Monday, May 11, 2009

Scare Tactics and Presumptions Continue as Congress Debates Medical Device Safety

As time approaches for Congress to protect our civil rights we see another misguided article intended to scare Congressional decision makers into believing that ending the 2 year old policy of FDA Preemption will destroy the inventiveness of the Pharmaceutical industry.
Shame on them for presuming (or at least presenting the position) that our Pharmaceutical Industry is not capable of making both effective and safe products.

Here again is the article in full to be examined for its falsity. Please also note the source -

Patients Call for Continued FDA Preemption Authority

FDA Best Positioned to Review Medical Technology
WASHINGTON, May 11 /PRNewswire-USNewswire/ -- Patients from across the country came to Washington, D.C., to share their stories about how medical technology has helped improve or save their lives in advance of a May 12 U.S. House of Representatives Energy & Commerce Committee hearing on the Medical Device Safety Act of 2009, legislation to repeal the Food and Drug Administration's (FDA) preemption authority.
"Without my medical device, I would not be here today," said Laura Doud of Arlington, Virginia, who received life-saving implantation of cardiac resynchronization therapy with defibrillation in 2004 after suffering almost fatal viral cardiomyopathy. "If the proposed legislation were passed, would the lawsuits facing inventors and manufacturers prevent devices like mine or future medical innovations from ever making it to patients like me?"
"Every day millions of patients' lives are saved or enhanced thanks to innovative and safe medical technology," said Stephen J. Ubl, president and CEO of AdvaMed. "Unfortunately, you are not likely to hear these patients' stories in tomorrow's hearing."
Ubl added, "The Supreme Court's 8-1 decision in Riegel v. Medtronic foreshadowed what we will see in courtrooms and what we will see in the hearing tomorrow -- that the thousands of patients who have benefited from these technologies will not be considered."
The 8-1 majority Supreme Court decision asks, "How many more lives will be saved by a device which, along with its greater effectiveness, brings a greater risk of harm? A jury, on the other hand, sees only the cost of a more dangerous design, and is not concerned with its benefits; the patients who reaped those benefits are not represented in court."
Patients came to Washington from across the country to explain the importance of medical devices in saving and enhancing their lives, and to speak out about protecting access to devices now and in the future. In addition to Laura Doud, medical device beneficiaries who attended the briefing include:
Adam Hammond, from Columbus, Ohio, a former U.S. Army Officer and Golden Knights parachutist who suffered life-threatening injuries when his parachute failed to open. He can now walk and function again without severe and debilitating chronic pain after receiving a neurostimulator.
Tom Price, a long-distance runner from Syracuse, New York, was unable to run more than a mile due to calcification and severe regurgitation in his bicuspid aortic valve. After aortic valve replacement, he has resumed his active lifestyle.
Mike Roman, from St. Louis, Missouri, a world-class race car driver who received a spinal cord stimulator to treat the constant, debilitating pain he felt after losing his leg to infection.
Olivia Vervaeke, a senior from Detroit, Michigan, graduating this week from the University of Notre Dame, born with a congenital heart defect that severely worsened in high school. Olivia required an implantable cardioverter defibrillator (ICD) in 2005.
The patients emphasized how critical it was for them to have access to devices when they needed them most.
"This device saved my life," said Olivia Vervaeke, who is graduating from college on Sunday, May 17 but took a break from wrapping up her final days at Notre Dame to come to Washington to tell her story. "I can run five miles a day now; I could never do that before."
"We should be working to strengthen FDA resources so more medical devices can be made and improved -- not make it more difficult for patients to access them," said Tom Price, who has run multiple half- and full-marathons less than two years after his aortic valve replacement surgery.
"I tried medicine, surgeries and even older technology without success. Thanks to continued research and innovation, I was able to receive a spinal cord stimulator that finally relieved my pain," said Roman, who uses his professional racing efforts to inform chronic pain sufferers that there is hope and they are not alone. "We need to preserve innovations for others like me."
Patients also expressed concern about turning the review of their complex medical devices, which can often take years of scientific and regulatory oversight, over to states and courtrooms that lack the necessary expertise and budgets.
"How does a lawyer or a judge or a jury know more than my doctor, the FDA or the engineers who invented and developed the medical device that gave me back my life?" said Adam Hammond, who is the first person in the world to be implanted with an Eon Mini neurostimulator.
"This legislation does not in any way improve patient safety," concluded Mr. Ubl. "It will only restrict patient access to essential medical technologies, produce a chilling effect on medical innovation, create more lawsuits and ultimately result in higher health care costs for all Americans. We can't let that happen."
The patients will remain in Washington for tomorrow's hearing and meet with their members of Congress about the importance of protecting access to safe and effective medical devices.
AdvaMed member companies produce the medical devices, diagnostic products and health information systems that are transforming health care through earlier disease detection, less invasive procedures and more effective treatments. Our members produce nearly 90 percent of the health care technology purchased annually in the United States and more than 50 percent purchased annually around the world. AdvaMed members range from the largest to the smallest medical technology innovators and companies. For more information, visit


  1. Here we see the classic PR strategy in action. It is a good case study (which I will use in my teaching).

    First, try to flood the newspapers (whatever survivors) with stories about greedy trial lawyers who will rip their defibrillators right out of their chests. (And suck whatever blood spurts out in the process).

    Then, commission and self-publish articles favorable to the anti-preemption position, which also suggest accountability will mean the end of all medical devices and the beginning of apocalypse. Get researchers associated with prestigious institutions (e.g. MIT) to sign or author them. Then later cite them as though they were substantive academic studies, with the presitigious institution given prominent billing.

    Then recruit "patient advocates" to go to Washington, suggesting a groundswell of concern by those about to have their devices rippped from their bodies. (Hint for journalists: Find out how each of these "patients" was recruited, who did so, who paid their expenses, and any other compensation associated).

    All of this....old as the hills, including capitol hills........

  2. For a listing of the 392 Pharmaceutical Corporations that the source of this article (Advamed) counts as supporting members see hereFor a listing of the advocates for the thousands of consumers hurt or killed yearly by medical devices if FDA Preemption is upheld...

    No listing is required - there would be no advocates allowed for these people. Their cry will not be heard. They will be turned away, each one at their most desparate time.

  3. Yes! There are many truly wonderful medical devices out there. Medical devices that allow people to enjoy pain free, angst free, barrier free lives. The medical device recipients who are represented in this article owe a great deal of gratitude to the manufacturers of the medical devices that gave them back a healthy life. I understand why they have a hard time seeing that their positive experience is not shared by all medical device recipients…most, but not all.

    I wonder if they would be so quick to give up their right to hold medical device companies accountable for the products they place on the market it they had been shocked multiple times by a cardiac defribrillator, or had their insides turned into a cheese grater by surgical mesh, or most of their intestines removed because of a reaction to an anti-adhesion barrier. And then if, in their efforts to find out what happened, they learned that the medical device manufacturer had been fraudulent in its reporting to the FDA in order to get or keep the product on the market but, because of medical device preemption, their efforts to bring this information to the attention of anyone is blocked, would they still stand so stoically behind all medical device manufacturers?

    I wonder, also, if these people are aware that their medical devices were, in all likelihood, developed when medical device preemption was not the law of the land. The Supreme Court ruled in favor of medical device preemption last year. Prior to that, innovative medical devices were researched, approved, marketed and sold. They provided people the opportunity to live pain free, angst free, barrier free lives. Many people owed a great deal of gratitude to the manufacturers of the medical devices that gave them back a healthy life…the only difference was that then, medical device manufacturers held some accountability for their products. They had to been concerned that, just because the FDA had given them its stamp of approval, they still had to demonstrate that their product was safe and efficacious and, if they didn’t, there might be hell to pay.

    Isn't that what keeps everyone on the straight and narrow? Why should medical device companies be uniquely free of this responsibility?

  4. Beautifully said, Laura.

    Needless to say, the strategy of the preemption lobby is to make it seem is that there are only two options: we have useful medical devices or (with preemption) we have nothing.

    It is sad that these people--some naively, some probably not--became part of the misinformation campaign. Should it succeed, they will end up being accessories to agonies fully equal to those that they (if the stories are true) have, for the moment, escaped.

  5. The Energy and Commerce Committee will hold a hearing on reversing device preemption today (Tuesday).

    Needless to say, that is what has sparked the flurry of pro-preemption activity discussed on this thread.

    Time to make your own views to your Congressfolk known.

  6. Thanks Laura. I guess they forgot to include the folks who have been harmed or killed by medical devices. They also don’t mention civil rights. Without the ability to seek legal recourse, how are victims or their families going to be compensated? Who is going to pay the bills when someone is harmed or killed by a medical device?

    I want civil rights, tort law, preserved in America. Plain and simple, those who are fighting against our democracy are in the pocket of those who bought them. If they win and ever find themselves in need of a medical device they might find out there is another pay day.

  7. I wonder how these patients will feel when they realize, because inevitably they will realize, that they have been duped. That they have been taken advantage of, lied to and betrayed.

    What a tricky ploy this is. It is time to right your congressman with a letter and attach this article and let them know that you know who is behind it. Then ask your congressman to do the right thing!

    That's what I am doing....

  8. Er write as opposed to right - honest Freudian slip.....


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