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Accutane: McCarrell Remanded For New Trial

By James M. Beck and Mark Herrmann

We know that headline is boring: "Accutane: McCarrell Remanded For New Trial."

But give us a break.

Levine comes down. We're duty-bound to blog about it. The press calls for reactions to it. We're writing about the case in print media. We're being asked to speak about the case.

And then there's our real jobs: Our long-dormant drug cases bust loose because all those stays pending Levine are now lifted.

And that same week -- that same week -- the !**@!! New Jersey Appellate Division hands down a 113-page appellate decision in McCarrell v. Hoffman-LaRoche, No. A-3280-07T1 (N.J. App. Div. Mar. 12, 2009) (link here). What's a blogger to do?

Here's what we'll do: We'll give you the shortest little description of McCarrell, tell you very briefly why it matters, and then call it quits. We apologize for giving you the bum's rush, but life's pretty hectic here.

Andrew McCarell took Accutane for acne and then developed inflammatory bowel disease, which led to, among other things, surgical removal of his colon. He sued Hoffman-LaRoche, the manufacturer of the drug, in New Jersey state court for product liability and consumer fraud. After a 15-day trial, the jury returned a verdict (of $119,000 for past medical expenses and $2.5 million in compensatory damages) in favor of McCarrell on the product liability claim, and a verdict in favor of Roche on the consumer fraud claim.

The first issue on appeal was the admissibility of plaintiff's expert testimony purportedly linking Accutane to IBD. (The federal MDL judge excluded similar expert testimony under Daubert, in a decision that was upheld by the Eleventh Circuit.) The New Jersey Appellate Division trotted through (at a length that's really not acceptable when we're this busy) the scientific evidence supporting plaintiff's expert's opinion. The court then concluded that (1) different experts testified in the MDL and in New Jersey state court, (2) the standards for admissibility are different in federal court and New Jersey state court, and (3) the evidentiary record in New Jersey was more developed, because it followed a trial. The court thus affirmed the decision to admit the expert's testimony on causation. Id. at 82.

The second issue on appeal was whether the trial court erred by letting plaintiff's witness refer to the number of adverse incidents reported about Accutane while excluding Roche's testimony about the large number of people who had ingested the drug and "the comparative significance of those figures." Id. at 92. The appellate division held "that the trial court erred in unduly restricting Roche's effort to provide relevant background statistics and other related proofs about Accutane usage to the jury." Id. at 104.

That's a holding that matters. Judge Higbee made similar evidentiary rulings in other Accutane cases that have been tried before her, so it's quite likely that other plaintiffs' verdicts will now be reversed on the same ground. And, needless to say, that holding protects defendants who manufacture other drugs from being forced into a similar evidentiary bind at trial.

Finally, the Appellate Division briefly addressed Roche's remaining arguments. The court affirmed the trial court's application of the New Jersey statute of limitations to this Alabama plaintiff and found that equitable tolling of the statute rendered plaintiff's lawsuit timely. Id. at 106. The court found "reasonable factual support" for the jury's conclusion that the warning label on Accutane was inadequate. Id. at 107. And the court remanded for the trial court to consider Roche's preemption defense in light of the holding in Wyeth v. Levine. In particular, the trial court is to address whether "Roche can show by 'clear evidence' that the FDA would not have approved a change to the Accutane label." Id. at 112. We don't know enough about the administrative record surrounding Accutane to speculate on how that issue will ultimately play out.

That's not a home run for Roche, but it's a hit of some kind: Score it a single, with the batter taking second on an error.

Full post as published by Drug and Device Law on March 13, 2009 (boomark / email).