hepatitisa.jpgSEATTLE–An outbreak of Hepatitis A in the Snoqualmie Valley has county health authorities asking people to get vaccinated.  Matias Valenzuela, public education coordinator with the county’s public health department, said his office has responded to six confirmed cases in the Valley, all in adults.  No word yet on the source of the outbreak. 

Hepatitis A

We hear about them so often these days–recalls of all kinds of products, from foods, to medications, to kids toys–that "recall" has become a working concept in everybody’s vocabulary.  But what is a recall?  Who has the legal obligation to announce them?  And what legal ramifications are there ot being involved in one?  

First, despite not having the legal authority to actually recall products, the FDA and USDA are frequently involved.  In fact, the USDA’s Food Safety and Inspection Service (the agency arm responsible for ensuring the safety of meat, poultry, and eggs) sets the standards for when, and what kind of, a recall is required.  

The FSIS defines three kinds of recall actions that can fairly be included under the same umbrella.  A "Class I recall" should occur in "a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death."  (Editor’s note: "should" is italicized because sometimes food product manufacturers do not issue class I recalls even when circumstances require it.)  Under this definition, a Class I recall should occur any time a food product is known or suspected to be contaminated with any foodborne pathogen, whether bacterial or viral.  The reason:  bacteria and viruses make people sick, and as a result, food contaminated by them will make people sick.

A "Class II recall" should occur in "a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote."  This is a little less clear than the definition of a Class I recall, but I certainly believe that the consequences of foodborne disease are simply too extreme for food companies to play fast and loose under these definitions.  A Class I recall should occur every time a food manufacturer knows, or has reason to know, that a product it has produced is or may be contaminated with a foodborne pathogen.  Every time.

Finally, a "market withdrawal"

occurs when a product has a minor violation that would not be subject to FDA legal action. The firm removes the product from the market or corrects the violation. For example, a product removed from the market due to tampering, without evidence of manufacturing or distribution problems, would be a market withdrawal.

A "market withdrawal" has no place in the world of food contamination.  Again, salmonella and e. coli and campylobacter and hepatitis and every other foodborne pathogen are simply too dangerous for companies to try to avoid their obligations by calling what should be a recall a "market withdrawal"–something done purely to avoid the media ramifications of saying that you’re product has been recalled.  This has been done before under circumstances where a Class I recall was surely warranted. Continue Reading Recall basics for food products

 The recent hepatitis A outbreak at a McDonalds in Milan, Illinois, has claimed at least 26 victims, and has caused the local health departments to innoculate 5,366 people, hopefully catching these folks in the modest window of time to prevent an infected person from becoming ill.  This raises a number of questions that we plan to find answers to.  

First, at what cost does this innoculation program come to the affected counties?  Not good timing, likely, considering the budgeting woes around the country.  Second, how many people are "out of the woods"–i.e., people who were infected at McDonalds, but who received their innoculations in time to prevent the onset of symptoms.  And finally, perhaps most importantly, what is the real human toll of this outbreak.  

As is the case with an illness caused by any bacteria or virus, colloquially called "food poisoning," many people pass off even hepatitis A as some diarrhea, some vomiting, maybe a little jaundice too, and the victim recovers.  True for some, but those would be the lucky ones . . . the exceptions to the rule.  More typically, hepatitis A causes weeks, if not months, of symptoms.  Ask anybody who has been unlucky enough to fall victim.  The fatigue is debilitating.  The illness (vomiting, nausea, etc.) is sometimes so extreme for so long that people miss enough work to lose their jobs.  And the jaundice that typically signifies that "youre on the mend" sometimes causes such embarrasment that victims won’t go out in public.  

But that’s just the "typical" hepatitis A illness.  We have represented many people who have had not-so-typical illnesses.  Here is a brief medical synopsis of how the virus can cause catastrophic liver failure (fulminant hepatitis), requiring liver transplantation for survival, or potentially causing death.

Fulminant hepatitis kills nearly 100 people each year in the United States. Among reported cases for all ages, the fatality rate is approximately 0.3%. This figure, however, increases with age. For sufferers of fulminant hepatitis over 40 years old, the fatality rate is approximately 2%.  Continue Reading Foodborne Hepatitis and Catastrophic Liver Failure