Preemption Aftermath: A Matter Of Trust
8 CommentsBy Ed Silverman // February 21st, 2008 // 10:54 am
The Supreme Court ruling yesterday that patients can’t file lawsuits against device makers when their products were approved by the FDA will cast an increasingly harsh light on device makers and the agency. Until now, of course, the recourse sought by aggrieved patients was to file a product-liability claim, but the court, as you know, ruled 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.
As a result, the central question, as the Drug and Device Law blog puts it so eloquently in an essay today, is “whether a high regulation, low litigation environment is as effective a method of ensuring the safety of the public…or if it’s a lousy way of ensuring safe medical devices.”
There is only one way to know - and that is the hard way. It is now up to device makers to adhere to regulations that govern safe testing and development of their products, as well as report any subsequent problems in a timely and comprehensive manner. And it is up to the FDA to rigorously review products before and after approval, and carefully inspect facilities. Industry and agency critics say this just isn’t possible, citing a plethora of scandals and letdowns that, they claim, are symptomatic of neglect or something worse.
There is no choice, though. And so this amounts to a crucial test for manufacturers and regulators alike. For the moment, the issue doesn’t extend to drugmakers - unlike medical devices, there is no statute providing for preemption for drugs. But the Supreme Court has two cases before it that will settle this argument as well. (You can read about one of them here).
At the end of the day, it comes down to trust in the system. As the Drug and Device Law blog notes, if the ‘high regulation, low litigation’ model doesn’t work - if there is no trust - Congress will change the law. That would likely happen, though, only after an untold number of eggregious missteps were to occur. This creates an opportunity then for manufacturers and regulators to prove that public health, not just profits or politics, are truly the priority. Is that asking too much?
Nathan
This is an excellent statement:
“As a result, the central question…is whether a high regulation, low litigation environment is as effective a method of ensuring the safety of the public…or if it’s a lousy a way of ensuring safe medical devices.”
However, this statement implies that the alternative is a “low regulation, high litigation” environment. However, we all know that isn’t take case. The current status of the system is “high regulation, high litigation”. One or the other should be lowered. I’d prefer that regulations be lowered, but litigation being lowered is a close second….
Justice in Michigan
I agree that Ed’s commentary is eloquent and excellent.
I also believe it is, indeed, asking too much. Everything we have learned about industry, FDA, and their relationship over the past decade (and much longer) tells us that they will not step up to the plate. Further, the very people who have pushed for preemption are precisely those who have worked to weaken the FDA before they captured it during the present administration. All their rhetoric to the contrary, it would be foolish to think their essential goals have changed. And those goals are not, centrally, about the public good or the public health.
I believe it a certainty, therefore, that disaster will occur, and it will be on a scale much larger and more devastating than anything we have seen because most of it will happen in the dark. When the levee breaks, it will entail more than burying the bodies and hoping for a Congressional fix. Trust in the FDA and the industry will be shattered for a very, very long time. And that itself will result in both economic and public health disaster. We will have a lot of dead people. And a lot of dead companies.
That is one reason I have been arguing for several years that preemption has never been in industry’s own interest. Entirely, the opposite. And the disapproval rates one sees now will be looked back upon as very good days compared to what is to come.
I am sorry to be so negative. Trust me, this is not a political statement. And it is precisely the opposite of anti-industry. It is looking a policy in the face - the policy of preemption - and simply saying what, in our hearts, we know to be true: it is logically, practically, and ethically bankrupt. It is a preemptive strike that will cost more, in both lives and treasure, than the preemptive strike on Iraq. It is an avoidable disaster (in the drug arena), but one that will almost certainly not be avoided.
And, sad to say, those who are on the inside of the industry know this best of all. And many of them, many of you, have told me.
The Supreme Court and the FDA « The Pump Handle
[...] Drug and Device Law blog (via Pharmalot) gives the defense lawyers’ perspective on the Riegel v. Medtronic decision: We defense lawyers [...]
Justice in Michigan
Thanks for adding this link, Ed.
For those of us who believe preemption is disastrous policy, it is good to hear that Kennedy and Waxman intend to respond in the legislature. Still, everyone knew this was coming. Why didn’t they act earlier?
The FDAAA provided an explicit opportunity to do so: that is, to state Congressional intent re: preemption. The relevant sentence was, in fact, removed. If Kennedy and Waxman believe what they say, they will not wait for the Court to drop its next bomb, as it assuredly will.
Nathan
Justice, you don’t sound too optimistic. Where is this Kennedy and Waxman link? What are they trying to do? I didn’t see it in the above story.
I was rather suprised that the verdict was 8-1. I expected a 4-5 split one way or the other. That doesn’t seem to bode well for your opinions in the upcoming cases. When are they supposed to hear them?
Justice in Michigan
Nathan - The Kennedy and Waxman quotes come from another NYT story linked in the above post. Since this was a statutory (not Constitutional) decision, Congress can still change the statute. So, in this instance (contrary to some of what I wrote yesterday), there is more leeway for Congress to impact the USC decision.
The most important next case, Levine, is scheduled to be argued in October, and probably decided a few months after that. That’s drugs.
The Kent case, which will be argued next week, has been much misreported because it involves a rather arcane aspect of our Michigan law. It is not about preemption in general, but preempting whether state courts can find fraud on FDA. This would impact punitive damages in other states (like one of the NJ Vioxx decisions).
Justice in Michigan
p.s. re: optimism, Bob Dylan said it well re: the weatherman. But, in the long run, I have no doubt all this preemption stuff will be looked back as a nightmare that should have been prevented - and, by then, will be history.
Justice in Michigan
OK, and also this. Whether the Court upholds my opinions is the least of my concerns. Over its history, the USC has upheld slavery, racial segregation, and all sorts of doctrines that are chilling to us today - doctrines based on greed, hatred, fear, and pure lunacy.
It’s not about the future of my opinions. It’s about the future of us all.