The Medtronic Way
There was time when MiniMed was known for the best customer service in the industry. Prior to being acquired by Medtronic (NYSE:MDT) it would be a fair statement to say that MiniMed set the standard by which all other insulin pump companies customer service departments are judged. Back in the day, MiniMed actually put the patient first.
Unfortunately, this tradition of putting the patient first did not carry over when the company was acquired by Medtronic. As Diabetic Investor has been reporting the company has done a poor job of informing their patients that the Paradigm line of insulin pumps has an issue should it come in close proximity to an MRI. Instead of shutting down, the pump can over-deliver insulin and potentially lead to a severe hypoglycemic event. This situation did lead to a recall but for reasons only Medtronic and the FDA seem to understand it was Class 2 recall and not Class 1 where the device would have to be replaced. Although everyone else sees severe hypoglycemia as a life threatening event, the FDA does not.
Medtronic’s stance on the issue is they went above and beyond what they were required to do. Sending out letters to their registered users and physicians. As Diabetic Investor reported there was no mention of the recall on the company’s web site and when we called the customer service department they were unaware of any recall. The issue did not go away as the company sent out another letter that reiterated the MRI issue and came with a sticker patients could place on their pump that warns against wearing the pump near an MRI.
Apparently Medtronic’s corporate policy is similar to what politicians do when they get in trouble, deny, deny and deny. Only when backed into a corner do they admit there is a problem. Evidence of this comes in today’s Wall Street Journal in an excellent front page article; “Medtronic Recall Exposes Gaps In Medical Safety.” The story outlines who the company handled a different problem with their defibrillator leads.
What is truly disturbing is the similarities between the two events. Although evidence of problem with the leads came to light in January of this year it took Medtronic nearly 10 months to pull the product from the market and admit they had a problem. In between the company did everything they could to avoid pulling the plug and admit what everyone else seemed to know. At first, they claimed physicians were inserting the leads improperly. Next they tried to convince physicians that the number of lead failures was statistically insignificant. Although patients were dying as a result, the company continued to claim the leads were safe.
According to the article; “The company was trying to get to the bottom of what was becoming a crisis. Medtronic says it learned about the five deaths potentially linked to Fidelis leads between August 2006 and this September. The patient study it had begun in 2004 by late July had data on 654 patients, and the separate, eight-month CareLink analysis of 25,000 patients was well under way. Using that information, Medtronic analysts by October determined that the Fidelis overall failure rate — 2.3% over 30 months on the market — was higher than the 0.9% rate for one of its Quattro models.”
It wasn’t until October 15th when the company acted and pulled all the leads related to this issue. Stating “is the right thing to do given currently available information.” To Diabetic Investor this last statement is pure hypocrisy. The reality is Medtronic was more interested in covering their backsides than putting the patient first.
We all know that no medical device is perfect, failures will occur. However any medical device that is critical to the lives of patients must meet a higher standard of performance. An insulin pump is such a device and no one failure should cause the pump to over deliver insulin. This is a $7000 device and for that type of money patients should have a reasonable expectation that the device they need every day of their lives won’t kill them.
Medtronic and the FDA should both be ashamed of themselves over how the Paradigm recall was handled. How many patients need to die before Medtronic admits there is a design flaw with the Paradigm pump? Does a patient have to drop dead right in their corporate headquarters before they “do the right thing”? What happened to putting the patient first?
Ralph Waldo Emerson once said “In failing circumstances no man can be relied on to keep his integrity.” Diabetic Investor understands fully Medtronic shares would suffer should they replace the Paradigm pumps in the market. To Diabetic Investor this is a small price to pay when one considers the value of a human life. This is the right thing to do, let’s just hope no one else has to die before Medtronic understands that.