Parker Waichman LLP Injury Alerts
PHTHALATES: The Evidence Mounts with Respect to the Potential Danger Posed by these Widely Used ChemicalsJun 1, 2010
As far back as November 2005, we were warning our readers about the growing concern a number of experts had over the potential health risks posed by the family of widely used chemicals known as phthalates (pronounced, “thalates”). Since that time, the debate over just how dangerous these chemicals are has heated up, especially in light of new evidence suggesting phthalates may be directly responsible for a number of serious health problems. While many harmful chemicals are well known to the general public by name and are often listed on product labels, most consumers have never heard of phthalates, which are contained (without being identified) in hundreds (if not thousands) of everyday products.
In a recent investigative report on “60 Minutes,” Dr. Shanna Swan, an epidemiologist at the University of Rochester Medical School, talked about the findings of a phthalates study she and her team conducted. Swan told CBS correspondent Lesley Stahl that her researchers found that as the level of phthalates in a mother's urine during pregnancy increased, so did the medical problems in their male offspring.
Asked what she found in babies, Swan said, "We found that the baby boys were in several subtle ways less completely masculine." Dr. Howard Snyder, a pediatric urologist at Children's Hospital in Philadelphia, says Swan's findings correspond with what he is seeing in newborn baby boys: an alarming increase in deformed sex organs. Dr. Snyder operated on a one-year-old boy to correct a condition known as hypospadias, a birth defect that causes problems in urination.
We hear there are more and more and more cases of hypospadias. Are you seeing a lot?" Stahl asked. Dr. Snyder responded: "Thirty, 40 years ago, the best data we had then was that hypospadias occurred in about one in every 300 live male births. It's up to now about one in 100. So there's been a threefold increase."
There's also been a two-fold increase in another abnormality: un-descended testicles. Dr. Snyder says something seems to be interfering in the womb with the production of testosterone, causing the male organs to form improperly. And he suspects it may be phthalates.
"You're moving in on these chemicals," Stahl remarked. "You don't think whatever we're seeing is smoking or diet or something else?"
"I think it's the chemical exposure that is most telling," Snyder replied. He points to studies beyond Dr. Swan's that suggest a link between phthalates and low sperm counts and low testosterone levels in adult males.
"There's just too much incremental data that has built up to be ignored. I think it's a real phenomenon. I really, honestly do," Dr. Snyder said.
Phthalates are organic chemicals produced from oil and are the most commonly used “plasticizers” worldwide. They are primarily used to make polyvinyl chloride soft and flexible.
Phthalates have been used for approximately 50 years and can be found in hair sprays, deodorants, shampoos, nail polish, perfumes, body washes, and skin creams. They make nail polish chip resistant and fragrances last longer. They can also be found in various insect repellants, detergents, vinyl products (raincoats, shower curtains, etc.), medical equipment, and food packaging. Children’s plastic toys very often contain phthalates, which are easily absorbed through the skin or nail bed and are ingested in food and beverages or through the air.
The cosmetic industry has been under scrutiny for the past several years as a result of animal testing, regulatory restrictions imposed by the European Union, and ongoing investigations by the FDA.
Early animal studies on phthalates showed that rats exposed to the chemicals have a higher rate of birth defects related to the male reproductive system. Other studies, however, only suggested possible links to early puberty in girls and decreased sperm counts in men.
Then, a study published in the journal Environmental Health Perspectives in 2005 indicated that phthalates could have adverse effects on the male reproductive system in humans. This study showed that when four particular phthalates are found above certain concentrations in the urine of pregnant women, the reproductive systems of their boys are negatively affected. The abnormalities included smaller penises and scrotums, and less developed testicles.
It appears that the chemicals suppress production of the male sex hormone testosterone. The researchers found that 25% of the women in the United States have concentrations of these four phthalates at this level. This study involved doctors and scientists at a number of universities and the Centers for Disease Control and Prevention (CDC).
The recent study led by Dr. Swan at the University of Rochester examined 134 boys and found that women with higher levels of phthalate-related chemicals in their blood were more likely to give birth to boys with undescended, or small testicles, small penises, or shorter distance than usual between the genitals and anus. It did not require exceptionally high levels of exposure to produce an effect; abnormalities were found in boys mothered by women exposed to levels below those found in a quarter of U.S. women. Swan, said, "We were able to show, even with our relatively small sample, that exposed boys were likely to display a cluster of genital changes."
Professor Richard Sharpe, of the UK Medical Research Council’s Human Reproductive Science Unit in Edinburgh, England, told the BBC News website, “It is significant. It is the first piece of evidence that we have that phthalates may cause adverse effects on reproductive development in human fetuses.”
It appears that the chemicals suppress testosterone production. This is significant since, as Dr. Sharpe recognized, “Testosterone is absolutely critical to development, most of the things that make males different to females are down to pre-natal exposure to the hormone. It is not just the effect on genital development, but also on tissues throughout the body, including the brain."
The conservation group WWF, which campaigns against harmful environmental chemicals, described the findings as "startling." Gwynne Lyons, toxics advisor to WWF UK, said, "This research highlights the need for tougher controls of gender bending chemicals. At the moment, regulation of the chemicals industry is woefully inadequate, and something needs to be done about this immediately." Several types of phthalates have already been banned.
A separate study done in 2005 linked phthalates to lupus in mice. Lupus is an auto-immune disease in which the immune system attacks the body’s own tissues as though they were foreign substances. The disease is potentially fatal and often damages the kidneys, heart, lungs, or blood cells.
For this study, researchers at Indiana State University injected mice with phthalates. They found the injections triggered lupus and caused development of glomerulonephritis. There was also a considerably shortened lifespan in mice that had a genetic disposition to the disease but not in other mice that were not pre-disposed to the disease. The research was published in the July 2005 issue of the Journal of Autoimmunity. “Our findings clearly show that lupus can be caused by an environmental factor like phthalate,” said Swapan K. Ghosh, professor and interim chair of life sciences at Indiana State.
A more recent study suggests that a variety of baby care products such as shampoos, lotions, and powders may expose infants to phthalates. Elevated levels of phthalates were found in the urine of babies who had recently been shampooed, powdered, or lotioned with baby products. This study, which appeared in the February 2008 issue of the journal Pediatrics, involved 163 babies. Most babies studied were white, between the ages of 2 to 28 months, and living in California, Minnesota, and Missouri. Researchers measured levels of several phthalates in urine from diapers and also questioned mothers about use in the previous 24 hours of baby products like lotions, powders, diaper creams, and baby wipes. All urine samples contained detectable levels of at least one phthalate, and most had levels of several more. The highest levels were linked with shampoos, lotions, and powders, and were most prevalent in babies younger than eight months.
“There is an obvious need for laws that force the beauty industry to clean up its act," said Stacy Malkan of Health Care Without Harm. The study's lead author, Dr. Sheela Sathyanarayana, a University of Washington pediatrician, said, "The bottom line is that these chemicals likely do exist in products that we're commonly using on our children and they potentially could cause health effects.” “Babies don't usually need special lotions and powders, and water alone or shampoo in very small amounts is generally enough to clean infant hair”, Sathyanarayana said.
Concerned parents should look for products labeled "phthalate-free," or check labels for common phthalates, which include DEP and DEHP. However, chemicals often do not appear on product labels because retail products are not required to list individual ingredients of fragrances, a common phthalate source. Many environmental advocacy groups are concerned about these chemicals and are calling for the government to step in and take action.
The Consumer Product Safety Commission (CPSC) Improvement Act of 2008 included a phthalate ban on products made for children under the age of 12. The ban prohibits the use of three phthalates with three others being temporarily banned from childcare products and toys children can place in their mouths. The ban did not apply to toys manufactured before February 10, 2009, which was when the ban went into effect.
Unfortunately, the law did not impose any legal obligation with respect to labeling. Thus, labels are not required to list the level of phthalates in a product or even whether toys like teething rings and pacifiers contain the chemicals.
At one point, Representative Janice Schakowsky (D – Illinois) claimed retailers and manufacturers were taking advantage of a loophole in the legislation stating that the CPSC “is willfully ignoring the Congressional intent, which is to protect children from toxic chemicals.” Schakowsky voiced concerns about “fire sales in toy stores across the country” as retailers sell such toys at attractive, reduced prices during the midst of a challenging, economic downturn.
Last year, a report found a link between phthalate concentrations in urine and attetion deficit/hyperactivity disorder (ADHD). The National Institute of Mental Health (NIMH) describes ADHD as involving difficulty staying focused, paying attention, and controlling behavior, and hyper- or over-activity.
The study, out of Korea and published by Elsevier in the November 15, 2009 issue of Biological Psychiatry, used computerized testing that measured attention and impulsivity levels and teacher-reported symptoms. The team found a noticeable link between phthalate metabolite levels in urine and ADHD test results and symptoms, with increased symptoms connected to increased phthalate levels.
According to senior study author Yun-Chul Hong, MD, PhD, "these data represent the first documented association between phthalate exposure and ADHD symptoms in school-aged children."
Also, the Editor of Biological Psychiatry, John Krystal, MD, said, "This emerging link between phthalates and symptoms of ADHD raises the concern that accidental environmental exposure to phthalates may be contributing to behavioral and cognitive problems in children. This concern calls for more definitive research." The study, conducted on a Korean population, is likely “comparable” to that in the U.S., Science Daily reported.
Based on all of the evidence to date, it would seem that phthalates deserve a higher priority when it comes to regulation and further testing. Safer substitutes should be sought and there should even be a move toward the elimination of phthalates in all products. At the very least, their use in products that come in close contact with consumers (especially children and pregnant women) should be strictly regulated and monitored. Labels should also require companies to disclose if their products contain phthalates.
Parker Waichman LLP is dedicated to protecting the public from the dangers of toxic substances and defective products and has been in the forefront of these types of litigation for many years. If you believe you or a loved one has suffered an injury as a result of being exposed to any toxic substance, do not hesitate to contact us at www.yourlawyer.com for a free consultation with one of our experienced attorneys.