Marler Blog - Providing commentary on food poisoning outbreaks & litigation

A lot of my blog followers and subscribers have been following the story of Linda Rivera and her fight against the E. coli O157:H7 bacteria.  As you might recall, Linda has been hospitalized since May 2, 2009 - yes, almost 11 months.  She has suffered kidney and liver failure.  She has suffered seizures and has had a portion of her colon removed.  She has had more near death experiences than anyone should ever have.  Her medical bills to date have nearly reached her life-time cap.  She and her husband have been unable to work and they are now on COBRA which will expire in less than a year.

So, why is Linda smiling?  Three reasons. 

First, she is being released from the hospital in the next week.  She will be entering a rehab center where she hopes to learn how to walk and care for her and her family (husband and six kids) again.  She has a very long road ahead, but I am hopeful that she is going to make the best recovery that she is able. 

Second, because she has more pre-existing conditions than you can imagine, and she faced a cap on and the end of her insurance, the new health care bill passed by the democrats in the House and Senate and signed by the President will help her.  She and her family will not face certain bankruptcy because she will now be able to find insurance despite her health history and no job.

Third, she and her husband, Richard, received a call from their Senator, Harry Reid today.  Linda and Richard were able to voice their support for S. 510 - FDA Food Safety Modernization Act.  It is not every day that you can turn a horrible tragedy into a reason for action.

That is why Linda is smiling.

FDA Food Safety Modernization Act - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to expand the authority of the Secretary of Health and Human Services (the Secretary) to regulate food, including by authorizing the Secretary to suspend the registration of a food facility.

Requires each food facility to evaluate hazards and implement preventive controls.

Directs the Secretary to assess and collect fees related to: (1) food facility reinspection; (2) food recalls; and (3) the voluntary qualified importer program.

Requires the Secretary and the Secretary of Agriculture to prepare the National Agriculture and Food Defense Strategy.

Requires the Secretary to: (1) identify preventive programs and practices to promote the safety and security of food; (2) promulgate regulations on sanitary food transportation practices; (3) develop a policy to manage the risk of food allergy and anaphylaxis in schools and early childhood education programs; (4) allocate inspection resources based on the risk profile of food facilities or food; (5) recognize bodies that accredit food testing laboratories; and (6) improve the capacity of the Secretary to track and trace raw agricultural commodities.

Requires the Secretary, acting through the Director of the Centers for Disease Control and Prevention (CDC), to enhance foodborne illness surveillance systems.

Authorizes the Secretary to order an immediate cessation of distribution, or a recall, of food. Requires the Administrator of the Environmental Protection Agency (EPA) to assist state, local, and tribal governments in preparing for, assessing, decontaminating, and recovering from an agriculture or food emergency.

Provides for: (1) foreign supplier verification activities; (2) a voluntary qualified importer program; and (3) the inspection of foreign facilities registered to import food.

Saint Cloud Times last week reported:

A Cold Spring woman who nearly died after getting E. coli from a tainted hamburger is asking for more than $56 million in her lawsuit against Cargill.

Stephanie Smith, 23, was left paralyzed from the waist down and with extensive, long-term injuries that one day will require a kidney transplant. A court filing this week in her federal lawsuit against Cargill for the first time in public documents itemizes her medical expenses to date and estimates her future medical expenses and future lost wages.

Cargill has admitted it is "strictly liable and thus responsible for Ms. Smith's injuries," according to a court filing this week in U.S. District Court. Cargill has paid about $390,000 for Smith's rehabilitation care and has bought her a handicapped-accessible van, according to Cargill's filing.

Smith's attorneys have filed documents showing Cargill's payments at about $360,000.

The court filing detailing her expenses indicates that her medical care has cost about $1.8 million so far. That filing estimates her future medical care at $29.5 million, and her lost future wages between $927,000 and $1.2 million. Smith's attorneys are seeking an additional $25 million in general damages from Cargill.

Cargill case statement

Smith case statement

No trial date has been set for the case. Smith's attorneys agreed to waive any punitive damages claim in exchange for a faster trial on compensatory damages only.

In its filing, Cargill indicates it hopes a settlement can be reached without a trial. Cargill has told the court it is reserving its rights to take action against suppliers "who provided improper materials," according to the court filing.

Smith is a former dance instructor who became ill in September 2007 after eating a hamburger produced by Cargill. She was diagnosed with an E. coli infection that developed into hemolytic uremic syndrome, a complication that causes kidney failure.

She suffered several seizures and was in a medically induced coma for three months. She has spent more than two years in rehabilitation and remains in a wheelchair.

The number of affected people continues to grow as more come forward to report shigella infections after eating at a Lombard Subway restaurant.

Dave Hass of the DuPage County Health Department said there are currently 116 confirmed shigella cases linked to the Subway restaurant as of today. Of those cases, 13 people were hospitalized and 12 were discharged.  Hass also said the source of the shigella is unknown at this time and might never be pinpointed. The restaurant, 1009 E. Roosevelt Road, has been closed since March 4.

Law firm Marler Clark now represents over 70 people affected by the outbreak.  Three lawsuits have been filed as of now.

Shigella infections are spread from person to person, and also can be acquired from contaminated food. The disease can be prevented by frequent hand washing with soap and water.

People who have developed these symptoms between Feb. 24 to March 1 after eating at the Lombard Subway restaurant are advised to contact their physicians and the DuPage County Health Department at (630) 682-7400. Information on shigellosis is available at http://www.idph.state.il.us/public/hb/hbshigellosis.htm.

Had an opportunity to speak with Tom Lutey of the Billings Gazette this week between traveling in Iowa, South Dakota and Nebraska about recalls and how government and industry could do better. The discussion comes on the heals of the HVP recall:

• The FDA Web site, www.accessdata.fda.gov/scripts/HVPCP, includes this information about each recalled food item: category, brand name, product description, recalling firm, size, lot numbers, stock numbers, product code.

• The list of recalled products, updated by the FDA on March 16, included 159 items.

• Food items in these categories are listed: bouillons, dressing and dressing mixes, flavoring bases and seasonings, frozen foods, gravy mixes, prepared salads, ready-to-eat meals, sauce and marinade mixes, snacks and snack mixes, soups, soup mixes, dips, dip mixes, spreads, flavoring base and seasoning products and stuffing.

The discussion with Mr. Lutey was the recent move by Congress to ask if supermarkets should be better at notifying customers of food recalls by tapping data collected through store loyalty cards and store club memberships.

“All of them have the ability to track people by purchases,” said Bill Marler, an attorney specializing in food-borne illness and publisher of Food Safety News, an online journal. “The question is whether they want to use it for good or evil, whether they want to find out if we buy a lot of Twinkies or if they want to let us know that we bought a poisonous product.”

Food recalls typically start after people get sick, or after a company receives notice from a lab that its food has tested positive for contaminants, Marler said. It’s not uncommon for the tainted food to continue being shipped for sale until the test comes back. Less often, a food manufacturer will test an ingredient bought from a supplier and contact the government over a bad result.

The Consumer Recall Notification Act introduced in the U.S. Senate last week would change the notification process. Food companies would have to notify restaurants and retailers of contaminated food within 24 hours. The federal government would have to extend its notifications far down the food chain, to clinics and emergency rooms.

It will be interesting to see how interested the public is in balancing privacy vs the ability to track poisoned food.

For all my clients who suffered severe illness due to food poisoning, like Hemolytic Uremic Syndrome, Guillain-Barre Syndrome or Reiter's Syndrome, Thank you President Obama and Senate and House Democrats for passing a comprehensive Health Care Bill.  My clients facing being dropped from insurance coverage, being excluded for pre-existing medical conditions or facing a life time cap on medical coverage, will sleep better tonight.  Thank you!  Here is an Email I just received:

William --

For the first time in our nation's history, Congress has passed comprehensive health care reform. America waited a hundred years and fought for decades to reach this moment. Tonight, thanks to you, we are finally here.

Consider the staggering scope of what you have just accomplished:

Because of you, every American will finally be guaranteed high quality, affordable health care coverage.

Every American will be covered under the toughest patient protections in history. Arbitrary premium hikes, insurance cancellations, and discrimination against pre-existing conditions will now be gone forever.

And we'll finally start reducing the cost of care -- creating millions of jobs, preventing families and businesses from plunging into bankruptcy, and removing over a trillion dollars of debt from the backs of our children.

But the victory that matters most tonight goes beyond the laws and far past the numbers.

It is the peace of mind enjoyed by every American, no longer one injury or illness away from catastrophe.

It is the workers and entrepreneurs who are now freed to pursue their slice of the American dream without fear of losing coverage or facing a crippling bill.

And it is the immeasurable joy of families in every part of this great nation, living happier, healthier lives together because they can finally receive the vital care they need.

This is what change looks like.

My gratitude tonight is profound. I am thankful for those in past generations whose heroic efforts brought this great goal within reach for our times. I am thankful for the members of Congress whose months of effort and brave votes made it possible to take this final step. But most of all, I am thankful for you.

This day is not the end of this journey. Much hard work remains, and we have a solemn responsibility to do it right. But we can face that work together with the confidence of those who have moved mountains.

Our journey began three years ago, driven by a shared belief that fundamental change is indeed still possible. We have worked hard together every day since to deliver on that belief.

We have shared moments of tremendous hope, and we've faced setbacks and doubt. We have all been forced to ask if our politics had simply become too polarized and too short-sighted to meet the pressing challenges of our time. This struggle became a test of whether the American people could still rally together when the cause was right -- and actually create the change we believe in.

Tonight, thanks to your mighty efforts, the answer is indisputable: Yes we can.

Thank you,

President Barack Obama

Looking forward to speaking at the Grocery Manufacturers Association Litigation Conference on April 7 and 8, 2010 in Washington DC.

Campylobacter Outbreak in Michigan Linked to Consumption of Raw Milk Products

The Michigan Department of Community Health (MDCH) is issuing a public health alert regarding illness from Campylobacter infections among people who have reported consuming raw milk products obtained from the Family Farms Cooperative in Vandalia, Michigan. Family Farms Cooperative operates a cow share program where members own part of a cow and in return receive raw dairy products. The milk for the Family Farm Cooperative cow share program comes from a dairy farm in Indiana. The plastic containers of raw milk have the following information on a green and white cap: "FOREST GROVE DAIRY, MIDDLEBURY, INDIANA; RAW COW'S MILK, WARNING-NOT PASTEURIZED, 128 FL OZ."

Cow share programs are not inspected or regulated under Michigan law. These products are not available at retail stores.

A total of eight confirmed Campylobacter cases have been reported in Macomb, Washtenaw, and Wayne counties. No hospitalizations have been reported to date. Ages of the ill range from 2 to 51 years old and the majority are young children under four years old with onset of illness beginning in early March. The outbreak investigation is ongoing with efforts to determine how widely these unregulated products are being distributed.

"Raw or unpasteurized milk and dairy products may carry many types of disease-causing germs such as Campylobacter, Salmonella and E. Coli," said Dr. Gregory Holzman, chief medical executive for MDCH. "People need to be aware that raw milk and raw dairy products have not been heat treated or pasteurized to kill germs."

Campylobacter is a bacterial illness causing diarrhea (often bloody), fever, and abdominal cramps 2-5 days after exposure. Illness may persist for 1-2 weeks. Some people require treatment. The elderly, infants, and those with weak immune systems are more likely to have a severe or enduring illness. Persons who are ill with these symptoms and have consumed raw milk recently should consult with their medical provider and ask about being tested for Campylobacter infection. Campylobacter illness is a reportable communicable disease in Michigan.

The House Agricultural Affairs Committee approved a proposal Thursday that would make it clear that anyone owning a cow, goat, or sheep, or sharing ownership of those animals could legally drink or consume its raw milk. Selling raw milk would still be illegal, but dairies could keep seven cows or 15 goats or sheep in an animal sharing agreement. Farms or dairies with more than three cows or seven goats or sheep would need to submit their raw milk to the Idaho State Department of Agriculture (ISDA) to test for bacteria and somatic cells, which can indicate infections in mammary glands.

I would hope to see the regulation and inspection portions of the bill strengthened as the process goes along.

As DuPage County Health Department spokesman David Hass official announced that a total of 78 people had fallen ill due to a Shigella outbreak at a Subway sandwich shop in the Chicago suburb of Lombard, our phones have been ringing with the calls of 51 of those former customers of Subway.

Mr. Hass further reported that 11 people had been hospitalized due to illnesses from the outbreak as of Wednesday, with 10 of those individuals being discharged. Six of those have contacted us. Hass said the investigation into the outbreak at the Subway restaurant in Lombard is ongoing. The eatery is currently closed. We have learned during our investigation that several of the 78 sickened by Shigella are/were employees of Subway.

If only they had washed their hands and wore gloves.

Shigella is a family of bacteria that can cause sudden and severe diarrhea (gastroenteritis) in humans. Shigellosis – the illness caused by the ingestion of Shigella bacteria – is also known as bacillary dysentery. It can occur after ingestion of fewer than 100 bacteria, making Shigella one of the most communicable and severe forms of the bacterial-induced diarrheas.

Shigella thrives in the human intestine and is commonly spread both through food and by person-to-person contact. Most Shigella infections are passed through the fecal-oral route. This happens when basic hygiene and handwashing habits are inadequate and can happen during certain types of sexual activity. Transmission is particularly likely to occur among toddlers who are not fully toilet-trained. Family members and playmates of such children are at high risk of becoming infected.

Food may become contaminated by infected food handlers who don’t wash their hands with soap after using the bathroom. Vegetables can become contaminated if they are harvested from a field with sewage in it. Flies can breed in infected feces and then contaminate food.

Water may become contaminated with Shigella bacteria if sewage goes into it or if someone with shigellosis swims in or plays with the water (especially in splash tables, untreated wading pools, or shallow play fountains used by daycare centers). Shigella infections can then be acquired by drinking, swimming in, or playing with the contaminated water.

The number of shigellosis cases reported annually to the Centers for Disease Control and Prevention (CDC) has varied over the past several years, from more than 17,000 during 1978–2003, to an all-time low of 14,000 in 2004, to almost 20,000 in 2007. Many cases go undiagnosed and/or unreported, however. The CDC estimates that 450,000 total cases of shigellosis occur in the U.S. every year.

Shigella is the third most common pathogen transmitted through food. During 2006, a total of 1,270 foodborne-related outbreaks from 48 states in the U.S. were reported. Although Shigella was responsible for only 10 (1%) of those outbreaks, 183 confirmed cases of shigellosis were reported. This contrasts with an average of 659 cases annually in the previous five years.

We are or have been involved in representing families who have suffered from this bacterium. Here are some examples:

Doubletree Hotel Shigella Outbreak - Colorado
Filiberto’s Shigella Outbreak - California
Gate Gourmet Shigella Outbreak - Hawaii, Nationwide
Royal Fork Shigella Outbreak - Washington
Senor Felix 5-Layer Dip Shigella Outbreak - Western States
Subway Restaurant Shigella Outbreak -Chicago
Viva Mexico Shigella Outbreak - California

This is not our first case against Subway in this litigation (we have filed three lawsuits so far), nor the first case we have had against Subway. We represented dozens in a Subway Hepatitis A Outbreak in Washington several years ago. Someone did not was their hands there either.

Alan J. Liddle of Nation's Restaurant News reports this afternoon that the number of people with confirmed cases of shigella illness associated with a franchised Subway restaurant here has climbed to 78, with 11 of those individuals requiring hospitalization with one still hospitalized.  He goes on:

In a related development, the Seattle-based law firm of Marler Clark, in conjunction with Newland, Newland and Newland of Arlington Heights, Ill., has filed three lawsuits against the owner of the Lombard Subway at 1009 E. Roosevelt Road on behalf of people allegedly sickened after eating at the restaurant.

Public health officials said shigella is spread through fecal contamination and that most people who are infected with the toxindevelop gastrointestinal illness, such as diarrhea, vomiting, fever and stomach cramps, one to two days after being exposed. Some people, especially young children and the elderly, may require hospitalizations and severe infections with high fevers can be associated with seizures in children younger than 2 years old.

DuPage County officials first publicized the outbreak March 4, when the number of confirmed shigella cases stood at eight. They said then that consumers should contact their physician if they had developed diarrheal illness 12 hours to four days after eating at the Subway store between Feb. 24 and March 1.

The lawsuits filed by Marler Clark and Newland, Newland & Newland in the Circuit Court of the 18th Judicial Circuit in DuPage County accuse the Lombard restaurant's operator, Neel Subway Inc., of being negligent in allegedly selling adulterated food or drink in breach of implied and expressed warranties. The suits seek unspecified compensation for actual, consequential and incidental damages tied to the illnesses suffered by the plaintiffs, which include three adults and a child.

The Chicago-area Subway that has been linked to over 50 Shigella illness has been hit once again by a customer's lawsuit.

Although I agree that consumers should be able to buy raw milk from a well-regulated, inspected farm - "know your farmer" - like what is done in California and Washington presently.  However, I believe that the law needs a warning that is much more stringent than the law now envisions.  I think this is what should be posted on the farm and the raw milk container:

"WARNING: This product has not been pasteurized and may contain harmful bacteria (not limited to E. coli O157:H7, Campylobacter, Listeria and Salmonella). Pregnant women, infants, children, the elderly and persons with lowered resistance to disease (immune compromised) have the highest risk of harm, which includes Diarrhea, Vomiting, Fever, Dehydration, Hemolytic Uremic Syndrome, Guillain-Barre Syndrome, Reactive Arthritis, Irritable Bowel Syndrome, Miscarriage, or Death, from use of this product."

Finally, why should raw milk be treated differently than pasteurized milk, hamburger or peanut butter?  Why should a raw milk farmer be immune from liability, but a pasteurized dairy be subject to my ability to sue them on behalf of an injured consumer?  If the farmer wants to argue that the consumer is at fault for consuming a product that may well be contaminated, that farmer can presently raise that defense under our civil law.  If food is sold that is contaminated the manufacturer - whether Cargill or Farmer Bob - needs to be responsible to the customer.  Raw milk outbreaks have happened and have caused extensive damages.  Those victims should not be left with thousands or millions of dollars in damages because the product they consumed was raw milk.  This is a bad bill as written.  It should not pass as is.

Here is the full Senate Bill 434:

Victims of foodborne illness gathered in the nation's capital last week to speak to Senators about the need to move food safety legislation forward. Senate bill 510 (S510, the Food Safety Modernization Act) passed unanimously out of committee in November, but has yet to come to the floor of the Senate for a vote.

"I think it went really well," said Peter Hurley, whose three-year-old son Jake Hurley fell ill to Salmonella during the 2009 Peanut Corporation of America peanut butter outbreak. Hurley has taken an active roll in lobbying members of Congress to strengthen food safety laws. "We had some really good meetings with Senators and their staff. Everybody is on board with this."

"Most of the Congressmen we spoke with were very receptive to our message," said Elizabeth Armstrong, whose children were sickened by E. coli O157:H7-tainted spinach in 2006. "Most of them did see the need for stricter food safety legislation. The frustrating part for us, though, was the general feeling that it was going to take some time to make this happen."

Lauren Bush explained how the trip affected her: "Going to Washington to lobby for food safety altered my perception of what happened to me. When I contracted E. coli O157:H7, I felt like a powerless victim whose entire life had been turned upside down by an invisible force that didn't have a face to confront. However, being involved with S.T.O.P. and going to D.C. changed that because I was able to sit in front of people who have the power to modify the laws that shape our country. It was incredibly powerful to discover that my voice matters."

Go Cougs.

From a Press Release I sent out this morning:

Food Safety attorney William Marler is calling for enforcement of a federal law that allows criminal sanctions to be imposed against food manufacturers that can prevent harmful food products from being distributed, but do not do so. The Federal Food, Drug, and Cosmetic Act (FD&C Act) is one of the federal government’s primary enforcement tools to prevent the distribution of contaminated or “adulterated” food.

According to Section III of the FD&C Act, a food manufacturer is guilty of a felony if the manufacturer knowingly adulterates a food product with the intent to defraud its customers. A food manufacturer commits a misdemeanor if the manufacturer is aware that a product is contaminated or “adulterated,” and has the power to stop the product from being distributed, but does not do so. The actions of Peanut Corporation of America (PCA) executives, who knowingly shipped Salmonella-tainted peanut products in 2008, qualify for prosecution under this federal statute, says Marler, as does the management of another company at the center of a current and rapidly expanding recall.

“In light of revelations that managers at Basic Food Flavors knew in mid-January that their plant was contaminated with Salmonella but continued to make Hydrolyzed Vegetable Protein (HVP) and sell it to foodmakers around the country, it is past time to prosecute companies and individuals who knowingly sell contaminated food,” said Marler.

“As with the Salmonella outbreak caused by Peanut Corporation of America (PCA) that sickened over 700 and killed nine, Basic Food Flavors knew it was shipping contaminated food destined for human consumption,” continued Marler. “It is time for executives of PCA and Basic Food Flavors to face the full force of criminal law.”

Well Food Safety News IPhone Application has been submitted.  Hopefully, it will be approved and up and running in the next few days - for free.

Sometimes lawsuits are a bit like a war, or perhaps more a long battle anyway. Like a battle or a war, the damages to each side in litigation are real – the injuries to the victims, the costs to the defendant. The decision when to file suit (when to go to war or battle) are difficult to make. And, during the course of the battle or war – or litigation – each side might seek or have advantages or disadvantages – setback or victories.

Tomorrow the following will be filed in DuPage County Circuit Court:

2.2.1 On February 26, 2010, Ron and Sarah Bowers purchased a meal for their child, JB, from the defendant’s Subway restaurant located at 1009 East Roosevelt Road in Lombard, Illinois. Unknown to the plaintiffs, the sandwich that the defendant had manufactured, distributed and sold to them, and that JB thereafter consumed at the defendant’s restaurant, was contaminated by Shigella sonnei, a potentially lethal bacteria.

2.2.2 On or about February 27, 2010, JB began to exhibit signs of discomfort and illness. He began to run a mild fever, and he developed extreme abdominal cramping. By the end of the day, he was exhausted, and his condition only continued to deteriorate.

2.2.3 JB’s illness worsened throughout the next day. That afternoon, he began to vomit; bouts of explosive diarrhea commenced shortly therafter. That night, JB was unable to sleep at all, having to make many hurried trips to the bathroom to vomit or suffer another bout of diarrhea. In fact, he soon became so dehydrated and ill that he feinted and fell onto the bathroom floor, where his parents found him.

2.2.4 JB’s mother, Sarah Bowers, took her ill son to see his pediatrician later in the morning of March 1, 2010. There, the pediatrician noted that JB was severely dehydrated. JB was started on intravenous fluids and instructed to rest as much as possible. The visit lasted multiple hours, until JB had been hydrated enough to be safely discharged.

2.2.5 JB continued to suffer from fevers, nausea, abdominal cramps, and frequent diarrhea throughout the rest of the week. On Friday, March 5, 2010, Sarah Bowers again had to take JB to see his pediatrician due to continuing illness.

2.2.6 Around the time of JB’s follow-up appointment with his pediatrician, Ron and Sarah Bowers saw a local news story highlighting the Shigella outbreak associated with the defendant’s Subway restaurant located at 1009 East Roosevelt Road. They quickly reported JB’s illness to the DuPage County Health Department and have remained in contact with health department officials since that time. A stool sample recently submitted by JB tested positive for Shigella, and JB is counted as a confirmed case in the outbreak linked to the defendant’s restaurant.

“I love the smell of a lawsuit in the morning.”

Shigella is a bacterium that can cause sudden and severe diarrhea (gastroenteritis) in humans. Shigellosis is the name of the disease that Shigella causes. The illness is also known as “bacillary dysentery.” Shigella bacteria can infect the intestinal tract after the ingestion of relatively few organisms. This is why shigellosis is the most communicable of the bacterial-induced diarrheas.

The source of Shigella bacteria is the excrement (feces) of an infected individual that is ultimately ingested by another person. The infectious material is spread to new cases by person-to-person contact or via contaminated food or water. Approximately 20% of the nearly 450,000 cases of shigellosis that occur annually in the U.S are foodborne-related. Generally, the food preparer is the individual who contaminates the food, but food may also become contaminated during processing.

Contamination of drinking water by Shigella is a problem that more often occurs in the developing world, but swimming pools and beaches in the U.S. can become contaminated by infected individuals. No group of individuals is immune to shigellosis, but certain individuals are at increased risk, particularly small children.

• Filiberto’s Shigella Outbreak
• Doubletree Hotel Shigella Outbreak
• Gate Gourmet Shigella Outbreak
• Royal Fork Shigella Outbreak
• Senor Felix 5-Layer Dip Shigella Outbreak
• Viva Mexico Shigella Outbreak

The DuPage County Illinois Health Department is keeping tabs on the rising number of gastrointestinal illnesses being reported from a Subway restaurant in Lombard.  Four more cases of shigellosis were confirmed Friday, bringing the total number of confirmed cases caused by the outbreak at the restaurant to 12. Of those 12 cases, seven have required hospitalization.

The FDA has updated its expanding recall list of various products containing Hydrolyzed Vegetable Protein.  The list includes:

Bouillon Products - Herbox

Dip and Dip Mix Products - Concord Foods, De la Casa, Delicioso, Follow Your Heart, Fresh Food, Concepts, Great Value, Johnny's Fine Foods, McCormick, Oak Lake Farms, Reser's, Rojo's, T. Marzetti

Dressing and Dressing Mix Products - Follow Your Heart, Reser's, Trader Joe's

Gravy Mix Products - McCormick

Pre-Packaged Meal Products - Follow Your Heart

Prepared Salad Products - Reser's

Snack and Snack Mix Products - CVS, HK Anderson, Hawaiian, National Pretzel Company, President's Choice, Safeway, Sunflower Markets

Soup Mix Products - Castella, Homemade Gourmet

Stuffing Products - McCormick

Interestingly, the GAO published a Report late last week noting that the FDA should strengthen its oversight of food ingredients determined to be generally recognized as safe (GRAS) - like Hydrolyzed Vegetable Protein. According to the report, the FDA has largely not responded to concerns about GRAS substances, such as salt and the trans fats in partially hydrogenated vegetable oils, that individuals and consumer groups have raised through 11 citizen petitions submitted to the agency between 2004 and 2008. Furthermore, FDA has not taken certain steps that could help ensure the safety of GRAS determinations, particularly those about which the agency has not been notified. In addition, FDA does not know to what extent, or even whether, companies track evolving scientific information about their GRAS substances. Read full report:

According to local press reports, the DuPage County Health Department is staffing its call center throughout the weekend to keep tabs on the rising number of gastrointestinal illnesses being reported from a Subway restaurant in Lombard.

Four more cases of shigellosis were confirmed Friday, bringing the total number of confirmed cases caused by the outbreak at the restaurant to 12, health department spokesman Dave Hass said. Of those 12 cases, seven have required hospitalization. Six of those who were hospitalized have been released, Hass said.

The restaurant at 1009 E. Roosevelt Road in Lombard remains closed as investigators try to determine the cause of the outbreak. Hass said the restaurant would open sometime next week at the earliest. Anyone who ate at the restaurant between Feb. 24 and March 1 and became ill within 12 hours to four days afterward is asked to report the incident to the health department by calling (630) 682-7400.

Shigella is a family of bacteria that can cause sudden and severe diarrhea (gastroenteritis) in humans. Shigellosis – the illness caused by the ingestion of Shigella bacteria – is also known as bacillary dysentery. It can occur after ingestion of fewer than 100 bacteria (American Public Health Association [APHA], 2000), making Shigella one of the most communicable and severe forms of the bacterial-induced diarrheas (Gomez et al., 2002). Shigella thrives in the human intestine and is commonly spread both through food and by person-to-person contact. It is named after Kiyoshi Shiga, a Japanese scientist who discovered Shigella dysenteriae type 1 in 1896 during a large epidemic of dysentery in Japan (Keusch & Acheson, 1996).

The number of shigellosis cases reported annually to the Centers for Disease Control and Prevention (CDC) has varied over the past several years, from more than 17,000 during 1978–2003, to an all-time low of 14,000 in 2004, to almost 20,000 in 2007 (CDC, 2009b). Many cases go undiagnosed and/or unreported, however. The CDC estimates that 450,000 total cases of shigellosis occur in the U.S. every year (Baer et al., 1999; CDC, 2009a). Shigellosis is also characterized by seasonality, with the largest percentage of reported isolates occurring between July and October and the smallest proportion occurring in January, February, and March (Gupta et al., 2004).

As part of the Salmonella Montevideo investigation, the Food and Drug Administration has been actively investigating the supply chain of black and red pepper supplied to Daniele International Inc., Pascoag, R.I.

The Centers for Disease Control and Prevention reports that 245 people have been infected with a matching strain of Salmonella Montevideo in at least 44 states and the District of Columbia. Analysis of an epidemiologic study comparing foods eaten by individuals who were sickened identified salami/salame as a possible source of illness.

Daniele International Inc. recalled a variety of ready-to-eat Italian-style meats after Salmonella was associated with its products. A complete listing of the recalled products, which are regulated by the U.S. Department of Agriculture’s Food Safety and Inspection Service.

As a result of the investigation, a number of spice products are now being recalled by Mincing Overseas Spice Company, Dayton, N.J.; and Wholesome Spice Company, Brooklyn, N.Y. Both supply pepper to Daniele International Inc. Based on recent test results, Mincing Overseas Spice Company and Wholesome Spice Company are conducting new recalls.

Products Recalled by Mincing Overseas Spice Company

A.  Black Pepper Lot 3258 in 50-pound, 25-pound, and 20-pound cartons with Mincing Overseas Spice Company’s name on the outside

B.  Black Pepper Lot 3309 in 50-pound, 25-pound, and 20-pound cartons with Mincing Overseas Spice Company’s name on the outside.

Products Recalled by Wholesome Spice Company

A.  Ground Red Pepper sold to Daniele International Inc.

B.  Whole Black Pepper sold to Daniele International Inc.

C.  Crushed Red Pepper sold from April 6, 2009, to Jan. 20, 2010 in 25-pound boxes (Recalled on Feb. 25.)

Both Mincing Overseas Spice Company and Wholesome Spice Company sell products directly to commercial customers, who may have incorporated them into their own products. The FDA is working with the suppliers to identify the customers who received the recalled product and determine if further recalls are necessary. Consumers are encouraged to frequently check FDA’s website for the latest company recall information.

The FDA is working with CDC, USDA-FSIS, the state of Rhode Island and other states to determine the extent to which pepper played in the Salmonella Montevideo outbreak. The Agency has collected 153 composite pepper samples, which represent more than 3,600 subsamples, at various locations in the supply chain. Samples from four products collected at Daniele International Inc. tested positive for Salmonella. Samples of crushed red pepper have tested positive for the outbreak strain; the FDA is working to determine if the type of Salmonella found in the other products also matches the outbreak strain.

As part of FDA’s investigation, the Agency collected samples of pepper from other customers who received product from Mincing Overseas Spice Company and Wholesome Spice Company. Thus far, two of the samples collected have tested positive for types of Salmonella not associated with the current national Salmonella Montevideo outbreak. These findings prompted Heartland Foods Inc. to recall course ground pepper and Mincing Overseas Spice Company to recall black pepper lot 3309.

The FDA is in the process of taking a closer look at the handling of spices from farm to table and in the spring of 2009 began work on a spice risk profile. A risk profile is designed to capture the current state of knowledge related to an issue and identify any knowledge gaps. This particular risk profile focuses on microbiological contaminants and filth issues related to spices. Some members of the spice industry have already agreed to provide data to FDA for the risk profile. The risk profile will provide vital information to risk management decision-makers and will help the agency determine the best way mitigate foodborne illness issues associated with spices. Specifically it can help FDA determine: how to allocate resources, whether guidance for industry or for FDA inspectors is appropriate, or even the need for new rulemaking.

Salmonella can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (infected aneurysms), endocarditis and arthritis. Individuals having consumed any Italian sausage products and who may be experiencing these symptoms should contact a health professional immediately. For details on Salmonella sources, symptoms, and treatment, please refer to the Salmonella page on FoodSafety.gov.

Although some say that government does not work - perhaps there are parts that do?  Did the FDA Reportable Food Registry work as it was supposed to and start the hydrolyzed vegetable protein Salmonella Tennessee recall?  The reality is that according to the FDA:

[t]he manufacturer of the affected product is Basic Food Flavors Inc in Las Vegas, Nevada. Only HVP manufactured by Basic Food Flavors is involved in this recall. The FDA conducted an investigation at the facility after a customer of Basic Food Flavors reported finding Salmonella Tennessee in one production lot of HVP to the new FDA Reportable Food Registry.

The Reportable Food Registry (RFR or the Registry) is an electronic portal for Industry to report when there is reasonable probability that an article of food will cause serious adverse health consequences. The Registry helps the FDA better protect public health by tracking patterns and targeting inspections. The Food and Drug Administration Amendments Act of 2007 (Pub. L.110-085), section 1005 directs the FDA to establish a Reportable Food Registry for Industry. The RFR applies to all FDA-regulated categories of food and feed, except dietary supplements and infant formula.  Registered Food Facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States under section 415(a) of the FD&C Act (21 U.S.C. 350d) are required to report when there is a reasonable probability that the use of, or exposure to, an article of food will cause serious adverse health consequences or death to humans or animals. Federal, state, and local government officials may voluntarily use the RFR portal to report information that may come to them about reportable foods.

The U.S. Food and Drug Administration is taking steps to protect the public following the early identification of Salmonella Tennessee in one company’s supply of hydrolyzed vegetable protein (HVP). This is a common ingredient used most frequently as a flavor enhancer in many processed foods, including soups, sauces, chilis, stews, hot dogs, gravies, seasoned snack foods, dips and dressings.  List Recall: Products Containing Hydrolyzed Vegetable Protein.

Kudos to a customer of Basic Food Flavors and the FDA's Reportable Food Registry.

According to an FDA press release, the FDA is taking steps to protect the public following the early identification of Salmonella Tennessee in one company’s supply of hydrolyzed vegetable protein (HVP). This is a common ingredient used most frequently as a flavor enhancer in many processed foods, including soups, sauces, chilis, stews, hot dogs, gravies, seasoned snack foods, dips and dressings.

In coordination with the Centers for Disease Control and Prevention, the U.S. Department of Agriculture, other federal agencies, and state health departments, FDA is closely monitoring and assessing the potential risks of illness from affected products.  “Our investigators were able to identify this problem before any illnesses occurred," said FDA commissioner Dr. Margaret A. Hamburg. "While the investigation is continuing, the agency is supporting reasonable steps to continue to protect the public health.”

The manufacturer of the affected product is Basic Food Flavors Inc in Las Vegas, Nevada. Only HVP manufactured by Basic Food Flavors is involved in this recall. The FDA conducted an investigation at the facility after a customer of Basic Food Flavors reported finding Salmonella Tennessee in one production lot of HVP to the new FDA Reportable Food Registry.

FDA collected and analyzed samples at the facility and confirmed the presence of Salmonella Tennessee in the company’s processing equipment. The company is recalling all hydrolyzed vegetable protein in powder and paste form that it has produced since Sept. 17, 2009.

“This situation clearly underscores the need for new food safety legislation to equip FDA with the tools we need to prevent contamination," said Dr. Jeff Farrar, associate commissioner for food protection, FDA’s Office of Foods.

At this time, there are no known illnesses associated with this contamination.  At this time, FDA is taking several steps to instruct industry and protect consumers from potential Salmonella infection.  FDA is advising industry that the recalled bulk HVP product should be destroyed or reconditioned according to FDA-approved procedures. FDA is also recommending recalls of certain products that might be eaten by consumers without any processing or cooking steps to address the potential risk.

As I said to CIDRAP this afternoon:

"It's such a ubiquitous product," food-safety attorney Bill Marler said in an interview. "It underscores how a potentially contaminated ingredient can have such an enormous impact upstream and downstream, on re-manufacturers and retailers." Marler's law firm, Marler Clark LLP, has been contacted by consumers complaining of diarrheal illness as recall notices trickled out over the past few days, and the firm plans to have tests conducted on products that remained on people's shelves, he said.

The CDC reports now a total of 245 individuals infected with the outbreak strain of Salmonella Montevideo have been reported from 44 states and District of Columbia since July 1, 2009. The number of ill persons identified in each state with this strain is as follows: AK (2), AL (2), AZ (7), CA (30), CO (5), CT (5), DC (1), DE (3), FL (3), GA (3), IA (1), ID (4), IL (19), IN (4), KS (5), LA (1), MA (14), MD (1), ME (1), MI (4), MN (6), MO (2), MS (1), NC (11), ND (1), NE (3), NH (2), NJ (9), NM (2), NY (18), OH (9), OK (1), OR (9), PA (7), RI (2), SC (1), SD (3), TN (5), TX (7), UT (9), VA (1), WA (17), WI (1), WV (1), and WY (2). In addition, Salmonella Senftenberg has been found in food samples from retail and a patient household during this outbreak investigation. PulseNet identified 6 persons who had illness caused by Salmonella Senftenberg with matching PFGE patterns between July 1, 2009 and today. Public health officials have interviewed 5 of the 6 ill persons with this strain of Salmonella Senftenberg and determined that two purchased a recalled salami product during the week before their illness began. These six cases are not included in the overall case count reported above.

FSIS continues to issue expanded recall notices - Product List for Recall 006-2010 and Expansions - as well as a list of stores that sold the product.

We should all be thankful for the hard work from the folks over at the Food Safety Project.  Here is a well-done piece on how to produce safe food while not ruining the environment at the same time:

Abstract

The safety of fresh produce persists as a pressing national issue. Farmers, environmental groups, and others are working together toward a common goal of promoting food safety and environmental stewardship. Members of these groups have expressed concerns that certain on-farm food safety requirements may do little to protect human health and might in fact damage the natural resources on which agriculture and all life depend. This report analyzes the state of the science behind integration of food safety and ecological health. Drawing from multiple sources – including more than 100 interviews with experts, observations at 68 farms, two large-scale surveys of growers, and a review of more than 250 scientific studies – the report provides the most in-depth examination to date of this topic. The main finding is that growers report yielding to tremendous pressure from auditors, inspectors, and other food safety professionals to change on-farm management practices in ways that not only generate uncertain food safety benefits, but also create serious environmental consequences. Environmental concerns include reduction of water quality, removal of wetland, riparian and other habitat, and elimination of wildlife on and near farmland. Many growers and a wide consortium of regional experts believe that “co-management” for food safety and environmental protection represents the optimal path forward, albeit one that faces several key obstacles. Co-management is defined as an approach to minimize microbiological hazards associated with food production while simultaneously conserving soil, water, air, wildlife, and other natural resources. It is based on the premise that farmers want to produce safe food, desire to be good land stewards, and can do both while still remaining economically viable. Although the report focuses on lettuce, spinach, and other leafy greens grown in the Central Coast region of California, its findings reflect concerns across the nation.

Full Report (click on image)

FSIS CLASS I RECALL

Randolph Packing Co. Inc., an Asheboro, N.C. establishment, is recalling approximately 96,000 pounds of beef products that may be contaminated with E. coli O157:H7, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

The products subject to recall include:

Combo bin packages of “Randolph Packing Co., Inc. BONELESS BEEF.”

Combo bin packages of “Randolph Packing Co. Knuckles 90% & 94%.”

30 lbs. boxes of “Beef Ribeye Rolls.”

Each package label bears the establishment number “EST. 6590” inside the USDA mark of inspection.  The products were produced on February 25, 2010, and were distributed to federal establishments for further processing in Ill., Mo., N.Y., Ohio, and Va. None of these products are available directly to consumers.  The problem was discovered through FSIS microbiological sampling.

Despite a Colorado state report that faulted the city of Alamosa for ignoring the deteriorating condition of its water tank years before a Salmonella outbreak sickened over 400 and killed one resident, the city refused to resolve claims of its citizens. The city of Alamosa was sued today.

The state report found animal waste likely contaminated an in-ground storage tank that had been identified as a problem in 1997. The 2008 outbreak included 442 reported cases of illness, but state health officials estimate as many as 1,300 of the towns 8,900 residents were sickened. One death was associated with the outbreak.