Saturday, December 22, 2007

Faulty Marquis Defibrillator? Here's $35K

We now can estimate what one device failure costs device companies per patient: $35,645.04. And throw in $18.5 million to be distributed amongst the lawyers who worked so hard on behalf of the nearly 2,682 patients.

Medtronic has agreed to pay $114 million to settle the liability claims against it but states the settlement does not mean it admits liability or the validity of any defenses in the litigation.


This is probably an important little "oh-by-the-way" as the Supreme Court decides the issue of whether device manufacturers are liable at the state level after the feds (a la the FDA) have approved such a device.

The Marquis battery recall occurred when the process of such recalls was in its infancy: doctors, ever ready to "protect their patients" removed the devices because of concerns the device could short-out and fail abruptly, leaving their patients without backup pacing or the ability to shock their arrhythmias. After replacing many of the devices, it later became apparent that there might be a downside to this approach: a small but real number of patients experienced an infection from the follow-up surgical procedure. Devices, leads and all, then had to be removed. It was a mess. So a more cautious approach was later advised: have the patient check their device with a magnet to listen for an "all's clear" tone each day. It was a pain in the rump for the patient, but it avoided the risk of infection. Doctors got smarter. Call it a learning curve.

And so, with the more recent Sprint Fidelis recall, we saw a more conservative approach - watch and wait. It remains to be seen if this is the right approach, but given our earlier experience, it might be more prudent.

And maybe just accepting that such recalls will cost the device companies about $35K per patient to settle.

Let's see: 235,000 active Sprint Fiedelis patients x $35K?

About $8.4 billion.

On second thought...


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