In the meantime, the corporate boys over at the DD&L blog actually speculate further. They suggest the “hypothesis” that the plaintiff’s lawyer’s deliberately messed up the paperwork because they didn’t think the ruling would work out for them. Given the current Supreme Court, that’s actually a reasonable guess.

However, as a psychologist, I can say it is more or less a law of nature that when we speculate about the other guy’s “dirty tricks,” we are almost always talking about our own (which doesn’t mean the other guys aren’t doing it too). So it does, indeed, give us new insight into the way things work.

Now, I am also ready to provide therapy to the DD&L lawyers at _their_ usual hourly rate (once again, applying the mirror principle). Luckily, there is no good drug for paranoia and dirty tricksterism. So this could be a very long and costly treatment. And I won’t even offer them coffee. It would muddy up the relationship.,

Yes, I would like coffee, but something decent and not expensive, which leaves us 1/2 way between Dunkin’ Donuts and Starbucks.

And I’m happy to say that I got the expressed vs. implied difference in there the first time around. Not that I didnt need help from someone else earlier today to make sure I got it right.

Anyway, don’t send a bill. I can’t pay it.

Best
ed

I don’t think even Dan Troy has argued that. Rather, the preemption folks have argued for “implied,” based on the arguments that (a) it would be impossible for a company to “obey” both FDA and state court findings (no real evidence for that) or (b) companies can’t change increase warnings on their own (clear evidence this is nonsense) or (c) the agency has gone through what I think is called the “Chevron” process (named after a case in which the company was involved) in which an agency made a final rule through an open process, with hearings, etc.. The now famous/infamous FDA “preamble” proclaiming preemption went out of its way _not_ to follow an open, Chevron-type process, although it may have glowed in the dark.

My secretary (if I had one) will send bill. Would you like some coffee while you’re waiting?

The position _against_ preemption is based on exactly what the situation is in most states (my own being a sad exception). Drugs need to be in compliance with FDA regulations, of course. The issue has been whether that is a “minimal” standard - and that there is more that a company reasonably should and often can do when it becomes aware of a problem (the “reasonably” is what is hashed out in court) - or whether the sheer fact of FDA compliance trumps (i.e., preempts) any other consideration, obligation, or grounds for liability, thus fully shielding that company from any lawsuits related to “failure to warn.”

As former FDA Chief Counsels have said (before Dan Troy) the civil liability system and FDA regulation have almost always operated in complementary ways, each offering “a layer of consumer protection” as one former FDA Chief Counselor put it.

What the preemption folks want to do is lop off that layer of protection.

No one is saying that state couirts should “take precedence” over an FDA rule. It is rather that FDA compliance is not the full and suffiicient story as far as liability is concerned, which it never has been in the 49 states that aren’t mine.

But if the current Supreme Court has a say on it - which it inevitably will before long - preemption could very well become the law of the land. No lawsuits, nohow, nowhere re: Vioxx, fenphen, Rezulin, Baycol, et. al.

As I’ve written, I know that sounds unbelievable. Believe it.