Inside the Beltz Pelvic Mesh Trial
Mesh Medical Device News Desk, May 27, 2017 ~ The $2.16 million verdict for Sharon Beltz brought to an end the fourth consecutive trial for mesh-injured Plaintiffs in this court.
The jury verdict came down Friday May 26th after a 12-day trial in the Philadelphia Court of Common Pleas.
Beltz was awarded a compensatory amount with no punitive damages that had been present in the last three trials, and which totaled $34.5 million.
A Failure to Warn?
Ethicon argued the Instructions for Use (IFU) that accompanied the Prolift were adequate in informing the implanting physician, Dr. Heather van Raalte.
The instructions urge surgeons to seek additional training since “The IFU does not convey the impression that it presents all available information concerning the Prolift.”
The condition of (dyspareunia , painful sex) is not in the IFU but its implied, said Ethicon.
In this case, Dr. Vincent Lucente, preceptor and consultant to Ethicon, trained the Beltz implanting physician, Dr. van Raalte. (Dr. Lucente also trained Dr. Becky Simpson, the surgeon who implanted Joan Budke, who ultimately died from an infection originating with her mesh implant it was revealed during her trial in November 2014.)
A second consent form signed by the Plaintiff in 2006 shows she understood the dangers ahead, argued Ethicon. It said:
“The benefits and purpose of the operation and/or procedure have been explained to me in language I understand by Dr. Heather van Raalte as well as the risks, alternatives and complications pertaining to the above procedure/surgery which include but is not limited to: infections, deep vein thrombosis, blood clots to the lungs, wound healing problems, complications from extensive blood loss, including shock and possible death. Other risks include but are not limited to: bleeding, injury to surrounding structures (bowel, bladder, ureters), failure, recurrence, voiding dysfunction, nerve injury, mesh erosion, possible coversion [sic] to laparotomy.”
It included chronic inflammation.
Ms Beltz testified her doctor warned her only about general risks of surgery and not risks particular to mesh or the Prolift device. Dr. van Raalte testified there were no long-term studies available on the Prolift to inform her patient, according to court records.
Mrs. Beltz also said she received no information on how the Prolift would be inserted with cannulas and trocars and puncture wounds to the vagina.
Dr. van Raalte was a consultant to Ethicon and received more than $100,000 for her services.
A motion by the Plaintiffs for Ethicon to produce its corporate designees including consultants Dr. Lucente, Dr. Kavaler, and Miles Murphy was quashed after Ethicon argued that it was a Plaintiff effort to harass.
On April 25, 2017 Ms. Beltz dropped her claims related to the TVT-O and would not make any claim that her current urinary and or incontinence issues were related to the Prolift.
Mr. Beltz also decided to voluntarily dismiss his claim for loss of consortium.
What remained were design defect of the Prolift a failure to adequately warn of the risks of Prolift, and negligent and/or fraudulent misrepresentations as to the attributes of Prolift, in addition to punitive damages.
The Plaintiff had already withdrawn the designated testimony of expert urogynecologist, Dr. Rosenzweig which related to defects in the TVT-O. Also withdrawn was the expert testimony of Dr. Uwe Klinge, a biomaterial researchers related to the TVT-O.
Sharon Beltz underlying and ongoing urinary issues were no longer an issue in this case.
That did not stop the Defense on May 9, 2017, when its counsel announced it planned to introduce evidence of safety and efficacy of the TVT-O as defense of the Prolift.
Any evidence submitted about the safety of the TVT-O is no longer relevant to this case argued the Plaintiffs, and a waste of time for the jurors and the Court.
MISBRANDED AND ADULTERATED
Peggy Pence, PhD, in her expert report concluded that Ethicon marketed a misbranded and adulterated Prolift device because it did not have an adequate pre-market clearance through the 510(k) when it was launched in March 2005.
In 2004, in preparation for launching the Prolift mesh kits, Ethicon initiated two non-randomized non-controlled studies to evaluate a pre-cut surgical mesh made of the same non-absorbable polypropylene Gynemesh PS. Studies were also conducted at eight sites in France and three sites in the U.S. In the U.S. the failure rate was 12% and 20% had dyspareunia in the French study.
There were adverse events in 25.6% of the patients in the French study, and 65.9% of patients in the U.S. experienced adverse events, reports Pence.
In February 2005, Sean O’Bryan, Senior Project Manager, Regulatory Affairs at Ethicon issued a notification that Gynecare Prolift Pelvic Floor Repair System was considered a line extension of the Gynecare Gynemesh PS which had received a 510(k) clearance in January 2002.
So with no 510(k) clearance, Ethicon launched Prolift for marketing in March 2005.
The FDA had no notice of the existence of Prolift even though this mesh would be a novel device – pre-cut and boxed for an anterior implant, a posterior implant and a total implant complete with Gynecare Gynemesh PS, and with guide needles, fasteners and a fastener delivery device system.
According to regulatory expert Dr. Pence, the misbranding went to labeling issues and failures to follow-up on adverse event reports or interpret the data on serious injuries. Ethicon withheld known adverse complications from physicians because of a failure to seek a 510(k) clearance, and withheld information from the FDA during the 510(k) review that would have led to it not being approved.
They were exempt from premarket clearance, said Ethicon, because they were custom devices.
Dr. Pence said they were neither a custom device and were not exempt from compliance with the 510(k) premarket notification requirements. Nor were the instruments.
“Ethicon marketed a product that violated safety and ethical standards,” she concluded.
Ethicon motioned to omit the expert reports of Drs. Klinge, Rosenzweig, Margolis and Pence because they will offer “improper and inadmissible testimony concerning the purported knowledge, intent and motives of Ethicon of the Food and Drug Administration.”