An editorial in today’s New England Journal of Medicine laments the result of the Riegel v. Medtronic decision, based mostly on the NEJM’s concern that “ preemption will result in medical devices that are less safe for the American people.” The editors point to the most recent example of preemption in action, in which a district court judge in Minnesota dismissed over 1000 cases that had been filed against Medtronic for injuries resulting from failures of its Sprint Fidelis implantable carioverter-defibrillator lead (see my March 15, 2009 post for details).
In addition to the disadvantages that Riegel imposes on American consumers of healthcare needing medical devices, the NEJM notes that in light of the more recent decision in Wyeth v. Levine , there has been created an unnecessary and ill-advised conflict: preemption for medical device makers; but not for drug companies with insufficient warning labels on their products, despite FDA approval.
The solution? The Medical Device Safety Act of 2009 . This bill would essentially nullify the Riegel ruling, and allow patients to seek redress when FDA-approved medical devices injure them. The NEJM editors are not only compassionate in the way doctors should be toward their patients, but their suggestion would resolve a legal conflict that makes little sense.
And of course, their argument gains additional traction when each news cycle reminds us of how little reliance we consumers of medical care can realistically place on FDA approval. In today’s ABA Journal , we learn: (a) that a study of the anti-psychotic drug Seroquel revealed risks of weight gain and diabetes for patients; (b) the study was disclosed to the FDA, but not to doctors or the public; and (c) the FDA nonetheless approved Seroquel as safe and effective, even though the study itself was supect due to the number of subjects who dropped out before its completion.
Here’s hoping that the new FDA, under new leadership, can do better.