Dr. Christina Pramudji, female urologist, Houston
This Day 7 of the Huskey v. Ethicon trial was a defense case with glowing reviews of the synthetic mid urethral sling.
Mrs. Huskey was implanted with a TVT-O made by Ethicon (J&J) in February 2011. The defense is wrapping up its version of events after the plaintiffs case which began last week. The plaintiff must prove, by the preponderance of the evidence, that the TVT-O family of polypropylene meshes is defective in its design, its manufacture and its instructions for use. The burden of pr0of falls on the plaintiff.
Before the case goes to the jury, expected this week, both sides will have another chance to speak to the jury in closing arguments.
This coverage is provided in conjunction with We Are Mesh Survivors, a coalition of synthetic vaginal mesh implant survivors united to demand justice for those who have suffered and to demand that existing products be pulled from the market until their safety can be demonstrated.
The first witness for the defense today was Dr. Elizabeth Mueller from Loyola, Illinois. Portions of her deposition were read by a different woman on the stand. See Dr. Mueller's Expert Report here. .
Dr. Mueller had examined Jo Huskey. She was referred by Dr. Gretchen Byrkit, who had implanted a TVT-O (transvaginal tape obturator) made by Ethicon in Mrs. Huskey in February 2011. After several months, Mrs. Huskey had pain and was referred to two doctors, both of whom perform partial mesh removals.
She was then referred to Dr. Elizabeth Mueller in May of 2013. Many women spent time invested in seeking out multiple doctors to find a remedy to their pain following a pelvic mesh implant.
Dave Thomas, an attorney for J&J, interjected Mrs. Huskey’s other problems.
“Would it be important for you to know she had been diagnosed with diverticulitis?” Important to know she had a forceps delivery? “Not this time, Dr. Mueller answered in her deposition.
Dr. Mueller had done an ultrasound on Mrs Huskey looking for her TVT-O mesh that remained. “Mesh is easily identified on ultrasound and I didn’t see it," said Dr. Mueller.
Ed Wallace, attorney for Jo Huskey
On Cross exam, Huskey’s attorney Ed Wallace (Wexler Wallace) asked “Could the remaining mesh continue to cause pain in a women? “Yes."
Was Mrs. Huskey being treated for nerve damage? “Yes. She was taking medications that are used for nerve damage, I believe Tramadol …”
Christina Pramudji, MD
Defense witnesses- Christina Pramudji MD- a Houston urologist, submitted her expert report for the defense and appeared on the stand this afternoon.
She is a board certified urologist with a sub-specialty board certification in Pelvic Floor Medicine and Reconstructive Surgery. She performed a recent physical exam on Mrs. Huskey to supplement her expert report, dated March 21, 2014. Dr. Pramudji says she's done over 900 sling procedures.
She believes SUI can be related with lifestyle changes and surgery and that the polypropylene slings, TVT and TVT-O have a better outcome than a burch (suture) or native tissue slings.
“Polypropylene mesh has been used for decades. TVT and TVT-O are safe and effective surgical options for the treatment of SUI in women like Mrs. Huskey," she said on the stand.
The urologist calls them the Gold Standard in her 49-page expert report and points to respected medical societies as echoing her beliefs such as the American Urogynecolgic Association, Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction, and the International Continence Society.
She says more than three million midurethral slings ( TVT, TVT-O) have been placed worldwide and they are used by 95 percent of the members of AUGS. See the afternoon story to continue the testimony of Dr. Pramudji.