Edel Rodríguez

This summer, a small Texas-based company began marketing a plastic baby bottle it claims is the first on the market to be “guaranteed” safe from health risks associated with bottles made from commonly used bisphenol-A (BPA).

The rollout is modest; the company is selling the bottle on a website and using crowdsourcing to fund broader distribution of a $19.95 baby bottle aimed at parents concerned about the health effects of plastics.

Yet this is no ordinary product launch. Behind the small-scale marketing of one new product by a tiny company is an important story with national implications. It’s a story that pits academic science against corporate science and raises as many questions about freedom of speech and commerce as about public health.

It starts with a University of Texas scientist named George Bittner, who has been one of the nation’s most relentless advocates of safer plastics, despite efforts by the Eastman Chemical Company to silence him. Bittner is one of the small-business owners behind the introduction of the “Productpure” baby bottle.

Productpure is a spinoff by two small private lab companies in Austin that Bittner, a neurobiology professor, founded. The two labs, CertiChem and PlastiPure, had a simple business model. CertiChem would test consumer plastics for “estrogenic activity” found in clear plastic bottles and liners of food cans made from BPA, and sometimes found in other plastics. PlastiPure would develop safe alternatives to estrogenic-active plastic products.

It seemed like a winning proposition. There is a growing scientific consensus linking estrogenic-active plastics to obesity, cancers, low sperm count, infertility, heart disease, and precocious puberty in girls. Health-conscious consumers were demanding plastic containers that don’t rewire their metabolism, or alter the development of their children’s reproductive systems.

With their tests discredited by a judge and jury, resources drained by more than a year of pre-trial discovery, and staffs reduced from 15 to five, CertiChem and PlastiPure looked like failing, undercapitalized startups.

Incorporated in 2000, the two labs began running scientific tests on consumer plastics so widely used that almost no child or adult living in a developed country could avoid exposure to them: baby bottles, sippy cups, clear plastic water bottles, sports bottles, and food store bins holding fresh fish, produce, and meat.

Then in 2010, CertiChem’s scientists made what turned out to be a critical mistake. They moved beyond testing BPA to testing a new copolymer plastic called Tritan, which Eastman Chemical began marketing in 2007 as a safe alternative to BPA.

PlastiPure’s marketing team made a second mistake. They advertised critical test findings on the company website, at a trade fair, and in commercial brochures.

Eastman filed suit in federal court in Austin. The multi-national corporation, which spun off from Eastman-Kodak in 1994, had poured tens of millions of dollars into developing and marketing Tritan, and the integrity of its product had been questioned by two Texas outfits no one had heard of.

The litigants were in no way evenly matched. Two small businesses operating out of a strip mall in Austin were confronted by a Fortune 500 company with $9 billion in annual revenue. (The Washington Spectator published two stories about the 2013 civil suit, which was initially ignored by most media outlets.)

Eastman’s lawyers asked for no monetary damages. They wanted the judge to rule that their client’s product had been falsely maligned, and to enjoin anyone associated with the labs from engaging in commercial speech about Eastman’s trademarked plastic or products made from it.

After four-and-a half days in court in the summer of 2013, a jury ruled that CertiChem and PlastiPure had unfairly disparaged Tritan. Federal District Judge Sam Sparks permanently enjoined anyone associated with the two labs from ever mentioning Tritan in commercial speech, and from saying that the breast-cancer-cell-based assays used by their scientists are a “definitive final test for estrogenic activity in chemicals or substances, including Tritan.”

The testing lab was shut out of the testing business. CamelBak, Tupperware, Nalgene, Evenflo, Thermos, Lock&Lock, Weil Baby and dozens of other companies that used Tritan in their EA-Free product lines were suddenly off limits. (CertiChem could test, but could not publish results of its testing.)

With their tests discredited by a judge and jury, resources drained by more than a year of pre-trial discovery, and staffs reduced from 15 to five, CertiChem and PlastiPure looked like failing, undercapitalized startups.

Three years later, they’re back—with a baby bottle to sell.

“The bottle is made from polypropylene,” PlastiPure CEO Mike Usey said in a phone interview.

The bottles are manufactured in China, using a process developed in PlastiPure’s Austin lab. Usey said a lot can go wrong in the process of turning plastic into a baby bottle: additives, catalysts, overheating, can create estrogenic activity in a “clean” plastic. Before bottles are shipped to retail outlets or individual buyers, samples of each production run are tested by CertiChem.

At the trial Eastman’s lawyers characterized Bittner and his business associates as grifters living on the largesse of the federal government. In fact, it was federal funding that made the new bottle a reality. The labs have been subsidized by government grants. One National Institute of Environmental Health Sciences grant of $1.3 million paid for research to develop an alternative to Eastman’s Tritan, according to documents obtained The Washington Spectator. So although they operate on economies of vastly different scales (14,000 employees to 15 employees), the Texas upstarts and Eastman are competitors.

No one is making book on Productpure’s new baby bottle making a dent in Tritan’s market dominance. Yet the owners of the Texas labs are betting there is a safe-baby-bottle market among mothers concerned about estrogenic activity in plastic, which represents the greatest health threat during early (embryonic to sexual maturity) stages of human development.

Science for Sale

Prior to the lawsuit that almost shuttered the two labs, Reuters science reporter Sharon Begley wrote a story that ran under the headline: “When science is for hire: ‘Independent’ labs that verified safety were paid by chemical firm.”

Bittner seemed unable to come to terms with the reality that lawsuits are won and lost on “facts and law,” not “scientific method and law.”

Begley posed the question on which the trial pivoted: can scientific research paid for by a corporation be considered independent research? She reported that Eastman had paid $10,000 to a toxicologist who described himself as “independent scientist” when he was listed as the author of an academic journal article that gave Eastman’s plastic a clean bill of health. The two co-authors of the article were Eastman scientists. She also reported, as did The Washington Spectator at the time, that the tests described in the article were shaped by Eastman scientists.

In fact, Eastman Chemical Inc. v. PlastiPure Inc. might have been styled Corporate Science v. Independent Science.

While defendant George Bittner was characterized by the plaintiffs as an academic hustler selling discredited tests, his day job on the University of Texas at Austin campus involved the chemical regeneration of invertebrate neurons. He had (according to Bloomberg’s executive profiles) published more than “150 peer-reviewed publications in synaptic biophysics, electro physiology, cell/molecular biology, and biochemistry of nerve regeneration,” and the tests Eastman set out to discredit had been accepted in research and academic labs since Ronald Reagan was in the White House.

Attorneys for the defendants brought in as expert witnesses a half-dozen preeminent and widely published scientists from university faculties.

Eastman relied on industry scientists. The expert witness who convinced the jury that only tests on living mammals could detect estrogenic activity, for example, described his past work for the American Chemistry Council, an industry group that lobbies against consumer-protection rules and legislation.

Bittner was better suited to a lab than the witness stand. Aloof, prickly, precise in a scientific way that angered the judge, alienated the jury, and frustrated attorneys, Bittner prefaced the answer to one question by criticizing plaintiff’s counsel for the way he waved his pointer in the air. He seemed unable to come to terms with the reality that lawsuits are won and lost on “facts and law,” not “scientific method and law.”

After the trial, although enjoined from commercial speech, the professor began a guerilla campaign, reiterating in scientific journals the same claims, and more, that had provoked the lawsuit.

An article Bittner and two CertiChem scientists published in the peer-reviewed journal Environmental Health describes tests that detected estrogenic activity in products made from Tritan, the Eastman plastic the professor is banned from discussing in commercial speech. Another article, also published in Environmental Health, describes tests on the Tritan co-polymer, which also detected estrogenic activity.

I asked Candy Eslinger in Eastman’s corporate communications office about the claims Bittner made about products made with Tritan, and similar claims in the journal article in which he described test results on Tritan itself. Eslinger responded by e-mail, saying in part:

Eastman can confidently say that comprehensive independent third-party testing using well-recognized scientific tests has shown that Eastman Tritan™ copolyesters are free of estrogenic and androgenic activity. Eastman Tritan™ copolyesters have been reviewed independently and cleared for food contact applications by several regulatory agencies, including: Health Canada, U.S. Food and Drug Administration, European Food Safety Authority and Japan Hygienic Olefin and Styrene Plastics Association (JHOSPA).

Her e-mail response to my questions also reiterated the jury’s ruling on tests Bittner had used.

“These are simply screening tests and should not be looked to as definitive tests for estrogenic activity.”

That was the big win for corporate science: a jury decision that lab tests using human cell lines are no longer valid to detect chemical exposure that institutions like the Mayo Clinic and the National Institutes of Health describe as a health risk.

Testing plastic with an assay using cancerous, human, breast-cell lines is a standard practice in university research labs and the private Texas labs. These “in vitro” assays cost less than $500 and can be completed in a day; “in vivo” studies using live rodents cost $100,000 and upward and require weeks to complete.

Eastman’s lead attorney even went so far as to dismiss scientific conclusions about risks associated with BPA, the plastic Eastman set out to replace with its safer alternative:

[A]round the turn of this century, there became some concern, some published concern

that BPA, bisphenol-A, which is a component of polycarbonate, another type of plastic, and at the time one of the most popular plastics making baby bottles and water bottles… it might be estrogenic. That’s never been scientifically established…

Except where it has been established by scientists.

Speaking to PBS Frontline in 1988, Frederick vom Saal, described as “a Professor of Biological Sciences, University of Missouri [and] a leading researcher in the field of developmental biology,” took a different position:

[B]isphenol-A mimics the hormone that women produce in their ovaries, and it mimics this hormone estradiol [estrogen] that is actually being produced in fetuses and during pregnancy.

Estradiol plays a critical role in development and then normal functioning of the body for the rest of an individual’s life. The amount of estradiol you’re exposed to throughout your life is also the best predictor of breast cancer. This chemical mimics that hormone. The body can’t tell the difference between bisphenol-A and estradiol. In other words, it sees this chemical and it thinks it’s getting exposed to its natural hormone.

Those two short quotes bring into high relief the scientific dispute on which a Texas jury ruled three years ago.

Eastman is standing by what it won in court three years ago: “In 2013, Eastman prevailed in a lawsuit against PlastiPure and CertiChem based on scientific evidence and expert testimony.”

The gagged university professor is arguing his case in scientific journals.

And selling bottles.