West Virginia has rejected the learned intermediary doctrine, a bad decision we sliced and diced here and here. This left us wondering if a defendant has a shot of winning summary judgment on proximate causation in a West Virginia failure to warn claim. Many failure to warn claims can be defended by taking the deposition of the treating doctor, which usually establishes one or more of the following facts: (1) the doctor already knew about the risk at issue; (2) the doctor never read the defendant’s label before prescribing the drug; or (3) even if the doctor had learned about the risk at issue, he or she still would have prescribed the drug. If we get one of these answers, we can crank up the summary judgment apparatus because those answers show that the alleged failure to warn about the risk did not proximately cause plaintiff’s injury. Because we can’t do that in West Virginia, our little friends, affected by the skepticism of a skeptical age, were saying that there is no summary judgment based on proximate causation.
A recent federal court has responded: yes, West Virginia, summary judgment, like Santa Claus, lives forever and will continue to make glad the hearts of defendants. Meade v. Parsley, No. 2:09-cv-00388 (S.D. W. Va. Nov. 24, 2010).
The plaintiff in Meade took PLIVA’s metoclopramide, the generic equivalent of Reglan, and developed tardive dyskinesia (TD). The plaintiff and her husband sued, claiming that the drug’s TD warning was inadequate. PLIVA deposed the plaintiff, who testified that she never read the written materials accompanying her metoclopramide prescriptions. Her doctor testified that he also didn’t read PLIVA’s labeling, although he did read the PDR on Reglan and discussed TD with the plaintiff. PLIVA then moved for summary judgment based on lack of proximate cause.
The court first noted that the West Virginia Supreme Court of Appeals had held that drug manufacturers had a duty to warn consumers but had not clarified whether they also had a duty to warn the physician. Id. at 23. The court did not need to resolve that question because the undisputed evidence showed that an enhanced warning would not have changed either the patient or doctor’s behavior in a manner that would have avoided the plaintiff’s injury because they did not read the labeling. Id. Plaintiffs pointed to the doctor’s reliance on the PDR entry for Reglan, but PLIVA did not create that entry. Id. The court therefore granted summary judgment because plaintiffs could not carry their burden of establishing proximate causation. Id. at 26.
Meade points out something that we’ve been thinking about ever since the Karl decision abolished the learned intermediary rule in West Virginia. As a practical matter the learned intermediary rule lives – because the plaintiff in Meade is like most other people. Very few patients in fact read prescription drug package inserts. Most patients rely on what their doctors tell them – that’s one reason why we have doctors, and it’s the main reason that the FDA requires prescriptions in the first place. Thus, despite West Virginia’s misguided decision to require direct communication of warnings, in a lot of cases, maybe most, it won’t make that much of a difference because that duty necessarily requires plaintiffs to read whatever warnings are supposed to be provided, and they simply don’t.
In a bonus ruling, the court found that plaintiffs also failed to prove general causation, i.e., that metoclopramide causes TD. Any plaintiffs’ lawyers reading this blog – and we know you are out there and are glad to have you here – may say, “Aw, c’mon, lots of experts have said in other cases that metoclopramide causes TD and the label now contains a black box warning about TD. How can the court do that?” The court, however, properly was swayed only by its examination of the evidence before it. The plaintiffs’ treating physicians talked all around this issue, including testimony suggesting that metoclopramide caused her TD (specific causation), but did not give a clear expert opinion on general causation. That was not enough, as even the West Virginia Supreme Court has held that “‘indeterminate expert testimony on causation that is based solely on possibility . . . is not sufficient to allow a reasonable juror to find causation.” Id. at 18 (quoting Tolley v. ACF Indus., Inc., 575 S.E.2d 158, 168 (W. Va. 2002)).
Plaintiff pointed to PLIVA’s own labeling warning of TD as a potential side effect, but the court said that causation must be established by expert scientific testimony. Id. at 19. A mere warning, which does not explain its scientific basis, “is no substitute for expert testimony that establishes causation in terms of reasonable probability.” Id. at 20.
Plaintiffs also cited a 2009 FDA directive requiring a black box warning about the risk of TD. The court noted that courts have rejected reliance on agency determinations as a basis for general causation. Id. “Inasmuch as the cost-benefit balancing employed by the FDA differs from the threshold standard for establishing causation in tort actions, this court likewise concludes that the FDA-mandated tardive dyskinesia warning cannot establish general causation in this case.” Id. at 20-21.
Perhaps mindful of the “Aw, c’mon” crowd, the court dropped a footnote acknowledging that experts in other metoclopramide/TD cases had testified about general causation and stating that the court would have considered allowing plaintiffs to file an expert report on general causation before dismissing their case. Id. at 21 n.6.
The important point for us is this: A court must decide general causation based solely on the record in the case. Assertions that everybody knows that X causes Y or even that other cases have found that X causes Y do not provide evidence a court can consider. If a defense lawyer sticks to his or her guns and insists that the court stick to the record, then sometimes, even in West Virginia, summary judgment is possible.
A tip of the cyberhat to Phil Combs at Allen Guthrie & Thomas for passing this along.