Can we really have pre-emption without review?

You can't corrupt the regulatory process on the one hand, then tell people they have no resort to courts on the other hand, and expect that to stand. You're asking for revolution if you do.

Get out of jail free card, Monopoly setWhen the federal Food and Drug Administration, as the final authority on the safety of drugs and medical devices, grants approval, it should mean something. 

That's a local political reporter in Atlanta arguing that FDA approvals should keep all suits against drugs and devices out of court. (Illustration from the original 1936 Parker Brothers game Monopoly.)

But there is an unintentional joke there, namely the fact that past approvals have meant almost nothing,  and had for years before the Supreme Court ruled last year they mean everything.

A neat trick. But as of Tuesday Alice doesn't live here anymore.

You can't corrupt the regulatory process on the one hand, then tell people they have no resort to courts on the other hand, and expect that to stand. You're asking for revolution if you do.

Makers of drugs and medical devices have been creating this Alice in Wonderland world for a long time, which has led us into our current predicament.

We pay 50% more for health care than people elsewhere, with no increase in lifespan. We subsidize the work of companies that seem to think their promises are like an old Microsoft EULA.

As a result we trust no one. We don't trust our doctors, we don't trust the government, we don't trust industry. That's clear in the Talkbacks sent to this blog. It's clear in the polls.

Those days are ending.

Beyond anything which may or may not be done with health reform, or the tricks pollsters may play to convince us we don't really want change, the medical industry needs to return to the rule of law, and the promises in law.

If you don't meet your promises you will be punished. We can punish you through prevention, which means regulation, through the civil courts, or through the criminal courts. Your choice.

If a loved one of mine dies through your negligence, those are your only choices. Let bygones be bygones is not a choice. It's a dodge.

So the industry faces a choice. Sound regulation that costs them money to follow. Civil law that forces them to pay for ignoring regulations. Or jail.

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