February 25, 2013 ~ Jurors in the Linda Gross v. Ethicon trial awarded the 47-year old woman from South Dakota and her husband $3.35 million today in an Atlantic City, New Jersey Courtroom.
Jurors have been deliberating 5 days now in the product liability trial.
Jurors decided the Prolift was not defectively designed by a 9-0 vote.
By a 7-2 vote the jurors decided there was a failure to provide adequate warning to Dr. Benson the implanting surgeon.
By a 7-2 vote jurors decided the Prolift was the proximate cause of injury to Ms. Gross.
By a 7-2 vote jurors decided there was no fraudulent misrepresentation to Dr. Benson, her implanting surgeon.
By a 7-2 vote plaintiffs proved a fraudulent misrepresentation was made to Ms. Gross and that was the proximate cause of injury to Linda Gross.
What amount of money compensates Linda Gross from her past pain and future pain of suffering, disability loss of enjoyment of life $1.1 million.
For her past wages- $180,000.
For her future wages $500,000.
For the reasonable value of past medical services $385,000.
For the reasonable cost of future medical treatment and household services $1 million.
Compensation to Jeff Gross $185,000 for loss of the companionship of his wife.
Punitive damages will now be considered by the court which could be five times compensatory damage or $350,000, which ever is greater.
The $3.35 million was awarded because Ethicon failed to properly warn of the risks of the vaginal mesh to Linda Gross and made fraudulent misrepresentations. The plaintiff did not prove the mesh had a defective design.
Late add here* Jurors were instructed by Judge Carol Higbee to call in at 4pm EST to see if the case was over or if they should return back tomorrow morning to decide punitive damages. Interestingly, when the jury was polled, Juror #7 said he didn’t think the pain and suffering awarded ($1.1 million) was a “fair amount.”
Late Late Add* 4:15 pm- Judge Higbee has called the jurors back to the courtroom at 9:30 tomorrow morning (Tues, Feb 26) to discuss punitive damages.
Linda Gross and her attorneys say Ethicon, a division of Johnson & Johnson, produced a defective Prolift transvaginal mesh used to treat prolapsed organs, and failed to tell doctors about the dangers. The plaintiffs also claimed Ethicon used deceit and fraudulent misrepresentation to promote Prolift.
The Prolift Pelvic Floor system was an innovative new transvaginal mesh that for the first time would be sold pre-cut in a kit with hook like trocars of metal implanting devices.
Made by Ethicon, the medical device division of Johnson & Johnson, Prolift would use the Gynemesh soft prolene (PS) used for hernia repair.
During the trial jurors saw that the marketing team always worked closely with Research & Development and Regulatory Affairs with a targeted March 2005 launch date. The date was important. Ethicon wanted to take advantage of the market and beat out the upcoming competition and charge a “premium price” for the Prolift, according to internal company records.
But as late as January 2005 the launch team was hearing from its French scientists who developed the TVM procedure (how to use new tools to place the mesh). Evidence was presented that showed they suggested a different type of mesh be used to replace the Gynemesh because early indications on cadaver and animal testing showed a 21 percent and higher complication rate with Gynemesh placed in the pelvis.
Gynemesh was called the “worst of a bad lot” of meshes and some inside the company thought it caused too many complications.
Ms. Gross who had worked as a hospice nurse, is now unable to sit any more than 20 minutes. She has to self-catheterize in order to urinate and has chronic pain in her legs and pelvis. She has undergone 9 mesh removal operations and over “400 medical encounters” since the Prolift was implanted in July 2006.
Her story painted a sympathetic picture of a woman who does not resemble her former self.
What was not introduced before the jury was the fact that Ethicon decided to bypass any approval by the FDA and instead just began marketing and selling Prolift, under the radar.
On the stand, the head of Regulatory Affairs Sean O’Bryan said the company thought the mesh was similar enough to the Gynemesh used for hernia repair, even though the technical implantation was entirely different and the area of the body it would be placed was a new applications.
Ethicon did not run any human clinical trials and did not study how best to remove the mesh if there were complications. Despite the red flags before launch, Prolift met its March 2005 date.
The case show how different “tiers” of doctors were chosen to be trained in Prolift. Some were “preceptors” used to teach other doctors on the new product. Often there was compensation for the doctors and large dinners and events to promote the product to new doctors. Within the company, the upper “tier” of doctors feared the lower “tiers” or less skilled doctors were not understanding how to implant the mesh in the “blind” procedure practiced during weekend cadaver teaching sessions.
An expert witness for Ethicon said Ms. Gross multiple removal surgeries caused her pelvic muscle to spasm and she never gave her body enough time to recover between surgeries.
Last year, Ethicon decided to remove Prolift and three other transvaginal meshes from the market in a phased stages over 18 months. An investigation by MDND recently found it can be purchased on eBay and is still sold overseas.
Last June, a California jury awarded $5.5 million to a woman injured by the C.R. Bard Avaulta mesh, another pelvic organ prolapse mesh that comes precut in a kit. That ruling is on appeal. (Story here)
Other cases naming Ethicon are filed in various state courts around the country. #