The Supreme Court handed down a major victory for the Bush administration today. Here's the NYT summary:
Makers of medical devices like implantable defibrillators or breast implants are immune from liability for personal injuries as long as the Food and Drug Administration approved the device before it was marketed and it meets the agency's specifications, the Supreme Court ruled on Wednesday.
The 8-to-1 decision was a victory for the Bush administration, which for years has sought broad authority to pre-empt tougher state regulation.In 2004, the administration reversed longstanding federal policy and began arguing that "premarket approval" of a new medical device by the F.D.A. overrides most claims for damages under state law. Because federal law makes no provision for damage suits against device makers, injured patients have turned to state law and have won substantial awards.
The Bush administration will continue its push for pre-emption in another F.D.A. case that the court has accepted for its next term, on whether the agency's approval of a drug, as opposed to a device, pre-empts personal injury suits. Drugs and medical devices are regulated under separate laws....
It was not immediately clear how many of the thousands of lawsuits against medical device manufacturers would be affected, though some pending cases will almost certainly be nullified.
The decision, for example, does not foreclose lawsuits claiming that a device was made improperly, in violation of F.D.A. specifications. Cases may also be brought under state laws that mirror federal rules, as opposed to supplementing them.
In theory, this makes perfect sense. If the FDA has approved a device and that device is flawed, the maker of that device deserves some sort of protection. In reality, there are several problems with this.
First, and most fundamentally, this means that the FDA's approval process must be rock solid. If liability is to be foreclosed after approval, then the approval process must be far more rigorous than it currently is.
Second, recognizing that no approval process could ever be perfect, if a device is approved and then causes widespread harm, will citizens be able to sue the FDA for failing in its duties to protect citizens?
And finally, third, there is the potential issue of moral hazard. Under the previous system, device makers who manipulated the FDA process to get approval for an unsafe device could be sued by both citizens and government alike, dramatically increasing the potential risk and penalty for lying to regulators. Now, however, the FDA approval grants a form of immunity, decreasing the potential cost for lying. FDA approval will act something similar to home base in a game of tag - if you can make it home, you're safe, no matter what. That has the potential to dramatically increase the incentive to push the envelope during the approval process. And that brings us right back around to point one.
If the FDA were a fully funded, completely independent agency that was fully insulated from the influence of those it regulates, this would make perfect sense. But it is not, of course, nor will it ever be.
This decision may be right on its merits, but it creates a serious policy problem that congress will need to solve. Thankfully, it looks like Rep. Waxman is already on the case.
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