Any time a sales rep’s conduct and statements are the centerpiece of a trial, our natural inclination as defense lawyers is to cringe. We know we will be fighting tooth and nail to explain to the judge and jury why the evidence should be excluded or ignored. Because let’s face it – the plaintiffs’ lawyer’s “Big Bad Pharma marketing in the air” theme is typically a tale “full of sound and fury, signifying nothing.”
Much as the plaintiffs’ bar hates to admit it, a trial focused on sales rep statements doesn’t necessarily have to end badly for a drug/device defendant. Flashback with us, Lost-style, to 2006, when the Connecticut Supreme Court reversed a trial court grant of summary judgment in a case called Hurley v. Heart Physicians, P.C., 898 A.2d 777 (Conn. 2006). In Hurley, the plaintiff was born with a serious heart condition – a congenital complete heart block – that required a cardiac pacemaker. Hurley v. The Heart Physicians, P.C., __ A.2d __, 2010 WL 3488962, at *1 (Conn. Sept. 14, 2010). Every few years, as the plaintiff grew, she received a new pacemaker. When the plaintiff was fourteen, her pacemaker’s replacement indicator signaled that the battery was wearing down, and it was time for a new pacemaker. The plaintiff’s cardiologist invited a representative of Medtronic, the defendant manufacturer, to attend an examination of the plaintiff and test the pacemaker. The representative performed the diagnostics, determined the battery was indeed dying, and explained that it needed to be replaced as soon as possible. So far, so good, but it goes bad pretty quickly.
Why? Because the plaintiff’s mother inexplicably refused to replace the pacemaker. Faced with this bizarre situation, the company representative also presented the option of lowering the “rate” of the pacemaker, which would at least conserve the failing battery. In consultation with the plaintiff’s cardiologist, the representative downward adjusted the rate, in accordance with what he understood the mother’s position to be. No good deed goes unpunished. A month later, the plaintiff tragically went into cardiac arrest and suffered permanent brain damage as a result. Id. at *1-2.
Back in 2006, the trial court granted summary judgment on the basis of the learned intermediary doctrine. The Connecticut Supreme Court, however, found that an issue of material fact existed as to whether the representative’s “words and actions were in derogation of the pacemaker’s technical manual.” Id. at *2. The supreme court therefore remanded for a new trial on the question of whether the representative’s conduct “actually contradicted” the pacemaker’s manual, “thereby vitiating and nullifying the manual’s warnings.” Id. at *4. After a 26-day trial on remand, the jury returned a verdict for the defendant, and the plaintiff again appealed to the supreme court.
Flashforward to 2010 – the plaintiff challenged the defense verdict on the grounds that the scope of the trial on remand was inappropriately limited. In essence, the plaintiff tried to dumb down the initial Hurley opinion. She argued she could prevail upon a showing that the representative’s statements were merely “inconsistent” with the technical manual, rather than actually “contradicting” the manual. Id. at *7. As an initial matter, the supreme court found the trial court properly conducted a retrial limited to the issue of whether the representative’s oral statements and adjustment of the pacemaker were for “diagnostic” purposes, or rather whether they “actually contradicted” the technical manual and thus nullified the accompanying warnings. Id. at *6. More fundamentally, the supreme court disagreed with the plaintiff’s hair-splitting, semantic-based argument that she needed only to satisfy a lesser standard of showing the representative’s statements and conduct were “inconsistent” with the manual. Id. at *7. The court had none of it, concluding that “inconsistent” and “contradicted” were synonymous; a showing that the statements “actually contradicted” the manual did not improperly heighten the burden of proof on the plaintiff. Id. The supreme court thus concluded the scope of the remand trial was proper, and upheld the defense verdict after disposing of the plaintiff’s other specious arguments.
We thought this case was worth reporting, first of all because it is somewhat unusual, involving a unique fact pattern and procedural history, and we don’t expect to see more trials like this. But it also got us riffing on this whole notion of alleged “inconsistent” marketing statements. Should those alleged statements have any impact on the outcome of a case? Certainly the plaintiffs’ bar thinks so. We’ve seen, on more than one occasion, plaintiffs’ lawyers argue that liability attaches whenever a sales rep makes statements that are “inconsistent” with the label – and typically, the plaintiffs’ lawyers go on to suggest that “inconsistency” is a pretty low burden to satisfy, much as the plaintiff argued in Hurley. But that’s a brazen attempt to end-run the learned intermediary doctrine. In most states, that’s not allowed; the learned intermediary’s testimony typically determines whether you can prove proximate causation in a prescription drug/device case (i.e., that a different warning would have caused the prescriber not to prescribe for the plaintiff). If the physician would have prescribed anyway, the case should be over. Plaintiffs’ lawyers often use evidence that a physician may have been visited by sales reps generally, or may have received information about the product at issue from the manufacturer, to suggest that such conduct was “inconsistent” with the warnings and risk information provided. The plaintiffs claim that this “inconsistency” renders the warnings per se inadequate, and thus the manufacturer should be liable regardless of what the prescriber knew or didn’t know, and regardless of whether the prescriber stands by the prescribing decision.
Even more egregious, plaintiffs’ lawyers often argue that “inconsistent” generalized marketing conduct, with no connection to the prescribing decision at issue, is sufficient, standing alone, to create a triable issue as to the adequacy of the warnings given and whether those allegedly inadequate warnings were the proximate cause of injury. In other words, good ole “fraud in the air.” But that’s just not the way the learned intermediary doctrine works. In fact, it ignores the actual reasons for the prescriber’s decision. We keep hoping that more judges will recognize this, and put an end to the typical plaintiffs’ tactic of sifting through call notes to find some snippet the lawyers can take out of context, distort, and ultimately claim is “inconsistent” with the label and thus actionable.