The FDA promotes its Genome Trakr database as a food safety compliance tool. The Genome Trakr network, established by the FDA in late 2012, is comprised of FDA, state, federal and international food safety laboratories sharing whole genome sequencing (WGS) data from bacteria that cause foodborne illness. Whole genome sequencing and sharing the WGS results helps speed up outbreak investigations. The faster that public health officials can identify the food or ingredient that caused the illness and where it came from, the faster the harmful ingredient can be removed from the food supply — and the more illnesses and deaths that can be averted.
According to the Centers for Disease Control and Prevention report “Estimates of Foodborne Illness in the United States,” each year roughly one in six Americans (or 48 million people) get sick, 128,000 are hospitalized, and 3,000 die of foodborne diseases. In the United States, more than nine million of these illnesses are accounted for by major pathogens tracked by the CDC, including bacteria, such as e. coli and salmonella; parasites, such as Toxoplasma gondi; and viruses, such as Norovirus.
Globally, almost one in ten people fall ill every year from eating contaminated food, and 420,000 die as a result, according to the World Health Organization. Children under five years of age are at particularly high risk, with 125,000 children dying from foodborne diseases every year.
Clearly, food production facilities reduce their liability exposure by reacting quickly when the Genome Trakr database identifies them as the source of a foodborne illness. But, what about those illnesses and deaths that are not averted? The Genome Trakr database provides other benefits for potential defendants in foodborne illness litigation. Because the FDA uses the Genome Trakr database to determine which illnesses are part of an outbreak and which are not, food production facilities could move for summary judgment quickly with regard to plaintiffs whose infections do not match the genomes of the bacteria at their facilities. Because the FDA uses the Genome Trakr to determine which ingredient in a multi-ingredient food is responsible for the outbreak, food production facilities could move for summary judgment quickly where the genes point to another food manufacturer or supplier as the source of the outbreak. Because the FDA uses the Genome Trakr to differentiate sources of contamination, even within the same outbreak, food production facilities can accurately exclude themselves from the chain of causation.
Could victims of foodborne illnesses use the Genome Trakr database to prove causation? Consider the case of Stephanie Smith, a 22-year-old dance instructor left paralyzed by an e. coli tainted hamburger, which was meticulously recounted by Michael Moss in an October 3, 2009, New York Times article, “The Burger That Shattered Her Life.” Before the application of whole genome sequencing to foodborne pathogens, victims like Ms. Smith faced an almost insurmountable task of connecting a particular person’s infection to a particular food source. In this age of globalized food production, one package of ground beef at the grocery store can be the product of multiple countries and multiple food processors. Ms. Smith’s hamburger was comprised of ingredients, “from slaughterhouses in Nebraska, Texas and Uruguay, and from a South Dakota company that processes fatty trimmings and treats them with ammonia to kill bacteria.”
The FDA is already using the Genome Trakr database to trace back infections to a specific source. As the FDA uses the Genome Trakr database to determine which illnesses are part of an outbreak and which are not, plaintiffs’ attorneys could do the same to establish the class of affected plaintiffs. As the FDA uses the Genome Trakr to determine which ingredient in a multi-ingredient food is responsible for the outbreak, plaintiffs’ attorneys could more narrowly focus on the responsible food manufacturers rather than wasting resources casting a broader net. As the FDA uses the Genome Trakr to differentiate sources of contamination, even within the same outbreak, plaintiffs’ attorneys could lay out the chain of causation with more accuracy and precision than ever before. As the FDA uses the Genome Trakr to link small numbers of illnesses, including geographically diverse illnesses occurring across multiple states, which might not otherwise have been identified as a common outbreak, plaintiffs’ attorneys could use the same tool to consolidate multi-state multiparty litigation and improve judicial efficiency.
By Sarah Kelman, JD, and the experts and editors at Medical Law Perspectives.
See also Medical Law Perspectives, July 2016 Report: Unlocking Genetic Secrets: Liability Risks for Genetic Testing and Information Providers
See also Medical Law Perspectives, July 2012 Report: Foodborne Illness: When Grabbing a Bite Can Be Deadly
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