We are beginning to feel like the Drug and Device Law theatre critic. Or perhaps we should say “theatre cheerleader,” as we rarely wax critical (at least about the stuff we include in our blog posts). Last week, we saw the wonderful new musical Come From Away. It is a true story, and it begins in the tiny town of Gander, Newfoundland on September 11, 2001. On that infamous day, Gander opened its doors, and its collective heart, to many thousands of U.S.A.-bound airline passengers whose planes were forced to land when U.S. airspace was closed in the wake of the 9-11 attacks. Despite the tragedy in the background – and in the foreground for some characters unable to confirm whether relatives were victims of the attacks – the play is an exquisitely energetic and joyful celebration of the openness of the human heart and the resilience of the human spirit. On the last note of the last song, the cheering audience rose in unison in a manner we have rarely seen.

As in Come From Away, tragic facts are common in our line of work, but they can sometimes provide the framework for a silver lining. In the hands of a rigorous judge committed to correct application of the law despite the pull of sympathy, difficult facts can produce laudable precedent. Such is not the case in today’s decision out of the Depakote litigation in the Southern District of Illinois.

In E.R.G. v. Abbott Laboratories, Inc., 2017 WL 3055520 (S.D. Ill. July 19, 2017), the plaintiff was a child who was conceived while his mother was taking Depakote and who was born with spina bifida and other birth defects. At trial, the jury found for the plaintiff on his claim of negligent failure to warn and awarded fifteen million dollars in compensatory damages. (The jury found that the evidence did not support an award of punitive damages.) The defendant filed a post-verdict motion for judgment as a matter of law, arguing that: 1) the plaintiff did not produce evidence that the defendant failed to provide adequate warnings of the risk of spina bifida; 2) the plaintiff did not produce evidence that the defendant failed to provide adequate warnings of other birth defects; and 3) the plaintiff failed to prove warnings causation because no doctor testified that a stronger warning would have altered his prescribing decision. In the alternative, the defendant moved for a new trial, citing evidentiary issues and improper comments during closing argument.

1. Motion for Judgment as a Matter of Law

Adequacy of Label Warnings

The defendant argued that the label warnings were adequate as a matter of law because the label contained a black-boxed warning of the (correct) 1-2% incidence of spina bifida when the drug was taken during pregnancy. This portion of the decision – like much of the rest – is confusing, but the judge seems to say that, notwithstanding the accurate spina bifida warning, it might have been the case that other portions of the label were inadequate and that the plaintiff’s mother might be saying that other proper warnings would have resulted in a decision to stop taking the drug when she was pregnant. It’s not clear where the judge is getting any of this, because none of this hypothetical testimony is cited in the decision. The judge also states that the plaintiff did not “concede” that the spina bifida warning was adequate. Instead, according to the judge, the jury could adopt the plaintiff’s expert’s theory that the spina bifida labeling was not adequate because it did not state that the drug should be used by pregnant women “only as a last resort.” In an opinion rife with wrong, we found this “last resort” argument to be the furthest from the mark. We know of nothing in law or regulation that invites a judge to deem that only specific semantics would have rendered a warning adequate, when the label warned of the precise risk that befell the plaintiff and included an accurate statement of the incidence of that risk.

Finally, the judge held that the jury could reasonably infer that the label was “materially misleading” when it stated that all antiepileptic drugs carried a risk of birth defects, based on evidence that the defendant’s drug carried a higher risk of spina bifida than other drugs in the class. As such, the judge held, the jury could conclude that the defendant “watered down” the spina bifida risk when it lumped the drug in with others that carried a “much lower risk of spina bifida.” E.R.G., 2017 WL 3055520 at *3. The judge concluded, “Ultimately, there was more than enough evidence presented in Plaintiff’s case in chief to support an argument that the label, including the spina bifida waning was inadequate.” Id.

Warnings Causation

Because the plaintiff’s mother’s physicians testified that they were aware of Depakote’s teratogenic effects when they prescribed the drug, the defendant argued that the plaintiff had not established that any inadequacy of the drug’s warnings was a proximate cause of the plaintiff’s injuries. The plaintiff countered that the issue was not whether the defendant “failed to warn generally of ‘teratogenic effects’” but whether the defendant “provided full, accurate, and complete information about Depakote’s total teratogenic risks and instructions on the safe use of Depakote in women of childbearing age . . . .” Id. Forgive us, but we fail to see the distinction here. One of the last two physicians to prescribe the drug before the plaintiff was conceived testified that he would have advised the plaintiff’s mother to stop taking the drug if he had been advised to use it as a “last resort” (the chosen language of the plaintiff’s expert and the judge), but he later testified that he would not have “taken away” the drug if the plaintiff’s mother had insisted on taking it. The judge concluded, “. . . [A] reasonable jury could find that . . . a stronger warning would have caused [the last prescriber] (who was already on the fence about the efficacy of Depakote for [the plaintiff’s mother], to stop prescribing the drug.” Id. at *4. We think this is a stretch, given the testimony.

The judge may have thought so, too, because she made a confusing attempt to justify her conclusion. She postulated, “If the jury believed that [the doctor] would have discontinued [plaintiff’s mother’s] prescription in favor of a different [drug], then the jury could reasonably infer that she would still have been off of Depakote when she went to see [the other doctor] for her final visit” to the doctors’ clinic. Id. “Nothing in the testimony of [the second doctor] indicates that if [the plaintiff’s mother] had shown up for her appointment on [a different drug], he would have independently restarted the Depakote prescription. [The second doctor] that, while he did make an independent assessment of [the plaintiff’s mother] at her last visit, he repeatedly asserted that he was ‘refilling’ her medication.” Id. (citation omitted). Have trouble following that? Can’t figure out what it has to do with warnings causation? Neither can we. Bottom line is that the prescribers knew that the drug could cause spina bifida and prescribed it anyway. And, even if the imaginary “last resort” language had been included, the doctor would not have taken the drug away from the plaintiff’s mother if she wanted to keep taking it. We fail to see how any of this adds up to warnings causation, except in the mind of a judge who didn’t want to grant the defendant’s motion.

2. Motion for New Trial

Predictably, the judge also denied the defendant’s motion for a new trial. Some highlights of that decision:

Mother’s Testimony

In this case, unlike what we are used to seeing in the prescription drug context, the patient – the plaintiff’s mother – was apparently warned about birth defects while the plaintiff alleged that the prescribers weren’t. This led to an upside-down trial in which plaintiff didn’t call his mother in his case in chief while the prescribers testified live. When the defendant learned that plaintiff’s mother was not being called, it filed a motion to compel her to sit for a de bene esse deposition. The judge denied the motion, and this denial was one of the bases of the defendant’s motion for a new trial. The judge held that her denial of the defendant’s motion was proper because the defendant had not adequately explained why the mother’s fact deposition (which was not videotaped) “did not accurately capture her testimony.” Id. (This in spite of the fact that, in our experience, plaintiffs routinely win motions like these.)

“Top 3” Opinion

The defendant challenged the admission of one of the plaintiff’s expert’s opinions that Depakote was one of the “top three” teratogenic drugs in the PDR, arguing that the opinion was not the product of a reliable methodology. The court disagreed, holding, “While a different expert may come to a different conclusion or may even use a different methodology to determine what the three worst drugs are in terms of teratology, that is not the test for excluding an opinion under Daubert.” Id. at *6.

Improper Comments in Plaintiff’s Closing Argument

The defendant argued that prejudicial comments in the plaintiff’s closing argument entitled it to a new trial. These included the comment that the defendant was “guilty as hell” (the judge had to explain to the jury that this was not a criminal trial), as well as comments suggesting that compensatory damages should be based on the defendant’s alleged “bad behavior” (the judge halted this line of argument after the defendant objected that it was an argument for punitive damages, not compensatories) and that the jury, through its award “had a chance to make a decision about the kind of world [it] wanted to live in.” Id. at *7 (citation omitted). The judge, predictably, held that none of the comments was “overly prejudicial.” Id.

And so the verdict was allowed to stand. While we reiterate that we were not always able to follow the judge’s reasoning, our takeaway was that she started with her desired result and worked backwards. As for us, our next foray onto the Great White Way occurs next week, when we accede to a request from the Drug and Device Law Rock Climber that we accompany her to the production of 1984 currently playing at the Hudson Theatre. This production is notable for the proliferation of audience members fainting and vomiting during the torture scene, so we suspect that cheerfulness may not permeate our description. And we will have to find a case that makes us queasy so we can easily tie it in. Based on today’s decision, we suspect this will not be too difficult. We’ll keep you posted.