In doing so, jurors found the Prosima pelvic mesh, made by Ethicon (J&J) is not defective in its design and in its instructions to doctors, the end users.
This is the first trial win for Johnson & Johnson after suffering $21.5 million in losses in four previous pelvic mesh trials.
Heated debate in the Cavness jury room resulted from confusion about the questions jurors had to answer about Design Defect of the Prosima pelvic mesh, and whether the Instructions to doctors were defective or inadequate.
Jurors told patient advocate, Joleen Chambers, the questions were “too legalese” for them and they were unclear how the questions related to the evidence shown in the case. The female jury foreman, who reportedly took 100 pages of notes, and another woman voted for Ms. Cavness. The other jurors voted ‘No’ to both questions.
Plaintiff, Carol Cavnes, 60, broke down in the courtroom and was ushered out. The two female jurors reportedly were also crying.
[Jurors are invited to contact this editor, Janeakre@meshnewsdesk.com to share their story]
Chambers says jurors told her if one word was changed it would have changed the whole thing. Friday jurors were convinced they would render a quick decision in favor of the Plaintiff, but that reportedly changed when they saw the jury questions, which they say, did not coincide with what they heard at trial.
Defense teams typically bring in lawyers specifically to write jury instructions at the end of trial. That reportedly happened here and the revised questions did not receive specific approval from Judge Molberg before going to the jury.
At trial, jurors heard about the injuries Ms. Cavness suffered and what the company knew prior to marketing Prosima.
Defense had asked for specific language in the two jury questions. Once Judge Molberg realized that, he spoke to the jury this morning asking them to change their thoughts about the definition of “Proximate Cause” to let jurors know they could find for the Plaintiff based on causation.
Molberg defined that as the cause which was a substantial factor in bringing about an injury and without such cause the injury would not have occurred.
“In order to be a proximate cause, the act or omission complained of must be such that a medical device manufacturing company, using ordinary care, would have foreseen the injury or some similar injury might reasonably result there from. There may be more than one proximate cause of an injury,” he said.
Around 11 am Central Time, Judge Molberg told jurors if they had answered either question, they should re-deliberate using the definition he just gave “because it is the proper legal definition.” That was all he could say to them about legal theory.
One male juror told Chambers the deliberations were very difficult. He said he learned a lot about female anatomy quickly. He learned you can have an injury and it could reappear later. He too said the language in the question made no sense given what they were told during trial.
Other pelvic mesh trials have focused on the polypropylene material used to form the woven plastic and how the resin makers specifically warned against using the raw polypropylene resin for use in implantable medical devices. The Material Safety Data Sheet, which contains the warning, was not presented in this trial.
This is the first trial win for J&J and its Ethicon division, maker of pelvic mesh implants.
On Friday, the Plaintiffs asked for $9.5 million in actual damages against J&J plus punitive damage awards.
Judge Ken Molberg, who had a previous appointment, had to leave while the jury deliberated today.
Judge Emily Tobolosky told the court the jury wanted to deliver a statement along with the verdict. Attorneys for Plaintiff Cavness did not want to hear the statement while the Defendant’s lawyers had no problem with the statement, which was not disclosed.
The jury decision came back just about 4 pm Central Time.
The Cavness case is the sixth product liability case filed against Ethicon over its pelvic mesh. Four cases that have gone to trial include Linda Batiste ($1.2 million) Jo Huskey ($3.57 million), Linda Gross ($11.1 million) and Coleen Perry ($5.7 million). The Carolyn Lewis case was dismissed after Judge Joseph Goodwin granted J&J a directed verdict last year.
Other cases naming Ethicon/ J&J have settled including Budke and Wicker, as well as a few cases in Missouri.
So far, two juries have found the TVT-O, mesh used for incontinence, and made of the same mesh as the Prosima, to have been defectively designed and manufactured.
At this writing, J&J faces 28,960 cases filed in multidistrict litigation in federal court in Charleston, WV. Thousands of other cases are filed in state courts and around the world. J&J has vowed to take the pelvic mesh litigation to trial rather than settle, as several other manufactures have begun doing.
Ethicon knew the mesh used in the Prosima could prompt an immune system response that would cause degradation of pelvic tissue, but that information was withheld, says her complaint. Instead the company called the mesh “safe and effective” in its marketing efforts.
“Contrary to the representations and marketing of defendants J&J and Ethicon, the pelvic mesh products have high failure, injury, and complication rates, fail to perform as intended, require frequent and often debilitating revision surgeries, and have caused severe and irreversible injuries, conditions, and damage to a significant number of women,” Cavness’ complaint states.
The Plaintiff’s complaint says implanting physician, Dr. Kowalczyk, failed to disclose the risks associated with the implantation and instead recommended it as a safe and effective.
Cavness was seeking compensatory damages for disfigurement, impairment, past and future medical expenses and mental anguish. Punitive damages were allowed, reports CVN, after Judge Ken Molberg denied Ethicon’s motion to deny punitive damages against the company.
The suit also included claims against the physician who implanted the mesh in Cavness, Teresa Kowalczyk. The doctor was negligent in the care and treatment to her patient and did not act as a reasonably prudent physician in caring for her patient, says the complaint.
THANKS TO COURTROOM VIEW NETWORK FOR ACCESS TO THIS AND OTHER TRIALS!
Postscript * David Matthews of the Matthews law firm tells Mesh News Desk “This is a devastating loss and we are going to pursue all remedies on behalf of Carol Cavness. This story is not over.”