Ethicon Abbrevo Trial Set for May After Courtroom Wrangling

Jane Akre
|
March 14, 2022

Ethicon Abbrevo Pelvic Mesh Trial Set for May After Courtroom Wrangling Pits Doctor Against Company


After at least three different trial dates and wrangling over a controversial expert report, the product liability defective product trial of J.S. is set for a Dallas County courtroom on May 24, 2022.

J.S. (she doesn’t want her full name used) was implanted with Ethicon’s (Johnson & Johnson) Abbrevo pelvic mesh in 2019 to treat stress urinary incontinence (SUI). Soon afterward, she developed post-operative leg and perineal pain. J.S. had a partial removal from her Ob-Gyn and another doctor, a urologist. Her pain persisted. 

Dr. Dionysios Veronikis, Mesh-removal expert


In July 2019, she traveled to St. Louis, Missouri, to have the embedded arms of the Abbrevo removed by mesh removal expert Dr. Dionysios Veronikis. 


She continues to suffer from chronic pain and nerve injury.

She sued not just mesh-maker Ethicon but, in an unusual move, also accused her implanting doctor, Dr. Charmaine Oladell, M.D., of medical negligence.


The latest hitch was a supplemental expert report by an Ethicon consultant that was supposed to soften the liability for the defendants by claiming the doctor used the standard of care, was not negligent, and the plaintiff’s injuries were due to a pre-existing condition. Instead, the report does the exact opposite.


Dr. Charmaine Oladell, implanting physician

Dr. Oladell wants it in; Ethicon wants it out, and it's clear why.

What Delayed the Trial?


The latest delay resulted from an effort by Ethicon to have Dr. Oladell’s expert report stricken. 


The supplemental expert report was created by a consultant and Ethicon “preceptor” Dr. Michael England, a Fort Worth, Texas physician board-certified in Female Pelvic Medicine and Reconstructive Surgery.   

Dr. England claims new evidence brought to his attention among multidistrict  (MDL) documents caused him to change his pro-Ethicon stance. He realized J&J would be trying to blame Dr. Oladell for the injuries. Dr. Oladell, for her part, claims it wasn't until the filing of Ethicon’s Motion to Dismiss that she became aware of the company’s assertions against her.


In early March, Ethicon filed a motion to have the England supplement report stricken from the trial, or alternatively, sought a  four to six-month continuance. In opposition, Dr. Oladell wanted the report included.  

One would presume a preceptor would testify that Dr. Oladell met the applicable standard of care and that she was not negligent; no act or omission on her part was the proximate cause of injury to J.S.; and that the injuries were due to factors out of the control of Dr. Oladell, for example, pre-existing conditions.
 

But Dr. England went well beyond the company line. Instead, the supplemental expert report is Ethicon’s worst nightmare.

It states:


  •  “It is also clear that in every instance Ethicon, via their representatives or witnesses, has blamed the surgeon for any complications that were serious and/or required removal. This is considerably alarming after their conveyance to the public that their product was easy to place and that the surgery was relatively simple, especially when using the tools provided.” 

  • “It's clear that patients who have giant cell reaction (foreign body reactions) over time are likely to have chronic pain/continued problems which require removal of mesh.”

  • “For 10 years I removed four mesh implants per week. Ethicon knew that the removals were occurring across the country for years; many of their experts discuss the same. There were in-house communications advising that this is not transient – it is chronic! Their own executive advised to “keep this concept elusive.”  “

  • “Ethicon had multiple reports of the PPM being explanted due to chronic pain from cell reaction, migration, erosion to the bladder/urethra/ureter/bowel and extrusion to the vagina. Ethicon continues to use the same mesh although other lightweight, large pore, non-prolene, safer products or procedures have been developed.”

  • “Two hundred studies show that Ethicon’s prolene TVT mesh comprised the highest percentage of explants because of the body’s reaction to mesh. This has nothing to do with physician placement.”

Dr. England adds that the IFU (Instructions for  Use) insert accompanying all mesh products should tell doctors that at least 20 to 30 percent of pelvic mesh are removed. Although surgeons from around the country have been removing mesh, none of these procedures are reported as failures, so the actual failure rate is likely highly underreported. 


Stricken from Trial


In early March, Ethicon filed a motion to have the England supplement report stricken from the trial, or alternatively, sought a  four to six-month continuance. In opposition, Dr. Oladell wanted the report included.  


On March 7, Dallas County Judge Paula Rosales denied Ethicon’s motion and set the trial date for Dallas County Court C, May 24, 2022. See Docket No. CC-19-05461D. 


J.S. is represented by the plaintiff firm is Ben Martin of Martin Baughman of Dallas, TX. 

TVT Abbrevo

TVT Abbrevo is a shortened 12 cm polypropylene transobturator mid-urethral sling using less mesh through the thigh muscles when compared to a full-length sling.  

Still, on the market, Abbrevo was the pelvic mesh that was the focus of the Coleen Perry trial in Bakersfield, California, in 2015. Perry claimed Abbrevo led to her permanent injuries. 

Eventually, the jury agreed and awarded her $700,000 in compensatory damages and $5 million in punitive damages. Jurors found that Abbrevo was defective in its design and instructions to doctors, the end-users.

This case is unusual because of the two defendants- Ethicon, a subsidiary of Johnson & Johnson that makes the Abbrevo pelvic mesh, and the doctor who implanted it, Dr. Charmaine Oladell.

Doctors were not charged with medical negligence in the past three dozen pelvic mesh trials in the past three dozen pelvic mesh trials. Instead, plaintiffs’ attorneys had doctors testify they knew nothing of the potential for long-lasting complications of pelvic mesh. If the company did not inform doctors about adverse events, that bolstered the claim for a failure to warn (the doctor). 

With the passage of time and media coverage, raising awareness about the dangers of pelvic and hernia mesh, expect to see more implanting physicians charged with medical negligence in these closely watched product liability trials. 

 

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Learn More:
MND, January 11, 2022, Ethicon Abbrevo Trial Set in Dallas for February

Snowden v Ethicon, J&J and Charmaine Oladell, M.D. Petition, filed 8-30-2019

MND, Ethicon Abbrevo - A TVT Family Member, January 2015
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