Monday, October 11, 2010

"Kentucky Windage" On "The Vaccines Court" Case Being Argued Before the Supremes, Tomorrow

Tomorrow at a little after 1 PM EDT, the United States Supreme Court will hear argument about yet another case, involving Wyeth (now Pfizer) as a defendant.

Last term it was FDA premption (in Levine), this time it is on the immunities granted manufacturers via the so-called Vaccine Court system, created by Congress in 1986. The windage, on the efficacy of Wyeth's arguments (upon the Supremes) in this case will be closely watched by lawyers at Whitehouse Station, given how important vaccine revenue is to Merck's global franchises.

So -- I suspect, sadly, that the Bruesewitz family -- the claimants here, are going to be rebuffed. I think the government's brief (as a friend of the court -- not a party to the underlying litigation) will persuade the Justices, and attract a majority of the Court, thus sayeth Matthew Scarola of the SCOTUS blog (do go read it all!):

. . . .In an amicus brief [warning: that's a large PDF file] echoing Wyeth’s policy concerns, the government contends that petitioners’ interpretation of Section 22(b)(1) would "expose manufacturers to greater liability for their vaccine designs than they would face under state law alone." In 1986, no state prevented a manufacturer from invoking comment k on a case-by-case basis. "Thus, on petitioners’ view, Congress achieved nothing in Section 22(b)(1) because it preempts liability only for conduct that state tort law would never have held tortious in the first place." Moreover, on petitioners’ view, Congress prohibited states from affording manufacturers additional protections against design defect claims.

The government argues that Section 22(b)(1) "limits certain claims against manufacturer," while Section 22(e) "bars state restrictions on plaintiffs’ causes of action beyond the restrictions the Act imposes. . . ." So if Section 22(b)(1) gives manufacturers only the case-by-case defense to comment k that they already had before the Act, and Section 22(e) preempts existing state laws that "give vaccine manufacturers a stronger defense to design defect claims," the net effect of the Act is to enlarge manufacturers’ liability—an outcome "irreconcilable with Congress’s ‘over-riding concern[]’ about ‘instability and unpredictability of the childhood vaccine market. . . ."

I do not completely agree with this characterization, but I think it does bode a rather ill wind, for the Bruesewitzes’ chances.

1 comment:

Anonymous said...

If plaintiffs are upheld by SCOTUS, does this not leave the US worse off, as a nation, in terms of vaccine supply, development, and availability than prior to the 1986 Act? IIRC, there were two manufacturers left, soon to be none, prior to the passage of the Act. If nothing else, would this not be a national security concern at some level?