Beijing Law Review, 2011, 2, 55-62
doi:10.4236/blr.2011.22006 Published Online June 2011 (
Copyright © 2011 SciRes. BLR
The In-Terrorem Value of Science: Bisphenol-A
Litigation and an Empirical Assessment of Science
as a Collective Litigation Tool
Suman Kakar1, Sanjeev Sirpal2
1School of Criminal Justice, Honors College, Florida International University, Miami, USA; 2College of Law, Florida International
University, Miami, USA.
Received June 10th, 2010; revised February 18th, 2011; accepted March 24th, 2011.
This paper examines the role that science plays as a tool in collective litigation to substantiate claims. Scientific data
and expert testimony are often included to buttress a claim and the admissibility of such evidence is often a conse-
quence of the extant evidentiary rules and their application. The article will focus on the multidistrict litigation con-
cerning Bisphenol-A (“BPA”) as a case study of the phenomena of scientific tailoring of evid ence and its admissibility.
BPA is a compound included in the synthesis of plastics and is found in food containers, plastic bottles, and ep-
oxy-based coatings used to avert the rusting process of food containers. There is a negligible amount of BPA in several
food and beverage products. Several countries along with the US Food and Drug Administration (FDA) and Environ-
mental Protection Agency (EPA) have marshaled scientific studies that demonstrate the lack of any definable negative
health effect attributable to an exposure to trace amounts of BPA. Notwithstanding the conclusions of these scientific
inquiries, opponents have asserted that BPA exposure results in an alteration of embryonic hormone levels, thereby
impacting their development and later reproductive function. This article will address these issues in addition to the
salient question of what role science plays as a tool for co llective litigation.
Keywords: Collective Litigation, Scientific Evidence, Bisphenol-A, BPA, Expert Testimony
1. Introduction
Bisphenol-A (“BPA”) is a compound included in the
synthesis of plastics and is found in food containers,
plastic bottles, and epoxy-based coatings used to avert
the rusting process of food containers. There is a negligi-
ble amount of BPA in several food and beverage prod-
ucts. Several countries alon g with the US Food and Drug
Administration (FDA) and Environmental Protection
Agency (EPA) have marshaled scientific studies that
demonstrate the lack of any definable negative health
effect attributable to an exposure to trace amounts of
BPA. Notwithstanding the conclusions of these scientific
inquiries, opponents have asserted that the negative con-
sequences of BPA exposure manifest as an alteration of
an embryo’s hormone levels which thereby impact their
development and later reproductiv e function.
The questions presented thus far in the litigation con-
cerning BPA1 surround 1) the issue of primary jurisdic-
tion and 2) federal preemption. Specifically, the court
considered the defense’s argument, i.e., the court lacks
primary jurisdiction as such lies with the FDA exclu-
sively on the BPA issue. The defendants’ argument was
presented as a basis for dismissal of the lawsuit. The
court denied the defense’s motion, and reasoned that
there is a distinction in the charge of the court at that
juncture and the regulatory latitude of the FDA as it re-
lates to BPA. The court held that, concerning the defen-
dants’ federal preemption argument, the question was
addressed by the Supreme Court’s ruling2 where it was
held that states could create and implement further regu-
lations above and beyond a federal regulatory “floor”.
This article will address these issues in addition to the
salient question of what role science plays as a tool for
collective litigation .
1In re Bisphenol-A (BPA) Polycarbonate Plastic Products Liability
Litigation, MDL No. 1967, Slip Op. 1 (W.D. Mo. Nov. 9, 2009).
2Wyeth v. Levine, 129 S. Ct. 1187 (2009).
The In-Terrorem Value of Science: Bisphenol-A Litigation and an Empirical Assessment of
56 Science as a Collective Litigation Tool
BPA is an endocrine disruptor found in many con-
sumer products including infant fo rmula cans and bo ttles.
It may be affecting the reproductive and metabo lic health
of infants and children. While some uncertainty exists
about its effects, there is some scientific evidence that
BPA is harmful, enough that some countries have banned
its usage from infant and children’s products. Proponents
of a ban on BPA argue that by adopting the precaution-
ary principle, these measures would protect our most
vulnerable population from harm as evaluation of BPA ’s
safety continues.
BPA is used as a liner in most tin cans including infan t
formula cans, and in baby bottles, sippy cups, dental sea-
lants, and bicycle helmets [1]. BPA is not acutely toxic,
meaning that poisonous effects do not occur following a
single exposure. Instead, BPA is an endocrine disruptor,
an agent which acts like a hormone inside the body and
interferes with natural physiological processes.
Some data indicates that there may be an effect of
low-level BPA exposure on the correct functioning of
hormones, especially during early stages of development
[2]. Infants are considered a particularly susceptible risk
group. In animals, BPA has been linked to various re-
productive, neurodevelopmental, and metabolic problems.
Epidemiological stud ies, which focus on health effects in
human populations, have found correlations between
higher levels of BPA and more of these physiological
effects, as well as higher levels of heart disease. However,
these studies are highly contested by plastics industry
Many countries are currently evaluating their response
to the regulation of BPA. Canada has banned BPA for
various products including baby bottles. In Japan, manu-
facturers have instituted a voluntary reduction on BPA’s
usage in food canisters. Following the voluntary reduc-
tion of BPA, Japanese BPA body burdens, the amount of
a substance found in each human body [3] have declined
as well. To date, America and the European Union (the
“EU”) currently hold that the use of BPA is acceptable.
In addition, despite recent voluntary production of BPA-
free plastic bottles in the United States, baby bottles con-
taining BPA continue to be produced internationally.
There is a recent American movement to remove BPA
from food and beverage receptacles, and products for
infants and children under age three. The U.S. FDA in
August 2008 reiterated its intention not to regulate BPA
in food and beverage receptacles. In response, in 2009,
the states of Minnesota and Connecticut, as well as local
governments in Chicago, Illinois and Suffolk County,
New York, all instituted local restrictions or bans on the
inclusion of BPA as a chemical component of baby bot-
tles, formula cans, or other children’s products.
Voluntary efforts have also limited BPA production.
In 2008, consumer groups voiced their concerns. Major
retailers responded by refusing to stock baby bottles and
other drinking containers containing BPA, and some
manufacturers began to produce BPA-free alternatives.
For instance, the six main corporate producers of baby
bottles agreed in March 2009 to a ban on the usage of
BPA in infant food sources or containers sold in the
United States. Next, a chemical manufacturer of BPA,
Sunuco, announced th at it would no longer sell its p lastic
to makers of children’s products. However, other manu-
facturers such as Dow Chemical Company, Bayer, and
Hexion Specialty Chemicals continue to market BPA and
to use it as a liner in cans of infant formula, in baby food
containers, in toddler sippy cups, and in many other in-
fant and children’s products.
In addition to voluntary efforts at BPA reduction, there
have been legislative efforts to achieve the same goal. In
March 2009, the U.S. House of Representatives intro-
duced a bill barring the inclusion of BPA in food and
beverage containers, and in July 2009, the FDA an-
nounced its intention to reconsider its BPA decision.
Proponents of a BPA ban point to the limited scien tific
data showing its deleterious effects and argue that a
comprehensive national plan for control of BPA would
be the most effective way to address these problems,
because voluntary efforts cannot be monitored or en-
forced. How strong is such scientific evidence and should
it be legally admissible to buttress a collective tort claim?
2. The Evolution of Legal Admissibility of
Scientific Evidence
This subsection traces the requirements for legal admis-
sibility of scientific evidence, starting with Federal Rule
of Evidence 702, and then a discussion of the Frye and
Daubert evidentiary standards. This analysis is subse-
quently applied to the evidence sought to be admitted in
In re BPA Litigation. The extent of evidentiary support
necessary to corroborate the admissibility of such evi-
dence is reviewed, along with a review of the available
published research. It is argued that the experimental
outcomes that would establish the health consequences of
BPA and the standards on which conclusions are based
are lacking. Accordingly, it is argued that the available
research on the deleterious health consequences of BPA
fail to meet judicial evidentiary standards for the admis-
sibility of scientific evidence.
Federal Rule of Evidence 702 states that:
If scientific, technical, or other specialized knowledge
will assist the trier of fact to understand the evidence or
to determine a fact in issue, a witness qualified as an ex-
Copyright © 2011 SciRes. BLR
The In-Terrorem Value of Science: Bisphenol-A Litigation and an Empirical Assessment of 57
Science as a Collective Litigation Tool
pert by knowledge, skill, experience, training, or educa-
tion, may testify thereto in the form of an opinion or o th-
erwise, if (1) the testimony is based upon sufficient facts
or data, (2) the testimony is the product of reliable prin-
ciples and methods, and (3) the witness has applied the
principles and methods reliably to the facts of the case.
A dissection of FRE 702 reveals a test for the admis-
sion of an expert’s opinion or scientific evidence: 1)
Does the expert’s opinion relate to a matter of scientific,
technical or specialized knowledge?; and 2) Will the ex-
pert’s testimony be helpful to the trier of fact in deter-
mining a fact at issue in the case? To be rendered admis-
sible, “scientific knowledge” must be more than a mere
belief; it must be fact or theory rooted in methods or
procedures of science.
Frye and Daubert were two decisions that subse-
quently informed the courts’ application of Rule 702 in
rulings on the admissibility of scientific evidence.
2.1. The Frye and Daubert Standards
Courts have historically (from the beginning of the four-
teenth century) circumscribed the admissibility of hear-
say evidence, specifically lay opinion testimony. Not-
withstanding the restricted admissibility of opinion tes-
timony, it was generally rendered admissible where such
evidence was determined to be something other than
common sense and the opinion is rather predicated on the
witness’s independent and objective qualifications as an
expert. Such expertise is generally gained through par-
ticular training, knowledge, skill or experience in the
relevant subject area. This has molded the courts’ rulings
on admission of scientific opinion testimony.
The “Frye Rule,” i.e., scientific evidence is admissible
only if it evinces “general acceptance” within the specific
area of study, delineated the initial substantive con-
straints on the admissibility of exp ert testimony/evidence.
The Frye rule remained the most broadly adopted and
followed rule regulating the admission of scientific ex-
pert testimony and corresponding expert scientific evi-
dence until Daubert.
“Before its admission as evidence, scientific evidence
must have gained general acceptance in the relevant sci-
entific community, evinced by reliability and acceptance
by disinterested members of the scientific community”.
Subsequent to Frye, there was a change in the admissibil-
ity of scientific eviden ce in the federal courts. This chan-
ge in legal doctrine occurred secondary to the United
States Supreme Court's landmark decision in Daubert v.
Merrell Dow Pharmaceuticals, Inc.
The Daubert Court held that Rule 702 of the Federal
Rules of Evidence, not Frye, was controlling as the ap-
propriate standard for determining admissibility of ex pert
testimony as to scientific evidence in federal courts.
The Daubert Court provided several factors pertinent
to the determination of the admissib ility of exp ert “scien-
tific knowledge”—1) whether the evidence is based on a
testable theory or technique; 2) whether the theory or
technique has been subjected to peer review and publica-
tion; 3) the known or potential error rate of th e theory or
technique; and, 4) general acceptance of the theory or
technique within the scientific community. These factors
are not all-inclusive and do not purport to be exhaustive.
Rather, they were intended as a guide in the application
of the “flexible” “inquiry envisioned by Rule 702.”
In a post-Daubert judiciary, federal court judges play a
“gatekeeper” role concerning the admissibility of scien-
tific evidence. The trial judge is charged with the dual
tasks of 1) determining the qualifications of the expert
and 2) determining “whether the expert’s methodology is
reliable.” Since these are considered “preliminary rul-
ings” within the Federal Rules of Eviden ce, in a Daubert
hearing, the trial judge applies Rule 104(a) to assess the
qualifications of the expert witness and determine
whether the specific rationale underlying the expert’s
scientific testimony is grounded in sou nd science and can
be applied appropriately to the facts at issue. In Daubert,
Justice Blackmun explicated the basis of Rule 702’s de-
viation from the strictures of the Frye test:
Nothing in the text of this Rule establishes “general
acceptance” as an absolute prerequisite to admissibility...
The drafting history makes no mention of Frye, and a
rigid “general acceptance” requirement would be at odds
with the “liberal thrust” of the Federal Rules and their
“general approach of relaxing the traditional barriers to
‘opinion’ testimony.”
Subsequent to Daubert, several states followed the
federal judiciary’s model and disposed of the Frye rule
and in its place, followed Daub ert’s newer, arguably less
stringent approach to the admissibility of expert testi-
mony/scientific evidence. Widespread ideological dif-
ferences soon erupted among courts and commentators as
to the scope of Daubert’s application—whether it was
applicable to expert testimony in general, or scientific
expert testimony in particu lar. Similarly, broad co nfusion
and disagreement permeated the discussion of whether
Daubert was applicable to “experience-based testimony”
in contrast to research-backed testimony.
The Supreme Court sought to address these concerns
in Kumho, a case arising due to a car crash which was
allegedly caused by the implosion of a tire. In that case,
the plaintiffs argued that the tire defect occurred secon-
dary to a latent manufacturing defect in the tire itself.
Expert testimony was proffered to buttress their stance.
The defendants attempted to suppress th e admissibility of
Copyright © 2011 SciRes. BLR
The In-Terrorem Value of Science: Bisphenol-A Litigation and an Empirical Assessment of
58 Science as a Collective Litigation Tool
plaintiff exp ert’s testimony based on ground s of Daubert.
The trial court rendered the plaintiff expert’s testimony
inadmissible on grounds of Daubert and accordingly
granted summary judgment for defendants. On appeal,
the plaintiffs adopted a stance that Daubert was inappli-
cable to “experience-based technical opinions”. The Su-
preme Court did not accept such reasoning and instead
found that the trial court’s “gatekeeping function under
Daubert applied not on ly to scientific testimon y but to all
expert testimony based on scientific, technical or other
specialized knowledge”. Examining the language of FRE
702, the Court stated that the rule does not distinguish
“scientific,” “technical” and “other specialized” knowl-
edge. Hence, Kumho states that the federal courts “gate-
keeping” function pursuant to Daubert is applicable to all
testimony offered pursuant to rule 702, even “experien-
tial technical testimony”.
This ruling may prove to be potentially prejudicial to
plaintiffs because of the broad latitude afforded trial
judges in making the determination of the reliability of
the proffered scientific testimony, but also, the means,
rationale, and methodology employed to determine reli-
ability. The Court’s holding in Kumho clarifies that evi-
dentiary rules evidence afford the trial court judge with
the same discretion when it reaches a decision on how to
determine reliability as the judge would have in making
the final reliability determination.
The role of the court as a gate keeper is supported by a
two-fold rationale [4]: 1) it is imperative that an expert
utilize the “same level of intellectual rigor in the court-
room that characterizes the practice of an expert in the
relevant field,” regardless of whether the professional
opinion is predicated on scientific studies or personal
experience and that 2) upon a challenge to the factual
basis of the opinion, methodologies, or their specific ap-
plication, the trial judge is charged with determining the
reliability of the testimony in terms of its scientific
and/or experiential underpinnings . Furthermore, the spe-
cific Daubert factor analysis is triggered in particular
cases where the lower court/tribunal reaches the conclu-
sion that “they are reasonable measures of the reliability
of expert testimony.”
The trial court’s charge is no t only to determine the re-
liability or usefulness of the methodology applied, but,
more importantly, to make such a determination in ac-
cordance to the specific factors and issues of the case.
The abuse of discretion standard is the appropriate stan-
dard on appellate review of the lower court’s bipartite
decision of 1) the reliability of the testimony and 2) “how
to determine whether it is reliable.”
The two aspects of the Daubert requirements, reliabil-
ity and general acceptance, are holdovers from the Frye
test. Among the Daubert factors, the initial three are es-
sentially a greater in-depth analysis of reliability factors
and how that determination was reached, while the final
is a holdover of the notion of general acceptance from
the Frye test. “Near unanimity is no t required to establish
acceptance, but some measure of approval from the sci-
entific community must be shown before use of scientific
3. The BPA Case’s Influence on the
Standard of Evidence
The origins of litigation surrounding the usage of Bis-
phenol A are found in the 2008 formation of the Bisphe-
nol-A/Phthalates Proposed Litigation Group by the
American Association of Justice (“AAJ”). The class ac-
tion lawsuit [5] was initiated in a Missour i federal district
court with the assistance of the AAJ. That suit was filed
against numerous baby bottles and baby formula corpo-
rate producers concerning the inclusion of BPA in baby
bottles, food containers, and as an adhesive in baby for-
mula cans.
The class action plaintiff consumers’ legal argument
was that the usage of BPA as a chemical component of
baby products amounted to a failure of disclosure of a
material fact, i.e., pursuant to applicable state consumer
protection laws, the manufacturer was legally obliged to
make such a disclosure. Notably, the plaintiffs are not
asserting any personal injury secondary to exposure to
BPA. Rather, plaintiffs are arguing consumer fraud, mis-
representation, breach of warranties, and economic injury.
The main assertion is that had they h ad knowledge of the
presence of BPA, they would not have purchased the
products at hand.
The federal district court, in response to the number of
putative consumer fraud class actions surrounding BPA
convened the Joint Panel on Multidistrict Litigation,
which created an MDL [5]. About forty-eight matters are
merged and are currently before the Western District of
Missouri3. The court issued a recent ruling on the De-
fendants’ motions to dismiss.
In its slip opinion, the court addressed the defense’s
motions to dismiss on th e dual bases of primary jurisdic-
tion and federal preemption4. The court then expounded
on the regulatory underpinnings of BPA. The FDA has
created regulations that specifically delineate the healthy
and sanctioned use of specific plastic derivatives that are
deemed approved “food additives” under the FDA [8],
i.e., resinous and polymeric co atin gs. The co ur t reach ed a
determination that there is a reasonable inference to draw
3Frye v United States, 54 US App DC 46; 293 F 1013 (1923).
4509 US 579; 113 S Ct 2786; 125 L Ed 2d 469 (1993).
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The In-Terrorem Value of Science: Bisphenol-A Litigation and an Empirical Assessment of 59
Science as a Collective Litigation Tool
that the FDA has concluded the safety of food additives
containing BPA without labeling since the FDA is ob-
liged to use such labeling if it were required for health
and/or safety reasons5.
The court denied the defense’s primary jurisdiction
argument, i.e., that the FDA has primary jurisdiction on
the BPA issue, rendering dismissal of plaintiff’s lawsuit
as the remedy sought by the defense. The court drew an
interesting, albeit presumptively spurious distinction be-
tween the charge of the court and the regulatory authority
of the FDA:
“However, the ultimate issues in these cases are
whether defendants failed to disclose material facts to
Plaintiffs and whether Defendants breached the implied
warranty of merchantability through the sale of products
containing BPA6. The FDA cannot resolve these ques-
tions, and the FDA’s determination that BPA is ‘safe’ is
not determinative of any of those issues.”
The court next examined the defendants’ federal pre-
emption argument7. The court declined to adopt the de-
fendants’ reasoning relying on a recent Supreme Court
decision finding conflict preemption in a case where a
particular state law claim would essentially effectuate a
denial of applicable federal law. Rather, the court found
dispositive another Supreme Court opinion8 wherein the
court held that “federal regulation represented a floor
above which states could impose additional require-
The court concluded otherwise concerning the infant
formula defendants. These defendants did not couch their
preemption argument in terms of ‘conflict preemption’,
but instead on the “express preemption provisions in-
volving the FDCA’s misbranding provisions and accom-
panying regulations”10. These defendants referenced the
“FDA’s determination that epoxy resins are exempt from
disclosure under the FDA’s regulation governing inci-
dental additives”11. Given that the FDCA has issued an
express prohibition on state institutio n of labelin g of food
distinguishable from federal requirements, the Court held
that “the plaintiffs’ claims would embody a disclosure
requirement that is the exact opposite of the nondisclo-
sure of incidental additives that the FDA’s regulation
provides” 12.
The class action plaintiffs argued that they should have
been classified as under a “safety exemption” to the ex-
press preemption provision of the FDCA. The court,
however, deferred in judgment to its earlier ruling, find-
ing that the FDA had conc luded that it is safe to use BPA
as an incidental additive. Accordingly, the court found
that “the claims against the infant formula defendants are
expressly preempted, but the claims against the baby
bottle defendants are no t”13.
In a second slip opinion, the court scru tinized the “mo-
tions to dismiss the individual co unts of th e complaint: [3]
violation of state consumer fraud laws, breach of express
warranties, breach of implied warranties, intentional mi-
srepresentation, negligent misrepresentation, and unjust
enrichment” [4].
The court first held that “the plaintiffs failed to plead
with the particularity required by Federal Rules of Civil
Procedure 8 and 9(b) the express statements that formed
the basis of their fraud, misrepresentation, and breach of
express warranty claims”, noting that “platitudes about a
particular Defendant’s commitment to safety and quality
or general allegations about a particular Defendant’s
marketing and advertising strategy were insufficient to
state a claim for misrepresentation”14. Analogously, the
court noted that the lack of specificity in pleading is ir-
reconcilable with the absolute requirement that “a plain-
tiff pleading a breach of express warranty claim plead
that it was part of the basis of the bargain.”
Notwithstanding this, the court denied Defendant’s
motion to dismiss the consumer fraud and misrepresenta-
tion claims (based on “the failure to disclose the presence
of BPA in the products”), reaso ning that “all j urisdiction s
surveyed create a duty to disclose material facts that are
more readily known by one side of the transaction.”15
However, imposing a duty of d isclosure is not predicated
solely on “superior” knowledge, but rather what is
deemed “material”. Interestingly, the imposition of a
“superior” knowledge disclosure requirement would re-
sult in the unmanageable and impractical disclosure of
each constituent of a final product. The court will likely
have to garner evidentiary support to sustain its finding
since the FDA already has reached a conclusion on the
safety of negligible amounts of BPA in bottles or formula.
Hence, the presence of BPA cannot be “material as a
matter of law”, especially since its presence is readily
ascertainable from public sou rces.
5Daubert, 509 U.S. at 579.
6Kumho Tire v. Carmichael, 119 S.Ct. 1167 (1999).
7Kumho Tire, 119 S.Ct. 1167 (1999).
8Daubert at 593-594.
9Daubert offers the following factors as key points of inquiry in estab-
lishing acceptance: (1) testing of the hypothesis, (2) peer review of the
hypothesis or technique, (3) error rates of and standards for the tech-
nique, and (4) the degree of acceptance within the relevant scientific
10Daubert at 593-594.
11In re: Bisphenol A (BPA) Polycarbonate, 571 F. Supp. 2d 1374
(J.P.M.L. 2008).
12In re Bisphenol-A (BPA) Polycarbonate Plastic Products Liability
Litigation, MDL No. 1967, Slip Op. 1 (W.D. Mo. Nov. 9, 2009).
13In re Bisphenol-A (BPA) Polycarbonate Plastic Products Liability
Litigation, MDL No. 1967, Slip Op. 1 (W.D. Mo. Nov. 9, 2009).
14Geier v. American Honda Motor Co., 529 U.S. 861 (2000).
15Wyeth v. Levine, 129 S. Ct. 1187 (2009).
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60 Science as a Collective Litigation Tool
The court dismissed the “claims for breach of the im-
plied warranty of fitness for a particular purpose because
plaintiffs failed to identify a purpose other than the typi-
cal one for the subject products”16. However, the court
did not thoroughly scrutinize the state unjust enrichment
law to even reach the merits on the Defendants’ motion
concerning this count. Additionally, the court had an
uncanny interpretation of the “unmanifested defect” ar-
gument [5]. Defendants argued that “without a plaintiff
having actually experienced a physical harm from the
product, he suffered no cognizable harm whatsoever” [5].
The court disagreed, suggesting:
“The buyer has been damaged regardless of whether
he replaces or disposes of the product because, either
way, he has paid the seller for a product that he would
not have purchased had he known that the poison was
present, and has received no use from the product. The
poison may not inju re him, but the co ndition complained
of—poison’s presence—is known to exist. Similarly, the
Plaintiffs in this category purchased a product they allege
they would not have purchased had they known the true
Based on this analysis, the court held that “plaintiffs
who had not used their products still had a claim”, while
“those who had used their products had obtained the full
value of their products and had not suffered any dam-
age.”17. The case is currently proceeding through discov-
The court’s conclusions are not easily reconcilable
with the court’s acknowledgement of the “safety” of food
additives including BPA. “A legal claim premised on
know[ledge] that the p oison was present is wholly incon -
sistent with the FDA’s safety determination that BPA is
not a ‘poison’ at all”. Presumably, ongoing litigation of
In re: Bisphenol A will involve the issue of BPA scienc e
and the complexity involved in solidifying general and
specific causation.
These concerns evoke the need for a scrutiny of the
scientific underpinnings of the deleterious consequences
of BPA.
3.1. Scientific Studies Concerning BPA
The health effects of BPA have been studied extensively
for years. The widespread focus on BPA largely is due to
the inclusion of BPA in many baby products. The limited
research showing that BPA may be considered an endo-
crine disruptor, i.e., that it may “interfere with normal
development of the reproductive system and other hor-
monally mediated systems”, has been another fact spark-
ing interest in BPA18.
BPA is consumed predominantly through oral inges-
tion. Specifically, polycarbonate bottles (i.e., plastic bot-
tles) can diffuse very small concentrations of BPA into
the liquid contained therein. Further, BPA can be dif-
fused from the inner lining of metallic and plastic food
and drink receptacles into the corresponding food and
liquids contained therein [7]. Most domestic producers of
canned baby formula use epoxy lin ings that include BPA,
and which can diffuse BPA into the infant formula, espe-
cially upon heating. “Microwaving plastic containers to
heat food is another po ssible expo sure pathw ay, although
it is generally recognized that the levels of BPA that
could leach from hard plastics is low. Nonetheless, con-
sumer groups recommend avoiding the use of plastic
containers to heat food, especially for young children.”
After being ingested, “BPA can bind to estrogen re-
ceptors, although its binding affinity is orders of magni-
tude lower than that of endogenous estrogen”. The main
point of contention between supporters of a BPA ban and
opponents arises because “evidence that a compound can
have a certain effect in the body under certain circum-
stances is a far cry from establishing that the compound
does affect the body at levels likely to be encountered
from the typical low-level oral or dermal ingestion that
occurs, for example, through leaching” [8]. As such basic
pharmacological principles of dose, duration, and species
extrapolation lie at the heart of the debate [8].
3.2. The Paucity of Published, Independent
Scientific Studies Evincing BPA’s Negative
Health Consequences
BPA’s low estrogenic potency, combined with the low
level of human exposure, has often been understood as
indicative of the lack of risk to humans from BPA expo-
sure. This lack of evidence evincing the negative health
consequences of BPA are supported by data from a re-
cent meta-analysis of “risks associated with low-level
exposure to BPA” conducted by the FDA (2008) and
experts at the Harvard Center for Risk Analysis (2004).
There, the authors found “no consistent evidence for
BPA-related health effects, supporting the safety of cur-
rent low levels of human exposure to BPA” [7].
Interestingly, in 2008, the National Toxicology Pro-
gram (“NTP”) at the National Institutes of Health (“NIH”)
reached an opposite result, i.e., concluded that the inclu-
18Recent evidence from the National Health and Nutrition Examination
Survey (“NHANES III”) conducted by the Centers for Disease Control
and Prevention (“CDC”) found detectable levels of BPA in most people
six years and older who were tested.
16In re Bisphenol-A (BPA) Polycarbonate Plastic Products Liability
Litigation, MDL No. 1967, Slip Op. 1 (W.D. Mo. Nov. 9, 2009).
17In See In re Bisphenol-A (BPA) Polycarbonate Plastic Products Li-
ability Litigation, MDL No. 1967, Slip Op. 2 (W.D. Mo. Nov. 9, 2009).
Copyright © 2011 SciRes. BLR
The In-Terrorem Value of Science: Bisphenol-A Litigation and an Empirical Assessment of 61
Science as a Collective Litigation Tool
sion of BPA may be concerning. In order to gauge the
admissibility of seemingly contradictory evidence, it is
important to apply the relevant evidentiary standards.
Notably, NTP reports are not peer-reviewed publications,
and are not even quantitative assessments. Rather, they
assess the negative consequences and toxicity of a sub-
stance as it relates to five “levels of concern.” “These
levels range from “serious concern” (the substance caus-
es reproductive/developmental effects in humans or in
laboratory animals under typical human exposure condi-
tions) to “neg ligible concern” [8] (there is good ev idence
that the substance under evaluation is not a reproductive
or developmental toxicant)”. The NTP report concluded
that “there was ‘some concern’ that BPA exposure in
fetuses and infants could possibly affect brain and pros-
tate health”. Notably, for all other facets of human BPA
exposure, the NTP found only “minimal” or “negligible
concern.” A finding of “some concern” by the NTP is
indicative of the need for more research. Indeed, the NTP
studies concede that there is only very limited evidence
of the negative effects of BPA on development. Hence,
the NTP studies themselves indicate the necessity for
more research to better understand the role of BPA and
its implications for human health. Notwithstanding the
limitations of the NTP report, its characterization by the
media led to public concern and a deluge of regulatory
and litigation activ ity19.
Echoing the results of the NTP report, the FDA on
January 15, 2010, issued an official update, presumably
on tremendous political pressure, expressing “some con-
cern about the potential effects of BPA on the brain, be-
havior and prostate gland of fetuses, infants and chil-
dren.” However, the FDA report noted that “there was no
evidence that BPA was unsafe. The Department of
Health and Human Services—through the CDC, NIH,
and the FDA—is investing more than $30 million in new
health studies in both animals and humans to better de-
termine and evaluate the potential health effects of BPA
exposure. These studies, involving rodents and nonhu-
man primates, will focus on the metabolic impact of oral
versus intravenously administered BPA, the effect of oral
BPA ingestion on the prostate and mammary glands, and
at what, if any, dose point BPA may negatively affect
behavioral and neuroanatomical development”. The re-
sults of these studies are expected to be released in ap-
proximately two years [8].
Judging from the media response of the NTP report, it
is likely that a similar response will be evoked upon the
release of the FDA report on this research. Awaiting
these results, proponent of stricter regu lation of BPA will
continue to buttress their claim on studies that likely do
not meet the applicable evidentiary standards for admis-
sibility, e.g., a recent “Consumer Reports article advo-
cating the avoidance of all canned foods due to the pres-
ence of leached BPA”. In parallel, such proponents will
likely dismiss empirical research demonstrating the safe-
ty of low-level BPA exposure as the product of industry
4. Conclusions
Applying the evidentiary standards for admissibility to
the BPA case, it is not difficult to reach the conclusion
that the available evidence of BPA’s negative health ef-
fects does not reach the applicable threshold for admissi-
bility. The available evidence demonstrates that BPA is
ubiquitous; it is found in negligible amounts in several
food and beverage products that humans regularly con-
sume. Further, the U.S. FDA and EPA, Canada, the Eu-
ropean Union, Germany, Japan, Norway, Australia, and
New Zealand, have all released the results of empirical
studies or meta-analyses indicating the lack of any
known health risk from low-dose exposure to BPA [8].
Notwithstanding this evidence and the notable paucity
of peer-reviewed research supporting a contrary finding,
proponents of BPA regulation, class action plain tiffs, and
some scientists have stoked the political fire, lodging
attacks against the FDA for its findings and promoting
strict regulation and prohibitions of the inclusion of BPA
in consumer products. Such proponents buttress their
claim on shaky science, the specter of “small concern”
that much higher than normal dose exposure to BPA can
affect embryos in utero and small children, affecting em-
bryological and later reproductiv e fu nction . Based on this
calculus, BPA litigation is a prime case study demon-
strating the notion that science can, and is, being used as
a tool of collective litigation.
[1] National Toxicology Program, U.S. Department of Health
& Human Services, NTP-CERHR Expert Panel Report
for Bisphenol A, 26 November 2007.
EPVF112607.pdf [hereinafter NTP Expert Panel Report]
(Description of NTP and Significance of This Report In-
fra Section IIIA).
[2] Environmental Working Group, “Bisphenol A: Toxic
Plastics Chemical in Canned Food: A Survey of Bisphe-
nol A in U.S. Canned Foods,” 2007. [hereinafter
EWG Report].
[3] U.S. Agency for Toxic Substance & Disease Registry,
“Glossary of Terms.” 2009 [hereinafter ATS
19Recently, a major independently-funded study by the EPA failed to
find evidence of low-dose effects from BPA.
Copyright © 2011 SciRes. BLR
The In-Terrorem Value of Science: Bisphenol-A Litigation and an Empirical Assessment of
Science as a Collective Litigation Tool
Copyright © 2011 SciRes. BLR
DR Glossary] (Defining “Body Burden”).
[4] “The Expert and Daubert,” Mac News Letters, Vol. 1996.
[5] P. Lee, “The Daubert Case and Expert Opinion,” Trans-
lating Evidence into Practice 1997 Conference Sum-
mary—Session B: Scientific Evidence and the Courts.
[6] “Are Plastic Products Safe? An Overview of the Sci-
[7] “Science Suppressed: How America Became Obsessed
with BPA.”
[8] “Update on Bisphenol A for Use in Fo od Contact Applica-
tions,” U.S. Food and Drug Administration, January 2010.
[9] “Concern over Canned Foods.”