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Elizabeth J. Cabraser (State Bar No. 083151)
Lexi J, Hazam (State Bar No. 224457)
Sarah R. London (State Bar No. 267083)
Tiseme G. Zegeye (State Bar No. 319927)
LIEFF CABRASER HEIMANN & BERNSTEIN, LLP
275 Battery Street, 29th Floor
San Francisco, CA 94111-3339
Telephone: 415.956.1000
Facsimile: 415.956.1008
Attorneys for Plaintiff Rachel Levin
ELECTRONICALLY
FILED
Superior Court of Catffornia,
County of San Francisco
08/30/2018
Clerk of the Court
BY:EDNALEEN ALEGRE
Deputy Clerk
SUPERIOR COURT OF THE STATE OF CALIFORNIA
COUNTY OF SAN FRANCISCO
RACHEL LEVIN,
Plaintiff,
Vv.
PACIFIC FERTILITY CENTER,
PRELUDE FERTILITY, INC., CHART
INDUSTRIES, INC., and DOES 1-25,
Defendants.
1604907.1
Case No. CGC-18-565570
AMENDED COMPLAINT
wee
Negligence and/or Gross Negligence;
Breach of Contract;
Bailment;
Premises Liability;
Breach of Fiduciary Duty — Failure to Use
Reasonable Care
Violation of the Unfair Competition Law,
Cal. Bus. & Prof. Code § 17200 et seq.;
Violations of the Consumes Legal Remedies
Act, Cal. Civ. Code § 1750 et seq.;
Deceit and Fraudulent Concealment;
Strict Products Liability — Failure to Warn;
. Strict Products Liability - Manufacturing
Defect;
. Strict Products Liability — Design Defect —
Consumer Expectation;
2. Strict Products Liability - Design Defect —
Risk-Benefit; and
. Negligent Failure to Recall
DEMAND FOR JURY TRIAL
AMENDED COMPLAINT
CASE NO. CGC-18-565570wv
Plaintiff Rachel Levin (“Plaintiff”) files this action against Defendants Pacific Fertility
Center (“Pacific Fertility”), Prelude Fertility, Inc. (“Prelude”), and Chart Industries (“Chart”), and
Does 1-25 (collectively, “Defendants”), and alleges as follows:
NATURE OF THE ACTION
1. Prelude and Pacific Fertility market and sell egg storage services as an “insurance
policy” to preserve women’s ability to have children when the time is right.
2. Recognizing that the eggs entrusted to their care are irreplaceable, Prelude and
Pacific Fertility have promised their clients, including Plaintiff, that they will use state-of-the-art
laboratory equipment and protocols to ensure their safekeeping. These promises include:
monitoring the liquid nitrogen in egg storage tanks, using backup redundancies to guard against a
catastrophic failure, conducting daily inspections of the tanks, and implementing alarm systems to
immediately notify staff of a potential failure.
3. On March 4, 2018, Pacific Fertility discovered that the liquid nitrogen levels in a
storage tank known as “Tank 4” had dropped to an unsafe level for an undetermined period of
time, destroying or jeopardizing the eggs and embryos stored in the tank, including all 10 eggs
that Plaintiff had entrusted to their care. Chart manufactured Tank 4.
4, On Sunday, March 11, 2018, Pacific Fertility sent a mass, boilerplate email
describing the failure as “a very unfortunate incident” in which the storage tank containing
Plaintiff's cryopreserved eggs “lost liquid nitrogen for a brief period of time,” and stated that a
“preliminary analysis” suggested some of the eggs and embryos in the tank may have been
destroyed.
5. Over a month later, on April 19, 2018, Pacific Fertility reported in another mass,
boilerplate email that an investigation had shown the incident resulted from “a failure of the
tank’s vacuum seal,” Four days later, Chart recalled several of its cryostorage tanks, citing
“reports of a vacuum leak or failure that could compromise the product.”
6. Pacific Fertility and Prelude were responsible for monitoring Tank 4’s
performance for fluctuations in temperature or liquid nitrogen levels, which could endanger the
enclosed eggs, and promised to maintain safety systems to mitigate a tank failure. Pacific
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Fertility and Prelude failed in that responsibility, committed gross negligence, and breached their
agreement by failing to do what they promised to safely preserve Plaintiffs eggs until she was
ready to use them.
7. To Plaintiff's shock and dismay, Pacific Fertility and Prelude stored all of her eggs
in one tank, failing to take even the most obvious, common sense precaution to mitigate risk.
8. As a result of Defendants’ failures, Plaintiff has suffered irreparable harm.
Learning that all of her eggs were compromised has caused her devastation, panic, and distress.
Pacific Fertility and Prelude have informed Plaintiff that it is not possible to know whether her
eggs are viable until they are thawed, and even then, the full extent of the damage cannot be
known without attempting a pregnancy. These messages have cast a cloud of uncertainty over
Plaintiff, causing anguish and despair. At age 43, she believes she may have lost her ability to
have another biological child, as further egg retrievals are likely to be futile—if they are even
possible, given the significant risks and burden to her body.
9. Plaintiff seeks all damages, equitable relief, and remedies available under the law.
JURISDICTION AND VENUE
10. This Court has personal jurisdiction over the Defendants, because the Defendants
are residents and/or do business in the State of California.
11. Venue is proper in this Court because the injury occurred in San Francisco County
and/or the Defendants reside in San Francisco County.
PARTIES
A. Plaintiff RACHEL LEVIN
12. Plaintiff Rachel Levin is a citizen and resident of San Francisco, California.
B. Defendants
1. Prelude
13. At all relevant times, Defendant Prelude Fertility, Inc. was a Delaware corporation
headquartered in Florida. Prelude owns and runs a network of fertility clinics and egg and
embryo storage facilities-including Pacific Fertility Center-across the country.
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14, Prelude was founded in 2016 by startup entrepreneur Martin Varsavsky with a
$200 million investment by New York-based Lee Equity Partners. Prelude’s stated business plan
is to create a national network of fertility clinics, as well as egg and embryo cryostorage centers
“all delivered with the highest level of personalized care by the nation’s leading reproductive
endocrinologists and practitioners.”' According to Varsavsky, “What Prelude does is bridge the
gap, it makes people’s biology meet their psychology” through “The Prelude Method”: “You
freeze your gametes when fertile, thaw them and create embryos when ready, genetically
sequence the embryos, and then transfer one embryo at a time. And you continue to do this until
you achieve your desired number of children.””
15. Included within the Prelude network is MyEggBank, which Prelude claims has the
largest and most diverse selection of egg donors in the country. Prelude also claims that its
embryo survival rates are greater than 90% and that women who use eggs from MyEggBank have
a 90% pregnancy success rate within three cycles.*
16. Prelude acquired Pacific Fertility in September 2017 as part of Prelude’s business
plan to build its national network. Prelude directs potential clients to Pacific Fertility via its
website and its network of fertility clinics. Prelude also provides financing plans for services at
Pacific Fertility.
17. Prelude represents that Pacific Fertility is one of “Our Clinics.” It represents that
Pacific Fertility’s clients are “Our” clients.*
18. In its press release announcing the addition of Pacific Fertility to its network of
fertility clinics, Prelude described “egg freezing, in vitro fertilization (IVF), genetic screening of
embryos, and donor egg matching” as part of “Prelude’s comprehensive services.” °
' 4 Modern Approach to Family, Prelude Fertility, https://www.preludefertility.com/about (last
visited May 18, 2018).
~ Martin Varsavsky, Why I founded Prelude Fertility: Background on vision and bringing on the
team to make it thrive (Mar. 7, 2017), http://vator.tv/news/2017-03-07-why-i-founded-prelude-
fertility (last visited May 30, 2018).
> Have Questions?, Prelude Fertility, https://preludefertility.com/faq (last visited May 18, 2018).
* Options Preserved, Our Clinics, Prelude Fertility, https://www preludefertility.com/freeze-eggs
(last visited May 18, 2018).
5 Pacific Fertility Center: San Francisco, Prelude Fertility,
https://www.preludefertility.com/clinic/pacific-fertility-center (last visited May 18, 2018).
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19, Despite the above announcement, Prelude does not perform any clinical services.
20. Prelude owns the laboratory, storage facility, and tanks at Pacific Fertility. It
owned Tank 4 at the time of the March 4, 2018, incident.
21. The employees responsible for performing daily monitoring and maintenance of
the tanks, including Tank 4, are employees of Prelude.
2. Pacific Fertility Center
22. Defendant Pacific Fertility Center is a private unincorporated entity located at 55
Francisco Street, Suite 500, San Francisco, California 94133.
23. Pacific Fertility was founded in 1999 and provides a full range of fertility services,
including egg and embryo cryostorage, IVF, genetic testing, and “cutting-edge laboratory
techniques and technology such as . . . vitrification.”
24. At all relevant times, Pacific Fertility’s on-site San Francisco laboratory has
cryopreserved and stored eggs and embryos, including those belonging to Plaintiff.*
25. At the time of the March 4, 2018, incident, Tank 4 was located at Pacific Fertility
Center’s laboratory in San Francisco.
3. Chart Industries, Inc.
26. Defendant Chart Industries, Inc. is a Delaware corporation headquartered in
Georgia.
27. Founded in 1992, Chart is a publicly traded global manufacturer of equipment
used in the production, storage, and application of industrial gases. Chart produces a variety of
cryogenic equipment. On its website, Chart states that its “focus is cryogenics.”” Chart claims
Footnote continued from previous page
° Prelude Fertility Expands Network with Pacific Fertility Center in San Francisco, Prelude
Fertility, https://www.prnewswire.com/news-releases/prelude-fertility-expands-network-with-
pacific-fertility-center-in-san-francisco-300524534.html (last visited May 18, 2018).
’ Prelude Fertility Expands Network with Pacific Fertility Center in San Francisco, Prelude
Fertility, https://www.preludefertility.com/press-release/prelude-fertility-expands-network-
pacific-fertility-center-san-francisco (last visited May 20, 2018).
® Sperm and Embryo Freezing, Pacific Fertility Center,
https://www.pacificfertilitycenter.com/treatment-care/sperm-and-embryo-freezing (last visited
May 18, 2018).
° About Chart, Chart Industries, http://www.chartindustries.com/About-Chart (last visited May
20, 2018).
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that its products “utilize our proprietary vacuum and insulation technologies, including storage
equipment,” and that “[oJur industry-proven core-competency provides the highest insulation
thermal performance in cryogenics [.]”!° Chart touts itself as “a recognized global brand for the
design and manufacture of highly engineered cryogenic equipment” and a “leading global
manufacturer of vacuum insulated products and cryogenic systems.”"!
28. In its annual report for 2017, Chart described itself as a “leading diversified global
manufacturer of highly engineered equipment, packaged solutions, and value-add services used
throughout the gas to liquid cycle in all industries that require gases as cryogenic liquids or
alternative equipment for gas generation, generally for the industrial gas, energy, and biomedical
industries.”
29. Through its MVE brand, Chart sells a line of cryogenic equipment that includes
freezers and metal storage tanks. Chart claims that its cryogenic products “are engineered for
13
reliability and durability”’” and that its MVE brand “is the benchmark for biological storage
systems, used for the cryogenic preservation of human . . . tissues.”!*
30. Chart’s BioMedical segment accounted for around 20% of its total sales. Its
“cryobiological storage products include vacuum insulated containment vessels for the storage of
biological materials.”'> Chart describes the competition for cryobiological storage products as
“significant” and notes that “competition in this field is focused on design, reliability, and
price.”"®
'° Cryogenics, Chart Industries, http://www.chartindustries.com/Industry/Markets-
Served/Cryogenics (last visited May 20, 2018).
"MVE Cryopreservation for Life Science, Chart Industries,
http://files.chartindustries.com/Cryopres%20Catalog%20ML-CR Y00009%20K%203b.pdf (last
visited May 20, 2018).
"2 SEC Form 10-K, Chart Industries, http://ir.chartindustries.com/Cache/392303934 pdf (last
visited May 20, 2018).
'8 Life Sciences, Chart Industries, http://www.chartindustries.com/Life-Sciences (last visited May
20, 2018).
4 4bout Chart, Chart Industries, http://www.chartindustries.com/About-Chart (last visited May
20, 2018).
'S SEC Form 10-K, Chart Industries, http://ir.chartindustries.com/Cache/392303934 pdf (last
visited May 20, 2018).
16 Tg
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31. Chart designed and manufactured the storage tank in which Plaintiff's eggs were
stored on the date of the subject incident.
4. DOES 1 through 25
32. Defendants DOES 1 through 5, and each of them, are and were, at all relevant
times herein, individuals, directors, corporations, or entities, form unknown, that were involved in
controlling, monitoring, inspecting, maintaining, repairing, selecting, purchasing and/or using the
cryogenic equipment, including the cryogenic tanks and their components, that were used for
freezing and storing eggs and embryos at Pacific Fertility, including Tank 4, and/or were
responsible for drafting the protocols, policies and procedures to be followed in cryogenic
preservation, when maintaining, monitoring, operating, or inspecting the cryogenic equipment at
Pacific Fertility and the cryogenic storage tanks, including Tank 4, used for freezing and storing
eggs or embryos, including Plaintiff's eggs.
33. Defendants DOES 6 through 10, and each of them, designed, manufactured, tested,
analyzed, distributed, recommended, merchandised, advertised, marketed, advocated, promoted,
supplied, maintained, repaired, and/or sold to distributors, retailers, physicians, fertility clinics,
fertility centers or other entities or providers, cryogenic equipment, including cryogenic freezers
or storage tanks, including the tanks used for storage and freezing of eggs and embryos in liquid
nitrogen, including Tank 4, which failed and endangered, damaged and/or destroyed frozen eggs
and embryos belonging to hundreds of people, including Plaintiff.
34. Defendants DOES 11 through 15, and each of them, are and were, at all relevant
times herein, individuals, directors, corporations, or entities, form unknown, that were involved in
controlling, monitoring, inspecting, maintaining, repairing, selecting, purchasing and/or using the
alarm systems at Pacific Fertility used when freezing and storing eggs or embryos, including
Plaintiffs eggs, and/or were responsible for drafting the protocols, policies and procedures to be
followed in cryogenic preservation, when maintaining, monitoring, operating, or inspecting the
alarm systems at Pacific Fertility used when freezing and storing eggs or embryos, including
Plaintiff's eggs.
35. Defendants DOES 16 through 20, and each of them, designed, manufactured,
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tested, analyzed, distributed, recommended, merchandised, advertised, marketed, advocated,
promoted, supplied, maintained, repaired, and/or sold to distributors, retailers, physicians, fertility
clinics, fertility centers or other entities or providers, the alarm systems used at Pacific Fertility
for storage and freezing of eggs and embryos in liquid nitrogen, which failed and endangered,
damaged and/or destroyed frozen eggs and embryos belonging to hundreds of people, including
Plaintiff.
36. Defendants DOES 21 through 25, and each of them, are and were, at all relevant
times herein, individuals, directors, corporations, or entities, form unknown, that were involved in
controlling, monitoring, inspecting, maintaining, repairing, selecting, purchasing and/or using the
generators used at Pacific Fertility for storage and freezing eggs or embryos, including Plaintiff's
eggs, and/or were responsible for drafting the protocols, policies and procedures to be followed in
cryogenic preservation, when maintaining, monitoring, operating, or inspecting the generators
used at Pacific Fertility for freezing and storing eggs or embryos, including Plaintiff's eggs.
37. The true names, capacities or involvement of the Doe Defendants, including
manufacturers, and/or suppliers, and/or distributors, and/or others responsible for the design,
operation, and/or maintenance of Tank 4 and its components, as well as related cryogenic
preservation equipment, including, but not limited to, its alarm system and back-up generators,
are unknown to Plaintiff. Upon discovery and if it would appropriate to do so, Plaintiff will move
to amend to add the correct names of these entities.
38. Nonetheless, the named Defendants are jointly and severally liable for the entire
harm for the breach of their non-delegable duty to Plaintiff.
39. Atall times herein mentioned, each and every of the Defendants herein was the
agent, servant, partner, joint venturer, employee and/or franchisee of each of the other
Defendants, and each was at all times acting within the course and scope of such agency, service,
employment, joint venture, partnership and/or franchise.
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FACTUAL ALLEGATIONS
1. Plaintiff Entrusted Prelude and Pacific Fertility with Keeping her Eggs Safe and
Secure.
40. Defendants Prelude and Pacific Fertility have partnered to offer egg and embryo
storage (“cryostorage”’), among other fertility services.
41. Prelude claims that it is “on a mission” to provide “the best options, science, and
wl7
care so everyone can have the opportunity to be a mom or dad when they are ready.
42. Pacific Fertility states that it has one goal: to help clients build a healthy family.'*
A. Defendants market their cryostorage services as an insurance policy that
unwinds the biological clock, preserving the opportunity to have children
when the time is right.
43. Human eggs, also known as oocytes, are a limited resource. According to Pacific
Fertility, a woman has about 600,000 eggs at birth, and this supply diminishes at the rate of about
1,000 per month, beginning at her birth.'° This decline is part of the natural aging process and is
commonly referred to as a woman’s biological clock. The loss of oocytes from the ovaries is
relentless and continues even in the absence of menstrual cycles, and even when women are
pregnant, nursing, or taking oral contraceptives. In addition, as Pacific Fertility acknowledges,
egg quality diminishes with time, with miscarriages and chromosomal abnormalities occurring
more frequently the older a woman is at the time of pregnancy. By their early-to-mid 40s, women
typically can no longer conceive a child naturally.”°
44. — Both Pacific Fertility Center and Prelude emphasize that their cryostorage services
allow for flexibility in their clients’ family planning.
'7 4 Modern Approach to Family, Prelude Fertility, https://www preludefertility.com/about (last
visited May 18, 2018).
'S Pacific Fertility Center, Pacific Fertility Center, https://www.pacificfertilitycenter.com/the-
center/infertility-center (last visited May 28, 2018).
'° Fee Freezing in Northern California, Pacific Fertility Center,
https://www.pacificfertilitycenter.com/treatment-care/fertility-preservation-egg-freezing (last
visited May 27, 2018).
01g
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45. Prelude advertises its cryostorage services as an “insurance policy” providing
“peace of mind” and more control over childbearing choices."! Prelude goes on to describe the
922
storage process as hassle free: “Set it and forget it until you’re ready.
46. Pacific Fertility offers cryostorage services as a means of preserving “a precious
resource, limited to just a few years of your life[,]” and states that cryopreserving eggs and
embryos “can increase your chances of conception by 5 to 10 times.””°
47. Pacific Fertility touts similar benefits from its fertility storage services:
6 Reasons to Preserve Your Fertility Today! (1) For a future family
. .. (2) To allow for educational pursuits . . . (3) To have time to
develop a business or career . . . (4) To give your relationship time
to mature .. . (5) To reduce the risk of medical treatments that
might impact fertility . . . (6) To achieve control over your future.
B. Defendants promised to keep Plaintiff’s eggs safe in a state-of-the-art facility.
48. Defendants emphasize that eggs and embryos will be safely stored, indefinitely,
for future family planning.
49. Pacific Fertility states that “there is no limit to how long cells remain viable in the
frozen state.”*>
50. Pacific Fertility claims that its laboratory is state of the art, meeting a “gold
standard,””° and that it has a large and experienced laboratory staff dedicated to the “care and well
being of eggs, embryos and sperm.”””
*! Meet Prelude Fertility, The $200 Million Startup That Wants To Stop The Biological Clock,
Forbes (Oct. 17, 2016), https://www.forbes.com/sites/miguelhelft/20 1 6/10/17/prelude-fertility-
200-million-startup-stop-biological-clock/#d05688c7260f.
2
Id.
33 Should | freeze my eggs?, Pacific Fertility Center,
https://www.pacificfertilitycenter.com/fertility-preservation/my-eggs (last visited May 18, 2018).
*4 6 Reasons to Preserve Your Fertility Today!, Pacific Fertility Center (June 30, 2017),
https://www.pacificfertilitycenter.cony fertility-preservation/blog/6-reasons-to-preserve-your-
fertility-today.
5 Sperm and Embryo Freezing, Pacific Fertility Center,
https://www.pacificfertilitycenter.com/treatment-care/sperm-and-embryo-freezing (last visited
May 18, 2018).
°° Pacific Fertility Center, https://www.pacificfertilitycenter.com/the-center/infertility-center (last
visited May 20, 2018).
*” IVF Laboratory Team, Pacific Fertility Center, https://www.pacificfertilitycenter.com/fertility-
specialists/ivf-laboratory-team (last visited May 20, 2018).
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51. Since the advent of cryopreservation, the main techniques to cryopreserve eggs
and embryos have been slow freezing and vitrification. With slow freezing-first used in 1986-it
takes about two hours for eggs to reach final storing temperature. Starting in the mid-2000s, eggs
and embryos began to be preserved through a rapid cryopreservation process called vitrification.
52. Vitrification is a more advanced and reliable technology that Pacific Fertility
describes as being “used in the embryo and egg freezing process so that they can be stored for
later use.”* Pacific Fertility states the newer vitrification process is safer than earlier slow-
freezing technologies, which could lead to crystallization threatening the viability of
cryopreserved tissue.
53. Pacific Fertility claims that liquid nitrogen “is very stable and easy to work with”
and that each tank is equipped with numerous sensors to monitor temperature increases above —
196°C or a drop in the level of liquid nitrogen.” Pacific Fertility also claims that the sensors
“are connected to a telephone alarm system that will alert staff to an alarm condition outside of
normal working hours. .. . The alarm system is tested weekly and continues to run on battery
power in the event of a power failure. The alarm system can also be checked remotely.” When a
tank alarm goes off, the on-call embryologist is supposed to arrive within 30 minutes regardless
of time of day and must conduct a physical inspection of the tank before the alarm can be turned
of f°
54, Pacific Fertility further claims that, in addition to being constantly monitored, each
tank “gets a physical inspection daily, looking for problems or signs of problems,” and that the
amount of nitrogen in the tank “is assessed as a means of monitoring for a possible slow leak or
an impending tank failure.”*!
55. Each tank is also supposed to receive a daily refill of nitrogen because the nitrogen
in the tanks continuously evaporates at a slow rate.*? It is standard in the egg and embryo storage
* Vitrification, Oocyte and Embryo Vitrification, Pacific Fertility Center,
https://www.pacificfertilitycenter.comy/treatment-care/vitrification (May 18, 2018).
Td.
30 Td.
31 Td.
32 Td.
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industry for facilities to equip their tanks with autofilling mechanisms to refill the liquid nitrogen
when the system detects that levels are low.
56. Pacific Fertility advertises the durability of its tanks and storage facility on its
website, stating:
The storage tanks require no power and would not be impacted by a
power failure or blackout. They are made of metal and would
probably survive a small or moderate fire. If the tanks were not
physically damaged or knocked over in a disaster, they should
survive intact. Even if no one was able to physically check the
tanks, or if we were unable to obtain liquid nitrogen, the tanks
should still maintain their temperature for several days.
57. Pacific Fertility represents that its egg and embryo cryostorage services are highly
134
successful, with egg survival rates of 83% and embryo survival rates consistently above 90%.*°
58. Prelude also touts “greater than 90%” egg and embryo survival rates.°°
IL. Precision and Care Are Required When Storing Frozen Eggs.
A. The process of retrieving and storing eggs is demanding, time consuming, and
expensive,
59. People who use Defendants’ cryostorage services, including Plaintiff, typically
make an enormous emotional investment. They endure painful and invasive procedures, financial
stress, and the strain the process puts on their mental health and relationships with others, all in
the hopes that one day they will be able to have a child.
60. Women take drug and hormone cocktails and injections over several weeks to
stabilize the uterine lining, stimulate ovaries into producing follicles, and stop these ovary
follicles from releasing eggs. Then, after an ovulation trigger injection, eggs are collected under
sedation or a general anesthetic. A woman may be subjected to multiple painful injections each
day, resulting in bruising, swelling, and overall discomfort. The drug and hormone therapy may
° Lab FAQs, Pacific Fertility Center, https://www.pacificfertilitycenter.com/the-center/lab-faq
(May 20, 2018).
4 What are your success rates?, Pacific Fertility Center,
https://www.pacificfertilitycenter.com/fertility-preservation/my-eggs#success (last visited May
20, 2018).
% Vitrification, Oocyte and Embryo Vitrification, Pacific Fertility Center,
https://www.pacificfertilitycenter.com/treatment-care/ vitrification (May 18, 2018).
36 Have Questions?, What are the chances of pregnancy with frozen embryos?, Prelude Fertility,
https://www.preludefertility.com/faq (last visited May 27, 2018).
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also trigger other side effects, such as tiredness, nausea, headaches, and blood clots, as well as
negative emotions. Many women also undergo acupuncture sessions, recommended by Pacific
Fertility, to improve IVF outcomes. The process can limit travel and other activities, and often
requires time off from work. The harvesting procedure itself can be painful and hard to endure,
requiring insertion of a thick needle through the vaginal wall to drain the ovary follicles of their
fluid. After the procedure, a woman often experiences residual pain for about a week and may
need bed rest for several days. Some women suffer significant side effects, such as ovarian
hyperstimulation syndrome, requiring hospitalization.
61. — Undergoing egg retrieval is “emotionally trying” as well as physically
demanding.*” Pacific Fertility acknowledges that feelings of anxiousness, depression, isolation,
and helplessness are common among clients undergoing IVF services, and that strained and
stressful relations with spouses, partners, and other loved ones are also common. IVF typically
causes those undergoing treatment to rely heavily on friends and significant others for support,
including, for example, with coping with stress and providing rides to and from appointments.**
62. According to Pacific Fertility’s website, “the time and energy that is needed, both
physically and emotionally can drain even the staunchest crusader.”
63. According to one research study, half of women seeking IVF services described
infertility as the most upsetting experience of their lives.*” Other studies show that infertility
causes anguish similar to that accompanying a cancer diagnosis or the loss of a loved one.*!
Infertility is associated with anger, depression, anxiety, marital problems, and loss of self-esteem
*7 Patient Support, Pacific Fertility Center, https://www-pacificfertilitycenter.com/treatment-
care/patient-support (last visited May 27, 2018).
38 Resources at Your Fingertips, Pacific Fertility Center (Nov. 22, 2004),
https://www.pacificfertilitycenter.conyblog/fertility-resources-your-fingertips.
3° Ig.
* The psychological impact of infertility and its treatment, Harvard Medical School (May 2009),
https://www.health.harvard.edu/newsletter_article/The-psychological-impact-of-infertility-and-
its-treatment.
*" A.D. Domar et al., The psychological impact of infertility: a comparison with patients with
other medical conditions, Journal of Psychosomatic Obstetrics & Gynecology (1993),
https://www.massgeneral.org/bhi/assets/pdfs/publications/Domar%201993%20J%20Psychosom
%200bstet%20Gynaecol.pdf; C. A. Bryson, Post IVF syndrome? Psychological implications of
failed IVF, The Obstetrician & Gynaecologist (2002),
https://obgyn.onlinelibrary.wiley.com/doi/pdf/10.1576/toag.2002.4.4.201.
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among prospective parents experiencing infertility.” Pacific Fertility warns clients that they may
experience intense anger, despair, and guilt, and that it is “is very common to experience
symptoms of anxiety and depression as a result of this experience.”
64. The cryostorage process compounds these emotions and stresses. For many, this
process represents their last hope for having children. Each cycle can produce anxiety and fear
that there won’t be enough eggs retrieved, or that the eggs retrieved won’t be of a high enough
quality. Multiple cycles are often required. Many women experience and express strong feelings
of anxiety, failure, hopelessness, and disappointment during this process.
65. Prelude acknowledges its clients’ vulnerability during the cryostorage process and
trains its staff on how to empathize with clients:
Fertility is such an incredibly personal and vulnerable subject. The
World Health Organization has designated infertility as the ‘third
biggest global epidemic,’ and yet as a society, we hardly even talk
about it . . . until it gets personal. As more people delay childbirth
past their peak fertility years to pursue careers, advanced degrees,
or the right life partner, the chances of having a baby the old
fashioned way start to decline.
kok OK
As women, mothers, sisters, and daughters we make it a priority to
educate and support all of our staff on how it feels to go through
these journeys and how much it means.
66. “The emotional part is driving what we are trying to do,” Prelude’s chief revenue
officer said. She further noted that a number of Prelude’s own employees have been touched by
infertility.“°
67. “Emotional health” and “well being” are central to Pacific Fertility’s stated
mission:
*” DK. Dekar et al., Psychological aspects of infertility, British Journal of Medical Practitioners
(2010), http://;www.bjmp.org/content/psychological-aspects-infertility.
4 Coping Strategies, Pacific Fertility Center, https://www.pacificfertilitycenter.com/treatment-
care/coping-strategies (last visited May 20, 2018).
* 4 Modern Approach to Family, Prelude Fertility, https://www.preludefertility.com/about (last
visited May 20, 2018).
4S 1g
“© Meet Prelude Fertility, The $200 Million Startup That Wants To Stop The Biological Clock,
Forbes (Oct. 17, 2016), https://www.forbes.com/sites/miguelhelft/2016/10/17/prelude-fertility-
200-million-startup-stop-biological-clock/#d05688c7260f.
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We are dedicated to a whole patient approach. We recognize that
fertility treatment may impact all corners of our patient’s lives,
including work, personal relationships and financial concerns,
When designing their treatment course, our physicians, nurses and
counselors work with them to accommodate all of these
considerations.
Our support is integrated. Emotional health and well being are
central to our patient’s care. Our clinic’s services include
acupuncture and an array of Mind/Body and stress reduction
workshops, seminars and support groups. Our in-house family
therapist is available to any patient and will also gladly provide
referrals to other qualified professionals.
68. Pacific Fertility recognizes the need to address clients’ “emotional and even
spiritual needs” during the “emotional ups and downs” of infertility:
At PACIFIC FERTILITY, we know that the physical demands and
emotional ups and downs of infertility experience can impact life at
home, at work and with family. This is a path that one likely did
not anticipate and, while there is much reason for hope, the
treatment process can also be emotionally trying. The well being of
our patients is a crucial aspect of fertility treatment, and we
encourage our patients to take advantage of the many resources we
have developed to address the emotional and even spiritual needs
they may have as a part of their journey.
PACIFIC FERTILITY’s extensive support system includes a
devoted patient care team, experienced clinical coordinators and
educators and an in-house marriage and family therapist who has
long specialized in fertility and third party parenting issues.**
69. Acknowledging the stress and challenges those contending with infertility face,
Pacific Fertility promises its clients that it will be “by their side every step of the way”:
A diagnosis of infertility can feel overwhelming and stressful for
individuals and couples who always assumed that pregnancy would
come easily. At Pacific Fertility Center, we see infertility as a
workable challenge. . . .
We feel strongly that the physical well being is tied to emotional
well being, and we take into account all of the challenges[,]...
[including d]iagnosis, treatment and the inevitable ‘waiting game’
as well as financial stress . .. . We are by their side every step of the
way to help address each and all of these needs.”
at Fertility Treatment and Care, Pacific Fertility Center,
https://www.pacificfertilitycenter.com/treatment-care/fertility-treatment-and-care (last visited
May 27, 2018).
“8 Patient Support, Pacific Fertility Center, https://www.pacificfertilityeenter.com/treatment-
care/patient-support (last visited May 27, 2018).
* Pacific Fertility Center, https://www.pacificfertilitycenter.com/the-center/infertility-center (last
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CASE NO. CGC-18-565570wv
70. Pacific Fertility and Prelude’s services are costly. Pacific Fertility charges
$11,595 for basic IVF, including clinical monitoring, egg retrieval, lab processing, and embryo
transfer.” If a client chooses to use Comprehensive Chromosome Screening to select the
healthiest embryo to transfer, Pacific Fertility’s basic IVF costs rise to $16,085."
71. The above amounts do not include the costs of in-person consultations ($375), pre-
cycle lab work, egg cryopreservation medications ($2,000-$6,000), embryo transferring ($2,845-
$4,460), embryo transfer medications ($300-$600), and continuing charges for egg and embryo
storage ($600 per year). Clients typically also pay thousands of dollars for fertility drugs
leading up to egg retrieval, and often spend hundreds of dollars on acupuncture and other
recommended services to improve outcomes. The entire process often costs many tens of
thousands of dollars.
72. In part because of these challenging processes, costs, and experiences, many
clients form strong emotional attachments to their eggs and embryos. It is not unusual for women
and their reproductive partners to think about their eggs or embryos every day.
B. The loss of eggs results in emotional trauma.
73. Prelude and Pacific Fertility are well aware of the lengths to which people go to
obtain eggs, how much these eggs mean to their clients, the clients’ emotional investment in the
survival of the eggs, and the clients’ expectations that great care will be taken to preserve and
protect the eggs to avoid irreparable, devastating harm.
74. Eggs are precious. They offer the opportunity to fulfill one of the most
fundamental human urges: to become a parent and create one’s own family when the time is right.
75. Eggs are irreplaceable. As women age, their egg quantity and quality diminish.
The most determinative factor in IVF success is the woman’s age at the time her eggs were
Footnote continued from previous page
visited May 20, 2018).
°° In-Vitro Fertilization (IVF) Costs, Pacific Fertility Center,
https://www.pacificfertilitycenter.com/financing-fees/vitro-fertilization-ivf-costs (last visited June
13, 2018).
Stig
2g
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extracted. At some point, usually around her mid-40s, a woman can no longer produce viable
eggs. Even if additional eggs can be retrieved, one cannot replace 42-year-old eggs with 47-year-
old eggs and expect the same result. When eggs are damaged or compromised, it may be
impossible for clients to build their family as they had planned.
76. The success or failure of egg storage services has emotional and psychological
ramifications for those seeking to become parents. Losing an egg or embryo provokes fear,
devastation and despair. Many experience grief and anguish when fertility treatment does not
result in pregnancy or when they lose fertility choices. Pacific Fertility’s website itself provides
coping strategies and techniques for reducing stress.**
c, Successful egg storage depends on strict adherence to protocols.
77. Eggs are fragile and must be handled and stored carefully. Cooling, warming, and
the removal of cryoprotectants must follow precise, controlled protocols. Failure to adhere to
these protocols can kill the egg, impair viability, and introduce chromosomal abnormalities.
78. Egg storage entails preserving the reproductive material at subzero temperatures.
A key goal of cryopreservation is to reduce cell damage caused by the formation of ice crystals
and the expansion of water as cryopreserved material cools to subzero temperatures. According
to Pacific Fertility, “[t]he key to successful egg freezing is determining a technique that will not
damage the fragile chromosomes of the egg”; this is because “the chromosomes of the egg are
vulnerable to damage, including damage from the exertion of the freezing and thawing process.”*>
79. As noted above, two primary cryopreservation technologies have emerged. Both
rely upon cryoprotectants, which are solutions added to the cells that reduce cell damage by
displacing water in a manner similar to antifreeze. The first technology, slow freezing (also
known as slow programmable freezing), utilizes specialized laboratory equipment that lowers the
°3C. A. Bryson, Post IVF syndrome? Psychological implications of failed IVF, The Obstetrician
& Gynaecologist (2002),
https://obgyn.onlinelibrary.wiley.com/doi/pdf/10.1576/toag.2002.4.4.201.
4 When to See a Therapist, Pacific Fertility Center,
https://www.pacificfertilitycenter.com/treatment-care/when-to-see-a-therapist (last viewed May
20, 2018).
55 New Clinical Study: New Technique for Egg Freezing, Pacific Fertility Center (Feb. 25, 2006),
https://www.pacificfertilitycenter.con/blog/new-clinical-study-new-technique-egg-freezing.
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temperature of embryos conditioned with cryoprotectants in a slow, controlled manner to 190°C.
The second and newer technology, vitrification, refers to any process resulting in “glass
formation’”—that is, the transformation from a liquid to a hardened liquid with minimal
crystallization (ice crystals). The ultra-rapid nature of this process minimizes (1) the formation of
ice crystals and (2) toxicity damage to the cells that cryoprotectants can cause during longer
exposure to warmer temperatures.
80. The process of warming eggs that have been cryopreserved is also precise and
dependent on specialized techniques and chemical solutions. A key part of the warming
procedure is the careful dilution and eventual replacement of the toxic cryoprotectant fluid with a
solvent compatible with cytoplasmic fluid.
81. For slow-frozen tissue, the failure to thaw slowly can result in cells over-
expanding, rupturing, and dying. For vitrification, it is important to warm quickly to avoid ice
formation. Thus, it is critical that tissue cryopreserved through slow freezing be thawed slowly,
and that tissue cryopreserved through vitrification be warmed quickly.* An uncontrolled rise in
temperature, like the one at issue here, can have catastrophic consequences for eggs and embryos.
Ill. Defendants Caused Irreparable Harm to Plaintiff by Failing to Protect Her Eggs.
82. On March 4, 2018, Pacific Fertility discovered a loss of a substantial amount of
liquid nitrogen in one of its cryogenic storage tanks, Tank 4, manufactured by Chart. This
incident affected thousands of cryostored eggs and embryos and more than 400 individuals and
families, including Plaintiff.
A. Prelude and Pacific Fertility should have had systems and processes in place
to ensure that Plaintiff's eggs were not damaged.
83. Liquid nitrogen in cryostorage tanks evaporates at a slow rate. Absent extreme
circumstances, even when a leak occurs it should take days for a tank to warm enough to cause
damage to the enclosed eggs and embryos.
84. Egg and embryo storage facilities have developed and implemented a variety of
systems and proces:
s to protect against liquid nitrogen levels dropping to levels low enough to
* Vitrification, Oocyte and Embryo Vitrification, Pacific Fertility Center,
https://www.pacificfertilitycenter.com/treatment-care/vitrification (May 18, 2018).
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endanger clients’ eggs and embryos. These systems and processes include daily tank inspections,
multiple alarm systems that detect and send alerts regarding low liquid nitrogen levels, and
autofillers that detect and automatically replenish low liquid nitrogen levels.
85. Pacific Fertility promised its clients that its laboratory was state of the art,
including that its tanks were equipped with around-the-clock monitoring, alarm systems, and
response protocols as well as daily walk-throughs. But no alarms or phone alerts notified Pacific
Fertility or Prelude of the March 4 malfunction. Instead, an embryologist discovered the problem
during a routine walk-through. Staff then had to manually replenish liquid nitrogen levels in the
tank.
86. Pacific Fertility and Prelude have not explained why they did not detect the
problem during prior walk-throughs or why they did not have a functional autofilling mechanism
to replenish the low liquid nitrogen levels. Pacific Fertility and Prelude also lacked monitoring,
alarm, and response systems and processes sufficient to detect and prevent harm from a
dangerous temperature rise in Tank 4. Pacific Fertility and Prelude further failed to mitigate risk
by failing to implement a policy and practice of storing multiple eggs and embryos belonging to a
given client in separate vials and tanks.
87. Pacific Fertility stated that “independent experts have been investigating the
incident” and preliminarily determined that it “likely involved a failure of the tank’s vacuum
seal.”
88. Pacific Fertility states that tanks can go without power or liquid nitrogen for
“several days” without compromising the enclosed reproductive tissue. It is unclear why Pacific
Fertility failed to detect the problem with Tank 4 until it was too late.
89. Pacific Fertility has since stated that it had implemented new protocols—“re-
inspection of onsite storage tanks, the purchase of several emergency tanks beyond our standard
back-up tanks, and an extra layer of redundancy in our warning systems”—to avoid future loss of
eggs and embryos, steps it should have taken before the incident.
90. Wired interviewed one laboratory director who noted preventive measures Pacific
Fertility and Prelude should have taken:
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“It’s really quite sad the samples weren’t split up,” says Nahid
Turan, who directs laboratory operations at the Coriell Institute for
Medical Research, one of the oldest and largest biobanks in the US.
“They were literally putting all the eggs in one basket.” In addition
to having samples in multiple tanks at their New Jersey facility,
Coriell also has back-up sites in multiple locations around the
country. And its software engineers built real-time monitoring
systems to flag any tanks trending in a troubling direction before
they fail.”
91. Cryopreserved eggs and embryos belonging to many hundreds of other people
were stored in the same tank as Plaintiff’s. Tank 4 housed up to 15% of Pacific Fertility’s total
cryopreserved tissue, consisting of thousands of eggs and embryos.
B. Chart recalled cryostorage tanks for vacuum seal defects after the Tank 4
incident.
92. On April 23, 2018, Chart, the manufacturer of Tank 4, recalled certain cryostorage
tanks, stating in its recall notice: “Chart is presently investigating the possible cause of the
VACUUM LEAK AND/OR FAILURE which may be due to inadequate adhesion of the
composite neck to the aluminum unit” (emphasis in original). Chart added that the “issue appears
to be an isolated occurrence involving the machine and binding agent used during the
manufacturing process.”
Cc. Multiple investigations were opened after the Tank 4 incident.
93. Various government entities and trade groups have responded to the March 4,
2018, incident. The College of American Pathologists (CAP) opened and is conducting a formal
investigation into the incident, as is the State of California. The American Society for
Reproductive Medicine also is studying the incident and intends to make recommendations to its
members based on its findings.
D. Defendants’ failure to keep Plaintiffs eggs safe and secure has caused
irreparable harm.
94, On March 23, 2013, at age 38, Plaintiff Rachel Levin contracted with Defendants
°7 M. Molteni, What Keeps Egg-Freezing Operations From Failing?, Wired (Mar. 13, 2018),
https://www.wired.com/story/what-keeps-egg-freezing-operations-from-failing/.
58 AE. Cha, FAQ: Are my frozen embryos safe? Everything you need to know about the freezer
malfunctions, The Washington Post (Mar. 14, 2018), https://(www.washingtonpost.com/news/to-
your-health/wp/2018/03/14/faq-are-my-frozen-embryos-safe-everything-you-need-to-know-
given-two-fertility-clinics-recent-problems/?utm_term=.86e4¢34f31f3.
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to have her eggs preserved for future reproductive use. Based on information provided by PFC
regarding IVF success rates at her age, as well as her favorable fertility profile, she underwent
one retrieval cycle, resulting in 10 eggs. All of her eggs were viable at the time they were frozen.
She later learned that all 12 of her frozen eggs were stored in Tank 4.
95. Plaintiff Rachel Levin incurred significant costs in the retrieval and egg storage, in
excess of $12,000. The process was time-consuming, physically burdensome, and emotionally
challenging. The drug regimen was difficult; there were days that Rachel Levin did not feel well
enough to go into work. During the retrieval cycle at PFC, Rachel Levin hemorrhaged causing
her to be hospitalized for three days. She also developed hyper ovarian stimulation after the
surgery, a serious complication that caused her to be hospitalized again for a week, and she was
unable to return to work for an entire month. However, ultimately, she believed that the process
was worth it, because, as PFC stated in its marketing, she could rest easier knowing that she had
taken measures toward her goal of having children when the time was right.
96. Plaintiff Rachel Levin has regularly and timely paid the fees for continued
cryostorage of the eggs.
97. Atall relevant times thereafter, Plaintiff's eggs were under Defendants’ protection,
custody, and control. Defendants kept Plaintiff's eggs frozen within a steel storage tank
containing liquid nitrogen at their San Francisco laboratory facility on Francisco Street.
98. Thousands of frozen eggs and embryos belonging to more than 400 patients were
stored in the same tank.
99. On information and belief, PFC does not have a policy or practice to place
patient’s eggs or embryos in different tanks to ensure that at least some tissue would be safe in the
event that one tank fails.
100. In other words, it appears that for a given IVF round, PFC stores all of a patient’s
eggs in the same proverbial basket. That was indeed the case for Rachel Levin.
101. On or around March 12, 2018, Plaintiff Rachel Levin learned for the first time that