Handling "Bad" Company Documents: Preventing Admission at Trial[dagger]

• Published in: FDCC quarterly 2005-10, Vol.56 (1), p.77
• Main Authors: O'Toole, Leslie C, Sexton, Wendy I
• Format: Article
• Language: English
• Subjects: Causality; Defective products; Drug dosages; Evidence; Fatalities; Federal Rules of Evidence; Liability; Litigation; Manufacturers; Medical equipment; Medical personnel; Medical technology; Pharmaceuticals; Prejudice; Product recalls; Public records; Records management; Studies; Trials
• ISSN: 1544-9947

One of the most powerful evidentiary tools available to plaintiffs is the use of a company's own bad documents against it at trial. In this age of technology, bad documents are more likely to be accessible because of increased use of computers, e-mail, and the Internet. Under the Federal Food, Drug, and Cosmetic Act and its accompanying regulations, drug and medical device manufacturers submit product safety reports to the Federal Drug Administration. Adverse Drug Events (ADEs) should be excluded from evidence at trial because they lack reliability, they lack relevance, and they pose a significant danger of unfair prejudice, issue confusion, and waste of time. Despite their marginal relevance to the case, preventing the facts contained in bad company documents from becoming influential evidence at trial is an uphill battle. Defense counsel must identify and critically examine bad company documents as early as possible to identify strategic legal grounds upon which to bar their admission at trial.