The Problem That Just Won’t Go Away

The Problem That Just Won’t Go Away

Back in July Diabetic Investor reported that the Food and Drug Administration (FDA) had initiated a recall of all Medtronic (NYSE:MDT) Paradigm insulin pumps. According to the recall;
“Exposure to Magnetic Resonance Imaging (MRI) has resulted in damage to the component that monitors and controls movement of the motor in the MiniMed Paradigm insulin infusion pump. Although there were alarms as a result of the damage, some users cleared these alarms and continued using the pump. Under such conditions, the pump will significantly over-deliver; potentially causing severe hypoglycemia”

On July 18th, we wrote-“ Searching through the FDA’s MAUDE database there were 29 deaths reported for patients using a MiniMed insulin pump. Although all 29 reports did not come with detailed explanations, 7 of the 29 specifically mentioned hypoglycemia or systems of severe hypoglycemia such as a coma or seizures. That means 24% of the deaths were associated with hypoglycemia – an event that FDA does not consider a serious risk. Diabetic Investor doubts the families of the 7 MiniMed patients who passed away as a result of hypoglycemia would see it that way.

Our search also discovered two more adverse event reports that specifically mention MRI. Both were from the 500 series one on 5/1/2007, the other on 5/2/2007- again well after the date when MiniMed said they sent out letters warning patients of this issue. This brings the total number of adverse event reports that specifically mention MRI or X-ray up to 9, 7 of which occurred weeks after MiniMed sent out letters warning patients of this issue.”

We speculated that although Medtronic was doing their best to downplay this issue, that the company knew there was a design flaw associated with the Paradigm line of pumps and were working on fix. Based on a letter sent to MiniMed patients dated September 17, 2007 it looks as though the company is having some problems fixing the problem. (A copy of the letter is attached.)

In what is becoming typical Medtronic fashion the company is trying to deflect the issue away from the design flaw and make it appear as if this is an industry wide problem. The letter states “Although our recent communications focused on Medtronic Diabetes products, other insulin pump manufacturers also warn against exposing their insulin pumps to MRI.”

This is a true statement but has nothing to with the real problem which is what happens when a pump is exposed to a MRI. Based on Diabetic Investor’s discussions with other insulin pump companies it appears Medtronic pumps are the only pumps that do not shut down automatically when the pump violates it’s programming. In reality insulin pumps are mini-computers programmed by their users. It appears that other pumps are designed to shut down should the pump violate the programmers instructions. In Medtronic’s case the pump is not only not detecting a programming violation, it also fails to detect that the pump is over-delivering insulin. When it comes to insulin pumps everyone but Medtronic takes the approach it’s better to shut down when a problem is detected than put the patient at risk.

This most recent letter from Medtronic is clear evidence that the original recall did not get the job done and the problem persists. Back when Diabetic Investor first reported on this issue we were astonished that so few Medtronic patients and physicians were aware of the recall, this in spite of the fact Medtronic claimed to have sent letters to patients and physicians. As we reported there was no mention of the recall on the company’s web site. Based on what we know today it’s obvious to Diabetic Investor that Medtronic knew the problem existed, tried to sweep it under the rug and may be responsible for several deaths.

Still the FDA does nothing. How many people need to die before the FDA takes action? Where is the outrage? How can people sit back and let the company mislead the patients who use their product and the physicians who prescribe it? Medtronic’s actions are not only shameful they are morally repugnant.

Prior to being acquired by Medtronic, MiniMed enjoyed an excellent reputation with patients and physicians. Back then the company placed the interest of the patient first knowing that by taking care of the patient the business side would take care of itself.

After being acquired by Medtronic this attitude of putting the patient first quickly dissolved as one of the first things Medtronic did was cut back the number of customer support personal. A move that was later reversed but only after the damage was done. Next the company experienced problems getting the Paradigm line into the marketplace, after extensive delays the products was launched prematurely and was beset with problems. After several changes in MiniMed’s management team it appeared the company had worked through their problems and was back on track.

Given the actions they taken with the Paradigm recall it appears once again the train has derailed.

Looking over the total body of evidence it appears that Medtronic has done to MiniMed what Abbott (NYSE:ABT) has done to Therasense and run a once great company into the ground. Only in Medtronic’s case the reasons for MiniMed’s fall from grace has less to do with poor management and is more directly related to plain old greed. The company made a conscious decision to low key the recall in order to avoid replacing a defective product.

The FDA is equally culpable here as they basically let the company deal with the issue on their terms instead of forcing the company to replace a product that has a design flaw.

The truly sad part is people have died as result of these decisions and that’s inexcusable.

David Kliff
Diabetic Investor
847-634-4646 fax
224-715-3761 mobile