Thursday, June 4, 2009


In an article solidly behind preemption we see this from the Southeastern Texas Record -

Citing federal preemption, MDL judge dismisses hundreds of Medtronic suits

"Stating the plaintiffs' claims are preempted by the Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act, Judge Kyle wrote that the court recognized that at 'least some plaintiffs have suffered injuries' but that the 'plaintiffs assert claims for which the Court simply cannot provide a remedy.'
The article goes on to support the decision but what becomes obvious is the simple fact that no matter how much harm might come to unsuspecting medical device patients and no matter what a judge might want to do to remedy that, preemption does not allow any other course of action, even including discussion, fact finding or investigation into management practices, fraud or outright criminal conduct.

With FDA Preemption we live in a town without a sheriff. Be very careful that you don’t come into the company of a bad crowd.


  1. Indeed. Which is why it is so important that Congress amend the MDA.

    The same Supreme Court that voted 6-3 against preemption in Levine voted 9-1 in favor in Riegel. The wording of the MDA, the the Court's own precedents, are the reasons why.

  2. Reading the article I found two statements in defense of preemption that send chills up ones spine.

    “In an FDA statement on the voluntary recall, the FDA states, "When a defibrillator lead is slightly more prone to fracture, it doesn't mean that every lead will break.”

    “Doctors and medical advisors advice against patients seeking replacement of the leads as the risks associated with removal far exceed the risk of a lead failure.”

    So here we have a situation in which a company sells a faulty product that is implanted in a patient but removal of the device could and has killed. How comforting to know that “(not) every lead will break”.

    I don’t know about you but I would sleep a little uneasy, maybe not at all, if I knew that I had unknowingly spun the roulette table of health.

    The thing about preemption is that it does tie the hands of Justice. Today it might be faulty electrical leads stuck in your heart and tomorrow it may be that thousands are killed by another device. Certainly over time the numbers of harmed patients will likely continue to climb at an increasing, not decreasing rate.

    But the bottom line is that this is of no concern to the medical device manufacturer. Does the manufacturer need to be ever vigilant about the design of its product? Well, no not really, they just need to get past FDA approval. Unfortunately some will do that by less than ethical means.

  3. To: Medtronic, et al.
    From: God@Heaven.above
    Cc: All Star League
    Subject: Hard Slap

    Medical devices breeze through testing.

    You are a major reason the phrase “Approved by the FDA,” has lost its gloss. If somehow you missed that fact, see:

    The ballgame now is, “The new FDA and Congress vs. The Medical Device Industry and Preemptors.”

    One way or the other, the tyranny is coming to an end. Congress will amend the law or the FDA will begin to use the powers they always had to protect the public.

    Can your hearts take it?

  4. Outrageous as it may sound -- FDA and all its tributaries need to be archived. Otherwise we're doomed to lobbyists and forever trying to put the toothpaste back into the tube. More efficient,time and cost-effective to begin a new agency.

  5. By the way - as you may have seen elsewhere the FDA has a blog! SEE HERE

  6. Anonymous -
    I agree there are some obvious and foundational problems with the FDA.

    Being wrapped around the finger of the industry it regulates is one way to put it.

    Here's another way it has been put from our father Ed Silverman of Pharmalot in October of 2007. THE FOX IN THE CHICKEN COOP


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