With more than 27,000 transvaginal mesh cases consolidated in one federal court in West Virginia, the first bellwether case is now in its second week.
Donna Cisson, 55 was implanted with a Bard Avaulta Plus Posterior BioSynthetic Support System in May 2009. She has undergone several removal operations after pain incapacitated her, but doctors were never able to fully remove the plastic medical device. She and her husband Dan are suing the C.R. Bard company in this first federal product liability trial.
Transvaginal mesh is sewn into a woman’s pelvic region to keep organs in place that are falling with gravity. Before the plastic implants were developed, surgeons would sew organs into place, a procedure that was moderately successful.
There have been two other cases that have put mesh manufacturers on the hot seat. The case of Christine Scott ended in June 2012 in a jury award of $5.5 million for Scott and her husband. That case named a Bard Avaulta product, similar to the one put in Cisson. Another case involving mesh manufacturer Ethicon, a division of Johnson & Johnson, resulted in an $11.1 million award to nurse Linda Gross and her husband, both from South Dakota.
Those cases are now on appeal.
The Cisson case is the first federal one where lawsuits involving six manufacturers have been consolidated before Judge Joseph R. Goodwin to move them through the court more expeditiously. The Cisson case will be followed by three other plaintiff cases against Bard.
So far Cisson’s implanting physician, Dr. Brian Raybon, has been on the stand. He is credited with being the first doctor in the U.S. to use the Avaulta and at the time was a consultant for the company. He told jurors he would have liked to have known that the company knew that its plastic resin raw material carried a warning that it was not to be made into implantable medical devices for humans. The end user is the physician, not the patient, and it is up to the doctor to be fully informed by any medical device manufacturer.
When that doesn’t happen, there can be no true informed consent for the patient.
Lawyers who represent transvaginal mesh victims must prove the company was aware of the risks associated with the Bard mesh products, but failed to let doctors know; that Bard never studied how to remove mesh after complications and that the company was using the Marlex raw material even though it saw a warning associated with the plastic.
A product liability case requires the legal team to establish that the mesh was defective in its design, its manufacture and in its warnings.
If that can be proven, expect punitive damages in this third case against a mesh manufacturer. A few more substantial losses into the millions or more, and even a company that vows to fight each case on its merits might have to rethink its strategy and offer settlements instead.