New Regulations for the Prevention of Legionnaires’ Disease: Implications for Product Manufacturers

Legionnaires’ disease, or legionellosis as it is known in medical circles, is a severe form of bacterial pneumonia first identified in 1976 following an outbreak among those attending an American Legion convention held at the historic Bellevue Stratford Hotel in Philadelphia. Research has since proven legionellae bacterium to be ubiquitous, occurring naturally in lakes and streams as well as potable water distribution systems. Studies have established that legionellae is present in virtually all municipal water supplies at some level. Given a proper food source, stagnant water flow and water temperatures averaging 98 degrees Fahrenheit, innocuous levels of the bacteria can quickly amplify to levels sufficient to cause infection. For inoculation to occur, water containing amplified levels of legionella must be aerosolized and ultimately breathed into the lungs of a susceptible host. Symptoms including high temperatures, shortness of breath, nausea and diarrhea develop within 2 to 14 days of exposure and can escalate rapidly. According to data published by the Centers for Disease Control and Prevention (CDC), the national infection rate for Legionnaire’s disease has risen by 286 percent between 2000 and 2014. Although considered a vastly underdiagnosed disease, the CDC estimates 18,000 hospitalizations per year from legionella infection. Even with competent medical care death rates among certain immunocompromised populations are high. See, CDC, MMWR, Vol. 65, No. 22, June 10, 2016.

The increasing trend in the number of diagnosed cases of Legionnaires’ disease is expected to continue. Newer and quicker diagnostic testing is identifying more cases. An aging “baby boom” population is increasing the number of susceptible hosts available to contract the infection. Deterioration of municipal water distribution infrastructure and growing water conservation practices are creating a more prolific environment for legionella bacteria amplification. Recent outbreaks in the South Bronx, New York claimed 12 lives and sickened 120 more. Outbreaks in Milwaukee, Wisconsin and Flint, Michigan have gained national attention and accelerated the clamor for new industry guidelines as well as state and municipal regulations.

In June 2015, the American Society of Heating, Refrigerating and Air-Conditioning Engineers (ASHRAE) issued its new standard, Legionellosis: Risk Management for Building Water Systems, more commonly referred to as Standard 188. It has been touted as consensus-based and “code ready,” adoptable by any regulatory body looking to put the force of law behind legionella management. ASHRAE Standard 188 is intended for use by the owners and managers of buildings that contain features associated with legionella amplification. It establishes a risk management protocol for building water systems, including a mandate that building owners establish a “water management program” and designate a specific “program team” to oversee it.

In August of 2015, The American Industrial Hygiene Association (AIHA) issued Recognition, Evaluation and Control of Legionella in Building Water Systems, setting forth technical guidance for competent professionals and technicians to follow when assessing legionella hazards using the fundamental principles of industrial hygiene.

In March of 2016, The Michigan Department of Health and Human Services (MDHHS) issued a draft “practical guide” to aid building managers in identifying areas within their buildings where legionella can be expected to amplify. This self-described “toolkit” was created by CDC, whose staff has assisted the MDHHS with its implementation. A final version of what is intended to be a national guidance document was issued by the CDC in June 2016.

ASHRAE’s Standard 188 remains a guideline only. No court has yet determined that ASHRAE Standard 188, or any other guidance document on the subject, is a definitive standard of care for the management and control of legionella. However, following outbreaks in both 2014 and 2015, New York issued new regulations mandating registration, periodic maintenance and periodic testing of cooling towers, a recognized source of legionella bacteria. Other local jurisdictions are contemplating similar regulations. To date, there have been no scientific studies conducted to determine the effect that compliance with any of these guidelines and regulations will have on the incidence of Legionnaires’ disease. Nonetheless, as new outbreaks occur, the number of new guidelines, statutes and regulations can be expected to grow.

The increasing incidence of Legionnaires’ disease and the growing number of guidelines and laws associated with preventing the amplification of legionella has not gone unnoticed by the plaintiffs’ bar. Personal injury lawyers are actively recruiting and filing claims for the serious injuries and losses associated with Legionnaires’ disease. For the most part, claims have been brought against the designers, owners and operators of hotels, hospitals, shopping malls and senior living facilities under a negligence theory. More recently, however, savvy plaintiffs’ lawyers, and even defense counsel looking for third party contribution, have begun to focus on manufacturers. These suits typically allege product design and manufacturing defects along with claims of missing or inadequate warnings, but also have included causes of action for strict liability and breach of express or implied warranty. Clearly the manufacturers of cooling towers, boilers and hot water heaters are in play. Less obvious targets may include the manufacturers of hot tubs, therapy baths, humidifiers, vaporizers, misters, faucets, aerators, decorative fountains and other water features. Allegations of liability may even extend to manufacturers of component parts used such as pumps, valves, filters and collection tanks. Manufacturers of chemical biocides sold to reduce biofilms and heterotrophic bacteria are also potentially implicated if proposed doses or concentrations fail to prevent legionella amplification.
Water safety is becoming an emerging litigation battleground. Manufacturers who produce, sell or distribute any product that is part of any water distribution system could be implicated in the growing number of lawsuits brought by those who have contracted Legionnaires’ disease.

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