Monday, October 18, 2010

A Deeper Dive -- On the Oral Arguments -- In The Wyeth Vaccine Case, Now Before The Supremes

I had a chance to listen to the Supreme Court oral arguments (a little over an hour investment), last night. I came away surprised. Surprised, and convinced that this is a closer case than I might have earlier guessed, based solely on a reading of the briefs, and the current political makeup of the court.

Importantly, at various points, Chief Justice Roberts (generally a very pro-free markets justice), Justice Alito (ditto) and even Justice Scalia (truly shocking!) made remarks, or asked questions, that were suggestive of the idea that they felt the whole Vaccine Court statutory schema has blunted any free-market incentive to improve vaccines, once approved. And that could foreshadow a decision at least moderatley helpful to the Bruesewitz family. Fascinating -- and yet more evidence (to remind me, personally!) that it makes sense to actually hear the arguments, not just read the cold, flat black and white legal briefs -- in any closely contested case.

The full transcript of the arguments is now online; the oral argument, as a streaming mp4 is here. Here is the most-intriguing bit:

. . . .Justice Sonia Sotomayor: All right. What is the motivation?

If there is no -- there's no approval mechanism for the FDA to look at that issue, what is the motivation for manufacturers to voluntarily remove a drug that is causing harm to the public before the FDA acts? If they are completely immune under your reading of this preemption statute, what motivates them to act more quickly?. . . .

Chief Justice John G. Roberts: Before you get to that, I think your answer to Justice Sotomayor's question is: Nothing; the manufacturers have no reason to take the vaccine off the market until the FDA tells them to.

Kathleen M. Sullivan [government's lawyer]: --That's not correct, Your Honor.

So the -- section 27.

Section 27 distinguishes vaccines from other drugs.

Section 27 says that the Secretary of Health and Human Services shall -- shall have an affirmative mandate to promote safer vaccines and to reduce the number of side effects.

And the Vaccine Act didn't just eliminate design defects --

Justice Anthony Kennedy: But if the manufacturer is slow or remiss or negligent or willful in not giving the information to the Government, there is nothing the injured person can do.

There is still complete preemption, under your view?

Kathleen M. Sullivan: Of design defect claims, Justice Kennedy, but not of warning claims. . . .

With Both Chief Justice Roberts and Justice Alito asking pointed questions of the government, here -- questions which suggest they don't really see any "free market" incentive to improve vaccines, once approved, under the existing (since 1986, at least) statutory Vaccine Court schema, this becomes a much closer question than I had earlier surmised. We will, as ever, keep you posted.


Anonymous said...

So, what is your take on the advice not to use the Australian-made 2010 version of the H1N1/seasonal childrens' flu vaccine? Design defect, or warning?

AFAIK, there were no reported injuries in the US, but only because the US government did not purchase the Australian H1N1 vaccine for administration in children during the 2009 pandemic.

condor said...

Hmm -- I'll have to look into it, in order to develop a more informed opinion, here -- but I don't believe Merck makes any H1N1 vaccine stock. I think there could be something to the idea that Baxter's H1N1 vaccine was purchased by many governments -- but not by the USA.

Doesn't CSL in Australia make the vaccine? There is a long and deep history of ferocious fighting between those two companies -- for what it is worth. . .

Namaste, and do stop back by.