A Tried And True Summary Judgment Option In Pharmaceutical And Medical Device Failure To Warn Cases

Summary judgment is a manufacturer's goal in almost every case. Often, it's an uphill battle. For example, a recent Supreme Court decision has made summary judgment more difficult to obtain in prescription drug cases that allege a failure to adequately warn, by limiting the scope of the federal preemption defense.1 Thus, a Food and Drug Administration ("FDA") decision that a particular risk need not be identified in the labeling is rarely a basis to preclude Plaintiffs from proceeding with litigation criticizing the FDA-approved labeling. Additionally, courts are reluctant to adjudicate, at the summary judgment stage, that labeling adequately warns of the risks at issue because this is perceived by many courts as a question for the jury.2 Moreover, Plaintiffs' lawyers can easily find "experts" to criticize labeling and to offer opinions that the labeling, albeit FDA-approved, should have disclosed additional or different risks, or disclosed them in a different manner. These expert opinions, even when weakly supported, are often enough to thwart a defense summary judgment motion in most state court actions.

But even when the alleged risk is not mentioned in the labeling, prescription drug and medical device manufacturers may still have a defense available in failure to warn cases. As set forth in a seminal California case on this subject, Plenger v. Alza Corporation, 11 Cal.App.4th 349 (1992), a manufacturer has no duty to warn of a risk that is well-known and well-appreciated by the medical community. Id. at 362. The manufacturer's duty to warn runs to the physician under the learned intermediary doctrine3 and there is no duty to warn where the intended audience for the warning is already aware of the risk or should have known of the risk. In addition, if the Plaintiff's physician is already aware of the risk (or is professionally obligated to be aware of it as common knowledge in the profession), a manufacturer's failure to warn of such a risk cannot be the proximate cause of any alleged injuries. Id.4 If the physician actually knew of the risk, then the absence of warning on the label would not have prevented the physician's use of the product. If the physician should have known of the risk but did not, then the proximate cause of the Plaintiffs' injury was the physician's failure to know about the risk, not the absence of a warning. In other words, no harm can be caused by failure to warn of a risk already known.5

Courts outside of California have also recognized these defenses.6 For example, as explained in Stanback v. Parke, Davis and Co., 657 F.2d 642 (4th Cir. 1981), there is no evidence of causation when it is firmly established that a more complete warning would not have changed the physician's course of action in prescribing or administering a prescription drug. Id. at 645-46. In Stanback, Plaintiff brought suit against a pharmaceutical manufacturer for its alleged failure to...