Analysis: what does the federal court embryonic ruling really mean & what’s next?

Knoepfler lab H1 human embryonic stem cell culture
Knoepfler lab H1 human embryonic stem cell culture.

Today the US Federal Court of Appeals via a 3-judge panel ruled in favor of continued NIH funding of human embryonic stem cell research (hESCR).

The ruling is a setback for pro-life extremists trying to shut down a very promising avenue of stem cell-based regenerative medicine with their lawsuit. It’s a good day for the stem cell field.

However, this legal battle is far from over. No champagne or noise makers. Perhaps just a glass of beer.

Why?

I’ve had several discussions today with different parties with interests in the case and none believe this is the end. It may be the beginning of the end, but there are still some more moves coming and there could be unexpected twists and turns.

Interestingly, there seems to be a consensus that the plaintiffs in the case who sued to stop federal funding of hESCR will not appeal to the Supreme Court as their next move.

Rather, they will request that the full Appeals Court rule on the case (something called ruling “en banc”).

Their rationale?

They are hoping the full Appeals Court may be more sympathetic to their case, but at the same time they want to prolong this case as long as possible. Even if they ultimately lose as long as the case continues there is a chill on the hESCR field and the plaintiffs know that.

What would be the basis of their legal request for the full court to review the case?

While the 3-judge panel ruled unanimously in favor of Obama administration and NIH, two of the judges wrote in decisions that they had some specific concerns with how the case had been handled previously related to something very legalistic called “Chevron Deference“. This opens the door to the plaintiffs asking the full court to review the case, which seems likely. The full Appeals Court will then vote as to whether to grant this request and majority will rule. They could reject the request, but I’m betting they won’t.

The next logical question then is how might the full Court of Appeals (11 judges as opposed to the 3-judge panel) rule?

This is very difficult to predict, but there is at least some reason for hope that they would rule in favor of continued hESCR funding given that is the trend of the case so far.

Still, it could be a 50-50 chance. That ruling would come some time in 2013.

However that turns out, the losing side would then ask the Supreme Court to take the case. The Supremes could say “no”, but I’m betting they will be more likely to want to weigh in on this important case. How they might rule is anyone’s guess.

A big question is should the full Appeals Court rule against NIH, would they invoke an injunction immediately barring hESCR funding during the interim before the Supreme Court ruling. I hope not.

So, today should be viewed as a big victory for patients and science, but the war isn’t over.

3 thoughts on “Analysis: what does the federal court embryonic ruling really mean & what’s next?”

  1. Thank you for this analysis, Paul. Highly tactical move on the part of the Plaintiffs and their supporters, and just in time for the elections.

    The big question for me is, given the likelihood that this lawsuit will carry into 2013 and perhaps even see its way to the Supreme Court, do you think there is there any opportunity, or obligation, in interim for the NIH to provide a long awaited redefinition of what they consider eligible lines for funding (reference to ACT’s NED lines 1-4)?

    Best Regards.

  2. Advanced Cell Technology has an HESC-derived blood program in the works that could be of great interest to the Department of Defense. I’m hoping that if the plaintiffs take this case further, DOD might weigh in with an amicus brief in favor of federal funding of stem cell research.

    * Full disclosure: I’m an ACT shareholder who holds more shares than any reasonable person ought to.

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