Northwestern Journal of Law & Social Policy
Volume 12 | Issue 1
Article 4
Fall 2016
When Religious Belief Becomes Scientific
Opinion: Burwell v. Hobby Lobby and the
Unraveling of Federal Rule 702
Meredith Rachel Mandell
Recommended Citation
Meredith Rachel Mandell, When Religious Belief Becomes Scientific Opinion: Burwell v. Hobby Lobby and the Unraveling of Federal Rule
702, 12 Nw. J. L. & Soc. Pol'y. 92 (2016).
http://scholarlycommons.law.northwestern.edu/njlsp/vol12/iss1/4
This Note or Comment is brought to you for free and open access by Northwestern University School of Law Scholarly Commons. It has been accepted
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Copyright 2016 by Northwestern University Pritzker School of Law
Northwestern Journal of Law and Social Policy
Vol. 10, Issue 3 (2016)
When Religious Belief Becomes Scientific
Opinion:
Burwell v. Hobby Lobby and the Unraveling of
Federal Rule 702
Meredith Rachel Mandell1
For over 20 years, the federal courts have adhered to a number of rules designed to
ensure that only valid and reliable science forms the basis for court decisions. The
seminal case is Daubert v. Merrell Dow Pharmaceuticals,2 in which the U.S. Supreme
Court set down the core standards for admissibility of scientific opinions. Those
standards later became embodied in Federal Rule of Evidence 702, which reads:
A witness who is qualified as an expert by knowledge, skill, experience,
training, or education may testify in the form of an opinion or otherwise if:
(a) the expert's scientific, technical, or other specialized knowledge will
help the trier of fact to understand the evidence or to determine a fact in
issue;
(b) the testimony is based on sufficient facts or data;
(c) the testimony is the product of reliable principles and methods; and
(d) the expert has reliably applied the principles and methods to the facts
of the case.3
There have been thousands of federal court decisions involving the Daubert/Rule 702
standards,4 and many state courts now follow the same standards. 5 A principal goal of
Rule 702 is to guard against the danger of “junk science” 6 tainting decisions that depend
on scientific or other specialized knowledge. 7 Yet, in spite of Rule 702 and its 20-year
1
J.D., 2016 Northwestern University School of Law. I greatly appreciate the generous help of Fern E.
Murdoch, Ph.D., Center for Reproductive Science, Northwestern University, on the scientific sections in
this Note. My thanks as well to my editors on the Northwestern Journal of Law and Social Policy for their
excellent edits, meaty comments, and patience with the writing process. All errors and omissions are my
own. I dedicate this article to my mother, Stephanie Scharf, a lawyer who has been a great mentor to me.
2
Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579 (1993).
3
FED. R EVID. 702.
4
WestlawNext shows over 100,000 citing references for both Daubert and Rule 702. See Westlaw,
next.westlaw.com (last visited Jan. 19, 2016).
5
See, e.g., ARIZ. R. EVID. 702; ARK. R. EVID. 702; CONN. CODE EVID. § 7-2; FLA. STAT. §§ 90.702.
6
See PETER W. HUBER, GALILEO’S REVENGE: JUNK SCIENCE IN THE COURTROOM 2–3, (Basic Books 1991).
The author provides a thorough historical and social review of “junk science,” its origins, and its invasion
of the American Courtroom.
7
See FED. R. EVID. 702 advisory committee’s note (2000 amendments) (“Rule 702 has been amended in
response to Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993), and to the many cases
applying Daubert, including Kumho Tire Co. v. Carmichael, 119 S. Ct. 1167 (1999). In Daubert the Court
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Meredith Rachel Mandell
history, a recent and highly publicized legal decision, which rested on faulty scientific
beliefs, was made without the benefit of a Rule 702 analysis.
The case is Burwell v. Hobby Lobby,8 in which the Supreme Court held that the
contraceptive mandate, a regulation promulgated by the Department of Health and
Human Services under the Affordable Care Act (the Act), 9 substantially burdened the
employers’ exercise of religion under the Religious Freedom Restoration Act of 1993
(RFRA).10 The mandate substantially burdened the Hobby Lobby employers’ religious
beliefs because it required the employers to provide access to four specific contraceptives
which they believed were abortifacients, 11 and the Department of Health and Human
Services had not proven the mandate was the “least restrictive means” of furthering a
compelling governmental interest. 12
The Supreme Court made a critical assumption that the four contraceptives at issue
were, in fact, abortifacients. But the Court received no scientific evidence, nor did any
court below, for the proposition that the challenged contraceptives were actually
tantamount to abortions. In essence, the Supreme Court deferred not only to the
employers’ religious beliefs that abortion is wrong, but also to their erroneous scientific
beliefs about whether any of four specific contraceptives constitutes an “abortion.”
Such deference became the basis for the Court’s decision that the four particular
types of contraceptives need not be funded by the Hobby Lobby employers. Importantly,
neither the Hobby Lobby trial courts 13 nor the Hobby Lobby appellate courts14 required a
Rule 702 review of the scientific opinions that were the basis Hobby Lobby plaintiffs’
position.
The lack of Rule 702 review begs the question: in light of more than 20 years of
federal jurisprudence setting the modern standards for the use of reliable and valid
science in federal litigation, how can the Supreme Court justify its reliance on a religious
belief rather than science for its conclusion about what what constitutes an abortion? In
essence, the Hobby Lobby court permitted junk science to trump access to contraceptives.
The decision is all the more troubling in light of the long-established constitutional right
of access to contraceptives. 15
In this paper, Part I will review the reasons why Rule 702 exists and what standards
are imposed on the admissibility of scientific opinions; Part II will review the decision in
charged trial judges with the responsibility of acting as gatekeepers to exclude unreliable expert testimony,
and the Court in Kumho clarified that this gatekeeper function applies to all expert testimony, not just
testimony based in science.”).
8
Burwell v. Hobby Lobby Stores, Inc., 134 S. Ct 2751 (2014). The Supreme Court decision encompassed
two consolidated cases: No. 13-354, Sebelius, Sec’y of Health and Human Serv. v. Hobby Lobby Stores;
and No. 13-356, Conestoga Wood Specialties v. Sebelius. I will refer to both cases as “Hobby Lobby.”
9
The Patient Protection and Affordable Care Act, 42 U.S.C. § 300gg-13 (2015).
10
Religious Freedom Restoration Act of 1993, 42 U.S.C. §2000bb et seq. (2015).
11
Hobby Lobby, 134 S. Ct. at 2759.
12
Id. at 2757.
13
Hobby Lobby Stores, Inc. v. Sebelius, 870 F.Supp.2d 1278 (W.D. Okla. 2012); Conestoga Wood
Specialties Corp. v. Sebelius, et al., 917 F.Supp.2d 394 (E.D. Pa. 2013).
14
Hobby Lobby Stores, Inc. v. Sebelius, No. 12-6294, 2012 WL 6930302, at *1 (10th Cir. 2012);
Conestoga Wood Specialties Corp. v. Sec’y of U.S. Dept. of Health and Human Serv., 724 F.3d 377 (3d.
Cir. 2013).
15
See Griswold v. Connecticut, 381 U.S. 479 (1965); Eisenstadt v. Baird, 405 U.S. 438 (1972).
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Hobby Lobby and the purported science involved in the case; Part III will review the lack
of Rule 702 review by the Hobby Lobby lower courts; Part IV will review the scientific
debate concerning contraceptives as abortifacients; Part V will consider the admissibility
of potentially conflicting scientific opinions in Hobby Lobby; and Part VI will examine
how scientific evidence could have changed the outcome of the case. In conclusion, I
consider the implications of Hobby Lobby from the perspective of how courts should
resolve factual disputes between scientific knowledge and religious beliefs.
I.RULE 702: ITS PURPOSE AND OPERATION WITH RESPECT TO SCIENTIFIC OPINIONS IN
LITIGATION
A.
Purpose of Rule 702
The purpose of Rule 702 is to protect the scientific integrity of decisions made in
courtrooms by barring “junk science.” 16 As explained by Peter Huber, one of many
commentators who castigated the pre-Daubert trend of junk science invading the
courtroom in high profile litigation cases:
Junk science is the mirror image of real science, with much of the same
form but none of the same substance. There is the astronomer, on the one
hand, and the astrologist, on the other. The chemist is paired with the
alchemist, the pharmacologist with the homoeopathist. Take the serious
sciences of allergy and immunology, brush away the detail and rigor, and
you have the junk science of clinical ecology. The orthopedic surgeon is
shadowed by the osteopath, the physical therapist by the chiropractor, the
mathematician by the numerologist and the cabalist … Junk science cuts
across chemistry and pharmacology, medicine and engineering. It is a
hodgepodge of biased data, spurious inference, and logical legerdemain,
patched together by researchers whose enthusiasm for discovery and
diagnosis far outstrips their skill. It is a catalog of every conceivable kind
of error: data dredging, wishful thinking, truculent dogmatism, and, now
and again, outright fraud. 17
Before the 20th century, courts in the United States did not rigorously examine the
reliability of expert testimony. 18 But as the nation leapt forward in the realms of science
and technology during the Industrial Revolution, expert scientific witnesses began to
16
MICHAEL H. GRAHAM, HANDBOOK OF FEDERAL EVIDENCE § 702:5 (7th ed. 2013).
See HUBER, supra note 6, at 2–3. Accord JACK KITAEFF, MALINGERING, LIES, AND JUNK SCIENCE IN THE
COURTROOM (2007); William Glaberson, The Nation: Assigning Blame; The Courts Vs. Scientific
Certainty, N.Y. TIMES, June 27, 1999, http://www.nytimes.com/1999/06/27/weekinreview/the-nationassigning-blame-the-courts-vs-scientific-certainty.html.
18
Janusz Puzniak, Expert Evidence: The Road from Daubert to Joiner and Kumho Tire, 37 COURT REV.
32, (Fall 2000) (citing Jack B. Weinstein, Improving Expert Testimony, 20 U. RICH. L. REV. 473, 474–75
(1986) [hereinafter Puzniak].
17
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appear more frequently to testify during trials. 19 As a consequence, legal scholars and
practitioners began to think about how best to assess expert testimony. 20
In Frye v. United States,21 where a criminal defendant questioned the admissibility
of a systolic blood pressure test as evidence, what was a crude precursor to the polygraph
“lie detector” test, the D.C. Circuit ruled that expert testimony must be grounded in
established scientific technique or, in other words, the “thing from which the deduction is
made must be sufficiently established to have gained general acceptance in the particular
field in which it belongs.” 22 This Frye test or the “general acceptance test” became the
common law standard for 70 years, surviving the adoption of the Federal Rules of
Evidence until the Supreme Court’s Daubert decision in 1993.23 The Frye test required
judges first to identify the scientific field of the testimony and then, second, determine
whether the specific scientific principle at issue was “generally accepted” by scientists in
that particular field. 24 The test was easy for judges to apply, but some felt it was overly
broad and excluded valuable scientific testimony. 25 As one commentator writing about
the genesis of Rule 702, noted:
The Frye test was relatively simple, but rigid in its all-or-nothing
approach. It was praised as guaranteeing uniformity of decisions,
eliminating the need for prolonged admissibility hearings, and providing
an effective method to determine the admissibility of the evidence by the
specialists. The test was criticized, however, for establishing too large a
threshold for useful and otherwise reliable scientific testimony that was
novel and not yet ‘generally accepted’ in the field. 26
In 1975, Congress approved the Federal Rules of Evidence, a new uniform code
that would apply to all federal civil and criminal cases. 27 The rules seemingly liberalized
the old “general acceptance test” to a less stringent “relevancy standard.” 28 The original
Rule 702 stated 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,” 29 then a witness
19
Id.
See e.g., Learned Hand, Historical and Practical Considerations Regarding Expert Testimony, HARV. L.
REV. 40–58 (1901).
21
Frye v. U.S., 293 F. 1013 (D.C. Cir. 1923).
22
Id. at 1014.
23
Puzniak, supra note 18, at 33.
24
Puzniak, supra note 18, at 33.
25
Puzniak, supra note 18, at 33.
26
Puzniak, supra note 18, at 33.
27
Paul R. Rice & Neals-Erik William Delker, Federal Rules of Evidence Advisory Committee: A Short
History of Too Little Consequence, 191 F.R.D. 678 (2000).
28
See Daubert v. Merrell Dow Pharmaceuticals, 509 U.S. 579, 588 (1993); see also Howard J. Zlotnick &
Jr. Lin, Handwriting Evidence in Federal Courts: From Frye to Kumho, 13 FORENSIC SCI. REV., 87-99
(2001) [hereinafter Zlotnick & Lin]; but cf. David E. Bernstein, Frye, Frye, Again: The Past, Present, and
Future of the General Acceptance Test, 41 JURIMETRICS J. 385 (2001) (arguing that Daubert, has in fact,
evolved into a stricter test than Frye).
29
JACK B. WEINSTEIN & MARGARET A. BERGER, WEINSTEIN’S FEDERAL EVIDENCE § 702 App.01 (Joseph
M. McLaughlin ed., Matthew Bender & Co. 2d ed. 2015).
20
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“qualified as an expert by knowledge, skill, experience, training, or education,” could
testify “in the form of opinion or otherwise.” 30 However, judges remained uncertain
whether the new federal rules overruled the old common law Frye standard. 31 There
were also concerns that the rules went too far, that they opened the floodgates for junk
science courtroom testimony. 32 These concerns came to a head in the 1980s “when some
judges grew skeptical of some of the scientific claims in high-profile cases.”33
The issues were reiterated in the Department of Justice’s Tort Working Group
1986 report examining the underlying causes of the “crisis in insurance availability and
affordability.” 34 The report decried the “undermining of causation” 35 and the
“increasingly serious problem in toxic tort cases” 36 of faulty science entering into
courtroom deliberations. The result was “findings of causation which simply cannot be
justified or understood from the standpoint of the current state of credible scientific and
medical knowledge” and “a deep and growing cynicism about the ability of tort law to
deal with difficult scientific and medical concepts in a principled and rational way.” 37
In large part, the root causes of junk science are the economic incentives for both
plaintiffs’ attorneys, who will get a lucrative cut from any settlement or win, and expert
witnesses who are paid gigantic sums by the hour and who need to find convenient
“scientific theories” to bolster their case. As one commentator concluded, “junk science
in the courtroom emanates from testimony by expert witnesses hired not for their
scientific expertise, but for their willingness, for a price, to say whatever is needed to
make the client’s case.” 38 Junk science was frequently a scare tactic, employed in
settlement negotiations to threaten the other side, with the specter that “so-called ‘expert’
testimony” could be an irreparable blow to the opponent’s case. 39
B.
Background to current Rule 702
In an effort to address the growing problem, the U.S. Supreme Court clarified Rule
702, the rule governing testimony by expert witnesses under the Federal Rules of
Evidence, in its landmark Daubert decision. 40 In Daubert, plaintiff-parents sued a
pharmaceutical company on behalf of their minor children who were born with serious
birth defects. 41 The parents alleged that the mothers’ ingestion of the company’s
30
Id.
Barbara Hughes Erard & Mimi Keidan Seltzer, Evolving Standard of Scientific Acceptance Under
Daubert, 73 MICH. B.J. 161 (1994).
32
Marc S. Klein, Expert Testimony in Pharmaceutical Product Liability Actions, 45 FOOD DRUG COSM.
L.J. 393, 394 (1990).
33
Glaberson, supra note 17.
34
U.S. DEP'T OF JUSTICE, REPORT OF THE TORT POLICY WORKING GROUP ON THE CAUSES, EXTENT AND
POLICY IMPLICATIONS OF THE CURRENT CRISIS IN INSURANCE AVAILABILITY AND AFFORDABILITY 1-91
(1986), [hereinafter TORT POLICY REPORT].
35
Id. at 33.
36
Id. at 35.
37
Id.
38
Dick Thornburgh, Junk Science—The Lawyer’s Ethical Responsibilities, 25 FORDHAM URB. L.J. 449
(1998).
39
Id.
40
Daubert, v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993).
41
Id. at 582.
31
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prescription anti-nausea drug, Bendectin, caused the birth defects. 42 After reviewing
scientific opinions supporting both the plaintiffs’ and defendant’s position, the district
court granted summary judgment to the defendant pharmaceutical manufacturer. The
court concluded that the plaintiffs’ expert evidence was insufficient to prove that
Bendectin caused the birth defects. The court specifically pointed to the plaintiffs’
inability to proffer epidemiological evidence from systematic studies of research on
people, in support of their claims, and that the plaintiffs’ expert testimony, based upon
newer laboratory research, including in vitro studies, chemical structure analyses and
animal studies, was insufficient to prove causation and thus could not be taken to a jury. 43
The Ninth Circuit affirmed under the prevailing “general acceptance” standard for
scientific evidence, holding that a scientific opinion “is admissible if it is generally
accepted as a reliable technique among the scientific community.” 44
On appeal, the U.S. Supreme Court detailed the nature of the scientific opinions
that the district court faced. 45 The defendant’s expert witness was a physician and
epidemiologist who had “published numerous articles on the magnitude of risk from
exposure to various chemical and biological substances.” 46 Summarizing the affidavit of
the defendant’s expert, which was submitted in support of its motion for summary
judgment, the Court stated:
[H]e had reviewed all the literature on Bendectin and human birth
defects—more than 30 published studies involving over 130,000 patients.
No study had found Bendectin to be a human teratogen (i.e., a substance
capable of causing malformations in fetuses). On the basis of this review,
Doctor Lamm concluded that maternal use of Bendectin during the first
trimester of pregnancy has not been shown to be a risk factor for human
birth defects.47
The plaintiffs responded to the defendant’s motion with the “testimony of eight
experts of their own, each of whom had impressive credentials.” 48 Contrary to the
defendant expert’s affidavit, the plaintiffs’ experts asserted that Bendectin could have
caused the birth defects.49 The plaintiffs’ experts based their conclusions on ‘in vitro’
(test tube) and ‘in vivo’ (live) animal studies that found a link between Bendectin and
malformations; pharmacological studies of the chemical structure of Bendectin that
purported to show similarities between the structure of the drug and that of other
substances known to cause birth defects; and the ‘reanalysis’ of previously published
epidemiological human statistical studies. 50
42
Id.
Daubert v. Merrell Dow Pharmaceuticals, Inc., 727 F. Supp. 570 (S.D. Cal. 1989), aff’d, 95 F.2d 1128
(9th Cir. 1991).
44
Id.
45
Daubert, 509 U.S. at 583.
46
Id. at 582 n.1 (explaining the district court case in Daubert).
47
Id. at 582.
48
Id. at 583.
49
Id.
50
Id.
43
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Vol. 12, Issue 1 (2016)
In deciding the case, the Supreme Court rejected the general acceptance standard as
the exclusive basis for assessing the admissibility of expert testimony. 51 Instead, the
court held that under the Federal Rules of Evidence, the “basic standard of relevance was
a liberal one,” more so than the common law Frye test.52 With specific regard to Rule
702, “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.’” 53 The
Court, however, cautioned that simply because the Federal Rules superseded Frye did not
mean that Rules placed “no limits on the admissibility of purportedly scientific
evidence.”54
The Daubert Court went on to articulate a set of factors that were meant to be nonexclusive guidelines to help judges determine what is valid science, including 1) whether
the expert's technique or theory can be or has been tested—that is, whether the expert's
theory can be challenged in some objective sense, or whether it is instead simply a
subjective, conclusory approach that cannot reasonably be assessed for reliability; (2)
peer review and publication; (3) the known or potential rate of error of the technique or
theory when applied; (4) the existence and maintenance of standards and controls; and (5)
whether the technique or theory has been generally accepted in the scientific
community. 55 The Supreme Court cautioned that a judge should not vet an expert’s
testimony based “on the conclusions they generate,” but rather the “focus, of course, must
be solely on principles and methodology.” 56
The Supreme Court concluded that the trial judge was responsible for ensuring that
“any and all scientific testimony or evidence admitted is not only relevant but reliable.” 57
Essentially, Daubert deemed trial judges to be “gatekeepers” of scientific evidence, who
have the obligation to exclude “unreliable testimony.”58
On remand from the Supreme Court, the Ninth Circuit sustained the district court’s
exclusion of testimony from the plaintiffs’ experts under the newly announced Daubert
standard. 59 The plaintiffs’ experts had not based their testimony on preexisting or
independent research, did not publish their work in scientific journals, and did not
adequately explain their methodology. 60 As a result, the testimony of the plaintiffs’
experts was inadmissible, and the plaintiffs could not prove causation. 61
51
Id. at 588.
Id. at 587.
53
Id. at 588.
54
Id. at 589.
55
Id.
56
Id. at 595.
57
Id.
58
FED. R. EVID. 702 advisory committee’s note (2000 amendments).
59
Daubert v. Merrell Dow Pharmaceuticals, Inc., 43 F. 3d 1311 (9th Cir. 1995).
60
Id. at 1317–19.
61
Id. at 1322.
52
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Meredith Rachel Mandell
The role of judge as “gatekeeper” and standards for admissibility of scientific
opinion under Rule 702
Following Daubert, Rule 702 was amended in 2000.62 The Advisory Committee
took pains to emphasize that the Daubert factors were meant to guide how courts would
evaluate the reliability of scientific testimony—and thus its admissibility—although the
factors were by no means an exclusive checklist. 63 And, in fact, subsequent to the
Supreme Court’s decision, courts have developed additional factors, for example,
whether experts are “proposing to testify about matters growing naturally and directly out
of research they have conducted independent of the litigation, or whether they have
developed their opinions expressly for the purposes of testifying.” 64
Even when courts rule on preliminary injunctions—which typically proceed faster
than proceedings on the merits—a Rule 702 analysis is required. For example, the 10 th
Circuit held in Oklahoma v. Tyson Foods 65 that a district court did not abuse its discretion
in denying a preliminary injunction after finding that expert testimony was unreliable 66
and entitled to “scant weight” 67 in accordance with Daubert. The State alleged a causal
link between poultry litter from poultry farmers and fecal bacteria contamination found in
the Illinois River Watershed, but the trial court held that the State could not “demonstrate
its likelihood of success on the merits, the first factor required
for preliminary injunctive relief” on the causation question. 68 The trial judge honed in on
the fact that the State’s expert testimony had not been peer reviewed or published, and
that no one outside the lawsuit had validated the expert’s work. 69 In denying the
preliminary injunction, the court held that even when the judge sits as fact-finder, Rule
702 standards must still be met.
II.
THE DISPUTE IN HOBBY LOBBY, AND THE SCIENTIFIC VIEWS THAT WERE THE
BASIS FOR THE DECISION
In 1993, Congress passed the Religious Freedom Restoration Act (RFRA),
requiring strict scrutiny when a neutral law of general applicability “substantially
burden[s] a person’s exercise of religion.” 70 RFRA was amended in 2000 by the
Religious Land Use and Institutionalized Persons Act (RLUIPA), to define “exercise of
62
See FED. R. EVID. 702.
FED. R. EVID. 702, supra note 58.
64
See Daubert v. Merrell Dow Pharmaceuticals, 43 F.3d 1311, 1317 (9th Cir. 1995); see supra note 58, for
a list of various additional factors that have been developed by other courts.
65
Oklahoma v. Tyson Foods, 565 F.3d 769 (10th Cir. 2009) (holding that the state was unlikely to establish
at trial that land application of poultry waste might present an imminent and substantial danger to health or
the environment, as required for relief under Resource Conservation and Recovery Act (RCRA) and also
that the trial court did not abuse its discretion in denying the preliminary injunction based on a conclusion
that the state’s witness testimony was unreliable and entitled to little weight).
66
Id. at 780.
67
Id. at 781.
68
Id. at 775.
69
Id. at 780.
70
Hobby Lobby, 134 U.S. at 2754; see also 42 U.S.C. §2000bb (2012).
63
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religion” broadly as any exercise of religion, “whether or not compelled by, or central to,
a system of religious belief,” 71 which is to be “construed in favor of a broad protection of
religious exercise, to the maximum extent permitted by the terms of this chapter and the
Constitution.”72
The Hobby Lobby plaintiffs claimed that the 2010 Patient Protection and
Affordable Care Act (the Act), 73 a federal law that aimed to overhaul the United States
insurance system, violated their religious freedom rights under RFRA. 74 While
lawmakers who passed the Act felt it would reform the healthcare system and give
uninsured Americans access to affordable and quality healthcare, 75 the law for a number
of reasons caused a political uproar. 76 Many Republicans alleged that the Act, dubbed
“Obamacare,” was a socialized healthcare program that would lead to reductions in
quality of care and impose penalties on small businesses. 77 Republicans in the House
have voted more than 50 times to repeal the law. 78 Some commentators view the Hobby
Lobby litigation as politically motivated, just one of many lawsuits brought by
ideologically driven plaintiffs who are part of a broader effort to repeal the controversial
Act.79
One of the key provisions in the Act is Section 2713, which prohibits group health
insurance plans from imposing cost-sharing requirements, such as deductibles or
copayments, for a number of “preventive health services” including “preventive care and
screenings” for women. 80 Congress did not define “preventive care” in the Act but left it
up to the Health Resources and Services Administration (HRSA) to determine what it
would encompass. 81
71
42 U.S.C. § 2000cc-5(7)(A) (2015). In 2006, the Supreme Court upheld the Constitutionality of the
Religious Freedom Restoration Act in Gonzales v. O Centro Espirita Beneficiente Uniao Do Vegetal et al.,
125 S. Ct. 1846 (2006).
72
42 U.S.C. § 2000CC-3 (2012).
73
42 U.S.C. § 300gg-13 (2012).
74
Hobby Lobby, 134 S. Ct. at 2759. Hobby Lobby Stores, Inc. is a nationwide chain of arts and crafts stores
owned by Christians; Conestoga Wood Specialties is a manufacturing company owned by Mennonites. Id.
at 2764, 2765.
75
Patient Protection and Affordable Care Act, Pub. L. 111-148, §5000, 124 Stat. 588, 120-1020 (2010).
76
Susan Cornwell, Republicans Vow to Keep Fighting Obamacare, Despite Court Ruling, REUTERS, June
25, 2015, http://news.yahoo.com/republicans-vow-keep-fighting-obamacare-despite-court-ruling160811704.html.
77
Id; see also James Surowiecki, The Business End of Obamacare, THE NEW YORKER, OCT. 14, 2013,
http://www.newyorker.com/magazine/2013/10/14/the-business-end-of-obamacare.
78
Kathleen Miller & Terrence Dopp, Core of Obamacare Would Be Repealed in Bill Passed by U.S.
House, BLOOMBERG POLITICS, Oct. 23, 2015, http://www.bloomberg.com/politics/articles/2015-1023/core-of-obamacare-would-be-repealed-in-bill-passed-by-u-s-house.
79
See Stephanie Mencimer, Are You There God? Its Me, Hobby Lobby, MOTHER JONES, Mar. 21, 2014,
http://www.motherjones.com/politics/2014/03/hobby-lobby-supreme-court-obamacare; See also Sam
Baker, Is SCOTUS Already Expanding on the Hobby Lobby Ruling?, THE ATLANTIC, July 7, 2014,
http://www.theatlantic.com/politics/archive/2014/07/is-scotus-already-expanding-on-the-hobby-lobbyruling/440931/; Dan Diamond, Hobby Lobby Isn't the End: Four Other Anti-ACA Lawsuits to Watch,
ADVISORY BOARD: DAILY BRIEFING BLOG (June 25, 2014), http://www.advisory.com/dailybriefing/blog/2014/06/hobby-lobby-isnt-the-end-other-anti-obamacare-lawsuits-still-loom.
80
42 U.S.C. § 300gg-13 (2015).
81
Id.
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HRSA adopted the evidence-based recommendations of the Institute of Medicine,
an independent non-profit dedicated to health policy and research that is essentially the
“health arm” of the National Academy of Sciences. 82 The Institute recommended
coverage of eight preventive services, including all FDA-approved methods of
contraception,83 without cost sharing.
The Hobby Lobby plaintiffs objected to their corporations providing health
insurance coverage to female employees for four specific contraceptives, which they
believed were abortifacients. 84 The plaintiffs held the religious belief that life begins at
fertilization, 85 and that any contraceptive method that disrupts the fertilized egg is an
abortifacient.86 The Supreme Court summarized the plaintiffs’ position as objecting to
any contraceptive that prevents “an already fertilized egg from developing any further by
inhibiting its attachment to the uterus.” 87 Though not objecting to coverage for all
contraceptives, 88 the Hobby Lobby plaintiffs complained about these four: Ella (ulipristal
DIPTI SINGH, NATIONAL HEALTH LAW PROGRAM, SUMMARY OF THE SUPREME COURT’S DECISION ON
THE ACA’S CONTRACEPTIVE COVERAGE REQUIREMENT, (July 7, 2014),
82
http://www.healthlaw.org/publications/browse-all-publications/Hobby-lobby-analysis#.
Id. A contraceptive is “an agent to prevent conception.” STEDMAN’S MEDICAL DICTIONARY, available
online at WestlawNext (database updated November 2014).
84
Hobby Lobby, 134 U.S. at 2759. The Court did not define the terms ”abortifacient” or “abortion.”
According to Stedman’s Medical Dictionary abortifacient is defined as “1. Producing abortion 2. An agent
that produces abortion.” STEDMAN’S supra note 83. Stedman’s Medical Dictionary defines abortion as “1.
Expulsion from the uterus of an embryo or fetus before viability (20 weeks' gestation [18 weeks after
fertilization] or fetal weight less than 500 g). A distinction made between abortion and premature birth is
that premature infants are those born after the stage of viability but before 37 weeks' gestation. Abortion
may be either spontaneous (occurring from natural causes) or induced (artificially or therapeutically). 2.
The arrest of any action or process before its normal completion.” Id. Underlying the scientific and
“values” debates about contraception, contraceptives and abortion are often conflicting definitions for the
core terms.
85
Hobby Lobby 2764–66. Stedman’s Medical Dictionary defines fertilization as, “The process beginning
with penetration of the secondary oocyte by the sperm and completed by fusion of the male and female
pronuclei.” See STEDMAN’S supra note 83.
86
First Amended Verified Complaint ¶30, Conestoga Wood Specialities Corp. v. Sebelius, No. 5:12-CV06744-MSG (E.D. Pa. Jan. 11, 2013) (“The Mennonite Church teaches that taking life which includes
anything that terminates a fertilized embryo is intrinsic evil and a sin against God to which they are held
accountable. Therefore, abortion and any abortifacient contraception that may cause an abortion is equally
objectionable to the Plaintiff”); Verified Complaint at ¶7, Hobby Lobby v. Sebelius, 870 F.Supp.2d 1278
(W.D. Okla. 2012) (No. CIV-12-1000-HE) (“The Green family’s religious beliefs forbid them from
participating in, providing access to, paying for, training others to engage in, or otherwise supporting
abortion-causing drugs and devices”). Note that the plaintiffs “have no religious objection to providing
coverage for non-abortion causing contraceptive drugs and devices.” Id. at ¶57.
87
Hobby Lobby, 134 S. Ct. at 2754. The Court also noted that federal regulations define pregnancy as
beginning at implantation, citing 62 Fed. Reg. 8611 (1997); 45 CFR §46.202(f) (2013). Id. at n.7. The
technical terms for attachment to the uterus is “implantation”, as defined in Stedman’s Medical Dictionary
“1. Attachment of the blastocyst to the endometrium, and its subsequent embedding in the compact layer,
occurring 6–7 days after fertilization of the oocyte in humans.” STEDMAN’S supra note 83.
88
The plaintiff’s views were markedly different from the views of traditional Catholics, represented by the
United States Conference of Catholic Bishops (USCCB), which held an even more stringent view and
lobbied adamantly against the entire slate of 20 contraceptives. The USCCB noted in its campaign against
the mandate that contraception “should not be considered part of preventive healthcare because pregnancy
is not a disease.” See Love and Sexuality, U.S. CONF. CATH. BISHOPS, http://www.usccb.org/beliefs-andteachings/what-we-believe/love-and-sexuality/index.cfm#contraception (Last visited Jan. 1, 2016). The
83
101
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acetate), Plan B (levonorgestrel), and two types of intrauterine devices (IUDs): ParaGard
(or copper IUDs) and Mirena and Skyla (or levonorgestrel-releasing IUDs).89
III.
THE JUDICIAL TREATMENT OF THE SCIENTIFIC VIEWS OFFERED BY THE HOBBY
LOBBY PLAINTIFFS: NO RULE 702 REVIEW BY ANY COURT
Despite the mandate of Rule 702, there was no Rule 702 review by any federal
court in the Hobby Lobby litigation. There was only an indirect reference made to the
fact that the plaintiff proffered no evidence showing that the four contraceptives in
question were abortifacients in a dissenting opinion by 10th Circuit Judge Mary Beck
Briscoe.90 Judge Briscoe opined that the plaintiffs did not meet their evidentiary burden
to show as a scientific matter that these contraceptives were abortifacients. 91 Without
mentioning Rule 702, the dissent was clearly troubled by the absence of valid scientific
evidence.
Specifically, Judge Briscoe noted that “there is no evidentiary support in the record
for plaintiffs’ allegations that the objected-to contraceptive drugs and devices actually
have the potential to prevent implantation of fertilized eggs.” 92 While there was
“agreement among the parties and amici that intrauterine devices have such potential,” by
contrast, she noted, “the same cannot be said about the challenged contraceptive drugs
(e.g., Plan B and Ella).”93 She concluded: “In light of these evidentiary deficiencies, I
fail to see how plaintiffs could reasonably be said to have carried their burden of
establishing their entitlement to a preliminary injunction.” 94
IV.
SCIENTIFIC OPINIONS ABOUT WHETHER THE FOUR HOBBY LOBBY METHODS
ARE ABORTIFACIENTS
The Hobby Lobby plaintiffs took the position that life begins at fertilization, 95 and
that the four methods of contraception, which they objected to, prevent implantation of a
fertilized egg. 96 In this section, I first look at scientific opinions on reproduction,
specifically opinions about the process of ovulation, how an egg gets fertilized, how
implantation occurs, and at what stage in the reproductive process scientists define the
beginning of pregnancy. I then review each of the four Hobby Lobby contraceptives in
USCCB, joined forces with the Hobby Lobby plaintiffs in opposing the mandate, see, e.g., Brief of the
United States Conference of Catholic Bishops as Amicus Curiae in Support of Hobby Lobby and
Conestoga Wood Specialties Corp., et al., Sebelius v. Hobby Lobby Stores, Inc., No. 13-354 (Jan. 28,
2014), http://www.usccb.org/about/general-counsel/amicus-briefs/upload/amicus-13-354-13-356-sebeliushobby-lobby-conestoga-wood.pdf.
89
Hobby Lobby, 134 S. Ct. at 2762–63, n.6; see also Brief for Petitioners at 10 n.4, Sebelius v. Hobby
Lobby Stores, Inc., 134 S. Ct 2751 (2014) (No. 13-354).
90
Hobby Lobby v. Sebelius, 723 F.3d 1114, 1164–65 (10th Cir. 2013) (Briscoe, J., dissenting).
91
Id.
92
Id.
93
Id.
94
Id.
95
Hobby Lobby, 134 S. Ct. at 2764–66.
96
Id.
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terms of their mechanism of action—specifically, scientific opinions about (1) how the
contraceptive works, and (2) whether the contraceptive acts on the process of ovulation,
acts before or after fertilization, or acts by interfering with implantation of the blastocyst
in the endometrial lining of the uterus.
A.
The Reproductive Process, Pregnancy, and Contraception
The first step in the reproductive process is ovulation. Each month inside a
woman’s ovaries, eggs grow in small, fluid-filled sacs called follicles. 97 During
ovulation, one of the eggs erupts from the follicle, typically about two weeks before a
woman starts menstruation. 98 After the egg exits the follicle, the follicle develops into
something called the corpus luteum. 99 The corpus luteum releases a hormone that
thickens the lining of the uterus, “getting it ready for the egg.” 100 Essentially, in order for
the egg to be fertilized by the sperm, the follicles must burst open in order for the eggs to
travel to the fallopian tube. 101
Normally, only one egg is released at one time, but occasionally two or more erupt
during the menstrual cycle.” 102 Typically, an egg erupts from a woman’s ovary on the
14th to 16th day of the approximately 28-day menstrual cycle. 103 “At ovulation, the mucus
in the cervix becomes more fluid and more elastic, allowing the sperm to enter the uterus
rapidly.”104 The sperm, upon entering the vagina, move through the cervix into the uterus
and toward the “funnel-shaped end of the fallopian tube—the usual site of
fertilization.”105 When a sperm penetrates the egg, fertilization results.106
The next step is that the fertilized egg (zygote) “divides repeatedly as it moves
down the fallopian tube to the uterus. First, the zygote becomes a solid ball of cells.
Then it becomes a hollow ball of cells called a blastocyst. Inside the uterus, the
blastocyst implants in the wall of the uterus, where it develops an embryo attached to a
placenta and surrounded by fluid-filled membranes.”107
There is a general consensus in the medical community that pregnancy begins upon
implantation of the blastocyst in the uterine wall. As a group of 15 doctors, scientists,
and medical professional associations wrote in a brief to the Supreme Court,
“[p]regnancy is established only upon the conclusion of such implantation.” 108 This
definition follows the American College of Obstetricians and Gynecologists’ definition:
the term “pregnancy” refers to the period between the implantation of the embryo in the
97
THE MERCK M ANUAL OF MEDICAL INFORMATION 1435–37 (Mark Beers ed., Simon & Shuster 2nd Home
ed. 2003).
98
Id.
99
Id.
100
Id.
101
Id.
102
Id.
103
Id.
104
Id.
105
Id.
106
Id.
107
Id.
108
Brief of Physicians For Reproductive Health, et al., as Amici Curiae Supporting Petitioners at 12,
Sebelius v. Hobby Lobby Stores, Inc., 134 S. Ct 2751 (2013) (No. 13-354).
103
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uterus and childbirth. 109
There is a clear scientific distinction between contraceptives and abortifacients.
“[A] ‘contraceptive’ refers to that which prevents fertilization of an egg or prevents
implantation of a fertilized egg—in other words, it prevents a pregnancy from taking
place.” 110 On the other hand, an abortifacient “works to disturb an embryo already
implanted in the uterine lining, which necessarily occurs after a pregnancy has been
established.”111
While there is a consensus view for how the four Hobby Lobby contraceptives
likely act to block reproduction, researchers have had some difficulty, depending on the
particular contraceptive at issue, in fully explaining the occasional pregnancy. 112
Research knowledge is constrained by a several factors such as the inability of scientists
to identify the exact moment of fertilization of the egg and the difficulty of finding
research subjects (not many women of child-bearing age are willing to have their
reproductive systems flushed in order to be studied). 113 There are also ethical
considerations because, in certain cases, testing would involve a human embryo. 114
Another factor adding to the difficulty of determining how a particular
contraceptive works is the general instability in the process of fertilization and
implantation. Loss of fertilized eggs is actually the norm. In healthy women not
practicing any method of contraception, an estimated 70 percent of fertilized eggs are lost
before or at the time of implantation 115.
B.
Ella
Ella is a pill that contains 30 mg of ulipristal acetate (UPA). Its product label
recommends use within 120 hours of unprotected sex.116 The strong scientific consensus
is that Ella works by inhibiting ovulation, 117 and that Ella’s main component, ulipristal
acetate, can prevent ovulation and even delay ovulation on the day of the LH peak for
twenty-four to forty-eight hours after the pill is taken.118
109
Maurizio Guida, et al., Emergency Contraception: An Updated Review, 1 TRANSLATIONAL MED. @
UNISA 271, 273 (2011).
110
Brief of Physicians For Reproductive Health, supra note 108, at 13.
111
Id.
112
E.g., Maria Elena Ortiz & Horacio B. Croxatto, Copper-T Intrauterine Device and Levonorgestrel
Intrauterine System: Biological Bases of Their Mechanism of Action, 75 CONTRACEPTION S16, S18 (2007)
(discussing in Table 3 that the number of control women was 111 and women with IUDs was even lower at
56 in the studies looking at the recovery of ova. This is just one example of the very few number of events
that have been directly studied in human females).
113
Id.
114
Id.
115
See CAROL COUGHLIN, ET AL. Recurrent Implantation Failure: Definition and Management 28
REPRODUCTIVE BIOMEDICINE ONLINE 14, 15 (2014) (stating that because the probability for an embryo to
successfully implant is only approximately 30%, the probability of it failing to implant is approximately
70%).
116
Association of Reproductive Health Professionals, The Facts About Emergency Contraception, (Dec.
2011), http://www.arhp.org/publications-and-resources/clinical-fact-sheets/facts-about-ec.
117
Ortiz, supra note 112.
118
Kristina Gemzell Danielsson, Cecilia Berger & P.G.L. Lalitkumar, Emergency Contraception—
Mechanisms of Action, 87 CONTRACEPTION 300, 302 (2013) (“…prior to the LH rise, UPA inhibited 100
104
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There is a minority view that Ella works by impacting endometrial development. 119
Endometrial tissue affects whether an egg can properly implant. 120 On that basis, an
argument is sometimes raised that Ella may affect post-fertilization implantation. 121
However, when used at the recommended dose and timing for emergency contraception,
no effect on the endometrium has been seen. 122
C.
Plan B (Levonorgestrel or “LNG ECP”)
Levonorgestrel is the scientific name for the pill called “Plan B” and other
hormonal pills that contain 1.5 mg LNG. It is a “synthetic version of the naturallyoccurring hormone progesterone.” 123 Plan B works by inhibiting ovulation. 124 The U.S.
Food and Drug Administration (FDA) approved Plan B packaging with a statement that a
post-fertilization effect is possible. 125 A reporter for the New York Times investigating
the issue of potentially-faulty FDA labeling of emergency contraceptives, such as Plan B,
said that the newspaper had reviewed “hundreds of pages of approval process
documents” but “found no discussion of evidence supporting implantation effects.”126
Plan B’s maker—Barr Pharmaceuticals, later acquired by Teva Pharmaceuticals—
asked the FDA not to list an implantation effect on the label. 127 While the FDA declined
to comment as to why the company’s request had been denied,128 at least some experts
percent of follicular ruptures…when the size of the leading follicle was >/=18 mm, follicular rupture failed
to occur within 5-6 days following treatment from 44 percent to 56 percent. Even on the day of the LH
peak, UPA could delay ovulation from 24-48 hrs…”). See also Kate McKeage & James D. Croxtall,
Ulipristal Acetate: A Review of Its Use in Emergency Contraception, 71 DRUGS 935, 935–36 (2011) (“The
principal effect of ulipristal acetate is to inhibit or delay ovulation. This effect may result from the drug's
ability to delay the onset of luteinizing hormone (LH) surge or postpone LH peak if LH surge has started,
or possibly by a direct inhibitory effect on follicular rupture, when administered in the follicular phase
(including just before ovulation).”). See also Kristina Gemzell-Danielsson, Mechanism of Action of
Emergency Contraception, 82 CONTRACEPTION 404, 404-409 (2010).
119
Bruno Mozzanega, MD, et al., Ulipristal Acetate: Critical Review About Endometrial and Ovulatory
Effects in Emergency Contraception, 21 REPRODUCTIVE SCIENCES 678, 678–79, (2014).
120
Id.
121
The Hobby Lobby plaintiffs complained that Ella and Plan B worked similarly to the abortion drug RU
486 or Mifepristone. See Verified Complaint ¶¶54-55, Hobby Lobby v. Sebelius, No. CIV-12-1000-HE
(W.D. Okla. Sept. 12, 2012) (Trial Pleading); See also First Amended Verified Complaint ¶46, Conestoga
Wood Specialties Corp. v. Sebelius, No. 5:12-CV-06744-MSG (E.D. Pa. Jan. 11, 2013) (Trial Pleading).
However, unlike ELLA Ella and Plan B, mifepristone acts on eggs already implanted in the uterus by
affecting progesterone activity and causing uterine contractions. See Label for mifepristone posted on U.S.
Food and Drug Administration website,
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020687s010-lbl.pdf.
122
Gemzell-Danielsson, supra note 118, at 304.
123
Brief of Physicians For Reproductive Health, supra note 108, at 8.
124
International Federation of Gynecology & Obstetrics (FIGO), Statement on Mechanisms of Action for
Emergency Contraception (Mar. 2011),
http://www.figo.org/sites/default/files/uploads/MOA_FINAL_2011_ENG.pdf
125
Pam Belluck, Abortion Qualms on Morning-After Pill May Be Unfounded, N.Y. TIMES, June 6, 2012, at
A1.
126
Id.
127
Id.
128
Id.
105
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hold the view that the FDA required an implantation mechanism on the label because of
endometrial effects, even though such effects do not interfere with implantation:
[D]aily birth control pills, some of which contain Plan B’s active
ingredient, appear to alter the endometrium, the lining of the uterus into
which fertilized eggs implant. Altering the endometrium has not been
proven to interfere with implantation . . . scientists say that unlike the
accumulating doses of daily birth control pills, the one-shot dose in
morning-after pills does not have time to affect the uterine lining. 129
The most up-to-date scientific consensus suggests that there is no meaningful
scientific evidence proving that Plan B interferes with the implantation of a fertilized egg.
In March 2011, the International Federation of Gynecology and Obstetrics (FIGO)
published a joint statement that levonorgestrel-only emergency contraceptive pills (LNG
ECPs) work by impairing ovulation, and do not inhibit implantation.130 The statement
summarized key findings from numerous scientific studies about levonorgestrel’s effects
on ovulation, sperm, implantation of the blastocyst and pregnancy:
Ovulation: The FIGO statement cited eight studies that showed “strong direct
evidence that LNG ECPs prevent or delay ovulation. 131 This is the primary
mechanism of action for LNG ECPs.” 132
Implantation: The FIGO statement cited a variety of studies to rebut the
contention that LNG ECPs affect implantation: 133
Two studies that confirmed a woman’s cycle day via “hormonal analysis”
compared to other studies, which “used a women’s self-reported day.”134
“In these studies no pregnancies occurred in women who took ECPs
before ovulation; while pregnancies occurred only in women who took
ECPs on or after the day of ovulation, providing evidence that ECPs were
unable to prevent implantation.”135
A number of studies “have evaluated whether ECPs produce changes in
the histological and bio-chemical characteristics of the endometrium.
Most studies show that LNG ECPs have no such effect on the
endometrium, indicating that they have no mechanism to prevent
implantation. One of these studies found that following administration of
double the standard dose of LNG, there are only minor or no alterations in
endometrial receptivity. One study found a single altered endometrial
parameter only when LNG was administered prior to the LH surge, at a
time when ECPs inhibit ovulation.” 136 In this latter study, endometrial
129
Id.
International Federation of Gynecology & Obstetrics, supra note 124. The FIGO statement cites to 17
studies published in scientific journals to support this conclusion.
131
International Federation of Gynecology & Obstetrics, supra note 124.
132
International Federation of Gynecology & Obstetrics, supra note 124.
133
International Federation of Gynecology & Obstetrics, supra note 124.
134
International Federation of Gynecology & Obstetrics, supra note 124.
135
International Federation of Gynecology & Obstetrics, supra note 124.
136
International Federation of Gynecology & Obstetrics, supra note 124.
130
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function being altered made no difference if the drug inhibited ovulation
altogether, because fertilization of an egg cannot take place without
ovulation.137
One study that showed LNG emergency contraceptive pills “did not
prevent the attachment of human embryos to a simulated (in vitro)
endometrial environment.”138
Two studies involving animals “demonstrated that LNG ECPs did not
prevent implantation of the fertilized egg in the endometrium.” 139
Sperm: The FIGO statement noted that “contradictory results exist regarding
whether LNG taken post-coitally and in doses used for ec (emergency
contraception) affects sperm function.” 140 The FIGO statement, citing two
studies, said “early studies suggested that LNG ECPs interfere with sperm
motility by thickening cervical mucus.” 141
The statement cautioned ,
however, that “two in vitro studies found that LNG in doses used for ec has no
direct effect on sperm function. Recent in vivo studies found no effect of
LNG on the number of viable sperm found in the female genital tract 24-28
hours after taking LNG. Interference in sperm migration is also a possible
explanation in women who took LNG ECP before ovulation, but had
documented follicle rupture in the following 5 days, yet did not get
pregnant.” 142 The FIGO statement concluded, “[g]iven these results, this
mechanism of action is still uncertain and warrants further studies.” 143
Effect on Pregnancy: The FIGO Statement concluded that LNG taken as an
emergency contraceptive has no apparent effect on pregnancy: “Two studies
of women who became pregnant in cycles when they took LNG ECPs found
no difference between pregnancy outcomes of women who had taken LNG
ECPs and those who had not. Variables included miscarriage, birth weight,
malformations, and sex ratio, indicating that LNG ECPs have no effect on an
established pregnancy even at very early stages.” 144
Based on 24 referenced studies, FIGO reached the conclusion that “inhibition or
delay of ovulation is LNG ECP’s principal and possibly only mechanism of action.” 145
Further:
Review of the evidence suggests that LNG ECPs cannot prevent
implantation of a fertilized egg. Language on implantation should not be
included in LnG ecP product labeling. The fact that LNG ECPs have no
demonstrated effect on implantation explains why they are not 100%
effective in preventing pregnancy, and are less effective the later they are
137
International Federation of Gynecology & Obstetrics, supra note 124.
International Federation of Gynecology & Obstetrics, supra note 124.
139
International Federation of Gynecology & Obstetrics, supra note 124.
140
International Federation of Gynecology & Obstetrics, supra note 124.
141
International Federation of Gynecology & Obstetrics, supra note 124.
142
International Federation of Gynecology & Obstetrics, supra note 124.
143
International Federation of Gynecology & Obstetrics, supra note 124.
144
International Federation of Gynecology & Obstetrics, supra note 124.
145
International Federation of Gynecology & Obstetrics, supra note 124.
138
107
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taken. Women should be given a clear message that LNG ECPs are more
effective the sooner they are taken. LNG ECPs do not interrupt a
pregnancy (by any definition of the beginning of pregnancy). However,
LNG ECPs can prevent abortions by reducing unwanted pregnancy. 146
D.
Intrauterine devices (IUD): copper-releasing IUD and levonorgestrel-releasing
IUD
Two of the four contraceptives at issue in Hobby Lobby are IUDs, one of which
releases copper and the other releases the hormone levonorgestrel. 147 A number of
studies suggest that the mechanism of IUD effectiveness typically occurs before
implantation: “The common belief that the usual mechanism of action of IUDs in women
is destruction of embryos in the uterus is not supported by empirical evidence.”148 The
usual mechanism of action in IUDs is by preventing fertilization (“preventing the
encounter of healthy gametes and the formation of viable embryos”). 149 Even if sperm do
reach the site of fertilization, there is evidence to suggest that they do not fertilize the egg
because of endometrial glycodelin secretion, which are substances secreted into the
female reproductive tract by the endometrium. 150 On the other hand, there have been
instances of fertilized eggs, and while interference with a fertilized egg may be
“exceptional” in the presence of a copper or hormonal IUD, it can occur, even if rarely. 151
Overall, the bulk of research supports the conclusion that IUDs do not interfere with the
reproductive process after fertilization has taken place. 152 Nonetheless, there is not full
consensus that IUDs prevent pregnancy by acting only before fertilization. 153
1.
ParaGard (copper-releasing IUD)
The consensus on the copper-releasing IUD is that it works as a contraceptive by
preventing the sperm from reaching the fallopian tube to fertilize the ovum. 154 Copper
ions in ParaGard “stimulate an intrauterine inflammatory reaction that is cytotoxic to the
146
International Federation of Gynecology & Obstetrics, supra note 124.
See Description of Terms, The Henry J. Kaiser Family Foundation, Intrauterine Devices (IUDs): Access
for Women in the U.S. (July 9, 2015), http://kff.org/womens-health-policy/fact-sheet/intrauterine-devicesiuds-access-for-women-in-the-u-s/.
148
Ortiz, supra note 112, at S28.
149
Ortiz, supra note 112, at S28.
150
Ortiz, supra note 112, at S18.
151
Ortiz, supra note 112, at S28.
152
Gemzell-Danielsson, supra note 118, at 304. These conclusions refers to chronic use of IUDs, as
distinguished from the situation when a copper IUD is used as an emergency contraception, with the
expectation that it may prevent implantation due to copper's effect of altering molecules present in the
endometrial lining of the uterus.
153
See, e.g., Joseph B. Stanford & Rafael T. Mikolajczyk, Mechanisms of Action of Intrauterine Devices:
Update and Estimation of Postfertilization Effects, 187 AM. J. OBSTET. GYNECOL.1699, 1699 (2002).
154
Anita Nelson, Safety, Efficacy and Patient Acceptability of the Copper T-380A Intrauterine
Contraceptive Device, 4 CLINICAL MED. INSIGHTS: WOMEN’S HEALTH 35, 35 (2011).
147
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sperm and phagocytizes [destroys] them; no viable spermatozoa remain in the
endometrial cavity 18 hours after natural insemination.”155
In short, copper is toxic to sperm and kills them before they reach the egg. 156 As
one study concluded about copper IUDs: “there is no evidence that the IUD works after
implantation.” 157 Further, “the evidence that IUDs do not work after fertilization by
blocking implantation comes from several different experimental designs.” 158 There are
several indications from scientific studies that copper IUDs work before fertilization
takes place:
“By studying ova retrieved during sterilization procedures from women who
had mid cycle coitus, it was seen that none of the specimens from women
using IUDs displayed normal cellular division indicating successful
fertilization. However, 50 percent of the ova from the women who used no
method showed such division.”159
“Similarly, no eggs were recovered from the uterine cavities of 56 IUD users
within 132 hours after the LH peak compared to 4 eggs found in the 115
control women.”160
“In addition, the fact that CuT380A [copper-releasing IUD] dramatically
decreases ectopic pregnancy risks supports the fact that the site of action is
before the fallopian tube—that fertilization is blocked.”161
Also of note, recent studies “have revealed that the copper IUD decreases
endometrial HOXA10 expression, which is essential for endometrial receptivity, but the
clinical significance of those changes is not known.”162 However, this point is moot if
there is no fertilization in the first place, and may be irrelevant to any Hobby Lobby
scientific review.
Finally, there is also an opposing view, albeit based on research almost 20 years old
and with a very small set of data , that copper IUDs work both as a pre-fertilization
spermicidal action and as a post-fertilization inhibition of uterine implantation. 163
2.
Mirena and Skyla (levonorgestrel-releasing IUD or LNG IUD)
This type of IUD acts by releasing progestin, a synthetic steroid that is different
from natural progesterone. 164 These contraceptives interfere with the sperm’s ability to
fertilize the egg. 165 The general medical view is that LNG IUDs work with a similar
155
Id.
Id.
157
Id.
158
Id.
159
Id.
160
Id.
161
Id.
162
Id.
163
Joseph A. Spinnato II MD, Mechanism of Action of Intrauterine Contraceptive Devices and Its Relation
to Informed Consent, 176 AM. J. OBSTET. GYNECOL., 503, 503–506 (1997).
164
Id.
164
Abdelhamid M. Attia, Magdy M. Ibrahim & Ahmed M. Abou-Setta, Role of the Levonorgestrel
Intrauterine System in Effective Contraception 7 Patient Pref. and Adherence 777, 778 (2013).
165
Ortiz, supra note 112, at S18.
156
109
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mechanism of action as copper-releasing IUDs, that is, they prevent fertilization. 166
However, just as with the copper IUD, there is not full scientific agreement. One review
of the scientific literature on the mechanism of action for IUDs noted that in rare
instances, LNG-IUDs may interfere with a fertilized egg, as suggested in a study by
Alvarez et al., where there was one fertilized egg recovered from a LNG IUD user. 167
V.
UNDER RULE 702, WOULD A COURT HAVE ADMITTED EVIDENCE THAT THESE
FOUR METHODS ARE ABORTIFACIENTS?
Under the court’s gatekeeping function—which applies to all expert testimony168—
the trial judge assesses whether scientific opinions are admissible, using the nonexclusive standards of Rule 702. 169 The inquiry focuses on whether expert opinions are
sufficiently reliable to be admitted before any fact-finding takes place (whether the factfinder is the jury or a judge). 170 The “focus, of course, must be solely on principles and
methodology, not on the conclusions they generate.” 171
Admissibility is not equivalent to a fact-finding conclusion. Thus, competing
opinions can be admitted so long as they meet the Rule 702 requirements. 172 Proponents
“do not have to demonstrate to the judge by a preponderance of the evidence that the
assessments of their experts are correct, they only have to demonstrate by a
preponderance of the evidence that their opinions are reliable. . . The evidentiary
requirement of reliability is lower than the merits standard of correctness.”173
There are four components to a Rule 702 analysis, although the components can be
overlapping.174 For purposes of this review, I assume that one or more of the authors
from the articles cited in Section IV would testify on whether the four contraceptives are
abortifacients. On that basis, I approach the Rule 702 analyses as follows.
First, in Section A below, I discuss admissibility under Rule 702(a) and show that
identifying a qualified expert is not likely to be an impediment to admissibility of
opinions contesting the Hobby Lobby beliefs about the four contraceptives.
Second, in Section B below, I analyze the Rule 702(b), (c) and (d) factors for each
contraceptive. The main reason for analyzing those factors together is that in this
situation, the Rule 702 factors—testimony based on sufficient facts, the product of
reliable principles and methods, and the reliable application of those principles and
methods—are highly overlapping. Hobby Lobby, unlike Daubert, does not involve the
application of scientific principles and methods to a single personal injury plaintiff. The
166
Ortiz, supra note 112, at S28.
Ortiz, supra note 112, at S27.
168
Kumho Tire Co. v. Carmichael, 119 S. Ct. 1167, 1178 (1999).
169
FED. R. EVID. 702.
170
Id.
171
Daubert, 509 U.S. at 595.
172
FED. R. EVID. 702, supra note 58.
173
In re Paoli R.R. Yard PCB Litigation, 35 F.3d 717, 744 (3d Cir. 1994). See also Daubert v. Merrell Dow
Pharmaceuticals, 43 F.3d 1311, 1318 (9th Cir. 1995) (scientific experts might be permitted to testify if they
could show that the methods they used were also employed by “a recognized minority of scientists in their
field.”).
174
FED. R. EVID. 702.
167
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principles and methods shown in the scientific literature are not dependent on a particular
individual but rather apply more generally to a widespread group of individuals. Clearly,
this was a case where the plaintiffs did not have individualized medical conditions; rather
they made general medical and scientific claims in their briefs to the court. Thus, the
court, in exercising its gatekeeper function, would evaluate expert testimony as it is
applied generally to the claims at hand, rather than to a specific person.
Here, the focus is on the reliability of scientific data and methods for studying the
general mechanism of action in a given contraceptive, and whether an expert’s opinion
shows that she reliably applied scientific principles and methods to her conclusions about
the mechanism of action in a particular contraceptive. As has been recognized by others,
there is considerable redundancy among those factors, and treating them as completely
independent would be pushing distinctions that may not exist. 175
A.
Will The Expert’s Specialized Knowledge Help The Trier Of Fact To Determine
Whether Each Contraceptive Is An Abortifacient Under Rule 702(A)?
How each contraceptive works is not a matter of everyday experience or intuition—
it is a matter of “scientific, technical, or other specialized knowledge.” 176 The authors of
the scientific articles cited in Section IV were qualified by education, training and
experience. The authors hold a medical degree and/or a doctoral degree in an appropriate
science, and specialize in gynecology and/or reproductive health. If one or more of these
scientists were called to testify at trial, their opinions about contraceptives would likely
pass muster under Rule 702(a) because each of them has the requisite “scientific,
technical, or other specialized knowledge” to help the trier of fact understand a key issue:
whether a particular contraceptive is an abortifacient, the “fact in issue.”177
Even when a witness does not have the strongest of credentials, it would be
unusual—indeed, possibly an abuse of the trial court’s discretion—for an M.D. practicing
or researching in the area of gynecology or obstetrics to be barred from testifying on the
basis of lack of specialized knowledge. 178 Disputes over the strength of qualifications
and credentials usually go to the weight that a fact-finder gives the expert testimony,
rather than to the admissibility of the testimony. 179 As the Daubert Court noted,
“[v]igorous cross-examination, presentation of contrary evidence, and careful instruction
on the burden of proof are the traditional and appropriate means of attacking shaky but
admissible evidence.”180
See, e.g., Munia Jabbar, Overcoming Daubert’s Shortcomings in Criminal Trials: Making the Error Rate
the Primary Factor in Daubert’s Validity Inquiry, 85 NYU LAW REV. 2034–64 (2010); DAVID L.
FAIGMAN, ET AL., 1 MODERN SCIENTIFIC EVIDENCE: THE LAW AND SCIENCE OF EXPERT TESTIMONY 20 (2d
ed. 2002).
176
FED. R. EVID. 702.
177
FED. F. EVID. 702(a).
178
Weinstein, supra note 29 at § 702.04(1)(a).
179
See, e.g., Jahn v. Equine Services, PSC, 233 F.3d 382, 393 n.8 (6th Cir. 2000); Arkansas Game and Fish
Comm’n v. United States, 736 F.3d 1364, 1378 (Fed. Cir. 2013).
180
Daubert, 509 U.S. at 596.
175
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In short, Rule 702(a) would not be an impediment to offering the scientific
opinions discussed in Section IV because those rendering the opinions have the required
specialized knowledge.
B.
Would the Court Have Admitted Evidence that Ella Is or Is Not an Abortifacient?
The overwhelming view from medical literature and numerous peer-reviewed
scientific studies is that Ella works by inhibiting ovulation—a process that takes place
before fertilization and before implantation of a fertilized egg. That conclusion hinges on
scientific facts and data subjected to peer review. Moreover, as shown in Section IV,
there is virtually no reliable basis for disputing that this opinion is the product of reliable
scientific principles and methods, which were reliably applied to the research. A court
should easily admit those opinions about Ella under Rule 702.
The question is whether a court would admit the contrary opinion, that Ella works
by impacting endometrial tissue and that on that basis, there is an effect on whether a
fertilized egg can properly implant. That opinion is a tougher call both because (1) it is
not a generally accepted view of how Ella works, (2) the opinion reflects an analytical
gap between principles and facts, and (3) it could be argued that the opinion does not
have sufficient facts or data to support it.
In any event, there is little question that a scientific opinion would be admitted
which is contrary to the position offered by the Hobby Lobby plaintiffs (that Ella acts on a
fertilized egg and that it prevents implantation of a fertilized egg).
C.
Would the Court Have Admitted Evidence that Plan B (pill form of
Levonorgestrel) Is or Is Not an Abortifacient?
Although Plan B has a checkered political history, the most recent prominent
scientific research concludes with strong direct evidence that the pill prevents or delays
ovluation and does not interfere with fertilization or affect implantation of the blastocyst.
The FIGO statement cited eight studies that showed strong direct evidence that Plan B
prevents or delays ovulation and is the primary mechanism of action for this
contraceptive.181 As shown in the FIGO Statement, there are two studies that conclude
emergency contraception does not affect implantation. 182 These two studies were
published in respected peer-reviewed scientific journals, one in Contraception, and the
other, in Human Reproduction.183 These are professional journals targeted to a medical
audience and not concerned about the politics of contraceptives.
For example, Contraception’s editorial statement says its aim is to “advance
reproductive health through the rapid publication of the best and most interesting new
scholarship regarding contraception and related fields such as abortion.” 184 It is the
official journal of the Association of Reproductive Health Professionals. 185 Human
181
International Federation of Gynecology & Obstetrics, supra note 124.
International Federation of Gynecology & Obstetrics, supra note 124.
183
International Federation of Gynecology & Obstetrics, supra note 124.
184
CONTRACEPTION, http://www.contraceptionjournal.org/content/authorinfo#idp1314592 (last visited Nov.
11, 2014).
185
Id.
182
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Reproduction is a similar journal published by Oxford, dedicated to “full-length, peerreviewed papers reporting original research, concise clinical case histories, as well as
opinions and debates on topical issues.” 186 Thus, by relying on research published in
high quality medical journals, the opinion that Levonorgestrel is not an abortifacient is
the product of reliable scientific research principles and methods.
Furthermore, these opinions are based on sufficient facts or data. All of the studies
cited involved testing a hypothesis with data and analysis, and comparing the data with a
control group. The tests were not funded by political action groups but rather were
conducted by independent researchers with funding by universities or government grants.
The researchers were required by their journals to disclose whether they had any conflicts
of interests in conducting the research.
Indeed, each of these experts—as reflected in their publications and reports of their
publications—has the ability to “give a dissertation or exposition of scientific . . .
principles relevant to the case.” 187 There is no question that this view of how Plan B
works would be admissible.
As with Ella, the question is whether an alternative view, supporting the position of
the Hobby Lobby plaintiffs, would also be admitted. An expert may point to the
manufacturer’s own packaging statement, that a post-fertilization effect is possible, even
though the FDA required the manufacturer to place that statement on the label over the
manufacturer’s objection that the statement was not scientifically justified. There is also
the notion that Plan B may have endometrial effects, even if there is no direct evidence
linking endometrial effects with disruption of implantation. Thus, it is not likely that the
Hobby Lobby plaintiffs’ view of the science would be admitted, but it is possible. In that
event, the fact-finder would receive both scientific views about how Plan B works and
would have to evaluate which opinion about Plan B’s mechanism of action is more
persuasive.
D.
Would the Court Have Admitted Evidence that IUDs Are or Are Not
Abortifacients?
The majority scientific view, based on facts and data published in well-regarded
professional publications, is that IUDs work by preventing fertilization. 188 Interference
with the reproductive process after fertilization has taken place is exceptional in the
presence of a copper or LNG IUD.189 Opinions that IUDS do not act on fertilized eggs
and do not disrupt implantation of a fertilized egg would be based on scientific facts and
data presented in reputable scientific publications, and based on scientific principles and
methods subject to peer review.
While the view that IUDs interfere with the reproductive process after fertilization
has taken place is not widely held, there are scientific articles that analyze research and
reach this conclusion. With respect to copper-releasing IUDs, the opinion could be
offered based on scientific analysis of research data that copper IUDs work both as a pre186
HUMAN REPRODUCTION, http://www.oxfordjournals.org/our_journals/humrep/about.html (last visited
Nov. 11, 2014).
187
FED. R. EVID. 702, advisory committee’s note, 1972 Proposed rules.
188
Ortiz, supra note 112.
189
Ortiz, supra note 112.
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fertilization spermicidal action and as a post-fertilization inhibition of uterine
implantation. While the research is not current and the opinion not broadly held,
nonetheless under Rule 702’s focus on “sufficient facts or data” and “reliable principles
and methods” it is likely that this opinion would be admitted.
With respect to LNG IUDs, while the general medical view is that these IUDs work
by preventing fertilization, there is not full scientific agreement. Some of the
disagreement is based on studies with a small number of patients, which may jeopardize
the reliability of such opinions under Rule 702, with its emphasis on “sufficient facts or
data” and “reliable principles and methods.” However, it is generally agreed that studies
of IUD effects are hard to complete on large number of patients, so opinions based on a
small number of patients could be admitted. 190
In short, opinions that IUDs, whether copper-releasing or LNG-releasing, work
before fertilization takes place are the prevailing scientific view and would likely be
admitted under Rule 702. It is also likely that the countervailing view could also be
admitted under Rule 702.
VI.
HOW WOULD THE HOBBY LOBBY DECISION CHANGE IF RULE 702 HAD BEEN
APPLIED?
If the trial court had performed a gatekeeping role, evidence that these four
contested Hobby Lobby contraceptives were not abortifacients should have been
admitted. This is not to say that competing evidence, taking the contrary view, would not
have also been admitted.191 Of course, those contending that the four contraceptives are
abortifacients would have the opportunity to buttress their belief with scientific
evidence. 192 The judge then would evaluate “whether expert testimony is sufficiently
reliable to be considered by the trier of fact.” 193 Ultimately, the judge or jury would then
weigh the competing evidence and make a factual determination of whether each
challenged contraceptive is an abortifacient. By neglecting the requirements of Rule 702,
the Hobby Lobby trial and appellate judges apparently assumed that the four
contraceptives at issue were abortifacients (with the exception of Judge Briscoe of the
10th Circuit).
The government’s failure to challenge Hobby Lobby’s premise that the
contraceptives at issue were abortifacients should not dispose of the need for scientific
proof. It is fundamental in litigation that the plaintiff has the burden of proof on every
element of a claim. In both underlying Hobby Lobby cases, the plaintiffs claimed that the
ACA imposed a substantial burden on the plaintiffs’ religious exercise because the Act
mandated “coverage or access to coverage of abortion-causing drugs or devices . . .
190
Ortiz, supra note 112, at S17.
FED. R. EVID. 702, supra note 58 (“When a trial court, applying this amendment, rules that an expert’s
testimony is reliable, this does not necessarily mean that contradictory expert testimony is unreliable.”); see
also Ruiz-Troche v. Pepsi Cola, 161 F. 3d 77, 85 (1st Cir. 1998).
192
In re Paoli R.R. Yard PCB Litigation, 35 F. 3d 717, 744 (3d Cir. 1994)(holding that a party does not
have to prove at the gatekeeping stage that its experts are correct, “they only have to demonstrate by a
preponderance of evidence that their opinions are reliable . . . .The evidentiary requirement of reliability is
lower than the merits standard of correctness”).
193
FED. R. EVID. 702, supra note 58.
191
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.” 194 Moreover, the Hobby Lobby plaintiffs did not simply object that their religious
beliefs prevented coverage of all contraceptives. Rather, their claim focused on particular
contraceptives that allegedly caused abortions. Therefore, to prevail, the plaintiffs
should have been required by the trial courts, and by any reviewing courts, to prove with
scientific evidence that each contraceptive at issue actually behaved in the way the
plaintiffs alleged. Such proof was all the more vital in the context of a preliminary
injunction, the procedure in both underlying cases, because a preliminary injunction is an
“extraordinary remedy that may only be awarded upon a clear showing that the plaintiff
is entitled to such relief.” 195 In short, without the scientific foundation for showing
whether the challenged contraceptives were indeed abortifacients, the plaintiffs failed to
prove an essential element of their claim.
In this vein, Fed. R. Evid. 706 provides a procedure for a trial judge to appoint an
expert to assist the court with its deliberations, whether or not the parties do so: “On a
party’s motion or on its own, the court may order the parties to show cause why expert
witnesses should not be appointed and may ask the parties to submit nominations. The
court may appoint any expert that the parties agree on and any of its own choosing. But
the court may only appoint someone who consents to act.” 196
If Rule 702 had been applied, the trial courts would have admitted scientific
evidence about the mechanism of action for the four methods of contraceptives. That
scientific evidence would become the basis to decide whether or not each method is an
abortifacient, thereby providing expert scientific opinions for reaching a factual
conclusion and properly challenging a major premise underlying the Hobby Lobby
decisions.
A.
Impact On The “Substantial Burden” Analysis
The finding that the Hobby Lobby plaintiffs’ claims were based on junk science
would have a significant impact on the Court’s “substantial burden” analysis. In Hobby
Lobby, where First Amendment and statutory religious freedom guarantees were at issue,
the Court decided that the challenged HHS regulations requiring contraceptive coverage
“substantially burdened the exercise of religion.” 197 The Court held that there was a
substantial burden 198 on Hobby Lobby and Conestoga because they “have religious
objections to abortions.” 199 Thus, they believed that by complying, they would
“facilitate[e] abortions,” but that “if they do not comply, they will pay a very heavy
price—as much as $1.3 million per day, or about $475 million per year, in the case of one
of the companies.”200
194
Complaint, Hobby Lobby, Inc. v. Sebelius, 2012 WL 4009450 (W.D. Okla. Sept. 12, 2012); First
Amended Complaint, Conestoga Wood Specialties Corp. v. Sebelius, 2013 WL 6181041 (E.D. Pa. Jan. 11,
2013) (making a similar allegation: that “Plaintiffs’ sincerely held religious beliefs prohibit them from
providing coverage for abortifacients and contraception with a possible abortifacient effect . . . .”).
195
Winter v. Natural Res. Def. Council, Inc., 555 U.S. 7, 22 (2008).
196
FED. R. EVID. 706.
197
Burwell v. Hobby Lobby, 134 S. Ct. 2751, 2759 (2014).
198
Id.
199
Id.
200
Id.
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But a reexamination of the contraceptive mandate shows that, in fact, it did not
actually infringe upon the corporations’ sincerely held beliefs. If the trial court had
applied Rule 702 to the Hobby Lobby respondents’ claims, the Supreme Court’s analysis
could have totally changed in favor of the government. At a minimum, the record would
contain substantial opinion evidence that none of these four contraceptives are
abortifacients. In addition, it is possible that for two of the four contraceptives—Ella and
Plan B—no contrary expert opinions would have been admitted. Thus, it is likely that the
case would have come before the Supreme Court with a factual finding below that at least
some, and perhaps all, of the challenged contraceptives were not abortifacients, and thus
could not possibly infringe upon the companies’ anti-abortion beliefs. Such a factual
finding would have been entitled to great deference by the Court.
B.
Does A Rule 702 Analysis Violate The Free Exercise Clause or RFRA?
A search of Westlaw reveals that no case has ever asked the question whether a
Rule 702 analysis violates the Free Exercise Clause or RFRA. Under RFRA, the
“Government shall not substantially burden a person’s exercise of religion even if the
burden results from a rule of general applicability.” 201 The burdened person is entitled to
an exemption unless the Government can demonstrate “that application of the burden to
the person –1) is in furtherance of a compelling governmental interest 2) is the least
restrictive means of furthering that compelling governmental interest.” 202
Under a post-Daubert review of the facts, the government arguably has a much
more compelling interest: to make sure that legal claims with scientific underpinnings are
factually correct. We should not want our court systems to be filled with junk scientific
claims about abortifacients, which would undermine the credibility of our legal system
and set bad precedent. Additionally, there would be equal protection concerns if courts
were lax in allowing junk science into the courtroom in cases about women’s
reproductive freedom, but were more diligent about policing junk science in other cases.
Certainly, the government has a compelling interest in ensuring that women are treated
equally in accordance with the due process and equal protection clauses of both the Fifth
and Fourteenth Amendments.
Furthermore, engaging in a Rule 702 analysis would not infringe on petitioners’
right to freely exercise their religious beliefs. Rather, the analysis would simply show
whether the underlying facts support a claim that religious exercise has been burdened: a
religious belief against abortion, no matter how sincere and compelling, is irrelevant if
the contraceptives in question are not, in fact, abortifacients.
Even the dissenting opinion in the Supreme Court’s decision failed to fully analyze
the lack of evidence under Rule 702. On the one hand, Justice Ginsburg alluded to the
fact there is a lack of evidence showing that plaintiffs will be substantially burdened. 203
She noted that “the Court barely pauses to inquire whether any burden imposed by the
contraceptive coverage requirement is substantial.” 204 But on the other hand, the analysis
201
Id.
Id.
203
Id. at 2798 (Ginsburg, J., dissenting).
204
Id.
202
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falls short because it focused on how much the plaintiffs will need to pay the government
in fines if they do not comply with the law, rather than the moral burden, which the
dissent—like the majority—presumes.205 It is that moral burden that is unsupported by
science, and should have been more closely scrutinized under Rule 702.
VII.
CONCLUSION
Hobby Lobby is an example of how the Supreme Court neglected its own
precedent. The Court should have remanded the case to the lower courts for further factfinding, subject to a Rule 702 analysis, before reaching a decision about whether
government action burdened religious beliefs where the alleged burden appears to be
rooted in bad science. Instead, by ignoring the faulty assumptions underlying the Hobby
Lobby plaintiffs’ claims, the Court upset the important precedent of Daubert and
reopened the risk of junk science in the courtroom.
Furthermore, the Court’s decision may have consequences for public health policy
in the United States and abroad. Unfortunately, the Hobby Lobby decision reinforces
medical myths that IUDs and emergency contraceptives are abortifacients. These
mistaken ideas could well undermine the ability of medical professionals to implement
effective family planning outreach with safe and reliable forms of contraception. 206
While this is not strictly a legal problem, courts have a responsibility to ensure that
science is evaluated appropriately in the courtroom because decisions made inside the
courtroom can have meaningful repercussions outside the courtroom as well. Moreover,
the Court’s precedent could lead lower courts to grant greater deference to religious
plaintiffs’ erroneous beliefs on secular, scientific questions. 207
The Court is also setting a bad precedent and potentially disregarding the
commands of the Fifth and Fourteenth Amendments when it allows matters related to
women’s bodies to be treated differently or with less scientific rigor in the courtroom.
Why is it that Rule 702, which requires a trial judge to review all sorts of scientific
testimony, is routinely applied in many different factual scenarios—from toxic torts to
criminal cases involving DNA testing—but in this case, involving women’s reproductive
choices, it was ignored?
Of course, the initial responsibility to require scientific evidence, and then to apply
Rule 702, lies with the trial judge. In neither of the two cases that were part of the Hobby
Lobby decision did the federal district judges raise the issue that the plaintiffs had not
proffered one bit of scientific evidence to back up their claims. Furthermore, the
government did not raise the scientific argument. It was only when the case arrived at the
Supreme Court that attorneys representing various physician groups raised the scientific
issues, albeit as amici curiae. 208 It is unclear why the government did not raise the issue:
was it out of concern that raising the claim’s lack of scientific validity might enrage
religious conservatives? President Barack Obama was running a tough reelection
205
Id.
Id. at 2788–89.
207
Though the Hobby Lobby plaintiffs’ beliefs about abortion were religious, its belief that the
contraceptives were abortifacients is a question of fact that can, and should, be answered by science alone.
208
Brief of Physicians For Reproductive Health, supra note 108.
206
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campaign in 2012, just as the Hobby Lobby cases were making their way through the
lower courts. Perhaps, in an effort to woo independent voters, his administration chose to
quietly argue Hobby Lobby on less controversial grounds rather than aggressively attack
the plaintiffs’ professed religious beliefs as junk science.
If this theory is correct, however, it shows compellingly why trial judges must act
on their responsibility to be the gatekeepers. If the adversaries themselves refuse to
challenge the junk science—because of a lack of financial resources, or a lack of political
will—the trial judge must be able to separate fiction from reality, upholding the integrity
of the judiciary even when the parties do not. In short, it is the trial judge who can, and
must, stop alchemy and astrology from running rampant and roughshod over the integrity
of the courtroom.
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