Former FDA Commish Argues Against Preemption
12 CommentsBy Ed Silverman // February 29th, 2008 // 10:15 am
In a lengthy essay in The Georgetown Law Journal, David Kessler, the former commish, and David Vladeck, a Georgetown University Law Center professor, are very clear about preemption - they don’t like it. The issue, of course, is whether FDA approval of a drug preempts state law claims challenging safety, efficacy, or labeling. The concept is being reviewed by the US Supreme Court, because preemption would preclude patients from suing a drugmaker through state law. This is a brief excerpt…
“This essay highlights what we believe are two of the most problematic aspects of the FDA’s pro-preemption position - one legal, the other practical - that do not stand out in more comprehensive treatments of the issue. The first point we make is that the FDA’s pro-preemption arguments are based on a reading of the (Food, Drug & Cosmetic Act) that, in our view, understates the ability of drug manufacturers to change labeling unilaterally to respond to newly discovered risks, or to seek labeling changes from the FDA. In fact, drug manufacturers have significant authority - and indeed, a responsibility - to modify labeling when hazards emerge and may do so without securing the FDA’s prior approval.
“Our second concern is that the FDA’s pro-preemption arguments are based on what we see as an unrealistic assessment of the agency’s practical ability - once it has approved the marketing of a drug - to detect unforeseen adverse effects of the drug and to take prompt and effective remedial action. After all, there are 11,000 FDA-regulated drugs on the market…with nearly 100 more approved each year. The reality is the FDA does not have the resources to perform the Herculean task of monitoring comprehensively the performance of every drug on the market…Given the FDA’s inability to police drug safety effectively on its own, we question the wisdom of the FDA’s efforts to restrict or eliminate the complementary discipline placed on the market by failure-to-warn litigation.
“But in our view, the FDA is wrong to focus on the moment of approval as determinative of the preemption question. The relevant timeframe is post-approval, and the question, in our opinion, is what did the FDA and the drug company know about a drug’s risks at the time the patient-plaintiff sustained the injury. After all, the FDA’s knowledge-base of the risks posed by a new drug is far from static. At the time of approval, the FDA’s knowledge-base may be close to perfect, but it is also highly limited because, at that point, the drug has been tested on a relatively small population of patients.
“Once the drug enters the marketplace, risks that are relatively rare, that manifest themselves only after an extended period of time, or that affect vulnerable subpopulations, begin to emerge. These are often not risks foreseen by the drug’s manufacturer or the FDA and, for that reason, are not addressed on the label. And at the time the FDA adopted its pro-preemption position, the agency did not have the authority to compel labeling changes, but instead had to negotiate changes with the drug’s sponsor. The FDA’s statutory and regulatory tools for gathering post-approval information are relatively crude and often ineffective, especially when contrasted with its tools for information gathering prior to approval. For that reason, the tort system has historically provided important information about these newly emerging risks to physicians, patients, and the FDA.
“The FDA’s shift of position also comes at a particularly inopportune time for the agency. Although the FDA now argues for broad preemption of failure-to-warn claims, the agency’s assertion that it is able single-handedly to ensure drug safety has been undermined by a number of highly publicized regulatory failures.”
Justice in Michigan
This is a good piece - one which has been cited before here.
The one aspect that I think Vladeck/Kessler don’t emphasize enough is the range of delinquencies entirely outside the province of the FDA, but relevant in civil liability. As I’ve noted, these include spinning journal articles via cherry-picking in genuinely misleading ways, intimidating researchers, etc.. These can be part of a pattern of intentionally misleading docs and pts, but entirely outside FDA’s regulatory sphere.
Thus even if we had utopian FDA (dream on…), the “two systems of consumer protection” - as a former FDA chief counsel put it - are usually “complementary.”
University Update - Georgetown University - Former FDA Commish Argues Against Preemption
[...] Virginia University Former FDA Commish Argues Against Preemption » This Summary is from an article posted at Pharmalot » News, Comment and Conversation on Friday, [...]
Nathan
Justice,
Here’s a quote I found to be a very elegant summary of the “pro-preemption” reasoning:
“A state statute, or a regulation adopted by a state agency, could at least be expected to apply cost-benefit analysis similar to that applied by the experts at the FDA: How many more lives will be saved by a device which, along with its greater effectiveness, brings a greater risk of harm? A jury, on the other hand, sees only the cost of a more dangerous design, and is not concerned with its benefits; the patients who reaped those benefits are not represented in court.”
This statement speaks for itself, I believe.
Here’s the link:
http://blog.pharmexec.com/2008/02/25/pre-emption-watch-legal-eagle-explains-riegel/
harpy
Nathan, there is a world of difference between devices and drugs. What’s right for the goose isn’t always right for the gander.
david egilman
The injured patients get compensated for the injuries that occur in torts only. The FDA knows the injuries will occur. The compensation costs (externalities) are built into the price of the drug. This is how capitalism is kept honest.
None of this has anything to do with the FDA. If the FDA wants to compensate fairly then pre-emption is justified.
Nathan
David,
What should the “injured patient” get compenasted for? For side effects? There should be NO compensation for anything unless a law was broken! (ie unless fraud was committed) Drugs have side effects — everyone knows that. You shouldn’t be able to sue unless you can show that the company knew about the ailment you were aflicted with and purposely withheld the info from the public and/or FDA.
Justice in Michigan
Nathan - In terms of your first post:
- State tort liability has nothing to do with state statutes and regulation that conflict with FDA. No jury has ever decided a device should be taken off the market. Those decisions remain the province of the FDA. And FDA’s views on those issues are virtually always part of the trial argument on manufacturers side. So it is not FDA _vs_ tort law; it is both together. Preemption flushes one side away.
- Much the same applies to the second point. I agree juries do not have the beneficiaries of the device/drug in front of them. But since their decion (if its negative) does nothing to take the device/drug away from those benficiaries, there is no issue here.
- As far as I know, there is only one case in which a class action settlement forced a drug off the market that turned out probably to not have the risks that were relevant. That was Benedictin. And that is why, if you read the arguments of the preemptors, it is all Benedectin, all the time.
- Re: the second point, I agree that liability should depend on company malfeasance, not simply because of injury that could not have been forseen. As has been reiterated here, the likelihood that FDA will discover such malfeasance, let alone act on it, is very small compared either with the discovery process of civil trials or whistleblowers. (It’s amazing how many actions that FDA/DOJ do end up taking essentially depended on either civil actions or whistleblowers.)
Justice in Michigan
Nathan or others - Here is the real tough question, and I think closer to reality.
Let’s say there was definitively proved fraud perpetrated by a company. Would you then agree that should open the gate to civil liability (lawsuits by injured plantiffs)?
That’s actually not the preemptors’ position. There would still be no tort remedy, even after proven fraud. Rather, the only consequence could be fines or other sanctions via the DOJ. Injured folks would still be out of luck unless - in a huge case - something was put together by the feds like the asbestos settlements.
Good policy?
Nathan
Justice says:
“I agree juries do not have the beneficiaries of the device/drug in front of them. But since their decion (if its negative) does nothing to take the device/drug away from those benficiaries, there is no issue here.”
That’s true — but huge liability lawsuits EFFECTIVELY take the product off the market by taking away the profit motive. For a medium or small sized market, it would only take a few major settlements for a company just to pull the product off the market and say “it’s not worth the effort”.
Justice in Michigan
I hear you, Nathan. That is apparently what happened in the case of Benedectin mentioned above. There may be other such instances, but I’ve never heard the preemption folk mention them. It’s all Benedectin, all the time.
(I should correct this. I know a few corp. lawyers who still think that Rezulin should, and would, still be on the market if it weren’t for the other kind of lawyers. I don’t know any docs who think this.)
Nathan
Justice says:
“Let’s say there was definitively proved fraud perpetrated by a company. Would you then agree that should open the gate to civil liability (lawsuits by injured plantiffs)?
That’s actually not the preemptors’ position. There would still be no tort remedy, even after proven fraud.”
Is there no “middle ground” on this issue? Why can’t an individual sue in federal court on grounds that the company broke a federal law? (fraud)
Justice in Michigan
As things now stand, I don’t think there is that “middle ground.” The FDA/DOJ amicus in Kent went out of its way to say that FDA findings of fraud, and response to those findings, ought not serve as “gatekeeper” to private litigation in any context. (And, as noted here, FDA/DOJ virtually never make such findings, but my example premised that they did - most likely, pressured by whistleblower revelations, media, and Congress).
That is why _some_ preemptors have tried to come up with some version of “no-fault” schemes in which proven victims could be compensated (there is no such viable model so far).
The bottom line remains to rule-out civil actions in any contexts, under any circumstances, including fraud.