Products Liability Update: The End of an Era: Lessons to Be Learned From the Bendectin Litigation


Merrell Dow manufactured a drug called Benedictin that was prescribed to pregnant women to alleviate the effects of morning sickness. Multiple lawsuits claimed that the drug was responsible for birth defects in the children of users. Years were spent litigating the issues with some appeals rising to the attention of the Supreme Court. One such case ended when the court issued a judgment non obstante veredicto (JNOV), also called a judgment notwithstanding the verdict, with the judge overruling the determinations of the jury upon determination that the decision must have a particular outcome as a matter of law.

With the entry of JNOV in favor of Merrell Dow in Blum v. Merrell Dow Pharm., Inc., 1997 Pa. Super. LEXIS 3861, at *4 (Pa. Super. Ct. Dec. 29, 1997), the Bendectin mass tort litigation, for all practical purposes, came to a close after more than ten years.

One of the most important lessons to be learned from the Bendectin litigation is that a vigorous attack against plaintiffs' medical theories and their experts may be the best strategy to defend and contain a litigation which has the potential to grow into a company-threatening mass tort. From the start of the Bendectin litigation, Merrell Dow successfully mounted an aggressive defense of Bendectin, principally challenging the admissibility of causation opinions by plaintiffs' experts. The Bendectin litigation led to the landmark decision in this area, Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579 (1993), recently interpreted in Daubert v. Merrell Dow Pharm., Inc., ("Daubert II"), 43 F.3d 1311 (9th Cir. 1995), cert. denied, 516 U.S. 869 (1995), and General Electric Co. v. Joiner, 118 S. Ct. 512 (1997).

As new products are targeted and causation theories for already besieged products change, it is imperative that manufacturers challenge plaintiffs' expert opinions at every turn, especially in the early stages of a case. Depositions of experts and treating physicians should be conducted from the beginning of any litigation in light of the factors which are key to the Daubert admissibility analysis: whether the expert's theory can be or has been tested, whether it has been subjected to peer review and publication, the potential rate of error in application, whether it enjoys general acceptance within the relevant scientific community, and whether the theory was developed solely for purposes of litigation. Daubert, 509 U.S. at 592-595; Daubert II, 43 F.3d at 1316-1317.

Another good example of using Daubert as a shield is the silicone breast implant litigation where Daubert issues abound. The tide of this litigation turned in favor of the manufacturers in large part due to their successful use of Daubert in challenging the admissibility of causation testimony by plaintiffs' expert witnesses, though it should also be noted that several companies entered into one of the largest settlements ever negotiated in a class-action lawsuit. Daubert is a powerful tool, but in the worst cases even its protections may not be enough to entirely shield a manufacturer from liablity.

The Benedictin mass tort litigation may be finally coming to an end but won't soon be forgotten. Attornies, both plaintiffs and defendants, would be wise to revisit these cases frequently for cautionary tales about the use of scientific evidence and experts, the management of multiple claims, and the importance of causation issues.