Medtronic Sprint Fidelis leads even more defective than believed at recall
The argument for allowing medical device manufacturers immunity gets weaker by the day as more information is learned about Medtronic's Sprint Fidelis leads. We have posted several log entries on this subject which can be reviewed for historical perspective. The Supreme Court recently "re-interpreted" the intent of Congress in enacting a 1970s-era law, in order to grant medical device manufacturers immunity for devices approved by the FDA. The Fidelis lead problem demonstrates graphically why this decision should be overturned.
Fidelis leads connect defibrillators to the heart. They are implanted in the body and are dangerous and difficult to remove. They are essential to the proper and safe operation of defribillators in the nearly quarter million Americans in whom Fidelis leads were implanted. Fidelis leads are much thinner than the metal cables they replaced, or their competitors' leads, and have been found to be unduly prone to breakage; as a result they are no longer implanted in patients. They were never carefully scrutinized for safety by the manufacturers or the FDA, because they were "grandfathered" for approval under their predecessor, thicker cables.
A new study conducted at Mayo Clinic and the Minneapolis Heart Institute, involving 3,000 patients, finds that only 88 percent of the Fidelis electrical leads are functioning three years after implant. It found that Fidelis leads demonstrated a failure rate of almost four percent per year, with the rate increasing with the age of the implant, compared with only a 0.6 percent, stable annual failure rate for other manufacturers' leads. Medtronic disputes the accuracy of the Mayo Clinic numbers. Medtronic had claimed that 95 percent were still functioning after three years; even that failure rate was sufficient to discontinue production and implant of the leads in patients.
As a result of being too thin, the Fidelis leads are prone to fracture and malfunction. By 2007, they were identified in at least five patient deaths, according to Medtronic's own data. Nevertheless, surgeons do not recommend removing them on a precautionary basis, because the surgery involved is too dangerous.
There is no public policy basis for protecting Medtronic from liability for its gamble with patient lives. Unlike other manufacturers, it chose to put an inadequately tested, unduly thin product on the market, relying, as we understand it, on prior approval of a dissimilar pacemaker device. Since FDA scrutiny and "approval" of the product was clearly and grossly inadequate, the approval process should not be relied upon to protect patients and should not secure immunity for the manufacturer.
These patients should enjoy a right of fair recourse against the wealthy manufacturer of the Fidelis device. If the device was to be marketed without adequate testing, should bear the resulting risk. Medtronic should have been required (by reasonable corporate standards) to purchase adequate insurance--based on adequate underwriting analysis--to fairly compensate potential victims and to protect shareholders from a catastrophic failure in judgment and overwhelming product liability claims.
While anyone can find flaws in the product liability schemes of any given state, any thoughtful, disinterested observer must recognize that appropriately designed product liability compensation systems protect consumers from precisely this kind of greed or stupidity. A bald grant of immunity to a profit-motivated corporation, where government regulation is inadequate, is clearly not in the public's interest.