More Professional Journalism
Leftover from Friday, more professionalism from the New York Time's editorial staff. This editorial is entitled "No Recourse For the Injured" and is in response to the Supreme Court's decision in Riegel v. Medtronic. Legal geeks can read the opinion here. The actual reporting of the decision is halfway decent, but still typically flawed in the way it fails to explain legal basic to the lay public. I won't bust on the Times for that, as it tends to be true of most legal coverage in the media. But the editorial is the exact sort of piece of been railing about, distorting the facts about the Supreme Court's decision in a way which misleads the public. And yeah, it's a little personal- I tried to post a comment Friday evening and either it never got posted or it was taken down. Here's the gist of the editorial:
Consumers are already at the mercy of the all-too-fallible Food and Drug Administration. So it is especially disturbing that the Supreme Court ruled this week that patients injured by defective medical devices cannot sue for damages in state courts if the device was approved for marketing by the F.D.A. and made to the agency’s specifications.
That means that any consumer harmed by a faulty device — whether it be an implanted defibrillator, a heart pump or an artificial knee — will have no chance of fair compensation and the manufacturers will have a dangerous sense of impunity.
And as briefly as possible, here's why it's misleading. Product liability is an area of the law where strict liability applies. Consumers need not show any fault on the part of the manufacturer if they are injured by a routine use of a product. Injured individuals need only show that every product produced is flawed, in the form of a design defect or that the individual product in question was flawed, in the form of a manufacturing defect. The intricacies can be much more complicated, but that's the basic framework you need to understand the case. The Supreme Court's decision only applies to design defects. It does not apply to manufacturing defects. Consumers are still free to bring suits in state court when a product is manufactured in a way that is different from the specs that have been approved by the FDA.
As a matter of law, the 8-1 nearly unanimous decision appears to be correct. The MDA (Medical Device Act) has a fairly clear preemption clause that would prevent individuals from suing over design defects. As Justice Scalia explains in his opinion, there is good reason for this. In order for a medical device to be sold to the public, the specific specs of that device must be approved by the FDA. In considering the request for approval the FDA weighs the risks and benefits of the device to the entire public. If individuals were permitted to sue over design defects, it would give a scientifically untrained jury the opportunity to overturn the expert judgment of the FDA based solely on an evaluation of the risks of the device to a single individual.
Towards the end of the editorial, the Times expresses concerns with the FDA's approval process and questions what recourse an individual would have when the FDA fails. It's a good question, but one that's obscured by completley off-the-mark self-righteousness that pervades the rest of the editorial. As a libertarian however, it's always important to take government incompetence into consideration. I don't have a real good answer in this case because of what I discussed above- even if the FDA does make a mistake in the approval process, an untrained jury looking at one specific instance hardly seems the appropriate forum to correct the FDA's mistakes.
The real interesting question is one of general legal theory- Should government regulation absolve manufacturers of liability? It's not quite the case here, but what if a government agency says you must do X, but your company wants to do Y and you do X just to comply with the law. A consumer is hurt by X and would not have been hurt by Y. Should the consumer be able to sue on theory that the company should have used Y? Generally, I think those sort of damned if you do, damned if you don't theories don't make for very good policy. But the real truth of the matter is that each regulation is different. What the New York Times needs to understand is that it's difficult to have it both ways- the more throughly companies are regulated, the more difficult you make it to sue companies.
Consumers are already at the mercy of the all-too-fallible Food and Drug Administration. So it is especially disturbing that the Supreme Court ruled this week that patients injured by defective medical devices cannot sue for damages in state courts if the device was approved for marketing by the F.D.A. and made to the agency’s specifications.
That means that any consumer harmed by a faulty device — whether it be an implanted defibrillator, a heart pump or an artificial knee — will have no chance of fair compensation and the manufacturers will have a dangerous sense of impunity.
And as briefly as possible, here's why it's misleading. Product liability is an area of the law where strict liability applies. Consumers need not show any fault on the part of the manufacturer if they are injured by a routine use of a product. Injured individuals need only show that every product produced is flawed, in the form of a design defect or that the individual product in question was flawed, in the form of a manufacturing defect. The intricacies can be much more complicated, but that's the basic framework you need to understand the case. The Supreme Court's decision only applies to design defects. It does not apply to manufacturing defects. Consumers are still free to bring suits in state court when a product is manufactured in a way that is different from the specs that have been approved by the FDA.
As a matter of law, the 8-1 nearly unanimous decision appears to be correct. The MDA (Medical Device Act) has a fairly clear preemption clause that would prevent individuals from suing over design defects. As Justice Scalia explains in his opinion, there is good reason for this. In order for a medical device to be sold to the public, the specific specs of that device must be approved by the FDA. In considering the request for approval the FDA weighs the risks and benefits of the device to the entire public. If individuals were permitted to sue over design defects, it would give a scientifically untrained jury the opportunity to overturn the expert judgment of the FDA based solely on an evaluation of the risks of the device to a single individual.
Towards the end of the editorial, the Times expresses concerns with the FDA's approval process and questions what recourse an individual would have when the FDA fails. It's a good question, but one that's obscured by completley off-the-mark self-righteousness that pervades the rest of the editorial. As a libertarian however, it's always important to take government incompetence into consideration. I don't have a real good answer in this case because of what I discussed above- even if the FDA does make a mistake in the approval process, an untrained jury looking at one specific instance hardly seems the appropriate forum to correct the FDA's mistakes.
The real interesting question is one of general legal theory- Should government regulation absolve manufacturers of liability? It's not quite the case here, but what if a government agency says you must do X, but your company wants to do Y and you do X just to comply with the law. A consumer is hurt by X and would not have been hurt by Y. Should the consumer be able to sue on theory that the company should have used Y? Generally, I think those sort of damned if you do, damned if you don't theories don't make for very good policy. But the real truth of the matter is that each regulation is different. What the New York Times needs to understand is that it's difficult to have it both ways- the more throughly companies are regulated, the more difficult you make it to sue companies.
posted by lonely libertarian at 7:09 PM
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