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2024-05-08 PLTFS' Brief in Support of Motion To Declare IVF Immunity Statutes Unconstitutional
2024-05-08 PLTFS' Brief in Support of Motion To Declare IVF Immunity Statutes Unconstitutional
ELECTRONICALLY FILED
5/8/2024 10:41 AM
02-CV-2024-900527.00
CIRCUIT COURT OF
MOBILE COUNTY, ALABAMA
SHARLA KNOX, CLERK
IN THE CIRCUIT COURT OF MOBILE COUNTY, ALABAMA
INTRODUCTION
Plaintiffs Raymond Lee Brackett and Sarah Brackett (“Mr. and Mrs. Brackett”)
contend the new IVF immunity statutes, Ala. Code §§ 6‐5‐810 and 6‐5‐811 (set forth
in full below and also attached as Appendix Exhibits A & B) are unconstitutional.
These statutes constitute unlawful attempts at abrogating rights and remedies which
were excepted out of governmental power when the People of Alabama voted in
DOCUMENT 39
“Declaration of Rights,” contains the first 36 of the Constitution’s 287 sections. The
“That the great, general, and essential principles of liberty and free
government may be recognized and established, we declare:”
“That this enumeration of certain rights shall not impair or deny others
retained by the people; and, to guard against any encroachments on
the rights herein retained, we declare that everything in this
Declaration of Rights is excepted out of the general powers of
government, and shall forever remain inviolate.”
Art. I, § 36 Ala. Const. of 1901 (emphasis added). These words were chosen carefully
by the framers to enshrine certain rights of each Alabama citizen and to forever
ensure those rights have primacy over the general powers of representative
government.
After the 2018 vote, Article 1, Section 36.06 of Alabama’s Constitution now
states:
(a) This state acknowledges, declares, and affirms that it is the public
policy of this state to recognize and support the sanctity of unborn life
and the rights of unborn children, including the right to life.
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(b) This state further acknowledges, declares, and affirms that it is the
public policy of this state to ensure the protection of the rights of the
unborn child in all manners and measures lawful and appropriate.
Art. I, §§ 36.06(a) and (b). Because the rights established in § 36.06 are excepted
from government, the legislature and governor cannot lawfully upset, impair, or take
Accordingly, Mr. and Mrs. Brackett contend the new IVF civil and criminal
• Art. IV, § 95, (No removal of cause of action after suit filed);
• and the rights of the Bracketts and their embryos to equal protection of
the laws pursuant to Art. I, §§ 1, 6, 13, and 22.
The Plaintiffs have served the Attorney General of Alabama with a copy of their
Motion and this Brief, as required by Ala. Code § 6‐6‐227 (“... if [a] statute ... is
alleged to be unconstitutional, the Attorney General of the state shall also be served
with a copy of the proceeding and be entitled to be heard.”). See attached Exhibit
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C.
(a) Related to in vitro fertilization and notwithstanding any provision of law, including
any cause of action provided in Chapter 5 of Title 6, Code of Alabama 1975, no
action, suit, or criminal prosecution for the damage to or death of an embryo shall
be brought or maintained against any individual or entity when providing or receiving
services related to in vitro fertilization.
(b) This section is intended to apply retroactively to any act, omission, or course of
services which are not the subject of litigation on the effective date of this act.
(a) Related to in vitro fertilization and notwithstanding any provision of law, including
any cause of action provided in Chapter 5 of Title 6, Code of Alabama 1975, for the
damage to or death of an embryo brought against the manufacturer of goods used
to facilitate the in vitro fertilization process or the transport of stored embryos,
damages shall be limited to compensatory damages calculated as the price paid for
the impacted in vitro cycle.
1
The Alabama Supreme Court released its opinion in LePage v. Center for
Reproductive Medicine, 2024 WL 656591, ___ So. 3d ___ (Ala. 2024) on February 16,
2024. Acts 2024‐20, S.B. No. 159, was introduced by Senator Melson on February
27th and after amendments, signed into law by Governor Ivey on March 6th. See bill
tracking summary attached as Exhibit D.
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as applied:
That all men are equally free and independent; that they are endowed
by their Creator with certain inalienable rights; that among these are
life, liberty, and the pursuit of happiness.
That all courts shall be open; that every person, or any injury done him,
in his lands, goods, person, or reputation, shall have a remedy by due
process of law; and right and justice shall be administered without sale,
denial, or delay.
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That no ex post facto law, nor any law, impairing the obligations of
contracts, or making any irrevocable or exclusive grants of special
privileges or immunities, shall be passed by the legislature; and every
grant or franchise privilege, or immunity, shall forever remain subject
to revocation, alteration, or amendment.
That this enumeration of certain rights shall not impair or deny others
retained by the people; and, to guard against any encroachments on the
rights herein retained, we declare that everything in this Declaration of
Rights is accepted out of the general powers of government, and shall
forever remain inviolate.
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Town of Cedar Bluff v. Citizens Caring for Children, 904 So. 2d 1253, 1256‐57 (Ala.
2004).
Mr. and Mrs. Brackett have standing to bring this motion challenging the
Association d/b/a Mobile Infirmary Medical Center (“MIMC”) and the Center for
Reproductive Medicine, P.C. (“CRM”) expressly rely upon the statutes in their April
23, 2024 joint motion pursuant to Ala. R. Civ. P. 12(b)(1) and (6) to dismiss the
Bracketts’ “action in its entirety.” Doc. 18, p. 1. In their motion, MIMC/CRM assert
at pages 8‐10 that dismissal is warranted because “Defendants are immune from
warranting dismissal of the Bracketts’ claims, the Bracketts have a right pursuant to
those statutes:
“Any person ... whose rights, status, or other legal relations are affected
by a statute ... may have determined any question of construction or
validity arising under the ... statute ..., and obtain a declaration of rights,
status, or other legal relations thereunder.”
With this motion, Mr. and Mrs. Brackett seek a declaration individually and in
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facially, and as applied to them in their individual and representative capacities – and
At least since Marbury v. Madison, 5 U.S. 137 (1803), courts have had the
State ex rel. Bassett v. Nelson, 210 Ala. 663, 98 So. 715 (1924)(emphasis added).
More specifically,
There is ... an obligatory duty of the courts, which are vested with the
power to pass upon the constitutionality of statutes, to not overlook
or disregard constitutional demands, which the judges are sworn to
support, and therefore, when it is clear that a statute transgresses the
authority vested in the Legislature by the Constitution, it is the duty
of the courts to declare the act unconstitutional, and from this duty
they cannot shirk without violating their oaths of office.
Ex parte E.R.G., 73 So. 3d 634, 649 (Ala. 2011), quoting McCall v. Automatic Voting
Mach. Corp., 236 Ala. 10, 13, 180 So. 695, 697 (1938)(emphasis added). See also Rice
v. English, 835 So. 2d 157, 162 (Ala. 2002) (noting that “it is incumbent upon the
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v. City of Birmingham, 354 So. 2d 808, 811 (Ala. 1978) (If an “act is repugnant to the
Constitution, the courts not only have the power, but it is their duty, when the issue
5. STANDARD OF REVIEW
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“ ‘In Home Indemnity Co. v. Anders, 459 So. 2d 836, 840 (Ala. 1984), this Court
stated:
Ex parte E.R.G., 73 So. 3d at 641‐42 quoting Lunsford v. Jefferson County, 973 So. 2d
The Supreme Court in Ex parte E.R.G. reiterated the imperative duty of courts
“In Rice v. English, 835 So. 2d 157, 162 (Ala. 2002), this
Court, citing Ex parte Selma & Gulf R.R., 45 Ala. 696
(1871), reiterated ‘the settled principle that the people
have forbidden the Legislature from conducting itself in
a manner inconsistent with their constitution and when
it does, it is incumbent upon the judiciary to nullify a
legislative enactment contrary to the constitution.’ ”
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Because the IVF civil and criminal immunity statutes implicate and would
presumption of constitutionality.
“The laws of nature teach us that the relation of parent and child is sacred.”
Ex parte E.R.G., supra, 73 So. 3d at 655, quoting Montgomery v. Hughes, 4 Ala. App.
245, 247, 58 So. 113, 113‐14 (1911). Mr. and Mrs. Brackett accordingly had (and
have) a constitutionally protected right to conceive children and raise a family. See
Weldon v. Ballow, 200 So. 3d 654, 674 (Ala. Civ. App. 2015).
The fundamental right to life, when taken away, is actionable under § 6‐5‐391.
LePage v. Center for Reproductive Medicine, 2024 WL 656591, ___ So. 3d ___ (Ala.
State action that limits or impairs such fundamental rights are generally
subject to strict scrutiny. Ex parte E.R.G., 73 So. 3d at 655. However, “[a] statute
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the burden shifts to the proponent to prove that the infringement furthers a
Ballow, 200 So. 3d at 674 (Donaldson, J., concurring) citing, inter alia, Herring v.
First and foremost, the legislature and the governor cannot purport to invoke
governmental powers and effectuate legislation which the people through the power
of their collective votes prohibited them from exercising. Ex parte E.R.G., 73 So. 3d
at 641‐42 (“settled principle that the people have forbidden the Legislature from
conducting itself in a manner inconsistent with the Constitution and when it does,
Automatic Voting Machine Corp.; State ex rel. Bassett v. Nelson; Ex parte Selma &
Gulf R.R. When the people in November 2018 voted to amend our Constitution’s
commanded that the legislature and the governor were powerless to take those
rights away. Our Constitution is paramount and the rights of unborn children are to
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be protected inviolate:
The Constitution of Alabama, like that of the nation and of the other
states, is the supreme law within the realm and sphere of its authority.
Subject only to the restraints resulting from the Constitution of the
United States, the Constitution of Alabama is the highest form and
expression of law that exists in this state. The source of its creation and
the character of its sanction, viz. the people’s deliberate will, invest the
Constitution with its paramount quality. The Constitution’s control is
absolute wherever and to whatever its provisions apply; and every
officer, executive, legislative, and judicial, is bound by oath ([Art. XVI,]
section 279) to support the Constitution, to vindicate and uphold its
mandates, and to observe and enforce its inhibitions without regard to
extrinsic circumstances. It commits to no body, officer, or agent any
authority or power whatever to change or modify or suspend the effect
or operation of its mandates or its prohibitions; the instrument itself
prescribes the exclusive modes by which it may be altered or amended,
or its effect and operation changed. Otherwise than as these exclusive
modes contemplate and authorize the Constitution’s alteration, its
character is permanent, its force and influence enduring. Both of these
exclusive modes are plainly stated in [Art. XVIII] sections 284‐287 of the
[Alabama] Constitution. Only through a constitutional convention,
called and convened as provided in the existing organic law, or through
amendment proposed and adopted as provided in the existing organic
law, can the Constitution be altered or changed.
Johnson v. Craft, 205 Ala. 386, 393, 87 So. 375, 380 (1921). See, also, Grantham v.
Denke, 359 So. 2d 785, 787 (Ala. 1978) (“‘[t]he constitution of this state is the
supreme law and limits the power of the legislature.’”), quoting Alexander v. State,
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upon IVF healthcare providers, deprive the Bracketts of their rights to rear children,
cautioned that because the People had spoken through the Democratic process in
amending our Constitution with such a clear expression of public policy protecting
unborn children, only further Constitutional action could then upset such protections
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Putting this all together, § 36.06 does much more than simply declare
a moral value that the People of Alabama like. Instead, this
constitutional provision tilts the scales of the law in favor of protecting
unborn life. Although § 36.06 may not resolve every case involving
unborn life, if reasonable minds could differ on whether a common‐law
rule, a statute, or even a constitutional provision protects life, § 36.06
instructs the Alabama government to construe the law in favor of
protecting the unborn. Furthermore, to exclude the unborn from §
36.06’s protection, the Legislature would have to do so very clearly and
for a reason that is consistent with upholding the sanctity of life.
Section 1 guarantees the right to life. Section 6 provides in pertinent part that
a citizen of Alabama “shall not be [...] deprived of life, except by due process of law.”
Thus, in the texts of Sections 1 and 6, the framers ensured that in Alabama life is
In Ex parte Frazier, 562 So. 2d 560, 565 (Ala. 1989), the Court explained that
the term, “due process of law,” as used in section 6 of the Alabama Constitution, “in
its most basic sense encompasses the observation of that degree of fundamental
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the Bracketts’ embryos) the statutes patently clash with Art. I, §§ 1 and 6 of the
Constitution and their guarantees of life, the right to bear children, and the right to
or their parents – of all the protections of Alabama law, including the remedies
afforded by the Wrongful Death of a Minor Act, § 6‐5‐391. See LePage v. Center for
Reproductive Medicine.
In Moore v. Mobile Infirmary Association, 592 So. 2d 156, 167 (Ala. 1991), the
Alabama Supreme Court declared § 6‐5‐544 of the Alabama Medical Liability Act,
only, unconstitutional under our Constitution’s trial by jury provision. In Moore, the
mandates of § 6‐5‐544(b), the trial court reduced the non‐economic portion of the
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describing the right to trial by jury under Ala. Const. Art. I, § 11:
"Section 11 provides in toto: 'That the right of trial by jury shall remain
inviolate.' As we explained in Gilbreath v. Wallace, 292 Ala. 267, 292 So.
2d 651 (1974), the 'crucial words' found in that section are “shall remain
inviolate.'” That clause 'forbid[s] the state through the legislative,
judicial, or executive department‐one or all‐from ever burdening,
disturbing, qualifying, or tampering with this right to the prejudice of
the people.' Section 11 'freezes' the right to trial by jury as that right
existed in 1901, the date of the ratification of our present
Constitution."
In Moore, the defendant contended that the right to a jury trial encompasses
only the finding of liability, not the amount of damages a plaintiff will receive, and
that limiting the plaintiff's remedy would not violate the right of trial by jury. The
Court rejected this argument, holding that determining the amount of damages is the
essence of the right to trial by jury and that applying a "cap" across the board for
non‐economic damages reduces the jury's function to "less than advisory status." Id.
at 164. Consequently, the Court held that the $400,000 limitation on non‐economic
damages represented an impermissible burden on the right to trial by jury under the
Alabama Constitution.
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purporting to limit compensatory damages to “the price paid for the impacted in
Similarly, in Henderson v. Alabama Power Co., 627 So. 2d 878 (Ala. 1993), the
Court declared that the $250,000 cap on punitive damages, Ala. Code § 6‐11‐21,
violates the right to trial by jury. Importantly, in Henderson, the Court noted that
Section 11 reaches not just those common law causes of action in which the right
existed in 1901, but also those statutory causes of action wherein the right existed
at that time:
"This Court has held that the jury trial right protected by § 11 of the
1901 Constitution is the right as it existed at common law: 'The right ...
is confined to those classes of cases in which the right existed at
common law, or in which it was used at the time of the adoption of
the Constitution." Gilbreath v. Wallace, 292 Ala. 267, 270, 292 So.2d
651, 653 (1974), quoting Alford v. State ex rel. Attorney General, 170
Ala. 178, 188‐89, 54 So. 213, 215‐16 (1910) (Mayfield, J, dissenting)."
Id. at 884 (emphasis added). Hence, since the right to trial by jury reaches the
statutory causes of action which provided a right to trial by jury at the time of the
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statute, Ala. Code § 6‐5‐3912. Since § 11 applies to wrongful death cases, the Court's
for the same reasons that § 6‐11‐21 violates the right to trial by jury provision, so do
The question in Gilbreath was whether a 1971 statute providing for a six‐
member jury in a will contest was unconstitutional. As a premise for its decision, the
Court observed:
"It is well settled that the legislature may confer the right of trial
by jury in actions in which the right did not previously exist. See
Stevenson v. King, 243 Ala. 551, 10 So.2d 825 (1942). Having conferred
such a right, the legislature has the power to abolish that right. It
therefore follows that the legislature might also constitutionally limit or
abridge that right. Hence, in Alabama, if the right of trial by jury in a will
contest exists solely by legislative grace, then Act No. 1734, which
affords the parties a 6‐man jury, would be clearly constitutional in this
context. On the other hand, if the right to a trial by jury in a will
contest is a right secured by the Alabama Constitution, then the
legislature may not abridge or limit the substance of that right."
Id. at 269 (emphasis added). After making this observation, the Court held:
2
Alabama’s wrongful death of a minor statute was first promulgated in 1876.
See Code 1876, § 2899, and has been extant in each succeeding version of our Code.
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"In Alford v. State, supra, the court quoted from Tims v. State,
supra, and set forth the principle as it applies to both civil and criminal
cases: 'The right (trial by jury) is confined to those classes of cases in
which the right existed at common law, or in which it was used at the
time of the adoption of the Constitution. Where there have been
several Constitutions, the right is in reference to its existence at the
time of the adoption of the last one.'
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Id. at 269‐70 (emphasis added; citations omitted). See also, Rule 38(a) of the
Alabama Rules of Civil Procedure ("The right of trial by jury as declared by the
parties inviolate"); Poston v. Gaddis, 335 So.2d 165, 166‐67 (Ala. 1976) ("Prior
practice gave the right to a trial by jury in all cases permitted at common law and by
The Alabama Legislature created a cause of action for wrongful death in 1852
and a cause of action for wrongful deaths of minors in 1876 and every Code enacted
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by the Legislature since that time has contained provisions affording causes of action
for wrongful death. See, Campbell v. Williams, 638 So. 2d 804 (Ala. 1994).
perpetuating, inviolate, the right to trial by jury” in wrongful death actions. Gilbreath
v. Wallace.
In Moore, the Court recognized that while the Legislature has the power to
"completely abolish" a cause of action, it cannot modify the right to trial by jury as
long as that cause of action exists. "Where the Legislature completely abolishes a
cause of action, 'the right to trial by jury becomes irrelevant.' . . . In other words, the
right to trial by jury does not arise in the absence of a cause of action requiring a
finder of fact." Moore, 592 So. 2d at 165. Here, of course, the wrongful death of a
minor statute (§ 6‐5‐391) still exists, so § 11 forbids the legislature from altering the
CRM/MIMC may argue that a plaintiff does not have a "right to punitive
supra. There, Alabama Power contended that a long line of Alabama cases had held
that "punitive damages are not recoverable as a matter of right except as provided
by statute". But, as the Court explained in Henderson, that language had been
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misconstrued. In each of those prior cases, the Court held that it was improper to
charge a jury that it should award punitive damages in the event it found the
defendant liable because "such damages being apart from compensation are not
recoverable as a matter of right. Their imposition is discretionary with the jury, acting
with regard to the enormity of the wrong and the necessity of preventing similar
"Obviously, these cases are not cited herein for any proposition that
punitive damages are recoverable as a matter of right, but only for the
proposition that the legislative prohibition against a jury's awarding
punitive damages in its sound discretion is subject to a challenge similar
to the objection to a trial court's instruction that a jury 'should' award
punitive damages. Just as a trial court cannot insist that a given jury
'should' award punitive damages, the Legislature cannot prohibit juries
from awarding an amount commensurate to the wrongdoing shown
by the evidence in a particular case."
The Court's decision in Moore v. Mobile Infirmary also flatly rejects any
contention that in statutory causes of action, the right to trial by jury attaches only
to the determination of liability, and not damages. The Court in Moore rejected the
rationale of Tull v. United States, 481 U.S. 412 (1987), which defendants cited in the
The same is true with regard to any suggestion the Legislature has "authority
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to remit punitive damages" pursuant to Article IV, § 104 of the Alabama Constitution.
In Henderson, the Court likewise rejected this contention with a lengthy discussion.
In sum, the legislature could not do what it purported to do in Senate Bill No.
159 or in Acts 2024‐20, as amended. This Court accordingly has a duty to declare the
Mr. and Mrs. Brackett contend §§ 6‐5‐810 and 6‐5‐811 violate equal protection
guarantees of the Alabama Constitution for the same reasons as the Alabama
Supreme Court found the AMLA’s former $1 million wrongful death damages cap (§
6‐5‐547) unconstitutional in Smith v. Schulte, 671 So. 2d 1334 (Ala. 1995). Because
the Court’s analysis in Schulte is on‐point and dispositive, the opinion and its
3
Indeed, this Court should simply substitute “§ 6‐5‐810 and § 6‐5‐811” for
each time the Schulte opinion cites “6‐5‐547.” The analysis is the same. The result
must be the same.
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4
Here the statutes eliminate damages altogether or limit them in wrongful
death claims “against the manufacturer of goods used to facilitate the in vitro
fertilization process or the transport of stored embryos” to “compensatory damages
calculated as the price paid for the impacted in vitro cycle.” See §§ 6‐5‐810(a) and
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The notion that the lives of some of Alabama’s citizens are worth less
than the lives of others is an idea that carries the gravest of
implications. We can conceive of nothing but the most compelling of
circumstances that could justify the consequences of such a
classification, with its attendant burden on the fundamental liberty
interest of our people. Nothing but the strongest possible connection
between the benefit sought and the means used to obtain it could
justify such an odious burden on the fundamental liberty interest
discussed above – which interest accrues to all Alabama citizens
equally. This case involves neither the circumstances nor the
necessary connection. Therefore, we hold that § 6–5–547 [§§ 6‐5‐810,
6‐5‐811] violates the equal protection guarantee of the Constitution
of Alabama.
It follows that any construction of §§ 6‐5‐810 and 6‐5‐811 prohibiting Mr. and
death claims and/or traditional wrongful death damages under § 6‐5‐391 also
6‐5‐811(a).
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671 So. 2d at 1342. Accord, Ex parte Melof, 735 So. 2d 1172, 1193, n. 10, 11 (Ala.
1999) (See, J., concurring, listing cases) (plurality opinion) (holding Alabama’s
Constitution ensures equal protection of the law); Moore v. Mobile Infirmary Ass’n,
guarantee equal protection under the laws of Alabama.”); Plitt v. Griggs, 585 So. 2d
1901, combine to guarantee the citizens of Alabama equal protection under the
laws.”); Peddy v. Montgomery, 345 So. 2d 631, 633 (Ala. 1977) (“Any doubt about
dispelled in Pickett v. Matthews, 238 Ala. 542, 192 So. 261 (1939), where it was held
guaranteed the equal protection of the laws and prohibit one from being deprived
The only way to ensure Mr. and Mrs. Brackett are not deprived of their § 13
guarantee of a remedy and their traditional § 6‐5‐391 cause of action for the deaths
Likewise, the only way to ensure that Brackett embryos A, B, and C are not
deprived of their § 1 right to life, their § 6 right not to be “deprived of life” ... “except
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by due process of law,” and their § 13 rights to a remedy and their § 36.06 guaranty
of protection by Alabama law “in all manners and measures lawful and appropriate”
The cause of action for the wrongful deaths of Brackett embryos A, B, and C
was recognized for the first time on February 16, 2024 when the Alabama Supreme
Court released its opinion in LePage, supra. The legal validity of such wrongful death
claims was confirmed when rehearing was overruled in LePage on May 3, 2024. Mr.
and Mrs. Brackett filed their lawsuit on February 29, 2024. Doc. 2.
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take away such cause of action.” Accordingly, any construction of §§ 6‐5‐810 or 6‐5‐
811 to deprive Mr. and Mrs. Brackett or their deceased embryos of their rights to sue
of our Constitution.
unconstitutional.
about the meaning and implications of the Supreme Court’s decision. This
“solutions” to the so‐called “problems” created by the decision. In result, Senate Bill
No. 159 was rushed through the legislative process and Acts 2024‐20 was signed into
The fact is there was zero need for criminal immunity because then‐present
Alabama law already provided criminal immunity for IVF healthcare professionals.
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Id. It was regrettable in the extreme that CRM, MIMC and their advocates would
cause IVF healthcare workers ‐ and Alabama Legislators ‐ to believe for one
second that criminal prosecution was even a possibility in Alabama for those
with respect to her unborn child.” Ala. Code § 13A‐6‐1(d) provided, then as now,
as follows:
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Again, the notion that CRM, MIMC, their advocates or anyone else would
exploit the raw emotions of hopeful IVF mothers and confuse Alabama Legislators
Now that the outcries are subsiding, thoughtful lawyers, judges, professors,
assessments find no fault with the Alabama Supreme Court’s reasoning in LePage5
while expressing profound criticisms of the notion of conferring absolute civil and
5
See, e.g., Mike Pence (former Vice‐President of the United States) and John
Mize, IVF in Alabama: The Real Story, Wall Street Journal April 4, 2024 (attached Ex.
E); Kayla Bartsch, Legal Protection of Embryos Does Not Spell the End of IVF in
America, National Review, March 3, 2024 (Ex. F); Richard M. Doerflinger, A Fact‐Free
Campaign Against Parents and Unborn Children in Alabama, On Point Series 100,
Charlotte Lozier Institute, April, 2024 (Ex. G); Yuval Levin and O. Carter Snead, The
Real Lessons of the Alabama IVF Ruling, The Atlantic, March, 2024 (Ex. H).
6
See, e.g., Edward Helmore, Alabama Legislature Passes Bill Aiming to Protect
IVF After Embryo Ruling, The Guardian, Feb. 29, 2024 (quoting legislators who
characterize the immunity statutes as a “temporary fix” and “Band‐Aid”) (Ex. I); John
McCormack, Alabama’s Mad Dash to Offer IVF Clinics Blanket Immunity, The
Dispatch, March 4, 2024 (quoting Notre Dame law professor Carter Snead (former
general counsel to President George W. Bush’s Council on Bioethics), who explains
that conferring blanket immunity is “a shocking error in judgment that will have
catastrophic results.”) (Ex. J); Kim Chandler, Alabama Says IVF Can Stay. But Big
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Bottom line: IVF healthcare professionals should bear liability for medical
negligence under the Alabama Medical Liability Act just like all other healthcare
Questions Remain., The Christian Science Monitor, March 7, 2024, quoting Alabama
Republican Senator Larry Stutts, an obstetrician, who voted against S. B. 159 because
it does not protect patients and “it is actually limiting the ability of mothers who are
involved in IVF to have recourse and it is placing a dollar value on human life.”) (Ex.
K); Lenny Bernstein and Yeganeh Torbati, Inside the Opaque World of IVF, Where
Errors Are Rarely Made Public, The Washington Post, April 28, 2024 (“Most of the
time, experts say, errors and accidents go unreported in the burgeoning fertility
industry, which is largely self‐policed. It is not mandated to report errant episodes
to the government, the public, any professional organization, or even patients –
despite a code of ethics that explicitly says practitioners should promptly tell patients
about lost or destroyed genetic material.”) (Ex. L); Richard Doerflinger, Fact and
Fiction in the Alabama Frozen‐Embryo Case, National Catholic Register, March 20,
2024 (“By allowing parents to sue clinics that lie to them and act negligently, the
Alabama ruling should encourage those clinics to reform their protocols on safety
and informed consent. More honesty in telling couples about IVF’s risks to embryos,
surviving children, and mothers would be one welcome change, allowing the couples
to make an informed decision whether to pursue IVF or explore alternatives that do
not pose those risks. That response to a largely unregulated fertility industry is one
that deserves bipartisan support.”) (Ex. M); Andrew Morriss, Bootleggers, Baptists,
and Fertility Clinics, Law & Liberty, Mar. 27, 2024 (“The media’s account of the
Alabama Supreme Court’s opinion in LePage misrepresented it as an attack on IVF.”)
(Ex. N).
7
See, e.g., Gerard Letterie, M.D. and Dov Fox, J.D., D. Phil., Lawsuit frequency
and claims basis over lost, damaged, and destroyed frozen embryos over a 10‐year
period. Fertil Steril Rep. Vol. 1, No. 2, Sept. 2020 2666‐3341 (analyzing 133 cases from
2009 through 2019 involving destruction/deaths of thousands of embryos from
freezer tank failures and other incidences of negligence and noting that 98% of such
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claims such as those advanced by the Bracketts in this case (and the plaintiffs in
Medical mistakes happen. People suffer grievously when they do. Our legislature
should not have rushed to judgment and conferred blanket civil or criminal
immunity. It is now incumbent upon this Court to declare that the legislature’s
cases were settled out of court) (attached as Exhibit O); Judith Dear, J.D., Legal
Liability Landscape and the Person/Property Divide, F S Rep. 2020 (“the legal liability
landscape surrounding mishandled cryopreserved gametes and embryos reveals the
struggle that courts and lawmakers confront in attempting to bring justice when a
patient’s dreams of biologic parenthood are shattered by professional wrongdoing.”)
(attached as Exhibit P); Gerard Letterie, M.D. and Dov Fox, J.D., D. Phil., Legal
Personhood and Frozen Embryos: Implications for Fertility Patients and Providers in
Post‐Roe America, Oxford Journal of Law and The Biosciences, 1‐13 (2023) (attached
as Exhibit Q).
35
DOCUMENT 39
CONCLUSION
For all the foregoing reasons, the Court is respectfully requested to find and
inviolate including the right to life, the right to Due Process, the right to a trial by
jury, the right to a remedy, and the right to equal protection of Alabama law.
legislature or governor, Mr. and Mrs. Brackett must be permitted to proceed with
their claims, including traditional wrongful death of a minor claims under § 6‐5‐
391 and the recovery of damages in the amount determined by the jury as
necessary to punish and deter and thereby preserve the sanctity of human life.
36
DOCUMENT 39
Respectfully submitted,
CERTIFICATE OF SERVICE
I do hereby certify that I have on this 8th day of May, 2024, filed the
foregoing with the Clerk of the Court using the AlaFile system, which will send
notification of such filing to all counsel of record, as follows:
37
DOCUMENT 39
Walter W. Bates
Sybil V. Newton
Starnes Davis Florie LLP
100 Brookwood Place, 7th Floor
Birmingham, Alabama 35209
[email protected]
[email protected]
38
DOCUMENT 39
APPENDIX
Exhibit A – § 6‐5‐810
Exhibit B – § 6‐5‐811
Exhibit E – Mike Pence (former Vice‐President of the United States) and John Mize,
IVF in Alabama: The Real Story, Wall Street Journal April 4, 2024
Exhibit F – Kayla Bartsch, Legal Protection of Embryos Does Not Spell the End of IVF
in America, National Review, March 3, 2024
Exhibit H – Yuval Levin and O. Carter Snead, The Real Lessons of the Alabama IVF
Ruling, The Atlantic, March, 2024
Exhibit I – Edward Helmore, Alabama Legislature Passes Bill Aiming to Protect IVF
After Embryo Ruling, The Guardian, Feb. 29, 2024
Exhibit J – John McCormack, Alabama’s Mad Dash to Offer IVF Clinics Blanket
Immunity, The Dispatch, March 4, 2024
Exhibit K – Kim Chandler, Alabama Says IVF Can Stay. But Big Questions Remain., The
Christian Science Monitor, March 7, 2024
Exhibit L – Lenny Bernstein and Yeganeh Torbati, Inside the Opaque World of IVF,
Where Errors Are Rarely Made Public, The Washington Post, April 28, 2024
Exhibit M – Richard Doerflinger, Fact and Fiction in the Alabama Frozen‐Embryo Case,
National Catholic Register, March 20, 2024
DOCUMENT 39
Exhibit N – Andrew Morriss, Bootleggers, Baptists, and Fertility Clinics, Law & Liberty,
Mar. 27, 2024
Exhibit O ‐ Gerard Letterie, M.D. and Dov Fox, J.D., D. Phil., Lawsuit Frequency and
Claims Basis over Lost, Damaged, and Destroyed Frozen Embryos over a 10‐year
Period, Fertil Steril Rep. Vol. 1, No. 2, Sept. 2020 2666‐3341
Exhibit P ‐ Judith Dear, J.D., Legal Liability Landscape and the Person/Property
Divide, F S Rep. 2020
Exhibit Q ‐ Gerard Letterie, M.D. and Dov Fox, J.D., D. Phil., Legal Personhood and
Frozen Embryos: Implications for Fertility Patients and Providers in Post‐Roe
America, Oxford Journal of Law and the Biosciences
DOCUMENT 39
EXHIBIT A
DOCUMENT 39
DOCUMENT 39
EXHIBIT B
DOCUMENT 39
DOCUMENT 39
EXHIBIT C
DOCUMENT 39
parents and next friends of three deceased Brackett embryos, embryo A, embryo B,
and embryo C, respectfully move the Court to declare S. B. No. 159, Acts 2024‐20,
now codified as Ala. Code §§ 6‐5‐810 and 6‐5‐811 (1975) (collectively the in vitro
Mr. and Mrs. Brackett contend this Court has the authority – and the duty –
DOCUMENT 39
fundamental rights, including the right to life, the right to raise and rear children, the
right to equal protection of Alabama law, the right to trial by jury under Art, I, § 11
of the Alabama Constitution, the right to a remedy under Art. I, § 13 of the Alabama
Constitution, and the right to protect Plaintiffs’ claims from retroactive legislation
Association d/b/a Mobile Infirmary Medical Center and the Center for Reproductive
Medicine, P.C., on April 23, 2024, jointly moved pursuant to Ala. R. Civ. P. 12(b)(1)
and (6) to dismiss the Bracketts’ “action in its entirety” through reliance in part upon
hastily conceived in vitro fertilization civil and criminal immunity statutes violate
any theory of law and thus must be declared unconstitutional and null and void and
of no legal effect.
Plaintiffs have today served the Alabama Attorney General with a copy of this
2
DOCUMENT 39
Respectfully submitted,
CERTIFICATE OF SERVICE
I do hereby certify that I have on this 8th day of May, 2024, filed the foregoing
with the Clerk of the Court using the AlaFile system, which will send notification of
such filing to all counsel of record, as follows:
3
DOCUMENT 39
Walter W. Bates
Sybil V. Newton
Starnes Davis Florie LLP
100 Brookwood Place, 7th Floor
Birmingham, Alabama 35209
[email protected]
[email protected]
4
DOCUMENT 39
EXHIBIT D
DOCUMENT 39
2024 Alabama Senate Bill No. 159 Alabama 2024 Regular..., 2024 Alabama Senate...
2024 Alabama Senate Bill No. 159 Alabama 2024 Regular Session
TITLE: In vitro fertilization; civil and criminal immunity for death or damage to
an embryo provided to persons when providing or receiving services related to IVF
SUMMARY: In vitro fertilization; civil and criminal immunity for death or damage to an embryo provided to persons when
providing or receiving services related to IVF
STATUS:
03/06/2024 SIGNED BY GOVERNOR
03/07/2024 (S) ENACTED
03/06/2024 (S) ENROLLED
03/06/2024 (S) DELIVERED TO GOVERNOR
03/06/2024 (H) SIGNATURE REQUESTED
03/06/2024 (S) READY TO ENROLL
03/06/2024 (S) REED MOTION TO CONCUR ADOPTED
03/06/2024 (H) THIRD READING IN SECOND HOUSE
03/06/2024 (H) MOTION TO READ A THIRD TIME AND PASS AS AMENDED - ADOPTED ROLL CALL 205
03/06/2024 (H) MOTION TO ADOPT - ADOPTED ROLL CALL 204
03/06/2024 (H) HLTH REPORTED SUBSTITUTE OFFERED
03/06/2024 (H) THIRD READING IN SECOND HOUSE
03/05/2024 (H) COMMITTEE AMENDMENT ADOPTED
03/05/2024 (H) COMMITTEE ENGROSSED SUBSTITUTE ADOPTED
03/05/2024 (H) READ FOR THE SECOND TIME AND PLACED ON THE CALENDAR
03/05/2024 (H) REPORTED OUT OF COMMITTEE SECOND HOUSE
02/29/2024 (S) ENGROSSED
02/29/2024 (H) READ FOR THE FIRST TIME AND REFERRED TO THE HOUSE COMMITTEE ON HEALTH
02/29/2024 (H) PENDING COMMITTEE ACTION IN SECOND HOUSE
02/29/2024 (S) COLEMAN-MADISON AMENDMENT OFFERED
02/29/2024 (S) COLEMAN-MADISON 2ND AMENDMENT OFFERED
02/29/2024 (S) MOTION TO READ A THIRD TIME AND PASS AS AMENDED - ADOPTED ROLL CALL 126
02/29/2024 (S) COLEMAN-MADISON MOTION TO ADOPT - ADOPTED ROLL CALL 125
02/29/2024 (S) MELSON MOTION TO TABLE - ADOPTED VOICE VOTE
02/29/2024 (S) MELSON MOTION TO ADOPT - ADOPTED ROLL CALL 123
02/29/2024 (S) HLTH SUBSTITUTE OFFERED
02/29/2024 (S) THIRD READING IN HOUSE OF ORIGIN
02/28/2024 (S) COMMITTEE SUBSTITUTE ADOPTED
02/28/2024 (S) READ FOR THE SECOND TIME AND PLACED ON THE CALENDAR
02/28/2024 (S) REPORTED OUT OF COMMITTEE HOUSE OF ORIGIN
02/27/2024 (S) PENDING COMMITTEE ACTION IN HOUSE OF ORIGIN
02/27/2024 (S) READ FOR THE FIRST TIME AND REFERRED TO THE SENATE COMMITTEE ON HEALTHCARE
End of Document © 2024 Thomson Reuters. No claim to original U.S. Government Works.
EXHIBIT E
DOCUMENT 39
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DOCUMENT 39
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DOCUMENT 39
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DOCUMENT 39
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EXHIBIT G
DOCUMENT 39
www.lozierinstitute.org
DOCUMENT 39
Previous Reports
Jeanneane Maxon, J.D., Fact of Life: American Cars (and Their Drivers) Exhibit Decidedly More Pro-life than Pro-
choice Views, On Point Series 99
Amanda Stirone Mansfield, J.D., Pro-Life Laws Exempt Women from Prosecution: An Analysis of Abortion Statutes
in 27 States, On Point Series 98
Ingrid Skop, M.D., Why We Need Federal Limits on Late Abortion to Protect Both Mother and Child, On Point Series
97
Mary E. Harned, J.D., Abortion “Shield Laws” : Pro-Abortion States Seek to Force Abortion on Life-Affirming States,
On Point Series 96
Michael J. New, Ph.D., Hyde @ 40: Analyzing the Impact of the Hyde Amendment with July 2020 and June 2023
Addenda, On Point Series 95
Richard M. Doerflinger, M.A., The Women’s Health Protection Act of 2023: Attacking the Health and Freedom of
Women, On Point Series 94
Mary E. Harned, J.D., Pro-Abortion States Accelerate Their Race to the Bottom, On Point Series 93
Richard M. Doerflinger, M.A., Lethal Non-Compliance with Washington’s “Death with Dignity Act,” On Point Series
92
Richard M. Doerflinger, M.A., The Effort to Reinterpret EMTALA to Mandate Abortions, On Point Series 91
Michael New, Ph.D., Texas’ Gain: The Lifesaving Impact of the Texas Heartbeat Act, On Point Series 90
Richard M. Doerflinger, M.A., Politifact and Fiction on Abortion, On Point Series 89
Mia Steupert, M.A., A Primer on the Standing with Moms Act, On Point Series 88
The views expressed in this paper are attributable to the author and do not necessarily represent the position of
the Charlotte Lozier Institute. Nothing in the content of this paper is intended to support or oppose the progress
of any bill before the U.S. Congress.
www.lozierinstitute.org 2
DOCUMENT 39
Strange things are happening with the reproductive technology known as in vitro fertilization
(IVF), through which human embryos are produced in a laboratory for couples struggling with infertility.
Reporting on Alabama’s approval of a new law on IVF, U.S. News hailed it as protecting
“providers and patients.” Virtually identical declarations were made by CNN, NPR, and ABC News.
The new law grants absolute immunity from both civil and criminal liability to IVF clinics for
destroying human embryos, without parents’ consent and for any reason. It protects clinics from
embryonic children’s grieving parents.
Leading up to the new law’s passage was a campaign of uninformed outrage. The campaign led
both Democratic and Republican politicians to criticize the Supreme Court of Alabama, after it ruled
that the state’s Wrongful Death of a Minor Act allows parents of an IVF embryo to file suit against
others who engage in the “wrongful” and “negligent” destruction of their offspring. That campaign also
led the Alabama legislature to pass the new law granting blanket immunity to clinics that destroy
embryos.
This court had already ruled in 2011 and 2012 that this law allows a suit filed by the parents of
an unborn child in the womb, from conception onward. Neither side in the current lawsuit challenged
those rulings. The new question for the court was this: Is the same unborn child, at the same stage of
development, covered outside the womb, or should the court imagine that the Act has an “unwritten
exception” saying that “location” overrides the embryo’s membership among living human beings?
Sensibly, the court overwhelmingly chose the former option.
One judge even noted during oral argument that some unborn children with medical problems
are briefly removed from the mother’s womb during pregnancy, given treatment, then returned to the
womb for later delivery. If the treatment is botched and the child dies outside the womb, should
parents have no legal recourse? It’s a good question.
Nonetheless, President Biden immediately blamed Donald Trump for an “outrageous” ruling
because he nominated some of the U.S. Supreme Court judges who voted to overturn Roe v. Wade in
2022. (Biden did not pause to wonder how the Alabama court’s rulings of 2011 and 2012 have remained
in effect for a decade during Roe’s hegemony.) Vice President Harris accused the Alabama court of
“robbing women of the freedom to decide when and how to build a family” – although the court was
only allowing women and men to sue a clinic that deprived them of exactly that freedom.
Former president Trump urged the Alabama legislature to pass a law protecting the “miracle of
life” of IVF. Republican Larry Hogan, the former governor of Maryland, said the ruling should be
overturned because “government should never stand in the way” of couples seeking “the joy of
parenthood.” And Republican congressman Matt Gaetz of Florida said the ruling turns couples who
want “the American dream” into “criminals.”
www.lozierinstitute.org 3
DOCUMENT 39
None of these statements attended to the facts of the case. As construed by the court,
Alabama’s law empowers parents themselves to file suit when, without their consent and against their
interests, a medical facility irresponsibly deprives them of that “miracle,” that dream, and that joy. The
Alabama court was standing up for couples’ rights, and it pointedly declined to extend its ruling to the
separate area of criminal law.
This case arose from a specific and tragic event. Alabama’s Center for Reproductive Medicine,
which provides cryopreservation of embryos not yet needed for an attempt at live birth, had warned
couples that the freezing process “could theoretically be injurious to the embryo.” But in this case, it left
a door to the adjoining hospital unlocked, allowing a hospital patient to wander in, seize the container
holding five frozen embryos, and drop it on the floor when the extreme cold hurt his hand. Three
couples sued the Center for its negligence in allowing the wrongful death of their embryonic children.
The state supreme court’s ruling did not decide the suit in their favor, but only reverses a trial court’s
ruling that dismissed it out of hand.
Some public commentaries charged the court with having banned IVF outright because some
discarding of embryos is “inherent” in the IVF process. But that charge ignored the facts as well. As an
attorney for the couples declared in oral argument before the state supreme court:
We're here advocating on behalf of the Plaintiffs who are supporters of in-vitro fertilization. It
worked for them. They have two beautiful children in each family because of in-vitro fertilization.
The notion that they would do anything to hinder or impair the right or access to IVF therapy is flat
wrong. That's not why we're here. What we're advocating is, if you're in the business of helping
create embryonic children, you better also be in the business of safeguarding them and protecting
them, locking the doors.
Of course, informed consent, including information about the risks of medical procedures, is
legally required throughout the country (or it was, until passage of the new Alabama “immunity” law
enacted to counter the court’s ruling). To ignore this requirement invites a malpractice suit. The Center
provides a lengthy standard consent form for IVF, informing couples that it may discard embryos if they
do not seem to be developing normally (while admitting that the technique for discerning abnormality
is “not perfect”). It also asks couples what should be done if various scenarios take place – for example,
if one or both partners later die, or they decide not to have any more children – and for each scenario
one option to check off is “Destroy the embryos.” So yes, couples consenting to IVF know that there
may be discarding or destruction of embryos.
Couples are not informed that the clinic may allow strangers to wander in and throw their
embryos on the floor, and surely, they would never sign a consent form entertaining that prospect. By
the same token, a hospital must inform a patient undergoing major surgery of any risk of harm or death
from that surgery – but it is not thereby authorized to allow the patient to be thrown out the window
instead. There is a major difference between anticipated risks and “wrongful” or “negligent” behavior
causing death, and the Alabama ruling had dealt only with the latter.
Yet some IVF clinics in Alabama reacted to the court’s ruling by suspending their operations.
Perhaps they saw a need to review their safety standards so such things cannot happen again. But if the
www.lozierinstitute.org 4
DOCUMENT 39
new law passed by the state legislature is any indication, they (or their insurance companies) may have
seen an opportunity to exempt themselves from the standards of responsible practice that all other
health professionals must comply with and told legislators that nothing less than absolute immunity
would convince them to reopen. But the implied claim that IVF clinics cannot operate without unlimited
discretion to destroy embryos is difficult to make. For example, Louisiana, which since 1986 has
recognized the IVF embryo as a “juridical person” with a right to careful treatment, has long had active
IVF clinics.
The new law declares that, notwithstanding any other law, “no action, suit, or criminal
prosecution for the damage to or death of an embryo shall be brought or maintained against any
individual or entity when providing or receiving services related to in vitro fertilization.” Of course, the
state supreme court ruling had nothing to do with liability for couples “receiving” IVF services, or with
criminal liability for anyone. Since the word “embryo” generally refers to the unborn child up to the
eighth week of pregnancy, the law even seems to exempt the clinics from any state restrictions on
abortion.
Legal experts are now worried that this law does more harm than good. As one law professor
told NBC News, the answer to such controversies should never be, “Well, let’s just immunize fertility
clinics and contribute to the Wild West of the fertility industry.”
The law does allow a suit against the “manufacturer” of equipment used in IVF, but with
damages limited to “compensatory damages calculated as the price paid for the impacted in vitro
cycle.” This is not a deterrent but a “buy one get one free” sale. And in cases like the present one, would
couples have to sue the manufacturer of the door that was left unlocked? The clinic itself could simply
throw away all of a couple’s embryos to get them to pay for another expensive reproductive cycle, with
no legal consequences.
In short, this law makes Alabama the most dangerous place in the country for an embryonic
child, and for parents wanting that child alive. If that seems an exaggeration, a study published in 2020
found 133 lawsuits in the U.S. in the previous decade that “credibly alleged the negligent destruction of
cryopreserved embryos.” Many of these arose from incidents in 2018 when clinics in San Francisco and
Cleveland accidentally allowed the thawing and death of embryos belonging to hundreds of couples. In
the California case, a jury awarded almost $15 million to grieving families, later appealed to result in
settlements of an undisclosed amount. Thus, one of the most pro-abortion states in the U.S., where the
IVF clinic’s president described the lost embryos as merely “tissue,” allows more accountability for the
deaths of embryonic children than Alabama now does.
Most infertile couples do not agree with the dehumanizing term “tissue.” In one study allowing
IVF patients to assess the moral status of their embryos on a scale from 1 to 7, 18% chose full moral
status and only 10% chose the lowest status, with others ranging between the two.
These incidents raise a question about the law’s treatment of abortion versus other attacks on
the unborn. President Biden’s statement ignored that distinction. Yet his Administration is required to
enforce “Laci and Conner’s Law,” which in federal jurisdictions provides for a separate charge of
homicide for any attack on a pregnant woman that kills her unborn child. 39 states, including Alabama,
www.lozierinstitute.org 5
DOCUMENT 39
have such fetal homicide laws. States participating in the federal Children’s Health Insurance Program
(CHIP) are allowed to provide federally subsidized health insurance to unborn children, which certainly
treats them as “children.” And 11 states have laws against harmful experimentation on human embryos
outside the womb.
Such laws have all been legally valid under Roe v. Wade. In the 1989 case Webster v.
Reproductive Health Services, the U.S. Supreme Court declined to invalidate the preamble of Missouri’s
abortion law, which declared that “the life of each human being begins at conception” and that “unborn
children have protectable interests in life, health, and wellbeing” that should be respected in the state’s
laws. The court cited its statement in the earlier Akron abortion case that “a State may not adopt one
theory of when life begins to justify its regulation of abortions” (emphasis added), and observed that
other areas of law are not covered by Roe.
Yet advocates who say they want to “codify Roe” have expressed outrage at the Alabama
court’s ruling, which would have been legally valid under Roe.
One possible explanation is that, while these advocates like to hold up Roe as a talisman
because it scores well in opinion polls, they have long been gravely disappointed by its actual scope.
That decision’s reliance on individual “privacy,” then on individual “liberty” in the 1992 case of Planned
Parenthood v. Casey, did not invalidate modest abortion regulations, restrictions on public funding of
abortion, or conscience laws for pro-life health care providers. So Planned Parenthood abandoned the
“pro-choice” theme a decade ago. Instead, such groups advance abortion as a positive good – a public
entitlement that government must promote as “essential health care.” Embodying this agenda is the
federal “Women’s Health Protection Act” (WHPA) endorsed by every major national pro-abortion
organization.
Now Roe is again invoked to advance an agenda far broader than the scope of the decision itself
– this time, to extinguish legal respect for the wanted unborn in non-abortion contexts. Despite the
breadth of the Alabama law protecting irresponsible IVF clinics, a Planned Parenthood spokesperson
criticized it for not explicitly stating that a human embryo cannot be a “child.”
In two other ways, the campaign against the Alabama court decision parallels the “reproductive
rights” movement’s response to new laws against abortion enacted after Roe’s reversal.
First, as noted in 2022, pro-abortion groups had ignored what the pro-life laws actually said,
instead “revving up a public relations apparatus to spread false and exaggerated claims in order to
‘paralyze’ physicians and discredit the laws.” In Missouri and Texas, for example, they falsely charged
that the pro-life laws made it a crime to treat ectopic pregnancies, and that they banned abortion
unless the woman is facing imminent death. Now, in order to frighten infertile couples and political
leaders, they raise the false charge that the Alabama ruling prohibited IVF.
Second, as the title of the WHPA suggests, these groups present their agenda as standing up
for the health of women against uncaring pro-lifers. In fact, the WHPA would authorize lawsuits against
policies that protect women. Even if an abortion clinic regulation clearly does protect women’s life and
health, anyone adversely affected by that policy (including a for-profit abortion clinic) can sue to have it
invalidated. The regulation only survives if supporters provide “clear and convincing evidence” that its
www.lozierinstitute.org 6
DOCUMENT 39
goal cannot be met by a policy that more fully advances ready “access” to abortion. Meeting that
burden of proof could require passing the abortion-friendly policy first, and watching as women die.
In the present case, the Alabama legislature was pressured to disenfranchise women, increase
their health risks through renewed efforts to conceive, and allow the wanton disposal of the unborn
offspring they very much want alive. Pro-life legislators should restore grieving parents’ rights.
Richard Doerflinger, M.A., is a Fellow with the Center for Ethics and Culture at the
University of Notre Dame, an Adjunct Fellow in Bioethics and Public Policy with the National
Catholic Bioethics Center, and an Associate Scholar of the Charlotte Lozier Institute.
www.lozierinstitute.org 7
DOCUMENT 39
EXHIBIT H
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DOCUMENT 39
I
t was one of the worst accidents in the history of reproductive medicine.
A storage tank at a San Francisco fertility center imploded, its trove of 4,000 human eggs and embryos damaged or destroyed. A jury later found that a manufacturing defect was largely to
blame for the disaster but also implicated the center. The lab director had unplugged a malfunctioning computer, muting 128 alarms that warned of trouble. Lab personnel did not transfer the
contents of the vessel to a backup tank when the computer failed. And there is no evidence that repairs were initiated for the 13 days between these first problems and the implosion.
The missteps were revealed only because a lawsuit and 2021 civil trial offered a rare glimpse inside the closed world of U.S. fertility care. Most of the time, experts say, errors and accidents go
unreported in the burgeoning fertility industry, which is largely self-policed. It is not mandated to report errant episodes to the government, the public, any professional organization or even
patients — despite a code of ethics that explicitly says practitioners should promptly tell patients about lost or destroyed genetic material.
This opaque system is under scrutiny again after the Alabama Supreme Court ruled this year that frozen embryos are children. That case involved a patient who accidentally dropped and
destroyed embryos belonging to three couples at a fertility clinic.
“In other areas of health care, states require hospitals to monitor and report major avoidable errors, things like mismatched blood transfusions or surgery on the wrong body part,” said Dov Fox,
a law professor and director of the Center for Health Law Policy and Bioethics at the University of San Diego, who studies the fertility industry. “They call these ‘never events’ because these are
things that just shouldn’t happen.
“No agency or authority tracks or polices what might be called ‘reproductive never events.’”
In vitro fertilization (IVF) is the most common form of assisted reproduction. Doctors retrieve eggs from a patient’s ovaries and an embryologist combines them with sperm to create embryos in a
lab. The embryos can be frozen for future use or transferred to the uterus days after they are created.
States license clinics and professional groups govern practitioners. But the inspection and accreditation of labs are handled mostly by private, voluntary organizations that consider that
information the property of clinics. Many inspectors are the directors of labs themselves, a fraternity of scientists who review one another’s work, looking for systemic problems, not lost
reproductive material, according to the College of American Pathologists.
The vast, vast The industry insists the error rate is low. Sean Tipton, chief advocacy and policy officer for the American Society for Reproductive Medicine,
which represents fertility practitioners, disputed the idea that they are more lightly regulated than other medical disciplines: “For the most part
supermajority of reproductive medicine and infertility care are regulated the same way as other areas of medicine.”
mistakes in fertility
clinics, the public If all else fails, he said, patients have access to the courts to redress wrongdoing, as they do for other kinds of doctors.
doesn’t even know But most lawsuits result in settlements with nondisclosure provisions, reinforcing the secrecy that surrounds the multibillion-dollar fertility
about. industry. Many cases are settled even before lawsuits are filed, attorneys said.
And suddenly that was gone. She tried to have more eggs retrieved, but the procedure did not work. She said she accepted settlements from the San Francisco clinic and Chart Inc., the tank
manufacturer, and is prohibited from disclosing the terms.
“It makes me sick, still,” Coakley, now 47, said in an interview. “I look at this money now that’s in my account and it doesn’t make me feel any better. I wake up most mornings and still go, ‘I can’t
believe I don’t have kids.’”
DOCUMENT 39
Officials and lawyers representing Pacific Fertility and Chart Inc. did not respond to numerous requests for comment.
Joseph Conaghan, the lab director who disconnected the computer that monitored conditions in the tank, no longer works at Pacific Fertility. Neither he nor his attorneys responded to requests
for comment.
At the trial, however, Conaghan defended his actions, saying his staff closely monitored Tank 4 after he unplugged the defective computer because it was delivering inaccurate readings in the
tank. Manual checks of the level of liquid nitrogen, which keeps eggs and embryos frozen, in tanks without computers have proved reliable for decades, he said, and a sudden crack in a weld in a
storage tank, which caused the catastrophe, could not have been foreseen.
I look at this money The same March 2018 weekend that Tank 4 imploded, a cryopreservation tank more than 2,200 miles away in suburban Cleveland also failed.
That accident, which caused temperatures in the tank to rise rapidly, destroyed 4,000 eggs and embryos belonging to about 950 people.
now that’s in my
account and it That disaster, clinic officials acknowledged, was due to human error. Staff at University Hospitals Ahuja in Beachwood, Ohio, had deactivated the
doesn’t make me remote alarm that should have notified lab employees of a problem with the tank on a Saturday.
feel any better. I All the lawsuits filed over the Cleveland failure were settled out of court. No terms were disclosed.
wake up most
mornings and still
go, ‘I can’t believe I IVF labs facing increased pressures
don’t have kids.’ The boom in egg and embryo freezing became possible a decade ago after new techniques allowed for quick freezing without harming delicate
— Monica Coakley cells. That is one of many advances in assisted reproduction since Louise Brown was born in Britain 46 years ago as the first human conceived by
IVF.
In the United States, there were 167,689 cycles to freeze eggs and embryos in 2021, nearly double the number in 2017, according to the Centers for Disease Control and Prevention. The demand
to perform increasing numbers of procedures has put pressure on IVF labs, where a shortage of trained lab workers — known as embryologists — has grown worse. Embryologists generally learn
the painstaking craft of handling 60-cell bundles on the job.
In most clinics, reproductive material is preserved in liquid nitrogen in double-walled tanks at nearly minus-200 degrees Celsius. These tanks use a vacuum between the two walls to keep
material cold, like a Thermos. Liquid nitrogen evaporates and must be added and monitored 365 days a year. Computers, alarms and auto-fill devices help, but ultimate responsibility falls on the
people running the lab.
No one has a solid Private equity firms have purchased many fertility clinics in recent years, building large chains and placing increasing emphasis on profitability.
In one study, the authors concluded that private equity appears to own a larger share of fertility clinics than it does in any other medical specialty
handle on what is or service.
An array of government organizations play limited roles in the assisted reproduction field. The CDC collects data on success rates from more than 450 clinics. The Food and Drug Administration
inspects equipment and tissue to prevent transmission of disease through eggs and sperm. The Centers for Medicare and Medicaid Services, which administers laboratory laws, exerts some
oversight. Some states add other requirements and may investigate accidents.
But generally the federal government stays out of fertility clinics because of the fraught politics, for both Democrats and Republicans, of regulating the creation and destruction of embryos.
In the United Kingdom, where fertility clinics are required by law to report mistakes, the government’s Human Fertilisation and Embryology Authority reported that fewer than 1 percent of
90,000 cycles resulted in a mistake of any kind in 2021-2022.
Tipton, of the American Society for Reproductive Medicine, noted that it is much easier for European governments to collect such data and more tightly regulate fertility practices because, for the
most part, they also control the delivery of health care.
“When government pays for something, they can exert a whole lot more control,” he said.
In one of the only academic studies of errors in U.S. fertility labs, Boston IVF, a large chain of fertility clinics, reported mistakes in 0.23 percent of 36,654 IVF treatment cycles in a review of its
own records from 2003 to 2015. Mistakes included discarding healthy embryos because a patient had signed a form giving “consent to thaw and discard embryos” rather than a document
providing “consent to thaw embryos” for implantation. The vast majority of errors had no impact on patients, according to the study.
The two organizations that accredit most clinics in the United States are the College of American Pathologists and the Joint Commission. The pathology group acknowledges that it investigates
only if a clinic reports an error, a lawsuit is filed or a problem reaches the media. But other mistakes should surface during biennial inspections, officials said.
“Is it theoretically possible that a serious mistake would happen and we wouldn’t know about it? Of course,” said Richard Scanlan, chairman of the College of American Pathologists’ accreditation
committee.
The Joint Commission, which employs paid surveyors to inspect labs, reviews complaints and may ask for responses or conduct follow-up inspections. But details are kept confidential.
DOCUMENT 39
Secret settlements
Hundreds of people who lost genetic material in the Pacific Fertility disaster initially sued both the clinic and the tank manufacturer. But contracts between Pacific Fertility and its patients
require such disputes to be settled by arbitration, ensuring they remain confidential. All cases against the clinic have been resolved, according to lawyers, who would not say more.
Chart Inc. lost the lawsuit brought by five patients that led to the 2021 civil trial. The jury awarded the patients a total of $15 million, setting the benchmark that helped determine payments to
hundreds of others in a March 2023 settlement, court records show. Jurors said Chart was responsible for 90 percent of the damage, and negligence by Pacific Fertility caused the rest. Terms of
the larger settlement were not disclosed.
Desperate to have children, some couples nevertheless tried to use the embryos in Tank 4 despite warnings from experts of health risks to both mother and child posed by the uncontrolled thaw
of their reproductive material. A report cited as evidence in the trial showed those couples had much less success becoming pregnant or having a live birth than others whose eggs and embryos
were not in Tank 4. They also had a significantly higher incidence of low-birth-weight babies.
When an expert witness compared the genetic material from the imploded tank with eggs and embryos thawed purposely from another Pacific Fertility tank, he found that only about a quarter as
many eggs and half as many embryos were viable after the catastrophe. A lawyer for Chart suggested there was no way the expert could predict what might happen with the rest of the material
that had not yet been implanted.
Kevin and Laura Parsell, an Ohio couple, had a boy and a girl from previous in vitro fertilization at Pacific Fertility. A third pregnancy assisted by the fertility clinic ended in miscarriage. But their
plan had always been seven healthy children.
The Ohio couple asked the fertility clinic to examine the four embryos they had stored in Tank 4 for signs of viability. They had the best two implanted, or “transferred” to Laura, in the parlance of
fertility care, according to testimony in the trial. But neither produced another child. Under questioning from a Chart attorney, one expert acknowledged it is impossible to be completely certain
the tank implosion was responsible for those two failures.
The couple took the remaining two embryos home and buried them in a cemetery. Each Christmas, they hang seven snowflake ornaments on their tree in memory of the family they don’t have.
“It is like me asking you to pick four of your family members … and they are ripped out of your life,” Laura Parsell testified. “It doesn’t matter if you picked a son or a daughter, or your
grandparent, the whole family tree is gone.”
DOCUMENT 39
EXHIBIT M
DOCUMENT 39
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DOCUMENT 39
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EXHIBIT O
Lawsuit frequency and claims basis
over lost, damaged, and destroyed
frozen embryos over a 10-year period
Gerard Letterie, M.D.a and Dov Fox, J.D., D.Phil.b
a
Seattle Reproductive Medicine, Seattle, Washington; and b School of Law, Center for Health Law and Policy and Bioethics,
University of San Diego, San Diego, California
Objective: To review the claims, claims basis, and frequency of lawsuits over lost or damaged frozen embryos and to estimate their
frequency over a 10-year interval.
Design: Retrospective analysis of case law.
Setting: Private in vitro fertilization clinic and school of law.
Patient(s): None.
Intervention(s): Case law identified using Bloomberg Law, Westlaw, and Lexis Nexis databases for coverage of court dockets regarding
allegations and claims.
Main Outcome Measure(s): Lawsuits brought and settled in state and federal court, with data extracted included claims basis and loca-
tion in federal or state courts.
Result(s): We reviewed case law from January 1, 2009, to April 22, 2019, using the terms frozen, discarded, lost, and damaged embryo/
s, and calculated clinical cases using frozen embryos from Centers for Disease Control and Prevention data. We identified 133 cases: 122
and 11 lawsuits in the state and federal court dockets, respectively. Of these, 87 cases involved alleged freezer tank failure in California
and Ohio in 2018–2019. In the remaining 44 cases, the majority (37 cases) were brought for personal injury, breach of contract or war-
ranty, product liability, professional negligence, unfair business practices, and miscellaneous tort. A minority (7 cases) were brought for
medical malpractice. During this interval, a total of 398,256 embryo-thaw procedures were reported nationally.
Conclusion(s): Allegations range from business practices to product liability and are seldom for medical malpractice. Our results sug-
gest that best practices in storage of frozen embryos should include not only improvements in hardware and monitoring of storage
conditions of specimens but also setting standards for communications among patients, providers, and embryology laboratories
regarding disposition of embryos. (Fertil Steril RepÒ 2020;1:78–82. Ó2020 by American Society for Reproductive Medicine.)
Key Words: Lost embryos, lawsuits over cryopreserved and damaged embryos
Discuss: You can discuss this article with its authors and other readers at https://www.fertstertdialog.com/posts/xfre-d-20-00055
C
ryopreservation techniques (3). These events spotlighted the legal, such as fertility preservation and em-
have dramatically improved ethical, and regulatory challenges to bryo creation for long-term family
since their introduction into current practice patterns and profes- building. The increasing number of
reproductive medicine in 1949 (1). sional liability, and they attracted sub- specimens will also increase the need
Storage and transportation of frozen stantial media attention. for reliable techniques and tools to
specimens are essential to assisted The considerable attention garnered create a haven for them. Case reports
reproductive technology (ART) such as in the press aside, the frequency and have yielded the best available insights
in vitro fertilization (IVF) and preim- causes for such losses remain largely into the causes of these and similar acci-
plantation genetic testing (2). Two unexplored. Liability for gametes and dents and may enable root cause anal-
recent catastrophic losses affected embryos in cryostorage will increase ysis and offer options on how improve
thousands of cryopreserved embryos alongside the expanding indications care. We studied the facts, merit, and
outcome of claims for lost, damaged,
Received March 31, 2020; revised June 9, 2020; accepted June 28, 2020. or destroyed embryos in U.S. courts
G.L. has nothing to disclose. D.F. has nothing to disclose.
Presented at the 75th Annual Meeting of the American Society Reproductive Medicine, Philadelphia, over a 10-year period.
Pennsylvania, October 12–16, 2019.
Reprint requests: Gerard Letterie, M.D., Seattle Reproductive Medicine, 1505 Westlake Avenue, Suite
400, Seattle, Washington 98104 (E-mail: [email protected]).
MATERIALS AND METHODS
Fertil Steril Rep® Vol. 1, No. 2, September 2020 2666-3341
© 2020 The Authors. Published by Elsevier Inc. on behalf of American Society for Reproductive Med- Case collection
icine. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/
licenses/by-nc-nd/4.0/).
Relevant embryo loss cases were identi-
https://doi.org/10.1016/j.xfre.2020.06.007 fied using the court dockets on
Bloomberg Law, Lexis, and Westlaw Edge. The case search the vast majority of 111 cases (84.1%) involved damage or
was limited to cases filed between January 1, 2009 and July destruction due to storage tank failure in two clinics in two
1, 2019. An additional search was run on Westlaw’s function states. Just three (2.3%) involved damage or destruction
for ‘‘Jury Verdicts and Settlements’’ and Lexis Advance’s from other forms of mishandling; eight (6%) involved em-
‘‘Jury and Settlement Analyzer.’’ Database coverage ran bryos lost or misplaced in the laboratory; five (3.8%) involved
from January 1, 2009 to July 1, 2019. These results were care- embryos lost or destroyed in transit; and six cases (4.5%)
fully reviewed for relevant claims of negligent embryo dam- involved damage or destruction due to miscommunication
age or destruction. This analysis yielded a total of 133 cases: or other human error.
122 in state court and 11 in federal. Access to the cases was Most of the 111 cases originated from two separate inci-
gained through a variety of search engines of public records. dents that occurred in early March of 2018, one in California
Bloomberg, Lexis, and Westlaw databases were used in com- and the other in Ohio. In both situations, the nitrogen level in
bination to cover the state court dockets. Federal court a storage tank dropped, causing the frozen embryos to
dockets were accessed through Bloomberg. These data are a possibly warm and lose viability. In the California incident,
matter of public record, do not involve any risk of disclosure the drop in liquid nitrogen and subsequent warming did not
of identity, and do not include any human subject experimen- trigger any alarm. Thirty-three consolidated cases currently
tation. The study is a description and classification of publicly remain open from this incident. In the Ohio incident, the
available data and as such was deemed exempt from institu- drop in liquid nitrogen triggered an on-site alarm, but no em-
tional review board process. ployees were present to respond, and a remote alarm system
had been silenced. Seventy-eight cases were filed as a result
Review of cases of the Ohio incident, most of which had been settled by late
September 2018 although 12 consolidated cases remain open.
The cases were divided between federal and state, and be- Of the 133 embryo-loss lawsuits, 90 cases were closed.
tween open and closed. Case status was derived from the These cases resolved 25 different legal claims in total
dockets available on Bloomberg, Westlaw, or Lexis. Open (Fig. 2). Most claims included breach of contract, bailment
cases, those still in the process of being resolved, were set (improper property transfer), and negligence (failure to meet
aside with a brief description of facts and status. Closed cases the standard of care). Just two other claims appeared in a sub-
were recorded with a summary of the allegations, claims, stantial minority of cases: breach of fiduciary duty (37.1%)
outcome, damages, judicial reasoning, and other relevant and conversion of personal property (28.6%). Additional de-
facts. Allegations and claims were based on the plaintiff’s tails of the clinical events, bases for claims, and settlements
complaint. are found in Supplemental Tables 1, 2, and 3 (available
There were two broad reference sources for reviewing online).
outcomes, damages, and reasoning: dismissed and adjudi- The closed cases provide insight into how negligent em-
cated. For cases that were dismissed, this came from court or- bryo destruction cases are resolved (Fig. 2). Of the 90 closed
ders and stipulations for dismissal. For cases that were cases, all but two (97.8%) were settled out of court. Of the
adjudicated, by contrast, these dimensions came from opin- 88 cases that settled, 65 did not mention any details about
ions issued by the court. This analysis resulted in 133 cases court cost or attorney fees, whereas 22 ordered the defendant
for consideration. These 133 cases were analyzed in detail to pay court costs. In the last of these settled cases, each party
and sorted into one of five incident categories, based on the bore its own attorney fees and costs. The average court cost
fact patterns of embryo outcomes: lost or misplaced in labo- (i.e., clerk’s fees, computer fees, court special projects fund,
ratory; lost or misplaced in transit; damaged or destroyed legal aid, legal news, and legal research) for the 22 cases
through mishandling; damaged or destroyed through that required the defendant to pay was US$523.32. The re-
miscommunication; and damaged or destroyed through stor- maining two closed cases that did not settle were outliers.
age tank failure. One found that mislabeling did not constitute libelous false
The 90 closed cases were analyzed for trends in legal statements damaging to the plaintiff’s reputation. The other
claims, outcomes, and damages. The number and outcomes involved federal removal back to state court for lack of juris-
of frozen embryo transfers were compiled from the most diction, where the case was later settled.
recent annual report published by the Centers for Disease These cases are complex, nuanced, and vary considerably
Control and Prevention (CDC), Division of Reproductive in the details of their claims. Cases studies are presented as
Health. This number provided a denominator to gain insight supplemental tables (Supplemental Tables 1, 2, and 3), which
into the approximate frequency (percentage of cases) of these are intended to give a sense of the facets of these cases and
events. their varied claims. Although they are not exhaustive of all
case law, these studies illustrate that the claims extend far
RESULTS beyond a loss of embryos and into the impact on options
One-hundred and thirty-three cases were filed from January for family building.
2009 through June 2019 that credibly alleged the negligent During this time period, a total of 398,256 embryo thaw
destruction of cryopreserved embryos. Of those 133 cases, procedures were reported to the CDC, including frozen trans-
11 cases (8.3%) were filed in federal court, and the remaining fers of embryos derived from autologous and donor oocytes
122 cases (91.7%) were filed in state court. We sorted the cases and donated embryos. A frequency of 131 cases during the
into five incident categories (Fig. 1). Of the 133 total lawsuits, observation interval translates to an incidence of much less
FIGURE 1
Lawsuits for lost, damaged, and destroyed frozen embryos: cases by incident category.
Letterie. Lost, damaged, or destroyed frozen embryos. Fertil Steril Rep 2020.
than 1%, making these events very unlikely clinically—but far maintenance to ensure optimal outcomes. These claims reach
more impactful on a case by case basis. beyond the familiar issues of medical malpractice and breach
of professional duty (9).
Most claims relate to hardware, to lapses in monitoring,
DISCUSSION record keeping, or communication with patients regarding
Assisted reproductive technology has undergone dramatic disposition, and in one case to employee relationships with
changes in recent years. Cryotechnology has emerged as an the IVF clinic. Our analysis shows that the failure of liquid ni-
integral part of contemporary care for patients seeking op- trogen tanks is by far the more common contributor to loss.
tions for family building (4). Freezing embryos is now stan- These data are influenced by the recent events in Ohio and
dard care and a hoped-for outcome in the IVF process (5). California, in which thousands of embryos were allegedly
Patients who use this technology often depend on their frozen lost due to tank breakdowns. Beyond these events, the losses
embryos for future family building (6). This dependency is were due to inadvertent events and were very low in fre-
predicated on safe storage and on the maintenance of the quency. The basis for claims suggests that medical malprac-
storage facilities to protect the long-term viability and avail- tice claims were relatively low on the scale (a value of 5)
ability of this inventory. But unique risks attend this imple- compared with the most common claims basis of negligence
mentation. Risk management in the area of gamete and and breach of contract (with values of 26 each). Medical
embryo cryopreservation has gained greater urgency, given malpractice claims require showing that patients were
the recent mass freezer malfunctions in Ohio and California harmed in physical or economic ways. These showings are
(7, 8). Analysis of these claims could help identify the root hard to make in claims for embryo loss. In terms of liability
causes of adverse events and provide guidance for improved risks, practitioners may do better to invest and insure
care. against contract and property claims associated with storage
Our data suggest that lost, damaged, or destroyed em- malfunctions.
bryos have a variety of causes but fall outside the scope of It is notable that the changes in the management of ART
generally defined medical malpractice. For purposes of this that are enabled by freezing embryos occur against a back-
discussion, we define medical malpractice in a more expan- ground of intense debate about definitions of unborn life
sive sense than simply the absence of skill and good judgment and legal personhood (10). In this respect, one of the claims
that results in injury during clinical care. We use the term and filed against University Hospitals in Cleveland warrants spe-
its related legal tenet of negligence to apply broadly to failure cial mention: in addition to their negligence claim, the plain-
of a practitioner to provide equipment and its monitoring and tiff couple sought a legal declaration that their lost embryos
FIGURE 2
Lawsuits for lost, damaged, and destroyed frozen embryos: causes of action in closed cases.
Letterie. Lost, damaged, or destroyed frozen embryos. Fertil Steril Rep 2020.
should be given legal standing as persons, sufficient to let best practices, and insurance liability. The second limit con-
them sue for wrongful death (11). The Cuyahoga County Court cerns the absence of comprehensive reports or reliable
of Common Pleas dismissed their case without giving a reason methods into the frequency and cause of adverse events asso-
or explanation about whether any settlement was reached. ciated with embryo loss.
The couple said they would appeal their claim to Ohio’s Su- No public or private body tracks errors or accidents aside
preme Court. This case is noteworthy both for its emotional from the popular media, and such cases tend to be settled within
impact and for touching on a hotly debated issue (Just what the legal system without further disclosure. Clinic reporting of
is personhood?). The ultimate disposition of this case also success rates and utilization is voluntary (12), and there are
has the potential to greatly impact options for embryo no rules to mandate the reporting of errors in handling or pro-
freezing and the liability risks that clinics and providers cessing specimens (13). Adverse events still look rare compared
face—not just for harm to fertility patients, but also to poten- with the total number of cases reported to CDC that involve
tial children. However, even in the current climate the chances frozen embryos. The main importance of these events lies in
for a successful claim are very low. their devastating impact on families and individuals, and the
Our study has two main limitations. First is the lack of ac- events’ prospects for reshaping the legal environment.
cess to settlements details. The parties are not required to file
the terms of their settlements in these cases, which comprised
the majority of our sample set. Not knowing which party paid CONCLUSION
how much or for what reasons limits the robustness and util- Our study provides insight into the basis of claims and the
ity of our findings. Nevertheless, we were left with sufficient clinical and laboratory events that resulted in these losses.
cases to generate evidence-based insights into root causes, We identified no single factor as recurrent, but we did identify
a broad claims basis beyond the more common basis of med- embryos in in vitro fertilization: a meta-analysis. Fertil Steril 2018;109:
ical malpractice and breach of professional duty. Our data 330–42.
6. Fox D. Procreation deprived. In: Birth rights and wrongs: how medicine and
suggest that these events are infrequent, and the actual num-
technology are remaking reproduction and law. Oxford: Oxford University
ber of events when viewed against the practice of ART and Press; 2019:100–12.
management of frozen embryos is quite small, at less than 1%. 7. Snow K, Gardella R, Edwards E. University Hospitals fertility clinic
A detailed review of contributory factors suggests their failure affects more patients than thought. NBC Today; March
avoidance will depend on not just reliable equipment but 27, 2018, Available at: www.nbcnews.com/health/womens-health/
also effective monitoring systems for managing the storage fa- university-hospitals-fertility-clinic-failure-affects-more-patients-thought-
cilities for frozen embryos (14). The U.S. Food and Drug n860291.
8. Cha AE. Class action lawsuit filed against Pacific Fertility for loss of up to a
Administration classifies these tanks as Class II devices, which
thousand embryos and eggs. Washington Post; March 14, 2018,
are not subject to even premarket approval (15). In the absence Available at: https://www.washingtonpost.com/news/to-your-health/wp/
of federal oversight, the manufacturing and use of cryopreser- 2018/03/14/class-action-lawsuit-filed-against-pacific-fertility-for-loss-of-
vation tanks could be regulated at the state level to minimize up-to-thousands-of-embryos-and-eggs/.
the risk of embryo loss. Our findings suggest that clinics 9. Letterie G. Outcomes of medical malpractice claim and assisted reproductive
must improve not just their storage hardware and maintenance technology over a 10-year period from a single carrier. J Assist Reprod Genet
2017;34:459–63.
systems, but also their labeling mechanisms. In addition, clear,
10. Daar J, Mutcherson K. Intersections in reproduction: perspectives on abor-
verified lines of communication between patients and the lab- tion and assisted reproductive technologies. J Law Med Ethics 2015;43:
oratory and clinic personnel are strongly recommended. 174–8.
11. Wendy and Rick Penniman v. University Hospitals Health System, Inc. Cuya-
hoga County, Ohio: Court of Common Pleas; March 30, 2018. Available at:
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1. Friedler S, Giudice LC, Lamb EJ. Cryopreservation of embryos and ova. Fertil Person.pdf.
Steril 1988;49:12–8. 12. Centers for Disease Control and Prevention. Assisted reproductive
2. Maheshwari A, Pandey S, Amalraj Raja E, Shetty A, Hamilton M, technology success rates. Available at: https://www.cdc.gov/art/
Bhattacharya S. Is frozen embryo transfer better for mothers and babies? artdata, Accessed October 1, 2019.
Can cumulative meta-analysis provide a definitive answer? Hum Reprod Up- 13. Ethics Committee of the American Society for Reproductive Medicine.
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3. Cohen IG, Fox D, Adashi EY. Losing embryos, finding justice: life, liberty, and mittee opinion. Fertil Steril 2016;106:59–63.
the pursuit of personhood. Ann Intern Med 2018;169:800–1. 14. Micaelson ZP, Bondalapati ST, Amrane S, Prosser RW, Hill DM, Gaur P, et al.
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EXHIBIT P
DOCUMENT 39
Legal strategies that avoid alleging embryo personhood in tort cases are
informed by the universal rejection of these claims in prior lawsuits. To date, every
court that has considered the wrongful death of an in vitro fertilization (IVF) embryo
has rejected that claim on the ground that the term “person” or “human being” does
not apply to frozen embryos under the meaning of state law (see, e.g., Gentry v.
Gilmore, 613 So.2d 1241, 1244 [Ala. 1993]); Jeter v. Mayo Clinic Ariz., 121 P.3d 1256,
1261–62 [Ariz. Ct. App. 2005]; McClain v. Univ. of Mich. Bd. of Regents, 665 N.W.2d
484, 486 [Mich. Ct. App. 2003]; Miccolis v. Amica Mut. Ins. Co., 587 A.2d 67, 71 [R.I.
1991]).2 Yet patients express a variety of views on the moral status of their frozen
embryos. In one survey, one in five patients reported ascribing full moral status to
their embryos, a view that informed their decisions about the treatment and retention
of unused embryos. The remaining respondents ascribed either no (10%) or some
intermediate status to their embryos, combining to reflect a classical wide range of
views that Americans generally embrace on embryo status. Given this breadth, it is
noteworthy that courts, as well as lawmakers, eschew positions that echo the nuanced
diversity of viewpoints on the subject.
1Letterie G., Fox D. Lawsuit Frequency and Claims Basis over Lost, Damaged, and
Destroyed Frozen Embryos over a 10-year Period. Fertil Steril Rep. Vol. 1, No. 2,
Sept. 2020 2666-3341.
2 Fox D. Oxford University Press; Oxford: 2019. Birth rights and wrongs.
DOCUMENT 39
The import that embryo classification takes on in law and clinical practice
invites us to consider a relative, rather than an absolute, approach applied
situationally. Strict classification as either person or property has its obvious
3 Lyerly A.D., Steinhauser K., Voils C., Narney E., Alexander C., Bankowski B.
Fertility patients’ views about embryo disposition: results of a multi-institutional
U.S. Survey. Fertil Steril. 2010;93:499–509.
4 American Society for Reproductive Medicine Ethics Committee Disposition of
drawbacks, but so does the intermediate approach where embryos are unclassified
(that is, neither person nor property) but given special respect because of their
potential for human life. Exactly what does that mean and how should this special
respect apply? Few, if any, satisfactory answers have been advanced. Instead, a fluid
approach that assesses a host of factors in determining embryo status in context could
appeal. Factors such as social policy, likelihood of harm to others, ability to assess
nonspeculative damages, and alignment with existing laws could be taken into
account when claims arise. The law is accustomed to situational relativism, even
when preborn life is involved. For example, in many states the non-abortion-related
killing of a fetus is considered homicide at any stage of development, whereas a civil
claim for wrongful death will proceed only if the fetus is born alive. The social policy
of punishing criminal acts that harm fetuses is strong, whereas concerns over damage
calculations in the case of negligence linked to an unborn fetus give some states pause
over the merit of such lawsuits.
EXHIBIT Q
Journal of Law and the Biosciences, 1–13
https://doi.org/10.1093/jlb/lsad006
Original Article
ABSTRACT
The demise of Roe v. Wade has prompted some state lawmakers to try to
redefine legal personhood to begin before birth and even before pregnancy.
The sweeping abortion bans passed and pending in the wake of Dobbs pose
a threat to reproductive rights that extends beyond abortion. That threat
spills over into in vitro fertilization (IVF) and other assisted reproductive
technologies (ART). If legislatures designate embryos as legal persons,
fertility clinics will be forced to change how they manage embryos, including
current standard practices such as pre-implantation genetic testing, storage
of unused embryos, and the disposal of those unlikely to have reproductive
potential. This essay examines the many ways in which conferring the status
of persons under private and public law is likely to impact patients pursuing
IVF and clinics practicing ART.
K E Y W O R D S: personhood, embryos, Roe, Dobbs, assisted reproductive
technology, in vitro fertilization
INTRODUCTION
On June 24, 2022, the Supreme Court overturned Roe v. Wade, which had affirmed a
constitutional right to abortion and rejected fetal personhood before birth. In abol-
ishing the abortion right, the Court’s decision in Dobbs v. Jackson Women’s Health
Organization also opened up space for states to confer the legal personhood status on
© The Author(s) 2023. Published by Oxford University Press on behalf of Duke University School of Law, Harvard
Law School, Oxford University Press, and Stanford Law School. This is an Open Access article distributed under
the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which
permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly
cited.
2 • Legal personhood and frozen embryos
1 I. Glenn Cohen, Judith Daar & Eli Y. Adashi, Opinion, What the Supreme Court’s Abortion Reversal Means for
In Vitro Fertilization, Bos. Globe ( June 30, 2022, 3:15 AM), https://www.bostonglobe.com/2022/06/30/
opinion/what-supreme-courts-abortion-reversal-means-vitrofertilization/ [https://perma.cc/3KXG-
M487].
2 La. Rev. Stat. § 9:121 (West 2021).
3 See Doe v. Obama, 631 F.3d 157, 160 (4th Cir. 2011); Sarah Zhang, Can Lost Embryos Give Rise to a Wrongful-
Death Suit?, Atlantic (Apr. 5, 2018), https://www.theatlantic.com/health/archive/2018/04/fertility-cli
nicembryos/557258/ [https://perma.cc/VH39-2N88].
4 See Steven R. Morrison, Personhood Amendments After Whole Woman’s Health v. Hellerstedt, 67 Case w.
Res. L. Rev. 447, 453–57 (2016).
Legal personhood and frozen embryos • 3
Other scenarios are easy to imagine: For example, patients and doctors being incen-
tivized to create and transfer multiple embryos in a single treatment, risking high risk
multiple births, which are more dangerous. These cases illustrate the practical day-to-
day management and decision making for any clinic that delivers assisted reproductive
technologies (ART). Since the inception of in vitro fertilization (IVF) and related
fertility practices, these decisions have been made according to well-defined medical
guidelines that are designed to maximize patient care and outcomes. Now, the state
threatens increasingly to tell fertility clinics and patients what can be done, and cannot,
imposing punitive penalties for failure to comply. This essay examines the far-reaching
implications that designating embryos as persons will have for the practice of ART in
post-Roe America.5 We consider these implications from three critical perspectives: (i)
patients; (ii) providers; and (iii) the embryo-as-shareholder.
Embryos have been described in various ways since inception of IVF in the 1970s.
Zygote, preembryo, early feto-placental unit are among a variety of terms used to charac-
terize life in these early stages. The political struggle for legal personhood of human
embryos has transformed fetal life from a ‘biological entity into a social one’ with
‘individuality, personhood, and rights.’6 Before World War II, preserved fetal remains
were seen as biological entities for scientific research or public display for educational
value.7 The post-war liberalism of the 1960 and growth of fetal protectionism after
Roe saw those same fetuses as ‘babies’ or ‘human bodies’ more worthy of burial than
use.8 This transformation accompanied anti-abortion efforts by the religious right in
the 1980s and 1990s to advance the evils of fetal pain together with photographs of
late-stage fetuses.9 Many pro-life advocates opposed IVF in the late 1970s and early
1980s because the practice, while it aimed at creating new people, often involved the
destruction of human life in the form of embryos that for one didn’t ultimately get
implanted.10 Much of the religious right saw things differently, accepting IVF because
it did not involve fetal pain.11 These factions came together in the 2000s and 2010s to
prioritize legal recognition of fetal personhood as a means to restrict abortion access.12
Dobbs emboldens those efforts and gives them new life. The decision does not
declare that embryos are constitutional persons with rights to due process and equal
protection under the law. But neither does it say that they are not. And it overrules
Roe, which had rejected such individual, personhood interests on the ground that ‘the
unborn have never been recognized in the law as ‘persons’ or ‘accord[ed] legal rights.’13
That an embryo or fetus ‘represents only the potentiality of life,’ the Court declared,
disqualifies that entity from having any individual interests before it is born.14 Its
possible acquisition of such interests in the future, the Court explained, is ‘contingent
5 See Henry T. Greely, The Death of Roe and the Future of Ex Vivo Embryos, 9 J. L. & Biosciences 1 (2022).
6 Sara Dubow, Ourselves Unborn: A History of the Fetus in Modern America 41 (2010).
7 Id. at 171.
8 Id. at 38–44.
9 Sara Dubow, Ourselves Unborn: A History of the Fetus in Modern America 157 (2010).
10 Daniel K. Williams, Defenders of the Unborn: The Pro-Life Movement Before Roe v. Wade 266 (2016).
11 Id.
12 Mary Ziegler, Abortion and the Law in America 184 (2020).
13 Roe v. Wade, 410 U.S. 113, 161–62 (1973).
14 Id. at 156.
4 • Legal personhood and frozen embryos
upon [its] live birth.’15 Accordingly, not even a fully developed fetus could have any
protectable interests of its own, apart from the interest in potential life that the state has
in it, like it does in great works of art or endangered species.16
Until Dobbs, courts entitled frozen embryos to ‘special respect,’ on account of their
‘potential to become a person.’17 This intermediate measure of standing—‘greater than
that accorded to human tissues’ like blood or hair, but less than a person—is what the
Tennessee Supreme Court said embryos are owed in a 1992 divorce action between
Mary Sue and Junior Davis. The former spouses agreed on all terms of the dissolution
except what to do with the seven embryos that they had cryopreserved while they were
married. She wanted to use them to get pregnant; he wanted them donated to a childless
couple.18 Other states had adopted the ‘special respect’ status the Tennessee high court
assigned to the frozen embryos in disposition disputes elsewhere.19
But Dobbs enhanced the legal status of potential life to the point that it justifies
outright bans on abortion—until then, a fundamental constitutional right—from the
moment of conception. By explicitly overruling Roe’s holding that abortion is a right,
the Dobbs majority implicitly opened space to reconsider Roe’s separate holding that
prenatal life lacks the legal status of personhood. This opening has not gone unnoticed
in the states, which have variously enacted measures to ‘[f]ully recognize the human
personhood of an unborn child . . . from the moment of fertilization.’20 Some lawmakers
have suggested that such laws be interpreted to forbid interventions that involve the
deliberate loss of nascent life even before pregnancy.21
Under current fertility medicine and technology, embryos are created either to ini-
tiate a pregnancy or freeze for future use. The availability of sensitive molecular studies
has enabled fertility specialists to characterize embryos as being normal genetically or
what is referred to as euploid; 1 of 2 categories of genetic abnormalities referred to as
mosaicism (high vs low) or aneuploid or abnormal. Previous practices and standards of
care have dictated that an abnormal embryo be discarded with essentially no implanta-
tion potential. Recent studies show an extremely low but definable likelihood of these
genetically abnormal embryos resulting in a healthy live birth.22 This essentially calls
15 Id. at 162.
16 Id.
17 Davis v. Davis, 842 S.W.2d 588, 602 (Tenn. 1992) (emphasis added).
18 Id. at 596–97.
19 See, eg, Jeter v. Mayo Clinic Ariz., 121 P.3d 1256, 1266–68 (Ariz. Ct. App. 2005); McQueen v. Gadberry,
507 S.W.3d 127, 148–49 (Mo. Ct. App. 2016).
20 Eg, H.B. 813, 2022 Leg., Reg. Sess. (La. 2022); H.R. 4327, 58th Leg., 2d Reg. Sess. (2022 Okla.); Utah
Code Ann. § 76–7-301 (West 2021); Ky. Rev. Stat. Ann. § 311.715 (West 2022).
21 See, eg, Ashton Pittman, Mississippi Leaders Supported 2011 Initiative Targeting Abortion, Contraception,
IVF, Miss. Free Press (May 16, 2022), https://www.mississippifreepress.org/23762/mississippileaders-
supported-2011-initiative-targeting-abortion-contraception-ivf [https://perma.cc/VFN6-ZASD]; Tessa
Weinberg, ‘Anything’s on the Table’: Missouri Legislature May Revisit Contraceptive Limits Post-Roe, MO. Inde-
pendent (May 20, 2022, 9:00 AM), https://missouriindependent.com/2022/05/20/anythings-on-the-
tablemissouri-legislature-may-revisit-contraceptive-limits-post-roe/ [https://perma.cc/4DDZ-HVXH];
Guilia Carbonaro, Roe v. Wade Being Overturned Could See IVF Banned in at Least 30 States, Newsweek
( June 14, 2022, 9:16 AM), https://www.newsweek.com/roe-v-wade-being-overturned-ivf-banned-30-sta
tes-1715576 [https://perma.cc/87MUGGFN].
22 See Norbert Gleicher, Pasquale Patrizio & Ali Brivanlou, Preimplantation Genetic Testing for Aneuploidy
– A Castle Built on Sand, 27 Trends Molecular Med. 731 (2021), https://pubmed.ncbi.nlm.nih.
gov/33446425/.
Legal personhood and frozen embryos • 5
into question the disposition of any embryo regardless of its genetics or appearance or
predicted likelihood of ending in a healthy live birth.
The ability to freeze embryos with a high likelihood of implantation and survival has
revolutionized fertility medicine, and brought with it a complexity of issues about what
to do with those frozen embryos.23 Current technologies have success rates anywhere
from 10 to 70 per cent live birth rates depending on the patient population. 24 Not
every embryo is biologically capable of implanting and resulting in a live born baby.
But it is still practically impossible to distinguish viable embryos from non-viable ones
with any scientific certainty.25 Under all but the most extreme circumstances, the only
way to prove that an embryo was non-viable is to transfer and await outcome. Thus any
embryo regardless of morphology or genetic complement must be considered under
these evolving concepts of personhood as resulting in a live birth.
The rationale behind the need to freeze is straightforward. Fertility medicine today
aims to maximize present and future reproductive options. Clinical care seeks to create
embryos for immediate use and to have a cohort available to freeze and create an
inventory for future use.26 These future options are enabled through long-term storage
facilities. Many individuals or patients who intend to create embryos to initiate a
pregnancy immediately also seek to maintain others in their frozen inventory for future
use.27 Maybe a couple is not quite prepared to move ahead with family building but is
sensitive to the impact of maternal age. Or an individual woman might seek to pursue
career plans, while preserving her likelihood of having children in the future. Both
embryo and oocyte freezing offer options to achieve these goals. Advances in clinical
care and technology have progressed to the point where embryo freezing is an essential
and routine part of ART.22 Estimates place the number of frozen embryos at >1.5
million.28 If personhood is granted to embryos, then the laws in many more states than
Louisiana are likely to bar patients and clinics from discarding them or using them for
valuable medical research and clauses in the laws may preclude transporting to states
with more liberal laws.29 In this setting the question becomes: how to manage this
inventory within restrictive laws?
The recent crashes of fertility freezers illustrate the potential liability stakes
that could now exist for destroying frozen embryos under the post-Roe regime.
23 See P.R. Koninckx & P. Schotsmans, Frozen Embryos: Too Cold to Touch? Spare Embryos: Symbols of Respect
for Humanity and Freezing in the Pronuclear Stage, 11 Hum. Reprod. 1841 (1996), https://academic.oup.
com/humrep/article/11/9/1841/615962.
24 See Ctrs. For Disease Control, Art Success Rates, https://www.cdc.gov/art/artdata/index.html
[https://perma.cc/8UVE-67L6].
25 See David K. Gardner, et al. Diagnosis of Human Preimplantation Embryo Viability, 21 Hum. Reprod. Update
727 (2015), https://pubmed.ncbi.nlm.nih.gov/25567750/.
26 See Laura Francesca Rienzi, Perspectives in Gamete and Embryo Cryopreservation, 36 Seminars in Reprod.
Med. 253 (2019), https://pubmed.ncbi.nlm.nih.gov/30947341/.
27 See S. Canosa et al., The Effect of Extended Cryo-Storage Following Vitrification on Embryo Competence: A
Systematic Review and Meta-Analysis, 39 J. Assisted Reprod. Genetics 873, https://pubmed.ncbi.nlm.ni
h.gov/35119549/.
28 See Gerard Letterie, In re: The Disposition of Frozen Embryos: 2022, 177 Fertility & Sterility 477
(2022), https://pubmed.ncbi.nlm.nih.gov/35131103/.
29 See David Badash, ‘From the Moment of Fertilization’: Louisiana Advances Bill Criminalizing Abortion as
Homicide – Women, Doctors Could be Jailed, Alternet (May 6, 2022), https://www.alternet.org/2022/05/
louisiana-house-abortion/.
6 • Legal personhood and frozen embryos
30 See Ariana Eunjung Cha, These Would-be Parents’ Embryos Were Lost. Now They’re Grieving—And Suing,
Wash. Post (Aug. 24, 2018), https://www.washingtonpost.com/national/health-science/these-would-
beparents-embryos-were-lost-now-theyre-grieving—and-suing/2018/08/24/57040ab0-733c-11e8-805c
4b67019fcfe4_story.html?noredirect=on&utm_term=.80e17d-f7e769.
31 See Natalie Lampert, Their Embryos Were Destroyed: Now They Mourn the Children They’ll Never
Have, The Guardian (May 13, 2018), https://www.theguardian.com/lifeandstyle/2018-/may/-13/thei
r-embryoswere-destroyed-now-they-mourn-the-children-theyll-never-have.
32 See Kayla Webley Adler, When Your Dreams of Motherhood Are Destroyed, Marie Claire (Oct. 1, 2018),
https://www.marieclaire.com/health-fitness/a23327231/egg-freezing-emryos-lack-of-regulation/.
33 See Amy Goldstein, Fertility Clinic Informs Hundreds of Patients Their Eggs May Have Been Damaged,
Wash. Post (Mar. 11, 2018), https://www.washingtonpost.com/national/healthscience/fertility-clini
c-informshundreds-of-patients-their-eggs-may-be-damaged/2018/03/11/b605ea82-2536-11e8-b79df3
d931db7f68_story.html?utm_term=.1155a73dbbec.
34 See Rich Gardella & Erika Edwards, Heartbreak, anxiety, lawsuits: The egg-freezing disaster a year later, Nbc
News (Mar. 4, 2019), https://www.nbcnews.com/news/all/heartbreak-anxietylawsuits-egg-freezingdisa
ster-year-later-n978891.
35 Mitchel C. Schiewe et al., Comprehensive Assessment of Cryogenic Storage Risk and Quality Management
Concerns: Best Practice Guidelines for ART Labs, 36 J. Assisted Reprod. & Genetics 5, 5 (2019); see also
Zahava P. Michaelson et al., Early Detection of Cryostorage Tank Failure Using a Weight-based Monitoring
System, 36. Assisted Reprod & Genetics 655 (2019).
36 See Gerard Letterie, In re: The Disposition of Frozen Embryos: 2022, 177 Fertility & Sterility 477 (2022),
https://pubmed.ncbi.nlm.nih.gov/35131103/.
37 See Wex S. Malone, The Genesis of Wrongful Death, 17 Stan. L. Rev. 1043, 1062–66 (1965).
Legal personhood and frozen embryos • 7
were born.38 But this expansion invited another puzzle. ‘Wrongful death’ now afforded
recovery to expecting parents whose fetuses survived a negligent injury, at least until live
delivery, but not where a fetus was injured so severely that it died during pregnancy.
When it came to prenatal misconduct, damages still seemed inappropriately lower in
response to a graver injury.39
To address this apparent paradox, the majority of states expanded the cause of action
again, this time to cover stillborn fetuses capable of surviving on their own. Since
statutes limit its application to the death of a ‘person,’ this move required defining
fetuses as persons—for the narrowly circumscribed purpose of victims who would have
been parents to recover.40 Compensation for wrongful fetal death does not protect the
lost fetus itself, or give it any rights that might be asserted against others. Instead, it
speaks to the devastating loss that expectant parents endure when negligence ends their
wanted pregnancy. 41 ‘Fetal personhood’ in this limited context did not entitle a fetus to
any interests of its own—so it need not implicate the fetus’s ability to inherit property,
or a woman’s right to abort it.42 Every court that had considered the ‘wrongful death’
of IVF embryos before Dobbs had rejected such claims on the ground that the term
‘person’ doesn’t apply to frozen embryos under the meaning of state law.43 Many cancer
survivors and older fertility patients whose embryos, oocytes or sperm are negligently
destroyed might also be robbed of their last chance to carry and raise a genetic child.
Yet judges have so far resisted claims to permit suits for the ‘wrongful death’ of lost
embryos like they have for post-viability fetuses. After Dobbs, liability risks could attach
for any damage to embryos in transporting or receiving from one clinic to the other, or if
spilling culture media in the lab and losing several embryos or if there is active decision
making on the part of an individual or couple to discard the embryo. Added to this is the
complexity of insurance coverage for everything from medical malpractice to criminal
abandonment.44
Options that have been considered as possible solutions are embryo donation
and restricting the number of eggs, or oocytes, that are inseminated and thus the
number of embryos in storage. Donation has been talked about as a win–win (excess
embryos “adopted” by those interested in pregnancy) but a relatively low uptake. In a
recent survey only 15 per cent of patients are willing to consider embryo donation.45
38 See William Prosser & W. Page Keeton, The Law of Torts § 127, at 945 (5th ed. 1984).
39 See Dov Fox, Birth Rights and Wrongs 48–49 (2019); Dov Fox, Reproductive Negligence, 117
Columbia Law Review 149, 218 (2017).
40 See Dov Fox, Interest Creep, 82 George Washington Law Review 273, 279 (2014).
41 See Dov Fox, Redressing Future Intangible Losses, 69 DePaul Law Review 419, 430 (2019).
42 See, eg, Carranza v. United States, 267 P.3d 912 (Utah 2011); Summerfield v. Superior Court, 698 P.2d 712,
715, 724 (Ariz. 1985).
43 See McClain v. Univ. of Mich. Bd. of Regents, 665 N.W.2d 484, 486 (Mich. Ct. App. 2003); Miccolis v. Amica
Mut. Ins. Co., 587 A.2d 67, 71 (1991); Gentry v. Gilmore, 613 So.2d 1241, 1244 (Ala. 1993); Jeter v. Mayo
Clinic Ariz., 121 P.3d 1256, 1261-62 (Ariz. Ct. App. 2005); Miller v. Am. Infertility Grp. of Ill., 897 N.E.2d
837, 839-40 (Ill. App. Ct. 2008).
44 See Jennifer F. Kawwass et al., Embryo Donation: National Trends and Outcomes, 2000–2013, 215 Amer. J.
Obstetrics Gynecology 747.e1, https://pubmed.ncbi.nlm.nih.gov/27393270/.
45 See Alison E. Zimon, et al., Embryo Donation: Survey of In-Vitro Fertilization (IVF) Patients and Randomized
Trial of Complimentary Counseling, 14 Plos One e0221149, https://pubmed.ncbi.nlm.nih.gov/31415660/.
8 • Legal personhood and frozen embryos
Would-be recipients are generally reluctant to use embryos that were generated from
an infertile couple where the embryos’ implantation potential is unclear.46
Though appealing in concept, the reality of embryo donation is far more com-
plicated. Three perspectives influence this option. From the perspective of patients
who are interested in donating embryos, key are issues related to identification and
disclosure of the donating families. The term of anonymous donors in any context has
been replaced by the term non-identified donors.47 This change in language reflects
the source of concern among would-be donors and relates to the inability to assure
anonymity with the prevalence of nonmedical/direct-to-consumer and social media
and networking.48 Other issues that prompt couples to decline embryo donation relates
to the simple fact that many families take a narrow view of having their embryos at large
with no control over their destiny.
From the standpoint of recipient families, donated embryos are derived from
patients undergoing IVF for reasons relating to infertility and thus have attached to
them a variable success rate depending on the clinical indications for the IVF cycle.49
In addition to this, the ‘de-selected’ embryos that remain in inventory are those of lower
implantation potential from the cohort derived from the IVF cycle (the more viable
embryos usually have been transferred).50 This leads to a lower likelihood of success
for the recipient family. An urgency and need to move forward quickly usually prompts
patients that have exhausted other family building options to move forward with the
most expeditious next step.51
From the standpoint of providers, many of the patients have not been adequately
screened prior to the generation of these stored embryos.52 These embryos may be
15 years old and frozen at a time prior to the extensive infectious screening now in place.
The US Food and Drug Administration (FDA), American Association of Tissue Banks,
US Centers for Disease Control and Prevention (CDC), and American Society for
Reproductive Medicine (ASRM) have developed extensive safeguards for the optimal
and safe storage and donation of any tissue embryos included.53 A waiver can be
attached with the following explicit statement: ‘WARNING: NOT EVALUATED
FOR INFECTIOUS SUBSTANCES’. The US FDA, American Association of Tissue
46 See V. Jadva, et al., Sperm and Oocyte Donors’ Experiences of Anonymous Donation and Subsequent Contact with
Their Donor Offspring, 26 Human Reprod. 638 (2011), https://pubmed.ncbi.nlm.nih.gov/21177310/.
47 See Julinda Lee, Embryo Donation: A Review, 82 Acta Obstectrica et Gynecologica Scandinavica
991 (2003), https://pubmed.ncbi.nlm.nih.gov/14616271/.
48 See Prac. Comm. of the Amer. Soc. for Reprod. Med. and the Prac. Comm. for the Soc. for Assisted Reprod.
Tech., Guidance Regarding Gamete and Embryo Donation, 115 Fertility & Sterility 1395 (2021), https://
pubmed.ncbi.nlm.nih.gov/33838871/ [hereinafter Gamete and Embryo Donation Guidance].
49 See Guido Pennings, et al., Attitudes of Sperm Donors Towards Offspring, Identity Release and Extended Genetic
Screening, 43 Reprod. Biomed. Online 700 (2021), https://pubmed.ncbi.nlm.nih.gov/34412975/.
50 See K Wånggren, et al., Attitudes Towards Embryo Donation Among Infertile Couples with Frozen Embryos, 28
Human Reprod. 2432 (2013), https://pubmed.ncbi.nlm.nih.gov/23756704?.
51 See Harry Hatasaka, An Efficient Infertility Evaluation, 54 Clinical Obstetrics Gynecology 644 (2011),
https://pubmed.ncbi.nlm.nih.gov/22031254/.
52 See Gamete and Embryo Donation Guidance, supra note 39.
53 See Food & Drug Admin., Guidance for Industry: Eligibility Determination for Donors of
Human Cells, Tissues, and Cellular and Tissue-Based Products (Hct/Ps) (2007), https://www.
fda.gov/media/73072/download [https://perma.cc/5FGB-WJWF].
Legal personhood and frozen embryos • 9
Banks, US CDC, and ASRM have developed extensive safeguards for the optimal and
safe storage and donation of any tissue embryos included.
The second option of restricting the number of oocytes inseminated has been
explored particularly in Italy as an example of government regulation of ART gone
awry. The passage of Law 40/2004 in Italy, which aims to prevent the ‘loss of any early
human embryo,’ dramatically affected the manner assisted reproduction was conducted
there.54 A recent attempt to modify this highly restrictive legislation failed to gain
popular support and was defeated in a 2005 referendum. It had the unintended impact
of forcing couples to move their care to other countries.55 The idea that some states
are advancing after Dobbs is a variation of this theme to restrict the number of oocytes
inseminated and thus reduce the number of embryos to contend with. As suggested
by the Italian experience, it is a flawed process divorced from the patient’s interest of
best outcomes in the shortest period with maximum future options.56 The inefficiency
of the process is instructive. IVF seeks to maximize the number of embryos from
each cycle to assure optimal present and future outcomes. This need is predicated
on the unreliable and unpredictable outcomes regarding sperm-oocyte interaction,
fertilization, and embryo development.57 Added to this is an inability to identify which
oocytes will yield quality embryos. Absent that, insemination of all oocytes offers the
most informative and efficient path forward. For example, perfect ‘looking’ oocytes will
result in a fertilization rate of only ∼80 per cent and embryo development of 30 per
cent under the best circumstances.58 These outcomes can be even lower depending on
clinical circumstances such as a maternal age beyond the age of 38 that will markedly
decrease the number of oocytes available.59
This ‘limited insemination’ option put forth also frustrates another key element to
contemporary IVF practices, namely generating sufficient number of embryos to freeze
for future use. Cryotechnology has enabled patients to build an inventory of embryos
frequently more than what they will ever use.60 These well-defined goals and definition
of best outcomes may pose one of the greatest conflicts with the Dobbs decision: how to
manage embryos unused embryos in a system where the option to discard is no longer
54 See Giuseppe Benagiano & Luca Gianaroli, The New Italian IVF Legislation, 9 Reprod. Biomed. Online
117-118 (2004), https://pubmed.ncbi.nlm.nih.gov/15333237/.
55 See Mark V. Sauer, Italian Law 40/2004: A View from the ‘Wild West,’ 12 Reprod. Biomed. Online 8 (2006),
https://pubmed.ncbi.nlm.nih.gov/16454924/.
56 See Dmitry Nikiforov et al., Human Oocyte Morphology and Outcomes of Infertility Treatment: a Systematic
Review, Reprod. Sci. (2021), https://pubmed.ncbi.nlm.nih.gov/34816375/.
57 See Jose Buratini et al., Maternal Age Affects the Relationship of Basal FSH and Anti-Müllerian Hormone
Concentrations with Post-ICSI/IVF Live Birth, 42 Reprod. Biomed. Online 748 (2021), https://pubme
d.ncbi.nlm.nih.gov/33653653/.
58 See Marine Poulain et al., Impact of Ovarian Yield-Number of Total and Mature Oocytes Per Antral Follicular
Count-On Live Birth Occurrence After IVF Treatment, 8 Frontiers in Med. (2021), https://pubmed.ncbi.
nlm.nih.gov/34504852.
59 See Natalie M. Crawford & Anne Z. Steiner, Age-related Infertility, 42 Obstetrics Gynecology Clinics
N. Amer. 15 (2015), https://pubmed.ncbi.nlm.nih.gov/25681837/.
60 See Adam S. Cifu, Long-term Physician-Patient Relationships—Persevering in a Practice, 179 Jama Internal
Med. 141 (2019), https://pubmed.ncbi.nlm.nih.gov/30508031/.
10 • Legal personhood and frozen embryos
available.61 The goal of the IVF process sets up a conflict and possible liability if laws
restrict the options for management.62
The relationship between patients and their providers is fundamental to high-
quality care.63 The patient–provider decision process has been upended where the state
grants rights to the embryo that supersede the interests of patients and physician guid-
ance. This insertion of the state runs counter to the cherished relationship providers
share with patients. The elements of a healthy provider–patient relationship include
(i) evidence-based recommendations for decision making within the doctor–patient
relationship; (ii) joint doctor–patient advocacy for best care and clear communication
among all parties; and (iii) privacy, confidentiality, trust and a safe zone for planning
effective care to reach decisions on best outcomes and patient interests.64 In the realm
of IVF, the decision making, and strategizing is especially complex. It involves embryos
with the assumption that decisions regarding the embryos are made with the patients
representing their interests in relationship to the embryos.65 Decision making between
patient and provider is an extremely nuanced exchange.66 Intrinsic to this process is
faith on the part of the patient that a provider will make the decision in their best
interest based on the best evidence to ensure the best outcome. State mandates about
management of reproductive options may force decisions that neither provider nor
patient want and are not in the patients’ best interest.
The point of the IVF process is to create the circumstances these laws are intended
to restrict: namely, to fertilize all oocytes and create as many embryos as clinically safe
and effective. These restrictions negatively impact a range of goals beyond treating
infertility. These include genetic screening of embryos as a form of very early pre-
natal diagnosis; fertility preservation and the empowerment of women; oncofertility
and the option of cancer patients to preserve future fertility in the face of cytotoxic
chemotherapy and its impact on fertility and the fertility infrastructures on which
much of the LGBTQIA+ community (LGBTQIA+ is an abbreviation for lesbian,
gay, bisexual, transgender, queer or questioning, intersex, asexual, and more.) looks
for their family building options.53 The argument is that the entire delivery of care
within the infertility sector will be impossible to execute on if the laws currently in
place or proposed are enforced.54 Enforcement will ignore the inexactitudes at play in
defining embryo viability and how to navigate within these restrictions.55 State laws
could bar practitioners from developing a treatment plan that would be in the patient’s
best interest but constrained by law. Dobbs could restrict clinics’ ability to treat patients
to provide them with quality fertility care.
61 See Selena E. Ortiz & Meredith B. Rosenthal, Medical Marketing, Trust, and the Patient-Physician Relationship,
32 Jama 40 (2019), https://pubmed.ncbi.nlm.nih.gov/30620354/.
62 See id.
63 See id.
64 See Jacquelin Forsey et al., The Basic Science of Patient-Physician Communication: A Critical Scoping Review,
96 Academic Med. J. Assoc. Amer. Med. Colleges S109 (2021), https://pubmed.ncbi.nlm.nih.
gov/34348382/.
65 See Catherine A. McMahon & Douglas M. Saunders, Attitudes of Couples with Stored Frozen Embryos
Toward Conditional Embryo Donation, 91 Fertility Sterility 140 (2009), https://pubmed.ncbi.nlm.ni
h.gov/18053994/.
66 See ACOG Committee Opinion No. 587: Effective Patient-physician Communication, 123 Obstetrics Gyne-
cology 389 (2014), https://pubmed.ncbi.nlm.nih.gov/24451677/.
Legal personhood and frozen embryos • 11
The threat is two-fold. First, is the erosion of the doctor–patient relationship and
impact on trust based on interference with clinical decisions in patients’ best interest.
The second threat is related: the risk for liability, including possible criminal prosecu-
tion for provider and patient alike. When it comes to the liability threat, this could
involve not just civil penalties like malpractice but criminal sanctions from fines to
prison. This shadow and threat may constrain options considered best treatment for
a patient. Providers could be conflicted: risk prosecution or abide by legal constraints
and the safety zone that this compliance may render. Lawsuits involving IVF centers
are infrequent, but the era post-Dobbs may change both the frequency and the penalties
paid.67 The attention post-Dobbs has largely centered on its impact on abortion access
and penalties to both providers and patients should violations ensue. But state policies
could affect everything from how miscarriages are managed and IVF.68 At issue in the
setting of ART is how restrictive laws that ban or severely limit abortion with penalties
attached for violators will impact IVF. The definition on which limits for IVF could turn
is how the laws define when life begins, and if under state laws, will embryos have legal
protections of personhood before transfer. If they do, conducting IVF could become
much more complicated in those states. Unresolved questions about the thousands of
IVF embryos that are currently sitting in freezers there would loom.69
Placing these possibilities in a brief historical context may be of value to gain insight
into possible trends ahead. IVF restriction after Dobbs could follow a path like the early
efforts by anti-abortion legislatures to restrict abortion services. Much of this legislation
prior to Dobbs while not eliminating abortion services resulted in restrictive rules and
regulations intended to make practice of abortion services complicated, expensive and
for smaller clinics unattainable.70 For example, in Texas regulations were passed to
require centers performing abortions to meet criteria applied to surgical centers.71
Fulfillment would mean as examples expanding hallway width and adding expensive
anesthesia equipment. Severe penalties were enforced for noncompliance.72 A similar
path could be envisioned at this early stage where regulations may restrict common
IVF procedures such as preimplantation genetic testing limiting but not eliminating
(at least at this time) options available that would assure best outcomes but not clearly
(at this time) eliminating the IVF options.73 Total bans are unlikely soon. But hastily
67 See Gerard Letterie, Outcomes of Medical Malpractice Claims in Assisted Reproductive Technology over a 10-year
Period from a Single Carrier, 34 J. Assisted Reprod. & Genetics 459 (2017), https://pubmed.ncbi.nlm.ni
h.gov/28190212/.
68 See Aria Bendix, States Say Abortion Bans Do not Affect IVF. Providers and Lawyers Are Worried Anyway, Nbc
News ( June 29, 2002, 9:56 AM), https://www.nbcnews.com/health/health-news/states-say-abortionba
ns-dont-affect-ivf-providers-lawyers-worry-rcna35556 [https://perma.cc/GLJ5-U9MB].
69 See Jan Hoffman, Infertility Patients and Doctors Fear Abortion Bans Could Restrict I.V.F., N.Y. Times, ( July 6,
2022), https://www.nytimes.com/2022/07/05/health/ivf-embryos-roe-dobbs.html [https://perma.cc/
F6UPQ7WC].
70 See Planned Parenthood Action Fund, What Are TRAP Laws?, https://www.plannedparenthoodaction.org/i
ssues/abortion/types-attacks/trap-laws [https://perma.cc/5MDB-PCAX].
71 See Tex. Health & Safety Code Ann. §§ 245.001–245.025 (West 2021), https://statutes.capitol.texas.
gov/Docs/HS/htm/HS.245.htm.
72 See James Studnicki et al., Doctors Who Perform Abortions: Their Characteristics and Patterns of Holding and
Using Hospital Privileges, 6 Health Svcs. Res. & Managerial Epidemiology (2019), https://pubmed.
ncbi.nlm.nih.gov/31020009/.
73 See Carey Goldberg, Abortion Ruling Clouds Future for In Vitro Fertility Patients, Bloomberg ( June 29, 2022,
2:00 AM), https://www.bloomberg.com/news/articles/2022-06-29/roe-v-wade-decision-clouds-future-
forin-vitro-fertility-patients.
12 • Legal personhood and frozen embryos
prepared laws with vague language could have unintended consequences for providers
and patients alike.
Expanded liability and risks of prosecution are eroding patient centric care and
instead shifts provider focus to a defensive posture. Recent events have brought risks of
criminal prosecution adding a new and alarming layer to an already complex process.
Criminal liability and loss of licensure now add to concerns about medical malprac-
tice.74 This transition from medical malpractice to criminal charges is increasing in
frequency, an unlikely event in the past. In addition to past cases, a recent conviction
against a Vanderbilt University nurse of two felonies for a fatal drug error highlights
the position that courts are taking for errors that result in fatalities.75 The prospect of
criminal indictment should give pause to any practitioner in the ART space but added to
this is possible lack of insurance coverage for these claims. Medical malpractice policies
do not cover criminal misconduct.76 Accidents happen in any clinical setting. In IVF,
embryos may be unintentionally damaged or discarded. But the implications for error
in this setting post-Dobbs changes the calculus and imposes a far greater risk, to say
nothing of actual charges that sound in criminal negligence.77
The risk of criminality is clear in recent state laws. A North Dakota law currently
defines murder as when one ‘[i]intentionally or knowingly causes the death of another
human being’ or when one ‘[c]auses the death of another human being under circum-
stances manifesting extreme indifference to the value of human life.’ Assuming, then,
that life begins at conception, doctors who administer IVF would apparently be acting
with the intent or at least with indifference to the lives of the multiple embryos with
unknown viability, some which could result in a live birth and others that simply would
not survive. These risks could also extend to other staff such as nurse, administrators,
hospital staff, and other medical assistants, who could be guilty of accomplice crimes,
including conspiracy to murder. Women and men who hope to become parents through
IVF could also be criminally liable.
Criminal penalties have not yet been defined, but the language of some bills
advanced in state legislature is cause for alarm on the part of practitioners and patients
alike. Louisiana lawmakers advanced a bill that would grant constitutional rights to ‘all
unborn children from the moment of fertilization’ and classify abortion as homicide.
The bill defines personhood as beginning from the moment of fertilization that would
subject people to murder prosecutions, punishable by life without parole, for having
abortions.
74 See Julia B. Berman & Guohua Li, Characteristics of criminal cases against physicians charged with opioid-related
offenses reported in the US news media, 1995–2019, 7 Injury Epidemiology 1 (2020), https://pubmed.ncbi.
nlm.nih.gov/32998773/.
75 See Brett Kelman, In Nurse’s Trial, Witness Says Hospital Bears ‘Heavy’ Responsibility for Patient Death,
NPR (Mar. 24, 2022, 5:00 PM), https://www.npr.org/sections/health-shots/2022/03/24/1088397359/i
nnurses-trial-witness-says-hospital-bears-heavy-responsibility-for-patient-dea [https://perma.cc/XYK3-
XW8Y].
76 See M.M. Reidenberg & O. Willis, Prosecution of Physicians for Prescribing Opioids to Patients, 81 Clinical
Pharmacology & Therapeutics 903 (2007), https://pubmed.ncbi.nlm.nih.gov/17329989/.
77 See Natasha Kay et al., Should doctors who make clinical errors be charged with manslaughter? A survey of medical
professionals and members of the public, 48 Medicine, Science, and the Law 317 (2008), https://pubme
d.ncbi.nlm.nih.gov/19051669/.
Legal personhood and frozen embryos • 13
A natural end point of these threats to care is this: practitioners may find themselves
in a position fraught with liability on two fronts: duty bound to make decisions in
a patient’s best interest but legally held responsible for a decision that may honor
the law but betray a patient trust. Put differently, practitioners may have a conflict
between using the highest clinical standards for patient care according to the prin-
ciples of beneficence and non-malfeasance or abide by strict laws that run counter
to these principles. Patients may find themselves accountable to laws that are against
their interests; prior commitments and contracts and exacerbate the vulnerability that
these patients carry with them. Personhood laws would pull fertility doctors between
opposing obligations—their commitment to treat patients with sound care, and their
obedience to the law. This crisis of conscience will exact a deep psychological toll on
clinicians and diminish the trust patients have in them to put their medical interests
first. This conflict threatens to arrest and upend 50 years of bioethics progress for the
well-being of patients in fertility science, medicine, and technology.
ACKNOWLEDGMENTS
The authors thank Hector Lozada for exceptional research assistance.
CONFLICT OF INTEREST
The authors have no disclosures or conflicts of interest.