Sunday, November 16, 2008

Product Liability and the Supremes

"Career officials at the Food and Drug Administration objected to the FDA blocking consumer lawsuits against drug makers in the past few years, according to agency documents released Wednesday in a congressional investigation. ... In that case, Wyeth v. Levine, the FDA says federal drug-approval and warning-label standards should trump stricter state laws. The FDA wants the high court to pre-empt lawsuits in state court over problems with federally regulated drugs. Two officials said in the memos it is wrong to assume FDA-approved drug labels are completely reliable, or that they are based on full disclosure of safety risks by drug makers. ... Rep. Henry Waxman (D., Calif) released the documents. They are likely to encourage him and other Democrats in Comgress who want to pass bills reversing the Bush administration's pre-emption policy", Alicia Mundy at the WSJ, 30 October 2008.

"Several Supreme Court justices expressed skepticism with arguments given Monday by business interests hoping for wide immunity from lawsuits over federally regulated products. ... Because other federally regulated industries are in a similar situation--Congress hasn't indicated whether federal oversight is intended to compliment or supplant parallel state laws--business hopes the court will rule in favor of pre-emption that can be applied to other fields. ... The justices seemed disinclined to permit private lawsuits to simply re-evaluate data that the FDA had fully considered. ... Justice Antonin Scalia said the label had mentioned the danger and that juries shouldn't be able to overrule the balance the FDA struck between risks and benefits", my emphasis, Jess Bravin at the WSJ, 4 November 2008.

"But this case is not just about Ms. Levine. It is about a drug-approval system that balances the risks of treatments against the risk of not being treated at all. And a jury, faced with a single sympathetic plaintiff, is in no position to rule on the correctness of those FDA judgments. ... The question is whether, in a case in which the FDA has made one determination about safety, a state jury should be permitted to come to another. As Justice Scalia put is yesterday, 'If you're telling me that FDA acted ... irresponsibly, then sue the FDA'," Editorial at the WSJ, 4 November 2008.

"Conservative who are interested in preserving our federal system and promoting America's core values should look askance at attempts by Republicans who seek to undermine both. Just because a politician has an 'R' after his name doesn't make him a conservative. Conservatives don't just mouth conservative principles, they live by them", Ken Connor (KC), 16 November 2008 at

I have to hand it to the Bushites. They claim to favor state's rights yet push for federal pre-emption of state tort suits against drug makers. The Bushites do not suffer from Emerson's disease, "Consistency is the hobgoblin of little minds".

Wyeth is a travesty. The Supremes should not have heard it. Scalia may be confused. It is a legal principle that judges review adminstrative agency actions under a "great deference" standard, upholding an adminstrative agency's actions if they have any rational basis. Giving Scalia every benefit of any doubt, he cannot distinguish between a jury verdict and a writ of mandamus. I see no basis to obviate state tort law here. Does Scalia think Wyeth is a collateral estoppel issue? Was Levine a party to the FDA proceedings? Is there res judicata here? Well?

Who is the WSJ kidding? Will Scalia, Roberts and Alito rule the FDA by approving a drug "stands in the manufacturers" shoes" to respond in damages? Or waive the "sovereign immunity" flag? This is a state's right's, 10th Amendment issue. Who cares what the FDA "decided" or what "basis" the FDA claims for its decision. The FDA can say anything. I can't see pre-empting state tort suits. I see no collateral estoppel or res judicata here. Challenge to the Supremes: convince me Levine was party to FDA v. Wyeth? Was there a case styled FDA v. Wyeth? Which federal district court heard it?

KC's is the first "conservative" voice I've seen raised against the Bush administration's unprincipled behavior in Wyeth.


printfaster said...

There is one argument to be made in favor of the Bush administration position and that is interstate commerce.

Since drugs are sold interstate, regulation should be federal. States regulating or adjudicating them creates an interstate commercial problem. It would be kind of like have different voltages across state lines. I guess that for drugs, I am in favor of one standard of efficacy. If someone wants to argue that they have a different view of efficacy, it would not benefit overall general welfare.

There is more to be gained by having one drug standard, and not having individual state courts peck away at "rich" drug companies for their political and pecuniary amusement.

Independent Accountant said...

There was a time when I was a wee little CPA that I accepted the interstate commerce argument. It is an argument. Why do I reject it now? Regulatory capture. I'd much rather trust juries in the 50 states than the FDA to keep the drug companies honest. It's much easier to control the FDA than juries. On 18 January 1961 President Eisenhower warned us about the "military-industrial complex". Now, among the many "complexes" we face is the: drug company-FDA-University-AMA Complex. I look at the SEC's revolving door with "Big Law" and the investment banks and see an SEC that provides no regulatory oversight. Similarly the FDA. I just don't trust these guys. I have too much gray hair.

Anonymous said...

I'm with IA on regulatory capture.

States provide a useful "checks and balances" to the power of corporate interests.

Standards can be somewhat fluid and still be useful. The federal government isn't the end all for setting standards.

printfaster said...


You are missing the construction of the legal industry underneath all of this. The John Edwards of the world are salivating over all the local tears that they can turn into cash. This is a costly game for pharmas, and yields such great rewards for the barristers. Very unbalanced.

Frankly, I want less regulation and tears over medicine and more personal choice, decision, and responsibility. This ambulance chasing is killing medicine.

What I really see the need for is more information and not emotion. Hard to do when lives and health are at stake.

Independent Accountant said...

I am missing nothing. You and I see the plaintiffs' bar differently. You see it as a "cost"; if you will "deadweight loss". I understand your position and disagree with it. I see the plaintiff's bar as an integral part of the regulatory system. We just disagree as to what should be done.