ethicon logoA string of corporate executives with Ethicon, a division of Johnson & Johnson, highlighted this next to last day for the plaintiffs’ case in Budke v. Ethicon.  These were the individuals who allowed the Prolift pelvic mesh to be marketed in March 2005 with very little warning to implanting doctors or to the women who would receive the polypropylene mesh implants to treat prolapse.

This is the first death trial involving transvaginal mesh among the 70,000 or so defective product cases awaiting their day in court. The last and only case involving the Prolift mesh led to a jury award of $11.1 million to the plaintiffs in an New Jersey court with $7.76 in punitive damages almost two years ago.

Judge William Hass, Camden Co Mo.

Judge William Hass, Camden Co Mo.

Judge Hass of this Circuit Court in Camden Co. Missouri wants this trial to come to an end. He frequently acts more like he’s directing traffic.  Today, the jury got a shortened lunch break so an overwhelming amount of information could be presented as the plaintiffs wrap up their case.

Dr. Becky Simpson

Dr. Becky Simpson

Dr. Becky Simpson

This defective product case against Ethicon (Johnson & Johnson) and its Prolift mesh is just one component of this case. Dr. Becky Simpson, the implanting physician is facing medical malpractice charges. The family of the late Joan Budke blame her use of the Prolift for Joan’s death. So this morning the doctor was led through a series of questions about her surgical technique. She explained in great detail how she performed a Prolift surgery, which was designed to show her attention to detail and patient care.  “I’ve not had a lot of recurrence with Prolift,” she explained.

She said she no longer uses Prolift but didn’t say why. The jury has not been told Prolift, and three other Ethicon pelvic meshes, were quietly removed from the market in June 2012, allegedly for business reasons. It continues to be sold overseas.

The doctor is calm and deliberate but clearly not happy to be here.  Dr. Simpson lost Joan Budke as a patient in February 2009 after an excision of the center portion of the Prolift and a treatment for infection failed to deliver any relief and Budke transferred to St. Louis for further treatment. Even Dr. Simpson, a mesh defender, says you never try to remove the mesh arms of a Prolift which she called “no man’s land.”

Prolene Mesh

Prolene Mesh

In other words, the polypropylene mesh implant can potentiate an infection but can never be fully removed when complications like infection take hold, as it did in Budke’s case.

Dr. Vince Lucente was one of the highest paid preceptors or trainers for Ethicon when he trained Dr. Simpson in 2006. She thought he was telling her the truth, about the erosion rate, the infection rate, the complication rate, and she admired him.

Dr. Vince Lucente

Dr. Vince Lucente

Referring to Lucente, plaintiffs’ attorney Adam Slater asked Dr. Simpson, “If Vince Lucente didn’t tell you the full truth about the risks of the Prolift, would you still admire him?

“If didn’t know the truth, no, it would change my admiration,” said Dr. Simpson.

To counter her competence, plaintiffs’ attorney Adam Slater showed the 15 jurors the videotape

Dr. Richard Luciani, medical expert

Dr. Richard Luciani, medical expert

deposition of Dr.  Richard Luciani, an ob/gyn who has been in private practice in Millburn, New Jersey for 35 years. He was brought in as an medical expert in the medical malpractice portion of the  case.prolift box 200

Dr. Luciani testified Dr. Simpson didn’t exhibit the standard of care a professional. She should never have used the large, heavy duty Prolift for a stage one prolapsed bladder, a mild condition and relatively normal, he said, in a 73-year-old woman.

There is absolutely no indication to use anterior Prolift mesh for first degree cystocele (bladder prolapse) and one that was asymptomatic, that is one not causing any problems,” he said.  In his practice he does a native tissue repair and doesn’t use mesh.

When asked on cross examination by the defense, the doctor said he made a practice of testifying in medical malpractice cases, yes, but in 80% of the cases, he determines the physician did nothing wrong.

 

Donald and Joan Budke

Donald and Joan Budke

Joan Budke – a Legacy of Love

The most heartbreaking was testimony today was from daughter Susan and husband Donald. Susan broke down on the stand as the courtroom saw a number of pictures of Joan’s life after her mesh implant. No doctors could determine what was wrong with her.

All everyone knew is she had a continuous series of infections about eight months after the Prolift, which eventually led to her death.

Susan, who lives in Minnesota, says she talked to her mother every day. She broke down at the picture of Joan being transported to a nearby care facility in St. Louis one month before her death.  It only lasted ten days before she was back in the hospital.

In each picture Joan, an attractive brunette, was always smiling.

“She was a rock,” said her daughter. Susan narrated a picture of Joan and Donald sitting down to lunch at a nearby apartment he had rented. It only lasted ten days before she had to back into the hospital.  Susan said, “I wanted a picture of that.” After she was put on the ventilator, Joan didn’t wake up.

“I told her that I loved her and prayed with her.” Slater asked was there any response? “One time I was standing by her holding her and a single tear came out of her eye,” said Susan. “Nothing else, I took a tissue and wiped it off.”

The last photo was almost unrecognizable, a vague human form under a canopy of tubes and hanging IVs. Joan was on a respirator. She never spoke again after that.

“I miss my mom so much every day. I wish she was still with me,” Susan concluded.

Donald Budke was upbeat and spry. For a man of 91, he didn’t miss a beat with words such as ‘HIPPA’ and ‘interventional radiologist’. After describing his life as a WWII bomber pilot and life in Glendale, California, he talked about how he spied Joan in church.  The two were inseparable. Volunteering was her life, as was church and their family.

Yesterday would have been their 59th wedding anniversary.

Joan had been a careful patient with two knee replacements and rotator cuff surgery. She did everything the doctors told her to do and recovered each time.  Now to correct this incontinence, which was an embarrassing problem, she assured her family, it was a simple outpatient procedure. “I’m in and out,” he recalled her saying.

Adam Slater

Adam Slater

A failure to inform doctors and patients is part of the defective product claim. Slater asked, “Knowing your wife, what would she have done if she knew of major risks. “I think she’d find something else to take its place. I don’t think she would take the risk,” he said.

In the end when Joan was in the hospital “I lost my bride,” he cried his hand to his head. The jury was teary. The defense table lawyers had their heads down.

Plausible Deniablility

In the afternoon, Slater showed a series of videotapes of present and past employees – sort of a round-robin of faces that came and went within the company. Some appeared less than professional.  Medical Director Charlotte Owens was in charge of green lighting the Prolift, without which, it would never have been sold. She said she spent one week in deposition preparation and appeared to be rehearsed.

Owens was four years out of her medical residency in gynecology when she was made the Worldwide medical director for Gynecare, a division of J&J. Slater asked “Before Gynecare would you be considered an expert in mesh? No, Owens said.  “I was competent I was not a urogynecologist, so that was not my focus, no.” Instead, she relied on the expertise of others in the company.

A former regulatory affairs director, appeared to be in his early twenties, while Renee Selman, former World wide President for Women’s Health and Urology looked disheveled. Each had experienced relatively short stints with their high profile jobs with Ethicon and J&J before they were shuffled to another job or left the company.

The only employee who looked and appeared professional was Sheri McCoy, former vice chairman of J&J, who left the company after losing the CEO appointment to the current CEO, Alex Gorsky.  McCoy is now CEO of Avon.

What is not mentioned in this trial is that each time one of these employees was reassigned within the company, which happened often, Johnson & Johnson destroyed hundreds of thousands of pages of company documents that were on a litigation hold in these pelvic proceedings. See this background story here.

Presumably, many of the documents proved what the company knew and when it knew it about the dangers of its pelvic mesh products including the Prolift.

Dr. Piet Hinoul, Linda Gross trial

Dr. Piet Hinoul, Linda Gross trial

Piet Hinoul, VP of Medical Affairs at Ethicon will be on the stand tomorrow in Camden Co. before the plaintiffs wrap their case.

It could go to the jury by next week to determine if the Prolift was defectively designed and if Dr. Simpson was negligent in her care of Ms. Budke. #