We sometimes take an impish delight in the comments we get from readers who are surprised that we tout defense wins, question the logic of decisions that allow plaintiffs to get past summary judgment with questionable evidence, or—gasp—use sarcasm in how we discuss cases.  The approach of this blog is not a mystery—the contributors spend most of their working days defending drug and device manufacturers from lawsuits that we often think are bogus, over reaching, and/or an affront to the regulatory scheme that governs the products at issue.  We describe cases or discuss recurring issues with the hopes that lawyers who do what we do or those in-house who hire them will be able to repeat successful strategies and avoid pitfalls in their own cases.  We also get the opportunity to blather on about things we think are important, legal or otherwise.

Sometimes, we run across a case that does not require much of our renowned wit.  We can just set out what happened and crow.

In Calisi v. Abbott Labs., No. 11-10671-DJC, 2013 U.S. Dist. LEXIS 139257 (D. Mass. Sept. 27, 2013), the court struck questionable expert testimony on the adequacy of a prescription rheumatoid arthritis drug’s warnings for lymphoma.  Without admissible expert testimony—and, as a Calisi instead of Khaleesi, she was unable to rely on bloodriders, dragons, or Unsullied for her cause—plaintiff had no way to carry her burden and lost.  Along the way, the court made a number of sensible decisions on issues that recur in prescription drug cases.

Plaintiff relied on Michael Hamrell, Ph.D., a semi-frequent flyer plaintiff expert who actually worked at FDA’s Center for Drug Evaluation and Research and for industry before going to the dark side, to offer expert opinion evidence that the drug’s warnings were inadequate in “downplaying” and “obfuscating” the risk of lymphoma by how the risk associated with the underlying condition being treated was discussed.  Before the decision we are discussing, the court had already rejected plaintiff’s aggressive move of trying to preclude the defendant manufacturer from “relying on” the learned intermediary doctrine, which is otherwise well-established in Massachusetts for prescription drugs.

The first issue for the court to tackle, reserved from the prior decision, was whether the defendant manufacturer had voluntarily assumed a duty to warn the plaintiff directly, as some pharmacies have been held to do when they directly provide the patient with a “detailed list of warnings, or, by way of advertising, promise[] to provide customers with information.”  Id. at *9 (quoting Cottam v. CVS Pharmacy, 764 N.E.2d 814 (Mass. 2002)).  Assuming without deciding that there could ever be a voluntary assumption by a prescription drug manufacturer of a duty to warn a patient directly, the court rejected that the defendant’s general marketing efforts, including handouts and a video for patients through their prescribers, created such a duty.  In addition to the fact that no case had recognized such a duty—and cases going back to the venerable Seley v. G.D. Searle, 423 N.E.2d 831 (Ohio 1981), case had rejected it—the plaintiff’s own testimony doomed her argument.

Whether offered out of honesty or a desire to disclaim that she had received lymphoma warnings, plaintiff disclaimed that she had “paid attention” to anything the manufacturer ever wrote about its product except a video she got from her prescriber, which clearly directed patients to prescribers for complete warning information.  This probably would have been enough to negate proximate cause for any alleged shortcoming in the warnings provided to patient, but it was enough to keep the learned intermediary where he belonged.

Skipping ahead somewhat, that meant that plaintiff could only survive summary judgment if she had admissible expert testimony to raise a genuine issue of fact as to whether the warning for physicians was inadequate.  (In an earlier footnote, the court offered the dicta that the adequacy of a warning intended for patients might be decided without expert testimony.) Somewhat ironically given the requirement of Rule 702(a) that “the expert’s scientific, technical, or other specialized knowledge will help the trier of fact to understand the evidence or to determine a fact in issue,” plaintiff tried to claim that the very issue for which she offered Dr. Hamrell—to prove that the physician warning was inadequate—was not sufficiently complex to require expert testimony.  After recapping the various arguments plaintiff had made about why various iterations of the drug’s label and communications about the drug provided inadequate warnings to doctors, the court concluded that whether a “warning was appropriate to educate a reasonable physician” was something the jury could not decide without expert testimony “except by engaging in impermissible conjecture.”  Id. at *57.

The court also rejected the plaintiff’s interpretation of the prescriber’s testimony as revealing confusion about the risk of lymphoma—presumably interpreted by the defendant as understanding that the risk was not clear—could substitute for expert evidence on inadequacy of the warning.  Id. at **57-58.  “But what the prescribing physician did or did not do in response to warnings does not answer the initial issue of whether the warnings given were adequate.”  Id. at *58.

This quote may be twisted in the future to suggest that physician testimony about finding a warning clear, understandable, and consistent with her understanding of the pertinent medical literature is not probative of whether a warning was adequate, but, in context, it made sense here.  So, plaintiff needed Hamrell’s opinions on the inadequacy of lymphoma warnings to pass Rule 702 and Daubert.

This brings us back to the meat of the decision.  For starters, the court’s analysis was thorough and aided by the understanding that plaintiff, as proponent of the evidence, had the burden to satisfy each element of Rule 702 for each opinion Hamrell wanted to offer.  We have seen too many courts relax the burden for experts simply because of the degrees they had or general experience they claimed.  Hamrell’s degree is a doctorate in pharmacology and his experience, accordingly, does not include prescribing drugs.  Whether from honesty, sloth, or a desire to be cagey about his background—we ran across him in cases more than a decade ago but cannot dredge up from our memory which is most likely—Hamrell was unable to spin his own experience to provide for expertise in or a reliable basis for opining on how doctors interpret warnings about drugs.

The focus on how doctors interpret warnings stemmed from an astute understanding of failure to warn claims for prescription drugs work.  This issue is not simply the “label’s factual incompleteness”—a subject as to which the court found expert testimony would assist the jury and Hamrell had an opinion “based on sufficient facts”—but how physicians who might use the label and other information on the drug would interpret the warnings.  Id. at **22-24.  “Here, the plain purpose of the information is to allow a medical doctor to make a properly informed decision when prescribing a drug,” so Hamrell’s offered opinions had to be evaluated in light of that purpose.  The court did not speak of it in terms of proximate cause, but it stands to reason that expert testimony on inadequacy of warnings should dovetail with the evidence to be offered that the prescriber would have done something different and avoided the injury if an adequate warning had been provided.

In other words, general warnings opinions are not helpful to the jury unless they fit with the case-specific evidence.  This ships-in-the-night dynamic often plays out on summary judgment or directed verdict, but it is also a reason why expert evidence should be excluded up front. Through personal experience and preparation to offer his opinions, “Hamrell has to have a sufficient basis for understanding what information is needed by a doctor in making his or her prescribing decision.”  Id. at *26.

Like many others who hold themselves out as experts for plaintiffs in this area, Hamrell was not a doctor, lacked specialized training in how doctors or other people interpret information, and had not bothered to get information on how any doctor had ever interpreted the information actually provided on the drug or the alternative warnings language he proposed.  It is to his credit that he actually tried to offer alternative language and that he candidly acknowledged in deposition the lack of support for his opinions on how doctors would interpret it, but we are somewhat surprised that the plaintiff and Hamrell did not come up with something during motion practice to make it seem like he was following a reliable methodology.

As far as we can tell, they did try any much of anything (and we are not offering a roadmap for the other side), so the court was left to methodically fail Hamrell’s labeling opinions against each requirement of Rule 702.  His proffered opinions on information in marketing materials and whether the defendant met the old but vague “reasonably prudent pharmaceutical company” standard fell for similar reasons.  One thing we find humorous is the attempt to distinguish the exclusion of Hamrell from the pass given Randall Tackett, a similar Ph.D. pharmacology plaintiff expert who has disclaimed expertise in drug labeling, in Bartlett v. Mutual Pharm Co., 678 F.3d 30 (1st Cir. 2012).  Id. at *41 n.13.  If Hamrell cannot opine on prescription drug labeling, then Tackett cannot opine on the standard of care for a prescription pharmaceutical manufacturer.

This tells us two things.  First, even when a court issues a sterling decision in one case, it is loath to say any prior decision was wrong.  Second, even when we say we will stick to the facts, there is a good chance we will end up finding something to mock.