Jim Shull- Observations on How Lawmakers View Medical Device Regulation

Feb 22nd, 2012 | By | Category: Op-Ed
Jim Shull testifies

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?”

##

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.  #

 

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3 Comments to “Jim Shull- Observations on How Lawmakers View Medical Device Regulation”

  1. mickeywhite says:

    Republicans passed the BIGGEST HEALTH CARE Bill since Medicare:
    But 400 BILLION to 1 TRILLION on unconstitutional health care is ok?
    Prescription Drug Benefit.
    The final version (conference report) of H.R. 1 would create a prescription drug benefit for Medicare recipients. Beginning in 2006, prescription coverage would be available to seniors through private insurers for a monthly premium estimated at $35. There would be a $250 annual deductible, then 75 percent of drug costs up to $2,250 would be reimbursed. Drug costs greater than $2,250 would not be covered until out-of pocket expenses exceeded $3,600, after which 95 percent of drug costs would be reimbursed. Low-income recipients would receive more subsidies than other seniors by paying lower premiums, having smaller deductibles, and making lower co-payments for each prescription. The total cost of the new prescription drug benefit would be limited to the $400 billion that Congress had budgeted earlier this year for the first 10 years of this new entitlement program. The House adopted the conference report on H.R. 1 on November 22, 2003 by a vote of 220 to 215 (Roll Call 669).
    Marsha Blackburn Voted FOR this bill.
    Marsha Blackburn is a Hypocrite.
    Marsha Blackburn is my Congressman
    See her unconstitutional votes at :
    http://mickeywhite.blogspot.com/2009/09/tn-congressman-marsha-blackburn-votes.html
    Mickey

  2. DJ says:

    Micky, what you wrote has nothing to do with the article.

    Jane, thanks for writing about this and bringing it to our awareness.
    Mr Shull and Lana, thanks for continuing the fight against defective medical products, including and especially surgical mesh. As a nurse and injured patient, I want patient SAFETY and informed consent, which is not possible when products are placed on the market by the antiquated 510(k) process, to be of paramount importance. The 510(k) process does not allow for pre marketing clinical TRIALS on medical products or post marketing FOLLOWUP.
    These members of Congress should be very ashamed of themselves for placing higher value on industry than on patients, including their constitutieInts, their own families and selves. How dare Senator Rogers not make time for “reports and lighthearted emails” concerning injured patients! How dare Senator Blackburn request that Dr. Shuren show more of a “sense of urgency” for medical device manufactures than for the American public who deserves and demands safe medical devices. Apparently they missed the findings released by the Institute of Medicine this past July 31, 2011, which found the FDA’s 510(k) process is outdated, antiquated, probably needs to be overhauled or even done away with, allows too many defective medical devices on the market too easily and does not do enough for patient safety.

    Thank you, Dr. Shuren, for standing up for American people who want the safest medical devices possible, with adequate testing ahead of time. You have a very difficult job indeed.

  3. EJH says:

    Thank you Jim for testifying. Thank you for this article, it did answer some questions I had after watching the session. The fact that the questions were set up in such a way to show a political agenda was obvious and I’m happy that I’m not the only one who realized it. To hear manufacturers claim they have to take their companies overseas to make a profit, is really saying, if the US is going to require safety with their medical devices and it costs us, it will be much easier to go elsewhere, and then implying that the lives that will be affected under the lower standards are not valued (lets go hurt people overseas) and what really matters is the profit margin. The very companies that claim they are in the business of making lives better, are hypocrites. When money is the bottom line, not quality or concern for patients – everyone loses. I did not hear one company say that they are concerned about the safety of the patients. Nor did they give any ideas on how to streamline some things while keeping high standards in place. Rather their concern was the profit margin and threatening to go overseas (implying job loses). All this while many medical products are hurting patients throughout the US, needlessly. I am an injured patient, from a non-life threatening problem. If safety had been a concern from the beginning I would not be living in constant pain, limited movement, and constant Dr. appts. The fact that the companies are still passing the buck to Dr.’s and even the patients in some cases, just shows the greed and the great need for change in the FDA 510K process. More paperwork would not be the issue if the quality of what is being put forth was there to begin with. If the medical industry wants to police itself – it better get busy and start doing the job. It is because they are not doing this, that programs like the 510K need to be scrutinized and the consumer protected. Shame on these companies whose sole goal is profit, while hiding under the guise of helping people. Shame on them for not taking responsibility for their own products, actions and fighting the very ones they have injured so greatly. Integrity, honesty, and pride need to be back in style. I would not be proud to be working for these companies at this time.

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We hope you find this a helpful resource. National News Editor, Jane Akre, began MDND with the hope of providing the latest news, information and perspective from the regulatory, industry and patient point of view, something that goes under-reported in much of the coverage of medical devices. The public is just now becoming aware that many devices do not undergo the same scrutiny as prescription drugs and are instead grandfathered in under an FDA loophole that has gone largely unchanged since the 1970s. As a result, patients become the post-market clinical trial subjects, and many suffer devastating and permanent injuries.