J & J Asks for Directed Verdict to End Defective Mesh Trial

The plaintiffs in the Budke v Ethicon trial in this Camden Co. Missouri courtroom planned to bring their eight day trial to a close today. But before they did, there was one more witness who appeared via videotape, Dr. Durwood Neal, a urologist from Columbia, Missouri.

Dr. Neal would be brought in talk about how he tried to save the failing Joan Budke, 77, in early 2009. She had been diagnosed with a massive infection in her pelvis that no one could identify. The infection became chronic and inflamed about eight months after the Prolift mesh was implanted in April 2008. Mesh manufacturer, Ethicon, a division of Johnson & Johnson, denies its mesh caused the infection even though a massive infection was found on the anterior wall of the vagina, where the mesh is placed close to the bladder in order to to treat incontinence.

Jurors, anonymous artist

A CT scan of the abdomen done in March 2009 revealed a mass 4.5 by 2.5 inches.

“To me it looked like a chronic inflammatory process secondary to a bacterial infection usually from an infected foreign body,” Dr. Neal said. While doctors were doing biopsies, thinking she might be suffering from cancer, Dr. Neal said he believed her Prolift polypropylene mesh was infected.

By March 2009, Joan had a wasted appearance. It was now 11 months since her Prolift implant. The infection had blocked her kidneys. Stents were implanted to drain the urine. Dr. Neal recommended the inflamed bladder might have to be removed and he suggested hyperbaric oxygen therapy to aid with healing.

Dr. Neal was one of a half dozen doctors brought in to try and save her life after a partial removal of the Prolift did not improve the infection. He also removed a portion of the mesh arms, which was shown to the jury.

The defense established the urologist never saw a culture that identified septic emboli, the plaintiffs’s lead theory. A pathologist this week testified that septic emboli is an infection that always originates in the pelvis before it travels up the body to seed in the lungs. See background story here

Lastly, the defense attorney asked if the doctor knew of the existence of a family journal. Dr. Neal hesitated, asking if one existed.

The unidentified writer in the journal allegedly wrote, “I do believe he said he didn’t know mesh was the cause. This infection could have started by itself and could be a bad reaction to a secondary infection,” the lawyer read off camera.

Do you dispute that’s what you told Ms. Budke’s family? “It sounds like generally me speaking but I don’t remember what I said. It was too many years ago,” said Dr. Neal.

J&J Asks Judge for Directed Verdict in Budke v Ethicon

It is never surprising when a corporation wants to end a case and it happened in this Camden Co. courtroom today. Lawyers for Ethicon, a division of Johnson & Johnson, asked that the judge bring the eight day defective product trial to an end with a directed verdict in favor of J&J.

Dan Ball, Bryan Cave Law, St. Louis

“The plaintiffs have not made a submissible case on negligence, a failure to warn, strict liability or design defect because they don’t have sufficient evidence it was defectively designed or unreasonably dangerous,” said Dan Ball of the Bryan Cave law firm of St. Louis.

The defense claims that not enough evidence has been submitted that the Prolift pelvic mesh caused plaintiff Joan Budke’s death or that the company failed to warn doctors, specifically her implanting physician, Dr. Becky Simpson.

Her wrongful death claim should also be thrown out of court, said Mr. Ball. Wrongful death is allowed in a product liability claim under Missouri law. See the statute here.

Other claims of a defective product include a breach of express warranty and of implied warranty. There is also insufficient evidence breach of implied warranty of merchantability, said the defense.

Finally, the defense asked Judge Hass for a directed verdict on punitive damages. In the last case involving a Prolift (Linda Gross), an Atlantic City, New Jersey jury awarded plaintiff Linda Gross $7.76 million in punitive damages to punish J&J, a $70 billion a year company.

Missing was clear and convincing evidence of a conscious disregard, malicious, wanton and willing disregard of safety that would merit that award said Mr. Ball.

“This is an important motion and it would be unfair in the law for this case to proceed any further in punitive damages claim,” he said.

A lawyer for Dr. Becky Simpson also asked for a directed verdict in her medical malpractice claim. Court will resume on Monday despite the fact it’s the Martin Luther King holiday.

Judge William Hass, Camden Co Mo.

Judge Hass said he would take the weekend to consider the directed verdict motion. “Some of this will take a little while to digest,” said the judge who on more than one occasion has admitted he was “confused” by the evidence presented so far. Admittedly there has been a lot of technical/medical testimony, some of it coming quickly. "I will get on it, I will do this. I will give it the most serious determination I can.”

In the Carolyn Lewis case of one year ago, (see background story here), Ethicon asked for a directed verdict on the eve of the plaintiffs’ case in Charleston, WV. Judge Goodwin granted the directed verdict ending the case.

Prior to the directed verdict in the Lewis case, the plaintiffs had a difficult burden to prove. Judge Goodwin had removed one element of a defective product case, defective warnings to physicians. He did that because the implanting physician said she had not read the IFU (instructions for use) since 2002. #