A Big Screw-Up In A Preemption Case?
5 CommentsBy Ed Silverman // September 21st, 2007 // 11:31 am
That’s the word circulating in the legal community this morning. Apparently, lawyers for the plaintiffs in a lawsuit that was brought against Medtronic, the big device maker, allegedly failed to file some routine paperwork to the US Supreme Court within a prescribed time. As a result, the case may not get heard, according to The Drug And Device Law blog (written by two attorneys whose firms rep drug and device makers; one has ‘tangential involvement’ in the case).
This is potentially significant. As the blog notes: “One of the biggest preemption cases (involving the medical device industry) could go down the tubes because the plaintiff’s lawyer screwed up some relatively routine ministerial function.” The screw-up, by the way, involved not filing papers substituting the plaintiff’s estate for the plaintiff, who passed away since the case was filed. And for those unaware, preemption gives companies some immunity against product liability claims, because the FDA has already deemed a product to be safe.
Background: After suffering an injury when a balloon catheter burst during angioplasty, Charles Riegel and his wife sued Medtronic, which tried to have the suit dismissed, arguing that the Food, Drug, and Cosmetic Act expressly preempts state law claims brought by patients who were hurt by devices that received premarket FDA approval. A court dismissed the case. The issue now…
…is whether the “express preemption provision” of the Medical Device Amendments to that federal law preempts state-law claims seeking damages for harm caused by devices that received premarket approval.
“If Riegel gets dismissed, then given the glacial speed with which the appellate wheels turn in litigation, there’s virtually no chance for another case presenting the same issue of medical device preemption to get to the Supreme Court on the merits until after the 2008 presidential election,” the blog writes. “The likelihood of a definitive resolution of the preemption issue as it relates to pre-market approved medical devices has suddenly dropped precipitously.”
Unlike medical devices, however, there is no statute providing for preemption for drugs. That fight - pitting drugmakers against patients (and consumer groups) centers on whether decisions by state courts and juries should have the right to trump an FDA rule, which the agency and industry say is the final word on safety and effectiveness. In legal parlance, this is the difference between expressed preemption and implied preemption.
Hank
A couple of clarifications.
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.
Ed Silverman
Thanks for pointing that out, Hank. I’ve clarified the language so that it, hopefully, reads as it should. ed
Hank
Thanks, Ed! It’s been fun “playing lawyer.” In that spirit, I think “express preemption” is where there is a definitive rule, law, shout from hilltop, etc. that Agency X preempts whatever state law Y says. It fully “occupies the field” as they say in lawyerland.
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?
Ed Silverman
Hi Hank,
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
Hank
OK. Hold the coffee. According to the textbook I’m trying to metabolize, there are a few score versions of preemption, inplied and otherwise. I’ll just take mocha.
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.,