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In tracking the progress of a case that produces multiple decisions, we sometimes feel like a distant relative getting intermittent updates of a child’s milestones.  As with a child, the milestones do not necessarily become more important and interesting. (Elementary school “graduation” does not eclipse starting school and not just because caps and gowns are absent.)  With Guenther v. Novartis Pharm. Corp., No. 6:08-cv-456-Orl-31DAB (M.D. Fla.), a case on remand from the Aredia/Zometa MDL, we have already posted three times this year on four separate decisions in the case.

Plaintiffs were not consolidated for trial, punitive damages were not available under New Jersey law, Dr. Parisian was limited in trying to make up new duties for drug companies, and the plaintiff was allowed to duck summary judgment on her warnings claims even though she lacked proximate cause evidence from her prescribing physician.  Some important and interesting issues, mostly decided correctly, with a notable exception. Now, as the case heads toward trial—which is undoubtedly an important and interesting event, but one unlikely to produce written decisions on which we would post—we return to Guenther for some rulings on motions in limine.  As we noted recently, pre-trial evidentiary rulings can seem, even at a quick glance, to be significant to the course of the coming trial and to involve recurring issues.  Others, like some photos of someone else’s kid that are sent with expectation of a positive response, clearly matter to the parties but are too fact-specific to matter to other cases.  The Guenther rulings are probably in the middle, yet unusual enough to draw our comment.

The plaintiff sought to preclude the defendant from offering two categories of evidence and argument relating to the drug’s benefit.  As with most in limine motions, the denial does not actually mean any evidence will end up being admitted at trial.  The proponent of the evidence will still need to weather potential form and foundation challenges, but may be most interested in getting to use the verbiage or make the arguments it wants during opening statement even if the actual evidence does not come in as hoped.

Because the drug at issue was approved to reduce the incidence of certain bone fractures in cancer patients—but is not used to treat cancer per se­­­—the plaintiff did not want the defendant to be able to call it a “cancer drug” or suggest that it prolongs the life of cancer patients.  Guenther v. Novartis Pharm. Corp., No. 6:08-cv-456-Orl-31DAB, 2013 U.S. Dist. LEXIS 116369, *5 (M.D. Fla. Aug. 16, 2013).  The motion was denied in a somewhat unusual application of Fed. R. Evid. 403, as “the Court cannot say with certainty that [the drug’s] off-label uses are necessarily irrelevant” and calling the drug a “cancer drug” was not unduly misleading or prejudicial.  Id. at **5-6.  We are not exactly sure what off-label use of the drug the defendant wanted to tout or how beneficial it is compared to on-label use, but the whole dynamic is reversed from how off-label use typically comes up in prescription drug product liability cases.  The plaintiff’s characterization of a use as off-label is often meant to suggest a greater risk to the patient and something improper done by the manufacturer to procure the use—ironically, as the same plaintiffs tend to argue that the FDA’s decision to approve a drug for a particular indication should be accorded little or no weight.  Similarly, it is usually the plaintiff who wants the consideration of risk-benefit in connection with design defect or implied warranty claims to be expansive.

Presumably, in this case, the defendant was comfortable with the possibility that expanding the discussion of the drug’s benefits could also expand the discussion of the drug’s risks beyond what the plaintiff claimed to have suffered.  In our experience, the goose-gander dynamic can play a large role in motions in limine.

The second category of benefit evidence that the plaintiff tried to exclude was of the drug’s benefit to the plaintiff—in helping her avoid broken bones.  Id. at *6.  Such evidence typically comes in as part of the presentation of the plaintiff’s medical history, but it is not always clear how it is probative of a claim or defense.  The benefit of the product in general, the promised benefit, and the benefits hoped for by the particular prescribing physician (and sometimes the patient herself) are clearly relevant.  Most liability questions are typically measured as of the time of the prescription or earlier—for example, whether the warning was adequate based upon reasonably available information—and do not depend on how much weight the plaintiff lost, the change in the plaintiff’s lipids, or some other measure of efficacy.

A warning is not better if the drug was apparently effective in the plaintiff or defectively designed if there were no signs of efficacy.  So, if whether the drug seems to help the plaintiff with regard to the indication for which it was prescribed is not relevant to liability, then to what is it relevant?  The answer, stemming from the original Restatement of Torts from 1939, is damages, specifically mitigating damages.  Id. at **6-7.  The idea is it is inequitable for the plaintiff to recover damages related to harm from tortious conduct without an off-set for benefits from the tortious conduct.  We have to say that this strikes us as wrong, at least for a drug (or device).  There is a distinction between what produces the benefit to the plaintiff—the pharmacologic action of the drug’s active ingredient(s)—and the tortious conduct that produces the injury—like the absence of adequate warnings of the products risk.  In addition, the plaintiff (or her insurers) presumably paid for the drug.  Moreover, the duty to mitigate damages starts with injury that produces damages, but benefits of a drug may precede the onset of injury.

Although not presented separately, the court suggests a reason that seems more plausible to us—plaintiff  “is arguing that she would not have consented to take [the drug] if she had been properly warned of its dangers, while [defendant] seeks to introduce evidence of medical harm she would have suffered but for taking the drug.”  Id. at *8.  This is still not exactly right—the hoped-for benefit was why plaintiff took the drug notwithstanding the risks she learned, and maybe her past experience with the drug is why she kept taking it through the point when her use allegedly produced an injury—but it is nice to see that the plaintiff’s prior dodge of proximate cause for failure to warn worked against her.  Just like expanded benefits evidence can open the way for expanded risk evidence, so can improperly shifting the focus from the decision making of the learned intermediary to the decision making of the plaintiff open the way for more evidence about the plaintiff.  (Later in the decision, plaintiff’s motion to exclude evidence of her alcohol abuse was denied because of “an open question” of alternative causation, but that could just as easily have turned on plaintiff’s willingness to accept health risks from her behavior.)  The real fight, though, is not whether defendant can mention the benefits plaintiff experienced while on the drug, but how the court will instruct the jury on how it can use that evidence in answering questions it will be charged to answer.  Then we will see for which party evidence of benefits was most beneficial.  Or not.