This is a link to a blog that clearly explains the flawed reasoning that medical device and drug preemption advocates are dealing with. Far from being an all knowing, faultless administration, the FDA is actually fraught with corruption,lack of funds, overwork, and the inability to fully investigate and follow up on products they have approved for market. Should the public be expected to bow to the FDA’s decisions and be left with no recourse when, by the FDA’s own admission, they are a flawed administration?

This is a link to a blog that clearly explains the flawed reasoning that medical device and drug preemption advocates are dealing with. Far from being an all knowing, faultless administration, the FDA is actually fraught with corruption,lack of funds, overwork, and the inability to fully investigate and follow up on products they have approved for market. Should the public be expected to bow to the FDA’s decisions and be left with no recourse when, by the FDA’s own admission, they are a flawed administration?

I was then told that I would need a defibrillator installed and that I could never play any contact sports ever again. What a blow that was.

As time went on I then recieved a letter in 2005 from Medtronic to contact my Dr about certain defects regarding my device. I spoke with my Dr and he said that I need to schedule a replacement surgery pronto. What these mega companies and these defense lawyers are not getting is that being told that your device is being recalled is something that is very depressing. I then looked into my situation and thought I can’t let this get me down. And I moved on.

I want to say about a couple months after my replacement surgery which took a couple of months to heal and is a life threatening procedure. I saw a news report stating that Medtronic new about the defective devices and still put them out there for profit. And then was paying doctors kickbacks to help promote there products.

Recieving this info put me in a state of depression. I looked at the situation like if I can’t trust my own doctor who can I trust. Medtronic made billions off the people by selling the people defective devices.

Medtronic argued that the federal Safe Medical Devices Act of 1990 preempted state law claims related to its products. “Medtronic thought that within one year, this litigation would be history because of preemption. Not the case. Rosenbaum ruled that the plaintiffs had raised triable issues of fact as to whether Medtronic had actual knowledge of the defect and hid that evidence from the FDA.
In his ruling, Rosenbaum wrote, “It defies logic, and flies in the face of Congress’s decision to impose a regime strictly regulating medical device manufacturers, to think Congress intended the result Medtronic advocates.”

Know with all this info on the table, it is an insult to the American public for these mega defense lawyers and mega corporations to think that they can do whatever they want to the people to gain profits. And it is another insult to know that the Bush administration is backing these corupt businesses. I’m wondering if Medtronic cut the Bush administration a check to join forces with them.

This issue is one of the biggest decisions the Supreme Court will ever have to face. Even with Judge Rosenbaum defending the people. Medtronic has equiped themselves with probably the best defense team put together. But with the edvidence against them its going to be a challenge for Medtronic to overcome these sticky charges. I am not looking for a big payday here I just want justice to be issued and Medtronic to be made the example of corupt business practises. To me Medtronic is worse than that well known Enron company.

To me this reminds me of the biblical story of David and Goliath. May God be with all the victims.

Reading back in time, fen-phen, Baycol, Rezulin, Vioxx, et. al. have also been awarded Bendectin status.

1. It is true that devices, unlike drugs, have enjoyed the shield of FDA preemption based on earlier Supreme Court decisions. That is the only reason preemption has been “express” for devices. It would be very surprising if the current Supreme Ct. reversed itself on this.

2. There is _no_ “implied preemption” in the arena of drugs as things now stand. Rather, it is the argument of those who defend FDA preemption that there _should_ be preemption; that is, they have come up with 1,001 reasons why preemption in the drug arena is, indeed, “implied.”

Thus, from their perspective - mainly lawyers who defend drug and device companies - they would like to see the same essential ban on bringing lawsuits over drugs that now applies over devices.

The FDA itsself did not argue for “implied preemption” (except in rare instances) until the beginning of the current Bush administration in 2001. Indeed, their position was that their regulations implied no such preemption.

3. “Trumping an FDA rule” is also framing things in the language of drug and device defense lawyers. It is essentially a circular argument. The only “FDA rule” that would be trumped via civil liability is the assertion of FDA preemption itself. The rule in question was in the preamble to the new labeling guidelines that came out in 2006. Once again, the “rule” is a creature of the current Administration, inside and outside FDA.

And, once again, in most instances, FDA’s position had beeb that the agency’s regulation and civil liability were generally _complementary_ layers of consumer protection, neither one “trumping” the other.

I would suggest that history shows they have, indeed, worked very well in tandem. Despite the arguments of the preemption folks, there has been no confusion, chaos, or disaster as a result of having both systems. Besides complementing each other, they also cover a number of different arenas.

The preemption folks will answer, “Remember Benedectin!” (as in “Remember the Alamo!”). Benedectin may be the one time a drug was withdrawn in the face of civil suits that turned out not to have the dangers suggested. So we hear a _lot_ about it! SSRIs are the “new Benedectin.” And Avandia is “the New Benedectin. And Zyprexa. And on. And on. And on.