Food Poison Journal - Food poisoning outbreaks and litigation: surveillance and analysis

Nestle USA’s flour supplier for its Danville, VA cookie dough plant is now the focus of a joint investigation by the U.S. Food and Drug Administration (FDA) and the Virginia Department of Agriculture and Consumer Services.

The name of the flour supplier was not made available.

FDA found the E. coli O157:H7 bacteria in samples of the prepackaged Nestle Tool House refrigerated cookie dough, but inspections inside the Danville plant found no traces on equipment or workers.

As result, FDA is turning to individual ingredients beginning with the flour in hopes of finding out how a deadly bacterium from the intestines of cattle came to be found in raw cookie dough.

The contaminated Nestle cookie dough is now blamed for infecting 72 people in 30 states with a strain of E. coli O157:H7 with a common DNA fingerprint. Fifty-one have been confirmed by advanced testing and additional confirmatory tests results are pending on the others.

The E. coli outbreak forced Nestle to recall an estimated 300,000 cases of the popular Toll House cookie dough, or 3.6 million individual packages.

The victims range in age from 2 to 65 years old. Most (71 percent) are female, and 65 percent are under 19 years of age. While no deaths have yet been attributed to the outbreak, 34 have been hospitalized and ten have developed the often life-threatening hemolytic uremic syndrome (HUS).

The number of infections is also continuing to rise.

Food safety attorney Bill Marler, managing partner of the Seattle law firm of Marler Clark, is urging Nestle to immediately begin paying the medical bills and lost wage claims of all legitimate victims of the outbreak. Marler has already sued Nestle on behave of victims in Colorado, California and Washington State.

“True, it will not completely prevent Nestle from being sued to both uncover why the outbreak happened and to deal with the suffering of the victims and the need for possible future medical expenses that might well include life time monitoring, kidney dialysis and transplant, but it certainly will not hurt, “ says Marler. 

As of Tuesday, June 30, 2009, 72 persons infected with a strain of E. coli O157:H7 with a particular DNA fingerprint have been reported from 30 states. Of these, 51 have been confirmed by an advanced DNA test as having the outbreak strain; these confirmatory test results are pending on the others. The number of ill persons identified in each state is as follows: Arizona (2), California (3), Colorado (6), Connecticut (1), Delaware (1), Georgia (1), Iowa (2), Illinois (5), Kentucky (2), Massachusetts (4), Maryland (2), Maine (3), Minnesota (6), Missouri (1), Montana (1), North Carolina (2), New Hampshire (2), New Jersey (1), Nevada (2), New York (1), Ohio (3), Oklahoma (1), Oregon (1), Pennsylvania (2), South Carolina (1), Texas (3), Utah (4), Virginia (2), Washington (6), and Wisconsin (1).

Ill persons range in age from 2 to 65 years; however, 65% are less than 19 years old; 71% are female. Thirty-four persons have been hospitalized, 10 developed hemolytic uremic syndrome (HUS); none have died. Reports of these infections increased above the expected baseline in May and continue into June.

From a Nestle press release from yesterday afternoon:

Nestle USA's Baking Division was informed today by the Food and Drug Administration (FDA) that it has found and confirmed evidence of E. coli 0 (sic – its a O) 157:H7 in a retained production sample of 16.5 oz. Nestle Toll House refrigerated chocolate chip cookie dough bar. The product has a day code of 9041 and a "Best before 10 JUN 2009" notation.

Nestle continues to work closely and in full cooperation with the FDA on the ongoing investigation. We are very concerned about those who have become ill from E. coli 0 (sic – its a O) 157:H7, and deeply regret that this has occurred.

Admitting you have a problem is the first step.  Saying sorry is a start.

However, there is more to do.  According to the CDC, as of Thursday, June 25, 2009, 69 persons infected with E. coli O157:H7 with a particular DNA fingerprint have been reported from 29 states. That number is expected to rise over the next few days.  We have filed three lawsuits so far.  We have a baker's dozen other ready to go.

The number of ill persons so far identified in each state is: Arizona (2), California (3), Colorado (5), Connecticut (1), Delaware (1), Georgia (1), Iowa (2), Illinois (5), Kentucky (3), Massachusetts (4), Maryland (2), Maine (3), Minnesota (6), Missouri (1), Montana (1), North Carolina (2), New Hampshire (2), New Jersey (1), Nevada (2), Ohio (3), Oklahoma (1), Oregon (1), Pennsylvania (2), South Carolina (1), Texas (3), Utah (2), Virginia (2), Washington (6), and Wisconsin (1).

Ill persons range in age from 2 to 65 years; however, 64% are less than 19 years old; 73% are female. Thirty-four persons have been hospitalized, and 9 developed hemolytic uremic syndrome (HUS).

Here is the reality – After 16 years of litigating every major E. coli O157:H7 outbreak, medical bills for these 69 (and counting) people may range from a few thousand to hundreds of thousands of dollars to date. Some have insurance but many do not. Many have spent weeks in the hospital caring for their sick child or spouse. Some have lost wages, some their jobs.

As I always tell companies - "It is a bad idea to poison your customers."  So, when is Nestle going to take the next step and offer to help its customers?

The recent (and still unfolding) E. coli O157:H7 outbreak linked to contaminated Toll House cookie dough manufactured by Nestle has no shortage of lessons to teach, including the reminder that this deadly pathogen can find its way into nearly any food product if sufficient care is not taken during its manufacture. But this sad outbreak is also a case study in the ridiculously complicated, and too-often ineffective, state of food safety inspection in the United States. What makes the outbreak such an excellent case-study is the fact that the Nestle plant located in Danville, Virginia was not only manufacturing Toll House cookie dough products, but also a variety of Buitoni flat and stuffed pastas, and pasta sauces. This made the plant what is called a “dual jurisdiction establishment” that fell under the regulatory authority of both the FDA and the USDA. And to make things even more interesting, Virginia Department of Agriculture and Consumer Services (VDACS) was performing routine plant inspections under contract with the FDA. So how come with all these agencies involved no one prevented the outbreak?

By way of background, the FDA has jurisdiction over all domestic and imported food products, except meat, poultry, or processed egg products, which fall under the jurisdiction of the USDA. But not all food products fall neatly on one side of the jurisdiction line or the other. For example, the products that Nestle manufactured for its Buitoni-brand fell on both sides of the line, with a few falling almost on the line. Meat-flavored pasta sauce would be inspected by the FDA, while meat sauce containing 3% or more of meat would be inspected by the USDA. The ravioli stuffed with cheese would be the responsibility of the FDA, while those stuffed with pork or prosciutto would be the responsibility of the USDA. Thus, if you look at the FDA Inspection Report from September 11 and 12, 2006, you will see that the inspector takes note of fettuccini and linguine being manufactured (FDA products), and chicken tortellini being manufactured (USDA product). Only the Toll House cookie dough products feel solely within the jurisdiction of the FDA. Nonetheless, the FDA plainly took note of all products being manufactured, without, however, making mention of whether or how what was found would be communicated to the USDA. Of course, since the USDA had an inspector onsite, and the FDA showed up in the plant only every year or so, it is the USDA that presumably knew much more about the plant.

Given the presence of the USDA in the plant on a daily basis, the obvious question then is what did the USDA know, and when did it know it? Another obvious question is: Could the USDA have prevented this outbreak from occurring? And, indeed, was it potentially in a better position to prevent this outbreak. (NOTE: As part of my firm’s investigation into this outbreak we are currently attempting to obtain the USDA inspection records for this plant.)

For more, please click on the Continue Reading link.

The FDA announced a recall of milk products on its website yesterday:

Plainview Milk Products Cooperative, Plainview, Minn., is voluntarily recalling instant nonfat dried milk, whey protein, fruit stabilizers, and gums (thickening agents) that it has manufactured over the past two years, because they might be contaminated with Salmonella.

Fortunately, no illnesses have yet been linked to the recall.   The recall was initiated when the FDA inspected the Plainview facility and "found that some of the equipment was contaminated with Salmonella."  The FDA was inspecting the plant as a result of testing done by the USDA that found Salmonella in a company product not intended for retail sale.

Hopefully, the recall was announced in time to avoid human illness.   The sequence of events is an excellent example of why companies shouldn't be fighting tooth and nail against increased inspection and testing.   If the USDA and the FDA had not uncovered both contaminated product and equipment, it would have been much more likely that ongoing contamination of product, and therefore human illness would have eventually resulted. This recall can only rightly be viewed as the less expensive outcome for both the company, and consumers.