Tuesday, August 11, 2009

Mr. Epstein and FDA Preemption

Mr. Epstein speaks out in Forbes against Medical Device Preemption AND repeal of Drug Preemption. Mr. Epstein is one of the leading proponents of FDA Preemption.

It is time to examine the arguments of this fine lawyer and see if his words hold water.

Please take a look at the link and let us know what you think.


  1. The most obvious problem with Epstein's argument is that he makes his whole defense of preemption depend on two cases--Levine and Riegel. Neither of these cases would have been brought to the Supreme Court at all were it not for the Bush II Solictor General. True, the Court (or 5 of the 9) decide for themselves whether to hear a case. But, given the current make-up of the Court, it is not surprising that they went along with the Bush admnistration's wishes, even though Levine came out differently than Bush, Inc. expected.

    Because Epstein rests his argument on these two cases--where, indeed, there may have been provider errors (and who, indeed, were also sued)--he makes it sound like the whole preemption issue boils down to such circumstances.

    Nothing could be further from the truth.

    Were a case involving Vioxx, fen-phen, Baycol, Rezulin, and a score of other drugs invoked to represent the preemption issue, all of Epstein's arguments would crumble. In the case of those drugs, no one has claimed "down stream" inappropriate prescribing. Rather, we now know that their manufacturers were aware of serious red flags, and ignored them, camouflaged them, denied them, and/or resorted to intimidation and manipulation of medical journals to keep their blockbuster on the market.

    By avoiding such cases, Mr. Epstein's argument becomes as vacuous and bankrupt and the policy he defends.

  2. It takes no more than the opening few words of this article to understand the duplicity of Mr. Epstein approach to FDA Preemption.

    He says -

    “Congressional mischief comes in large packages, like health care reform, and in small bundles, like the ill-advised Medical Device Safety Act of 2009 (MDSA) which is now moving forward in both the House and Senate.”

    He labels the MDSA of 2009 as “Congressional mischief”! He has the audacity to label the proper form of lawmaking (by Congress) as mischief when he fully knows that FDA Preemption improperly circumvented Congress in its route to revoking the civil right to a day in court by all Americans who feel they have been harmed by a pharmaceutical product. Never mind if their claim is true or false, that is not the point.

    If the proper discussion, presentation, voting and passage of a bill in Congress is “mischief”; what is the clandestine rewriting of drug and device law without presentation to Congress for review and vote make FDA Preemption?

    This demonizing of the fight against the bankrupt concept of FDA Preemption is typical of pro-preemptors. It is extremely difficult for them to base their arguments on facts and logic, therefore presumption, accusation and data absent “facts” have to do. Read the rest of the article and you see what I mean.

  3. In a related development, the Head of Radiological Health (Devices) at FDA is leaving. He is the person about whom whistleblower/reviewers recently complained of squashing debate and pushing approval regardless of data.

    The WSJ story is at:


  4. Seeya, the link you shared states, “The departure [of Dr. Schultz] follows internal dissent over device-approval decisions that the regulator's critics said were too friendly to industry.” Near the end of the article is the comment, “The Advanced Medical Technology Association, a medical-device industry group, praised Dr. Schultz, saying he ensured stable funding for the FDA via industry user fees.”

    This is interesting because it was The Advanced Medical Technology Association who gave Ernst Berndt and Mark Trusheim a grant so they could indulge in a pro-preemption study regarding medical devices. Their study ends with the disclaimer, “The report was made possible by a grant from the Advanced Medical Technology Association. The views expressed are those of the authors only, and do not necessarily reflect views of the sponsor or MIT.”

    Pharmalittle commented on their report on May 6, 2009, see: “STUDY ON MEDICAL DEVICE PREEMPTION - Your Thoughts?”

  5. Hey, Dianne, you win the detective of the month award--great work connecting the dots!

    So, in upshot, we make the links between user fees (PDUFA for devices), defending preemption, industry funding, white papers signed off on by MIT profs, and the director of a major FDA division.

    Did I miss anyone? Perhaps someone in Congress?

  6. And they say we need tort reform!

  7. Presumably, Hamburg has much to do with this exit. Perhaps there will be more to come.

  8. Thanks Dotty. However, I’m not a detective, just an average American who has become an activist in the fight against the business friendly policies of preemption and tort reform. What has taken place is all by design. The changeover, however, looks promising.

  9. Hey, Dianne, you are always an ace detective in my book! But that's how it happens--we decide to find out how things really work when they don't work the way they were "supposed" to...

    I think we all want to be "friendly" to businesses. We just don't want to be reamed by them.

  10. I agree, Dotty. But it’s a lot easier being friendly when you’re not being raped.


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