Budke Day Two – No Show Juror
Things got off to a slow start on Thursday morning because one of the 16 jurors, a young man who appeared to be a teenager, was missing in action. Since the jury pool would eventually be narrowed to 12, talk was that the proceedings could continue without him. Two calls to both of his numbers yielded no results.
By 10:45 with no juror in sight, juror number two, Jacob Bean, was officially “kicked” from the jury pool. Juror 16 would now become juror number two. Judge William Hass said he would have a “come to Jesus” session with him during the first break and fine the absent juror $200. If he didn’t pay, Judge Hass said he’d have him locked up.
Plaintiff, Donald Budke sat next to his two daughters as he had the day before. Resembling a French painter with a neat goatee and lean looks, Budke walked slowly with a cane. The third adult child, a son, has not been present in the courtroom. The burden will be on the plaintiff to prove their defective product case, through the preponderance of the evidence, against Johnson & Johnson and medical malpractice case against the implanting physician, Dr. Becky Simpson.
In April 2008, Joan Budke, 76, was implanted with J&J’s Prolift System, a large pelvic mesh to address her mild incontinence. The Budke’s contend that eventually led to a septic condition and her death in August 2009.
The day started off contentious and continued throughout the day.
“Come on guys, you’ve got to take a reasonable position on something,” Adam Slater said in frustration to the defense attorneys as they waited for the juror. The defense team wanted to eliminate Dr. Vincent Lucente’s testimony about removing the word “experimental” from the ACOG practice bulletin. “He’s the highest paid consultant for the company” Slater argued. It’s hearsay, said Christy Jones, but I’ll consider it during the break.
Removing the word “experimental” opened the door to insurance coverage of the controversial treatment when it was launched in March 2005.
Slater called his first witness to the stand, Scott Ciarocca, who still works for Ethicon Inc of Sommerville, NJ, the medical device division of Johnson & Johnson. If one wants a cooperative witness and a flowing testimony, a hostile witness might not be the best choice.
Ciarocca started in research and development with the company in 1997. By June 2002, with just a bachelor’s degree in electrical engineering, he would became the head of the unit that would bring the Prolift to market. Ciarocca would rely on the medical expertise of the Worldwide Medical Director Dr. Charlotte Owens, plucked from obscurity from a Florida women’s clinic and just four years out of her residency. The gynecologist would be in charge of signing off on documents presented to her to launch the Prolift.
Eventually the launch date was set for March 2005 and there appeared to be very little to stand in its way.
The name of the project to develop Prolift to market was Project D’Art, a French name because the principal developers included the French TVM (transvaginal mesh) team, Michel Cosson, Professor Bernard Jacquetin and Axel Arnaud, all working as consultants for Ethicon. They had been testing tools and meshes for a new pelvic mesh application. Professor Jacquetin was the leader and most experienced of the group. A patent had been filed by him to own the right to the concept that would become Prolift. Eventually he sold that patent to Ethicon.
The group would make occasional presentations to executives to secure funding to continue or not continue the project. The ultimate goal would be a product release authorization- the very last step when a product, in this case the Prolift, would be officially released for sale.
Patient safety was very important wasn’t it, asked Slater of the witness. “We focus on patient safety very much,” said Ciarocca. Marketing concerns and how much we will make should not impact patient safety right? asked Slater. “I don’t believe a commercial concern would trump a patient safety concern,” answered the project manager.
Why then only a six month clinical study to say it was safe to put on the market, asked Slater. “Your company thought six months of a study would be enough to make sure it’s safe?”
“We did have extensive experience with suture mesh and Gynemesh PS” answered Ciarocca, comparing suture thread and flat hernia mesh with the Prolift.
Prolift – A Marketing Advantage
With a September 2004 launch date initially there were some critical assumptions from the marketing department of J&J, shown to the jury on a full screen.
“Product features will justify a premium price as compared to Gynemesh PS sheets.”
‘Multiple kits will be required to fully exploit the market
“Adoption of synthetic mesh procedure in US will meet expectations.”
Key opinion leaders such as Ethicon consultant, Dr. Vincent Lucente, would help lead professional training of other doctors. He was accumulating data relied upon as part of the TVM study, data that said the product was safe and effective.
Exhibit 967 was an email from Michel Cosson to Ciarocca about the straps of the implant. “About the implants, we have performed more than 200 tvm with no slippage of the implant. The problems are more erosion, retraction. It is possible to have a recurrence but it is usually due to a retraction of the mesh and the arms of the mesh are still in place in those cases, sincerely, Michel.”
Slater reminds the witness the company’s own risk assessment says go back to the concept stage and delay launch if there are problems. Ciarocca said they were still using the Gynemesh PS it to treat patients. “I believe if they thought it was a substantial complication they wouldn’t have continued” said Ciarocca. Is it typical to have marketing people involved at a high level before you know a product is safe, asked Slater, referring to the internal emails stressing a “risk of losing the momentum” of the Prolift launch.
Ciarocca appears to be a hostile witness and refuses to agree with any Slater question. He elaborates and adds verbiage even if he is agreeing. It slows the proceedings but the judge never asks him to just answer the question.
By the late morning, Judge Hass had his session with the missing juror. With the jury out of the room, he swore in the now found juror, Jacob Bean, and asked him if he had taken an oath to serve on the jury. Yes, said the young man. Jacob apologized for his tardiness by saying it was a problem in high school and on the job. “I’m going to fine you $300 and give you until January 15 to pay to the circuit court office and it it is not paid I will be here and you will go to jail for 5 days. You will pay the jail bill. That 5 days will run as much as your fine.” Jacob reportedly paid the fine within the hour.
Safe and Effective
Slater continued with Ciarocca. If there was a design requirement it needed to be met? Yes, the witness agreed. But the European clinical study failed the grade. The failure rate at six months was 12.6 percent but when the confidence interval was applied it went to 20.1 percent. At the same time, the clinical strategy recurrence rate needed to be under 20 percent. “So under the clinical strategy this failed, said Slater. “I don’t know” said Ciarocca.
Christy Jones, defense attorney for J&J objected to the previous deposition testimony of Ciarocca being on the screen. The judge sustained the objection.
“The results show a failure rate at 12 months of 18.4% with a 90% CI of 26.6. (confidence interval).
Judge Hass raised his own objection. “I don’t know what that means. Maybe some jurors don’t either.”
Ciarocca said he was not familiar with what was going on with the TVM group in Paris, he didn’t know if the design evaluation was flawed. Ciarocca didn’t know why they never studied what a physician would have to do if the mesh needed to be removed.
The judge said he would give Slater latitude but if Ciarocca didn’t know, he didn’t know. The engineer should not have to testify about what a doctor knew. Slater affirmed Ciarocca was the principal developer of Prolift and in a position to know.
Internal documents showed Ciarocca needed copies of the TVT-O and Gynemesh documents so he could make a draft of the final report and hand it to Sean O’Bryan of regulatory affairs to polish off. That’s what it says? Yes.
Sean O’Bryan responded, “Please shred these two documents once you read them. “
Cut and Paste
Who exactly drafted the clinical expert report? Ciarocca admitted he took a draft of the Gynecare PS (flat hernia mesh) report and “added in the instruments that went with the kit and forwarded a draft to her,” referring to Charlotte Owens, the medical director who was in charge of green lighting the project. Putting the Prolift final clinical expert report alongside the Gynemesh PS report showed the introductions were identical, except for the name of the product. In the clinical evidence section, Ciarocca said he provided Owens with a ‘draft” which included a typo identical in both reports. Prolapse was misspelled “prolaspe.”
When prompted with questions about medical data, lawyers for the defense objected. Ciarocca is not a doctor, they argued. That was the point argued Slater in a sidebar, Ciarocca was deeply involved in writing the science for the medical director.
IFUs Already Printed
In another exhibit from Dr. Axel Arnaud, dated January 11, 2005, two months before the launch of the Prolift, Arnaud wanted to add a warning to the Instructions for Use (IFU) about a vaginal placement of mesh and complications. He wanted it in there as soon as possible. Ciarocca’s response two days later was they had already printed the launch stock for the IFU. They would make the changes on the next revision.
Slater asked, “There was a time pressure on you, right?” Competitor meshes Apogee and Perigee had just been launched in direct competition. Ciarocca denied they were in a rush. “We had a good solution we were anxious to get it on the market.”
Mesh Kit was Never Tested
On March 4, 2005 Prolift received the product release authorization. Slater asked Ciarocca that at the time no studies had been done on the marketed kit. Yes, on the tools but not on the mesh, agreed Ciarocca. “The final Prolift kit was not part of the study.” The unique tools, this unique shape of the pre-cut mesh had never been tested? “Correct.”
Wrapping up the day, defense attorney Jones in cross examination had an easy time with the now agreeable Ciarocca. A design review team had come in from the outside to make sure the final review of Prolift was thorough. “Did you make any compromises simply to be the first to market?” “No we did not.”
Jones showed a memo from Barbara Schwartz PhD Worldwide president of Gynecare which said, “I don’t care if the other companies can occasionally push a product out of the door faster. Ultimately taking the high road as Gynecare has done is going to farther distance you from your competitors.”
The lawyer for Dr. Becky Simpson, at 5:30 pm concluded, the emails, clinical expert reports all of the internal documents, doctors like Dr. Simpson don’t get those documents do they?
No, it is all internal, answered Ciarocca.#