Germ Genetics, New Rules Drive Foodborne Illness Litigation

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By Steven M. Sellers

June 8 — Personal injury litigation over foodborne illness outbreaks will be increasingly influenced by genetic profiling of pathogens and new federal food safety standards, experienced food safety lawyers tell Bloomberg BNA.

A new genetic test for bacteria and viruses rolled out by the Centers for Disease Control and Prevention precisely pairs foodborne illness outbreak victims to a contaminated source, using the pathogen's DNA as a guide.

The new test, known as Whole Genome Sequencing, promises to better track and identify the 48 million foodborne illnesses that occur in the U.S. each year—particularly those that trigger multi-state outbreaks.

That scientific stride will be furthered by food facility testing and other measures mandated by the FDA Food Safety Modernization Act, a federal law designed to shift the national focus from responding to food contamination to preventing it.

The Food and Drug Administration finalized in May the last of seven major rules to implement the law enacted in 2011 (44 PSLR ???, 6/13/16).

The developments, in tandem, may enhance food safety in the nation, but may also work to strengthen plaintiffs' evidence in personal injury and wrongful death litigation over foodborne illness outbreaks that do occur, the lawyers say.

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It remains to be seen whether the science and rules may affect pending foodborne illness litigation against Chipotle Mexican Grill Inc., Blue Bell Creameries Inc., Dole Vegetables Inc. and other major food producers.

“A lot of times we couldn’t find a wrongdoer to go after,” plaintiff's attorney Fred Pritzker, of PritzkerOlsen in Minneapolis, recently told Bloomberg BNA.

“We just didn’t know where the pathogen came from,” said Pritzker, who has litigated numerous multi-state foodborne illness cases. “As the tools become more sophisticated and refined, it’s easier to link cases together and find a common source. That’s a big issue.”

Sleuthing Bacterial DNA

WGC is a big improvement over currently existing technology used by federal regulators in outbreak investigations. Known as Pulsed-Field Gel Electophoresis, the current test takes a narrower snapshot of a pathogen.

“[PFGE] would be like taking a jigsaw puzzle with a hundred pieces and you have two pieces that match,” defense attorney Sarah Brew, of Faegre Baker Daniels in Minneapolis, told Bloomberg BNA.

But full genome sequencing, she said, “is like the entire puzzle put together with all the pieces.”

“CDC [the Centers for Disease Control and Prevention] describes it as comparable to identical twins—on that level of assurance,” Brew said. “They can go back and look at cases from four or five years ago even without doing the standard shoe-level epidemiology of asking people what they ate,” she said.

Brew, who has extensive experience in defending food industry clients, spoke generally and not in regard to any particular pending or prior cases she's been involved in.

And the government's use of the new genetic test in foodborne illness outbreaks is expanding, plaintiff's lawyer William Marler, of Marler Clark in Seattle, told Bloomberg BNA.

“Right now, FDA, FSIS [the USDA's Food Safety Inspection Service] and CDC are rolling this out in listeria cases, and I've been at a couple of conferences where [they said] they're going to start rolling it out in salmonella, E. coli and other cases,” said Marler. He has litigated numerous high-profile foodborne illness cases since 1993.

Litigation Impact Debated

Scientists may be better able to sleuth pathogens as a result of WGS, but courts have yet to weigh in on the evidentiary value of the new test.

 


Some Pending Foodborne Illness Cases

“It’s a little early to say how much whole genome sequencing is going to change things,” Marler said. “I think it’s going to be more definitive, but we haven’t seen WGS tested in a courtroom yet.”

Defense lawyer David Ernst, of Davis Wright Tremaine in Portland, Ore., said the new science is likely to benefit plaintiffs in outbreak litigation.

Ernst represents national restaurant chains and food producers, and has litigated numerous food contamination cases.

“From a litigation standpoint, [plaintiff] firms don't have to worry too much about liability,” said Ernst, referring to cases in which a victim is definitively linked to a contaminated food source. “I think you'll see more of that because of the advancement of science.”

Taking on the CDC and FDA in a “linked” outbreak case can be “very tough” in any event, said Brew.

“It's not impossible, and can be done, and there are cases where it should be done. But in most cases—and what runs these cases is strict liability—all you have to do is show a defect and causation,” Brew said.

Such cases often settle, in part because of the strict liability standard typically applied by courts.

Foodborne illness outbreaks aren't necessarily increasing, the lawyers say—bigger numbers may simply be the result of more accurate scientific tools used in investigations.

“It's unclear whether the amount of illness is going up, but what these technologies do is increase, slightly, the number of illnesses traced to a particular contaminated food,” said Marler.

Ernst agreed. “I don't believe our food is less safe—or that there have been more outbreaks,” said Ernst. “But more outbreaks are being solved.”

‘Huge' FSMA Effect Seen

Lawyers on both sides of the outbreak cases said the new Food and Drug Administration rules will surely have an effect on civil litigation.

The FSMA includes mandated preventative controls and inspections of food facilities, minimum standards for harvesting fruits and vegetables, stronger regulation of imported foods and other safety measures (43 PSLR 1076, 9/14/15).

“I think it's going to have a huge effect,” said Brew. “The more testing that's done, and the more data that exists, the more opportunity for FDA and CDC to link pathogens to prior illnesses that before might have flown under the radar.”

Pritzker, of PritzkerOlsen, said the law will create “a significant change in the landscape” by creating a new language that will be common to all cases.

“The statute and the regulation now define any number of terms that will make it collectively easier because everyone will have to follow the same rule,” he said.

Suppliers may feel FSMA's pinch more strongly than companies with stringent standards of care already in place, according to Alan Maxwell, a defense lawyer with Weinberg Wheeler Hudgins Gunn & Dial in Atlanta.

Maxwell, who leads the firm's foodborne illness practice group, also has served as a special master in high-profile outbreak cases.

“Where I think it’s very important is imported food products, such that the importer is going to be held to the standard of the foreign manufacturer,” said Maxwell.

“That importer will have to show that the foreign manufacturer, grower, [or] whatever, is complying with the U.S. regulatory structure, including FSMA,” he said.

Old Scourges, Wider Impact

Harmful bacteria, such as Salmonella enteritidis, Listeria monocytogenes and Escherichia monocytogenes (E. coli) are among the top pathogens cited by the CDC in its most recent online report of foodborne illness outbreaks.

Lawyers on both sides of food safety cases point to an increased incidence of listeria.

Some plaintiff's lawyers say that is partly due to the bug's resistance to eradication efforts in food processing plants—a point also noted by defense lawyers who spoke with Bloomberg BNA. But the plaintiff's lawyers go on to say the consolidation of food production runs the risk of dispersing pathogens more broadly.

“Bagged salads are a perfect example,” said Denis Stearns, a co-founder of Marler Clark. “Twenty years ago, that product didn’t exist. Leafy greens weren’t distributed nationwide.”

“So, you might say the number of illnesses linked to leafy greens hasn’t increased,” Stearns said, “but I think it has increased in terms of that product category, because that category didn’t exist before.”

Maxwell said that economies of scale must be taken into account in any analysis of food consolidation and its effect on food safety.

“If you have a local grower that poisons a couple of people who bought lettuce at a local farm market, that's not going to be a national problem,” Maxwell said.

“You also have to appreciate the quantity of product being put to market. You get more people struck by lightning than will die from salmonella,” he said, adding that the U.S. “is the safest place to eat.”

Outbreak Settings Vary

In 2014, the most recent year for the CDC's annual report on foodborne disease outbreaks, 864 foodborne disease outbreaks were reported nationally. Those outbreaks resulted in 13,246 illnesses, 712 hospitalizations, 21 deaths and 21 food recalls, according to the report.

Bacteria accounted for slightly more than half of the reported outbreaks, followed by viruses (35 percent), chemicals (12 percent) and parasites (2 percent).

Cucumbers and tomatoes were most frequently linked to outbreak-associated illnesses (16 percent), but fish, chicken and dairy products were also commonly implicated in outbreaks (43 PSLR 1125, 9/28/15).

Foodborne illness outbreaks currently under investigation by the CDC and FDA include one over E.coli contamination traced to flour manufactured by General Mills Inc. Other outbreaks involve listeria in frozen vegetables produced by Washington-based CRF Frozen Foods, and salmonella-tainted pistachios distributed by Wonderful Pistachios in California.

Industry Standards, Consumer Expectations

“I think what we’ll see is that the industry standard of care is going to change because of FSMA, because of developments in the sensitivity and rapidity of tests,” said Brew, referring to negligence standards applied to food producers.

“There will be more environmental testing and more testing of ingredients coming in from suppliers, especially foreign ingredients, and more testing of finished product,” she said.

Marler added that an overarching issue in foodborne illness outbreaks—both for food safety and litigation about it—arises from consumer demands that food be both safe and convenient.

“As long as industry keeps chasing more convenience and consumers buy it, in a perfect world those products should be safer,” said Marler.

“There's lots of opportunities for companies to invest in food safety, but the problem is if they’re not paying attention, and take their eye off the ball for just a second, there’s going to be an outbreak,” he said.

To contact the reporter on this story: Steven M. Sellers in Washington at ssellers@bna.com.

To contact the editor responsible for this story: Steven Patrick at spatrick@bna.com .