Biotech Values

[DewDiligence]

zipet: Justice Souter found the obvious hole
in your argument on FDA labeling—the same
one I mentioned in #msg-33208189.

http://online.wsj.com/article/SB122572239149293091.html

›Justices Stake Out Middle Ground in Wyeth Case

By JESS BRAVIN
NOVEMBER 4, 2008

WASHINGTON -- Several Supreme Court justices expressed skepticism with arguments given Monday by business interests hoping for wide immunity from lawsuits over federally regulated products.

The case came from Vermont, where a guitarist, Diana Levine, won a $6.8 million judgment against Wyeth after misadministration of its drug Phenergan caused gangrene and required the amputation of her hand and forearm. The antinausea drug is normally injected into muscle, but the label also provides directions for intravenous use.

A jury found that the drug's label should have warned against administering the drug through an intravenous injection, known as "IV push." Wyeth contends it is immune to the state negligence lawsuit because the federal Food and Drug Administration approved Phenergan's label.

Although federal law is silent on whether Congress intended to bar state lawsuits over drug labeling, Wyeth contends that such claims implicitly conflict with the FDA regulatory scheme. Because other federally regulated industries are in a similar situation -- Congress hasn't indicated whether federal oversight is intended to complement or supplant parallel state laws -- business hopes the court will rule in favor of pre-emption that can be applied to other fields.

In February, an 8-1 court found that federal law, which explicitly pre-empted state regulation of medical devices, implicitly blocked private negligence lawsuits as well. In 2006, by contrast, the Vermont Supreme Court found no conflict between federal law and the judgment against Wyeth.

Monday, several justices seemed to be searching for a moderate position, whereby private lawsuits might be permitted in extraordinary circumstances. The justices seemed disinclined to permit private lawsuits to simply re-evaluate data that the FDA had fully considered.

Attorney Seth Waxman, representing Wyeth, argued that because the FDA uses similar procedures to approve drug uses as it does for medical devices, the same rule should apply. Permitting juries to second-guess FDA labeling decisions could put manufacturers in an impossible situation, he said.

"As a textual matter, as a logical matter, as a semantic matter, I don't agree," said Justice Anthony Kennedy.

Justice David Souter said that "Wyeth could have gone back to the FDA at any time and said, either based on experience or just our rethinking of the data that we have, we think the label ought to be changed to say, 'Don't use IV push.'" [As discussed in #msg-33208189, Wyeth’s assertion that it’s difficult to change the label to make it *more* restrictive is not going to fly with the Court, I predict.]

The parties disagreed over whether the FDA had fully considered the risks of IV push before approving the label. Justice Antonin Scalia said the label had mentioned the dangers and that juries shouldn't be able to overrule the balance the FDA struck between risks and benefits. But Justice Samuel Alito suggested that the facts in the case suggested the FDA label was inadequate.

A decision is expected by June.‹