Tuesday, February 24, 2009


The results of a 2004-2008 study by Dr. Robert G. Hauser, Minneapolis Heart Institute, and Dr. David L. Hayes of the Mayo Clinic indicate that the failure rate of Medtronic’s Sprint Fidelis lead is, over time, increasing.

The study involved of 3,000 heart defibrillator leads, 848 of which were Medtronic’s Sprint Fidelis. In comparison to the others, the Sprint Fidelis had a significantly higher rate of failure and was less stable. See: Study Suggests Higher Failures for Heart Device - NYTimes.com

Recently, after citing the Riegel v Medtronic Supreme Court decision, a federal judge threw out hundreds of lawsuits regarding Medtronic’s Sprint Fidelis lead. Please read the NYT link and come back and tell us what you think. Should devices with such a poor track record be protected under FDA preemption?


  1. Dianne asks: "Should devices with such a poor track record be protected under FDA preemption?"

    Strictly speaking, I think the arguments for or against preemption as policy do not depend on the track records of particular devices. No need to reiterate all that.

    But examples of major regulatory failure, if that is what has happened, should force us to put ourselves in the role of those who have been injured as part of whatever policy balance we think best faciliates justice, public health, and the proper balance between the claims of industry, FDA, and citizens/patients.

    Preemptors tell us that lawsuits, by focusing on "sympathetic plantiffs," lead us to ignore the "big picture" (which, somehow, only FDA is capable of doing).

    Ironically, there have been a number of thoughtful, pro-preemption people who happened to be among those seriously injured by a drug or device.

    As far as I know, every one of them modified their views as a result of their experience. All of a sudden, they themselves, and potentially any one of us, were in the picture.

  2. As an example of what I describe above, consider the case of Gary Murphree. He had been honorary chair of the Mississippi Republican Party. He was a $100,000 donor to the 2000 Bush campaign. A year later, he suffered through three failed pacemakers (not Medtronic's) and seven surgeries.

    His case happened to be one of the first in which Dan Troy intervened as FDA Chief Counsel using the FDA preemption defense.

    Murphree went through disbelief to outrage. "I'm for tort reform," he concluded, but "not for taking away people's rights."

    The story is summarized in Stephanie Mercimer's book and in a number of articles.

  3. Preemption certainly takes away some measure of incentive to monitor, evaluate and possibly change a product after FDA approval. If you have spent any time in industry you know that a company will not spend resources that that it absolutely does not have to or need to spend. Corporations are about making money. It is foolish to spend resources on anything that does not promote profit. Taking it a step further. Why would a company spend more than they need to to test a product prior to approval. You only test to the degree you feel you need to to get approval. Cutting corners, if they are justified, is good business practice.

    This is why we need liability law suits and why we can't allow preemption. The natural course of business is to make the least costly product that performs to just the acceptable level for the consumer thereby maximizing profit. Getting as close to this line as possible is the endeavor of all smart companies.
    Going over the line and getting caught and having to pay for it or losing consumer confidence is the only thing that forces a company to spend more resources than they normally would on things like performance and safety.

    The reason that preemption came into being is for profit maximization. It relieves companies of the resource sapping activities.

  4. Justice, is this where the phrase “Murphy’s Law” came from?

    Should we pray for Mr. Troy’s heart…Oh, forget it, he doesn’t have one.

  5. To Jaynesday--To "try on" an alternative argument, companies would assert that making the most safe and effective products will itself lead them to greater market share. So they don't need the threat of lawsuits (or even FDA regulation) to do the best thing--both for pts and themselves.

    In fact, I believe that in most instances. It is specifically in the "blockbuster" arena that we see most problems, for obvious reasons. The whole franchise, or much of it, may be riding on success.

  6. Justice,
    You are correct, safe and effective is a real selling point.
    However still for any product there comes a point that this question is asked. How can we make the same product at less cost? Is there anything in the life cycle of a product that can be cut out and still maintain the maximum profit. How close can we get to the minimum cost line (think of a graph) without affecting our product safety and performance?

    In doing this the risk that we will cause safety/performance issues increases. But profit will be greater.

    It's one thing to minimize cost when you make a filing cabinet but totally another thing when you are making drugs or devices that you ingest or implant in a human body.

    You would think that Pharma would not dare to get too close to this minimum cost line, but you can't help but understand that they wish to.

    I don't know that this next thought is true or not but...
    I've often heard it said that we can't expect totally safe pharma products and that we can't live without some pharma products. Does this way of thinking allow some companies a level of comfort in designing or producing product too close to the minimum cost line? Does preemption facilitate such a decision?

  7. J - I agree with what you say. For obvious reasons, the pressure to "push the envelope" is just much stronger for blockbusters and blockbuster wannabes. Indeed, it's almost irresistable, especially if you assume the competition is doing it, which assumption keeps the cycle going. Virtually all the internal documents we've seen confirm this.

    Re: your last point, yes, I do think (and have heard it said by industry folks) that people will never bail on the industry more generally because of obvious need. On the other hand, the drugs that have done the most damage--Vioxx, fen-phen, Baycol, thalidomide, et. al.--were neither uniquely efficacious (the contrary) nor filling a need that wasn't already being filled by numerous alternatives. The Rezulin situation is a bit more complicated because it was first in class, but there was certainly no shortage of diabetes drugs.

    So I think that way of thinking may be based on a kind of mutual illusion--emperor's clothes--that may not be as sturdy as some think.

    I know of instances in which genuinely exploitative lawsuits pushed good people inside companies into silence and, in essence, ambivalent complicity. But, overall, it is hard to imagine that the potential of lawsuits in general does not have a "temporizing" effect, again, in the blockbuster arena most specifically. That, too, is what insiders and internal documents suggest.

  8. Dianne, thank you for posting this article. This is a good discussion. Jaynesday said, "Going over the line and getting caught and having to pay for it or losing consumer confidence is the only thing that forces a company to spend more resources than they normally would on things like performance and safety." Here is a good example of this:

    Click on my name to read an article in The Dallas Morning News about a medical device company executive who is on the run after being indicted last week for selling tainted syringes. Use of the tainted syringes killed five patients and made hundreds ill, including 20 patients at Children's Medical Center Dallas.

    These so-called businessmen are on their way to prison.

  9. P-brittle,
    There are all kinds of people (good and bad) that can come to a position in a company in which they can, if they want, take advantage of the good will of the consumer. Even with the FDA as our watchdog.

    Because our society allows this, we can not allow corporations to have freedom from inspection by the courts. This freedom is insured under preemption.

  10. "FDA didn't inspect syringe plant despite reports..."

  11. Medtronic CEO speaks out.

    Click on "Glad" for the rest of the story...

  12. Medtronic seems to be on a PR offensive. They recently announced that they would release "moneyto docs" that amounted to 5K or more.

    Of ocurse, that is 50 X what the Grassley bill class for and 10X what PhRMA's alternative "guidelines" call for. They juggle for a while trying to explain the difference between drugs and devices.


Note - Due to a time out issue with Blogger, you may receive a message that requires you to resend your comment. This will not affect its contents.