A Deadly Hospital-Acquired Infection Becomes a Products Liability Claim
In today's news is a tragic story about the parents of a two-year old boy whose death from a nosocomial (hospital-acquired) infection they blame on alcohol wipes contaminated with Bacillus cereus. According to the complaint filed February 13th in federal court here in Houston the Kothari's son developed bacterial meningitis following an otherwise uneventful craniotomy performed at Children's Memorial Hermann Hospital for a benign arachnoid cyst. During the course of his treatment alcohol pads and swabs were used on his surgical wounds and within days he developed a B. cereus infection (established by positive cultures from cerebrospinal fluid) and died shortly thereafter. The next month Triad, alleged to have been the manufacturer of the alcohol pads and swabs, recalled the products saying they were potentially contaminated with B. cereus. Two days later the FDA announced a recall of all such Triad pads and swabs saying that their use "could lead to life-threatening infections, especially in at risk populations, including immune suppressed and surgical patients."
It's estimated that in the U.S. two million patients are sickened and 80,000 are killed annually by nosocomial infections. Accordingly, it's a very big problem and so has the potential to be a very big mass tort.
Yet a big part of the problem, and the biggest impediment in the past to tort claims arising from these illnesses, are the twin issues of tracing the infection to a putative source and then establishing that the bacteria cultured from the victim are the descendants of bacteria found in the defendant's products or at its manufacturing facilities. Since most bacteria responsible for nosocomial infections, including B. cereus, are ubiquitous in the environment and were, until recently, impossible to distinguish phylogenetically, establishing causation has been essentially impossible. Now, thanks to epidemiology returning to its humble origins and genetic sequencing taking giant strides forward, it may be possible to trace an infection to its origin and conclusively establish ancestry.
Unfortunately the Kothari complaint does not reveal whether or not anything beyond a post hoc ergo propter hoc inference supports their claim. One allegation is that B. cereus infections are rare in hospitals and yet the first thing that pops up on PubMed is "Bacillus cereus Bacteremia Outbreak Due to Contaminated Hospital Linens". And as to the proposition that B. cereus infection is somehow unusual and thus more likely due to something gone astray see "Bacillus cereus, a Volatile Human Pathogen". Finally, as to the claim that B. cereus meningitis in children is exceedingly rare see (ungated) "Bacillus cereus Bacteremia and Meningitis in Immunocompromised Children".
Did the hospital have a record of B. cereus infections? Were catheters employed that B. cereus could have used as an escalator to infection? Was the strain identified identical to the one that prompted the recall? Were there other sources of that strain? If so, how is one deemed more likely the cause than the other?
Efforts to identify strains of disease-causing bacteria and to trace them back to their origin have put us on the verge of being able to identify and hopefully thereupon eradicate the causes of an enormous portion of human suffering. But we're not quite there yet as demonstrated by tonight's report of the National Academy of Sciences on the 2001 anthrax attacks. B. cereus is a cousin of B. anthracis - the causative agent of anthrax. B. anthracis was long thought to be less promiscuous than its cousins and so less likely to vary widely thus making its origin easier to identify. But it ain't so. See Chapter 5.2 "Identification of the B. anthracis Strain". The very same difficulties will likely hamper any attempt to match strains of B. cereus.
Establishing a common strain of bacteria and tracing it back to a particular defendant remains a very high hurdle for any plaintiff to clear. But when the day comes that both are readily doable "Katy bar the door" because the number of deaths from cancer, heart disease, diabetes, etc being laid at the feet of infectious agents is staggering and rising every day. Worst of all, thanks to the ability of these ancient predators to evolve at a fantastic rate. there's little anyone can do to predict where and from which formerly benign little bug the next onslaught is likely to arise.
