Endocrine disrupters: the potential cloud of manufacturer toxic tort liability.

• Author: Berger, Bruce J.

THE PUBLICATION of Our Stolen Future (1) in 1996 created a firestorm of publicity and public anguish concerning the possibility that tiny amounts of some widely-used chemicals--characterized as "endocrine disrupters" ("EDs")--might be causing a variety of adverse human health effects. Congress took action at that time, directing EPA to commission scientific studies of such low-level effects. (2) The government-funded and government-conducted research has ground along and, if anything, seems to be accelerating. Yet today, ten years into the EPA scientific program on EDs, answers remain elusive. Although public anxiety about EDs has largely abated, numerous sources continue to report on the myriad human health and environmental effects possibly attributable to EDs.

As recently as September, 2006, for instance, the front page of The Washington Post carried an article that reported widespread ED pollution in the Potomac River. The article characterized EDs as "pollution that drives hormone systems haywire," and speculated that EDs may becausing male large- and small-mouth bass in the river to develop immature eggs inside their sex organs:

The cause of the abnormalities is unknown, but scientists suspect a class of waterborne contaminants that can confuse animals' growth and reproductive systems. These pollutants are poorly understood, however, leaving many observers with questions about what the problems in fish mean for the Potomac and the millions of people who take their tap water from it. (3) The tone of the article is typical of the numerous publications about EDs: On one hand, the article readily concedes that little is understood about the human health effects associated with exposure to EDs; nonetheless, an unmistakable alarm is sounded.

Interestingly, the speculation and uncertainty surrounding EDs is not constrained to purely new chemical inventions. Many will recall that the makers of DES were plunged into litigation over claims that its use by pregnant mothers caused birth defects. Today, DES is alleged to be an ED with other possible health implications. On October 17, 2006, the Reuters Health Information service reported that "[w]omen who were exposed to diethylstilbestrol (DES) in utero tend to go through menopause at a younger age than non-exposed women," an important finding since, according to the article, young age at menopause is associated with heart disease, osteoporosis, and breast and endometrial cancer. The short article concluded with a quote from one of the study's authors, stating that "there could be some health implications for the DES exposed," even though the results of the study showed a very small difference in age of menopause in the exposed versus the unexposed groups. (4)

Growing concerns about the identity, location, and possible effects of EDs are manifest in today's toxic tort and products liability landscape. (5) On November 17, 2006, for example, the online Insurance Journal reported on DuPont's expanding studies (and potential liabilities) concerning the largely unknown health effects associated with PFOA, a chemical--and a suspected ED--used in the manufacture of Teflon-coated, non-stick housewares. As part of its settlement with West Virginia and Ohio residents who claimed personal injuries associated with their exposure to PFOA contaminated in groundwater, DuPont agreed to sponsor nine studies to be performed by a panel of independent scientists. Those studies contemplate health screenings of approximately 70,000 residents in two states, and at this time are projected to take an estimated three to six years to complete. The panelists are now urging that a tenth study be performed and funded by DuPont. Depending upon the outcome of the studies--which "will look at possible links between [PFOA] and heart disease, stroke, diabetes and other disorders"--DuPont could be required to spend an additional $235 million to monitor the health of the residents allegedly exposed to EDs. (6)

It is clear that the ongoing research and speculation about an ever-growing list of potential EDs casts a cloud of potential toxic tort liability for manufacturers of EDs and the numerous, everyday products incorporating them. And while some suspected EDs are relatively new chemicals borne out of modern scientific advances, ED theories give rise to new toxic tort claims and potential liabilities with older chemicals, such as DES.

This article briefly reviews the concept of endocrine disrupters and then describes the findings and the faults of some medical and scientific arguments and studies that future product liability and environmental tort claimants are likely to utilize.

Endocrine Disrupter Theory

Essentially, endocrines are chemicals (commonly known as hormones) secreted by various bodily organs such as the ovaries, the testes, the adrenal gland, or the pituitary gland. Endocrines serve as messengers to other cells throughout the body when they attach to receptors on the surface of such cells. EDs are chemicals that interfere with, i.e., "disrupt," the normal signaling of the endogenous hormones at these receptors. For example, by occupying the receptor itself, the ED might block the body's own hormone (e.g. estrogen or androgen) and prevent the physiologically "correct" response of the target cell. Similarly, by occupying the receptor an ED might cause the cell to overreact (or underreact) and create more (or less) of an effect on bodily function than would the body's own chemical. Thus, an ED is simply any chemical that, at low levels, can act at endocrine, androgen, or steroid receptors and cause toxic effects. (7)

The chemicals that are now alleged to be endocrine disrupters are numerous and include: diethylstilbestrol ("DES"), bisphenol-A ("BPA") (a building block of polycarbonate plastic typically found in baby bottles, compact discs, computer parts, dental sealants, eyeglasses, and food containers), polychlorinated biphenyls ("PCBs"), polyfluorinated octanoic acid ("PFOA") (an ingredient used in the manufacture of some non-stick coatings), brominated flame retardants (PDBEs) (commonly used in many consumer products such as Styrofoam, carpets, office equipment), dioxin, and foods containing high soy proteins and isoflavones. (8)

Like so many indispensable chemicals that have found wide usage in all manner of products, potential EDs are everywhere, including in our bodies. The Natural Resources Defense Council's advice on how to reduce one' s risk of exposure to EDs speaks volumes about the prevalence of EDs in modern society. That advice consists of the following:

* Educate yourself about endocrine disruptors, and educate your family and friends.

* Buy organic food whenever possible.

* Avoid using pesticides in your home or yard, or on your pet--use baits or traps instead, keepin[g] your home especially clean to prevent ant or roach infestations.

* Find out if pesticides are used in your child's school or day care center and campaign for non-toxic alternatives.

* Avoid fatty foods such as cheese and meat whenever possible.

* If you eat fish from lakes, rivers, or bays, check with your state to see if they are contaminated.

* Avoid heating food in plastic containers, or storing fatty foods in plastic containers or plastic wrap.

* Do not give young children soft plastic teethers or toys, since these leach potential endocrine disrupting chemicals.

* Support efforts to get strong government regulation of and increased research on endocrine disrupting chemicals. (9)

But following the NRDC's advice simply may not be enough to avoid exposure to suspected EDs. Indeed, given rapid developments in analytical chemistry that allow scientists to find low levels of chemicals in blood and urine, it is now known that many potential EDs are found generally in the population at median levels of about 1 part per billion (ppb). (10) In effect, everyone is exposed, and, if such low levels of EDs actually cause harm, everyone is potentially at some level of risk.

Studies of Possible Human Health & Environmental Effects Attributable to EDs

According to Our Stolen Future, "the most dramatic and troubling sign that hormone disrupters may already have taken a major toll comes from reports that human male sperm counts have plummeted over the past half century" and that "Danish researchers found that the average male sperm count has dropped forty-five (45) percent from 1940 to 1990." In the years since Our Stolen Future was first published, numerous other "signs" of the possible ill-effects of EDs have been identified. In 2006, R. Hauser reported on a possible connection between exposure to widely-used industrial chemicals and "altered semen quality," (11) providing further possible support for the theory that exposure to EDs adversely affects the human reproductive system. D-H Lee published a study in 2006 reporting a statistically significant association between exposure to six "persistent organic pollutants" and type II diabetes, a common medical condition generally thought to be associated with hereditary factors and poor dietary habits. (12) Another 2006 study found that adults working in rooms with ED-containing plastic walling materials are more than twice as likely to develop asthma. The authors also found that the risk of asthma was higher for people working in settings with wall-to-wall carpeting, especially in the presence of mold. (13) Zhang published a study in 2004 in the American Journal of Epidemiology on EDs and the risk of breast cancer. (14) The authors reported a higher risk of breast cancer in women with a particular genetic variant having higher blood levels of PCBs. For such women, increased levels of PCBs resulted in a statistically-significant Odds Ratio of 4.2, i.e., suggesting that exposure to PCBs may have increased the risk of breast cancer by a factor of four. Yang, et al., published the abstract of a case-control study in 2005 of girls who experienced early...