Today, a jury in Atlantic County, New Jersey awarded Ms. Linda Gross $3.35 million dollars for damages caused by the Prolift®, a transvaginal mesh device manufactured by Ethicon (a subsidiary of Johnson & Johnson) designed to treat Pelvic Organ Prolapse in women. The Prolift® was one of the first Pelvic Organ Prolapse Kits (POP Kits) to hit the market as part of a new wave of “innovative” women’s health treatment devices.
During trial, Ms. Gross and her doctors testified regarding the extensive tissue, organ, and nerve damage that had been caused by the Prolift’s® inherent defects. Ms. Gross testified that, over the past several years, she has experienced constant pain in her legs and pelvis, and that she takes up to 20 different medications to cope with her severe issues. Since receiving the Prolift® during surgery in 2006, she has undergone over 400 medical encounters, including office visits, surgeries, and physical therapy. She testified that, because of the damages caused by the product, she has become a shell of her former self, having to resign from her job as a nurse. She now rarely ever leaves the house. Ms. Gross’ key treating doctors also took the stand to solidify some of the technical medical aspects of Ms. Gross’ extensive treatment. The degree of damages encountered by Ms. Gross and the effect on her husband and family evidently impacted the jury.
The Prolift® device is a large, palm-sized piece of polypropylene (the same material used in fishing line) that has been pre-formed and retrofitted with “arms.” The device is pre-packaged with metal hook-like tools called “trocars.” These kits are handed to doctors by device manufacturer sales representatives for treatment of Pelvic Organ Prolapse. When Ethicon brought the Prolift® to market, company representatives made the decision to simply not bother to even submit the device to the FDA. During trial, video testimony of Sean O’Bryan (Ethicon’s Senior Project Manager for Regulatory Affairs) showed that the company decided not to submit the Prolift® to the FDA because it did not feel that a 510(k) application was even necessary. O’Bryan and other Ethicon officials apparently believed that the difference between the Prolift® and a previous device, the Gynemesh® patch, was “not significant enough,” even though there are several differences between the two products (size, shape, design, method of insertion, packaging with trocars, etc.). O’Brien’s testimony also showed how Ethicon did nothing to educate others or prepare for what would happen if the device caused horrific complications, as it did in Ms. Gross’ case. Testimony by other Ethicon employees, including Ethicon’s World Wide Medical Director, showed that Ethicon aggressively marketed the Prolift® without regard to the skillset of the doctor or surgeon and designed the product literature and warning labels in a very generic fashion. The testimony of Ethicon’s employees shed some very interesting light on how little thought, skill, and design was put into a device that was touted as such a revolutionary product.
The Plaintiff’s experts testifying on behalf of Ms. Gross outlined the true dangers of the Prolift® product from a design, safety, and regulatory standpoint. From a design safety standpoint, the Prolift poses numerous problems that are specific to mesh “POP Kits” and are not seen in traditional surgeries. To surgically implant the Prolift®, a surgeon must use the trocars that come with the kit to “tunnel” the mesh through skin, nerves, and tissue, causing damage in the process. Once the Prolift® is implanted, a dangerous foreign body response takes place. The mesh encounters a “shrinkage” effect, the body undergoes an inflammatory response, and the subsequent events lead to nerve, tissue, and organ destruction. The Plaintiffs’ biomaterials expert, Dr. Klinge, testified regarding the biocompatibility of meshes in general and discussed some of the inherent design problems of the Prolift®. The Prolift® is among the “worst of the worst” of this generation of devices, as it consists of a larger, heavier mesh with a smaller pore size, thereby exacerbating the destructive effects. Ethicon was able to hide behind the true picture of the Prolift® product by standing behind inaccurate data, omitting adverse event reports, and overstating the alleged success of the product.
In September, 2011, the FDA ordered that Ethicon and other manufacturers perform post-market studies to demonstrate the efficacy and safety of their products. Rather than follow through with the FDA’s orders, Ethicon decided instead to withdraw the Prolift® and a number of other devices from the market. Now, the Prolift® and many other dangerous pelvic mesh devices are no longer being placed on surgeon’s shelves. Unfortunately, tens of thousands of women lie permanently injured from the effects of these devices.
This is the second large verdict involving a Pelvic Organ Prolapse kit. In June, 2012, a California Jury awarded an injured woman $5.5 million for damages caused by the C.R. Bard Avaulta® product, a POP Kit similar to the Prolift® device. The continued success at a trial level will hopefully push these defective device manufacturers to compensate victims of device failure. “This verdict should signal to manufacturers of medical devices like the Prolift® that the victims of defective medical devices deserve recourse for damage caused by faulty products,” says Troy Rafferty, a pharmaceutical and medical device product liability attorney and partner at the Levin, Papantonio law firm in Pensacola, Florida. Mounting evidence is showing that Pelvic Organ Prolapse Kits and their sister predecessor devices, Stress Urinary Incontinence Slings (also known as Bladder Slings) are backed by very little safety and efficacy data. It is becoming more apparent that the Prolift® and many other transvaginal mesh kits are essentially experimental devices that were rushed to the market by corporate sales tactics and capitalistic medicine.
Robert E. Price is an associate attorney at the law firm of Levin, Papantonio, Thomas, Mitchell, Rafferty & Proctor, P.A. He focuses his practice on products liability cases involving defective drugs and medical devices. Robert currently serves on the Plaintiffs’ Steering Committee for federal multidistrict transvaginal mesh litigation, MDLs 2187, 2325, 2326, and 2327.