In the world of developing products and getting them out to consumers, the last thing anyone wants is a recall. Planning for a recall may seem almost as bad — who wants to plan for something negative when every possible precaution has been taken in the development stage to avoid it? This is true even more so in the pharmaceutical and medical-device arena, in which the development phase also includes getting FDA approval to go to market.

Despite the counter intuition, there are things that manufacturers can, and should, do during the development and going-to-market phase of a product that can significantly improve the litigation prognosis should the manufacturer decide on a voluntary recall. In other words, prepare for your potential recall and weave safeguards into the process that will diminish the likelihood of lawsuits or other liability issues.

First, give medical personnel a brief primer on the Rules of Evidence. The medical experts involved in the approval and recall of a product are probably not trained in the Rules of Evidence. Nor do they often understand the weight their words (written words in particular) will carry with a jury because of their status as medical experts. Unlike lawyers, engineers and scientists speak in black and white. Phrases such as “there is a statistically significant correlation,” “the product did not perform as designed,” or worse, “there appears to be a significant failure rate,” are all appropriate scientific conclusions and ones you want your researchers to reach if warranted. What you need to teach your medical personnel, though, is to keep those statements within the context of a medical discussion where they can be explained scientifically through their context. “Significant” as a scientific term quantifies a degree greater than insignificant. “Significant” to the lay public means big, many, or a lot. You do not want these phrases in a one-line email without the scientific context. They look terrible when blown up on a large screen for the jury.

Next, include in-house litigation attorneys at the beginning of recall discussions. A common mistake in recall planning is that the decision to recall, and often the plan for developing the recall, is developed without the consultation of litigation attorneys. To minimize the impact though litigation avoidance, it is critical that an attorney assist in planning for a recall. While the main focus of the recall is primarily consumer protection, a clear secondary goal is to handle it in a way that will maintain the viability of the company and minimize the impact. In this capacity, a litigation attorney can add tremendous value.

Develop a clear and concise protocol for customer-service representatives who will be handling customer calls. Generally, one of a manufacturer's worst nightmares in litigation is when plaintiffs can obtain and use other potentially “similar” situations to support claims in a particular case. In terms of a recall, lawyers for those hurt by a product will already know that these possibly related incidents exist. The records that a manufacturer keeps of consumer calls following a recall are often discoverable, even if they are not admissible, and they can provide plaintiffs' counsel with information about other potentially similar occurrences. As you'd expect, there are many who try to take advantage of the situation and will contact the company even though their circumstances do not relate to the recall situation. The best way to avoid having these non-similar incidents discovered is through training your staff for the appropriate handling of these contacts. They should consistently record the same information, and ask callers the questions that allow separating genuine recall conditions from those that are not. Keeping nongenu-ine-recall records out of plaintiffs' counsel's hands can save much time, money, and potential prejudice later on.

Know your insurance coverage and prerequisites. Every company should investigate — before the need becomes critical — whether they have insurance coverage to support a recall. If you do have coverage, pay particular attention to the prerequisites and limitations of coverage. Some recall insurance is onerous about the requirements to notify the insurer and letting the insurer “approve” various steps in the recall. Other policies cover the company's costs in physically recalling the product but will not cover other related activities, such as the public relations efforts that coincide with it.

Knowing your coverage limitations can provide great reassurance during a recall because it may limit some of the company's financial exposure. Conversely, not knowing the particulars can be costly, as was evidenced after the Tylenol-tampering cases and subsequent litigation surrounding coverage for that nationwide recall.

Confidently assert your “good company” story. At first blush, a recall is viewed as a negative: the company's product failed in some way, whether it is an undiscovered side effect, a lower success rate, or ineffective packaging. On the other side of the coin, the company's decision to make a voluntary recall can be a big positive. Here also, the Tylenol tampering case is a great example. The message is that “this is a company putting its consumers ahead of profits.” Not only is this a smart public-relations message, it is also a good litigation-avoidance message. Every potential plaintiff and potential juror that thinks of your company as a white knight is potentially one less claim, or one more defense vote.