Ethicon, Inc. is a subsidiary of Johnson & Johnson that primarily sells women’s health products. Part of their product lineup includes Gynecare Prolift transvaginal mesh kits, and these are the products that are making consumers run to the courthouse to get compensation from Ethicon. While women from Chicago make up a large number of the plaintiffs, women from the UK and Australia have also spoken up against the Prolift vaginal mesh.
What’s a transvaginal mesh?
For those who don’t know, transvaginal mesh is a net-like implant that’s permanently inserted inside women to treat urinary incontinence, and vaginal prolapse. Primarily the mesh allows women who deal with stress incontinence or discomfort after giving birth to lead a life with less discomfort. Those who suffer from vaginal prolapse occasionally report difficulty doing routine things like urinating or sex, so a transvaginal mesh is their solution. Vaginal mesh is a support system for vaginal tissues.
Implanting the mesh requires a surgical procedure, in which an incision is made either on the abdomen or vagina, and then the mesh is put into place. In an ideal situation, tissue grows into the holes of the mesh to create a rigid and strong support system.
What products are affected?
Gynecare products first hit the markets in 2005. If you’ve used any of the following products since then and have mesh-related complications, you may be eligible for compensation: Gynecare Prolift, Gynecare Prolift+M, Gynecare Prosima Pelvic Mesh, Gynecare Gynemesh, Gynecare TVT Secur System, Gynecare TVT Sling, Prolene Polypropylene Mesh Patch, and Ethicon Prolene Mesh. Time may be running out on getting compensation because of statutes of repose and limitations, so if you are experiencing complications from the Prolift (exposure or erosion of mesh, urinary difficulties, as some examples) you should contact an experienced attorney immediately.
When Ethicon released their products in 2005, they used the FDA’s 501(k) clearance method to allow it for public use. The 501(k) clearance method is when a product is “cleared” (not approved, which has significant legal implications with preemption) because it is similar to an already approved device does. Four years later, in 2008, the FDA released a memo to the public, stating that they were receiving reports of serious complications due to using Prolift products.
During the entire marketing process, Ethicon went to doctors and explained to them the efficacy and safety of their product without adequately explaining to them the possible complications. This meant many doctors were using Prolift products to help women without properly explaining the risks involved with using Prolift to repair their prolapsed organ, as they themselves weren’t properly informed by Ethicon. The assumption is that many women wouldn’t have proceeded with the surgery had they been properly informed on the possible ramifications.
Because of this, thousands of women had the mesh installed, and then later had to deal with life-changing consequences. The edges of the mesh would frequently dig into the skin and cause small lacerations prone to infection. Women reported everything, from headaches to whole-body discomfort, as their body tried to adjust to the Prolift mesh surgery. But then, for many women, the only option was to have the mesh removed.
By 2011, the FDA had received thousands of complaints from women and required all transvaginal mesh products to be properly tested before being allowed back on the market. Ethicon stopped manufacturing and selling their Prolift mesh products by 2012.
Court cases brought against Ethicon
Since the product caused much pain and suffering, and came with financial implications, people have begun to seek damages against Johnson & Johnson for negligently selling their product into doctors’ offices across the nation. The company put profits ahead of patient safety. The doctors could not properly explain the risks, as they were told the products were safe and FDA-approved (when they were only cleared), so the women were robbed of their ability to make an informed decision before proceeding.
As of March 31st, 2019, approximately 30,000 direct claims have been brought against J&J and Ethicon relating to complications from their meshes.
A noteworthy case occurred in Philadelphia in which Ethicon was forced to pay 80 million dollars concerning the case of a woman who suffered from inflammation, pain, inability to have sex, and infection. Of the 80 million they had to pay, 50 in punitive damages, and 30 in compensatory damage. The money was given directly to the plaintiff.
A resident of Illinois was awarded 3.27 million dollars in damages after using the TVT-O sling product offered by Ethicon. After having the TVT-O sling implanted, it eroded and caused the plaintiff significant amounts of pain. Three surgeries later, doctors could not remove the mesh, and the plaintiff still experiences pain to this day. The case took nine days, and the jury returned unanimous against Ethicon. The husband of the plaintiff was also awarded 200,000 dollars for the loss of consortium the entire debacle caused.
In a case by attorney Tom Plouff of Chicago, the Hammond Indiana jury returned a $35 million verdict, 10 in compensatory, 25 million in punitive
Ethicon has had to pay out or been held responsible for over 300 million dollars to plaintiffs since the lawsuits have begun, with them now eagerly settling out of court instead of taking their chances.
Sales Reps Not Safe From Litigation
Most cases involving Chicago clients are brought against Ethicon in federal court because when there are citizens of different states then the out of state defendant, like Ethicon can remove the case to federal court. However, if there is a valid basis for bringing a Chicago area local doctor or Ethicon sales representative, then that destroys diversity of citizenship so that if the case is filed in Chicago/Cook County then the case cannot be removed to federal court. There are many advantages to being in state rather than federal court but that is beyond the scope of this article.
A possible basis to name Ethicon sales representatives as a defendant is a claim for negligent misrepresentations. The sales reps are a cog in the overall Ethicon misinformation machine. These reps often spoke to both doctors about implanting Prolift in Chicago area patients. Sometimes the sales reps are in the operating room during an implant. These sales reps frequently glossed over any potential ramifications of Prolift and other mesh products.
Sometimes, women implanted with mesh sue their doctors, for not properly informing them of the risk of the mesh surgery. But often this is not done because these doctors may give testimony unfavorable to the Plaintiff in the Prolift or other mesh product liability action. Often the doctor will put culpability on the manufacturer or its sales representative for providing the implanting doctors with the information they supplied the patient. Not only that, sales managers have been found to tell their sales reps that erosion rates of 20% or more are “acceptable”, one of many aspects of their sales tactics thought by consumers and courts to have been borderline aggressive. Sales representatives doing their jobs is one thing, but when there is proof of obfuscating the dangers while aggressively speaking about how necessary the procedure is, they must stand behind Prolift and the other mesh products and face any potential legal actions.
Since sales reps were often told about the potential complications of the product and seldom passed that information down the line to customers, ultimately, they are culpable as individuals who misrepresented the supposed “need” the product filled. Sales representatives face the possibility of being in hot water themselves should money damages be sought against them.
If you or anyone you know has suffered major pelvic issues since their implantation of a transvaginal mesh, it’s recommended that they collect any and all records of the procedure being done, so they can prepare their court case and receive the compensation they are entitled to. These products were sold negligently and without care, requiring many women to undergo many supplementary surgeries with some not returning to the same condition they were in pre-mesh.
Women who’ve had a mesh installed and haven’t experienced complications may in the future experience complications as the plastic mesh will continue throughout their lifetime to interact with their body tissue and the tissue will continue to interact with the mesh. You may want to discuss this with your gynecologist, urogynecologist, or pelvic floor surgeon as the possibility of having it removed isn’t out of the question. Women with the mesh installed for urinary incontinence are less likely to report complications, while women who received the mesh to correct organ prolapse are very often at the center of these lawsuits.
While the products themselves may be off the shelves for good, the issues caused by Prolift products are still felt by many women to this day. This is precisely why many Chicago women are taking Ethicon to court, so they can attempt to lead something resembling a normal life.