Mesh News Desk correspondent Aaron Horton is sitting in this Dallas courtroom where the first state case since Linda Gross is being heard against Ethicon over its TVT-O transvaginal mesh.  Horton will take a breather and occasionally add her comments and observations. MND really appreciates her efforts! 

Aaron horton two

Aaron Horton

The 14-member jury was selected (including alternates) and seated before opening statements began at 9:50 CST, Tuesday, March 18, in the trial that pits Linda Batiste against healthcare giant Ethicon, a unit of Johnson & Johnson. 

Consisting of seven men and seven women, the racial makeup of the jury includes four African-American men, two white men, one Asian man, one Hispanic woman, two Asian women, two white women and two African-American women.  All are around 45 years old, except two who appear to be a bit older.

Linda Batiste (L.B.) is also African-American and has spent the majority of her 64 years in Dallas.

Dr. John R. McNabb

Dr. John R. McNabb

On January 12, 2011 she was implanted with an Ethicon TVT-O by Dr. John Robert McNabb at the Baylor Medical Center as a treatment for stress urinary incontinence. Originally the case was filed in state court because Dr. McNabb was named in a medical malpractice action. That was dropped because the doctor is suffering early onset Alzheimer’s disease and is reportedly unable to speak for himself.

TVT-O

The TVT-O was launched by Ethicon in 2004 as an update to the TVT (transvaginal tape).

tvt0The “O” stands for obturator approach, a new way to attach the mesh inside the pelvis as opposed to the retropubic approach.

As plaintiffs’ counsel showed time and time again using various Ethicon-generated and peer reviewed scientific papers, the TVT-O proved to be more damaging than the company’s previously released TVT. Both meshes use Prolene (polypropylene) mesh, the same material known to cause adverse events in hernia patients.  The procedure, as outlined by many scientific journals and papers appeared to be more likely to cause, specifically groin/leg pain and a higher possibility to damage the nerve closest to the obturator bone.  Nerve damage of any kind is more often than not, permanent.

While not overweight (something that the defense has in the past used against a plaintiff), Batiste has diabetes and has had multiple back surgeries to address other medical conditions.

Aaron Horton

Aaron Horton

During the trial, MND contributor Aaron Horton, had several brief exchanges with Batiste.  She has attempted with multiple surgeries to have the mesh removed, but as is common, the surgeons were not able to remove all the mesh. Today she is left with what appears to be permanent symptoms including dyspareunia (painful sex), severe chronic groin and leg pain and pelvic pain.  She walks with a cane.  

Before the attempts to remove her mesh in its entirety, she also suffered vaginal erosion, which will continue to cause pain and infection, her lawyer said.  Vaginal erosion was never included as a possible side effect/adverse event in any of J&J/Ethicon’s IFU (Instructions for Use) product insert supplied to doctors, so the patient could not receive warning about that complication.

TVT-O from beckenbodenzentrummuenster.de

TVT-O from beckenbodenzentrummuenster.de

During the opening, Richard Freese (Freese & Goss) showed slides to explain the condition of stress urinary incontinence (SUI) to the jurors.

Ethicon’s IFU

In any product liability case, it is the job of the manufacturer (in this case Ethicon) to prove the product is safe before it is offered to the market, and when warning signs present, the manufacturer has an obligation to investigate these complaints and to update the safety information in its IFU (Information for Use) pamphlet and, as is stated in J&J/Ethicon’s own credo, to put the safety of the patient before all other goals, including profits.

d9 ethicon a j & j company  200J&J/Ethicon principally updates the doctor regarding new warnings or safety issues via the IFU, and the doctor is considered the intermediary of such information, and is obligated by his/her own creed (The Hippocratic Oath) to place the safety of the patient first (“First do no harm . . .” as the beginning of the doctors’ oath states).

Ethicon employs what is known in the industry as a “passive” complaint practice, whereby patients are required to contact the company, rather than the company sending representatives out to doctors’ offices to follow up on their initial marketing reps’ sales visits with the specific task of evaluating the product’s effectiveness and/or safety, including patient complaints.

Much like any device a consumer might purchase such as a television or dishwasher, the IFU is the standard by which doctors typically operate, use or implant any device.  They read the manual.  But as is true with medical devices, the doctor, not the patient, is considered the end-user, therefore, true informed consent can only occur when a patient understands, via their doctor, all of the benefits and risks of a given device as well as the procedure used to implant such a device, the information contained in the IFU. Deficient or misleading instructions is just one element of a defective product.

The 40 Year Old Mesh Story

The mesh story starts in 1974 when Ethicon was selling its hernia mesh marketed as Prolene Mesh, made of polypropylene plastic, a petroleum-based product. Used in traditional abdominal surgeries as well as the less-invasive laparoscopic surgery for hernia repair, Ethicon reportedly began receiving reports of complications from hernia patients as early as 1974, the year the product was introduced. The company soon learned from its own doctors and engineers as well as implanting doctors and patients that the mesh was too heavy and had pores that were too small, thus, according to Ethicon’s internal communications, creating most of the complications from the hernia mesh as well as the same mesh formulation, now newly used for repair of SUI.

Complaints were vast and varied including reports that the mesh had shrunk, causing painful tension in the body, erosion into organs including the vagina and other surrounding organs.  The company sought a redesign of the heavy hernia mesh while still selling the older 1974 version through Gynecare, the Woman’s Division of Ethicon.

The idea was originated by Swedish inventor Ulf Ulmsten. He was taking Prolene mesh and cutting it into strips to be used as a mesh sling to treat incontinence. Eventually Ethicon paid Ulmsten millions of dollars to deliver a series of studies showing the success of the repurposed mesh. The inventor was paid in excess of $25 million when he delivered the patent for the TVT (transvaginal tape) to Ethicon which began marketing TVT in Europe in 1997 and in the U.S. in 1998.

Mr. Freese took the TVT-O out of its package and showed it to the jury. With two steel needles attached at each end called trocars used for placement, it resembles a long strip of coarse white screen.

Heavy Mesh

Showing a diagram of Prolene mesh, Freese told jurors Prolene was design to treat hernias, not for placement in a woman’s body; it is cut by machines leaving sharp edges; it curls, ropes and frays; it loses particles as it degrades. The result is the body reacts to the mesh causing FBR (foreign body response) causing the mesh to become stiff, form a dense scar plate and as the scar grows, abdominal wall restriction (shrinks) and a state of chronic inflammation.

Using a basketball net as an example, Freese then demonstrated to jurors how the large pores collapse under tension as well.

Prolene mesh

Prolene mesh

Prolene Mesh 

The afternoon’s testimony showed that Ethicon was aware via internal documents from its own scientists, engineers and Directors of Global Medicine that these risks persisted and the company was failing to make that known to patients via doctors.  At the same time it was marketing Vypro Mesh, a polypropylene mesh 70 percent lighter than Prolene for hernia repair, the TVT mesh implants, were being manufactured and sold to women under the TVT/Prolene brand name, comprised of the very same material the company knew was causing problems in hernia mesh patients.

Prolene Soft and Ultra Pro were also developed at that time, but the original hernia mesh continued to be used in the TVT and TVT-O products for repair of SUI.

In a videotaped deposition, Dr. Jorg Holste, Ethicon’s global medical director agreed nobody would bring a heavyweight mesh to market today.

Judge Ken Molberg appeared to be listening intently to the proceedings, while one older female juror appeared to be resting her eyes.

A deposition from Ethicon’s David Robinson confirmed the company failed to do any long-term studies on its mesh.  In 1992, a ten-year-study on dogs was stopped at five years because the Prolene was shown to continually degrade in the body as more time passed. The men in the jury seemed much more interested in this study than the women.

Inadequate IFU

Freese showed jurors the IFU was inadequate indicating any leg pain can be managed with mild analgesics and that the pain is transitory.  Missing from the IFU was degradation, shrinkage, chronic foreign body reaction, inflammation, dyspareunia, groin pain, difficult moving, difficulty removing all of the mesh, particle loss, the severity and most importantly, the duration of complications and the development of local sarcomas found in rat studies.

The burden on the plaintiff’s lawyers will be to show with the preponderance of the evidence that there is an association between L.B.’s device and her complications, not necessarily that there is a causation between the device and complications.

Dr. Peggy Pence, from Linda Gross trial

Dr. Peggy Pence, from Linda Gross trial

Testing Medical Devices

During the afternoon Dr. Peggy Pence appeared on the stand. She was an expert at the Linda Gross trial in New Jersey last year. A toxicologist and pharmacologist, Pence was involved in clinical trials for the development of new drugs and medical devices for many manufacturers as a consultant.

As far as complaints which began coming into the company – pelvic pain, groin pain, shrinkage, contraction, scarring and the worsening (not the curing) of incontinence, Ethicon took a “passive” approach to those complaints said Dr. Pence, even though the company understood chronic pain was associated with the TVT-O as far back as 2004.

Typically animal tests are followed by clinical trials on humans performed in phases to determine whether or not a product is safe enough to be marketed.  In the case of TVT-O however, that Ethicon did not do studies, but instead relied on the inventor of the product, Dr Jean deLeval, a doctor from France, who did the original development and study on the TVT-O. See study here.

Ethicon POV

Attorneys for Ethicon declared to the jurors that TVT-O is safe and effective and has helped millions of women.  Of all of the treatments for SUI, the TVT is the least invasive and it is the muscles that hold the mesh in place jurors were told by defense attorneys  David Noteward and Kay Demming.

The defense claims that Ms. Batiste’s nine abdominal surgeries and back surgeries could have caused her pain and that diabetes is a complicating condition.

Before you make a “snap” judgment make sure you listen to “the rest of the story” Demming said quoting the beloved, late radio personality, Paul Harvey.

Dr. Tom Margolis, female pelvic surgeon

Dr. Tom Margolis, female pelvic surgeon

Wednesday

Dr. Tom Margolis, a female pelvic reconstruction surgeon from San Francisco, is expected to take the stand as an expert witness on behalf of Ms. Batiste. Wednesday she will tell her story to jurors.