Personal Injury Law

Medtronic Recall: Comment on Wall Street Journal Editorial

An editorial in the Wall Street Journal last week discusses the Medtronic recall of its Sprint Fidelis defibrillator leads. On October 15, 2007, due to reports of at least five patient deaths associated with defects in its Sprint Fidelis defibrillator leads, Medtronic withdrew from the market all defibrillators with those leads. Leads are connected to a defibrillator that both transport information of an irregular heartbeat to the defibrillator and carry what are often lifesaving electric impulses to the heart. The Sprint Fidelis leads were withdrawn because many of the leads were either not performing at all or were administering unnecessary shocks to the heart.

This editorial, as you would expect in the Wall Street Journal, has a pro-medical device manufacturer slant. The article claims that cardiologists have been calling for smaller leads because they are easier to thread through the veins when implanting the defibrillator and because they are less likely to lead to blood clots or distort heart valves. The actual evidence as to this groundswell among cardiologists for thinner leads is less clear.

This editorial argues that in the post-Vioxx era, drug and medical device companies ?are under pressure to get out in front of even modest risks in spite of the fact that all therapies carry some risk.? The editorial opines that these withdrawals ?strip choices from patients and their doctors.?

But this editorial does not point to a single medical doctor in the country who has stated that he/she would still rather use the Sprint Fidelis leads instead of the Sprint Quattro leads that were working just fine before the Fidelis leads came along. In fact, the editorial does not refer to any recent time when doctors protested the withdrawal of any drug or medical device because risk/benefit analysis favored continued use of the drug.

The editorial also expresses concern that Republican Senator Chuck Grassley is pushing legislation to require full disclosure of the terms of drug and medical device companies? financial relationships with doctors to resolve the problem of pharmaceutical companies buying the allegiance of the leading doctors and researchers.

Trust me, as someone who has gone around the country developing experts for both drug and medical device companies, this is a huge problem. With certain drugs and medical devices, it is impossible to find a doctor who is an opinion leader with no financial ties ? directly or indirectly ? to a pharmaceutical company. Most of these doctors are good, honest doctors trying to do the right thing by patients, but it is hard even for the straight shooters not to be influenced by financial ties with these companies. And if you do cross these companies, look out. They very well may come after the doctor?s career. (This post discusses just one example.)

On this issue, this Wall Street Journal editorial goes to the tried and true: blame the trial lawyers. It claims that publishing the names of doctors will ?create a registry of the deepest pockets for trial lawyer browsing,? which will have a chilling impact on the participation of the best doctors needed to conduct the studies to get these drugs on the market.

Full post as published by Maryland Injury Lawyer Blog on January 10, 2008 (boomark / email).