Saying this was the first mistrial he had declared in his 20 years on the bench, U.S. District Judge Joseph R. Goodwin ended a product liability trial naming C.R. Bard after a witness for the plaintiffs made a statement that could not be undone.
Dr. Lennox Hoyte, a female pelvic medicine professor at the University of South Florida, told the jury of 8 (5 women, 3 men) that no one used the Avaulta Plus transvaginal mesh any more and that it had been taken off the market and was no longer sold.
Dr. Hoyte was testifying on behalf of Donna Cisson, 55, of Toccoa, Georgia who had the mesh implanted in 2009 as a treatment for a rectocele, or a bulge of her rectum through the vagina. Her implanting physician, Dr. Brian Raybon, worked as a consultant to mesh maker Bard and believed the mesh was tested, safe and effective.
When the second witness, Dr. Hoyte told the jury the mesh was off the market, he opened the door to an explanation about the FDA that Judge Goodwin had decided should stay out of this trial.
In January 2012, the Food and Drug Administration knew it had a problem.
There was a five-fold increase in complaints to the agency about transvaginal and incontinence mesh complications, some devastating and debilitating including pain, erosion, infection, nerve damage, mesh migration, etc. Knowing it had to do something, the FDA ordered 33 manufacturers of urogynecologic surgical mesh for POP; and seven manufacturers of single-incision mini-slings for SUI, to study their products and how they were faring in the approximately 100,000 women implanted with synthetic mesh every year. One would think testing before selling would be preferable but that is not what the FDA requires. The three-year post-approval monitoring studies would track the women for complications and outcomes.
Instead of conducting the tests, both Johnson & Johnson’s Ethicon unit and C.R. Bard decided to remove their most controversial meshes from the market, that is, those meshes delivered to doctors pre-cut in kits along with steel trocars or implanting tools.
In a huge concession to industry, the FDA did not then require them to conduct those studies – studies which most close to these cases say would only prove the mesh was defective and should never have been put on the market. Bard and Ethicon had profited but now their feet would not be held to the fire. The FDA tends to work with industry whenever it can, and industry is fully aware that it is often in the driver’s seat when it comes to the agency.
What does this have to do with a mistrial?
The attorney for Bard argued before Judge Goodwin that she could not possibly explain that the Bard mesh had been removed from the market for “financial reasons” without telling jurors about the FDA’s requirement for three-years of testing.
Knowing that Bard would file an appeal and knowing that he couldn’t tell jurors to just ignore the bomb that had been dropped in the courtroom, he declared a mistrial.
The Donna Cisson trial has been rescheduled for July 29, 2013, followed by three back-to-back cases against C.R. Bard over its Avaulta meshes. These are the first federal cases to be heard.
So far the news has not been good for mesh manufacturers in state court. In the two transvaginal mesh trials, the one that named Bard mesh ended in a $5.5 million verdict in favor of the mesh-injured woman in California. Another trial in New Jersey ended in an $11.1 million verdict in favor of an injured nurse from South Dakota.
A few more defeats like that and the rest of the nearly 27,000 cases filed in this one West Virginia court may be made to go away with a substantial settlement offered by one or several of the six companies facing trials in Charleston. Stay tuned!