Thursday, August 22, 2013

Recurring Intermittent Headache

          Do you remember way back yesterday when we posted on Daubert rulings from an OTC pediatric ibuprofen SJS case?  The rulings were in March but just popped up on Lexis last week.  We led in with a discussion of video games as a clever segue to the games some experts play.  Really, no glimmer of recognition?  Well, the same case had summary judgment rulings that have now been “published,” so we are giving you a double dose.  See Newman v. McNeil Consumer Healthcare, No. 10 C 1541, 2013 U.S. Dist. LEXIS 113440 (N.D. Ill. Mar. 29, 2013).  As with the expert rulings, there is a mix of good and bad, but the bad gets stuck in our throat.  Dispensing with the lame medication jokes, on to the rulings, the good ones first.

            Plaintiffs asserted a claim under the Illinois Consumer Fraud Act premised on “standby statements” from 2003 and 2005 concerning separate reports of SJS/TEN in children using defendants’ ibuprofen products.  This claim failed both because the statements were not deceptive—an obvious element of the claim—and because the defendants established the applicability of the Act’s regulatory compliance defense.  (The Act did not require that the plaintiff rely on the deceptive statement, only that the defendants intended that there be reliance, or there would have been another obvious basis where plaintiffs and their parents surely never saw the statements before using the product.)  As anyone who has ever participated in drafting any statements on adverse events knows, the line between saying something that will later be called an admission of causation and saying something that will later be called minimizing is a fine one.  The statements at issue described the particular cases as “allegedly associated” with the defendants’ product and noted that SJS and/or TEN, in general, “are associated” or “reported to be associated” with ibuprofen and other medications.  The FDA-approved label from 2009, when the plaintiffs used the product, included the warning that “[i]buprofen may cause a severe allergic reaction . . . .”  Under these circumstances, the statements were held consistent with the label and not “so misleading or deceptive in the context that federal law itself might not regard [it] as adequate.”  Id. at *19 (quoting Bober v. Glaxo Wellcome PLC, 246 F.ed 934, 941 (7th Cir. 2001)).  It was very sensible to not read “associated with” as deceptive simply because the label later said “may cause.”
            The sensible approach continued in the evaluation of the evidence offered on the regulatory compliance defense—an unnecessary analysis given the lack of an otherwise actionable deceptive statement.  Without rehashing the discussion, which overlaps with the Daubert analysis at issue in yesterday’s post, the part that interested us was the use of statements from FDA in light of the inevitable allegations that defendants had underreported adverse events and generally kept FDA in the dark about the SJS risk of ibuprofen.  Defendants here were able to rely both on a 2006 denial of a citizen’s petition call for withdrawal of all OTC ibuprofen products—for once, not made by Public Citizen, at least openly—and deposition testimony of an FDA official.  The denial included the statement that “we have no evidence that there is additional undisclosed safety information that was withheld by ibuprofen manufacturers” and the FDA official did not suggest that defendants failed to perform any required analysis of adverse events.  Id. at **23-26.  With this back drop, the plaintiffs’ “slight, at best,” evidence of noncompliance could not be assumed to have “affected . . . FDA’s decision making.”  Id. at **26-27.  Placing the burden on plaintiffs to come forward with evidence that alleged noncompliance with regulatory requirements somehow invalidated FDA’s authorization of defendants’ statements was predictably fatal to plaintiff’s claim.

            Plaintiff’s express warranty claim also got handled with some common sense.  Plaintiff contended that putting “Pain Reliever/Fever Reducer” on the packaging for the product constituted an express warranty that was breached when plaintiffs experienced worse fever and pain sometime after taking the product.  “Pain Reliever/Fever Reducer” is identified as the “purpose” of the product, so there is no “guarantee [of] effectiveness or safety.”  Id. at *28.  This is particularly so given the label’s caution to stop the product if “pain gets worse or lasts more than 10 days [or if] fever gets worse or lasts more than 3 days.”  Thus, the plaintiffs were informed “that the product might not relieve pain and might not reduce fever,” which is not an express warranty.  Id. at *29.
            At this point in the decision, common sense seemed to go out the window, returning only for the consideration of plaintiff’s motion for summary judgment on the assumption of risk defense.  Maybe a fever was involved.   We are not sure, but the evaluation of strict liability design defect and implied warranty claims signaled a shift.  It made sense to deal with these together, although it is hard to see how implied warranty is not subsumed by strict liability design defect, when available.  The court held that plaintiffs raised genuine issues of material fact as to both claims.  Two things in particular strike us about letting these claims get past summary judgment—setting aside that these claims are clearly preempted, something the court rejected in a separate prior ruling.  First, the plaintiff’s experts’ speculation about reporting rates of adverse events that the court failed to jettison  was used to suggest that the jury “could reasonably determine . . . that there is a safety problem with Defendants’ product.”  Id. at **33-34.  Last we checked, the Seventh Circuit does not allow calculations based on spontaneous adverse event reports to be used as proof of causation, so we cannot see why they could be used to show that the product allegedly used by the patients described in those reports poses an unacceptable risk.

            Second, as we have pointed out, alternative feasible design almost never makes sense in the context of a drug, even if it were not for the preemption issue we are setting aside.  Here, plaintiff offered two alternative “designs”:  (1) replacing ibuprofen, a racemic mixture, with just the right-side stereoisomer, dexibuprofen—we are sure the pharmacology dorks reading this need no explanation of terms—and (2) replacing ibuprofen with a fairly well-known but quite different drug, acetaminophen.  As to the former, FDA had already rejected an application to market dexibuprofen—and clearly treated it as a different drug than ibuprofen—but the court still concluded that “Defendants could have applied for FDA approval of dexibuprofen and been successful.”  Id. at **37-38.  Forget what we said about setting aside preemption; that claim is clearly preempted post-Bartlett even if the court thought it was not pre-Bartlett.  Even it were not preempted, admissible expert opinion that Defendants would have been allowed to market their OTC pediatric products with a previously rejected compound is hard to fathom.  As is the reasoning for allowing acetaminophen to count as an alternative design.  Faced with Texas cases disallowing it and no Illinois case allowing it, the court noted that “Defendants do not suggest that the courts of Illinois have adopted similar reasoning” to the Texas courts.  Id. at *40.  We are all for restraint when federal courts sitting in diversity try to predict state law, but it was plaintiffs—not defendants—arguing for new law.  A cat is no more an alternative design of a dog than acetaminophen is an alternative design of ibuprofen.  The court also pushed aside the apparently undisputed fact that a cat, we mean acetaminophen, “poses risks of liver toxicity than ibuprofen does not”—risks that get these same defendants and other acetaminophen manufacturers sued—with the finding that a “material issue of fact exists on whether acetaminophen constitutes a safer alternative design that was available and feasible at the time the product was manufactured.”  Id. at *41.  Presumably, the court would have the same finding ibuprofen as a purported safer alternative design in an acetaminophen liver case.  That is enough to make us reach for a few hundred milligrams of each drug.
            At least as the court presented it, defendants did not have much to say about the plaintiffs’ strict liability failure to warn claims other than to re-cast preemption as a matter of “public policy,” since the warnings at issue were not just approved, but “mandated” by FDA.  Id. at *43.  Given that plaintiff, again relying on questionable expert testimony based on adverse event reports, contended that there was new evidence of a greater SJS/TEN risk since FDA mandated the warning language on the label, the result was predictable.  The plaintiff, however, was not required to come forward with evidence of proximate cause for failure to warn, as far as we can tell.  The court noted that “a jury is required to decide the parties’ disputes regarding causation,” but the existence of a genuine issue as to the adequacy of the warning was enough to defeat summary judgment.  Id. at *45.  Even without a learned intermediary in the middle, there should still be some consideration of whether the proposed adequate warning would have changed the outcome.  The plaintiffs’ respective mothers claim to have read the warnings about “severe allergic reactions” that could include “shock,” but they still needed to offer self-serving testimony that inclusion of the urged warnings would have prevented the injury.

            The court continued to give plaintiffs a pass with its cursory analysis of the negligence claims.  The negligent design claim was automatically determined by the strict liability design defect claim and the negligent warnings claim was automatically determined by the strict liability warning claim.  Id. at *46.  Maybe it is semantics or hazy recollection of hornbook law from when we looked at actual books on law, but “strict liability” is supposed to be stricter than negligence.  Negligence requires evidence that the defendant’s conduct in design or warnings fell below the applicable standard of care, not just that the design or warnings themselves were inadequate.  So, the court again needed to look at the proffered evidence on additional elements of the cause of action before letting plaintiffs get past summary judgment.

            Punitive damages followed the same pattern.  While court acknowledged that the focus should be on evidence of defendants’ intent in the allegedly culpable actions and inactions, no evidence of anything suggesting bad intent—“willful and wanton misconduct”—was identified.  To the contrary, the court identified that reliance on FDA could show the absence of bad intent, but held that such reliance did not “as a matter of law, preclude Plaintiffs’ claims from going to the jury.”  Id. at *50.  Ultimately, plaintiffs’ mere allegation of bad intent was enough:

Plaintiffs maintain that Defendants’ failure [to change the label, stop selling the product, or make it a completely new product]  constitutes willful and wanton misconduct.  Defendants’ arguments, neither individually nor in the aggregate, demonstrate that a reasonable jury could not determine that Defendants’ conduct was willful and wanton.
Id. at *54 (emphasis added).  Apparently, on summary judgment, plaintiff did not need to come forward with any evidence to keep their claim for punitive damages.

            Defendants, by contrast, lost one of two challenged affirmative defenses for failing to offer evidence.  Each minor plaintiff’s mother administered an additional dose of defendant’s product after the appearance of the symptoms that the label advised should result in stopping use and getting medical help.  But “Defendants fail to offer any evidence that either parent’s provision of one additional dose of [defendants’ product] after the appearance of new symptoms contributed to Plaintiffs’ injuries.”  Id. at *56.  So, a defendant has to come forward with evidence of proximate cause for a defense like comparative negligence, but the plaintiff does not have come forward with evidence of proximate cause for a claim.  After all this, the defendants were allowed to keep their defense that the mothers assumed the risk by reading the warnings and giving their children the medication.  As you would expect, the dispute centered on whether knowledge of a risk of “severe allergic reaction” with listed symptoms could count as assuming the risk of SJS/TEN.  This time, the court’s trust in what a reasonable jury could find worked to the defendants’ advantage, as such a jury could find the mothers were “aware of the specific kinds of dangers that use of the products entailed.”  Id. at *60 (emphasis in original).  To show we do not just say rulings for a plaintiff are bad and rulings for a defendant are good—we do not—this ruling leaves open the issue of what risk needs to be assumed for there to be an effective assumption of risk defense.  We would say that issue could be a real headache at trial, but that would be the sort of lame medication joke we dispensed with nine paragraphs ago.

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