Sustained Outrage

Judge in C8 case tells DuPont: A deal is a deal

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When the C8 Science Panel issued its last set of “probable link” findings nearly three years ago, the next step for Mid-Ohio Valley residents was supposed to be relatively simple: If they felt they had illnesses the panel had linked to C8 exposure, they could sue DuPont, without having to prove again that the illnesses in question could be caused by C8.

But as the first of thousands of lawsuits against DuPont prepares for a mid-September trial in federal court in Ohio, it hasn’t worked out that way. DuPont attorneys have continued to try to re-litigate the Science Panel findings — over and over again.

Now, U.S. District judge Edmund A. Sargus Jr. seems to have had enough. In this ruling issued earlier in the week, Judge Sargus reminded DuPont of its agreement all those years ago in the settlement of the Leach case, in which the parties agreed to live with the Science Panel’s conclusions: In the six instances (kidney cancer, testicular cancer, thyroid disease, ulcerative colitis, high cholesterol, pregnancy-induced hypertension, and preeclampsia) where the panel found a probable link to C8 exposure, DuPont would have to live with those findings in court. In the dozens of other instances where the panel found no link, residents would likewise have to live with those findings.

As Judge Sargus tried to explain in an earlier ruling on this back in December 2014:

…The Court concludes that if the individual plaintiffs prove that they are Leach Class members, and that they suffer or suffered from a Linked Disease, the Probably Link Finding is applicable to them. This means, for example, that the individual plaintiffs are not required to come forward with evidence proving that their individual dosage of C8 is sufficient to permit the Probable Link Finding to be applied to them. Under these circumstances, by agreeing to the Leach settlement, DuPont has contractually agreed to a finding of general causation.

 DuPont, though, insisted that they needed the judge to further clarify things. Company lawyers wanted to be able to argue at trial about dose, and to — in the judge’s words — “re-evaluating” the Science Panel’s reports. Judge Sargus explained:

DuPont’s mistake is focusing on the Science Panel’s reports/evaluations, instead of its findings .. DuPont has received the benefit of the No Probable Link Findings, immunity from lawsuits based on over forty diseases that tens of thousands of members of the Leach Class believe were caused by their ingestion of C8 that was released into their drinking water by DuPont.  None of those class members may engage in any analysis of the No Probable Link reports/evaluations. The conclusions reached in the No Probably Link reports, that is, the No Probable Link Findings, universally apply to the Leach Class.

The judge continued:

By way of further explanation, the Leach Settlement established a novel procedure for dealing with the approximately 80,000 individuals that make up the Leach Class by establishing the Science Panel and directing its work. Unlike the usual situation where epidemiologists start with a chemical exposure and then attempt to define the dose of that chemical which presents a sufficiently increased risk to conclude that such dose is ‘more likely than not’ sufficient to cause a particular disease, the parties directed the Science Panel to follow a very different process. The Science Panel was focused on an identified group of people (the Leach Class) with a defined level of exposure (0.5 ppb or greater of C8 for the period of at least one year) to a particular chemical (C8) and determine not how much of the chemical it might take to cause various diseases in humans generally, but which diseases were linked to the actual C8 exposures in that defined group. the Science Panel’s Probable Link Findings are, by agreement of the parties and by definition, links that exist and are ‘probable’ in the entire Leach Class.

New scrutiny for C8 alternatives and DuPont

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DuPont, C8 and chemicals being used to replace C8 are receiving new attention today, with the publication of a major essay in a scientific journal and the release of a critical report by the advocacy organization Environmental Working Group.

The New York Times wrapped these developments into a story headlined, “Commonly used chemicals come under new scrutiny“:

A top federal health official and hundreds of environmental scientists on Friday voiced new health concerns about a common class of chemicals used in products as varied as pizza boxes and carpet treatments.

The concerted public campaign renews a years-old debate about a class of chemicals known as poly- and perfluoroalkyl substances, or PFASs. After studies showed that some PFASs lingered in people’s bodies for years, and appeared to increase the risks of cancer and other health problems, the chemical manufacturer DuPont banned the use of one type of PFAS in its popular Teflon products, and other companies followed suit.

At issue now are replacement chemicals developed by those manufacturers and used in thousands of products, including electronics, footwear, sleeping bags, tents, protective gear for firefighters and even the foams used to extinguish fires.

The new commentary, by Linda S. Birnbaum of the National Institutes of Health and Harvard’s Philippe Grandjean, explains:

Research is needed to understand the potential for adverse health effects from exposure to the short-chain PFASs, especially regarding low-dose endocrine disruption and immunotoxicity. In parallel, research is needed to find safe alternatives for all current uses of PFASs. The question is, should these chemicals continue to be used in consumer products in the meantime, given their persistence in the environment? And, in the absence of indisputably safe alternatives, are consumers willing to give up certain product functionalities, such as stain resistance, to protect themselves against potential health risks? These conundrums cannot be resolved by science alone but need to be considered in an open discussion informed by the scientific evidence.

The Environmental Working Group report adds:

Production, use and importation of PFOA has ended in the United States, but in its place DuPont and other companies are using similar compounds that may not be much – if at all – safer. These next-generation PFCs are used in greaseproof food wrappers, waterproof clothing and other products. Few have been tested for safety, and the names, composition and health effects of most are hidden as trade secrets. With the new PFCs’ potential for harm, continued global production, the chemicals’ persistence in the environment and presence in drinking water in at least 29 states, we’re a long way from the day when PFCs will be no cause for concern.

 EWG also notes, citing what’s known as the “Madrid Statement”:

In a just-published paper, 14 international scientists have sounded the alarm, calling for tighter controls on all PFCs lest the tragic history of C8 repeat itself. Writing in Environmental Health Perspectives, they likened the new PFCs (which they refer to as PFASs) to the chemicals that replaced another group of fluorine-based substances found in the 1980s to be depleting Earth’s protective ozone layer. Although those chemicals were banned worldwide under a 1987 treaty, the scientists wrote, the alternatives are also harmful:

Global action through the Montreal Protocol successfully reduced the use of the highly persistent ozone-depleting chlorofluorocarbons (CFCs), thus allowing for the recovery of the ozone layer. However, many of the organofluorine replacements for CFCs are still of concern due to their high global warming potential. It is essential to learn from such past efforts and take measures at the international level to reduce the use of PFASs in products and prevent their replacement with fluorinated alternatives in order to avoid long-term harm to human health and the environment.

Continue reading…

Study says EPA advisory for C8 is far too weak

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Earlier this month, Callie Lyons wrote an important piece about lingering questions regarding exposure to toxic C8 among residents of the Mid-Ohio Valley area. She explained:

… More than a decade after the deadly controversy came to light, in many ways the extent of the contamination remains unknown. The impact on local cattle, hens, milk, eggs and produce remains largely unmeasured … An extensive paper trail reveals that DuPont promised to fill in data gaps identified by the EPA as early as 2003, then repeatedly failed to deliver the requested information.

 
And now, we have a new peer-reviewed study from Harvard University that raises serious questions about the provisional health advisories that EPA issued in the final days of the Bush administration in response to concerns about water supplies polluted with C8:

The current EPA limit for this PFC is 300-fold higher. Thus, the recent evidence on PFC immunotoxicity in humans and toxicity in animal models suggests that current limits for drinking water contamination are too permissive and must be decreased substantially.

Current drinking water limits therefore need to be reconsidered in the light of the observed immunotoxicity associated with PFC exposure.

UPDATED, APRIL 30, 2013 — Read more in this story.

New studies raise more questions about C8

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There are two new studies out this week that raise more questions about the dangers of DuPont Co.’s chemical, C8.

First, there’s this paper published in the journal Environmental Health Perspectives, concluding:

This study suggests an association between PFC exposure and juvenile asthma. Due to widespread exposure to these chemicals, these findings may be of potential public health concern.

Then, there’s this paper, also published yesterday in that same journal:

This study suggests that higher PFOA serum levels may be associated with testicular, kidney, prostate, and ovarian cancers and non-Hodgkin’s lymphoma. Strengths of this study include near-complete case ascertainment for state residents, and well characterized contrasts in predicted PFOA serum levels from 6 contaminated water supplies.

That one is especially interesting, given that it was co-authored by Tony Fletcher of the London School of Hygiene and Tropical Medicine. Dr. Fletcher was a member of the C8 Science Panel, which previously ruled that the only “probable links” between C8 exposure and cancers were for testicular and kidney cancers.

UPDATED: I asked Dr. Fletcher to explain the contradictions between this new study and the Science Panel’s probable link findings, and this is the email he sent me:

This is a general issue of assessing the evidence which has been faced for all the probable link assessments.  As described in the Science Panel Probable Links reports, for each evaluation we considered evidence together from published studies done by others, and from published and unpublished work done by the Science Panel. We considered the weight of the evidence, including consistency across studies. We took into account the capability of different study designs to detect a disease risk if such a risk exists: this capability of each study depends on both study size (a large study is better able to show the presence or absence of risk) and study quality (how good was the exposure assessment, how complete was the study population, how well controlled were the potential confounding factors etc). In many cases we found that some results were quite different , where one study suggested a risk and another did not, or within one study, different ways of analysing the results lead to different patterns of results. In each case we then judged whether the balance of evidence convinced us that it is more likely than not that an observed excess risk was explained by the connection between PFOA exposure and the particular human disease. Or alternatively we judged that an excess was more likely than not due to chance or study artefact. Where an individual positive association was based on stronger evidence (for example with a convincing pattern of increasing risk with exposure category and strong statistical significance), this carries more weight than results with weaker significance tests and without supportive results from other studies/analyses. Such considerations guide us in determining what is a “probable link” as defined in the Settlement Agreement.

The specific questions you raise are examples of this. Some of the particular set of results you can see in this paper (prostate cancer, ovarian cancer and non-Hodgkin’s lymphoma) were based on small numbers or showed unimpressive p-values or were not replicated by other studies, and when we put the evidence together we concluded for these that there was overall insufficient evidence to support a probable link with C8.

Finally, there was a third paper, this article, published in late December in the journal Environmental Science and Technology:

The present study investigated variation in perfluorocarbon levels of 9,952 women of childbearing age who had been exposed to perfluorooctanoic acid (PFOA) in drinking water contaminated by industrial waste. An analysis of variance with contrast was performed to compare the levels of PFOA and perfluorooctanesulfonic acid (PFOS) in pregnant and nonpregnant women overall and during each trimester of pregnancy. We found that pregnant women had lower circulating PFOA and PFOS concentrations in peripheral blood than nonpregnant women and that PFOA levels were consistently lower throughout all trimesters for pregnancy, suggesting transfer to the fetus at an early stage of gestation. These results are discussed in the context of the endocrine-disrupting properties of perfluoroalkyl substances that have been characterized in animal and human studies. Our conclusion is that further, systematic study of the potential implications of intrauterine perfluorocarbon exposure during critical periods of fetal development is urgently needed.

Final C8 Science Panel reports due out Monday

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The C8 Science Panel has scheduled a press conference for Monday morning in Parkersburg, to announce its final reports of its long investigation into the dangers of the DuPont chemical. Here’s the media advisory sent out this morning:

On the morning of Monday, October 29, final reports on whether there is a probable link between C8 and human disease will be delivered to the Wood County Court on behalf of the C8 Science Panel.  Immediately following submission to the court, the three Science Panel members will hold a press conference in Parkersburg/Vienna, WV at 10 am at the Wingate Hotel (next to Lowe’s).

The Science Panel has already released three rounds of its “probable link” reports, finding connections between C8 exposure and a variety of illnesses: High blood pressure during pregnancy, kidney and testicular cancer, and thyroid and bowel disease. The panel is now due to make public its findings regarding liver disease, kidney disease, osteoarthritis, parkinson’s disease, heart disease, hypercholesterolemia and hypertension.

Interestingly, there were a couple of stories in the Parkersburg paper today related to C8. One of the stories reported this development:

The first three West Virginia lawsuits have been filed in Wood County Circuit Court against DuPont alleging personal injury and, in one case, a death allegedly linked to C8 exposure.

These new suits were filed by Charleston lawyer Kathy Brown, who is apparently working with an Alabama law firm, Cory Watson Crowder & DeGaris, as the Parkersburg paper reported:

Brown is working with the law firm of Cory Watson Crowder & DeGaris, P.C. Cory Watson is a Birmingham, Ala., personal injury law firm known for handling similar multi-plaintiff and personal injury lawsuits. Cory Watson has also handled contamination litigation throughout the country involving other multi-national corporate defendants such as Monsanto, BP Oil, Pharmacia, Pfizer and Chevron.

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Study suggests C8 link to cardiovascular disease

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There’s a new study out this week from West Virginia University researchers that concludes exposure to C8 is associated with increased risk of cardiovascular disease, or CVD, and peripheral arterial disease, or PAD. According to a news release:

Anoop Shankar, M.D., Ph.D., and colleagues from the West Virginia University School of Public Health, Morgantown, examined the association between serum (blood) levels of PFOA and the presence of CVD and PAD, a marker of atherosclerosis, in a nationally representative group of adults. The study used merged data from the 1999-2000 and 2003-2004 National Health and Nutrition Examination Survey (NHANES).

The study suggests that increasing serum PFOA levels were positively associated with the presence of CVD and PAD, and the association appeared to be independent of confounders such as age, sex, race/ethnicity, smoking status, body mass index, diabetes mellitus, hypertension and serum cholesterol level, the authors comment.

“Our results contribute to the emerging data on health effects of PFCs [perfluoroalkyl chemicals], suggesting for the first time that PFOA exposure is potentially related to CVD and PAD. However, owing to the cross-sectional nature of the present study, we cannot conclude that the association is causal,” the authors comment.

The study, published in the Journal of the American Medical Association’s Archives of Internal Medicine, is available online (through a subscription only site) here.   Readers who are following C8 issues may recall that the C8 Science Panel has issued a report concluding that there is no “probable link” between C8 exposure and stroke, but that the Science Panel’s findings about heart disease are not due out now until sometime next month.

In a commentary also published in the journal, Dr. Debabrata Mukherjee of Texas Tech University Health Sciences Center, El Paso, writes:

These results contribute to the evolving data on the adverse health effects of PFOA, suggesting that PFOA exposure may be potentially related to CVD.  However, a major limitation is the cross-sectional nature of the study. Given this significant limitation, causality or the temporal nature of the association between PFOA and CVD cannot be concluded from the current analysis.  Although it seems clear that additional prospective research is needed to tease out the true adverse cardiovascular effects of PFOA, given the concerns raised by this and prior studies, clinicians will need to act now. From a societal point of view, it would make sense to limit or to eliminate the use of PFOA and its congeners in industry through legislation and regulation while improving water purification and treatment techniques to try and remove this potentially toxic chemical from our water supply.

C8 update: Another paper, but still no regulations

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There’s a very interesting new paper out on C8 that concludes:

Girls with higher prenatal exposure to each of the PFCs examined were smaller at birth than those with lower exposure. In addition, those with higher exposure to (PFOS) were larger at 20 months.

This is especially interesting, given the previous findings of the C8 Science Panel last December:

On the basis of epidemiologic and other scientific data available to the C8 Science Panel, we conclude that there is not a probable link between exposure to PFOA (C8) and preterm birth or low birthweight.

Meanwhile, Callie Lyons had an important blog post on C8 issues, reporting this:

Despite lawsuits and health studies, the controversial manufacturing substance C8 remains unregulated by the US Environmental Protection Agency. Cincinnati attorney Rob Bilott is urging the agency to take swift action in light of recent findings from the C8 Science Panel.

Bilott says he is concerned because he recently discovered EPA intends to delay actual regulatory activity until 2025 – or 24 years after he first requested action on the part of his Mid Ohio Valley clients.
“On behalf of our individual resident clients who have been and/or continue to be exposed to PFOA in their residential drinking water, we again urge US EPA to take action more quickly to release appropriate limits and guidelines for PFOA in drinking water applicable to long-term, chronic exposures, particularly given the recent data confirming thousands of cases of serious human disease linked to such exposures among impacted residential communities,” Bilott said in an Aug. 20 letter to EPA. “Twenty four years is far too long to ask our clients to wait.”

Judge: C8 Science Panel delay ‘frustrating’

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Earlier today, Wood Circuit Judge J.D. Beane held a brief hearing in Parkersburg, so that members of the C8 Science Panel would have to explain in a public forum the reasons for their announced three-month delay (see here and here)  in releasing final results of their examination of the chemical’s impact on the health of Mid-Ohio Valley residents.

Until late last month, Science Panel members were publicly sticking to their promise that the last of their “probable link” determinations would be done and released by the end of July. Now, they say it will be the end of October before this work is completed and results relayed to area residents. Here’s the reason, as explained by the Science Panel:

The primary reason that we were not able to fulfill our commitment to meet the deadline of July for all the assessments was that we underestimated the painstaking process of resolving several assessments that are very close to the balance between presence or absence of a Probable Link. The process of preparing a Probable Link assessment involves generating data from our own research, integrating that information with studies conducted by others, careful evaluation and deliberation, and then writing a document to summarize the evidence and explain our reasoning. The process of assessing the evidence and composing the documents is far more demanding than we had anticipated at the outset, and each disease is handled separately.

In each case we have had to examine the data we have, consider consistency with published data where available, confer on how to make the results more definitive and, where necessary, go back to the data for additional analysis. For diseases which are borderline between yes and no, this necessitates additional effort, sometimes in several cycles. For all diseases, but especially those for which the evidence places them close to the “more probable than not” threshold, the process demands substantial time. In judging whether to try to truncate that level of scrutiny and rush through the remaining diseases, including some of the most important ones of concern, versus incurring a delay in order to be sure that each of the reports received our full attention, we have chosen the latter.

Lawyers for residents and for DuPont Co. seemed to accept this explanation, and neither side offered any criticism of the panel’s delay. Judge Beane, though, did say:

It’s frustrating when deadlines are set and then those deadlines are not met. The people who live throughout this community are wanting to know and we set these deadlines for a reason.

And if October comes and there’s another delay? Judge Beane said:

If it continues to be an issue, with whatever means I have to look into that, I will.

FDA reaches deals on C8 food packaging phase-out

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Today, the U.S. Food and Drug Administration posted this potentially important announcement on its website, revealing the somewhat old news that three makers of C8-based food packaging have agreed to voluntarily withdraw those products from the market. The FDA announcement spun it this way:

Recent scientific studies have raised safety concerns with one type of perfluorinated chemicals, known as C8 compounds. These compounds have perfluorinated chain lengths of 8-carbons (C8) or longer. The studies indicate that these C8 compounds persist in the environment and can have toxic effects on humans and animals.

In response to these studies, FDA initiated a comprehensive review of the available data on C8 compounds and worked with several manufacturers to remove greaseproofing agents containing C8 perfluorinated compounds from the marketplace. As a result of FDA’s initiative, these manufacturers volunteered to stop distributing products containing C8 compounds in interstate commerce for food-contact purposes as of October 1, 2011. Existing supplies of these greaseproofing agents already in the marketplace and paper products with these greaseproofing agents can be used until they run out.

The industry’s voluntary action to cease using greaseproofing agents containing C8 perfluorinated compounds means that these products will be out of the marketplace in a relatively short period of time. Because the potential danger from C8 compounds is a result of chronic exposure to such substances, FDA has determined that the exposure which will occur during this sell-off period will not impact public health. The agency will also conduct a market survey to determine whether any manufacturers are still using greaseproofing agents which contain C8 compounds.

We’ve written before in the Gazette about the link between food packaging and C8 exposure (see here, here and here), and today’s announcement comes just after the C8 Science Panel — which has linked chemical exposure to human disease — announced last week that it needs more time to complete all of its work. The FDA announcement was first reported on the website Food Poisoning Bulletin. There’s also been some very interesting reporting on C8 issues recently from Callie Lyons, including this story and a follow-up piece.

Keep in mind that makers of these products had already agreed to a voluntary phase out in a deal with the U.S. Environmental Protection Agency, so the meaning of FDA’s announcement is not exactly clear yet. Leann Brown, spokeswoman for the Environmental Working Group told me today:

This isn’t a groundbreaking announcement. Several companies have reaffirmed that they are in the process of voluntarily phasing out these toxic chemicals from commerce, and the FDA is officially acknowledging their intention.

 

Just a few weeks after the latest probable link finding from the C8 Science Panel in the Mid-Ohio Valley, we’ve got a very interesting new paper out that focuses attention on how some health effects related to C8 exposure appear to be happening at very low levels — levels to which the general public is exposed.

The new paper was written by Gloria Post of the New Jersey Department of Environmental Protection, Perry Cohn of the New Jersey Department of Health, and Keith Cooper of Rutgers University. It’s called “Perfluorooctanoic acid (PFOA), an emerging drinking water contaminant: A critical review of recent literature” and was published online by the peer-reviewed journal Environmental Research (subscription required).

Among other things, the study reports:

— Continued exposure to even relatively low concentrations in drinking water can substantially increase total human exposure, with a serum drinking water ratio of about 100:1.

— Infants are potentially a sensitive sub-population for PFOA’s developmental effects, and their exposure through breast milk from mothers who use contaminated drinking water and/or from formula prepared with contaminated drinking water is higher than in adults exposed to the same drinking water concentration.

— Numerous health endpoints are associated with human PFOA exposure in the general population, communities with contaminated drinking water, and workers.

While the study notes that, “as is the case for most such epidemiology studies, causality for these effects is not proven,” it also reports:

Unlike most other well-studied drinking water contaminants,the human dose-response curve for several effects appears to be steepest at the lower exposure levels,including the general population range,with no apparent threshold for some end points.

And, the study says:

This information suggests that continued human exposure to even relatively low concentrations of PFOA in drinking water results in elevated body burdens that may increase the risk of health effects.