The Accutane guys are on a roll.

We posted last month about the defense win on Daubert in the Accutane MDL, and before that about the order excluding “relatedness assessments” as proof of causation in the inflammatory bowel disease cases.

The new news just arrived on Wednesday, August 15. It involves the “psychiatric-track cases.”
In those cases, plaintiffs allege that Accutane causes patients to develop suicidal thinking (or to attempt suicide, or actually to commit suicide).

As readers of this blog know, when investigators report adverse events in clinical trials (such as, for example, where a patient ingesting Accutane develops suicidal thinking), investigators must then provide their best guess of whether the adverse event is “related” to the patient’s ingestion of the drug. The relatedness assessment is not a complete wild guess; the investigator uses his or her clinical judgment to assess relatedness. On the other hand, the relatedness assessment is hardly proof of anything, either. For example, investigators routinely say that an adverse event is “related” to drug use only to learn, when the patient in the clinical trial is unblinded, that the patient was actually taking a placebo, not the drug.

In his newest decision, In re Accutane Prods. Liab. Litig., MDL No. 1626, slip op. (M.D. Fla. Aug. 15, 2007), Judge Moody grants Hoffman-La Roche’s motion to exclude evidence regarding “causality assessments” in the psychiatric-track cases. (We don’t even like the phrase “causality assessments,” because that confuses the medical term “relatedness” with the legal concept of “proximate cause.” But we didn’t write this order; we’re just reporting about it.) Judge Moody notes that neither a drug manufacturer nor the FDA draws conclusions about causality from relatedness assessments. Id., slip op at 2. He says that the relatedness assessments are not needed to prove notice, because the underlying report of the adverse event — not the relatedness assessment — provides any notice to the defendant. Id. And Judge Moody says that the case reports are available to plaintiffs as well as defendants, so the plaintiffs could investigate them if they cared to. Id.

Finally, and helpfully in other cases, Judge Moody notes that “the danger of the causality assessments is that the wording used in them is subject to being mischaracterized as an admission of causation when they are not. In that way, they are highly prejudicial and excludable under [Federal Rule of Evidence] 403.” Id., slip op. at 2-3.

That last point is indisputably true. Plaintiff’s counsel always say, before trial, that they want the relatedness assessments admitted only to show that the defendant was on notice of the adverse event. As soon as a jury is empaneled, however, counsel trumpet assessments that an adverse event was related to drug use as absolute proof of causation. To illustrate the point, Judge Moody points to what happened at trial in an Accutane case in New Jersey state court. (The opinion itself does not recite the examples, but the defendants’ brief does.)

Defense lawyers should note a wise tactical choice that defense counsel Mike Imbroscio and Paul Schmidt (of Covington & Burling) made in this case: They did not move to exclude the entire case reports, which include the relatedness assessments. That motion would bite off more than it needs to chew — the underlying case reports may (in some circumstances) be relevant to notice, and the case reports are not the information that is unduly prejudicial. Imbroscio and Schmidt moved only to exclude one piece of the case reports — the relatedness assessments. By focusing on that narrow point, they achieved the right (and helpful) result: The relatedness assessments are excluded; the underlying case reports can be addressed separately.

Nice work, guys. Keep those defense victories coming.