[Drug and Device Law] More Defanging of Depakote Claims
It’s been one of those weeks and it’s only Tuesday. So, we aren’t going to try to be clever or witty today (we know some of you are relieved). Nor are we going for scholarly or particularly profound. We’re just going to point you to an interesting decision that popped up on our radar today – Rheinfrank v. Abbott Laboratories, Inc., No. 1:13-cv-144, slip op. (S.D. Ohio ______). We previously posted on this case when the court took a sizeable bite out of plaintiff’s failure to warn claim and we refer you to that post for the details. With an already much thinner case to take to trial, the court did some more trimming with these recent in limine rulings:
- Preempted labeling issues are excluded. For this one we definitely recommend you revisit our earlier post. But the short of it is that the court dismissed plaintiff’s failure to warn of the risk of developmental delay as preempted based on “clear evidence” that the FDA would have rejected the inclusion of such a warning in the labeling. Id. at 2-3. So, evidence that defendant should have strengthened its warning to include developmental delay is irrelevant and inadmissible. This includes any argument that defendant could have unilaterally changed the warning via the CBE process. Id. at 4-5. Plaintiffs are allowed to introduce evidence that defendant could have “suggested stronger language” for its warning, but not related to developmental delay.
- Subsequent labels and label changes are excluded. After plaintiff conceived her daughter, the Depakote label was changed three times. The court ruled that both the labels and evidence of changes in those labels was irrelevant and unduly prejudicial. “If the jury is presented with labels after this timeframe, the jury may conclude that Abbott’s earlier labels were inadequate merely because the latter labels include expanded warnings not present in the 2003-2004 version.” Id. at 5.
- Subsequent medical information limited to causation. Unfortunately, the court didn’t apply the same reasoning to medical or scientific information that post-dated the birth of plaintiff’s daughter. On this the court found that it might be relevant to what defendant could have or should have known. Id. at 14. Doesn’t it really show what was knowable after the fact? We think the same issues of jury confusion and undue prejudice that warranted exclusion of later labels should keep out later science. The up side is the court limited introduction of post-injury science to only evidence that “can be linked to the causation issues in the case.” Id. at 14.
- Other off-label marketing and promotion excluded. One of plaintiff’s allegations is that defendant promoted Depakote off-label to treat tonic-clonic seizures, her reason for use. Id. at 8. So defendant moved to exclude evidence of other alleged off-label marketing activities that plaintiff wanted to use as evidence of a “nationwide scheme.” The court agreed with defendant that promotion related to conditions other than one at issue in the case was irrelevant. Id. at 9. That same reasoning applied to evidence related to defendant’s plea, settlement, and agreement reached in an entirely different case. Id. at 8. The other case was an enforcement action regarding alleged off-label promotion of other uses. In addition to finding this evidence irrelevant, the court found the probative value was significantly outweighed by unfair prejudice, jury confusion, and wasting time. Id. at 8-9. The court also more generally excluded evidence of other lawsuits, claims or investigations. Id. at 12.
- Duty to conduct post-marketing studies excluded. This sounds more like a summary judgment topic, but the in limine motion went to whether plaintiff could offer evidence that defendant had a duty to conduct a specific post-marketing safety analysis; in this case a pregnancy registry. The court said no, but. Here the but is that plaintiff’s experts could opine that creating a pregnancy registry was something defendant could have done, just not something it was required to do. Id. at 10-11.
- New FDA labeling requirements excluded. In 2014, the FDA changed its requirements to remove the use-in-pregnancy ratings from all prescription drugs. Since plaintiff used the drug when the ratings were required, evidence about the new regulations is irrelevant. Id. at 14-15.
- Plaintiff’s personal information is relevant. Plaintiff moved to exclude various pieces of personal information from the trial. For instance, plaintiff wanted to exclude that during her pregnancy she used phenobarbital, she smoked, and she was the victim of domestic abuse. Id. at 20, 22. The court ruled all were appropriate areas of cross-examination of plaintiff’s experts regarding alternative causation. Plaintiff also wanted to exclude evidence of her medical history and specifically her use of Depakote through four prior pregnancies. This evidence the court found was relevant to plaintiff’s knowledge of the risks of birth defects associated with Depakote. Id. at 21.
Not all the rulings went in favor of defendant. The court was more generous if it believed the evidence went to defendant’s knowledge during the relevant time period. So, for instance, defendant’s motion to exclude foreign labeling was denied because it was relevant to what Abbott knew at that time. Id. at 6-7. For the same reason, the court was unwilling to exclude all promotional materials which defendant argued were irrelevant because the prescribing physician testified that she did not recall any sales representatives or any promotional activities. Id. at 9-10. See also id. at 19-20 (allowing evidence regarding off-label promotion of the condition for which plaintiff was prescribed).
The continued paring down of this case is good news and makes us hopeful that more good news is still to come.
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Posted By Michelle Yeary to Drug and Device Law at 9/15/2015 09:17:00 PM --
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