Perry v. Ethicon: Sales Rep, Doc in the Dark about Pelvic Mesh Dangers
Thanks to Courtroom View Network for allowing Mesh News Desk (MND) to observe the proceedings. No quotations or images may be replicated by MND.
Day four of the Perry v. Ethicon pelvic mesh trial in Bakersfield, California saw a leading sales representative for Ethicon on the stand to testify how he encouraged doctors to use the Abbrevo sling, a member of the TVT family of pelvic meshes.
Ricky Chahal, was the salesman who encouraged Dr. Hung Luu to switch from his Boston Scientific Obtryx incontinence mesh treatment to the Abbrevo, the newest in the line of TVT (transvaginal tape) products from Ethicon, a division of Johnson & Johnson. Chahal joined the company in April 2010 and soon rose to the top ranks within the sales division before he left two years later.
Under questioning by plaintiffs’ attorney Peter de la Cerda, Chahal told jurors in this product liability trial that he spent about 90 percent of his time in the operating room with the doctors instructing them on the procedure as he had been trained by Ethicon in cadaver labs.
Mr. Chahal is not a doctor and had no medical training outside of his orientation as a salesman for the company. (See background story on sales reps in operating rooms here.)
In fact, the sales rep was able to take doctors out to dinner to convince them to convert to Abbrevo, as long as there was an ‘educational component’ to the meeting.
Dr. Luu didn’t need much training inside or outside the operating room. That’s because he had been extensively trained as a surgeon with training at Tulane University and a residency in Los Angeles and New York City when Tulane, in New Orleans, was hit by Hurricane Katrina.
The J&J Credo was introduced to the jurors by the plaintiffs. It basically says the company’s first responsibility is to doctors and nurses and to patients, mothers and fathers. Chahal was schooled in the credo. He knew it by heart. It included all of the risks and benefits, he was assured.
But when questioned further about the risks of the Abbrevo, Chahal came up short. The additional risks of erosions and the need for multiple explant surgeries; the rigidity of the laser cut mesh; permanent life-altering vaginal pain; dyspareunia; inflammation and scarring – none of those warnings appeared in the Instructions for Use (IFU).
The salesman was told he could not deviate from the IFU in his training of doctors.
What the IFU did say was that the Abbrevo was contraindicated for women who are smokers, were obese or likely to become pregnant.
As part of his training, in a demonstration by Ethicon, the TVT-O and Abbrevo would be stretched or pulled. With the Abbrevo (laser cut mesh) the sides didn’t fray like the TVT-O (machine cut). Chahal was told that was a real advantage.
He told Dr. Luu the Abbrevo was light weight. The sales rep was never told the Prolene mesh in the Abbrevo was actually a heavy weight. He had learned independently lighter mesh such as Prolift +M was an improvement, but whatever he learned outside of Abbrevo training, he was forbidden from sharing. Chahal also was taught Prolene is inert and nonreactive in the body and does not degrade.
He told Peter de la Cerda he was not aware of those other material facts.
At the end of the day his job was sales. To generate revenue for the company.
For the defense, attorney Kim Schmid established that Ricky Chahal provided Dr. Luu with information that was “fair and balanced” information on the Abbrevo providing all risks and benefits. [Why the Fox Television/News Corp. slogan is introduced in this trial is unknown].
She also established that Ethicon has a medical affairs team of doctors who are there to answer any questions doctors might have.
Dr. Hung Luu
On Wednesday, implanting physician Dr. Hung Luu, an ob/gyn from Bakersfield testified on the stand for the plaintiffs. Increasingly, doctors who implant transvaginal mesh are being accused of medical malpractice and Coleen and Patrick Perry have done just that.
But on the stand, Dr. Luu exhibited he had been extensively trained in gynecology but he showed a lack of knowledge about the product. Under questioning by Richard Freese (Freese and Goss) it was established that he would not have prescribed the Abbrevo for Ms. Perry if he had been told it was heavy weight and small pore Prolene mesh.
He would not have used Abbrevo if he had been aware it degraded.
Dr. Bruce Rosenzweig
Following the testimony of Mr Chahal, the plaintiffs called their next witness. Dr. Bruce Rosenzweig has been an expert medical witness in other pelvic mesh trials (Huskey, Tyree). Questioned by attorney Thomas Cartmell, it was established the urogynecologist from Rush University in Chicago, did a fellowship at UCLA and has had advanced training in pelvic surgery. Currently in his own practice in chicago he operates up to two days a week and sees patients the other two.
For stress urinary incontinence (SUI)and pelvic organ prolapse treatments, he chooses nonsurgical options including the burch procedure. He also performs mesh excisions (removals), a small portion at first if it is merited.
Dr. Rosenzweig says he has so far done about 300 revision surgeries and has treated about 2,000 patients for SUI.
In 2003 he started using synthetic slings as an operation for women who have very bad stress urinary incontinence, something he indicated was a last resort. Dr. Rosenzweig had come to the attention of Ethicon and was flown to Belgium to train with the inventor of the TVT-O (transvaginal tape obturator), Dr. Jean de Leval.
While he used synthetic polypropylene mesh for a few years, the doctor said he stopped their use in 2006 or 2007, the same year he began treating women with pelvic mesh complications.
His treatment of choice for women include nonsurgical and surgical options, nerve blocks and physical therapy. The majority of patients he treats, about three-quarters, are for mid-urethral polypropylene sling complications, slings like the Abbrevo. #
The afternoon session continued, this story is in production.
JNJ CREDO HERE
WHEN SALES REPS ARE IN THE OPERATING ROOM, Washington Post, April 2013