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April 2016

Screen Shot 2016-04-28 at 12.11.23 PMI always find FDA’s Form 483 Inspection Reports both interesting and educational.  It is too bad that the FDA tend to make getting copies of them difficult through requiring FOIA’s to be sent instead of simply making the investigation public.

Here are the high’s and low’s of the inspection at Dole’s Springfield Ohio facility which occurred after the plant was linked to a Listeria outbreak that began as early as July 5, 2015. On January 27, 2016, Dole issued a voluntary recall of all salad mixes produced at the Springfield plant. Thus far, 19 people in the United States and 14 in Canada have been identified as contracting Listeria from this outbreak, including one pregnant woman in Michigan. Every patient identified has been hospitalized, and 4 have died. 72% of US cases and 55% of Canadian cases are female. Every age group has been affected: in the United States, victims range in age from 3 to 83 years old.

On the first visits the FDA found:  OBSERVATION: “Failure to perform microbial testing where necessary to identify sanitation failures and possible food contamination.”  The FDA through both product and environmental sampling found numerous samples positive for Listeria.  The FDA also noted that Dole was aware of positive Listeria tests from product that it had exported to Canada.  The FDA found that Dole in late January 2016 implemented a new “Environmental Program Corrective Action Report” apparently in response to a Listeria positive test by a third party laboratory.  FDA also noted that Dole had positive Listeria test dating back to at least July 2014.

Prior visits found:

OBSERVATION 1: “Failure to maintain food contact surfaces to protect food from contamination by any source, including unlawful indirect food additives.”

OBSERVATION 2: “The plant is not constructed in such a manner to allow floors and walls to be kept in good repair.”

OBSERVATION 3: “Failure to provide adequate screening or other protection against pests.”

Here is the 484 – Worth the Read.

recalled-bag-Organic-by-Nature-peasCostco’s recall of the Organic by Nature frozen peas from locations in British Colombia, Alberta, Manitoba and Saskatchewan comes a day after CRF Frozen Foods of Pasco, WA, recalled 15 frozen vegetable products in the U.S. and Canada.

The CRF initiated the recall, which includes the Organic by Nature peas sold at Canadian Costco stores, after Ohio officials detected Listeria monocytogenes in a samples of frozen peas and frozen corn in CRF products collected at the retail level.

Consumers can identify the recalled Organic by Nature brand frozen organic sweet peas by looking for the following label information:

  • 2.5 kg
  • Best by dates: 10-22-17; 12-03-17; 03-16-18
  • UPC number 8 46355 00061 9

Because of the long shelf life of the frozen organic peas, the Canadian Food Inspection Agency (CFIA) is encouraging consumers to check their freezers to make sure they do not have the recalled vegetables in their homes.

“Recalled products should be thrown out or returned to the store where they were purchased,” the CFIA recall notice states. “Food contaminated with Listeria monocytogenes may not look or smell spoiled but can still make you sick.”

Symptoms of Listeria infection can include vomiting, nausea, persistent fever, muscle aches, severe headache and neck stiffness. Pregnant women, the elderly young children and people with weakened immune systems are particularly at risk. Although infected pregnant women may experience only mild, flu-like symptoms, the infection can lead to premature delivery, infection of the newborn or even stillbirth. In severe cases of illness, people may die.

CRF’s recall includes four brands: Schwans, True Goodness by Meijer; Wellsley Farms Organic; and Organic by Nature. The recall is for various varieties of peas, corn and mixed vegetables.

“We know the recalled frozen vegetables were distributed to retailers and distribution centers between Sept. 13, 2015, and March 16 in the following states, and may be redistributed in other states nationwide: AL, AZ, CA, CO, CT, DE, FL, GA, ID, IL, IN, LA, MD, MA, MI, MN, MO, MT, NV, NH, NJ, NY, NC, OH, OR, PA, RI, SC, TN, UT, VT, VA, WA, WV, WI, and in British Columbia, Alberta, Manitoba, Saskatchewan of Canada,” according to the company’s recall notice on the U.S. Food and Drug Administration website.

No illnesses had been reported as of Friday in connection with the frozen organic vegetables.

The recalled vegetables were sold in plastic bags and are marked with “Use By Dates” located on the back of the package. All of the dates are in 2017 or 2018.

A complete list of the specific vegetables being recalled and product codes on their packages is available in the CRF recall notice.

bean-sprout-gettySouth Australia Health today issued a public health warning to South Australians not to eat raw bean sprouts following a significant increase in the number of Salmonella Saintpaul cases.

Over the past 11 days there have been 108 Salmonella Saintpaul cases reported. South Australia sees around 15 to 20 cases each year.

Since the start of December, South Australia Health has been notified of 233 cases of Salmonella Saintpaul.

Investigations by South Australia Health, in conjunction with local councils and food suppliers, at this stage indicate that bean sprouts eaten raw may be responsible for these increased numbers of Salmonella Saintpaul.

Of the 233 cases, 43 people have been hospitalised.

Thanks to my friends at Barf Blog for a list of sprout breaks.

big-map-4-21-16A total of 33 people infected with the outbreak strain of Salmonella Virchow were reported from 23 states. Among people for whom information was available, illnesses started on dates ranging from December 5, 2015 to March 18, 2016. Ill people ranged in age from less than 1 year to 84, with a median age of 35. Fifty-three percent of ill people were female. Among 27 ill people with available information, 6 (22%) were hospitalized, and no deaths were reported.

Epidemiologic and laboratory evidence indicated that RAW Meal Organic Shake & Meal products made by Garden of Life, LLC were the likely source of this outbreak.

State and local public health officials interviewed ill people to obtain information about foods they might have eaten and other exposures in the week before they became ill. Of the 30 ill people who were interviewed, 28 (93%) reported consuming powdered supplements or meal replacement powders in the week before illness onset; 27 of these 28 (96%) ill people specifically reported consuming RAW Meal products made by Garden of Life, LLC.

On January 29, 2016, Garden of Life, LLC voluntarily recalled a limited quantity of its RAW Meal Organic Shake & Meal products available in chocolate, original, vanilla, and vanilla chai because they had the potential to be contaminated with Salmonella Virchow. The recalled products were available for purchase nationwide in many retail stores and online.

The Utah Public Health Laboratory and Oklahoma Public Health Laboratory isolated the outbreak strain of Salmonella Virchow from open containers of Garden of Life RAW Meal collected from ill people’s homes in Utah and Oklahoma.  Both products that were tested were from lots covered under the recalls announced by Garden of Life, LLC.

FDA sampling confirmed the presence of the outbreak strain of Salmonella Virchow in Organic Moringa Leaf powder used in RAW Meal Organic Shake & Meal Replacement products. On February 12, 2016, Garden of Life, LLC issued an expanded recall of its RAW Meal Organic Shake & Meal products available in chocolate, original, vanilla, and vanilla chai to include additional lots that contained the contaminated Organic Moringa Leaf powder.

This outbreak investigation is over. However, the recalled products have a long shelf life and may still be in people’s homes. Consumers unaware of the recalls could continue to eat the products and get sick.

hep-aCostco is once again offering hepatitis A vaccinations to customers/members who were potentially exposed to hepatitis A contaminated frozen berries it sold (good on ya Costco).  This time it is Canadian customers/members who purchased (and presumably consumed) Nature’s Touch Organic Berry Cherry Blend a frozen berry mix recently recalled by the Canadian Food Inspection Agency. The frozen berry mix was sold exclusively at Costco stores in Ontario, Quebec, New Brunswick, Nova Scotia, and Newfoundland and Labrador. Thirteen cases of Hepatitis A have been linked to the product — nine in Ontario, three in Quebec, and one in Newfoundland and Labrador — with the individuals becoming sick in February and March and three people were hospitalized.  It is unclear at this point how many will receive vaccinations.

In 2013 Costco faced the same issues – contaminated frozen berries and hepatitis A and vaccines.  A certified class action is still pending in Federal Court in California.  There the named-plaintiffs and class members (estimated to be 25,000) allege injury as a result of actual exposure, or the imminent and real risk of having been exposed, to the hepatitis A in the “Townsend Farms Organic Anti-Oxidant Blend” that was subject to a recall announced in a press release that the defendant Townsend Farms issued on June 4, 2013. The FDA had sought the recall of the product because of the risk of hepatitis A infection created by the fact that the consumption of the recalled product had caused a hepatitis A outbreak. According to Townsend Farms, the product-recall was “because [the Product] has the potential to be contaminated with hepatitis A, based on an ongoing epidemiological and traceback investigation by the FDA and the CDC of an illness outbreak.” See http://www.townsendfarms.com/ (checked June 9, 2013). Because of the imminent and real risk of being infected as a result of having consumed the recalled-product, or having been exposed by intimate contact with someone actually infected by consumption of the recalled-product, the named-plaintiffs and class members took the medically-reasonable steps recommended by public health agencies—i.e., to obtain a hepatitis A vaccination or IG-shot—to avoid falling ill with hepatitis A.

In the 2013 lawsuit the defendants (both Costco and Townsend Farms) have argued against liability (despite the warning to get a vaccine to avoid developing hepatitis A) and despite that the vaccinations likely prevented hundreds of illnesses (and financial exposure for damages) that:

  • “the number of bags containing contaminated pomegranate arils from … was very small compared to the total production during the relevant time period;”[1]
  • “the vast majority of the putative class was not exposed to the Hepatitis A Virus;”[2]
  • that for the plaintiffs to prove that the recalled product was “defective,” they must show that each bag of the recalled product was actually contaminated with Hepatitis A virus;[3]
  • “[m]ost of the product sold by Costco was apparently uncontaminated and perfectly fit for human consumption;”[4]
  • “in the parlance of product liability law, most of the mixed berries sold were not defective;”[5] and
  • “each Plaintiff must prove contamination in the package of berries he or she consumed.”[6]

[1] Costco Opposition (Dkt. 159) at 5/18-20.

[2] Costco Opposition Brief (Dkt. 159) at 5/23-4.

[3] United Juice’s Opposition (Dkt. 158) at 1/26-8 and 2/1-2.

[4] See United Juice’s Opposition Brief (Dkt. 158) at 5/20-2.

[5] See United Juice’s Opposition Brief (Dkt. 158) at 5/22-3.

[6] See United Juice’s Opposition Brief (Dkt. 158) at 8/3-4.

natures-touch-berry-cherry-blendThe Public Health Agency of Canada is collaborating with federal and provincial public health partners to investigate an outbreak of Hepatitis A infections in three provinces linked to the frozen fruit product: Nature’s Touch Organic Berry Cherry Blend. The Canadian Food Inspection Agency (CFIA) has issued a food recall warning advising Canadians of the recall of the frozen fruit product that has been distributed in Ontario, Quebec, New Brunswick, Nova Scotia, and Newfoundland and Labrador.

The Public Health Agency of Canada advises Canadians not to consume the frozen fruit product Nature’s Touch Organic Berry Cherry Blend sold exclusively at Costco warehouse locations in Ontario, Quebec, New Brunswick, Nova Scotia, and Newfoundland and Labrador.

The overall risk to Canadians is low. Hepatitis A is a disease that can cause inflammation of the liver. Hepatitis A can range in severity from a mild illness lasting a few weeks to a severe illness lasting several months. You can get the Hepatitis A virus by eating contaminated food or water or through contact with an infected person’s stool. Adequate vaccination can protect against the Hepatitis A virus.

Currently, there are 12 cases of Hepatitis A in three provinces related to this outbreak: Ontario (9), Quebec (2), and Newfoundland and Labrador (1). Individuals became sick in February and March of this year. Some of the individuals who became ill have reported eating the recalled product. The majority of cases (58%) are male, with an average age of 37 years. Three cases have been hospitalized.

I was “asked” by a New York state court judge on Friday to be in court the next Tuesday (tomorrow) on a hepatitis A case that has been pending for some time, so when checking the weather for for the city, this recall notice popped up:

generic-dried-yellow-fishA Brooklyn import-export company is recalling an undisclosed amount of dried yellow fish after a sample tested positive for the bacterium that causes botulism poisoning.

The notice on the FDA’s website did not indicate whether the recalled dried yellow fish was sold whole or in pieces.

The fish is a product of China, but was sold in New York City retail stores in unlabeled bulk boxes that do not have any identifying marks or traceability codes, according to the recall notice on the U.S. Food and Drug Administration website.

“Consumers who have purchased dried fish are advised not to eat it, but should return it to the place of purchase. Consumers with questions may contact the company at 718-567-3339,” the recall notice states.

The Clostridium botulinum contamination was found in the dried yellow fish distributed by WD Import and Export Inc. in Brooklyn when staff from the New York State Department of Agriculture and Markets Food Inspection program collected a random sample for testing.

“Subsequent analysis of the product by Food Laboratory personnel confirmed that the fish was not properly eviscerated prior to processing,” according to the recall notice.

Clostridium botulinum can cause botulism, a potentially fatal form of food poisoning. Symptoms include general weakness, dizziness, blurred or double-vision and trouble with speaking or swallowing. Difficulty in breathing, weakness of other muscles, abdominal distention and constipation are also common symptoms. People experiencing these problems should seek immediate medical attention.

imagesmoneyjailPRINCIPAL DEPUTY ASSISTANT ATTORNEY GENERAL BENJAMIN C. MIZER DELIVERS REMARKS AT THE CONSUMER FEDERATION OF AMERICA’S 39TH ANNUAL NATIONAL FOOD POLICY CONFERENCE 

Remarks as prepared for delivery 

WASHINGTON, D.C.

Thank you for that kind introduction.  And thank you to the Consumer Federation of America and organizers of the National Food Policy Conference for inviting me to speak to you today.  I am honored to be here.

This audience is full of consumer advocates, representatives of the food industry, nutritionists and government regulators, many of whom are experts on food safety and related issues.  I would not presume to teach you about food safety.  To the contrary, I hope to learn much from you.  You are the people who have dedicated your careers to bringing safe and healthy food to consumers across the country and around the world.  You are the people who ensure that we have confidence in what we eat – that the food that we feed our families and that our children receive at school will not cause them harm.

But I hope my presence here is recognition of the important role that the Justice Department can play in helping those of you in this room ensure the safety of the food supply.  That’s what I want to talk about today – the Justice Department’s role and, more specifically, the various enforcement tools that we have at our disposal.  I appreciate the opportunity to speak with you because I think engagement and dialogue between all of the stakeholders here – between government, industry and consumer advocates – is vitally important to bridging the gaps between our worlds and protecting American consumers.  I believe that we at the Justice Department can be more successful in our role if you on the front lines understand what we do and how we can contribute to your mission.

For the Department of Justice – and for the Civil Division, which I am proud to be a part of – protecting Americans is at the core of our work.  Sometimes that means combating terrorism or cybercrime or violent gangs.  Sometimes it means preserving our financial security by fighting fraud.  Sometimes it means ensuring the safety of the products that Americans use every day to keep themselves healthy – drugs, medical devices and dietary supplements.

Our food safety work is fundamental to our consumer protection mission, because no product plays a more vital role in the lives of every single American.  That is why we take food safety no less seriously than any of the other risks that face the American people and why it has been the subject of much of our work during my time in the Civil Division.

I don’t need to tell the people in this room that one of the challenges the food industry faces is that it can be hard for consumers to protect themselves and their families from unsafe food.  We can and should take steps to protect ourselves while driving or riding our bikes.  We can and should consult a doctor before taking drugs or dietary supplements.  We can even protect ourselves from many kinds of fraud against consumers.

But when it comes to food safety, we have to rely on the companies who manufacture and distribute food to ensure that the food we buy is safe.  In fact, most consumers give little thought to the safety of their food.  I know I don’t and I bet many of you don’t either.  We simply don’t expect to get sick from the food at our favorite restaurant, or from the peanut butter or the eggs or the cantaloupes or the countless other products that we buy at the supermarket.  That is why food safety is a priority for the Justice Department.  Our role in protecting consumer safety is at its apex when consumers can least protect themselves.

There’s no question that the overwhelming majority of food produced and consumed in the United States is safe.  America’s incidence of foodborne illness is below the average in other developed countries and it continues to drop.  Americans can be confident in the quality of the food that they buy and eat every day.  That said, foodborne illness still imposes a significant public health burden on the American people.  About 48 million Americans, or one out of every six people, get sick each year from food.  For many of those people, the problem isn’t just a stomach ache.  It can cause life-long chronic diseases, like arthritis and kidney failure.  The Centers for Disease Control and Prevention (CDC) estimate that 3,000 people die each year from foodborne illness and 128,000 people are hospitalized.

One of the government’s highest obligations is to protect citizens when they cannot protect themselves.  That is what the Food, Drug and Cosmetic Act (FDCA) and other food safety laws are designed to do.  That is why the CDC, the Food and Drug Administration, and the Department of Agriculture (USDA) continue to do groundbreaking work to identify the causes that contribute to foodborne illness and to promote conditions that minimize them.  And it is why the Justice Department works closely with our federal agency partners to ensure that our enforcement efforts are making a positive difference to food safety and quality.  We rely on their technical expertise, their investigative support and their deep knowledge of the industries they regulate as keys to building cases.

Against that backdrop, I want to describe some of the enforcement tools that the Justice Department uses to help ensure the safety of the food supply.  And I want to focus on the FDCA.  Many of the laws we enforce are laws of general applicability – in other words, they govern conduct in all industries, not just the food industry.  The laws prohibiting mail and wire fraud, for instance, apply to every industry and we use those tools to protect food safety in appropriate cases.  For example, in the Peanut Corporation of America case, which I will say more about in a little bit, the jury found the defendants guilty not just of FDCA violations, but also of conspiracy, mail fraud, wire fraud and obstruction of justice.

But the FDCA is a special tool designed to address the unique interests at stake in the production of food and medicine.  It provides for criminal penalties and civil relief against those who introduce adulterated foods into interstate commerce.  Under the FDCA, a food is considered adulterated if, among other things, it is contaminated with a substance that may make someone sick or if it was prepared, packed, or held under unsanitary conditions.  So when the Justice Department – in concert with our FDA colleagues – decides to bring a food safety case under the FDCA, one of the decisions that we have to make is whether to use our civil authority or our criminal authority.  This decision is based primarily on our answer to two questions: First, what do the facts and evidence show?  And second, which enforcement tool is most appropriate in that particular case to ensure the safety of our food supply?

Let me start with our civil enforcement authority.  Although criminal prosecutions get most of the headlines and can be an effective way to deter illegal conduct, our enforcement actions often take the form of civil cases, designed to prevent the distribution of adulterated food in the first place.  These civil enforcement actions are a critical tool for protecting the health and safety of American consumers.  When we see evidence of unlawful practices or conditions – usually brought to our attention by a partner agency – we may ask a court to order the seizure of potentially unsafe products or to temporarily prevent a facility from operating until sanitary conditions are established.  In these cases, we routinely seek measures that require companies to institute new health and safety procedures, including independent monitoring programs.  Often, rather than asking a court to impose requirements, we are able to resolve these actions through a negotiated agreement that promotes a safe production environment.

To give an example of a litigated matter, we brought suit in New York after FDA inspections found that a Brooklyn fish processor was consistently missing steps necessary to prevent listeria contamination.  A court barred the processor from operating its facility until an independent laboratory and an independent sanitation expert develop a satisfactory Listeria Monitoring Program and until the processor establishes that it will fully comply with that program on an ongoing basis.  The facility cannot begin operating again until the processor has cleaned and sanitized it, and until laboratory testing has confirmed that the listeria bacteria are no longer present.

We often use our civil enforcement authority in cases involving unsanitary conditions.  As you might imagine, these cases do not involve the most pleasant facts.  Sometimes they’re downright disgusting.  For instance, we recently obtained an injunction against a California-based manufacturer and distributor of soy products that had a history of processing foods under unsanitary conditions.  During the most recent FDA inspection, investigators found a host of violations, including live and dead cockroaches and rodent activity where the food was produced and stored.  You’ll be relieved to hear that the production facility is now closed and cannot reopen without FDA approval.

Finally, we have had success with civil enforcement in cases involving the administration of drugs – and antibiotics in particular – to animals intended for human consumption.  To take one example, we recently obtained a consent decree against a dairy farm in Vermont that was selling livestock for slaughter and human consumption even though unsafe drug residues were present in the meat.  This type of behavior not only poses a health risk to those who consume the meat, but specifically with respect to antibiotics, it jeopardizes broader public health by giving rise to antibiotic resistant bacteria.  In this particular case, the defendants are now subject to heightened FDA oversight and they cannot operate until they implement certain safeguards and the FDA confirms that they have come into compliance with the law.

These cases are illustrative of our wide-ranging civil enforcement practice.  In each case, our top priority is safety.  We seek to ensure that a facility that has produced adulterated food in the past cannot distribute such food going forward until the government can verify that the defendant has taken all of the steps necessary to prevent a recurrence.  And even if we resolve a case with a negotiated agreement, any such agreement is then submitted to a court for entry of a permanent injunction, so that we can seek additional enforcement if there is a violation of the agreement.

Now, the civil remedies available under the FDCA are important and civil cases make up the majority of the food safety actions we bring.  But sometimes it’s important that we hold criminally accountable those individuals and entities that place consumers at risk by putting unsafe food on our table and in our lunchboxes.  That way we make clear to people in the industry that they have a responsibility to protect the safety of the public.

In deciding whether to use our civil or our criminal enforcement tools, the Justice Department follows the same set of guidelines that apply to every criminal prosecution.  Among other things, prosecutors evaluate the nature and seriousness of the offense, the deterrent effect of the prosecution and the culpability of the individuals or entities involved.

When we decide that criminal prosecution under the FDCA is warranted, we then choose between two types of criminal charges: misdemeanor and felony.  Congress has made the prohibition on introducing adulterated food into interstate commerce a strict liability offense, meaning that a company or individual violates the law and can face misdemeanor charges whether or not it intended to distribute adulterated food.

So, for example, the department brought charges under the FDCA against the owners of a cantaloupe distributor in Colorado.  When the distributor decided to install a new system for washing their cantaloupes, they adopted a system that was meant for washing potatoes and elected not to use a chlorine spray to kill certain bacteria.  Their decision caused an outbreak of Listeria that resulted in the deaths of 33 people.  The defendants pled guilty to misdemeanor charges and were sentenced to probation, six months of home detention, and a fine.

Similarly, we recently entered a plea agreement with a company that distributed cheese that was connected to a Listeria outbreak that infected at least eight people, including three newborns.  The company pleaded guilty to a misdemeanor violation of the FDCA.  We also obtained civil relief in that case against the two principals of the company, which required them to stop producing cheese until they were in compliance with the provisions of the permanent injunction entered by the court.

Make no mistake: misdemeanor violations can mean serious penalties.  In 2014, we entered a plea agreements with an Iowa egg production company, its owner, and its CEO.  The company had produced and distributed adulterated eggs that led to a nationwide salmonella outbreak, which caused almost 2,000 reported illnesses.  The company’s personnel had disregarded food safety standards and practices and misled major customers about the company’s food safety practices.  The company pleaded guilty to both misdemeanor and felony violations of the FDCA and to bribery of a public official, was ordered to pay a $6.79 million fine and received three years of probation.  And the owner and CEO each pleaded guilty to a misdemeanor violation of the FDCA and were sentenced to three months in prison, one year of supervised release and a $100,000 fine.

In some cases, the facts are so egregious that it is appropriate for the Justice Department to bring the full force of the law to bear.  When we can show an intent to defraud or to mislead consumers or the FDA, a defendant can face felony charges.

Many of you are probably aware of the criminal trial and convictions of two former officials of and one food broker for the Peanut Corporation of America, or PCA.  One of the defendants was the former owner and President of PCA.  PCA products were tied to a salmonella outbreak that, according to the CDC, led to over 700 reported infections and nine deaths.  Using epidemiological projections, the CDC estimates that more than 22,000 individuals may have been affected by salmonella.

The human toll of an outbreak on this scale is heartbreaking and the actions that caused it are disturbing.  The evidence the Justice Department introduced at trial showed that the officials misled PCA’s customers about what they had done to test their products and covered up the fact that some of the products had tested positive for salmonella.  For example, they fabricated certificates of analysis accompanying various shipments of peanut products so that the certificates stated that the food in the packages was free of pathogens.  In fact, there had been no testing of the food – or, even worse, tests had revealed that the food was contaminated.

After a seven week trial, a federal jury found defendants guilty of FDCA violations, conspiracy, mail fraud, and wire fraud, as well as obstruction of justice in connection with the FDA investigation of the PCA facility.  PCA’s former president was sentenced to 28 years in prison, the largest criminal sentence ever given in a food safety case.  The other two defendants who were tried were sentenced to 20 years and five years in prison.  Two defendants who pleaded guilty in connection with the PCA matter were sentenced to six years and three years in prison.

Fortunately, the PCA case is not representative of the food industry as a whole.  In the main, American consumers can have confidence that the food they eat is safe.  But what the PCA case shows is that even a single bad actor can cause enormous harm.  That is why the Justice Department will continue to remain vigilant in safeguarding America’s food supply and will hold accountable those in the food industry who violate the public trust.

The Justice Department’s focus on food safety and our recent successful prosecutions – some of which I have mentioned here today – have accomplished a great deal.  The cases that we bring help create conditions that ensure the safety of the food supply.  They create incentives for good behavior and they deter misconduct.  They empower those within an organization who see unsafe practices to speak out.  They help to educate the industry and to support the great work that the FDA, the USDA and others are doing.  In short, aggressive enforcement of the FDCA and other food safety laws helps to ensure that making safe food is not only the best ethical and moral decision, but also the best business decision.

We are committed to continuing to vigorously prosecute food safety cases.  We also look forward to continuing to support your work and I hope you will let us know if there is anything that the Justice Department can do to help you protect consumers, so that Americans can have the utmost confidence in the safety of the food that they eat.

Thank you.

ct-dph-282x300The State Department of Public Health (DPH) today issued the following update on the E. coli outbreak linked to the Oak Leaf Farm in Lebanon, CT.

DPH is investigating 34 confirmed cases of E. coli O157 infection linked to the farm.  The patients range in age from 10 months to 45 years, with a median age of five years.  The patients include six adults and 28 children 14 years old and under; 18 of the children are age five years or under.  In total, nine patients have been hospitalized with four still in the hospital.  Three of the hospitalized patients have been diagnosed with hemolytic uremic syndrome (HUS), a rare but serious illness that affects the kidneys and blood clotting system.

DPH is aware of three patients who did not visit Oak Leaf Farm but became ill with E. coli after having contact with someone with an E. coli infection who did visit the farm. These people are referred to as secondary cases. DPH continues to monitor for additional reports of secondary cases. 

The investigation by DPH, Department of Agriculture, and the Centers for Disease Control and Prevention (CDC) is continuing and expected to last several weeks.  DPH, in collaboration with CDC, is planning additional studies to better understand the scope of the outbreak and specific risk factors for illness among persons who visited the farm.

Oak Leaf Farm remains closed to the public and its owners are cooperating with the investigation.  The CT Department of Agriculture advises anyone who recently purchased goats from Oak Leaf Farm to consult with their livestock veterinarian.

The outbreak was first identified on Thursday, March 24th when six of seven individuals sickened with E. coli were confirmed by DPH to have recently visited Oak Leaf Farm and come into contact with goats on the farm.  DPH has been able to determine that the exposures happened between March 6th and March 20th, with onset of symptoms occurring between March 7th and March 24th.

12440266_1113713065346354_443694790606224620_oSo, who plays me from 1993?

Last year I offered to give a book to each new person who subscribed to my blog up to 500 – I have 100 paperback books left.  So, the next 100 new subscribers will get a free book.  Just subscribe here and email me your mailing address at bmarler@marlerclark.com.

I given the book free to every member of Congress, the President and the heads of both the FDA and FSIS.  Dave Theno (former head of food safety at Jack in the Box) and I also gave 1,000 books to folks who attended the 2010 IAFP conference.  I also gave away books at the several conferences I have spoken at in the last months.

Here is a sample platter of the reviews on Poisoned that have come out.

Roanoke Times:

“He also gives balanced treatment to the fast-food chain’s executives — men who could easily be vilified for the oversights that led to the tragedy — for their goal to set new industry standards for safety, to keep their company from shutting down in a storm of bad publicity, and for what seemed to be a genuine desire to help the families they inadvertently hurt, no matter how high the cost.”

“Benedict also touches on the ways the potentially deadly bacteria entered the food supply and how this outbreak, unlike others that preceded it, ended up improving standards for food handling in restaurants and processing plants.”

The News Advance:

“The story moves to Seattle, where hundreds of children get sick. Marler, a young lawyer frustrated with his career, starts learning about E. coli and amasses a list of clients.”

“He later helps one of those clients, Brianne Kiner, secure a $15 million settlement, the largest personal injury settlement at that time.”

“Benedict knows how to make a story both informative and important. “Poisoned” explains technical details as lawyers wrangle over legal fees and doctors run tests on micro-organisms, while also weaving in the emotions of individuals and families.”

The Richmond Times Dispatch:

“Anyone who has suffered from food poisoning knows the misery of the condition without going into detail. But few have found it life-threatening.”

The Day:

“A stunningly researched work, “Poisoned” reads as though Clarence Darrow had written “The Jungle” – and further proves Benedict is at the very top of those artistes whose narrative nonfiction burns like beach-happy, page-blasting thrillers.”

Poor Taste Magazine:

“After reading the first seven pages of your book, I was in tears, one hand covering my mouth, my heart racing as I learned the appalling story of six-year-old Lauren Rudolph, who succumbed to death just one week after consuming a dangerous, bacteria-filled hamburger. I was absolutely sucked in to your retelling of the outrageous, deadly E. Coli outbreak of the early ‘90s — a massive eruption of the most virulent strain of the bacteria that sickened over 600 people, killed four children, and nearly annihilated the Jack in the Box fast-food chain. Your simple but eloquent writing style kept me intrigued page after page, and as a result, Poisoned, with its revealing and heartbreaking stories of the victims of foodborne illnesses, took over my life for an entire week.”

Poisoned Jeff BenedictTri-State Livestock News:

“Benedict’s portrayal of those involved in the case of tainted hamburger traced to Jack in the Box restaurants is compelling, captivating and cautionary. As horrifying as the account is, Benedict tells it with compassion and class. So often lacking in what passes for news writing today, Benedict covers the story from every angle without passing judgment; he does it while presenting the humanness of those involved. From young patients to their parents, fry cooks to restaurant executives, physicians and scientists to the lawyers representing both sides, the reader rides shotgun in the fast-paced thriller that could pass for fiction. Only it’s not.”

New York Times:

“Jeff Benedict manages to deliver a full literary experience of a medico-legal thriller in a work of nonfiction … Benedict delivers the story in a staccato, you-are-there fashion.” “There is only one supremely colorful character in the story that Mr. Benedict overlooks, and that is E. coli itself.”

“Poisoned” also received some extra exposure when another New York Times writer, Mark Bittman, who discussed “some stomach-churning facts about the E. coli outbreak,” with central character Bill Marler, the lawyer who sued Jack in the Box in the early 1990s.”

“The guy we have to thank for having our current level of protection against E. coli … is Bill Marler who made his bones in the Jack in the Box case.”

San Diego Tribune:

“Benedict proves to be a master storyteller,” she wrote. “And his subtext is that because of what happened at Jack in the Box, the government changed its regulations, the company provided an all-encompassing plan that it shared with others in the industry to keep food products safe and people changed the way — and what — they eat.”

CS Monitor:

“Then Benedict moves on to the legal battle over the deaths, with a movie-like focus on the young attorney who represents one of the children. That lawyer, Bill Marler, breaks all the usual rules – viewing the child’s injuries, for instance, “more through the eyes of a parent than a lawyer.” But his unconventional approach proved successful and laid the groundwork for his current status as one of the country’s leading and most impassioned food safety lawyers.”

AP:

“Once the legal story gets rolling, however, ‘Poisoned’ becomes a fast-paced narrative and a cautionary tale about how public health policy, corporate practices and public relations, and lawyers’ chutzpah and frenzy for fees can converge in a place we all know well: the neighborhood hamburger joint,” Sullivan wrote.

Bainbridge Island Review:

“Bainbridge Island resident Bill Marler remembers the outbreak well. After graduating from WSU, Marler was a third-year associate at the Seattle law firm of Keller Rohrbach. While the drama dominated the national media, Marler received a call from the mother of one of the afflicted children. A high-stakes legal battle ensued, wrought with cinematic-worthy drama.”

“The landmark $15 million settlement Marler won in a class action suit against the fast food chain propelled him into the spotlight. These days, Marler is considered the nation’s leading food safety lawyer.”

Kirkus Review:

“Just in time for BBQ season, an investigative journalist traces the path of a devastating outbreak of food-borne illness linked to hamburger meat.”

King County Bar Journal:

“Benedict has crafted Poisoned as a multi-part narrative, which takes us behind the scenes at JIB, into the slaughterhouses and hospitals, and through the legal machinations, bureaucracy, and skullduggery. Part of the story is the outbreak and the resulting, well-known legal case; the other side is the lesser-known – and still ongoing – changes in the food industry designed to clean up food processing and prevent future outbreaks. Most of these were initiated by Jack in the Box itself, which hired a leading food safety consultant as a full-time management employee to change the way – and what – Americans eat.”

“But there are two main characters: Bill Marler, the Seattle lawyer who represented many of the plaintiffs and made his name in the case, and 9-year-old Brianne Kiner of Seattle, his “biggest” client.”

Desert News:

Poisoned,” continues to grab headlines across the country.”

“With the recent E. coli outbreaks in Germany and France, Benedict’s nonfiction work is becoming a resource for people concerned about food poisoning issues.”

Grist:

“The result is a fast-paced, incredibly readable, even if at times a tad overly dramatized, story. (To be fair, it’s difficult to charge someone with overstating tragedy when it comes to the death of children.)”