Ghostbusting prejudicial evidence: no haunting the manufacturer.

• Author: Streza, Ralph

Writing in the March newsletter of the Drug, Device and Biotech Committee, Ralph Streza and Carmen Morris Twyman of the Cleveland office of Porter Wright Morris & Arthur, LLP, discuss preventing former statements:

It's a cold, blustery March day, and Alex, an accomplished defense attorney, is wrapping up another long day of preparing for a trial that is only two weeks away. The trial involves a product liability action against Device Co., the designer and manufacturer of a medical device. The plaintiff claims the device was defectively designed and that Device Co. failed to warn of dangers that were discovered post-manufacture and after the device was implanted into the plaintiff.

Alex was just about to leave the office when the phone rang, and Dr. Bernard Inventure, an out-of-state, non-party fact witness in the case, informs Alex that a records deposition subpoena has just been served on him by the plaintiff's counsel.

The subpoena seeks Dr. Inventure's authentication of a presentation made by him and recorded on videotape and of trial testimony given by him five years ago in a similar lawsuit against Device Co. Knowing that Dr. Inventure was deposed several months ago and that discovery has closed, Alex is somewhat disquieted by the subpoena. When Dr. Inventure served as an expert witness for Device Co. in the five-year-old product liability action involving the same medical device, the plaintiff in that case impeached Dr. Inventure with the videotape. That case involved, of course, a very different plaintiff. Neither the videotape nor the other trial testimony was mentioned in Dr. Inventure's deposition in the current litigation, and Alex has no intention of calling Dr. Inventure as a witness at the upcoming trial.

He's involved

Dr. Inventure was intimately involved in the initial design and testing of the medical device and has been involved in the continuing clinical experience with the device. As is common within the evolutionary process in which the clinical community understands implantable medical devices, Dr. Inventure made some statements about the design of the medical device several years ago at a surgeons' meeting. It's a common phenomenon--doctors share knowledge and opinions in order to advance and improve the medical technology. Unfortunately, his earlier statements concerning his opinions on the design of the medical device were captured for posterity on the subpoenaed videotape. The statements that Dr. Inventure made, if used in the trial by the plaintiff, could be misleading and therefore damaging in the upcoming trial.

The recent subpoena makes it clear that the plaintiffs counsel intends to use Dr. Inventure's years-old videotape statements and the other trial testimony as substantive evidence of other accidents, or at the very least, for impeachment purposes in the upcoming trial. If the testimony were to be allowed in, the task of convincing the jury that the plaintiff's injuries were not a result of a design defect would be incredibly more difficult, primarily because the plaintiff will attempt to introduce the prior statements to support their claims regarding the design of the medical device.

What can Alex do?

Can Alex convince the court that the videotape and Dr. Inventure's testimony should be left in the past and out of the trial? The answer lies in identifying the arguments that the plaintiff might raise in an effort to bring Dr. Inventure's former testimony into the current litigation.

There are a few options under which the plaintiff may seek to have Dr. Inventure's out-of-court statements admitted. First, the plaintiff may seek to have the testimony admitted as former testimony of an absent witness. Second, the plaintiff may argue that Dr. Inventure's testimony should come into evidence as an admission of a party opponent. Finally, the plaintiff may try to admit portions of Dr. Inventure's testimony from the five-year-old trial as prior inconsistent statements.

With the plaintiff's expected arguments in mind, Alex can file a motion in limine arguing that Dr. Inventure's videotaped interview and unrelated expert opinion trial testimony are irrelevant, prejudicial, unnecessary, unreliable and hearsay, and therefore should not be admitted as evidence at trial.

Statements that haunt

Even in the highly regulated pre-marketing world of medical devices, a manufacturer is exposed to liability as it develops or redesigns a product. Most safety and efficiency conscious manufacturers will not design, tool, manufacture and immediately release the product to the field. While the shortcut method allows minimum time for field and life testing and maximizes potential profit, it is also the most certain way to expose the manufacturer to product liability litigation. Quick product releases inevitably overlook the guiding principle in judging a product to be safe: all foreseeable hazards are taken into account and addressed to the greatest extent feasible.

It follows that every effort should be made to identify hazards and eliminate those found. As most medical device manufacturers appreciate, "every effort" means using the best technology available at the time for finding hazards, for designing them out, and for employing competent surgeons and/or other medical professionals to help the design and improvement process. The difficulty is that technology is constantly changing, and the designer-surgeon is often forced to evaluate and reevaluate the medical device in order to meet the constantly changing safety standard.

For this reason alone, it is vitally important that manufacturers facilitate open discussions in non-threatening environments with the designer-surgeons and medical professionals that have used the medical device in order to identify imperfections and vulnerabilities in the device and to assist in designing those imperfections away. Abiding by this process will ensure that the medical device evolves and improves after it is tested, approved and manufactured.

It is within that process, however, that the manufacturer can expect critical opinions from the designer-surgeons. In the courtroom, plaintiffs are likely to attempt to bring in these critical opinions and statements, which inevitably would serve to...