The six women, three men jury returned the verdict after approximately six hours of deliberation.
In doing so they determined that Johnson & Johnson and its Ethicon medical device division, marketed, sold and recruited physicians worldwide to implant the Prolift pelvic mesh, an "unreasonably dangerous" pelvic mesh, defective in its design and in its warnings to end user physicians.
Kaiser, 69, was represented by attorneys Ed Wallace (Wexler Wallace, Jeff Kuntz (Wagstaff Cartmell) and Indiana attorney Thomas O. Plouff, of Costello, McMahon & Burke, & Murphy Ltd., who said in a press release:
"Ethicon defended an indefensible product and the jury stood up for Barb Kaiser. They were asked to send a message to Ethicon to deter future wrong doing and they did, a company that sold a medical device without doing any clinical testing and caused thousands of women to suffer painful complications from mesh in their pelvic area."
This was not the first trial for Prolift, a large, controversial polypropylene medical device used to treat pelvic organ prolapse (POP). It has been found defectively designed in both the Hyrmoc trial in New Jersey, the Beltz case in Philadelphia, and the Hammons case in Pennsylvania.
J&J quietly removed Prolift from the market in June 2012, along with three other pelvic meshes, to avoid conducting three-years of post-market surveillance.
See Prolift trials, Gross, Hrymoc, and Hammons below.
Plaintiff Barbara Kaiser, was implanted with Ethicon's Prolift mesh on January 27, 2009. She was being treated for prolapse as well as SUI (stress urinary incontinence) and Dr. Gregory Bales of Munster Community Hospital in Munster, Indiana decided the extra-large Prolift, with its six polypropylene arms should be the mesh of choice.
Kaiser suffers dyspareunia (painful sex), pelvic pain, levator myalgia, bladder spasms and groin pain. She underwent one attempted revision surgery.
The lawsuit claimed the polypropylene implant is incompatible with humans and leads to an immune reaction and severe adverse reactions.
"Defendants knew that the pelvic mesh products were not safe for their intended purposes and that the pelvic mesh products would cause, and did cause, serious medical problems, and in some patients, catastrophic and permanent injuries," the complaint said.
Canadian Pathologist Vladimir Iakovlev was among the experts who appeared at trial. He studies the effects of mesh on the body. See more on Iakovlev here.
Ethicon said it was not to blame for the alleged injuries. J&J continues to stand by its product, said a company spokeswoman.
Bales, in his deposition, said he was probably one of the early users of Prolift, which came onto the market in March 2005. Bales said he had performed a couple hundred procedures with either total Prolift System or the Anterior Prolift System which incorporates the bladder.
Dr. Bales received some of his training on Prolift by Vince Lucente MD, a urogynecologist who has made millions as a consultant to Ethicon and has trained new doctors on the procedure and product.
Lucente's name has been heard in the previous mesh trials of Linda Gross and Joan Budke where Dr. Lucente trained their doctors as well on the Prolift.
Dr. Bales admitted in his deposition that had he known about the complications associated with the use of Prolift, he “may not have started using the Prolift.”
Dr. Bales admitted that the “majority of the times the reps would be present,” referring to sales reps in the operating room.
Ms. Kaiser later learned from Raphael Albert, MD that her complaints of lower pelvic pain could be related to the Prolift.
After her implant, she was attended by Dr. Douglass Hale, former head of the American Urogynecological Society (AUGS), who eventually stopped using Prolift.
Hale admits in his deposition that he was a consultant to Ethicon as part of the original TVT studies (Tension-free vaginal tape) and that he authored a study that shows a 16.7% dyspareunia rate with Prolift pelvic mesh.
The Kaiser case was one of the earliest ones filed in U.S. District Court in Charleston, West Virginia where a pelvic mesh multidistrict litigation consolidated thousands of cases for trial.
The Kaiser case No. 2:12-cv-00887, was remanded to the Northern District of Indiana with a new case number 2:17-cv-00114 on March 15, 2017.
Lawyer Ed Wallace, one attorney for Ms. Kaiser says, “This is one of the first cases remanded and yes it will start to happen with others, hopefully."
After eight years in his West Virginia federal court, Judge Goodwin has announced he wants the pelvic mesh MDL (multidistrict litigation) to finally be resolved.
Because Ms. Kaiser was implanted in Indiana, the Indiana Products Liability Act must be followed.
It requires the plaintiff to show a product is defective and unreasonably dangerous through design defect, its manufacturing defect or a failure to warn, all counts in the Kaiser claim along with negligence, strict liability defective product, common law fraud, fraudulent concealment, constructive fraud, negligent infliction of emotional distress, breach of express warranty, breach of implied warranty and gross negligence.
The jury decided that Kaiser established her claims, that Prolift mesh was defective in design and there was a failure to warn doctors.
Also jurors agreed that J&J was malicious or wanton and willful in its disregard of the Kaiser's rights.
In January of last year, Plaintiffs asked the court to exclude evidence related to the FDA and its 510(k) clearance process that allows most medical devices on the market with no clinical trials to assure safety and efficacy. There was no mention of the FDA at this trial and no introduction of evidence about spoliation, that is, the destruction of documents by J&J that were on a litigation hold for pelvic mesh cases.
Plaintiffs felt any mention of the U.S Food and Drug Administration (FDA) might add legitimacy to the device that had skirted through safety assurances through the fast-track 510(k) clearance-to-sell process.
To explain how the majority of medical devices make it to market would have required an extraordinary amount of time to delve into the FDA's process that requires a manufacturer name a "predicate device" already in commerce similar to the new device. With that designation, no clinical trials are required unlike the FDA requirement for a new drug clearance.
For its part, the defendant wanted to exclude the “522 letters.” In January 2012, the FDA issued a mandate to mesh makers which required them to show the safety of their POP meshes in order to stay on the market.
What resulted was a mass, yet quiet removal of most POP meshes from the market including the Prolift, relieving the mesh makers of conducting expensive clinical trials proving the products were safe.
Never mind the thousands of women, like Barbara Kaiser, who live today with POP polypropylene meshes placed in their pelvic region and its consequences.
In January 2016, the FDA moved to reclassify POP mesh as a high risk device, requiring clinical trials to prove safety and efficacy.
To date no new POP meshes have attempted to clear that hurdle. ###