On Thursday, February 26, Perry v. Ethicon went to the jury. After a five-week trial, jurors will decide if the Abbrevo mini-sling, used to treat incontinence was defectively designed and whether the instructions to doctors were adequate. That same day, attorneys for Ms. Perry asked for $17.2 million in their closing arguments, an attorney representing Ethicon, a division of Johnson & Johnson, presented his closing remarks to the jury gathered in a Bakersfield, California courtroom.
Thanks to Courtroom View Network to access to a live feed during this trial. The conditions imposed by the court are that the Mesh News not quote directly or show any images from the trial.
Ethicon attorney William Gage (of Butler Snow, same law firm as Christy Jones), is animated and incredulous – how can the jury not see through what the plaintiffs have presented in Perry v. Ethicon?
He proceeded for two hours to outline what he says are holes in the plaintiffs’ product liability case – their accusations about the degradation of the Prolene mesh used to make the Abbrevo, for example. We showed you the sutures goes back to 1969, said Mr. Gage, comparing a single strand of suture to a woven mesh implant made up of many strands. He told the jurors he is still trying to understand how it is safe for a suture and not the Abbrevo?
In chronological order, the TVT (transvaginal tape) came out in 1998, the TVT-O (transvaginal tape obturator) was launched in 2003-2004; then came the TVT Abbrevo, all made with the same ingredient – Prolene. The TVT revolutionized surgery, he said. Before this was out, there was nothing to treat the condition of prolapse. Since 1998 there have been more than 1,000 studies of TVT, over 100 randomized clinical trials (RTC) since 1998. TVT-O was cleared by the FDA in 2003 and there have been over 60 RCT on the TVT-O, Gage told the jurors. Abbrevo, made of Prolene, was cleared by the FDA in 2010, and it was found it to be as safe and effective as the TVT-O. Mr. Gage said he’s having trouble understanding the theory that Prolene degrades. It cannot co-exist with the long successful history of Prolene as they’ve laid it out.
Dr. Grier has been a practicing surgery for 30 years and he relies on Prolene sutures, said Mr. Gage. If they degrade, patients will die! It doesn’t degrade, said Mr. Gage. He said we saw things at the molecular level; they said it’s got to be degrading. If it degrades, there should have been wheelbarrows of evidence to show it degrades! They didn’t do it because it doesn’t degrade, he says. Was there any evidence the material was degrading? Was it degrading where you can measure molecules coming off it? No, it’s not there, he said. They have the burden to show you how it degrades. They have Ms. Perry’s mesh and they didn’t analyze it. Dr. Scott Guelcher is professor of polymer science they brought him here. He didn’t do it.
When I heard this I almost fell out of my chair, said Mr. Gage referring to Dr. Guelcher saying he had no evidence of degradation in Ms. Perry’s mesh. Dr. Margolis had testified the mesh was under the skin and he never saw it. Mr. Gage referred repeatedly to Dr. Margolis as “Plan B,” in other words, he was there to deliver the goods that Dr. Gulelcher could not. The tissue reaction causes the mesh to shrink, said Dr. Margolis. There is no wording of mesh degradation in her medical report, Mr. Gage told jurors.
Why did the word “lightweight” mesh disappear from the Ethicon product description on the website during this trial? (much of the trial has focused on light v. heavyweight mesh) A corporate representative said a website revamp had been underway for two months, explaining it away. It is what it is, said Mr. Gage.
We talked a lot about pore size. Is there anything about our mesh that they accept? Nothing, he said. It’s too heavy, it degrades, nothing! TVT has the largest pore size. Folks, there is no evidence, we are the largest pore size, said Mr. Gage referring to Prolene. In 2010, Dr. Klinge said the gold standard is the mid-urethral vaginal sling, the TVT. The whole purpose of lighter weight larger pore mesh is to eliminate erosion and there is a .4 percent erosion rate with Abbrevo. Laser cut mesh the surgeons overwhelmingly preferred, said Mr. Gage, contrary to what was presented in court. In the real world, laser and mechanical cut are identical, he said. Details matter. Gage is apparently agitated now. He admits TVT Secur is not on the market. The Abbrevo is within the standard of care, he says.
Blame the Victim
Ms. Perry had cryoablation in 2010 because of painful periods. She had stress urinary incontinence. Her doctor, Dr. Luu didn’t even do the burch procedures. March 23 she has four vaginal surgeries for anterior colporrhaphy, to treat a cystocele, she got an Abbrevo and had a posterior colporrhapy. The known complications of those three surgeries carry those risks.
While in San Francisco visiting with Dr. M. Tom Margolis, Ms. Perry picks up the phone to Dr. Allen telling him she forgot to mention she was having pain with intercourse. You gotta be with me, she’s in San Francisco, she picks up the phone to see Dr. Allen who she saw four days earlier, said Mr. Gage exasparated. She said she forgot to tell him she was having pain with intercourse. She forgot to tell the pain specialist she is having pain with sex. In October 2014 penile abrasion was reported by her and her husband. Dr. Allen found no exposed mesh, neither did Dr. Margolis or Dr. Flynn. You have to have exposed mesh to have an abrasion, Mr. Gage says.
Ms. Perry saw a TV ad on mesh litigation and that’s what got things going, according to the defense. After that she went to Kauai, the big island, she is zip lining, hiking and snorkeling. After trips to Las Vegas, Grand Canyon, Sedona and San Diego. After her pelvic surgery Ms. Perry writes her energy levels are through the roof and the pain is gone and she’s been walking 4.5 miles a day, sleeping through the night and life is good, she wrote, said Mr. Gage. What comes after that? A lawsuit, he said.
After her car accident in Las Vegas she has as team of lawyers dealing with that, he says. Is her mesh about to erode in the future, Mr. Gage asked. Dr. Margolis told you only 5 percent of his patients need more surgery after a mesh erosion. He told you there were an unknown number of surgeries ahead. Does it cost $4,000 or $65,000 to have a surgery, asked Gage highlighting the difference estimates between Dr. Allen and Dr. Margolis. She signed an informed consent by Dr. Luu, she was specifically warned synthetic mesh may cause erosion. She was warned of the need of additional surgery, of pain, of scar tissue or poor healing. Dr. Luu knew this and warned her of this. She signed it. The informed consent warns of everything that happened to her, said Mr. Gage.
The case has shown the mesh is heavyweight, small pore, subject to degradation and shrinkage. When Dr. Luu was a defendant, he sat on the stand and said if he had known he would not have implanted the mesh in her. Dr. Luu is no longer a defendant in this case, said Mr. Gage.
If we can’t rely on the ink on the document, our institutions will fail, warned Mr. Gage referring to a signed informed consent agreement.
Mr. Gage appears tightly wound on this day. He recounts 27 days in court, 12 live witnesses who never brought you evidence on why Abbrevo, when compared to other pelvic mesh, is bad, he recounted. You’ve got to get through informed consent, the smoking (Ms. Perry), the erosion. When it comes to erosion, they had to bring in Dr. Margolis when there was a hole in the testimony. Ten-thousand dollars a day. Even Ms. Perry and Dr. Luu can’t see eye-to-eye whether they had a risk consultation. You’ve got to get through all of that, he says, to reach a conclusion for the plaintiffs. And on punitive damages, you’ve got to be kidding, you’ve got to be kidding, repeats Mr. Gage. Like lady justice with the blindfold on, you have to put the blindfold on, you have to weigh the evidence in the courtroom, not outside the courtroom.
Then there is a break and a rebuttal by Richard Freese who is also incredulous.
Thank you for being here said Mr. Freese. The good news is I’m the last person you will hear from in this trial. He first shows an exhibit and highlights the first document. A credo from the Johnson & Johnson. Every employee of J&J is commanded to abiding to this credo.
The first sentence, ‘We believe our first responsibility is to doctors, nurses and patients who use our services.’ Please keep that sentence in mind, says Mr. Freese. Remember Dr. Luu said he did not know it was heavyweight mesh and it was stiff mesh and there was an alternative. I did not know it degraded. If you had known those facts would you use the product? He said no. That evidence is uncontradicted.
Once it is put in a woman it cannot be removed. If it goes wrong it cannot be removed. The industry did not tell doctors how to get it out. Nobody told you they ever had any training on how to get the product out. If J&J had provided that information we would not be having this case now, said Mr. Freese. She made the assumption that a reasonable manufacturer could be relied on, that her doctor could be relied on. I recognize they have experts and we have experts. Freese said Dr. Rosenzweig is not on an island, he was picked by Ethicon to go to Sweden and train with Dr. Ulmsten; he was part of their team. (countering what Mr. Gage had said that Dr. Rosenzweig was on an island somewhere in his singular opinion).
They did not find a single doctor outside of their payroll to come here and defend the product, they bring in their paid consultants. They did laser cut mesh because it was cheaper and faster. They did not have a single witness tell you laser cut mesh was safe because, said Mr. Freese, it isn’t. Why aren’t the Ethicon engineers here to tell you it’s safer? As to Dr. Flynn, half of his patients are men and he doesn’t even use Abbrevo. You realize Dr. Flynn is the only doctor in the case who blames her obesity, smoking and her calorie restricted diet had something to do with her wound healing.
For Ms. Perry, her life has been on display. She’s had to be in this courtroom to listen to the most personal details of her life. While she was here every day at trial, not one person from Ethicon sat and watched this trial, said Mr. Freese. Instead they go after her personally. Patients are first unless you make us defend the safety of our product, he said referring to the J&J creed. In that case we will attack you and go into your medical records back in time and see whether we can pick out something to pick on you, said Mr. Freese. She must be making it up, he said, and what does that have to do with whether something is negligently designed, he asked. Nothing.
Pain and suffering noneconomic damages
Lawyers have struggled forever – how do you explain noneconomic damages to jurors. How do you put a dollar value on something you can’t see, he asked. On punitive damages, Mr. Gage said ‘Are you kidding me?’ He asked you to ignore the judges directions which are you must look at their financial condition if you decide to award punitive damages ($70 billion a year). The judge has said punitive damages are intended to discourage this kind of behavior, said Mr. Freese. (Mr. Freese is not allowed to mention the number of punitive damages because the defendant did not in its closing.) Mr. Freese said remember this is a company that did not do a single test on laser-cut TVT Abbrevo. They lied to the FDA and didn’t listen to their own scientists, said Mr. Freese.
If it’s the gold standard to ignore your scientists, and the real world of women’s bodies, don’t tell your sales reps and the FDA the full story; don’t tell doctors the full story. You cannot take a piece of plastic mesh and put it in a woman’s pelvis, you’ can’t do that, he said. If you believe they didn’t put Ms. Perry first, make them pay for that mistake. Thank you very much, Mr. Freese concluded. #