Medtronic Recall: Comment on Wall Street Journal Editorial

An editorial in the Wall Street Journal last week discusses theMedtronic 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 The Sprint Fidelis leads were withdrawn because many of the leads were either not performing at all or were administering unnecessary shocks to the heart.

Quick 2013 Update to Readers: We are handling Medtronic lawsuits involving their bone infuse product but are not handling lead recall cases.

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.

This argument is specious for a number of reasons. First, the plaintiffs’ lawyers’ hunt for deep pockets begins and ends with the pharmaceutical and medical device companies. Plaintiffs’ lawyers are not trying to tap into a doctor’s million dollar policy when they have a multibillion dollar company like Medtronic right in front of them. So, as a practical matter, lawyers are not trying to hunt down doctors who participated in the pre-market or post-market studies. But if there is a psychological barrier to disclosure, the pharmaceutical companies could simply indemnify the doctors from any claims, which many already do, anyway, because the companies know their liability is overlapping.

Disclosure would be productive because when a post-market problem develops, it would allow for determining the bias, or lack thereof, of the doctors assessing the risk. When problems first surfaced with the Medtronic leads in February last year, doctors split into two camps. Some defended the Medtronic Fidelis leads as safe and efficacious and others discontinued the use of those questioned defibrillator leads. Like juries do with expert witnesses at trial, the medical community and the FDA should be armed with the information of financial bias of those advocating the continued use or the withdrawal of a drug or medical device. The door swings both ways on this point. If a doctor who was critical of the Medtronic leads had a financial incentive to disparage a Medtronic lead because he/she had a stake in St. Jude Medical, one of Medtronic’s competitors, that is obviously relevant as well.

This editorial also laments the public’s overreaction to medical risk. Many patients, after a recall, may stop taking a drug or have a medical device taken out even when it is imprudent to do so, in spite of the accompanying risks. It quotes Medtonic’s CEO as saying that “society’s tolerance for any risks associated with medical technology is nearing zero” but for some, not using a device or drug is far worse for them than the possibility of malfunction.

There is absolutely some truth to this. But what is the alternative? To not tell patients about risks for fear that they might overreact? The irony is rich. The Wall Street Journal has the back of big business at every turn. Big business preaches that consumers should be given information and choices. Yes, let’s sell cigarettes and alcohol by the billions without sin taxes because consumers should be able to make up their own minds. Yet the Wall Street Journal now contends, with a paternalistic tone, that the opportunism of trial lawyers and politicians exposes consumers to information about risks of the drugs and medical devices they use.

The editorial’s last rather random jab at trial lawyers comes in the final sentences, which call the trial lawyers the main problem, noting that the first lawsuits against Medtronic were filed literally the morning after the announcement of withdrawal. Look, I admit that this is unseemly. The rush to file a lawsuit is by lawyers hoping to get their names in the papers as the leading players in the Medtronic cases. I don’t like it either. But it has nothing to do with patient safety. It was just a jab the Wall Street Journal was dying to give but couldn’t find a segue, so it just tossed it in at the end of the article.

The Wall Street Journal is a great paper. But its editorial section is always just a shill for big business. Give me any topic and I can tell you the paper’s opinion without reading a word.

Contact Information