Technological Advancements and Traces of Infectious Disease

What's behind this new understanding of the impact of viruses, bacteria and fungi on health and disease? It started with the ability to detect them. When you don't know a thing exists, it's pretty hard to assign blame to it. If you had collected a sample from a stomach ulcer and nothing grew in your Petri dish, the natural assumption was that nothing was there to be grown. And if you relied on your reason to fill in the rest of the explanation, something like, “it makes sense because bacteria surely could not survive the hydrochloric acid found in the stomach,” you would have overlooked the leading cause of gastric cancer, gastritis and peptic ulcer disease. But if you were one of the scientists who kept looking and who found Helicobacter pylori, you would have won the 2005 Nobel Prize in medicine and saved a lot of lives.

Science had been blinded by its own success. By the late 1960s, most public health officials had come to believe that thanks to antibiotics, the age of infectious disease was fast receding behind us. That mindset, and the unexpected stealth capabilities of bacteria, kept their secrets hidden for years. Now that the search is on in earnest, and thanks to technological developments that allow quick and cheap sequencing of tiny amounts of genetic material that can then be compared to vast libraries of genetic code from tens of thousands of strains of microorganisms, the genetic fingerprints of microscopic perpetrators are being found at the scenes of harms that nobody ever suspected of having been caused by infectious agents.

Tracing the Biological Culprits

By tracing these genetic fingerprints, investigators can follow, say, norovirus' path from sample to bed- rail to wheelchair to elevator button to a patient on another floor. They can trace food-borne illness from contaminated food to factory to a microscopic crevice on the surface of a stainless steel mixer to the biofilm anchored to it which harbors seemingly harmless microorganism but which are in fact themselves inhabited by Listeria monocytogenes. Other examples include tracing an infection from patient to hospital to operating room to a reusable medical device to a component of the device that couldn't effectively be cleaned; and, tracing Legionnaire's disease from a handful of patients to an apartment complex to a swimming pool to a biofilm on a dirty drain cover that served as a reservoir of Legionella pneumophilia.

Do you see where this is going? You not only figure out where the pathogen came from, you identify everyone and everything that facilitated the spread of the pathogen. There's potential liability each step of the way, and some of the liability questions posed aren' t easy to answer.

What to Expect

Certain metals, like copper, are natural-born microbe killers. Should copper-clad examining tables become a thing? There's a new UV sterilizing system that costs 10 times as much as the one your client is using, and it promises to destroy 50% more microbes on your sterile wipes packaging line ' what's a reasonable manufacturer to do? If a useful diagnostic medical device that costs $5,000 is notoriously hard to completely sterilize, who should bear the loss when a patient is infected as a result of the device's re-use?

Those examples are just a peek at what's to come. With some manufacturers now racing to create microbial pesticides and herbicides to satisfy demand for “organic” or “green” farming aids and others introducing designer microbes into our food supply, aimed at altering or augmenting the trillions of microorganisms that live in and on us (and which, among other amazing capabilities, tune our immune systems), the ability to quickly trace a rogue bacteria back to its source means there will be no place to hide for its manufacturer.

In the Courts

Courts will have some interesting questions to answer. One goes to duty. For example, perhaps you didn't know that the drain in the swimming pool at your apartment complex harbored a strain of Legionella (the one that causes Legionnaires' disease) that somehow managed to survive the hostile environment, but did you have a duty to look?

Another question goes to foreseeability. Assuming the process has not changed, if you've been making ice cream for decades without incident and suddenly have an outbreak, is the first bite, like the legendary dog's, free? If not, what are the consequences of effectively declaring that all infections are foreseeable, irrespective of past experience, when we live in a world in which we are vastly outnumbered by rapidly mutating microbes that we're only just beginning to perceive, much less understand?

Speaking of mutations, what happens if your safe and useful product (e.g., billions of bacteria) enters the stream of commerce and later mutates into something harmful or picks up a plasmid from a passing bacteria that gives it the capability of becoming virulent? A statute of repose for designer bugs, perhaps? And how should the law handle warranty claims on a product that evolves on its own according to natural laws that we only vaguely comprehend?

Questions about causation won't be easy either. At first blush, things look otherwise ' either you have E. coli O157 or you don't. There's no need to resort to epidemiology and the attempts at statistical inference that bedevil toxic tort litigation. Alas, most cases won't be so clear-cut. An example: A plaintiff with severe asthma was born by caesarian section and so missed out on the coating of immune-system-priming bacteria that the mother would otherwise have given her child, which would have greatly reduced that child's chance of ever developing asthma. As an infant, the plaintiff had an unrelated infection, but was treated with an antibiotic that dramatically altered the beneficial bacteria living in her gut and lungs (part of her “microbiome”) and her body's ability to sort harmful from harmless dusts. As an adolescent, she picked up a viral respiratory tract infection while on a cruise ship that predisposes her to an allergic asthma attack. Years later pollen triggered a deadly attack. Who is responsible for her death?

Conclusion

So, here we are, in a time of great uncertainty. Never really defeated, harmful viruses, bacteria and fungi have continued to evolve since their imminent demise was announced decades ago. Some have become more virulent, some have developed immunity to the medicines in our arsenal, some have developed defenses to the harshest sanitizing methods and some have become more stealthy. They're responsible for a great deal of harm and the law is only just beginning to address the question of who ' besides the microbes ' should bear the blame.

David A. Oliver is a partner with Vorys Sater Seymour and Pease, in Houston. Natalia Steele is an associate with the firm. Oliver is the editor of the blog “Mass Torts: State of the Art.” Steele has experience in products and food liability, specifically in the regulatory side of food-borne illness issues. This article also appeared in Texas'Lawyer, an ALM sister publication of this newsletter.

Outbreaks of infectious disease make their way into the headlines from time to time, but always appear to be one-off sorts of things. The problem is soon solved and we're told go back to fretting about heart disease, cancer, stroke, obesity and the like. However, a number of recent discoveries are challenging the idea that infectious diseases are sporadic and relatively rare causes of illness and death. These discoveries are revolutionizing our understanding of the microbial world around us ' and presage significant changes in the legal landscape.

Background

Litigation involving outbreaks of such infectious diseases has been around a long time, but now, thanks to new technologies and a greater awareness, more cases are being discovered. Infections can now be traced to their sources and opportunities for preventing their spread are being identified. The resulting impact on litigation has been dramatic.

What's behind this new understanding of the impact of viruses, bacteria and fungi on health and disease? It started with the ability to detect them. When you don't know a thing exists, it's pretty hard to assign blame to it. If you had collected a sample from a stomach ulcer and nothing grew in your Petri dish, the natural assumption was that nothing was there to be grown. And if you relied on your reason to fill in the rest of the explanation, something like, “it makes sense because bacteria surely could not survive the hydrochloric acid found in the stomach,” you would have overlooked the leading cause of gastric cancer, gastritis and peptic ulcer disease. But if you were one of the scientists who kept looking and who found Helicobacter pylori, you would have won the 2005 Nobel Prize in medicine and saved a lot of lives.

Science had been blinded by its own success. By the late 1960s, most public health officials had come to believe that thanks to antibiotics, the age of infectious disease was fast receding behind us. That mindset, and the unexpected stealth capabilities of bacteria, kept their secrets hidden for years. Now that the search is on in earnest, and thanks to technological developments that allow quick and cheap sequencing of tiny amounts of genetic material that can then be compared to vast libraries of genetic code from tens of thousands of strains of microorganisms, the genetic fingerprints of microscopic perpetrators are being found at the scenes of harms that nobody ever suspected of having been caused by infectious agents.

Tracing the Biological Culprits

By tracing these genetic fingerprints, investigators can follow, say, norovirus' path from sample to bed- rail to wheelchair to elevator button to a patient on another floor. They can trace food-borne illness from contaminated food to factory to a microscopic crevice on the surface of a stainless steel mixer to the biofilm anchored to it which harbors seemingly harmless microorganism but which are in fact themselves inhabited by Listeria monocytogenes. Other examples include tracing an infection from patient to hospital to operating room to a reusable medical device to a component of the device that couldn't effectively be cleaned; and, tracing Legionnaire's disease from a handful of patients to an apartment complex to a swimming pool to a biofilm on a dirty drain cover that served as a reservoir of Legionella pneumophilia.

Do you see where this is going? You not only figure out where the pathogen came from, you identify everyone and everything that facilitated the spread of the pathogen. There's potential liability each step of the way, and some of the liability questions posed aren' t easy to answer.

What to Expect

Certain metals, like copper, are natural-born microbe killers. Should copper-clad examining tables become a thing? There's a new UV sterilizing system that costs 10 times as much as the one your client is using, and it promises to destroy 50% more microbes on your sterile wipes packaging line ' what's a reasonable manufacturer to do? If a useful diagnostic medical device that costs $5,000 is notoriously hard to completely sterilize, who should bear the loss when a patient is infected as a result of the device's re-use?

Those examples are just a peek at what's to come. With some manufacturers now racing to create microbial pesticides and herbicides to satisfy demand for “organic” or “green” farming aids and others introducing designer microbes into our food supply, aimed at altering or augmenting the trillions of microorganisms that live in and on us (and which, among other amazing capabilities, tune our immune systems), the ability to quickly trace a rogue bacteria back to its source means there will be no place to hide for its manufacturer.

In the Courts

Courts will have some interesting questions to answer. One goes to duty. For example, perhaps you didn't know that the drain in the swimming pool at your apartment complex harbored a strain of Legionella (the one that causes Legionnaires' disease) that somehow managed to survive the hostile environment, but did you have a duty to look?

Another question goes to foreseeability. Assuming the process has not changed, if you've been making ice cream for decades without incident and suddenly have an outbreak, is the first bite, like the legendary dog's, free? If not, what are the consequences of effectively declaring that all infections are foreseeable, irrespective of past experience, when we live in a world in which we are vastly outnumbered by rapidly mutating microbes that we're only just beginning to perceive, much less understand?

Speaking of mutations, what happens if your safe and useful product (e.g., billions of bacteria) enters the stream of commerce and later mutates into something harmful or picks up a plasmid from a passing bacteria that gives it the capability of becoming virulent? A statute of repose for designer bugs, perhaps? And how should the law handle warranty claims on a product that evolves on its own according to natural laws that we only vaguely comprehend?

Questions about causation won't be easy either. At first blush, things look otherwise ' either you have E. coli O157 or you don't. There's no need to resort to epidemiology and the attempts at statistical inference that bedevil toxic tort litigation. Alas, most cases won't be so clear-cut. An example: A plaintiff with severe asthma was born by caesarian section and so missed out on the coating of immune-system-priming bacteria that the mother would otherwise have given her child, which would have greatly reduced that child's chance of ever developing asthma. As an infant, the plaintiff had an unrelated infection, but was treated with an antibiotic that dramatically altered the beneficial bacteria living in her gut and lungs (part of her “microbiome”) and her body's ability to sort harmful from harmless dusts. As an adolescent, she picked up a viral respiratory tract infection while on a cruise ship that predisposes her to an allergic asthma attack. Years later pollen triggered a deadly attack. Who is responsible for her death?

Conclusion

So, here we are, in a time of great uncertainty. Never really defeated, harmful viruses, bacteria and fungi have continued to evolve since their imminent demise was announced decades ago. Some have become more virulent, some have developed immunity to the medicines in our arsenal, some have developed defenses to the harshest sanitizing methods and some have become more stealthy. They're responsible for a great deal of harm and the law is only just beginning to address the question of who ' besides the microbes ' should bear the blame.

David A. Oliver is a partner with Vorys Sater Seymour and Pease, in Houston. Natalia Steele is an associate with the firm. Oliver is the editor of the blog “Mass Torts: State of the Art.” Steele has experience in products and food liability, specifically in the regulatory side of food-borne illness issues. This article also appeared in Texas'Lawyer, an ALM sister publication of this newsletter.