Impure Plastic?

On its face, Eastman Chemical’s lawsuit against two small Texas labs that have said its plastics may be unsafe for consumption looks like a David and Goliath kind of fight (in fact, that’s how the labs are describing it). Corporate giant attempts to silence scientists -- including a professor at the University of Texas at Austin -- from publicizing research that runs counter to its commercial interests.

But the case is also more nuanced, with both sides potentially having a financial stake in the outcome. That's given it unusual sticking power in a legal system that typically leaves questions of science to the scientists, and raised questions about the intersection of academic freedom and private enterprise. And in a development that has attracted conflict-of-interest watchdogs in the publishing realm, Eastman is trying to block the release of letters showing its funding the writing of a paper that supports its position.

Eastman is suing Austin-based CertiChem and PlastiPure, for misrepresentation of its Tritan resins under the Lanham Act against false advertising. Tritan, found in baby bottles and other consumer plastics, is marketed as being a safe alternative to plastics made with Bisphenol A. More commonly known as BPA, the monomer has been found to have hormone-like properties that may disrupt the endocrine system, making them potentially unsafe for consumer products – especially those used by pregnant women, infants and young children. (The U.S., Canada and European Union all have banned its use in the production of baby bottles in recent years.)

Although relevant research in human subjects is scant, exposure to BPA in utero has been linked in animals to abnormal breast tissue development, early puberty and decreased fertility. Several recent studies also have connected childhood exposure to BPA to obesity.

Eastman says that Tritan products are not estrogen-active, and therefore, unlike BPA-based products, do not disrupt hormone function. But research published in 2011 by George Bittner, a professor of neurobiology at the University of Texas, showed otherwise. Funded in part by the National Institutes of Health, Bittner and a team of fellow scientists, some of whom are affiliated with CertiChem and PlastiPure, used a test based on a line of breast cancer cells said to be extremely sensitive to estrogenic activity to show that several Tritan products still demonstrated estrogenic activity following certain stress tests. They published their findings about Tritan and dozens of other plastics also shown to be estrogen active in Environmental Health Perspectives, a peer-reviewed journal published by the National Institute of Environmental Health Sciences.

Eastman commissioned a response to that article criticizing Bittner and his team for using an in vitro assay (a kind of test) and not a live animal test, among other study details, according to court documents. It also funded third-party research to look into disproving Bittner’s claims. The study in Food and Chemical Toxicology, a peer-reviewed journal published by Elsevier, detailed a battery of computer modeling, in vitro and in vivo tests showing that Tritan products do not bond to estrogenic or androgenic (male hormone) receptors.

In the midst of the publishing flurry, in early 2012, Eastman also launched its suit against CertiChem, the certification lab of which Bittner is founder, and PlastiPure, a closely related private company Bittner founded to develop non-estrogen-active plastics. In its suit, Eastman claims that both labs, through published research and in promotional materials, made false and misleading statements about Tritan copolyester based on a single, “non-definitive” screening test. Because false positives can be observed with the MCF-7 assay Bittner used, Eastman says that more definitive tests are needed to draw conclusions about a polymer’s potential for estrogenic or androgenic activity. It also states that its in vivo testing methods in rats, documented in the Food and Chemical Toxicology study, are the scientific community’s “gold standard” for testing for endocrine disruption, and – unlike CertiChem’s assay – are recognized by the Environmental Protection Agency.

Eastman’s suit does not challenge Bittner’s results. Rather it hinges mainly on what Eastman sees as Bittner’s conflict of interest as chief scientific officer at PlastiPure. By showing other plastics to be estrogen-active, it says, PlastiPure stands to benefit by marketing itself as the “first and only company developing plastic materials, processes, and products that are safer both for humans and the environment” by using the “most sensitive available [estrogen activity] assay."

Eastman is expected to seek more than $5 million damages related to CertiChem and PlastiPure’s research and marketing, and recovery of any profits the labs made “from the false advertising herein.” (Eastman asked the labs to stop using the Tritan name in their advertising and to stop claiming to be the first and only company developing non-estrogen-active plastics in a letter sent before the suit.)

In its response and counterclaim, CertiChem and PlastiPure allege that Eastman is launching the suit to silence debate about a serious public health issue.

It reads: “This ought to be a scientific dispute to be resolved in the way scientific disagreements are normally resolved, the way countless scientific debates have been resolved over hundreds of years, i.e., by study, experimentation, exchange of ideas and data, publication of test results and analysis, and debate, all ultimately aiming at attaining a resolution of a legitimate and important scientific issue.”

CertiChem and PlastiPure assert the value of their assay and outline steps taken to avoid false negatives and defend their normal use stress tests. They also allege that Eastman's animal study, led by Thomas Osimitz, toxicologist and founder of the consulting firm Science Strategies, was flawed, including that it used rats known to be insensitive to estrogen. Osimitz did not return requests for comment.

Eastman has successfully requested that numerous documents relating to the case be sealed, including letters required by the journal that show Eastman commissioned Osimitz and other scientists to pen the study upholding Tritan’s integrity, court documents show. Eastman’s lawyer, Rick Harrison, argued the letters should be sealed because the scientists’ potential for conflict of interest wasn’t disclosed in the Food and Chemical Toxicology article, and that including them in the case could consequently taint the value of the research.

He argued to Judge Sam Sparks, “Here, we have a situation where five statements of conflict that were filled out for this publisher were filled out truthfully, and so forth, and then, the publisher, for whatever reason, decided not to publish it."

It’s unclear why the potential for conflict of interest wasn’t included in the article. Jeffrey Beall, a librarian at the University of Colorado at Denver and editor of Scholarly Open Access, a blog about academic publishing, said that Elsevier is a respected publisher and its conflict of interest policies are standard within the publishing world in that they require disclosures from authors and publish them. Authors also must disclose funding sources.

A. Wallace Hayes, the editor of Food and Chemical Toxicology did not respond to requests for comment about the case.

Some of the confusion could be related to Elsevier’s classifications of conflict of interest, said Jane Robbins, senior lecturer at the University of Arizona’s McGuire Center for Entrepreneurship (and writer of this publication’s Sounding Board blog). “[If] your form of conflict is not strictly one of the ones listed, and you decide that a ‘consultancy’ (listed) is actually a ‘service fee’ (not listed),” it can become easy to rationalize omissions or half-truths.

“This is the biggest problem with disclosure: It is unreliable, partial, and of course does not either prevent conflict or do anything other than let us know we may not want to trust the source," she said.

In expert testimony, Michael Denison, professor of environmental toxicology of the University of California at Davis, said he had "many concerns about the data presented in the figures in the Osimitz paper," which include "many unexplained omissions" and lack statistical analysis. "It is possible if not likely that some data points are significantly different from the control activity."

And CertiChem and PlastiPure face their own set of questions about conflict of interest.

In an interview, Bittner said the fact that he’s affiliated with both labs doesn’t change his data. “Our integrity is important to us and there are going to be a fair number of expert witnesses” at the trial, he said. (Ana Soto, a professor of anatomy and cellular biology at Tufts who helped discover the E-Screen assay type used by CertiChem, is among those who offered a deposition in the case. In an interview, Soto said that, at least “on paper,” it looked as if Bittner’s use of the assay was adequate for his purposes, and that she was unaware of any superior assays to detect estrogenic activity.)

Mike Usey, CEO of PlastiPure, said that his company did not benefit from denouncing other plastics companies, and that research related to the Tritan findings was an attempt to find estrogen-free building blocks to develop its plastics. “We were hoping it would be a polycarbonate replacement because we didn’t have an alternative product,” he said. “If it was, we could have closed more deals.”

Sheldon Krimsky, a professor of urban and environmental policy and planning at Tufts who has written extensively about scientific research, conflict of interest and the law, said the case is complicated in that both sides have an interest in the outcome of their research. It’s not as clear-cut as a company trying to research patented material for the public good, for example, he said.

Still, Robbins said she guessed the occurrence of corporations suing certification labs for findings that put their products in a bad light was fairly low; the large consumer lab that tests thousands of products for Consumer Reports, for example, is rarely sued and has never lost or even settled a case, she said.

“Scientific research is always evolving and you can’t just sue because you don’t like a finding,” said Robbins. “You can try to discredit it, or refute it in your own way, but a suit requires showing the findings were wrong, and more likely intentionally wrong and, in particular, wrong within the measures used.” That's hard to prove, and much of what's presented in the suit boils down to simple competition between two businesses, she added. "Get out of the kitchen if you can't take the heat."

That being the case, the suit could be an attempt to scare PlastiPure out of the business. PlastiPure “is claiming to [be developing] a next-generation plastic, and Eastman appears to be worried. If Eastman is large and PlastiPure is small, they may see them as an upstart and a relatively easy target to scare.”

Bittner anticipates legal fees amounting to $2 million, he said. “This is a suit designed to put a small firm out of business.”

A recent legal development may offer insight into how it will play out when the trial begins later this month in a federal court in Austin.

In June, U.S. Circuit Court of Appeals for the Second Circuit in New York found that researchers who publish findings relating to open scientific questions cannot be sued for defamation. The ruling related to a Lanham Act suit launched by ONY, Inc., against Cornerstone Theraupeutics, Inc., the Italian company Chiesi Farmaceutici SpA, a group of doctors, and the American Academy of Pediatrics.

ONY, a pharmaceutical company, alleged that findings about its respiratory drug for premature infants from comparative study of similar drugs commissioned by fellow drug maker Chiesi, misrepresented its effectiveness. Parts of the study were published in the pediatrics academy’s Journal of Perinatology, which Chiesi later used to tout the effectiveness of its own drug.

Speaking for the unanimous three-judge panel, Judge Gerard E. Lynch wrote in his opinion, “As a matter of law, statements of scientific conclusions about unsettled matters of scientific debate cannot give rise to liability for damages sounding in defamation.” Academic freedom, he added, “is a special concern of the First Amendment.”

The court also found companies can use their published findings for promotional reasons, as long as they are not misleading.

Although the decision applies technically only within that court’s jurisdiction -- New York, Connecticut and Vermont – it can be noted as a precedent within other districts.

Bittner said questions about estrogen activity shouldn’t be debated in court, but rather within scientific discourse and, at the consumer level, in the court of public opinion. But, he said, the case at least is shedding on light on what could potentially be a significant public health issue.

Citing legal concerns, a spokeswoman for Eastman declined to talk in detail about the case. But in an e-mailed statement, Lucian Boldea, vice president and general manager of specialty materials at Eastman said, “We remain confident in the science behind our product and remain focused on continuing to meet our customers’ needs.”