Shares of Medtronic fell today after it announced it was recalling its Sprint Fidelis defibrillation leads from the market.
The FDA was quick to note that the recall does not mean currently-implanted leads should be taken out of patients' pacemakers. The company said it had found "just" five deaths where the leads could have been a "contributing factor."
There are roughly 235,000 patients who have the leads, and they're being asked to see their doctor in case a "fracture" has occurred in it. Vice President Cheney's pacemaker, it is noted, is an earlier model and doesn't have the lead.
So, is that it? Has Medtronic done enough?
I happen to recall a very early episode of Law & Order which dealt with this issue. In The Corporate Veil, the owners of a pacemaker company were held personally liable for problems with cheap leads they had chosen to buy. The owner got 20 years, if I recall. And the D.A. had found about five deaths attributable to the faulty leads.
How old a show was it? Michael Moriarty (above) played the assistant D.A., Ben Stone. That's how old it was.
In the TV show, the company was well aware the leads were faulty. There is no evidence, yet, that Medtronic had a clue about this. Should we look into that?
Have we reached a point in the device market where the criminal law is our best protection, rather than civil litigation or regulation? How bad is it out there?