Lewis v Ethicon: Day Four ~ When did Ethicon Know TVT Had Problems?
Its difficult to know what’s missing if you are a juror watching this trial.
Ten jurors sit in the Charleston, WV courtroom to listen to the first of 15,000 cases filed against Ethicon, a subsidiary of Johnson & Johnson over its polypropylene transvaginal mesh. In this case, Plaintiff Carolyn Lewis had a TVT (tension-free tape) implanted in 2009 to stop a problem of urine leakage, or SUI (stress urinary incontinence), usually not a painful condition, just annoying and embarrassing.
The permanent plastic medical device still pains Lewis to this day. Some of the mesh was eventually removed but the arms of the TVT remain behind, a sort of ticking time bomb if you believe plaintiff witnesses’ who say that the polypropylene (PP) takes on destructive life of its own inside the body. Today Lewis says she feels about 85 percent better.
What was Lewis promised by her doctor before agreeing to the procedure? Was she told there could be complications, astronomical medical costs and a series of surgeries? Was she told she might suffer dyspareunia (painful sex) and have a return of incontinence as well as pelvic and chronic nerve pain.
We will not know the answer to that question because one of the elements of a defective product case, as this is, is a failure to warn. Judge Joseph Goodwin had ruled pretrial that the failure to warn element is off the table. Why? Because the implanting physician, Dr. Muriel Boreham of Dallas, hadn’t read the product instructions (IFU or Instructions for Use) since 2002.
Never mind that the instructions that inform a doctor who then in turn informs her patient, haven’t changed much since then. Ethicon never contained in its IFU information that it had received hundreds if not thousands of patient complaints concerning chronic pelvic pain, mesh erosion, infection, nerve entrapment, an inability to have pain free sex, repeat surgeries and mesh removal.
Without a failure to warn case, Lewis v. Ethicon has become a highly technical defective product case with battling videotaped depositions of scientists. The level of energy from a screen replacing a live person on the stand is generally low and there were three back-to-back videotaped depositions presented to the jury throughout the morning and part of the afternoon. Some jurors paid attention, some didn’t while Judge Goodwin seemed to be resting his eyes for awhile. More on the videotapes in a moment.
The German Doctor and Scenes of a Mesh Gone Wrong
Things picked up a bit late in the afternoon with the arrival of Dr.Uwe Klinge. His deposition has been entered into evidence in this case here.
The German medical doctor works at Aauchen University where the technical aspects of hundreds of mesh explants are studied in a laboratory. The top university for biomaterials in Germany, no one else has studied and published more than he and Dr. Klosterhalfen (See yesterday’s report here).
Using histopathology to analyze tissue at the microscopic level that the eye can’t see, they have established criteria to define the good and bad responses to mesh implanted in the human body for both hernia repair, pelvic organ prolapse and SUI. Dr. Klinge told the jurors that he had viewed at least 20,000 of these slides where he saw small pore mesh amass scar tissue and inflammation around it. Nerves became entrapped as the body tried to rid itself of this foreign invader and a a result, patients are left in pain.
Dr. Klinge told jurors that polypropylene (PP) plastic is commonly used in our everyday lives, for plastic bags for example. This was not something they had heard before, nor have they heard PP is used in making plastic blinds or indoor-outdoor carpets. A few jurors took notes.
Dr. Klinge began analyzing PP mesh (the same mesh used in TVT) in 1994. Beginning in the early 90’s, what he described as “intense discussions” began within the medical community whether to continue using mesh or to just use sutures, the traditional repair.
“We felt it was necessary to learn more about mesh because we saw some complications. We said we have to learn more about this material in the hopes of reducing the amount of material and to make it safe.”
At this time, most of the PP mesh used was in hernia repair but by 1998 the same mesh would be crafted into the TVT mesh for SUI repair.
Ethicon, a division of Johnson & Johnson, had a research facility in Germany and together with local scientists/consultants, including Dr. Klinge, they developed the Vypro and UltraPro, one-third the weight with 3mm pores (macropores) three times larger than the PP mesh (brand name Prolene) that improved patient outcomes.
Questioned by attorney Ben Anderson: “When did Ethicon stop selling Prolene for hernia mesh?”
Dr K: “I remember in 2001, the old Prolene was replaced with the new version.”
Anderson: “Is there a light weight small pore mesh for SUI?”
Dr. K: “No.”
Anderson: “Do you know why Ethicon continues to sell …”Objection, said David Thomas for Ethicon.
Judge Goodwin had ruled earlier on limiting the testimony from Dr. Klinge. See here.
Anderson tried to ask, how many of your explanted meshes are hernia versus pelvic floor mesh? Again an objection from Thomas which resulted in an attorney sidebar with the judge. Those in the courtroom looked around- what was happening?
As part of his expert report for the case, Dr. Klinge presented stained slides of Ms. Lewis explant samples magnified 40 times. They showed areas like white land masses surrounded by pink which were actually scar tissue masses surrounding the plastic mesh fibers. Tissues had activated a foreign body defense mechanism in reaction to the Prolene mesh. Scars (bridging fibrosis) shrink and lead to chronic pain in patients. Nerves entrapped in scar tissue cause pain and are often the reason mesh has to be removed.
A second slide was an example of deformed mesh that had folded, something Dr. Klinge had seen in explants. “The complications from folding increase the risk of pain and erosion into adjacent organs,” he told the jurors.
The judge cautioned jurors that correlation might not mean causation.
Anderson asked, ” Do you have an opinion with a reasonable degree of medical certainty whether the images we’ve seen today are related to the pain in Ms. Lewis? “Objection” again said Thomas. “I’ll allow it,” said the judge.
Dr. Klinge started to answer blaming “overengineered mesh” but again his answer was interrupted with an “objection.”
On cross exam, David Thomas established that Dr. Klinge did not himself prepare the Ms. Lewis slides, that he’s not a pathologist, hadn’t performed surgery since 2006 and that he’s never done SUI surgery. “A ‘real pathologist’ prepared this report?” Yes, said the doctor.
“You did hernia surgery knowing the risks,” said Thomas referring to the fact that Dr. Klinge had in the past used PP for hernia repair. “You used Prolene believing the benefits exceeded the risks?”
“Yes, but I’ve changed over time significantly,” Dr. Klinge uttered.
Thomas then pointed out that in a 2010 book, Dr. Klinge said the “gold standard” for SUI repair is the sub-urethral sling using tension-free TVT tape, to point out his inconsistencies. Underneath the portion of the book he had highlighted was an unhighlighted portion in the same book that said there are fewer injuries with macroporous (large pore) mesh.
Dr. Hart is a general and cardiovorasic surgeon who was hired by Johnson & Johnson where he worked in medical affairs for Ethicon from 2005 to 2007. He began testimony via videotape for the plaintiffs’ in the morning.
Dr. Ulm Ulmsten from Sweden had initiated a new application for an old Prolene mesh, a small pore heavy weight polypropylene mesh used for hernia repair. His invention, the TVT would be used in women to shore up a sagging urethra and prevent urine leakage. In 1997 he sold his patent and the TVT product to Ethicon and was eventually paid in excess of $25 million. However, the second payment ($400,000) depended on the doctor delivering studies, which he oversaw, that had to reach certain benchmarks. On videotape the plaintiffs’ attorney asked Dr. Hart if that was a conflict of interest?
Dr. Hart admitted it would be a conflict today but back in 1998, “It wouldn’t have been a conflict ten years ago.”
“Dr. Ulmsten had $400-thousand reasons to make sure his studies met the benchmark, am I correct? said the attorney for Ms. Lewis.
“It’s a conflict and it’s unavoidable. They were not the only studies done for the TVT. It’s a conflict yes,” Dr. Hart said. When asked, he was unaware that Dr. Ulmsten owned MedScan, the company that eventually sold its TVT patent to Johnson & Johnson.
The new CEO of Johnson & Johnson, Alex Gorsky, in 2009 initiated a transparency initiative that would disallow company support for studies where the scientist had an economic stake in the product or to rely on studies with a predetermined conclusion.