The legal term “preemption” is one of those boring sounding words that makes eyes glaze over and starts the snoozefest. Seems like the Bush administration is counting on that reaction in its latest threat to consumer safety.

Preemption is a concept that provides that federal law can trump or overrule state standards when Congress passes a law and intends that its law displaces inconsistent state law. Like I said, it’s a yawner. But in this era of anything goes, hands-off deregulation, the ability to thwart state law claims means a lot to powerful corporate interests that don’t want to face juries.

And that’s how consumers get hurt.

The latest story is that now federal agencies are trying to grab power and extend preemption, claiming the right to do so. So when–for example–the FDA passes a rule that only federal standards regulate medical devices, the agency is grabbing power to claim preemption. Here is a more detailed account of how it’s being done.

What a sad and cynical world. At some point you have to conclude that this is just about greed. If you want to deregulate the world, then you have to have a means of giving injured consumers the ability to obtain compensation for their harms and losses. Or alternatively, you could create a truly effective safety scheme. But this current administration wants none of it. No regulations. No way for injured consumers to cover their harms and losses. No answering to a jury in court.

There’s that popular culture thingy–not really a saying, so much as a signifier, “Don’t worry; I’ve got your back.” It almost applies here, but you have to edit or tweak it just a tad to achieve accuracy. I worked on it some. Took some thought, actually. With a little re-working, it applies beautifully here. I’ve edited down to, “Worry.”

David Sugerman

Good article today online in the New York Times about how consumer safety is threatened by the Bush administration’s push for greater federal preemption. The article explains how in this new era, the Federal Drug Administration claims that injury lawsuits arising from a claim that a drug is dangerous should be barred because the FDA’s safety standards will take care of the problem.

Amazing. This is the same agency that admits that it can’t force manufacturers to issue warnings about unsafe drugs. It is the same federal agency that has seen a run of failures in protecting consumers from unsafe or ineffective drugs, including Zyprexia, Vioxx, and Rezulin to name just a few of the recent problems. And then let’s not get started on Vytorin.

The problem is that the FDA is not fully funded. It often doesn’t independently test drugs. In fact, it has in the past acknowledged that civil lawsuits aid it in its mission.

The goal is, of course, to provide safe and effective drugs to consumers. Seems like we have two clear choices. If we really want to eliminate lawsuits, we simply have to fully fund the FDA and tightly regulate drug manufacturers. That approach is completely at odds with the drum beat for less regulation. So if we’re not going to do that, seems that the only choice is to have a functioning civil justice system so that consumers injured by less-than-tight regulation will not be straddled with the harms and losses caused by unsafe products.

David Sugerman

In its current session, U.S. Supreme Court issued a number of pro-business rulings including this one about federal preemption. “Federal preemption” is a legal term that means that federal law trumps or displaces state laws and claims based on the laws of the state.

The theory behind federal preemption is that when the federal government regulates in a uniform way, allowing state law rules or even state law claims would undermine the ability to enforce federal standards. Sounds reasonable in theory, I suppose. But in practice it’s a killer.

Here’s a good example. The FDA faces serious questions about its failure to inspect tainted Heparin. Patient deaths have resulted from import of tainted Heparin from China. Lax FDA enforcement is the best argument against preemption. If we can’t count on our federal agencies to protect us from unsafe products, consumers must have access to the courts. Otherwise, we’re all at the mercy of a market place that puts profits first.

The fact of the matter is that product safety lawsuits protect consumers. If the government won’t take oversight seriously, the Court must stand aside.

David F. Sugerman