Not exactly fresh out of committee, but out of committee nonetheless, senate bill 510 (a/k/a the Food Safety Modernization Act) makes its way to the senate floor soon, possibly this week.  The full senate debate and subsequent vote is certainly timely, as just today Michael Moss was awarded the Pulitzer Prize for his story on Stephanie Smiths E. coli O157:H7 illness and Linda Rivera’s long-awaited emergence from a Nevada hospital where she has spent almost a year after also being infected by E. coli O157:H7.  Stephanie was sickened by a hamburger made by Cargill, and Linda by contaminated cookie dough made by Nestle

The Food Safety Modernization Act is truly an important piece of legislation, in that it affects every citizen of this country, and even some abroad, on a daily basis.  The bill substantially modifies the Federal Food Drug and Cosmetics Act, and generally gives the Food and Drug Administration better authority and ability to monitor the safety of our food supply, and take quicker and more effective action for food companies that don’t adequately protect against foodpoisoning risks. 

Among other, more specific, things, the Food Safety Modernization Act:

Continue Reading Summary of Food Safety Modernization Act (Senate debate pending)

Web updates on outbreaks from the Centers for Disease Control and Prevention (CDC) are like those old “paint by numbers” sets.   Sometimes it takes several passes, but eventually the picture is filled out pretty well.

In its fifth and final update on the multi-state outbreak of E. coli O157:H7 infections linked to eating raw refrigerated

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.Continue Reading The “Guess Who Inspects It Game”: Nestle E. coli Cookie Dough Edition

Two reports of past inspections were made public today.  The most notable inspection occurred in September 2006 at the Nestle plant in Danville, Virginia where it manufactures cookie dough products, as well as stuffed pastas and pasta sauces.  A number of deficiencies were noted as part of the inspection. These were:

Three live ant-like insects

We filed suit yesterday in Federal Court for the District of Colorado on behalf of Madison Sedbrook, who is six years old, and her parents Tristan and Cindy.  Madison ate cookie dough on multiple occasions in April 2009 and developed a severe gastrointestinal illness.  She bounced from hospital to hospital, doctor to doctor, while nobody

We have already heard from several families whose children have developed hemolytic uremic syndrome (HUS) after contracting E. coli O157:H7 from Nestle cookie dough.  Most often, though we certainly see cases where the pathalogic process described below affects other organs, HUS affects the kidneys.  Here is a short explanation of what HUS is, and why it is so

 Today’s recall of Nestle cookie dough got me thinking about other E. coli O157:H7 cases that we’ve recently handled.  John McDonald was a 5-year-old boy who we represented in a ground beef outbreak that occurred in 2007.  Unfortunately, John’s illness was about as bad as an illness can get without causing a death.  (it is unbelievable how many times I find myself saying that about our clients) 

John was hospitalized at East Tennessee Children’s Hospital from October 4 through 12, then was transferred to the University of Tennessee Medical Center where he remained until October 29.  During his hospitalization, John’s kidneys failed requiring extensive dialysis to cleanse his blood, and he became badly anemic requiring many blood transfusions.

But these conditions, though in and of themselves potentially lethal, were just the beginning.  What truly separates John’s illness from most of the hemolytic uremic syndrome illnesses that we see was the extent of injury to his gastrointestinal tract. 

Jim McDonald, John’s father, was present at the moment it became apparent just how severe John’s illness was.  It occurred in the early morning hours of Thursday, October 11, 2007.  He recalls: 

As usual, I got up to help as much as possible when the nurses came in and woke us up. When we opened his diaper, I got excited since it looked like he had had dark brown diarrhea, which told me that his digestive system was finally starting to kick in again. Realizing how liquidy the diaper was, we turned on an extra light to help us while changing him.

Continue Reading Cookies and E. coli: Here’s an E. coli story we will never forget

We have been investigating several seemingly unrelated E. coli O157:H7 illnesses that may not be so unrelated.  There are 63 confirmed illnesses possibly linked to Nestle’s Toll House Cookies.  Before you say, "No way, cookies can’t be contaminated" or "E. coli is just a ground beef problem," realize that if these illnesses are, in fact, linked