DIABETES CHARITABLE GROUP DUMPS MEDTRONIC

IPump.Org, Inc. Will Refuse Diabetic Supplies Made by Medtronic

In what could become an unprecedented kind of initiative, IPump, Inc. has issued a statement that it will no longer accept donated products manufactured by Medtronic.

IPump is a 501(c)3 organization founded to get needed supplies to diabetic children in families that cannot otherwise afford that care. It is no small thing, therefore, for such an organization to close the door on a corporate donor.

IPump's statement on the matter can be accessed at:

http://www.ipump.org/blog/2009/08/08/why-we-are-no-longer-accepting-medtronic-insulin-pumps-and-pump-supplies/

There is discussion both of recurrently failing Medtronic devices, cover-ups, and Medtronic's role in the the fight for FDA preemption in the arena of medical devices.

The statement begins:

"Legal and Ethical Concerns Over Medtronic’s Business Practices

Medtronic has a court-documented track record of failing to properly notify its customers in a timely fashion of known product defects. Product failure has resulted in deaths, hospitalizations, and both individual and class action lawsuits against the company. Their inexcusable behavior has even prompted new proposed legislation because legal rights for patients who died or were injured by Medtronic products were substantially limited when it came to suing for tort damages."

IPump further describes Medtronic collecting used and returned devices and "donating" them to IPump, so that the organization has become (their phrase) a "medical device dumpster." It is also a tax write-off for individual donors of used devices and, until now, good PR for the company.

Quite extraordinary development, I think.

WE WON!

David Vladeck to FTC

When Dan Troy left his role as FDA Chief Counsel in 2004, he had only a few comments to the press. One was his reflection, "We won," referring the the 2004 Bush reelection and perhaps more.

Troy continued to impact matters FDA and the superstructure of rule-making--the 2006 preamble, the CBE changes, etc.--all of which were to be part of the yellow brick road to preemption.

Of course, as it turned out, the road was a house of cards. It was whisked away as "meritless" in the Levine majority and essentially ignored in the dissent. It turned out that nothing was won after all, at least not on that front.

So, with relevant perspective, we can celebrate a bit here after learning of the appointment of David Vladeck to FTC. (Hat tip to Pharmalot in exile and various links along the line). Most here will know Vladeck through his writings against preemption that, it turns out, were cited at significant points in the majority opinion in Levine.

So there are still battles to fight: Device preemption as represented by the Riegel decision; Michigan's odious shield law which is on another legal planet even relative to the dissent in Levine. But there should always be a moment when we can kick back, check in on a link,

http://www.democraticmedia.org/jcblog/?p=791

open a brewsky, and say--with relevant satisfaction--"We won."

And they didn't.

The New England Journal of Medicine's Opinion on Medical Device Safety

THE SUPREME COURT'S RULING IN RIEGEL - NOT BASED ON WHAT IS BEST FOR THE HEALTH OF THE PUBLIC.

The attached statement by The New England Journal of Medicine says it all and explains their view on what needs to be done.

The Medical Device Safety Act of 2009

Past Time to Right a Wrong

Remember Riegel v Medtronic and the Supreme Court decision exonerating Medtronic because their heart catheter was FDA approved? Well, Medtronic is back in the news. It should be apparent to anyone who reads the NYT’s article Lawmakers Seek to Return Right to Sue Device Makers - NYTimes.com, that enough is enough.

Because of the Supreme’s misguided Riegel decision, injured Americans throughout the country have had their cases tossed out of court. Bills have been written to end this insanity, but have not yet passed. Congress needs to pass them, now, before anymore women are burned internally, hearts are shocked or torn apart, and defective implants and treatments go horribly wrong.
Please read the Times piece and come back and tell us your thoughts.