Monday, March 17, 2008

Dukakis and Riegel

Sometimes, two contrasting images make for a good title.

We figured we'd use two completely unrelated images: Dukakis and Riegel.

First, Dukakis:

Governor Michael Dukakis opposed the death penalty. In the 1988 Presidential debates, a reporter asked Dukakis whether he'd still oppose the death penalty if someone raped and murdered his wife. Dukakis thought for a while and then answered in a monotone.

Wrong answer!

The right answer is:

"Of course I'd oppose the death penalty in that situation! I'd personally pull the switch to fry that guy! In fact, forget electrocution -- I'd personally tear him limb from limb!

"That's exactly why we don't make public policy in America when we're outraged. We make policy by carefully considering the pros and cons of laws when we're not emotionally involved in the events. I'm a husband, and of course I'd want to strangle the guy who killed my wife. But, in the calm light of day, I know that the right policy for America is to forbid the government from killing its own citizens. That's why I oppose the death penalty."

Or something like that.

What does that have to do with Riegel?

Nothing; we just wanted to remind you about the 1988 Presidential debates.

Nah, we're kidding.

To our eye, having juries evaluate the safety and efficacy of a drug or medical device when they're sitting in the presence of an injured plaintiff is the same as asking Dukakis how he'd feel if someone hurt a loved one: Of course you want to punish the drug company that did this to that poor plaintiff -- the same way you'd want to retaliate against someone who hurt a family member.

But that's no way to make public policy.

We should make public policy calmly and rationally, at a time when we're not emotionally involved in the events.

That's exactly why the neutral experts at the FDA -- not juries sitting in the presence of an injured plaintiff -- should evaluate the safety of drugs and devices.

6 comments:

Anonymous said...

I guess it's all in the way you look at it. Is it "punishment" that the jury is providing or "accountability"? My mother was handed a death sentence the day that the medical device that killed her was placed in her. All we are asking for is our day in court, something that is the right of every American, in order to hold the medical device company accountable for what they are selling to the public.
If we could truly count on the "neutral experts at the FDA" to evaluate the safety of drugs and devices, my mother would be alive today because the medical device that was placed in her would not be on the market.

Henry Greenspan said...

What we've learned, though, is that the "neutral experts" often disagree profoundly among themselves.

Follow the histories of Zyprexa, Rezulin, fen-phen, et. al. - regulatory agencies in other countries - Japan, UK, et. al. = made profoundly radically decisions concerning withdrawal and/or warnings with regard these and other medications.

Indeed, it could be suggested that the experts, internationally, have differed _more_ profoundly among themselves regarding a number drugs that went to litigation than lay juries in the U.S. have differed between each other.

So the "emotional immediacy" versus "neutral expert" issue should probably be taken with several scoops of salt.

So also the suggestion that different conclusions lead to some sort of dangerous chaos, as defenders of preemption often assert. Profound differences among international regulatory conclusions have led to no chaos whatsoever, as far as I can see.

Just differences.

Henry Greenspan said...

What we've learned, though, is that the "neutral experts" often disagree profoundly among themselves.

Follow the histories of Zyprexa, Rezulin, fen-phen, et. al. - regulatory agencies in other countries - Japan, UK, et. al. = made radically different decisions concerning withdrawal and/or warnings with regard these and other medications.

Indeed, it could be suggested that the experts, internationally, have differed _more_ profoundly among themselves regarding a number drugs that ened up in litigation than lay juries in the U.S. have differed between each other.

So the "emotional immediacy" versus "neutral expert" issue should probably be taken with several scoops of salt.

So also the suggestion that different conclusions lead to some sort of dangerous chaos, as defenders of preemption often assert. Profound differences among international regulatory conclusions have led to no chaos whatsoever, as far as I can see.

Just differences.

Anonymous said...

You are absolutely correct in your premise and Dukakis is a great example. And just because the victims are easier to see than the hidden benefits does not mean that we should also yield to the pain that is right in front of our face. All of this is correct. We shouldn't not defer to the FDA because "how would you feel if you were a victim?" Instead, we should not defer to the FDA because it is stupid to ask the immates counsel to guard the prison.

The New York personal injury lawyer blog made a great point about how the logical extention of Reagan's theories about the perils of relying on government (even though you mocked it). This is no slam on the FDA in many ways. Why don't we get rid of the federal whistle blowers statute? We have prosecutors, right? While we are at it, the state tests doctors and lawyers, who are plaintiffs to suggest they committed malpractice? Why even have juries for any cases really?

Unless the FDA is actually doing its own research - multiply its budget by 10,000 - it can never have the information the drug companies have and can never be put in their shoes. That's what juries do, folks, they put themselves in the shoes of the companies looking at the entire picture from the company's vantage point to determine if they were negligent.

Ron Miller

Anonymous said...

First. Have loved this blog. Great reading, esp. for young pharm defense attys such as myself. I understand that no lawyer who cares about winning clients is going to argue the other side.

Still, the "FDA is a neutral watchdog" argument is getting a little stale, at least for me. How do you account for the fact that FDA policy re: preemption was exactly the opposite under the more plaintiffs' bar friendly Clinton administration? Clearly the agency makes decisions based on politics as much as science.

Second, instead of making strange, offputting analogies between our drug company clients and rapists and murderers, let me suggest you practice what you preach and present some law and economics style arguments (i.e. facially neutral/objective) and data in favor of preemption. What are the costs of MDLs vs. the costs of plaintiffs' injuries in the aggregate? Are there studies evaluating the effect these trials have on pharmaceutical company practices? Would it make more sense to set up a larger system of governmental adjudication and payment of adverse drug experience claims like in the vaccine cases?

Jennifer said...

Anonymous 1's moving story illustrates why the FDA is not, and never will be, a neutral panel of experts. As Milton Friedman explains, “If you . . . approve a thalidomide[,] your name will be spread over the front page of every newspaper.” The FDA is, and continues to be, biased in favor of safety over innovation. Adding more responsibility to the FDA through allowing FDA preemption will only increase the FDA's exposure to public criticism and therefore, will cause the FDA to hold up the production of even more drugs and/or medical devices.

Even if one is in favor of promoting drug and medical device safety over innovation, do we really want the FDA in charge of our floor AND our ceiling? Despite the fact that 80% of the active pharmaceutical ingredients of drugs consumed in the United States are manufactured abroad, the FDA has not complied a single accurate database of foreign drug firms importing medicines into the United States, or even a list of approved drugs. This is not the track record of an agency that has it together!

Increasing the FDA's bureaucracy through FDA preemption will not fix our tort system.