Tuesday, October 21, 2008

Obama Wins!

You read it here first!

It's hard to scoop the mainstream media, so we're jumping the gun to give ourselves a chance: We're calling Barack Obama the winner of the 2008 presidential election.

If North Carolina and Indiana are seriously in play, then this election is over, and Obama won it handily.

(Then again, if we'd been alive in 1948, we'd have called that puppy for Dewey. So take our prediction for what it's worth.)

Also: The Democrats have won 58 seats in the Senate! (We're basically just picking a random number here between 51 and 60. But, if we're wildly wrong, no one will remember. We are, after all, just drug and device lawyers. On the other hand, if we're right, you'll see us on "Meet the Press" on November 9, because we'll be the hottest political pundits of this election cycle.)

Now we'll turn to what interests us: What's the effect of Obama's win on drug and device law?

First, Obama's election will have no effect on the pending case of Wyeth v. Levine. Levine is being argued on November 3. The election is not until November 4. Obama won't be sworn in until January 20.

If changing the face of the FDA is President Obama's first priority, then the country chose pretty poorly. The global economy is collapsing and we're fighting a pair of wars. We're as fascinated by the FDA as the next guy, but the FDA ain't gonna be job one in the Obama administration.

Even if it were, it would take a while to nominate a new FDA Commissioner and to get that person confirmed. And even if the new Commissioner violently opposed preemption, the Solicitor General's office would not change its position in a pending case.

We'll get a decision in Levine some time in the first half of 2009, and a changed administration will have no impact on the result in that case.

Will the Obama administration change the Supreme Court in a way that matters?

There are plenty of Supreme Court scholars who can answer that question better than we can. But our ignorant guess is that Roberts (age 53), Alito (58), Thomas (60), Scalia (72) and Kennedy (72) aren't retiring soon or in a Democratic administration.

The three justices most likely to retire are Stevens (88), Ginsberg (75 and rumored to be in poor health), and Souter (69, but rumored to be considering retirement).

Obama is thus likely to have an opportunity to replace three moderate-to-liberal justices with three new moderate-to-liberal justices. (Remember? We called the Senate at 58 Democrats. If the Democrats win 60 seats, the filibuster-proof majority might be able to replace three moderate-to-liberal justices with three avowedly liberal justices. Even then, that wouldn't dramatically change the result in most cases.)

That covers Wyeth v. Levine and the Supreme Court. What about Congress? We do think that a new administration is far more likely to be able to enact laws (such as the one proposed to undo the effect of Riegel v. Medtronic) than the current divided government can. You might see a change there.

Finally, administrative agencies. A Democratic presidency would make life much easier for the FDA. The FDA has aptly been described as a slow-moving animal that bleeds profusely when wounded. That makes the FDA a favorite target for Congress when it wants to attack an executive branch from a different party. The FDA thus went under seige when the Republicans controlled Congress and Clinton was in the White House, and the agency was again attacked when the Democrats controlled Congress and Bush (II) was in the White House.

Under the new Obama administration, the Democrats will control both the executive and legislative branches, so the FDA will drop out of the spotlight for a while. The agency will have a chance to re-group until we enter the next period of divided government.

If we're right about any of this, maybe we'll go into fortune-telling. It's kind of fun.

Come to think of it, contact us off-line if you'd like our pick for the World Series.


Anonymous said...

Couldn't an all-democratic congress and democratic executive just statutorily overrule Wyeth should it come down in the drug-and-device-law-blog's favor?

Anonymous said...

Does anyone know how popular the Wyeth v. Levine oral arguments will be on the 3rd? For those who are planning to attend, how early would you go? Thanks.

hg said...

Since we're reading tea leaves, my tea is on the notion that FDA will be a higher priority than suggested, mainly because pharma and accountability are on the tea table in a very different way.

The attacks on the agency in the
90s, amounting to calls for its dissolution, came from many of the same folks who support preemption today. Deregulation and preemption are part of a single movement. Dingell, Waxman, et. al. remember it well.

Anonymous said...

A legislative fix would certainly occur given the importance of trial lawyer contributions to the Democratic party and the trial lawyers have lots of chips to call in. Second, any decision in Levine will likely be narrowly drawn and not field preemption as the Wyeth lawyers have told their client. Isn't amazing how Wyeth continually gets it wrong? You want tea leaves: Watch the HRT litigation bankrupt Wyeth.

Anonymous said...

Bye bye Billable hours.

B. Martin, MD said...

You're amateurs. Tell us what the market's going to do. (And no fair saying it's going to go up during the next 30 years.)

Anonymous said...

Here is a copy of an email that was under protected order until the Ortho Evra plaintiffs got it released. It shows the exact mentality of the drug companies:

Email from Paul Soons (Dr Paul Soons, Vice President Clinical Development Johnson & Johnson)

“Just got a strange(great??) idea on solving the issue of which product to take as reference product in a possible future (BE) study if we were to reformulate EVRA…why not take an IV comparison in such trial and really confirm what is in the label: “…releases 20 micrograms of EE to the blood stream per 24 hours…and…Css of EE during one week of patch wear is approx. 40-50pg/ml…”

So this is how they pharmaceutical companies trick us. They did not tell the women that the estrogen level on the package was for IV administation and not the patch that was worn on the body. And this email is directly from the VP/Dr. of Clincial Development. And you want to trust these folks?