This Essay explores the potential role of the tort system to plug the regulatory gap created by the reluctance of the Food and Drug Administration (FDA) to reduce the use of antibiotics in animal food production despite increasing evidence that this practice increases the risk of human infections that cannot be treated by available antibiotics. This regulatory gap could be addressed if plaintiffs were able to establish that antibiotic use is a product defect, but this will be difficult because of the requirements of proof in a tort action including establishing that a defendant was the cause of the plaintiff's antibiotic-resistant infection. Despite these hurdles, a plaintiff could potentially succeed, which may be the only way to deter the risk to the public caused by the use of antibiotics in animal food production until FDA acts to protect the public.
I INTRODUCTION 558 II THE PUBLIC HEALTH RISK 558 III. REGULATION VERSUS TORT LAW AS A RESPONSE 562 IV. THE RELUCTANT REGULATOR 566 V. PRODUCTS LIABILITY LITIGATION AS AN ALTERNATIVE 571 A. Legal Standards of Liability 572 1. Manufacturing Defect 572 2. Design Defect 573 a. Consumer Expectation Test 574 b. Risk-Utility Test 576 c. Hybrid Test 578 B. Causation 579 VT. CONCLUSION 580 I. INTRODUCTION
The development and proliferation of antibiotic-resistant bacteria has increased the risk that humans will develop infections that are resistant to treatment by antibiotics. The Food and Drug Administration (FDA) has been aware of this public health risk for decades, but its only effort to regulate came in June 2015, (1) which only partially addressed the risk. Since there are good reasons to believe that FDA's regulatory effort will fall short of protecting the public, this Essay explores the potential of the civil justice system to fill this gap in public health protection.
The outburst of health, safety, and environmental legislation in the 1960s and 1970s was, in significant part, a response to the failure of state law to adequately protect people and the environment. (2) The need for federal regulation arose in part because the civil justice system is constrained by a number of aspects of tort law that limit its effectiveness in protecting the public. These same limitations are likely to constrain tort law in deterring the overuse of antibiotics in animal-food production, but these hurdles are not insurmountable. This Essay examines the potential success of a product liability lawsuit by someone who becomes ill after eating pork or poultry contaminated with antibiotic-resistant bacteria.
More broadly, this Essay explores the roles of regulation and tort law in protecting the public from antibiotic-resistant bacterial infections in four steps. Part II describes the risk to the public of the use of antibiotics in animal production. Part III considers the reasons why, as a general matter, it is preferable to use regulation to address public health risks. The tort system, however, can be an important backup to regulation when, as here, it appears that regulators have failed to adequately address a public health risk. Part IV describes and evaluates FDA's response to the development and proliferation of antibiotic-resistant bacteria. This Part also explains why FDA's efforts are likely to be insufficient to protect the public. Finally, Part V evaluates whether this gap in protection can be reduced using product liability law. The conclusion is that successful litigation will be hampered by the same limitations that make tort law a less successful way to respond to public health risks than regulation. Nevertheless, it is possible that a tort plaintiff could succeed in a products liability action.
THE PUBLIC HEALTH RISK
The use of antibiotics in animal production has led to a significant increase in antibiotic-resistant bacteria. (3) Although the magnitude of this problem is unknown, the most recent statistics reveal that antibiotic use in food production accounts for about 73% of all medically significant antibiotics sold in the United States. (4)
Antibiotics are used in agriculture because most of America's pigs and chickens are raised in artificial and extremely confined conditions known as confined animal feeding operations (CAFOs). (5) A CAFO typically keeps animals confined for a period of over forty-five days and brings feed to the animals, rather than permitting the animals to graze or forage for food. (6) A CAFO is designed to fit as many animals as possible in extremely cramped conditions and to fatten the animals to market weight as quickly as possible. Because the practices of industrial animal agriculture are largely non-transparent, no one knows precisely how many animals are confined in CAFOs, although it is estimated that 99% of all farmed animals are raised this way. (7) CAFOs are subject to disease outbreaks because of the unsanitary concentrated conditions in which the animals are raised. (8)
The solution industry has used is to administer low-level (subtherapeutic) doses of antibiotics in the animals' food or water for long periods of time prophylactically to prevent infections. (9) FDA estimates that 80% of the antibiotics used in the United States are fed to farmed animals. (10) Moreover, this practice is growing. According to FDA, antibiotic use in food-producing animals increased 26% between 2009 and 2015. (11)
The prophylactic administration of low doses of antibiotics fosters the development of drug-resistant bacteria in animals. (12) Since the antibiotics kill off the most susceptible bacteria, it allows drug-resistant bacteria to replicate in an animal's gut. In turn, the public can become exposed to the drug-resistant bacteria by direct contact with the animal's waste or by contact with meat or poultry contaminated with the waste. (13)
Workers in CAFOs, for example, can become colonized with drug-resistant bacteria. Those workers may then spread the bacteria into their homes and their communities after they leave their workplaces. (14) Since the trucks that carry live broiler chickens to slaughterhouses are highly contaminated with antibiotic-resistant bacteria from chicken litter, people traveling on the same roads can be exposed to the bacteria through the air for a period of time after the truck passes by. (15) Drug-resistant bacteria can also travel through the air, moving from a CAFO to nearby communities, motor vehicles, and individuals. (16) Even flies that come into contact with the bacteria from hog and chicken waste can subsequently expose people to this risk. (17)
Contact between humans and foods containing drug-resistant bacteria is another route of exposure. This can occur when people eat meat or vegetables contaminated with antibiotic-resistant bacteria. (18) Slaughterhouses process animals at such high speeds that feces from the animals, which contain the drug-resistant bacteria, can contaminate the meat products. (19) The drug-resistant bacteria are transferred to vegetables by the direct application of manure as fertilizer on vegetable crops or from run-off water that has been contaminated by animal waste that is subsequently used to water vegetable crops. (20)
Drug-resistant bacteria are estimated to kill at least 23,000 people and sicken a total of 2,000,000 people each year in the United States, (21) which results in $20 billion dollars in health costs. (22) The Centers for Disease Control and Prevention (CDC) estimates that germs from food and animals cause one in five drug-resistant infections in humans. (23)
Scientists first warned about the threat posed by antibiotic use in animal production around 1970. In 1969, a committee of the National Academy of Sciences recommended the minimal use of antibiotics in food animals for growth promotion and the discontinuation of antibiotic use for disease prevention. (24) A 1970 FDA task force warned subtherapeutic use of antibiotics could become "a reservoir of antibiotic resistant pathogens" that "can produce human infections." (25) A 1977 FDA advisory committee recommended that FDA "immediately withdraw approval for the subtherapeutic uses of penicillin, i.e., growth promotion/feed efficiency, and disease control." (26) The advisory committee also recommended that FDA propose to withdraw regulatory approval for most subtherapeutic uses of oxytetracycline and chlortetracycline in animal feed and all subtherapeutic uses of penicillin in animal feed. (27)
The warnings have continued to the present day. In 2015, the American Academy of Pediatrics warned that "the overuse and misuse of antimicrobial agents in veterinary and human medicine is, in large part, responsible for the emergence of antibiotic resistance," and that children under five years old are the most susceptible to food-borne pathogen infections. (28) The physicians called for ending the use of subtherapeutic use of antibiotics in food production. (29) In 2016, a coalition of medical and scientific groups called for "principles for appropriate livestock and poultry antibiotic use." (30)
Outside of the United States, in 1969, the Swann Report in the United Kingdom recognized a potential link between the use of antibiotics in agriculture and the drug-resistant infections, (31) and the World Health Organization recommended against using antibiotics used by humans for growth promotion in 1973. (32) In 1999, the European Union banned the use of antibiotics for growth promotion. (33)
REGULATION VERSUS TORT LAW AS A RESPONSE
The government has two ways in which it can reduce the public health risk created by antibiotic use in CAFOs. As the introduction points out, the government has relied primarily on standard setting since the 1970s to address safety and health risks. Nevertheless, tort law can deter behavior that is dangerous to the public in addition to its role of compensating individuals for harms done to them. (34)
Regulatory standard setting has a number of advantages over the civil justice system...