Cooking in a pot that doesn't stick, a magical spray that repels stains from fabric and carpeting, food containers that don't leak — sold under the brand names of Teflon, Stainmaster, Scotchgard, and SilverStone, just to name a few — these are all products that many Americans have grown up with and likely never give a second thought to.
But last month, the manufacturer of chemicals used in some of these products, DuPont, faced its third lawsuit for health damage allegedly resulting from the chemicals.
The culprit at hand is perfluorooctanoic acid, also known as PFOA or C8, which is the chemical used to manufacture Teflon and other products. The byproducts of C8 were dumped into the Ohio River near the DuPont plant at Parkersburg, West Virginia, contaminating the drinking water that served two districts in West Virginia and four in Ohio.
In the latest lawsuit, held in early July 2016, the jury said that DuPont had "acted with malice." The jury awarded the plaintiff $5.1 million in compensatory damages and an additional $500,000 in punitive damages. The plaintiff was David Freeman, a 56-year-old man from Washington County, Ohio, who developed testicular cancer that he blames on drinking the tainted water, and the jury apparently agreed.
DuPont has said that it will appeal this ruling.
But this case is merely the tip of the iceberg in what promises to be a very lengthy and protracted legal battle against DuPont.
Currently, about 3500 lawsuits against DuPont are pending, all citing an assortment of health problems — including cancer — that can be traced to drinking water laced with C8.
Mr Freeman's case was the third of six bellwether cases that are testing the legal waters, so to speak, but it struck a deep chord because of its additional award for punitive damages.
According to the attorneys for the plaintiffs, holding DuPont liable for actual malice might change the course of litigation for the remaining 3500 plus cases.
In a report at Law360.com, Stephen Schwarz of Faraci Lange LLP, who is helping to bring litigation against other companies over the same compound, said, "The concept that their actions were grossly negligent, reckless or wanton — depending on exactly what the language was there, in that court — could potentially be something that carries forward, so that the next jury doesn't have to decide that and they might be facing punitive damage awards in every case that goes to trial thereafter, without even a chance to convince the jury that they're not entitled to it."
Two Other Lawsuits Already Heard
The first bellwether case was heard in October 2015, when a federal jury in Ohio ruled that DuPont was responsible for the plaintiff's kidney cancer and awarded her $1.6 million in compensatory damages. However, they did not ask for punitive damages, as in the Freeman case.
DuPont is appealing that verdict, but in the midst of doing so, it settled a second case in which the plaintiff alleged that drinking contaminated water had resulted in subsequent ulcerative colitis. That trial was scheduled to begin in March 2016 but instead was settled earlier out of court. Neither side has revealed the terms or amount of the settlement.
Implications Are "Huge"
PFOA is a fluorinated organic chemical that is part of a larger group generally referred to as perfluorinated compounds (PFCs) or perfluorinated alkylate substances (PFASs).
"PFOA was used to make Teflon, although it's important to note that it is not in Teflon, although Teflon can break down back into it," said Bill Walker, vice president and managing editor of the Environmental Working Group (EWG)/West Coast.
He noted that a related chemical, perfluorooctane sulfonate (PFOS), was used to make another popular product, Scotchgard (manufactured by 3M).
"The two major producers of these chemicals are DuPont for PFOA and the 3M Company for PFOS," he told Medscape Medical News.
The Centers for Disease Control and Prevention, in their periodic testing of people's blood and urine, have "found evidence of these chemicals in almost everyone in the country," Walker said. "They test random samples and then extrapolate it to the general population. The last number they had was in excess of 95%."
Thus, the bellwether cases may well be the beginning of litigation that extends far beyond the residents who drank contaminated water from the Ohio River, as reports of similar incidents have been springing up all over the country.
One brewing hotspot is Hoosick Falls, a small town in upstate New York, which also appears to be an epicenter for PFOA contamination and has in fact been declared a Superfund site by the governor, according to an article in the New York Times.
The article reported that dangerously high levels of PFOA were confirmed last year in the town's drinking water, which comes from municipal wells. Installation of new filtration systems, blood testing, and other measures have since been undertaken.
The sources of the contamination were identified as Saint-Gobain Performance Plastics and Honeywell International Plastics, local area manufacturing plants.
The first personal injury lawsuit has just been filed against Saint-Gobain and Honeywell. In addition, residents of the town had already begun filing class lawsuits against the two companies.
Down South, 100,000 residents in North Alabama were told last month not to drink tap water until further notice because of potentially hazardous levels of PFOA and related PFOS.
Drinking water in the West Morgan-East Lawrence Water and Sewer Authority in Alabama comes from the Tennessee River, which is located downstream from where 3M and other companies manufactured these chemicals or used them to make consumer products.
Last fall, the water authority filed a lawsuit against 3M, and the environmental group Tennessee Riverkeeper has also issued a notice of intent that they also plan on litigation.
Other hotspots include private wells in North Bennington, Vermont, located near the now-closed ChemFab plant, that have tested positive for PFOA. In the nearby hamlet of Petersburgh, home of the Taconic Plastics plant, PFOA has been found in public wells that serve dozens of families.
EPA Revises Guidelines
After years of pressure from public health officials and advocacy groups, the Environmental Protection Agency (EPA) has this year revised its guidelines for chemical testing. The stricter limits were in part prompted by the evolving evidence that implicated PFOA and PFOS in testicular and kidney cancers, as well as other serious health conditions, the agency said.
Under the new guidelines, long-term exposure to either chemical at concentrations above 70 parts per trillion could have adverse health effects. This is significantly lower than the previous level, which was based on short-term exposure of 400 parts per trillion.
With the new EPA advisory, 13 water systems subsequently tested across the United States have PFOA levels above the new 70 parts per trillion threshold, while 46 have high levels of PFOS. In water supplies where both chemicals were present, the combined amounts were counted.
PFOA concentrations of about 100 parts per trillion were found in the drinking water of Petersburgh, New York, and North Bennington, Vermont, but a second testing in North Bennington revealed levels of up to 2730 parts per trillion. This level is nearly 40 times higher than the EPA's new advisory limit.
Use in Firefighting Foam, a Global Problem
Richard Clapp, DSc, MPH, professor emeritus of environmental health, Boston University School of Public Health and adjunct professor at the University of Massachusetts, Lowell, pointed out that the Air Force's use of PFCs in firefighting foam is another potential hazard.
"This is something that we are going to see all over the country, at Air Force bases where it was likely used," Dr Clapp told Medscape Medical News.
"In fact, we have air force bases all over the world so this is a global problem," he said. "There are studies ongoing right now, and testing people who live in communities around the air bases."
The Air Force estimates that there are 200 active, closed, and reserve bases that probably used the foam. As of March 2016, 30 bases have been tested, with 4 having PFC levels above those advised by the EPA.
But Walker from the Environmental Working Group suggested that the global issue goes beyond military bases. "We know from scientific studies that these compounds have spread throughout the world," he said. "They've been found in polar bears in the Arctic, in Atlantic salmon, and dolphins in the Mediterranean Sea, to name a few."
A Long Time Coming
The current lawsuits involving DuPont actually date back 15 years, to a 2001 class-action suit known as Leach v DuPont that was filed in West Virginia state court.
But the events leading up to that litigation first surfaced more than half a century ago, when DuPont first began purchasing PFOA from 3M (which had invented PFOA in the late 1940s), to be used in manufacturing Teflon.
According to the New York Times , even though PFOA was not classified as a hazardous substance, 3M had given DuPont recommendations on how to safely dispose of it: that it should be incinerated or sent to chemical-waste facilities.
DuPont's own instructions also specified that PFOA should not be released into surface water or sewers, but over the years, hundreds of thousands of pounds of PFOA powder were pumped through the outfall pipes of their Parkersburg facility into the Ohio River, along with tons of PFOA-laced sludge into open, unlined pits on the facility's property.
Both 3M and DuPont had long suspected that exposure to PFOA could be detrimental for health and had been conducting their own secretive studies for more than 40 years, according to the New York Times article . As far back as 1961, they discovered that PFOA could enlarge the livers of laboratory animals.
Blood tests in the 1970s revealed high concentrations of PFOA in factory workers at the DuPont plant, but the EPA was not notified. The realization by both DuPont and 3M that PFOA exposure could cause birth defects was also not shared publicly.
These events eventually came to light in 1988, when Robert Bilott, an attorney from Cincinnati, Ohio, obtained a court order to look at documentation from DuPont.
Hired by a Parkersburg family whose cows had died after drinking from a stream that ran through a DuPont dump, Bilott eventually discovered tens of thousands of documents revealing a story that went well beyond a single contaminated stream.
Bilott notified the EPA in 2001 about the contamination in Parkersburg, and 4 years later the agency fined DuPont $16.5 million for their failure to disclose the dangers of PFOA. This was the largest civil administrative penalty that the EPA has ever obtained under any federal environmental statute.
"The settlement of that suit included a remarkable action," Walker told Medscape Medical News. "DuPont agreed to fund an independent panel to investigate the connection between PFOA and various diseases."
When this type of study is done, they usually have a very small cohort, he said. "But in this case, they were able to test the blood from 70,000 people who may have been exposed. DuPont spent millions of dollars to conduct this investigation."
It ultimately cost DuPont $33 million for the investigation. In a separate action, the company also settled the class-action suit in 2005, on behalf of almost 90,000 residents residing in the mid-Ohio Valley. Among many other provisions, DuPont was required to set up a medical monitoring fund and make up to $235 million available for that purpose.
In the meantime, after 6 years of investigation, in 2011 the independent scientific panel that had been funded by DuPont found that PFOA had probable links to six conditions: pregnancy-induced hypertension, kidney and testicular cancer, ulcerative colitis, thyroid disease, and high cholesterol.
Participants in the Leach class-action lawsuit could now pursue personal-injury claims against DuPont, but only for the six conditions that were covered in the panel's report. Six test cases were selected from the approximately 3500 residents who decided to pursue personal injury claims, and these will go to trial or settle by the end of 2016. So far, three cases (relating to testicular cancer, kidney cancer, and ulcerative colitis) have been heard, as detailed above.
As for the remaining 3500 cases, a federal judge has given priority to the 260 cancer lawsuits, and an aggressive schedule has been set up to hear four trials per month, beginning in April 2017.
Overall it has been a very long and drawn-out procedure. "But these toxic exposure cases take a long time to resolve for a variety of reasons," said Robert L. Rabin, JD, PhD, A. Calder Mackay Professor of Law at Stanford Law School in California.
"A principal reason is that causation is complicated to resolve in these long latency cases," Dr Rabin told Medscape Medical News. "Defendants can frequently argue that plaintiff was exposed to a variety of chemicals in the environment, or through lifestyle, or was a victim of genetic factors."
"In addition, defendants can sometimes argue that the dosage from the exposure, even if the chemical is a carcinogen, was not sufficient to cause the disease," he added. "Or that the scientific connection simply hasn't been established by the evidence."
More Reasons to Worry
While six conditions were identified by the independent scientific panel as having a probable association to PFOA, they are not the only ones that have come up in studies.
"There are 3M workers who have excessive rates of prostate cancer," explained Dr Clapp. "In fact, prostate cancer was the first to surface in the 3M workers, before the DuPont cases."
"Another study in Europe showed excess pancreatic cancers, and I think we may see more cases as time goes on," he continued. "It is premature to say at this point, but we may be seeing other cancers as well."
People are most likely exposed to PFOA by drinking from contaminated water sources, and possibly by using products that contain PFOA, but breast feeding can also expose infants to the chemical.
"On average a child's serum concentration will increase by about 20% for each month of breastfeeding, and long-term nursing can increase the child's concentration by several-fold above the mother's," said Phillipe Grandjean, MD, PhD, an adjunct professor of environmental health at the Harvard School of Public Health, Boston, Massachusetts, who has conducted studies on the relationship between breastfeeding and exposure. "These results suggest that we need to pay particular attention to adverse effects that may be associated with PFAS exposures in infancy as a developmental stage of high vulnerability."
"As very little evidence on this issue is available, exposure limits need to take into account that the documentation is incomplete and that these chemicals may be more toxic than current data indicate," Dr Grandjean told Medscape Medical News.
Previous research has shown that early exposure to these chemicals can have a deleterious effect on the immune system and cause vaccinations to fail or be much less potent (Environ Health. 2015;14:47). Notably, 7-year-old children with twice the blood levels of PFAs had about half of the levels of tetanus and diphtheria antibodies as children with average exposure.
"We used our own data on lower vaccine antibody responses to calculate exposure limits that would be likely to protect against adverse effects on the immune system," said Dr Grandjean. "We relied on serum-PFAS concentrations at age 5 years and the decreases in antibody concentrations at ages 5 and 7."
Using the method recommended by the US EPA, they calculated that exposure limits must be much lower than those currently applied, many of which rely on animal studies from several years ago, he noted. "The difference is about 100-fold or more, so this is a serious case where human studies reveal adverse effects much below the exposures that were thought to be innocuous."
Childhood cancer rates have been rising, but it is impossible to say if they are related to exposure to this group of chemicals, Dr Grandjean commented. "It has been shown that there is exposure to chemicals in utero or in breast milk or cord blood and that it can reduce immune response and make vaccines less effective," said Dr Clapp. "Whether it will show up as increased cancer is too early to say, but there is evidence that it is suppressing the immune system."
Other than environmental exposures, there is no other obvious explanation for increasing rates of childhood cancers, he added. "So it does point to something in the environment — maybe in the chemical soup that we have in our 'overdeveloped' societies."
Lessons Learned — or Not
3M stopped manufacturing both PFOA and PFOS in 2002, while DuPont and other companies didn't phase out PFOA until 2013 or later. But they have been replaced by products that may not be any safer.
"We know that these perfluorinated compounds are incredibly persistent in the environment," commented Ted Schettler, MD, MPH, science director of the Science & Environmental Health Network. "They don't break down easily and many of them — but not all — are bioaccumulative."
The 8–carbon chain compounds, which include PFOA and PFOS, are bioaccumulative and persistent, but now they have been replaced by 6–carbon chain compounds.
"DuPont has moved away from the 8 carbon chain and are making C6 chemicals, and these are also quite persistent," Dr Schettler explained in an interview. "There is an argument that they are not as bioaccumulative. But I have reviewed the literature, and in my view, they have not been adequately tested for toxicity."
The data on C6 show that some compounds are bioaccumulative and some are not. "DuPont has been patting themselves on the back, that they've taken care of the problem," said Dr Schettler. "They are trying to make the case that even though they [the C6 chemicals] are persistent, and don't break down easily, you will excrete them more rapidly so there is nothing to worry about."
The problem is that the studies are in rodents, which have very different metabolisms and excretory systems from humans. Chemicals will pass through much more rapidly, he pointed out.
"So the problem with this 'solution' is twofold," he said. "First, the testing is on rodents, so that is not adequate to prove safety."
"And second, if we are loading up the environment with C6 instead of C8, eventually we will create circumstances where wildlife and people are going to be frequently and repetitively exposed," Dr. Schettler continued. "So even if they aren't bioaccumulative they are persistent, and we will have an ongoing exposure scenario and we will be facing the same problem."
"The lesson is that we shouldn't be producing these chemicals that are going to get out into the environment and pretend that we can manage them," he emphasized. "That should be our lesson, but these chemicals have such interesting properties that there is a real market for them. "
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Cite this: DuPont 'Acted With Malice,' Says Jury in Cancer Lawsuit - Medscape - Aug 02, 2016.
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