Tuesday, April 22, 2008

And They Might Even Get Away With It...

As you may recall, I wrote a little about the EPA's inexplicable denial of California's request for a waiver under the Clean Air Act. This waiver would have allowed California to increase its air quality requirements. California has, as expected, filed suit against the EPA seeking to overturn the agency's decision.

In the interim, however, something may have changed. That something would be the concept of federal preemption.

Now, as every law student who has finished their first semester of Constitutional Law can tell you, federal preemption means that the laws of the United States (both the Constitution and those passed by Congress) are the supreme laws of the land. When state regulations come into conflict with Federal laws or regulations, the Federal rules prevail. Now, that is the simple version. The more complicated version of preemption is whether the Federal law actually meant to completely preempt the states from introducing additional legislation which would enhance the Federal law.

Tucked away within the new fuel standards, which the EPA is basing its refusal upon, is a provision which says that individual state attempts to regulate tailpipe emissions are an impediment to the Federal standards. Therefore, they are specifically pre-empted by the rule. Another instance of Federal preemption by rule-making.

Now, there has been an argument that preemption by rule, especially where the statute is silent on the issue, is improper. Not only may this be improper, but the agencies undertaking to preempt by rules are ill-equipped to to police the products or areas which they have essentially deprived states or individuals from having any jurisdiction to act.

The only problem with this argument, is that it seems to be losing one. Between the time that the EPA rejected California's application and today, the Supreme Court handed down the decision in the case of Riegel v. Medtronic.

In Reigel, Riegel underwent a surgery which required the use of a catheter for his heart. Unfortunately, the catheter was defective and failed. What should have been a fairly routine procedure to treat an myocardial infarction required Riegel to be placed on life support and subjected to a second surgery, an emergency coronary bypass surgery. Among the causes of action alleged in their complaint, filed in U.S.D.C for the Northern District of New York, were claims based on New York state law. New York state law has a higher standard for medical devices.

Medtronic defended on the grounds that the Riegel's case was barred because of the Medical Device Amendments of 1976. Specifically, Medtronic argued that because the FDA had approved the design, there could be no causes of action for strict liability, breach of implied warranty, negligence in design, or negligence in manufacturing. The reasoning for this was that the FDA had already reviewed the product, put it through tests of its own and passed it in a form which the FDA's tests have shown will make the product safe and effective.

So how does this relate back to California's case against the EPA? Well, the first things that defending attorneys like to do is try and knock a case out without ever reaching the merits. Especially when on the merits, it looks like the EPA abused it discretion to grant or not grant a waiver to the State of California. A fair reading of a the Riegel decision could be extended to California's suit against the EPA.

The rationale, however, may break down because the factual situation is slightly different. The Clean Air Act, which is the law which establishes federal minimum for air quality, gives that job to the EPA. However, the EPA is relying on a regulation which has been promulgated by the National Highway Traffic Safety Administration. This is important because really waht the NHTSA deals with are cars, fuel efficiency, and attendant safety issues. Their own mission statement states, "Our Mission: Save lives, prevent injuries, reduce vehicle-related crashes." On the other hand, the EPA is supposed to be about environmental regulation.

The Riegel decision was premised, in part, on the fact that FDA is the agency which is ultimately supposed to be responsible for medical devices. They test them. They approve them. They have statutory authority for them to regulate. Completely unlike the situation that exists here. Right? Well, then we get into a conflict between the statutes. And depending on how the statutes are interpreted by the courts, they could come to the opinion that one takes precedence over the other or that both should be given equal reading because they are not mutually exclusive when it comes to this issue.

However, the Bush Administration, in its effort to fight torts has been pushing this agenda, so I would not be surprised to see the argument made that California is completely preempted by the NHTSA's regulation.

Then again, maybe I am just looking for problems where there are none to be had. Perhaps this will go as it should, just as it was predicted by the EPA's own in-house legal department.

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