Check Out Our New Forum!
The Your Turn Forum provides a space where people can post questions about mesh and medical device related issues and get advice and support from the Mesh News Desk community.
Join the Discussion!
The pelvic mesh death case of Budke v. Ethicon continued Monday in a Camden Co. Missouri courtroom with the defense granted its motion to deny punitive damages to the plaintiffs.
Last Friday, attorneys for Johnson & Johnson, the parent company of Ethicon, requested that punitive damages be denied and the case be thrown out in a directed verdict in favor of J&J. Defense claimed attorneys for the Budke family did not make their defective product case.
The directed verdict motion was denied, but punitive damages will not be allowed.
Joan Budke was implanted with a Prolift pelvic mesh to treat incontinence in April 2008. A series of infections originating in the pelvis had traveled to lodge in her lung, according to the plaintiffs' theory. Budke died of a septic emboli and pneumonia in August 2009.
The only previous pelvic mesh trial involving a Prolift mesh, the Linda Gross case in Atlantic City, New Jersey nearly two years ago, saw a jury award of $7.76 million in punitive damages of a total $11.1 million jury award. Punitive damages are intended to send a message to a corporation that its misdeeds will not be tolerated. In a civil action where corporate executives are not imprisoned for wrongdoing, punitive damages are one way to send a clear and convincing message to a $70 billion a year company such as J&J.
DEFENSE CASE USES SAME EXPERT AS LINDA GROSS CASE
Dr. Elizabeth Kavaler, from Linda Gross case
The Budke v. Ethicon case in may ways echoes the Linda Gross case. On Friday, Piet Hinoul appeared on the stand. Dr. Elizabeth Kavaler from the Gross case appeared this week, Your editor is not in the courtroom any longer but is receiving reports from court watchers! THANK YOU COURT WATCHERS.
Dr. Kavaler might be familiar. The Manhattan-based urogynecologist examined Linda Gross for the defense in the Gross v Ethicon trial in New Jersey Superior Court which concluded February 2013 with an $11.1 verdict in favor of the plaintiffs.
Elizabeth Kavaler, is appearing in this Camden Co Missouri courtroom on behalf of Ethicon.
Here are excerpts from the last time Dr. Kavaler appeared for the defense. This is from the Linda Gross trial not the Budke v. Ethicon case. Both women had the Prolift implanted.
DEFENSE CASE BUDKE V. ETHICON
The New York City-based doctor practices medicine at Lenox Hill Hospital and Cornell Medical School where she also teaches. About 80% of her patients are women who have problems with prolapse, incontinence, infections and pain. She told the jury in the Gross case she's treated all kinds of patients with pelvic floor dysfunction.
See Background here:
And here:
Dr. Kavaler told jurors in that case that the cause of Ms. Gross’ pelvic pain was due to the number of pelvic surgeries she endured after the Prolift implant was used to treat prolapse in 2006. Eventually she had many pelvic surgeries in an attempt to remove the Prolift after pelvic pain became intense and unrelenting.
Dr. Kavaler, indicating that in the Gross case, the Prolift had corrected the problem it was intended to treat.
“That spasm pain is what really has created the issues going forward. Her body didn’t get a chance to heal from those spasms and she had operations and they continued to cause trauma and the spasms were kicked up. The Prolift was not the source! It’s the pelvic floor surgery. If she had time to heal I don’t think she’d be in the position she’s in,” said the doctor, negating the entire defective product case of Linda Gross before the jurors.
But a muscle spasm is painful and difficult to isolate because it’s so deep inside, she said. Similar to a back spasm, this pelvic floor dysfunction can cause difficulty urinating, defecating and pain with sexual activity. What causes it, asked Jones. Stress could be a factor, so could surgical trauma.
FROM THE GROSS TRIAL
At times Dr. Kavaler seemed to be second guessing the medical care Linda Gross received. Three doctors performed surgery to remove mesh, which the urogynecologist said she wouldn’t have done.
Describing pelvic spasms resulting from trauma of surgeries the doctor said, “They are painful. It takes time. It takes patience for these to resolve and mostly rest and recovery not necessarily lying in bed. The pelvic floor has to have a chance to quiet down. She’s had two surgeries in addition to the original one. The removal of mesh seems to be making it worse. The location of pain is not over the site of the mesh.”
Dr. Kavaler insisted that mesh does not move around within the pelvic area. “It does not have a life of its own,” she said.
In the Budke case, Ms. Budke had two remotal attempts. Her implanting physician Dr. Simpson excised the center portion of the Prolift mesh in January 2009. Dr. Neal excised or removed one of the mesh arms.
Christy Jones, from Linda Gross trial Feb 2013
From the Linda Gross case - Christy Jones, attorney for Ethicon asked: ‘If she didn’t have pain before the Prolift surgery, how can you say the Prolift and mesh associated with Prolift didn’t cause her pain?”
Kavaler: “If she had pain from the Prolift, taking it out would help, but her pain got worse.”
Jones closed with her witness: “Based on your training and experience, was Prolift an effective medical treatment for her pelvic organ prolapse? Yes it was, said the doctor.
Jones: “Did Prolift cause the plaintiff’s pain we’ve been talking about this morning?”
Kavaler: “In my opinion it is not the source of her migratory myofascial pain.”
BACKGROUND ON ELIZABETH KAVALER
In the Linda Gross case - Adam Slater established Dr. Kavaler charged $7,000 for the day of testimony and another $400 an hour to prepare for the case. But there was more.
Slater: “You’ve been an expert witness in 20-25 cases, all but one for the defense?
Kavaler: “Correct.”
Dr. Lucente, preceptor for Ethicon
Slater recounted her deposition where she said she “was a big mesh user.” That is what got her the attention of Dr. Vincent Lucente, an Ethicon consultant, who introduced her to Ethicon. Dr. Kavaler was driven to the company headquarters and attended a dinner in the Meat Packing District in New York City where she said she wanted to talk to other doctors.
After first being contacted by Ethicon in 2009, she began teaching courses for the company on the use of another mesh, Prosima. She was also hired to proctor a cadaver lab.
Slater made the point – Before the Prolift, Linda Gross had no pelvic pain, no dyspareunia, no pudendal nerve damage. Correct said the doctor.
“You would have treated her different than other doctors right?’ he asked. “I have the benefit of hindsight,” she said not wanting to disparage the treatment Ms. Gross had received.
Slater; “Linda is taking the advice and guidance of her doctors right?”
Kavaler: “Yes she is.”
Slater: “They are trying to deal with a very difficult situation.”
Kavaler: “Yes they are.
Slater said and the doctor agreed that there is a lack of any information about mesh extrusions, removals and Ethicon (Johnson & Johnson) was not informing surgeons then and even today what to expect.
Slater: “In 2006 there was much less information then there is now right?
Kavaler: “Yes, that’s right.”
In a heated moment Slater and Kavaler disagreed over whether mesh moves. While mesh extruded in Linda’s body the doctor said mesh finds the incision line and extrudes there. Often it does not cause problems and she leaves it behind.
Slater: “You certainly don’t think it’s a good thing for Linda to have pieces of mesh around her pelvis?”
Kavaler: “I think it’s more hurtful to go after them.”
Slater: “He found mass of mesh and scar tissue actually enveloped one of her ureters. He thought it was reasonable. It’s not normal for the mesh to envelope the ureter is it? Is it reasonable that a doctor from the Mayo Clinic remove it? It’s reasonable right?
Kavaler: “That’s not what I would have done.”
Slater: “Is that according to the Ethicon consultant book? Leave it in and hope for the best?”
She had a catastrophic outcome after her Prolift implant wouldn’t you agree, said Slater.
Dr. Kavaler: “I’d say she is in an unfortunate and painful place, I agree with that, I don’t agree the cause is the Prolift.”
On cross examination, Ethicon attorney Christy Jones (also representing the company in Butke v. Ethicon) asked, considering all of the procedures Linda Gross endured, would anything be considered to be a contraindication for another pelvic surgery involving Prolift?
“No,” answered Dr. Kavaler. “I think Prolift was a very good option for her.”
