Friday, February 22, 2008

Random Thoughts on Comments We've Received About Riegel

We've had an unusual number of plaintiffs' side blogs link to our Riegel posts over the past several days. While we're flattered that the other side thinks we're worth noticing, the traffic from these links has produced quite a few comments trashing either the Supreme Court (especially Justice Scalia), the FDA, or both. We've returned fire, but since it's our blog we've decided to elevate our comments to a small post. We've got basically two things to say:

About the Supreme Court:

Plaintiffs' lawyers need to look in the mirror. The Riegel case involved a product put to a contraindicated use (calcified arteries) and then misused (overinflated) on top of that. Yet it was the manufacturer that was sued. Why? It was a suit that should never have been brought (at least against Medtronic), but the plaintiffs' side appealed it all the way to the Supreme Court. That's spelled h-u-b-r-i-s.

And then there's the whole mass tort industry, which we parodied in Anatomy of a Mass Tort. Nowadays, if there's recall, a warning letter, or practically any other other adverse information of any sort about a prescription drug or medical device, within a week there've been ten class actions filed and a massive plaintiff solicitation campaign going on. It's so predictable and blatantly extortionate that it would be humorous, if it weren't for all the time, effort, and money defendants are forced to spend defending against the mass tort of the week.

The tort system has gotten out of control. For one thing, it's tried to usurp the role of the FDA. It's not surprising to see courts looking for ways to rein it in.

The plaintiff's side should stop criticizing Justice Scalia as if he were some sort of traitor. Plaintiffs never had Justice Scalia on preemption, but he's no knee jerk vote for our side either. He's kicked us in the teeth regularly on punitive damages. Justice Scalia has been a tort preemptionist of longstanding. He wasn't what caused the plaintiff's side to lose Riegel.

Again, a little mirror viewing is in order. As recently as Lohr - as recently as Bates - five justices voted against (most) preemption. The plaintiffs' side lost four of those five in Riegel. That should say something. Plaintiffs appealed a lousy case all the way to the Supreme Court. They made some bad and extreme arguments, some of which been rejected by the Court several times before. But most importantly, the plaintiffs were trying to seize for themselves the FDA's power to determine how devices (and drugs, but that's Levine) are designed and what their labels would say. It's not suprising that the FDA would oppose that.

The plaintiffs' side should take a long hard look at the facts in Levine. Quite frankly, you're doing it again - bad facts, bad arguments, and trying to usurp the FDA's authority over drug labeling.

About the FDA:

We've had several comments calling the FDA a "joke" or something similar and mentioning (even attaching excerpts from) the recent advisory committee report commissioned by the FDA that is critical of a number (quite a few, actually) of the Agency's shortcomings.

It's easy to criticize, but it's a lot harder to try to make things better. Perhaps it's just the way the other side thinks - since second-guessing and criticizing defendants is the plaintiffs' stock in trade - but we can't think of anything the other side has ever actually done to try to improve the operation of the FDA. The Agency is no joke. Like it or not, it's the entity that Congress has charged with overseeing the safety of drugs, medical devices, food, vaccines, and a lot of other stuff that keeps us alive and functioning.

The FDA only becomes a "joke" if Congress refuses to adequately fund it and otherwise fails to provide it with the authority and tools it needs to do the job - and if the administration fails to provide the leadership and will for the Agency to do its job (compare FEMA under the last two administrations). Even during the love-in that the plaintiff's side had with the FDA under former Commissioner Kessler (amazingly, a Republican appointee), they did nothing to strengthen the Agency. All of the recent legislation that has provided additional funding sources and statutory authority for the Agency - FDAMA, user fees, and FDAAA - have been pushed by industry and either ignored, or actively sabotaged, by the other side of the "v".

Industry even agreed to tax itself for the benefit of the FDA (something we've never seen lawyers do - the bar vehemently opposes any taxes on legal fees), but still the plaintiffs' side carps. We've seen their hired experts come into court and call the FDA's user fee program some sort of conflict of interest. The committee report says the FDA needs more money. That's true. Well where's that money going to come from? Industry has stepped up to the plate; the other side contents itself with throwing bottles from the stands.


Henry Greenspan, Ph.D. said...

And, of course, there were also those comments that had nothing to do with "plaintiff's side," but were attempts to assess the costs/benefits of policy as rationally as one is able.

BTW, you know very well that FDAAA was the product of multiple compromises (profound ones), on all sides of the "v." and including the perspectives of those who don't divide the world into a series of "v"s.

Beck/Herrmann said...

What we know is that the plaintiffs tried to sink FDAAA with an anti-preemption rider.

Anonymous said...

The debate over a preemption clause went back and forth through the history of FDARA and FDAAA.

It only looks like "sinking" something if a particular clause happens to be one whichever side disagrees with.

Meanwhile, FDAAA passed unanimously. No sinking. No pirates. No morality play.

Anonymous said...

Also, I have not been practicing for 30 years but there has never been a love in with the plaintiffs and the FDA, although I'm sure they less shrills for industry under President Clinton. The reason is that most drugs and medical devices find their way to the market and the defense is almost invariably - in design case - FDA approved.

I don't know how to solve the mess that is the FDA. And it is a mess. They are not a joke, they are in large measure serious people with a difficult job in the first place. But it is more systemic then funding. The FDA wants people with experience. This makes sense. People with experience overwhelming come from industry and many expect to return. And they act accordingly. The whole paradigm is screwed up. I don't have the wisdom to know the solution. But a part of the problem, as they say, is admitting the problem in the first place and admitting that more funding is not the only solution.

The Scalia opinion offended me mostly with the line about the good work the products do never find their way to the trials in these cases. Of course, they do. Defendants would be committing legal malpractice if they didn't raise the benefits of the device. That comment reminds me of President Bush in 1988 with the scanners at the grocery store. He needs to sit in on a jury trial in one of these cases. But I also think it code for "juries are not smart enough to handle these problems."

Ron Miller