Day Three: Lewis v. Ethicon ~Polypropylene Under the Microscope
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As a huge snow storm headed toward Charleston, it was plenty warm in the courthouse for the first federal trial of the Johnson & Johnson’s transvaginal mesh known as TVT (tension-free tape). The medical device was marketed in 1998 by Ethicon, a subsidiary of Johnson & Johnson, for permanent implantation in women to treat stress urinary incontinence (SUI) despite the red flags that were waving, according to lawyers for Ms. Lewis.
The case of Carolyn Lewis is the first of 15,000 cases consolidated in this federal court. Altogether six manufacturers are facing 50,000 defective product cases, all transvaginal mesh made of polypropylene, used to reinforce sagging pelvic organs.
First on the stand before the 10 jurors was a taped deposition of Dr. Richard Isenberg. He was the first Medical Director for the new division with Johnson & Johnson called Gynecare, which was established to develop and market medical devices for the female population, known to make more use of medical care than men.
Gynecare is Born
Dr. Isenberg, a urogynecologist from Philadelphia, had many jobs within the healthcare giant. One was to solicit doctors who would become the first group trained on a new Prolene mesh. Prolene was the Ethicon (J&J) trade name for polypropylene, a petroleum-based plastic increasingly finding new applications as medical devices after its initial use in the Hula-Hoop and for kitchen storage containers.
The solicited doctors would in turn train other doctors one-on-one or before medical societies in a sort of grass roots marketing from the ground up. “We would assist them in preparation with their slide decks, it was their data,” said the doctor to the jurors.
The TVT implanted in plaintiff Carolyn Lewis had its roots in Sweden. Scientist Professor Ulf Ulmsten invented an intervaginal sling plasty (IVS). On videotape Dr. Isenberg said it was not exactly the same as what would eventually be marketed in the EU in 1997 and the U.S. in 1998. The IVS had different needles to pierce the woman’s groin to introduce the mesh.
But it was the same Prolene mesh as the TVT. “They are the essentially the same product. I presume he was hand-cutting the Prolene mesh whereas TVT is machine cut,” said Dr. Isenberg.
Marketing materials developed by Gynecare would include glowing promises of the new product – it had an 84 percent success rate, said one article by a Dr. Christian Falconer.
“But it wasn’t the Prolene mesh was it?” It was polyester not Prolene?” Dr. Isenberg agreed.
And in a risk-benefit analysis produced by Ethicon there was no mention of dyspareunia (painful sex), chronic pain, the need for mesh removal or mesh contraction. In a cross- examination the defense established those reports did not exist in 1998, the year the product was launched.
Could a $400,000 financial incentive to Dr. Ulmsten have compromised his opinions? As medical director for Gynecare, did you look at Dr. Ulmsten’s data? No, said the doctor. Do you know whether he duplicated patients in studies. “No I do not.”
Polypropylene Under the Microscope
By 10:30 am Dr. Howard Jordi was sworn in to appear on the stand in the Charleston courtroom.
Jordi is a biochemist whose lab did an analysis of the explant of the Lewis TVT, a partial removal of her mesh.
Typically half of the sample goes to defense and half goes to the plaintiffs’ side for their individual analysis. The defense sample was cleaned in a 20-step process by the lab at the University of Southern Missouri. Dr. Jordi used forceps to pick the protein material off of the sample. As the mesh was rolled, particles fell off. Those were analyzed and magnified 150 times under a SEM (scanning micron microscopy). The enlarged strands of mesh were displayed on a screen before the jury. First the jury saw a side by side comparison of PVDF, another polymer plastic.
After two years the PVDF remained smooth. But a polypropylene fiber displayed signs of cracking and degrading. “Polypropylene is more susceptible to degrading” concluded Dr. Jordi. The degradation will continue indefinitely?
“Absolutely” he said, “As long as it’s implanted it will continue to degrade.”
The early studies into comparison degradation were conducted in 1998, the same year the TVT was launched.
Under cross examination, attorney David Thomas, representing Ethicon, had to discredit the science. You are critical of the way the defense lab conducted its analysis of Ms. Lewis mesh aren’t you?
“The cleaning process, I’ve never in my life have I seen that. It seems hugely excessive to me,” said Dr. Jordi. Thomas pointed out Dr. Jordi rolled his mesh, suggesting some of the particles he eventually analyzed showing huge cracking and degrading mesh may have been from the mesh handling.
“Do you have any evidence the nitric acid used in the 20-step cleaning process might have changed the polypropylene?” asked Thomas. “I do” answered Jordi. A huge pause followed as Thomas shuffled papers. “We’ll go back there,” he said.
The lab for the defense contents Dr. Jordi didn’t clean the Lewis sample well enough instead of analyzing pure polypropylene, as he said on the stand, he analyzed protein and formaldehyde protein from the unclean mesh. That is what he believed was the cracked polypropylene, accused Thomas.
“You tested the particle and didn’t test the mesh is that correct?” Yes, affirmed Dr. Jordi.
Lucrative Contracts and Mishandled Documents
The issue of spoliation was raised in the afternoon but unless you knew the background it passed with barely a wimper. Spoliation refers to the destruction or mishandling of documents by one side during the discovery process.
A lower court judge ruled last week that Johnson & Johnson “mishandled” thousands of pages of documents that might have been entered as evidence into this trial. As soon an executive was moved from one lucrative position to another inside the healthcare giant, their computer hard drive went missing along with their emails, contracts, inner office secrets that can make or break a lawsuit. This was done while a document hold for litigation purposes had been issued inside the company.
Plaintiffs’ attorneys had asked for serious sanctions, for favorable rulings to level the playing field for their clients and to send a message to the J&J as a warning to others not to destroy documents essential to litigation. See the background story here.
Judge Goodwin had said he would deal with the issue.
This afternoon on videotape former Marketing VP Laura Angelini told the ten jurors that she left the company in December 2005 and when she returned in January 2006, her computer hard drive had been wiped, lucrative contracts with consultants were gone and so were inner office emails. The jury seemed distracted. A couple of people slumped in their chairs. One twirled her hair. There were no signs of outrage so clearly outlined in plaintiffs’ pleadings to Judge Goodwin.
Angelini recalled a contract with a Dr. Ulf Ulmsten, a Swedish scientist associated with MedScan, a company in which he was a shareholder. Ulmsten had essentially created the TVT by cutting up old heavy weight small pore hernia mesh and fashioning it into a pelvic area reinforcement to be implanted in women through their vagina (transvaginally). Heavy steel trocars would be part of the device to pierce a woman’s groin area so a surgeon could thread the TVT under her urethra offering support so she no longer leaked urine.
Dr. Ulmsten had reached out to Ethicon and it was interested. His initial studies in six medical centers throughout Sweden and Finland showed the TVT device, which he called the Intervaginal Sling Plasty (IVS) was safe and effective. He hoped to strike a lucrative contract to become the exclusive supplier of the polypropylene small pore heavy weight mesh implant to J&J’s Ethicon unit.
The two struck a deal, a lucrative deal. Ethicon would launch the TVT as it was named (tension-free tape) in Europe in January 1998 and in the U.S. later that year. The deal made Professor Ulmsten a very rich man. A payment of $200,000 would be paid five days after the initial agreement was executed, another $400,000 would come in February 1997 when the clinical trials were completed. But there was a catch, the trials had to show the same positive results that Ethicon had seen in Ulmsten’s earlier published work in 1996. The trial were not due to be completed until May 1997.
In November 1999 Ethicon struck an exclusive agreement with MedScan purchasing not just the TVT but eventually its patent. Professor Ulmsten would receive $20 million and a second installment of $2,500,000. A third installment would be paid if sales of the TVT reached 140,000. It did. The professor eventually received in excess of $25 million for his innovative use of an old product. He passed away before the last payment on a $400,000 non-compete payment could be issued fully.
Again, the jurors looked bored they stretched. It was now 3:15 pm and a storm was approaching Charleston.
In marketing materials, Angelini told jurors the discussion within Ethicon was that the description dyspareunia (painful sex) would not be included because it couldn’t be measured. “It’s gonna kill us” said someone within the company if the term came out in a pamphlet or materials for surgeons eager to learn more. “Spin it more as a safety issue than a complication” said one email. When asked about the word “spin” Angelini suggested it was perhaps that English was not her native language, Italian was. Spin to her meant turn around.
Dr. Tom Margolis will take the stand Thursday. He is experienced in mesh removals and consulted with Ms. Lewis on her case.