The Catheter Popped! But Whose to Blame?

The ruling by the United States Supreme Court on February 20, 2008 protects medical device manufacturers from law suits by patients who have been injured by some malfunction of the device if the device has been approved and allowed to be distributed by review of the Food and Drug Administration (FDA). You can read about the decision in the Washington Post of February 21, 2008. In the Fall of this year, the Supreme Court will be deciding whether to protect pharmaceutical companies against lawsuits regarding the FDA approved drugs.


As I understand it, the Court doesn’t want the states or others to interfere with the decision making of the FDA with regard to medical devices. If the FDA finds that the devices are safe and effective and may be used, that is sufficient to deny claims against the manufacturer. If it could be proven that that the manufacturer failed to follow FDA rules or presented false or misleading information to the FDA then the manufacturer could be held liable for injuries to patients.

But if patients have been injured by a device or a drug which the FDA concludes is safe, who is responsible for the consequences? If the FDA is considered by the courts as the final decider of safety and effectiveness, shouldn’t the FDA be held responsible for any inadequate evaluation it has made? Who should be responsible party when there is harm, the manufacturer, the FDA, the physician or the patient? It appears that the current Supreme Court ruling, by protecting the manufacturer and with no recourse against the FDA, it is the patient who must ultimately bear the burden of errors in the system apparently in order not to stifle medical research and development which would be of benefit to the many patients. What do you think about the ruling and who should be responsible? Are the harms simply spontaneous accidents and therefore simply an act of God and nobody should be penalized? ..Maurice.