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Plastics Ingredient Vinyl Chloride is Focus of Suit Against Rohm and Haas

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Bryan Freund compares his fragile condition to having “a time bomb in your head. You just don’t know when it’s going to go off.”

Freund, 49, has brain cancer, which he blames on careless practices at a chemical plant just north of his home. He’s among 17 current or former residents of the village of McCullom Lake, Ill., who have developed the disease since 1993; 10 have died. The plant, operated by Rohm and Haas, a subsidiary of Dow Chemical Co., is at the root of a potentially groundbreaking lawsuit scheduled for trial Sept. 20 in Philadelphia. “This is the biggest brain cancer cluster case I’m aware of,” said Aaron Freiwald, a lawyer for the plaintiffs who has worked on the case for nearly five years.

The seeming excess of brain cancer in McCullom Lake — a municipality of barely 1,000 people in McHenry County, about 50 miles northwest of Chicago — is striking in itself, given that malignant brain tumors occur in the general U.S. population at the rate of 6.4 per 100,000, according to the National Cancer Institute. But the town has recorded 13 benign brain tumors in addition to the 17 malignancies, as well as one case of liver disease severe enough to require a transplant.

All 31 victims, or their survivors, are suing Philadelphia-based Rohm and Haas; the family of Franklin Branham, who died in 2004, will be the first to go to trial. “Just looking at the numbers alone clearly demonstrates something out of the ordinary here,” Freund said.

The lawsuits allege that a Rohm and Haas adhesives and sealants plant in Ringwood, Illinois, about a mile upstream and upwind of McCullom Lake, contaminated the air and groundwater with a compound called vinyl chloride, among other carcinogens. State data confirm that the brain cancer rate in and around the village from 1986 to 2006 was markedly higher than the rates for the rest of Illinois or McHenry County, one of Freiwald’s scientific consultants wrote in a recent report.

But Rohm and Haas vigorously denies its plant is to blame. In a statement to the Center for Public Integrity, Maureen Garrity, a spokeswoman for the firm, wrote that the company “believes that these claims are factually and scientifically unfounded, and for this reason, will continue to vigorously defend these cases. Based on all available data, as well as local, state and federal public health reviews, no scientific evidence has indicated that operations at the [plant] pose any past or present threat to public health in the community or neighboring communities, including McCullom Lake Village.”

To be sure, proving a link between chemical exposure and cancer is difficult, especially in the courtroom, where many millions of dollars are at stake. Both the Environmental Protection Agency and the International Agency for Research on Cancer, part of the World Health Organization, have concluded that there is insufficient evidence to connect vinyl chloride to brain cancer.

The case against Rohm and Haas is “very, very significant because vinyl chloride is a bad chemical,” said Rena Steinzor, a law professor at the University of Maryland and president of the Center for Progressive Reform, a nonprofit organization that endorses strict health, safety and environmental regulation. “There’s been suspicion of brain cancer for long time. If [the plaintiffs] were to prevail, it would solidify that theory.”

In what is believed to be the only successful lawsuit in the United States alleging that vinyl chloride exposure caused brain cancer, a jury in 2006 awarded $1.2 million to the widow of a man who had worked at a Shell Chemical plant near Trenton, New Jersey; the case was subsequently settled for an undisclosed sum. The widow’s lawyer, Steven Wodka, said the victim, 57-year-old Donald Lattin, succumbed in 2003 to a type of brain cancer called glioblastoma multiforme. It’s the same type that has afflicted 10 of the McCullom Lake plaintiffs.

Link Between Brain Cancer, PVC Ingredient?
 

Regardless of the outcome, the trial promises to trigger a scientific debate with implications that go far beyond McCullom Lake.

The issue is the strength of the association between vinyl chloride — an ingredient in polyvinyl chloride (PVC) plastic and a byproduct of some chemical processes — and brain cancer. Experts for Rohm and Haas argue that the link is tenuous at best and concede only that vinyl chloride in high doses can cause a rare liver cancer called angiosarcoma.

But Freiwald believes he can prove that an industry-funded study on which the company is expected to rely is flawed. His investigation indicates that the study of more than 10,000 workers at vinyl chloride plants, begun in 1973 and updated most recently by epidemiologist Kenneth Mundt in the 1990s, failed to include as many as two dozen fatal cases of brain cancer.

“More brain cancer cases included in Mundt’s work completely changes his findings,” Freiwald said.

”Instead of the Mundt study being something that Rohm and Haas and other chemical companies can point to as casting doubt on the link between vinyl chloride and brain cancer, it would become very strong evidence of that link,” Freiwald added. “It really takes away from companies that are fighting lawsuits a pretty important piece of evidence.”

Mundt, who holds a PhD in epidemiology, edits two scientific journals and is a principal at the consulting firm ENVIRON in Amherst, Massachusetts, declined repeated interview requests from the Center. Garrity, the Rohm and Haas spokeswoman, would not comment on Mundt’s work.

A stronger tie to brain cancer also could affect how regulatory and scientific bodies view the risk posed by vinyl chloride, discharged by factories in places like Geismar, Louisiana, and Delaware City, Delaware, and a common contaminant at toxic-waste sites.

In 2008, according to the EPA’s Toxics Release Inventory, an estimated 385,715 pounds of the chemical were released into the air, down sharply from 773,826 pounds in 2000. Allen Blakey, a vice president with the Vinyl Institute, a trade group, said the reduction was achieved through a combination of improved technology, regulations and voluntary measures.

In 2007, the Agency for Toxic Substances and Disease Registry, part of the Centers for Disease Control and Prevention, ranked vinyl chloride as the No. 4 chemical of concern at Superfund sites based on its toxicity, its pervasiveness, and the potential for human exposure. The No. 16 chemical on the list — the solvent trichloroethylene (TCE), itself a suspected carcinogen — can be converted to vinyl chloride by bacteria in soil.

The EPA last did a risk assessment for vinyl chloride more than a decade ago, concluding in a 2000 report that it “is not likely to be associated strongly with cancers other than liver in humans.”

In a 2005 paper, three researchers — including Jennifer Sass, a senior scientist with the Natural Resources Defense Council — delivered a harsh critique of the EPA’s risk assessment. They said the EPA’s analysis was “drafted with substantial input from the chemical industry” and minimized cancer risks.

The EPA’s 2000 “estimate of cancer potency was reduced 10-fold from values previously used for environmental decision making,” Sass and her co-authors wrote, “a finding that reduces the cost and extent of pollution reduction and cleanup measures. We suggest that this assessment reflects discredited scientific practices and recommend that the U.S. EPA reverse its trend toward ever-increasing collaborations with the regulated industries when generating scientific reviews and risk assessments.” The paper appeared in Environmental Health Perspectives, a peer-reviewed journal published by the National Institute of Environmental Health Sciences.

Indeed, documents obtained in the course of litigation show that the industry had pushed for the EPA review of vinyl chloride. A 1994 report prepared by an industry consultant concluded, for example, that rodent studies “significantly overestimate” vinyl chloride’s ability to cause cancer in humans.

In a statement to the Center, an EPA spokeswoman wrote that the 2000 risk assessment “was based on EPA’s analysis of the strengths and weaknesses of the available peer-reviewed scientific literature data and the expert and public comments that were received.

EPA depends on a rigorous process of independent external peer review and public comment of its draft assessments to ensure an open, transparent, and participatory process and the highest possible scientific quality of [its] human health assessments.”

The most recent update of the vinyl chloride worker study, by Mundt, wasn’t published in time to be considered as part of the EPA’s 2000 risk assessment. In a paper that same year, Mundt concluded that the risk of death from brain cancer “has attenuated, but its relation with exposure to vinyl chloride remains unclear.”

A working group of the International Agency for Research on Cancer (IARC) considered Mundt’s study and others when it reviewed the scientific literature on vinyl chloride in 2007. “There wasn’t enough evidence for them to say that brain cancer was significantly elevated” among vinyl chloride workers, said Vincent Cogliano, head of the IARC Monographs program in Lyon, France. “Only angiosarcoma and hepatocellular carcinoma [another cancer of the liver] were considered causally related to vinyl chloride. They didn’t find good evidence for brain tumors.”

Should it turn out that two dozen brain cancer deaths were missed in the Mundt paper, “it would be compellingly significant,” said Cogliano, a former EPA risk assessor who worked on the agency’s 2000 vinyl chloride report.

Mundt testified during the 2006 Lattin trial that he bid to update the worker study because he was “fascinated” with the origins of brain cancer. “I was trying to understand risk factors for brain cancer because so little is known about it,” he testified, according to a court transcript. Mundt said that the Chemical Manufacturers Association – now known as the American Chemistry Council – paid him and his research team about $600,000 over the three-plus years it took to complete the update. He testified that the criteria he used to determine which brain cancer cases should be included “were not my criteria but, rather, the criteria of the originators of the study back in the middle ‘70s.”

“What Is This Smell?”
 

The chemical plant that is the subject of the litigation opened in the early 1940s and was operated by Morton Chemical Co. until 1999, when Morton was acquired by Rohm and Haas.

Joanne Branham, her husband, Franklin, and their five children lived about a mile south of the plant from 1960 to 1997. They breathed vinyl chloride that wafted up from an eight-acre waste lagoon used from about 1960 to 1977 and from a shallow aquifer that a Morton Chemical consultant found to be tainted with the chemical. The carcinogens benzene and vinylidene chloride were found in the aquifer as well. Vinylidene chloride breaks down into vinyl chloride when dumped on the ground.

The Branham family also drank and bathed in water from a deeper aquifer that went untested by the company until late 2006, after the first three lawsuits were filed. There is evidence that this aquifer contained vinyl chloride at one time, Freiwald said.

Joanne Branham recalls the foul odors that permeated her neighborhood, especially during the 1970s. “The smell was so bad that we had to keep our windows closed in the summertime,” she said. “There were times when it almost hurt your eyes.” At one point, she went to the plant office to complain. “I said, ‘What is this smell?’ and they said, ‘Oh, it’s nothing. It’s just stuff we put in the chemicals.’”

Their children grown, Joanne and Franklin Branham left McCullom Lake for Apache Junction, Arizona, in 1997. Five years later, Franklin began having unexplained seizures. An MRI in 2004 revealed the cause: glioblastoma multiforme. “They wanted to put him in a nursing home because he couldn’t walk,” Joanne said of her husband. “I said, ‘No way.’ We took him home.”

On June 18, 2004, Franklin Branham dropped dead on his front lawn. He was 63. His family’s case against Rohm and Haas will be the first to go to trial, and Joanne is adamant that the company be held accountable for her husband’s death. “What they did was very wrong,” she said. “My husband was my best friend. My kids lost their father.”

Bryan Freund has lived in McCullom Lake for 23 years and was the Branhams’ next-door neighbor from 1987 to 1997. A truck driver who ran a successful jewelry business on the side, Freund was diagnosed with oligodendroglioma — a form of brain cancer even rarer than glioblastoma multiforme — in December 2004. Unable to work, he lives on disability payments. “I’d probably be buried in debt if I weren’t a veteran,” he said.

Freund’s life since the diagnosis has been “a struggle in every way,” he said. “Often I wake up with a very bad headache that will last several days. I have a very hard time reaching any sort of goals. It’s a very bad way to be thrust into retirement.”

Company: No Cluster of Brain Cancer Cases


In her statement to the Center, Rohm and Haas spokeswoman Garrity wrote that agencies such as the Illinois Department of Public Health have “concluded that a ‘cluster’ of primary brain tumors does not exist in McHenry County.”

Freiwald argues, however, that studies of brain cancer incidence in McHenry County and its population of 300,000 have no relevance to events in tiny McCullom Lake. The judge in the upcoming trial agreed.

In a May 12 order, Judge Allan L. Tereshko of the Court of Common Pleas of Philadelphia County wrote that studies of both the county and the ZIP code in which the town lies — 60050 — encompass “a much larger geographical area and a much greater population than the Village. These larger areas are not alleged to be in the same exposure zone as the Village …. Therefore, these analyses or studies are irrelevant to the issues before this Court, and can only serve as a source of confusion and misdirection.” The judge granted Freiwald’s motion to exclude the studies from the trial.

One of Freiwald’s experts — Richard Neugebauer, an epidemiologist on the medical school faculty at Columbia University — analyzed data obtained from the Illinois State Cancer Registry for the relatively small areas in which air or groundwater exposures to vinyl chloride and other chemicals are alleged to have occurred.

Within the air exposure zone, Neugebauer reported in July, the brain cancer rate from 1986 to 2006 was nearly three times the rates for Illinois or McHenry County; this difference, he wrote, was “statistically significant,” or unlikely to be due to chance. Within the groundwater exposure zone, the rate was more than five times that of the state or the county. All of McCullom Lake Village is in the air exposure zone, and most of it is in the groundwater exposure zone.

About 2½ years ago, all of the plaintiffs settled with Modine Manufacturing Co., a maker of automobile radiators alleged to have dumped small amounts of TCE upstream of McCullom Lake Village. Freiwald, however, described Modine as a minor player in the brain cancer saga. His focus is Rohm and Haas.

“This wasn’t just any company that dumped millions of gallons of chemicals,” Freiwald said. “This was a chemical company. They knew what they were doing and they knew the harm they could be causing.”

In fact, a confidential 1973 Morton Chemical memorandum warns of “gross pollution” from the waste lagoon. The contamination “is not generally considered highly toxic, and one has no reason to believe that there is any potential for a serious health hazard,” the memo says. It adds, however, that “if the seepage problem were brought to the attention of the state and federal regulatory agencies, we could expect action to be taken rather abruptly.”

The 1973 memo doesn’t mention vinyl chloride or other volatile organic compounds that will come up during the Philadelphia trial. But a 1985 consultant’s report — also confidential — does. Monitoring wells, it says, revealed “high concentrations of benzene and vinylidene chloride” in the shallow aquifer. “Both of the compounds are listed carcinogens,” the report notes. It also documents the presence of vinyl chloride, “a listed carcinogen, with a recommended concentration in water to protect human health of zero.”

Brain Cancer Deaths: Questioning the Numbers
 

A former investigative reporter with Legal Times, The American Lawyer, and Court TV, Freiwald has spent almost five years building his case against Rohm and Haas. After reviewing old chemical industry documents, court filings, and newspaper clippings and interviewing survivors of dead workers, Freiwald and his colleagues concluded that up to two dozen brain cancer deaths had been left out of Mundt’s update of the vinyl chloride workers study.

Mundt reported 36 brain cancer deaths; the actual number, in Freiwald’s view, is closer to 60.

“Mundt inherited a lot of problems from those earlier studies,” Freiwald said. “The companies determined which workers were included and which weren’t. Older workers, in many instances, were not included. Those were the people with the highest exposures in most cases.”

The undercounting, Freiwald said, was most pronounced at Union Carbide’s now-closed vinyl resin plant in Texas City, Texas. (Union Carbide was acquired by Dow in 2001). Mundt’s study makes note of only one fatal case of brain cancer at the plant. But a Union Carbide document shows 19 cases — 13 that apparently met Mundt’s criteria for inclusion in the study and six that didn’t.

The original worker study was conceived by a trade group called the Manufacturing Chemists Association — later known as the Chemical Manufacturers Association and now the American Chemistry Council — in the early 1970s, after rodent tests suggested that vinyl chloride could cause cancer. Minutes of the December 14, 1971, meeting of a Manufacturing Chemists Association panel show that industry officials were clearly worried: The panel concluded that there was a need “to assure the employees of the industry that management was concerned for, and diligent in seeking the information necessary, to protect their health.” There also was a need “to develop data useful in defense of the industry against invalid claims for injury for alleged occupational or community exposure.”

In January 1974, B.F. Goodrich informed federal officials that four employees of its PVC plant near Louisville, Kentucky, had been diagnosed with angiosarcoma since 1967. The tumor was so rare that only about 25 cases per year occurred in the U.S., according to the CDC. The Occupational Safety and Health Administration moved quickly to crack down on vinyl chloride, proposing a 500-fold reduction in the exposure limit in the space of a few months. Despite industry predictions of an economic cataclysm, PVC plants were able to achieve the reduction in short order, and the risk of angiosarcoma among workers was “virtually eliminated,” the CDC found.

The industry’s original worker study, also completed in 1974, didn’t specify a death rate for brain cancer. But a follow-up study, completed in 1978, found a “significant excess” of deaths from brain cancer and other malignancies of the nervous system.

The idea of further investigation took on new urgency in 1979, when news accounts of a brain cancer cluster at the Union Carbide plant in Texas City began to surface. “Controversial issue here, thus need to act quickly,” state the minutes of the March 4, 1980, meeting of the Chemical Manufacturers Association’s Vinyl Chloride Technical Panel. One attendee commented “that we may find out what we do not want to know with regards to brain cancer.”

In a memo on September 26, 1980, Z. G. Bell, an official with PPG Industries, a vinyl chloride manufacturer, wrote, “If we can gain information to help in future lawsuits, then this effort would be worthwhile.”

In a 1991 update of the worker study, a team of researchers led by Otto Wong reported an “excess in cancer of the brain and [central nervous system].” Two years later — after the Chemical Manufacturers Association complained that he had published without the trade group’s permission — Wong backtracked, stating in a letter to the American Journal of Industrial Medicine that the seeming excess of brain tumors among workers may have been due to better diagnosis and reporting of such tumors by large corporations as compared to the general population.

“We conclude that our finding of an excess of brain cancer among U.S. vinyl chloride workers reported earlier was not likely related to the chemical,” Wong, who could not be reached for comment, wrote in 1993. Mundt reported seven years later that “any risk of brain cancer associated with employment in the vinyl chloride industry has tapered off.”

Bryan Freund is undeterred by such findings. He’s convinced that his illness and the illnesses suffered by his neighbors are not happenstance and is eager to have his day in court. “Maybe we’ll be able to link [vinyl chloride] more conclusively to brain cancer and save lives where chemical plants are making this poison,” Freund said. “Ten people are dead from this and many more are on the way.”

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