Merrell Dow Pharmaceuticals

In 1983, Merrell Dow Pharmaceuticals, Inc. voluntarily removed Bendectin from the market because of the many product liability suits pending. However, subsequent in-depth analysis of epidemiological and scientific data indicated that the therapeutic use of Bendectin had no measurable teratogenic effects. Nevertheless, despite the overwhelming scientific evidence, a number of jury decisions were rendered against the company (providing an argument for tort reform). 

In 1993, an opinion from the Supreme Court of the United States in Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 US 579, held that the adoption of the Federal Rules impliedly overturned the decision in Frye. Importantly, the text of the FRE does... 

The Federal Rules of Evidence (ERE) were adopted in 1975. Subsequently most states (at least 37) have adopted their own codified rules of evidence modeled closely on the FRE. For scientific evidence, the most relevant of the Rules are found in Article VII of the FRE in a section known as Opinions and Expert Testimony. Prior to 1993, some federal appellate courts had applied Rule 702 of the Federal Rules of Evidence to medical and scientific experts. (Rule 702 authorizes scientific testimony whenever it will assist the trier of fact to understand the evidence or to determine a fact in issue.) In 1993, in Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 US 579, the Supreme Court of the United States issued an important interpretation of Rule 702. Seven of the nine justices ruled that judges must serve as evidentiary gatekeepers who determine whether proffered evidence is scientifically valid and relevant. The Court suggested several factors for judges to consider in determining whether to admit a particular theory or technique Is the theory or hypothesis testable Has it been tested Has the theory or technique been subjected to peer review and publication For a particular scientific technique or methodology, what is the known or potential rate of error What (if any) are the standards that control the technique s operation To what extent is the theory or technique generally accepted in the scientific community ... 

Halazy, S., and Danzin, C., PhosphonoaUcylpurine derivatives as purine nucleoside phosphorylase inhibitors, Merrell Dow Pharmaceuticals, Eur. Patent Appl. EP 338168, 1989 Chem. Abstr., 112, 158267, 1990. 

Stemerick, D.M.. Farnesyl protein transferase inhibitors as anticancer agents, Merrell Dow Pharmaceuticals, Int. Patent Appl. WO 9419357, 1994 Chem. Abstr, 121, 301073, 1994. 

At the same time, Dow moved to bolster its position in pharmaceuticals by acquiring a leading mid-sized firm, Marion Laboratories. Dow consolidated its new property with Merrell-Dow Pharmaceutical and its Allied Laboratories to form Marion Merrell Dow, the ninth-largest pharmaceutical company in the United States. To finance this move, it took the company public while retaining 67 percent of its equity. ... 

The analysis found 85,694 different Federal product liability cases involving a total of 19,456 lead defendants. Pharmaceuticals and health care products represented 13.5 percent of the total cases but only 2.2 percent of the total number of defendants. Of the 11,292 suits for pharmaceutical and other health products filed, 72 percent are attributable to five fins, and 60 percent are attributable to two companies-A H. Robins and Merrell Dow Pharmaceuticals.9Figures 7-1 and 7-2 show trends in these cases over time. 

In the case of Daubert v. Merrell Dow Pharmaceuticals, Inc. (1993), the U.S. Supreme Court ruled that the trial judge should function as a gatekeeper who allows the jury access to expert testimony only after the court has made an initial determination regarding the scientific reliability and relevance of that testimony, and of the proposed experts witnesses. The Daubert Rule applies to federal courts and to some states. It is gaining increased recognition and use. 

In courtroom litigation about toxic effects alleged to be caused by carpet, the defense had Anderson s expert testimony stricken from evidence based on a 1993 Supreme Court mling, Daubert v. Merrell Dow Pharmaceuticals, which had estabhshed a new set of standards for judging scientific evidence, including peer review and independent rephcation of findings. Sandra Ruffin Catherin Ruffin v. Shaw Industries, Incorporated Sherwin-Williams Company, 94-1882 (4th Cir. Ct. of Appeals, 1998). 

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