circuit stated, “hefty.” What had the jury convinced is how outstandingly shocking Ethicon’s marketing practices were regarding hiding reports of issues caused by their product, while still actively touting the Prolift line of products as safe solutions for women dealing with vaginal prolapse.
The decision is considered a landmark for several reasons – mainly because it now has been determined in a court of law that Ethicon did not design their Prolift product with safety in mind, and that doctors weren’t given adequate information as to the safety and efficacy of Prolift products in women in Chicago, and Indiana, and the rest of the country. Vaginal prolapse is a condition that can merit surgery should a woman think a procedure will alleviate her symptoms. It’s now on record that Ethicon abused that desire for symptom relief by selling faulty products that often required a secondary surgery to correct the issues caused by that very same product.
And Ethicon did not have a clue how the mesh could be removed if there were complications, and now it is virtually impossible to have all the mesh removed.
Women who undergo a procedure in which a vaginal mesh has been implanted, but now deal with new symptoms that didn’t exist pre-surgery, have a precedent set for their compensation. One symptom possible is lower pelvic pain. Also, women have reported generalized inflammation and pain with sexual intercourse to have occurred due to the pelvic mesh.
This case has galvanized women across America to take Ethicon to court over their issues suffered from using Prolift products. With this case serving as an important precedent, we can expect a lot more in compensation to be paid out by Johnson & Johnson and Ethicon as time moves forward.
Please contact Tom Plouff to discuss your legal remedies if you have experienced these types of medical problems following an implant of mesh. Tom handles cases primarily in Chicago and Indiana but will be able offer some assistance in getting you the right representation regardless of where you live.