Scientific data is the underpinning of the best ingredients and finished products in the dietary supplement and functional foods industry. But when it comes time to use that information to defend your product in court, whether in a product liability case, patent infringement lawsuit or a breach of contract case, that blizzard of data, however convincing to your fellow PhDs, can get in the way, experts say. Data doesn't speak for itself. When communicating those results, all the Westen blots and data charts in the world aren’t worth a clear, effective and simple explanation of what the data says about the product and about the company.
“The good company story is really important for executives in food companies to understand because it is really important to present the case to the jury of a company that cares, a company that is doing good and its products are good for society,” said Michelle Gillette, a San Francisco-based attorney with the firm with Mintz, Levin, Cohn, Ferris, Glovsky and Popeo PC.
“The best story wins. Create a cast of characters and give each important aspect of the case a character that the jury can relate to. Stories are persuasive and far more engaging than a mere recitation of the facts,” Kantha Shelke, PhD, a food consultant and expert witness based in Chicago told NutraIngredients-USA.
Stick to the crux of the matter
Shelke breaks the approach down this way: Be credible, be simple, tell a good story, and refute the other side’s assertions early on. Honing in on what’s critically important can help identify what story to tell, she said.
“For better or worse (and mostly the latter), judges and juries have preconceived notions about scientific evidence due to popular TV dramas featuring forensic investigations. It is very important to understand the crux of the matter—i.e., the core of the dispute—and to provide scientific evidence to support your opinion,” Shelke said. “It is more effective to identify, anticipate, and knock down, with science, the strongest and the weakest aspects of the other side at the very start than to try and tackle them during the rebuttal.”
The company’s scientific strategy doesn’t necessarily need to be designed with an end game in court in mind. But a well designed set of studies, to amass safety data, to identify modes of action and so forth, each with clear goals in mind, can make an attorney’s life easier on the bad day when a company winds up in litigation.
“Clinical trials should be designed, conducted and analyzed according to sound scientific principles to achieve their objectives; and should be reported appropriately. The essence of nutritional ingredients is to ask important questions and answer them with appropriate studies. The primary objectives of any study should be clear and explicitly stated. Clinical trials should be specific to the risk and complexity of each trial and not governed by one-size-fits-all requirements of sponsors and their contracted organizations,” Shelke said.
And everything that is said about that program can form part of the story in court—for both sides.
“You have to be mindful of what you are saying in the research and development of the product three, four, five years before you launch it,” Gillette said.
Identify your story teller
Gillette said identifying a good witness within the company is a critical part of success in court. The person needs to be likeable, friendly and knowledgable. After that groundwork is established, it’s time to bring on the expert witness.
“It is really important for the company executive to set the ground work for why the product is out there, what the company is trying to accomplish, and then have the expert witness go into detail,” Gillette said.
“There are two kinds of witnesses presenting scientific testimony: witnesses of fact or expert witnesses. The former, regardless of their scientific training, can testify only to matters of fact that they have witnessed and cannot give opinions. The latter, is one who, by special study, practice, and experience, has acquired unique skill and knowledge relevant to some particular science, art, profession, or trade,” Shelke said.
“The main reason for an expert testimony is to interpret complicated and difficult-to-comprehend facts to the judge and to the jury. The court permits the expert to evaluate the evidence and explain its significance to the case under consideration. Giving opinions based on data, facts, and principles is strategic and yields maximum impact,” she said. The perceived impartiality of those opinions are key to their effectiveness, Shelke said. Expert witnesses, and the attorneys who put the questions to them, have to guard against starting to sound like a member of the company’s marketing department.
And as for marketing, Gillette said it’s wise to use restraint right from the start of a product’s development cycle. Hyperbolic product descriptions and claims can be a stick your opponents will beat you with in court.
“Your legal department within the company has to be involved with the marketing department. The marketing department wants to come up with a rosy picture for the product description, which is not always in your company’s best interests,” Gillette said. “It is easy to solve if you do it in the beginning.”