February 2015

mad cowIn recent years, “mad cow” disease has created considerable confusion for American consumers as it has grabbed headlines, thanks to several now infamous North American bovines – including two recently found in Canada.

The question in many minds is whether litigation will follow.

Many Americans reflexively assume it will; after all, Products Liability 101 teaches that the manufacture and sale of bad food creates liability, and beef from “mad cows” is certainly bad food. From a litigation perspective, however, beef tainted with a potentially brain-wasting disease presents singular difficulties that more common bugs such as Salmonella and E. coli O157:H7 do not.

Bovine spongiform encephalopathy (“BSE”), better known as mad cow disease, was first diagnosed in 1986 by British doctors. Since then, the disease has been confirmed in more than 178,000 head of cattle in Great Britain alone, with a peak rate in January 1993 of 1,000 cases each week.

BSE is a degenerative nervous system disease that, unless something else does the job, will kill every cow that contracts it. Currently, we are without a test to detect BSE in a live animal. Veterinary pathologists confirm the disease posthumously through microscopic examination of brain tissue, which will appear spongy, or by the detection of the infectious protein structures known as prions (short for proteinaceous infectious particles and pronounced “pree-ons”).

BSE does not occur in humans. However, it can cause a similar disease called new variant Creutzfeldt-Jakob Disease (“vCJD”), a rare, degenerative and fatal brain disorder. As of December 1, 2003, a total of 153 cases of vCJD had been reported worldwide: 143 from the United Kingdom, six from France and one each from Canada, Ireland, Italy, and the United States. Nearly all cases had multiple-year exposures in the United Kingdom between 1980 and 1996, which roughly coincided with the large BSE outbreak among U.K. cattle.

Occurrence of vCJD in humans likely occurs by consuming BSE-contaminated cattle meat products. Knowledge of the specific foods that are associated with transmission is obscure at best — an unsettling thought given the ubiquitous nature of the cow and its constituent parts. Tests on experimentally infected cattle have confirmed signs of BSE in the brain, spinal cord, retina, dorsal root ganglia, distal ileum and bone marrow, suggesting that these tissues are associated with a heightened risk of transmission.

Many countries, particularly those in which an indigenous BSE case has occurred, have implemented control measures to prevent potentially BSE-infected tissues from entering the human food supply. These include increased herd surveillance, destroying sick animals and banning the use of certain “high risk” cattle parts in human or bovine food.

The U.K., for instance, excludes from the human and bovine food supply the parts of all cows older than thirty months of age. Certain European countries require testing of almost every slaughtered cow. Loopholes do remain, however, and certain countries have been less pro-active. In many countries, there remains no prohibition against using poultry litter, cattle blood and restaurant leftovers in cattle feed, and all of these ingredients have roots in the high-risk cattle parts described above.

We do not plan to head any new-fangled ABA mad cow litigation section, not in the short term at least, and for two primary reasons. The first is that the disease is simply not currently prevalent in the United States. As noted above, only one case of BSE has ever been reported in the U.S.

The second problem is less about available markets, and more about causation and other law school basics. As with any foodborne-illness case, the science of the particular bug involved is critically important to the rights and remedies available to victims. More specifically, the incubation period — that is, the length of time between ingesting a pathogen and falling ill — helps to narrow the range of meals or specific food items that could have been the source of somebody’s illness.

For instance, a hamburger consumed 10 minutes before the onset of an E. coli O157:H7 illness cannot possibly have been the source of the infection because the average incubation period for E. coli O157:H7 is measured in days (typically between two and five), not minutes. The source of an E. coli O157:H7 illness must have been something eaten within the expected medical range prior to the onset of symptoms.

In stark contrast to E. coli O157:H7 and other more common foodborne illnesses, the incubation period for vCJD is extremely long, probably more than a decade. No one is going to recall sources of beef consumed years before, much less the more particular identifying information typically necessary to implicate a given defendant.

With other common foodborne pathogens, incubation periods range from a few hours to a couple of weeks. Once an individual tests positive for a pathogen like E. coli O157:H7, Salmonella or Shigella, for example, his or her recent food history can be identified with relative ease. Epidemiological investigation tools can then be used to conclusively establish a link to a particular product, even where there are no contaminated “leftovers.” With BSE-contaminated beef, however, the possible period for consumption is unknown, but is likely years and possibly decades in breadth. This severely limits the effectiveness of an epidemiological investigation.

Nevertheless, mad cow litigation cannot be discounted permanently on these bases. Not so long ago, even the more common foodborne diseases were more difficult to track, for lawyers and health departments alike. Scientific and technological advances have made for more sound conclusions. For example, we are now able to match the

DNA of a particular sample of E. coli O157:H7 or Salmonella — each of these bugs can be likened to a species with different subspecies, each having its own genetic profile — to another sample, thus creating more certainty that the samples had a similar source.

There are steps that the cattle industry can take to minimize the chances that beef from a BSE-infected cow will be transferred to a human in the United States. The industry can and should document where individual cows come from and where specific lots of meat are sold, thus allowing the companies that produced or sold contaminated meat a meaningful opportunity to recall the bad product and avoid injury. Given that, it is plausible to suggest that an enterprising attorney might have success with “enterprise” or “market share liability” theories against the cattle industry as a whole.

It is difficult, at least in part due to the lengthy incubation period of the disease, to accurately assess the threat that BSE presents both in the U.S. and globally. Litigation to address individual cases of BSE is not imminent, and frankly can only come too late for the individual involved. The responsibility for protecting the public lies with regulatory agencies like the USDA and the members of the cattle industry.

_65912134_fsaThe United Kingdom’s Food Standards Agency (FSA) today published the latest set of results from its year-long survey of Campylobacter on fresh chickens at retail.

The results to date show:

  • 19% of chickens tested positive for Campylobacter within the highest band of contamination.
  • 73% of chickens tested positive for the presence of Campylobacter.
  • 7% of packaging tested positive for the presence of Campylobacter.

More than 3,000 samples of fresh whole chilled chickens and packaging have now been tested. The FSA’s 12-month survey, running from February 2014 to February 2015, will test around 4,000 samples of whole chickens bought from UK retail outlets and smaller independent stores and butchers. The full set of results is expected to be published in May.

Wouldn’t be interesting if our government did the same?

“We’re going to move the timeline up,” Vilsack told Rep. Rosa DeLauro, D-Conn.

mechanically-tenderized-beefPhil Brasher reports that special safety labels for mechanically tenderized meat are likely to take effect as soon as 2016, two years earlier than expected, Agriculture Secretary Tom Vilsack told lawmakers. At a hearing with the House Agriculture Appropriations Subcommittee, Vilsack said his department would suspend a regulation that would otherwise prevent the labeling for mechanically tenderized meat to take effect until 2018, because the administration failed to finalize the labeling rule before the end of last year.

USDA’s Food Safety and Inspection Service first proposed the labeling for mechanically tenderized meat in June 2013 out of concern that consumers aren’t cooking the meat properly to eliminate pathogens. The meat is tenderized with knives and needles that can drive bacteria inside the product.

USDA officials did not send the final rule to the White House Office of Management and Budget for review until November 21. The regulation remains pending at OMB. Under FSIS labeling regulations, the labeling rule could have taken effect as soon as 2016 only if it had been cleared by OMB and approved by USDA by December 31.

Screen Shot 2015-02-24 at 7.59.54 PMThe FDA, CDC and the USDA’s FSIS today released a report on the new method for analyzing outbreak data to determine which foods are responsible for illness related to four major foodborne bacteria. The report, titled “Foodborne Illness Source Attribution Estimates for Salmonella, Escherichia coli O157 (E. coli O157), Listeria monocytogenes (Lm), and Campylobacter using Outbreak Surveillance Data,” was produced by the Interagency Food Safety Analytics Collaboration (IFSAC).

As outlined in the report, IFSAC analyzed data from nearly 1,000 outbreaks that occurred from 1998 to 2012 to assess which categories of foods were most responsible for making people sick with Salmonella, E. coli O157, Listeria, and Campylobacter. The pathogens were chosen because of the frequency or severity of the illnesses they cause, and because targeted interventions can have a significant impact in reducing them. Some of the findings include:

  • More than 80 percent of E. coli O157 illnesses were attributed to beef and vegetable row crops, such as leafy vegetables.
  • Salmonella illnesses were broadly attributed across food commodities, with 77 percent of illnesses related to seeded vegetables (such as tomatoes), eggs, fruits, chicken, beef, sprouts and pork.
  • Nearly 75 percent of Campylobacter illnesses were attributed to dairy (66 percent) and chicken (8 percent). Most of the dairy outbreaks used in the analysis were related to raw milk or cheese produced from raw milk, such as unpasteurized queso fresco.
  • More than 80 percent of Listeria illnesses were attributed to fruit (50 percent) and dairy (31 percent). Data were sparse for Listeria, and the estimate for fruit reflects the impact of a single large outbreak linked to cantaloupes in 2011.

Reception in their honor Monday February 23

Join us Monday, February 23 for a reception in honor of our guest and visiting professor, Bill Marler and his law partner Denis Stearns.  Bill and Denis will be here teaching a condensed course for us,  Food Safety Litigation, Monday and Tuesday.

The reception will be Monday evening from 5:00-7:00 with a presentation by Bill at 5:30.

bill marler reception 2-2015

MMWR reported today: In August 2014, PulseNet, the national molecular subtyping network for foodborne disease surveillance, detected a multistate cluster of Salmonella enterica serotype Newport infections with an indistinguishable pulse-field gel electrophoresis (PFGE) pattern (XbaI PFGE pattern JJPX01.0061).* Outbreaks of illnesses associated with this PFGE pattern have previously been linked to consumption of tomatoes harvested from Virginia’s Eastern Shore in the Delmarva region and have not been linked to cucumbers or other produce items (1). To identify the contaminated food and find the source of the contamination, CDC, state and local health and agriculture departments and laboratories, and the Food and Drug Administration (FDA) conducted epidemiologic, traceback, and laboratory investigations. A total of 275 patients in 29 states and the District of Columbia were identified, with illness onsets occurring during May 20–September 30, 2014. Whole genome sequencing (WGS), a highly discriminating subtyping method, was used to further characterize PFGE pattern JJPX01.0061 isolates. Epidemiologic, microbiologic, and product traceback evidence suggests that cucumbers were a source of Salmonella Newport infections in this outbreak. The epidemiologic link to a novel outbreak vehicle suggests an environmental reservoir for Salmonella in the Delmarva region that should be identified and mitigated to prevent future outbreaks.

Purdue University research shows that standard cleaning procedures in retail delis may not eradicate Listeria monocytogenes bacteria.

A study led by Haley Oliver, assistant professor of food science, found that 6.8 percent of samples taken in 15 delis before daily operation had begun tested positive for Listeria monocytogenes   In a second sampling phase, 9.5 percent of samples taken in 30 delis during operation over six months tested positive for the bacteria. In 12 delis, the same subtypes of the bacteria cropped up in several of the monthly samplings, which could mean that Listeria monocytogenes can persist in growth niches over time.

Listeria monocytogenes can cause listeriosis – a serious systemic infection – in immunocompromised people such as the elderly, infants and children, pregnant women and people with HIV. In severe cases, L. monocytogenes can pass through the intestinal membrane and into the bloodstream or cross the blood-brain barrier. The bacteria can also cross the placental barrier in pregnant women, which can trigger abortion.

Ready-to-eat deli meats are the food most associated with L. monocytogenes, which can grow at refrigerator temperatures, unlike Salmonella and E. coli.

Stringent control measures and inspections have tamped down the presence of L. monocytogenes at meat processing plants, but there are no regulations specific to Listeria for retail delis. Recent risk assessments suggest that up to 83 percent of listeriosis cases linked to deli meats are attributable to products contaminated at retail.

The paper was published in the Journal of Food Protection.

Being at the office on a Saturday allows for a bit of catch up after a week of traveling (and hand surgery).  Today is a day to double-check that all the t’s are crossed and i’s dotted in finalizing the Listeria Cantaloupe Litigation.  After three years, five months and one day, I am glad for all concerned that the litigation is behind.  My hope is that the lessons learned will translate into far fewer future outbreaks; because regardless of the settlement, no amount of money changes the fact that nearly forty people needlessly died and a hundred more were injured, many permanently.  An added bonus to the quiet in the office is this email I just received from one of those clients:

I wanted to send an email to say Thank You for all of the hard work and patience that you and your staff gave me and my family.  I hope that we didn’t call or email too much during this process.  This was a new experience for my family since we haven’t been involved in a lawsuit before.
The reason we initially contacted you was because I wanted to do something, anything about my father passing away before it was his time.  I didn’t know if we had a valid claim or if anyone cared about my father passing away.  I also knew that if I didn’t do something that someday I would regret it when someone would ask “What did you do about your dad dying from Listeria?”
Thank you for the closure.
Thank you for caring.
Thank you for answering all my emails.
Thank you for answering all my phone calls.
Please continue to fight for food safety.

Its why I work Saturdays.

CDC collaborated with public health officials in several states and with the U.S. Food and Drug Administration (FDA) to investigate an outbreak of Listeria monocytogenes infections (listeriosis). Joint investigation efforts indicated that commercially produced, prepackaged caramel apples made from Bidart Bros. apples were the likely source of this outbreak.

Public health investigators used the PulseNet system to identify illnesses that were part of this outbreak. PulseNet is the national subtyping network of public health and food regulatory agency laboratories coordinated by CDC. DNA “fingerprinting” is performed on Listeria bacteria isolated from ill people using techniques called pulsed-field gel electrophoresis (PFGE) and whole genome sequencing (WGS).

The 35 ill people included in this outbreak investigation were reported from 12 states: Arizona (5), California (3), Colorado (1), Minnesota (4), Missouri (5), Nevada (1), New Mexico (6), North Carolina (1), Texas (4), Utah (1), Washington (1), and Wisconsin (3). Illness onset dates ranged from October 17, 2014, to January 6, 2015. Eleven illnesses were associated with a pregnancy (occurred in a pregnant woman or her newborn infant). One fetal loss was reported. Among people whose illnesses were not associated with a pregnancy, ages ranged from 7 to 92 years, with a median age of 62 years, and 33% were female. Three invasive illnesses (meningitis) occurred among otherwise healthy children aged 5–15 years. Thirty-four people were hospitalized, and listeriosis contributed to at least three of the seven deaths reported.

The Public Health Agency of Canada (PHAC) identified two cases of listeriosis in Canada with the same PFGE patterns as those seen in the U.S. outbreak. More detailed testing using WGS showed that the isolate from only one of the two cases was genetically related to the U.S. outbreak. That person reported eating a caramel apple.

On January 6, 2015, Bidart Bros. of Bakersfield, California, voluntarily recalled Granny Smith and Gala apples because environmental testing revealed contamination with Listeria monocytogenes at the firm’s apple-packing facility. The recall included all Granny Smith and Gala apples shipped from its Shafter, California, packing facility in 2014. On January 8, 2015, FDA laboratory analyses using PFGE showed that environmental Listeria isolates from the Bidart Bros. facility were indistinguishable from the outbreak strains. On January 18, 2015, WGS found that these isolates were highly related to the outbreak strains. In addition, WGS showed that Listeria isolates from whole apples produced by Bidart Bros., collected along the distribution chain, also were highly related to the outbreak strains.

Three firms that produce caramel apples issued voluntary recalls after receiving notice from Bidart Bros. that there may be a connection between Bidart Bros. apples and this listeriosis outbreak. On December 24, 2014, Happy Apple Company of Washington, Missouri, voluntarily recalled Happy Apples brand caramel apples with a best use by date between August 25 and November 23, 2014. On December 31, 2014, Happy Apple Company expanded the recall to include Kroger brand caramel apples produced by Happy Apple Company with a best use by date between September 15 and November 18, 2014. On December 27, 2014, California Snack Foods voluntarily recalled Karm’l Dapple brand caramel apples with a best use by date between August 15 and November 28, 2014. On December 29, 2014, Merb’s Candies of St. Louis, Missouri issued a voluntary recall of Merb’s Candies Bionic Apples and Double Dipped Apples that would have been available from September 8 through November 25, 2014.