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Food Poison Journal

Food Poisoning Outbreaks and Litigation: Surveillance and Analysis

Marler: What you need to know about Botulism

BOTULISM—A Rare, But Deadly Disease
Botulism is a rare, life-threatening paralytic illness caused by neurotoxins produced by an anaerobic, gram-positive, spore-forming bacterium, Clostridium botulinum.[1]  Unlike Clostridium perfringens, which requires the ingestion of large numbers of viable cells to cause symptoms, the symptoms of botulism are caused by the ingestion of highly toxic, soluble exotoxins produced by C. botulinum while growing in foods.[2]  These rod-shaped bacteria grow best under anaerobic (or, low oxygen), low-salt, and low-acid conditions.[3]  Bacterial growth is inhibited by refrigeration below 4° C., heating above 121° C, and high water-activity or acidity.[4]  And although the toxin is destroyed by heating to 85° C. for at least five minutes, the spores formed by the bacteria are not inactivated unless the food is heated under high pressure to 121° C. for at least twenty minutes.[5]

C. botulinum bacteria and spores are widely distributed in nature, because they are indigenous to soils and waters.[6] They occur in both cultivated and forest soils, bottom sediment of streams, lakes, and coastal waters, in the intestinal tracts of fish and mammals, and in the gills and viscera of crabs and other shellfish.[7]

The incidence of foodborne botulism is extremely low.[8]  Nonetheless, the extreme danger posed by the bacteria has required that “intensive surveillance is maintained for botulism cases in the United States, and every case is treated as a public health emergency.”[9] This danger includes a mortality rate of up to 65% when victims are not treated immediately and properly.[10] Most of the botulism events[11] that are reported annually in the United States are associated with home-canned foods that have not been safely processed.[12]  Very occasionally, however, commercially- processed foods are implicated as the source of a botulism events, including sausages, beef stew, canned vegetables, and seafood products.[13]

Symptoms of Botulism

After their ingestion, botulinum neurotoxins are absorbed primarily in the duodenum and jejunum, and pass into the bloodstream and travel to synapses in the nervous system.[14] There, the neurotoxins cause flaccid paralysis by preventing the release of acetylcholine, a neurotransmitter, at neuromuscular junctions, thereby preventing motor-fiber stimulation.[15] The flaccid paralysis progresses symmetrically downward, usually starting with the eyes and face, then moving to the throat, chest, and extremities.[16] When the diaphragm and chest muscles become fully involved, respiration is inhibited and, unless the patient is ventilated, death from asphyxia results.[17]

Classic symptoms of botulism include nausea, vomiting, fatigue, dizziness, double vision, drooping eyelids, slurred speech, difficulty swallowing, dryness of skin, mouth, and throat, lack of fever, muscle weakness, and paralysis.[18]  Infants with botulism appear lethargic, feed poorly, are constipated, and have a weak cry and poor muscle tone.[19] Throughout all such symptoms, the victims are fully alert and the results of sensory examination are normal.[20]

In foodborne botulism cases, symptoms usually begin anywhere between 12 and 72 hours after the ingestion of toxin-containing food.[21]  Longer incubation periods—up to 10 days—are not unknown, however.  The duration of the illness is from 1 to 10 (or more) days, depending on host-resistance, the amount of toxin ingested, and other factors.[22]  Full recovery often takes from weeks to months.[23] And, as earlier indicated, mortality rate can be from 30% to 65%, with rates generally lower in European countries than in the United States.[24]

Detection and Treatment of Botulism

Although botulism can be diagnosed based on clinical symptoms, its differentiation from other diseases is often difficult—especially in the absence of other known persons affected by the condition.[25] Once suspected, the most direct and effective way to confirm the diagnosis of botulism in the laboratory is testing for the presence of the botulinum toxin in the serum, stool, or gastric secretions of the patient.[26]  The food consumed by the patient can also be tested for the presence of toxins.[27]  Currently, the most sensitive and widely used method for the detection of the toxins is the mouse neutralization test, which involves injecting serum into mice and looking for signs of botulism.[28]  This test typically takes 48 hours, while the direct culturing of specimens takes 5-7 days.[29] Some cases of botulism may go undiagnosed because symptoms are transient or mild, or are misdiagnosed as Guillain-Barre Syndrome.[30]

If diagnosed early, foodborne botulism can be treated with an antitoxin that blocks the action of toxin circulating in the blood.[31] This can prevent patients from worsening, but recovery still takes many weeks.[32] The mainstay of therapy is supportive treatment in intensive care, and mechanical ventilation in case of respiratory failure, which is common.[33]

Long-Term and Permanent Injury

Although a minority of botulism patients eventually recover their pre-infection health, the majority do not. For those who fully recover, the greatest improvement in muscle strength occurs in the first three months after the acute phase of illness.[34]  The outside limit for such improvement appears, however, to be one year.[35]  Consequently, physical limitations that still exist beyond the one-year mark are more probably than not permanent.  Recovery from acute botulism symptoms may also be followed by persistent psychological dysfunction that may require intervention.[36]

According to a recently-published study that tracked the long-term outcomes of 217 cases of botulism, a large majority of patients reported “significant health, functional, and psychosocial limitations that are likely the consequences of the illness.”[37]  These limitations included: fatigue, weakness, dizziness, dry mouth, and difficulty lifting things.  The victims also reported difficulty breathing caused by moderate exertions, such as walking or lifting heavy items.  They were also more likely to have limitations in vigorous activities, like running or playing sports, climbing up three flights of stairs, or carrying groceries. Summarizing its finding, the study concluded that:

Even several years after acute illness, patients who had botulism were more likely than control subjects to experience fatigue, generalized weakness, dizziness, dry mouth, difficulty lifting things, and difficulty breathing caused by moderate exertion….In addition, patients…reported worse overall psycho-social status than did control subjects, with patients being significantly less likely to report feeling happy, calm and peaceful, or full of pep.[38]

There is, as a result, no question that the damaging effects of botulism are life-long.

SOME BACKGROUND INFORMATION ON CANNING[39]

The canning process dates back to the late 18th century in France when the Emperor Napoleon Bonaparte, concerned about keeping his armies fed, offered a cash prize to whoever could develop a reliable method of food preservation. Nicholas Appert conceived the idea of preserving food in bottles, like wine. After fifteen years of experimentation, he realized if food is sufficiently heated and sealed in an airtight container, it will not spoil. More than fifty years later, Louis Pasteur provided the explanation for effectiveness of canning when he was able to demonstrate that the growth of microorganisms is the cause of food spoilage.[40]

An Englishman, Peter Durand, took the idea one step further and replaced the breakable glass bottles with cylindrical tinplate canisters (later shortened to “cans”). Durand did not can foods himself, but sold his patent to two other Englishmen, Bryan Donkin and John Hall, who set up a commercial canning factory.  By 1813, Donkin and Hall were busily producing their first canned goods for the British army, thus continuing the connection of canning to the military.

The basic principles of canning have not changed dramatically since Nicholas Appert and Peter Durand developed the process. Heat sufficient to destroy microorganisms is applied to foods packed into sealed, or “airtight” containers.  The canned foods are then heated under steam pressure at temperatures of 240-250°F (116-121°C). The amount of time needed for processing is different for each food, depending on the food’s acidity, density and ability to transfer heat.

Processing conditions are chosen and designed to be the minimum needed to ensure that the foods are made “commercially sterile,” while still retaining the greatest flavor and nutrition.[41] All canning-processes must first be approved by the U.S. Food and Drug Administration.[42] Once the cans are sealed and heat processed, the resulting canned food must maintain its high eating quality for more than two years and be safe to eat as long as the can is not damaged in any way.  Historically, commercially-canned food has a near-perfect track record, having caused only four outbreaks in over forty years.[43] The last outbreak occurred in 1974 and involved beef stew.[44]


[1]           See J. Sobel, et al., Foodborne Botulism in the United States, 1990-2000, Emerging Infectious Diseases, Vol. 10, No. 9, at 1606 (Sept. 2004).

[2]           James M. Jay, MODERN FOOD MICROBIOLOGY, 466 (6th Ed. 2000)

[3]           Id. at 469-71; see also Sobel, supra note 2, at 1606.

[4]           Sobel, supra note 2, at 1606.

[5]           Id.

[6]           Jay, supra note 3, at 467-69.  See also, generally H. Houschild, Clostridium Botulinum, in FOODBORNE BACTERIAL PATHOGENS, at 112-89  (M. Doyle Ed. 1989)

[7]           Jay, supra note 3, at 467-69.

[8]           Sobel, supra note 2, at 1607-09; Jay, supra note 3, at 472-76.

[9]           Sobel, supra note 2, at 1606-07 (also noting that the CDC maintains a 24-hour clinical consultation and emergency antitoxin release service).

[10]          Jay, supra note 3, at 474.

[11]          With botulism, the broader term “event” is used to encompass both outbreaks—i.e., two or more cases of botulism caused by a common-source, as well as individual (or sporadic) cases.

[12]          Sobel, supra note 2, at 1610; Jay, supra note 3, at 474.

[13]          Id.

[14]          Thomas P. Bleck, Clostridium botulinum (Botulism), in MANDELL, DOUGLAS AND BENNETT’S PRINCIPLES AND PRACTICE OF INFECTIOUS DISEASE 2543, 2544 (5th ed. 2000).

[15]          Id.; Sobel, supra note 2, at 1606.

[16]          Bleck, supra note 15, at 2545; see also BOTULISM FACT SHEET, National Agricultural Bio-Security Center, Kansas State University, online at http://nabc.ksu.edu/content/factsheets/category/Botulism#f26

[17]          Bleck, supra note 15, at 2545; Sobel, supra note 2, at 1606.

[18]          Sobel, supra note 2, at 1606; Jay, supra note 3, at 474.

[19]          Jay, supra note 3, at 476-77.

[20]          Sobel, supra note 2, at 1606.

[21]          Jay, supra note 3, at 474.

[22]          Id.

[23]          R. Shapiro, et al., Botulism in the United States: A Clinical and Epidemiologic Review, Ann. Intern. Med. 1998; 129:221-28.

[24]          Jay, supra note 3, at 474.

[25]          Bleck, supra note 15, at 2546 (noting that “botulism has a limited differential diagnosis”).

[26]          Sobel, supra note 2, at 1607; see also FDA/CFSAN Bad Bug Book, Clostridium Botulinum, available at http://vm.cfsan.fda.gov/~mow/chap2.html

[27]          Id.

[28]          Bleck, supra note 15, at 2546.  See also, e.g. MMWWR, supra note 1, at 2 (“CDC detected botulinum toxin Type A by mouse bioassay in the man’s serum sample”).

[29]          Bad Bug Book, supra note at 25.

[30]          Sobel, supra note 2, at 1606; Shapiro, supra note 23, at 223.

[31]          Jay, supra note 3, at 474; Sobel, supra note 2, at 1606.

[32]          Id.; Bleck, supra note 15, at 2546-67.

[33]          Sobel, supra note 2, at 1606.

[34]          Bleck, supra note 15, at 2547. See also P. Wilcox, et al., Recovery of Ventilatory and Upper Airway Muscles and Exercise Performance After Type-A Botulism, Chest, 98:620-26 (1990); J. Mann, et al., Patient Recovery From Type-A Botulism: Morbidity Assessment Following a Large Outbreak, Am. J. Public Health, 71 (3):266-69 (Mar. 1981).

[35]          Id.

[36]          Bleck, supra note 15, at 2547. See also F. Cohen, et al., Physical and Psychosocial Health Status 3 Years After Catastrophic Illness—Botulism, Issues Mental Health Nurs., 9:387098 (1988)

[37]          S. Gottlieb, et al., Long-Term Outcomes of 217 Botulism Cases in the Republic of Georgia, Clin. Infectious Disease, 45: 174-80, at 180 (220&).

[38]          Id. at 179.

[39]          The following introductory material is based on information from the Wikipedia entry on canning, online at http://en.wikipedia.org/wiki/Canning, and the sources there cited. See also Jay, supra note 2, a 4-5 (describing the events that lead to the discovery of canning).

[40]          Tony Baird-Packer, The Production of Microbiologically Safe and Stable Foods, in Volume 1 of THE MICROBIOLOGICAL SAFETY AND QUALITY OF FOOD, 4 (B. Lund, et al. Eds. 2000) (also noting that the manufacture of canned foods is “now more than a 300 billion dollar business worldwide”).

[41]          The term “commercial sterility” is used to describe the process endpoint of canned foods. Id. at 36.

[42]          See Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers, 21 CFR Part 113 and Acidified Foods, 21 CFR Part 114 (describing “requirements” for manufacturing, processing and packing foods “to prevent” an environment conducive to the growth of Clostridium botulinum).

[43]          Sobel, supra note 2, at 1609-10.

[44]          See, e.g. MMWWR, supra note 1, at 3 (citing P. Blake, et al., Type A Botulism from Commercially-Canned Beef Stew, South. Med. J. 1977; 70:5-7).

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Frozen Wegetables Recalled Over Listeria

Inventure Foods, Inc. has issued a voluntary recall of certain varieties of its Fresh Frozen™ line of frozen vegetables as well as select varieties of its Jamba “At Home” line of smoothie kits due to finding of Listeria monocytogenes, in its Jefferson, GA facility. Listeria is an organism that can cause infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, listeria infection can cause miscarriages and stillbirths among pregnant women.

These recalled products did not test positive for Listeria monocytogenes, and there are no known illnesses linked to consumption of Fresh Frozen IQF frozen vegetables or Jamba “At Home” smoothies to date. However, Inventure Foods has decided to err on the side of utmost caution and issue a voluntary recall because Listeria monocytogenes was detected in the facility during routine testing.

The Fresh Frozen products being recalled are distributed to retail outlets, including food service accounts, mass merchandise stores and supermarkets in Alabama, Arizona, Arkansas, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Michigan, Mississippi, Nebraska, North Carolina, Ohio, Oklahoma, South Carolina, Tennessee, Texas, Virginia, West Virginia and Wisconsin.

The Jamba “At Home” smoothies’ products being recalled are distributed to retail outlets, including mass merchandise stores and supermarkets east of the Mississippi River. Only specific Jamba “At Home” branded products are involved in this recall. No other Jamba® branded products are affected.

Blue Bell Ice Cream Listeria Outbreak – Illnesses Began in 2010

Illnesses to Date:  As of April 21, 2015, a total of ten patients infected with several strains of Listeria monocytogenes were reported from four states: Arizona (1), Kansas (5), Oklahoma (1), and Texas (3). Since the last update on April 8, 2015, two additional patients, one each from Arizona and Oklahoma, were confirmed to be a part of the outbreak by whole genome sequencing.

map-04-21-2015-full

More ilnesses likely to be linked:  All ten (100%) patients were hospitalized. Three deaths were reported from Kansas.  One additional isolate from a patient with listeriosis is undergoing further molecular laboratory testing to determine whether this illness may be related to this outbreak. Results of this testing will be reported once they are available. CDC and state and local public health partners are continuing laboratory surveillance through PulseNet to identify any other ill persons that may be part of this outbreak.

epi-04-21-2015-full

Illnesses began in 2010:  Illness onset dates ranged from January 2010 through January 2015. The patients with illness onsets ranging from 2010-2014 were identified through a retrospective review of the PulseNet database for DNA fingerprints that were similar to isolates collected from Blue Bell ice cream samples.

Outbreak and recall prompted by product test:  In an unrelated investigation, the South Carolina Department of Health and Environmental Control isolated Listeria monocytogenes from the following Blue Bell brand single-serving ice cream products collected from a distribution center in 2015: Chocolate Chip Country Cookie Sandwiches and Great Divide Bars.  In response to the findings in South Carolina, the Texas Department of State Health Services collected product samples from the Blue Bell Creameries production facility in Brenham, Texas. These samples yielded Listeria monocytogenes from the same two products tested by South Carolina and also from the ice cream Scoops, which is made on the same production line. Listeria monocytogenes was not found in other Blue Bell brand ice cream products tested.

All Blue Bell product recalled:  On April 20, 2015, Blue Bell Creameries voluntarily recalled all of its products currently on the market made at all of its facilities, including ice cream, frozen yogurt, sherbet, and frozen snacks, because they have the potential to be contaminated with Listeria monocytogenes. Blue Bell announced this recall after sampling by the company revealed that Chocolate Chip Cookie Dough Ice Cream half gallons produced on March 17, 2015 and March 27, 2015 contained the bacteria. Listeria monocytogenes was previously found in other Blue Bell products. CDC recommends that consumers do not eat any Blue Bell brand products, and that institutions and retailers do not serve or sell them.

Listeria: Marler Clark, The Food Safety Law Firm, is the nation’s leading law firm representing victims of Listeria outbreaks. The Listeria lawyers of Marler Clark have represented thousands of victims of Listeria and other foodborne illness outbreaks and have recovered over $600 million for clients. Marler Clark is the only law firm in the nation with a practice focused exclusively on foodborne illness litigation. Our Listeria lawyers have litigated Listeria cases stemming from outbreaks traced to a variety of foods, such as caramel apples, cantaloupe, cheese, celery and milk.

Bill Marler: A Week Talking To The Media About Listeria And Ice Cream

Neither agencies nor Blue Bell tested products for Listeria

The Blue Bell recall underscores how Listeria outbreaks can occur without being traced to a specific product, said Bill Marler, a Seattle food-safety lawyer. Blue Bell’s Listeria strains have been matched to 10 illnesses in four states, dating to 2010.

The Centers for Disease Control and Prevention said the Listeria strains found in Blue Bell products were matched to human illnesses using a national computer database, called PulseNet. About 800 listeriosis cases are added to the list annually.

“It shows that the outbreak was going on with no knowledge by Blue Bell, no knowledge by the CDC and no knowledge by health departments,” Marler said. “And the people who had gotten sick had no knowledge that it was the Blue Bell ice cream that made them sick.”

Blue Bell outbreak dates to 2010

“It has evolved with human refrigeration,” said Seattle attorney Bill Marler. “In a sense, we’ve created this monster by our desire to have mass-produced food in cool, wet environments.”

Marler, who built a career on major verdicts for food-borne illness victims, and who may take on clients in this outbreak, said he thinks Blue Bell runs pretty clean plants. But listeria can lurk in crevices of equipment even with aggressive cleaning.

“That doesn’t mean Blue Bell gets a pass legally or morally on this,” he said. “But listeria is a hard thing.”

For Blue Bell, a Drastic Move to Recall Ice Cream as Listeria Findings Rose

Bill Marler, a personal injury lawyer and food safety advocate who is now working with Snoqualmie to make changes at its factory, said that the company had since overhauled its production processes, installing new flooring and sanitizing equipment, and adopting third-party sample testing for all batches of ice cream before they are shipped.Outside experts brought in to track down the source of the listeria infection discovered traces of the bacteria on pallets used by a supplier to deliver milk to the plant, Mr. Marler said. Snoqualmie now keeps pallets out of the production room, and it has also strengthened rules on cleaning uniforms, boots and strip curtains in production zones. Snoqualmie was cleared to start shipping ice cream again after 60 days.Mr. Marler stressed that Snoqualmie had immediately decided to recall all its products even though only a certain line of small-tub ice creams had been linked to the listeria case.“Limiting the recall might seem like a good idea,” he said. “But then if you keep expanding your recall, it’s a death by a thousand cuts. You look like you’re dragging your feet.”

Blue Bell Recalls Entire Line; CEO Vows To ‘Get It Right’

“Once the bacteria gets into a plant, it can grow very rapidly and is really difficult to eradicate,” Bill Marler, a Seattle lawyer who specializes in food-safety cases, tells them.

More listeria illnesses linked to Blue Bell products after recall

More Blue Bell-related listeria cases are likely on the horizon, according to Seattle-based foodborne-illness attorney Bill Marler.

Marler said he has been contacted by “dozens” of people who have been ill with gastrointestinal symptoms and have eaten Blue Bell products — “but there is no way to link them legally. The only sure test is a blood test (or spinal fluid), and you need to be very sick for that usually.” He said he has also heard from several who have listeria infections “but have not yet been linked to Blue Bell genetically,” and that “there are a number of background listeria cases that may or may not be linked.”

“Listeria is an environmental pathogen that loves a cool, wet environment and grows very well at refrigerator temperatures,” Marler said. “That is why it’s such a problem in manufacturing facilities like meat, cheese, cantaloupe and now ice cream. Once it gets into a plant, it is very hard to get rid of.”

“What we know is that the problem has been going on in these [Blue Bell] plants for some time,” he said. “But for South Carolina doing an apparently random test on product in February, no one would have known about this at all.”

CDC expands Blue Bell-related illnesses to 10 people in four states

Food safety attorney Bill Marler said he was “not particularly surprised” by the announcement.

Once tests show Listeria is in a finished product it is likely it is in the manufacturing facility, which is tough to combat, he said.

“Now that it’s expanded, it shows that Listeria is endemic in their plants,” he said.

“What is sad about the Blue Bell situation, had it had more thorough testing of product and more thorough cleaning of its plant and equipment beforehand, an outbreak could have been avoided. The devastation to Blue Bell’s customers and its reputation could have been avoided,” he said.

Marler said other companies have launched broad recalls, including Peter Pan peanut butter, which had years’ worth of products recalled.

“It’s a big hit, but there are a lot of companies that have taken a big hit and come back,” Marler said.

Blue Bell recall shows difficulty of controlling Listeria

“Once the bacteria gets into a plant, it can grow very rapidly and is really difficult to eradicate,” said Bill Marler, a Seattle lawyer who specializes in food-safety cases.

Blue Bell can capitalize on loyalty, industry woes

Frozen desserts have never been a usual suspect for listeria outbreaks, a fact that baffles Seattle attorney Bill Marler, who is helping Snoqualmie through its crisis and who routinely sues food manufacturers. He won a major verdict for one of the Jack in the Box victims.

Listeria thrives in cold, damp places. Ice cream companies and regulators could have been testing for listeria all along, Marler said. He predicts more illnesses and more ice creams linked to listeria before industry catches on – just as costs, tests and safety in ground beef ramped up in the 1990s and early 2000s after E. coli poisonings.

“In six months, instead of having no testing … on ice cream, everybody except tiny companies are going to be testing and swabbing in their facilities looking for listeria,” Marler said. “You won’t see as many recalls, and you won’t see as many illnesses, and that’s exactly what happened with hamburger.”

Marler Clark, The Food Safety Law Firm, is the nation’s leading law firm representing victims of Listeria outbreaks. The Listeria lawyers of Marler Clark have represented thousands of victims of Listeria and other foodborne illness outbreaks and have recovered over $600 million for clients. Marler Clark is the only law firm in the nation with a practice focused exclusively on foodborne illness litigation. Our Listeria lawyers have litigated Listeria cases stemming from outbreaks traced to a variety of foods, such as caramel apples, cantaloupe, cheese, celery and milk.