Jim Shull- Observations on How Lawmakers View Medical Device Regulation

Jim Shull testifies

February 22, 2012 ~ Jim Shull was a member of a patient advocacy group when in October of 2008, the Food and Drug Administration, largely at the group’s urging, issued its first public health notification (PHN) about transvaginal mesh (here).

Thousands of women were coming forward with injuries attributed to use of synthetic surgical mesh used to hold up descending pelvic organs and to treat incontinence. Men were injured by the same mesh used for hernia repair, but the notification did not mention hernia mesh, the medical device that injured Shull.

“It was kind of disheartening. Even though it was a huge step, I didn’t understand why not put out a PHN for both products,” Shull said to MDND.

That might have been the end of Mr. Shull’s activism. But this month, Consumers Union brought him to Washington, D.C. to meet with members of Congress. CU is concerned that a tentative $595 million in user fees industry agreed to pay the FDA for medical device reviews, fails to mention patient safety among its demands for faster and more predictable product approvals.

Shull’s representative in Congress, Rep. Frank Pallone (D-NJ) and his staff invited Shull to testify before the House Energy and Commerce Committee’s Subcommittee on Health about the Medical Device User Fee Act (MDUFA) on February 15, 2012, to remind the members of Congress that patient safety is at least as important as making life easier for manufacturers.

Here is the taped hearing online.

Inside the Beltway and Medical Device Safety

Shull tells MDND he sat there and watched a grilling of the head of the medical devices division within the FDA, Dr. Jeffrey Shuren. What he heard was an overwhelming concern for the health of the medical device manufacturers and not patients.

“Jeff Shuren inherited this mess and I really believe he is doing the best he can with what he has. And he is slowly making headway. I had new found appreciation for him after watching him. I thought they were just brutal with him. I just felt like they kept twisting the knife in him. “

If one didn’t know better, he says, it sounded like the medical device industry was the constituent of the lawmakers.

Rep. Rogers, MDUFA hearing Feb. 15, 2012

“Rep. Mike Rogers (R-Mi): “Investment is moving overseas so if you’re truly trying to change that equation, we don’t have time for reports and light-hearted emails about how to change in the future. The policies here don’t work together and that’s why people like me are very frustrated with the FDA. Would you find it concerning that according to this survey, 44% of American venture capital firms are going to invest in life science firms in Europe and Asia? Is that concerning to you?”

Shull called the hearing a “dog and pony show”. The House Energy and Commerce Committee has jurisdiction over issues pertaining to energy, environment, health care, commerce and telecommunications.

Rep. Blackburn, MDUFA hearings, Feb. 15, 2012

“Rep. Marsha Blackburn (R-TN) “Dr. Shuren, we would like to see a sense of urgency from you to do more than talk about issues. When you talk about a global task force we are running out of time. A lot of our constituents and their companies complain with the way they are dealt with by the FDA. In their mind, time is money.”

Dog & Pony Show

Shull says the “show” was put on by members of Congress to show the medical device industry that they’re doing their job. While he and others were testifying about patient safety, Shull says the representatives were reading their paper and drinking their coffee. Rep. Burgess was reading the Congressional newspaper. Shull says the chairman, Rep. Pitts, didn’t raise his head once. By the time Shull testified there were only four Congressmen left in the room. (In fairness, the others may have had to leave for a vote).

“I thought it was disrespectful waste of tax dollars. I’m proud of what I did but I don’t think any of them heard it.”

He says, “I felt horrible for Dr. Shuren. He wants to do the right thing; he knows what he has to do yet he’s being fought every step of the way. Industry pays nominal fees to get approval of their devices. A small company pays about $2,500 to get their device approved. I can go get a floor mat from my truck and say this is a new hernia mesh, its true, and I can use a predicate device as any hernia mesh on the market. I can get approval for the floor mat. It’s a joke it really is.”

Dr. Jeff Shuren, CDRH

In fact, the rehearsed nature of the hearing was revealed when Rep. Bill Cassidy of Louisiana gave the rest of his time back to Rep. Michael Burgess (R-TX) who had clearly planned to ask about the motivation a personal injury lawsuit might have played in the aftermath of Shull's medical device injury. After asking whether or not Dr. Kesselheim was involved in consulting for attorneys concerning artificial hips, Rep. Burgess asked Shull whether he had benefitted from litigation.

Rep Burgess, MDUFA hearing Feb. 15, 2012

Rep. Burgess: “Mr. Shull, let me ask you, certainly there has been a lawsuit involved I would presume? Yes. “And currently your lawsuit? Shull: “It’s settled. Burgess: “With whom did you settle? Shull: “The doctor. Burgess: “Was the product ultimately recalled from the market? Shull: “No it was never recalled. Burgess- “Did you file suit against the company? Shull: “I did but the product was deemed used off-label. Burgess: “So it was physician-involved, not the company? Shull: “The company exchanged testimony for me to drop my suit against them.”

Shull says he wanted time to answer but the hearing was officially concluded. Had he had time, he would have said that the doctor who put in his hernia mesh used it off-label in that Shull did not have a hernia but a lypoma, a piece of fat, but that it wasn’t the doctor’s fault that the product went bad.

“All I can do I put my trust in God they heard me and something gets done. But I was told somebody is probably going to ask that question and I was expecting it,” he says.

During his five minutes of testimony, Shull said the room became quiet and there was a gasp when he talked about the 70 injections he had received in his groin to relieve the pain from the hernia mesh which has his disabled with permanent nerve damage. When the hearing adjourned, Shull says he was approached by Dr. Shuren who told him his testimony was very moving.

“I told him the 510(k) is antiquated and it’s past its prime and has to be done away with. How can you approve a hernia mesh based on a predicate of sutures?”

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Editor’s Note: Shull had filed a medical malpractice lawsuit against his doctor and a product liability lawsuit against hernia mesh manufacturer, C.R. Bard. The company agreed to have its VP of Research & Development testify against the doctor if Shull dropped his product liability lawsuit against the company. Shull agreed with the caveat that if the mesh product was recalled within 18 months, Shull could reopen his product liability lawsuit against Bard. That never happened. #