Ya cudda knocked me over with a feather, as the cliché goes, when the U.S. Supreme Court on March 3 split 4-4 on in the Warner-Lambert v. Kent Michigan drug preemption case. So fast (just a week after arguments)! So . . . split!

Many observers thought this case was going to be pharma’s first Supreme Court win: the drug preemption theory was ripe and a Republican-appointed, and a presumably pro-business, anti-tort court, was seated. The recusal of Chief Justice John G. Roberts Jr. was hardly noticed by news reports when the case was accepted by the court, and his absence was barely mentioned when arguments were heard Feb. 25. After the 8-1 vote in the Riegel v. Medtronic medical device preemption a few weeks earlier, perhaps most thought pharma had it in the bag even minus one vote. Instead, we got a quick 4-4 split and affirmance of a Second Circuit decision that allowed the fraud-based claims of Michigan Rezulin users to go forward.

Roberts, according to reports, recused himself because he owns less than $15,000 worth of stock in Pfizer, which was the real party in interest in Warner-Lambert v. Kent. No surprise there: it happens with judges sometimes.

Then all eyes turned, as another cliché goes, to Levine v. Wyeth, the real test of the drug preemption theory which the court accepted but which won’t be heard until next term. In the certiorari vote there, no justices recused. In theory, then, we’ll have all nine justices on board and presumably, no worse than a 5-4 split on drug preemption.

But there was another little-noticed development the same week as the Kent 4-4 tie: On March 27, Justice Antonin Scalia will speak at the annual meeting of the Food and Drug Law Institute. What he will speak about isn’t listed on the agenda. However, the FDLI, as it’s known, did provide a forum in January 2005 to Dan Troy, the father of drug preemption. When Troy was in private practice, Pfizer was one of his firm’s clients. He became the FDA’s chief counsel and while in that position spoke at a May 2003 drug and medical device meeting of the Defense Research Institute (DRI) and invited companies to help the FDA write briefs. When he resigned from the FDA, he spoke at the January 2005 FDLI meeting at which he noted that lower courts at that time weren’t buying drug preemption and said a claims resolution procedure might be needed. Then drug preemption got its second wind and Troy and his firm, drug defense firm Sidley Austin, showed up as counsel for Pfizer in the Kent case.  Troy will follow Justice Scalia as a speaker later March 27 at the FDLI meeting.

In addition, the FDLI program includes FDA Commissioner Andrew von Eschenbach.  Under von Eschenbach's watch, the FDA has continued to advocate preemption of drug tort claims, both through the Preamble to the Final Rule and through amicus briefs.  Troy and von Eschenbach are entitled to their views on drug preemption, and the FDLI has a First Amendment right to sponsor a forum in which the issue is presented to one extent or the other, and to voice its own view on the issue.

But the question is: if Justice Scalia speaks in a forum where drug preemption was publicly advocated in 2005 and may be again in March 2007, can he then, in seven or nine months, objectively participate in arguments on that very issue, or should he, like Chief Justice Roberts in Kent, recuse himself? And if Justice Scalia recuses, would Levine be headed for another 4-4 tie?

There are variables: a few years ago, Justice Scalia brushed off suggestions that he recuse himself from a case involving Vice President Dick Cheney because he went hunting with Cheney. If a similar conflict of interest is raised in the Levine case, will he dismiss that as well?

It might be clearer if we knew how the justices voted in the 4-4 tie, but it was a per curiam ruling. Justice Stephen Breyer raised the question of who is in a better position to determine the safety of a drug, the FDA or a jury. And it was Justice Scalia who raised — for the first time — the notion that the FDA itself could order a drug company to pay restitution to people injured by drugs. Maybe that’s what he’ll talk about on March 27 at the FDLI. But if he does, can he then ask questions — and vote — on a drug claim issue during the Supreme Court’s next term?