THE PRICE TAG ON DESIGNER BABIES: MARKET SHARE LIABILITY

319

THE PRICE TAG ON DESIGNER BABIES:

MARKET SHARE LIABILITY

Abstract: The prospect of genetically modifying humans has loomed over the pub-

lic for decades. Now, science fiction is becoming reality. New technology and ex-

panding research are positioned to make genetic alteration a routine, pre-concep-

tion appointment. For several years, China has been experimenting with germline

editing on non-viable human embryos. In April 2016, the UK also approved a

group of scientists to begin similar research. In the United States, genetic engineer-

ing is a multibillion-dollar industry. Although ethical debates over human genetic

modification have checked the industry, the potential for clinical trials has become

a reality as companies race to dominate the technology. In light of the potential im-

pact of problematic genetic alterations on future generations, the harm inflicted on

victims parallels the Diethylstilbestrol cases of the 1980s, signaling a re-emergence

of market share liability.

INTRODUCTION

Genetically modified humans have been the source of Hollywood, dysto-

pian science-fiction plot lines, yet such advancements are now the reality of

today’s headlines.

On February 9, 2016, former United States Director of Na-

See, e.g., Stephen S. Hall, The First Tinkering with Human Heredity May Happen in the Infertil-

ity Clinic,

315 SCIENTIFIC AMERICAN 54, 54–61 (2016); John Harris & Marcy Darnovsky, Pro and

Con: Should Gene Editing Be Performed on Human Embryos?, N

AT’L GEOGRAPHIC (Aug. 2016)

https://www.nationalgeographic.com/magazine/2016/08/human-gene-editing-pro-con-opinions/

[https://perma.cc/9KGV-K2Q4]; Heidi Ledford, Riding the CRISPR Wave, 531 N

ATURE 156, 156–59

(2016); Fraser Nelson, The Return of Eugenics, S

PECTATOR (Apr. 2, 2016) https://www.spectator.

co.uk/2016/04/the-return-of-eugenics/ [https://perma.cc/7F2N-53BE]; Alice Park, A New Technique

That Lets Scientists Edit DNA Is Transforming Science—And Raising Difficult Questions, T

IME (Jun.

23, 2016) http://time.com/4379503/crispr-scientists-edit-dna/ [https://perma.cc/B3Q3-7XWJ]; Alice

Park et al., How the Science CRISPR Can Change Your Genes, T

IME (Jun. 23, 2016) http://time.com/

4377130/crispr-genome-editing/ [https://perma.cc/FQL8-D9YE]; Jason Pontin, Editing Human DNA,

MIT

TECH. REV. (Apr. 21, 2015), https://www.technologyreview.com/s/536696/editing-human-dna/

[https://perma.cc/7TTE-FNJE]; Sara Reardon, The CRISPR Zoo, 531 N

ATURE 160, 160–63 (2016);

Michael Specter, How the DNA Revolution Is Changing Us, N

AT’L GEOGRAPHIC (Aug. 2016)

https://www.nationalgeographic.com/magazine/2016/08/dna-crispr-gene-editing-science-ethics/

[https://perma.cc/GJU7-MTL7]; Michael Specter, The Gene Hackers, N

EW YORKER (Nov. 16, 2015),

https://www.newyorker.com/magazine/2015/11/16/the-gene-hackerS [https://perma.cc/CYR2-PAD8];

ATTACA (Columbia Pictures 1997) (portraying a world where humans can be genetically modified

pre-birth for physical, mental, and emotional enhancements); Genome Editing: The Age of the Red

Pen,

ECONOMIST (Aug. 22, 2015), https://www.economist.com/news/briefing/21661799-it-now-easy-

edit-genomes-plants-animals-and-humans-age-red-pen [https://perma.cc/34NW-4CRE]; Human Gene

Editing: A Timeline of CRISPR Cover Stories, C

TR. FOR GENETICS & SOC’Y (Sept. 20, 2016), https://

www.geneticsandsociety.org/internal-content/human-gene-editing-timeline-crispr-cover-stories

[https://perma.cc/K8WG-ZNAP] (collecting headlines with CRISPR cover stories).

320 Boston College Law Review [Vol. 59:319

tional Intelligence, James Clapper, categorized genome editing as a “weapo[n]

of mass destruction and proliferation.”

In the Worldwide Threat Assessment of

the US Intelligence Community report, Clapper stated that new technology has

realized the possibility that flawed heritable human genetic alterations may

result from manipulation of the human genome through “deliberate or uninten-

tional misuse.”

The report added a caveat that the complexity of the human

genome still poses a limit on the ability of researchers to manipulate the ge-

nome effectively.

Nonetheless, the technology is available.

The past few years—2015 in particular—have seen the emergence of

simple, precise, and affordable DNA altering techniques.

These techniques

include the use of clustered regularly interspaced short palindromic repeats

(“CRISPR”) and the enzyme, protein-9 nuclease (“Cas9”).

Using CRISPR-

Cas9, scientists can effectively and efficiently alter the human germline.

“Human germline editing” involves targeting DNA in human sperm, eggs, or

embryos that is passed on to future generations through normal reproduction.

The potential benefits of germline editing to human society are enormous.

JAMES R. CLAPPER, SENATE ARMED SERVS. COMM., WORLDWIDE THREAT ASSESSMENT OF

THE

US INTELLIGENCE COMMUNITY 9 (Feb. 9, 2016), https://www.armed-services.senate.gov/imo/

media/doc/Clapper_02-09-16.pdf [https://perma.cc/NH7Q-J42E]; Antonio Regalado, Top U.S. Intelli-

gence Official Calls Gene Editing a WMD Threat, MIT

TECH. REV. (Feb. 9, 2016), https://www.

technologyreview.com/s/600774/top-us-intelligence-official-calls-gene-editing-a-wmd-threat/ [https://

perma.cc/KL4D-JEUQ].

CLAPPER, supra note 2, at 9 (explaining that gene altering technology is rapidly progressing,

and misuse of the technology in humans might lead to spreading heritable diseases or defects).

See id. (noting that researchers will “probably” run into problems wielding this technology

because of genome complexity, but providing little explanation as to why this is so).

See id.; Regalado, supra note 2 (explaining how CRISPR is expected to advance gene treatment

for diseases).

See Fathima Benazir & Gowlikar Abhinayani, CRISPR/Cas9 Technology: A New Boon in Ge-

nome Editing, 7 I

NT’L J. PHARMACEUTICAL SCI. & RES. 3336, 3336 (2016) (showcasing other genetic

editing technology as compared to CRISPR-Cas9). For instance, zinc finger nucleases (“ZFN”) was the

first genome altering method to use proteins. Id. at 3338. Transcription activator-like effector of nucleas-

es (“TALEN”) is a gene editing method that relies on data gathered from repetitive protein repeats and

nucleotide sequences. Id. at 3341. On the other hand, CRISPR-Cas9 editing technology is more simple

and precise than both ZFN and TALEN because rather than using an engineered protein, edits are made

using a small sequence of guide RNA. Id. at 3336; see also Antonio Regalado, Everything You Need to

Know About CRISPR Gene Editing’s Monster Year, MIT

TECH. REV. (Dec. 1, 2015), https://www.

technologyreview.com/s/543941/everything-you-need-to-know-about-crispr-gene-editings-monster-

year/ [https://perma.cc/J3NL-KU8W] (describing the innovative features of CRISPR-Cas9 gene edit-

ing technology).

Benazir & Abhinayani, supra note 6, at 3338–39 (detailing the use of Cas9 enzymes to alter

gene sequences identified as threats on the CRISPR locus by guide RNA).

See Regalado, supra note 6 (describing the widespread availability of CRISPR-Cas9 and use of

CRISPR-Cas9 to make beagles more muscular and mosquitoes malaria resistant).

Id.

See Heidi Ledford, CRISPR Fixes Disease Gene in Viable Human Embryos, 548 NATURE 13,

13–14 (2017) (describing an international research team’s success using CRISPR to reverse a muta-

tion in a human embryo that is the primary cause of death in young athletes–hypertrophic cardiomyo-

2018] The Price Tag on Designer Babies: Market Share Liability 321

Researchers are hopeful that they can reduce—or eliminate—the risk of herit-

able diseases such as Huntington’s disease.

Likewise, researchers want to

introduce beneficial genes to strengthen one’s body and prolong good health.

Nonetheless, CRISPR-Cas9 is not a magic bullet.

According to Dr.

Keith Joung, a renowned pathologist at the Massachusetts General Hospital

and Harvard Medical School, more research is needed to reduce off-target gene

editing before CRISPR-Cas9 can be used in clinical applications.

“Off-

targets” occur when the splicing enzyme matches the designated sequence to

the wrong gene causing potentially disastrous side-effects.

For instance, an

off-target impact may result in creating a higher likelihood of a future cancer

diagnosis.

While scientists remain hopeful that they will be able to more ac-

curately assess the risk of unintended editing through advancing technology,

the effects remain unclear for now.

Off-target gene altering may create unin-

tended and uncertain changes in a gene pool that could last for generations.

One major difficulty with off-target editing is creating a legal scheme that

will compensate victims whose symptoms may not appear for generations.

pathy); David Warmflash, How Will We Use Gene Editing to Treat Human Disease?, GENETIC LIT-

ERACY

PROJECT (Sept. 12, 2016), https://www.geneticliteracyproject.org/2016/09/12/will-use-gene-

editing-treat-human-disease/ [https://perma.cc/U8SL-L593] (explaining the potential for genetic engi-

neering to fix a person’s inherited abnormal gene pair so that a disease never manifests itself).

Warmflash, supra note 10 (explaining how Huntington’s disease could be erased from a child’s

embryo by replacing the abnormal allele sequence).

Eric S. Lander, Brave New Genome, 373 NEW ENG. J. MED. 5, 7 (2015) (researching the possi-

bility of adding a gene to increase one’s oxygen count for endurance).

See generally Yanfang Fu et al., High-Frequency Off-Target Mutagenesis Induced by CRISPR-

Cas Nucleases in Human Cells, 31 N

ATURE BIOTECHNOLOGY 822 (2013) (studying the unpredictable

nature of CRISPR-Cas9 on human cells that are not targeted for gene modification).

See Sharon Begley, Do CRISPR Enthusiasts Have Their Head in the Sand About the Safety of

Gene Editing?, S

TAT (July 18, 2016), https://www.statnews.com/2016/07/18/crispr-off-target-effects/

[https://perma.cc/9YG5-EB46] (questioning the safety and clinical readiness of CRISPR-Cas9 in light

of research showing that scientists underestimate the frequency of off-target genetic impacts); Fu et

al., supra note 13, at 1 (providing Dr. Joung’s credentials at Harvard Medical School and Massachu-

setts General Hospital).

Begley, supra note 14.

See id. (quoting Dr. Joung, from the Massachusetts General Hospital, that off-target impacts

“var[y] by ethnic group” and that the unpredictable nature of the off-targets is a problem scientists are

ignoring).

See id. (describing scientist Dr. Bill Lundberg, from the large genome-editing company

CRISPR Therapeutics, as confident that algorithms will display the risk of inaccuracies and improve

single-guide RNA to reduce those risks).

See Lander, supra note 12, at 7 (expressing the inability to “recall” a defective gene from the

human gene pool); Jim Kozubek, How Gene Editing Could Ruin Human Evolution, T

IME (Jan. 9,

2017), http://time.com/4626571/crispr-gene-modification-evolution/ [https://perma.cc/2CRK-KRZ6]

(warning that genetic manipulation of the human germline may simultaneously strip humans of genes

with harmful mutations but that are also essential for human environmental adaptation).

See Sarah Ashley Barnett, Regulating Human Germline Modification in Light of CIRSPR, 51

RICH. L. REV. 553, 568–69 (2017) (explaining that scientists are unlikely to fully understand how

322 Boston College Law Review [Vol. 59:319

The Diethylstilbestrol (“DES”) drug from the 1980s was a drug prescribed to

pregnant women who, years later, suffered from cervical cancer and passed on

this genetic predisposition and other health issues to their daughters.

DES

cases provide a useful framework for addressing generational products liabil-

ity.

They also demonstrate the need to establish a streamlined theory of re-

covery before cases arise.

The potential for market share liability incentivizes

genetic manufacturers to anticipate and limit their liability before entering the

market.

Part I of this Note explores the expanding germline editing field and the po-

tential risks inherent in human genetic modifications.

It also assesses the DES

cases to provide insight on how courts have implemented generational tort prod-

ucts liability in the past.

Part II analyzes the development of market share lia-

bility across the DES cases and how it is analogous to germline engineering lia-

bility.

Part III draws from the successes and failures of the DES cases to pro-

pose a market share liability regime for generational germline editing cases.

HUMAN GERMLINE EDITING AND TORT PRODUCTS LIABILITY

Human germline editing is a 2018 reality.

In addition to the fierce ethi-

cal debate about whether germline editing is moral or beneficial, society needs

off-target effects will present themselves in humans until clinical trials take place, which poses huge

problems since CRISPR-Cas9 can lead to generations of unintended genetic changes).

DES History, CTRS. FOR DISEASE CONTROL, https://www.cdc.gov/des/consumers/about/

history.html [https://perma.cc/RN6D-A4FN] (recounting the history and legacy of DES).

Naomi Sheiner, Comment, DES and a Proposed Theory of Enterprise Liability, 46 FORDHAM

L. REV. 963, 995–96 (1978) (recommending a new theory of tort liability based on market share so

that DES victims could recover despite not knowing which specific defendant caused the harm). In

fact, the California Supreme Court adapted this student’s Comment recommendation to extend liabil-

ity to DES manufacturers on a proportional scheme for recovery. See Sindell v. Abbott Labs., 607

P.2d 924, 937 (Cal. 1980).

See Sheiner, supra note 21, at 1007 (cautioning future courts of the problems modern technolo-

gy may create when a gap in tort law precludes recovery for harmed consumers).

See id. at 1005 (stating that increased liability by virtue of market share liability should result

in 1) companies maintaining better records in order to demonstrate their innocence from an accusation

of wrongdoing, and 2) companies retaining insurance for cases in which innocence cannot be proven).

See infra notes 28–87 and accompanying text.

See infra notes 88–122 and accompanying text.

See infra notes 123–179 and accompanying text.

See infra notes 180–242 and accompanying text.

See Lydia Ramsey, A Revolutionary Gene-Editing Technology Is on Track to Be a $10 Billion

Market by 2025, B

US. INSIDER (Nov. 2, 2017), http://www.businessinsider.com/crispr-set-to-be-a-10-

billion-market-by-2025-citi-2017-11 [https://perma.cc/8MDB-N5JW] (citing Disruptive Innovations

V: Ten More Things to Stop and Think About, C

ITI, (Nov. 2017), https://ir.citi.com/uims9KeGQB

xXr2JWqUOQjpNwL9HlVE9xT6rG0XYhQI%2BlmtfIYoLJ16k%2BJB%2FT48WZqbCUF2pD

gc0%3D [https://perma.cc/G5T5-H53D] (predicting that CRISPR-Cas9 will grow to a $10 billion

dollar industry, and that CRISPR-based medicine will enter the market in about six years); Human

Gene Editing: A Timeline of CRISPR Cover Stories, supra note 1 (illustrating the nearing possibility

and technological breakthroughs of human germline editing through recent cover stories and articles).

2018] The Price Tag on Designer Babies: Market Share Liability 323

a liability scheme for unintended gene editing effects.

Courts have dealt with

a similar issue of unpredictable generational liability through tort litigation.

For instance, germline editing’s impact on successive generations resembles

the DES cases involving birth defects from the 1940s and 1970s that are still

being litigated today.

The DES cases impart important lessons for allocating

tort liability moving forward.

This Part describes the history and recent breakthrough behind the new

gene editing technology—CRISPR-Cas9—and how market share liability

emerged in response to DES victims.

Section A explains how CRISPR-Cas9

technology is used and regulated, and discusses potential mishaps with the

technology.

Section B analyzes the history of DES and the rise of market

share liability in response to harms that do not manifest for decades but last for

generations.

A. Human Germline Editing

1. Recent Technology Developments Involving CRISPR-Cas9

Praised as Science’s “2015 Breakthrough of the Year,” CRISPR-Cas9

gives researchers the tools to edit genes in the human germline with remarka-

ble precision.

This breakthrough was the result of scientists studying the in-

See Sarah Karlin, Gene Editing: The Next Frontier in America’s Abortion Wars, POLITICO

(Feb. 16, 2016), http://www.politico.com/story/2016/02/gene-editing-abortion-wars-219230 [https://

perma.cc/8BAL-M683] (explaining how the contentious debate on whether to modify genes may unite

both pro-life and pro-choice advocates but for varying policy reasons, and that the technology is sus-

ceptible to “catastrophic errors”).

See Sindell v. Abbott Labs., 607 P.2d 924, 937 (Cal. 1980) (applying market share liability for

recovery from DES injuries); Bichler v. Eli Lilly & Co., 436 N.Y.S.2d 625, 625 (App. Div. 1981)

(using market share liability to award future compensation damages for cancer arising from DES

ingestion).

See Settlement Reached in Eli Lilly Pregnancy Drug Linked to Breast Cancer Case, CBS NEWS

(Jan. 9, 2013), http://www.cbsnews.com/news/settlement-reached-in-eli-lilly-pregnancy-drug-linked-

to-breast-cancer-case/ [https://perma.cc/U2KG-XNGH] (stating there are over fifty-one women with

pending DES cases in the U.S. District Court for the District of Massachusetts). Negative health ef-

fects from both germline genetic modification and DES exposure can be passed on to generations of

children. Compare Sindell, 607 P.2d at 936 (bringing suit for DES injuries in children), with Karlin,

supra note 29 (describing the potential for scientists to edit the human germline and “tinker with the

human race”).

See Sheiner, supra note 21, at 1003 (arguing for courts to consider, for the first time, the appli-

cation of enterprise liability as a means of recovery for DES victims because the latency period of the

drug effectively precluded normal tort recovery); Settlement Reached in Eli Lilly Pregnancy Drug

Linked to Breast Cancer Case, supra note 31 (finding that the numerous pending DES cases and that

proof of DES injury by a specific defendant serve as some of the greatest legal barriers).

See infra notes 36–122 and accompanying text.

See infra notes 36–87 and accompanying text.

See infra notes 88–122 and accompanying text.

Marcia McNutt, Editorial, Breakthrough to Genome Editing, 350 SCI. 1445, 1445 (2015) (de-

claring CRISPR gene editing technology to be the scientific breakthrough of the year “poised to revo-

324 Boston College Law Review [Vol. 59:319

teractions between bacteria and viruses and using their same natural defenses

to target specific genes.

Bacteria and viruses differ in that bacteria are more

complex and can live on their own, whereas, viruses are much smaller and re-

quire a host cell in order to survive.

Viruses invade bacteria cells by attaching

and inserting its genetic DNA or RNA into it.

If the bacteria does not recog-

nize it as foreign DNA, it will begin reproducing the viral DNA or RNA until it

explodes, thereby, creating more viruses.

“CRISPR” describes sections of

DNA that serve as part of the bacteria’s immune system to protect itself against

viruses that it has previously encountered.

But, if a bacterium is re-infected

with a virus, the CRISPR memory sequences will trigger the bacterium to re-

lease a cutting enzyme that fastens itself to the genes of the virus and removes

the genes from the bacteria’s genome.

lutionize research”). Science articles and journals are sponsored by the American Association for the

Advancement of Science (“AAAS”), which is comprised of over 262 scientific societies and is the

oldest general science organization. About Science & AAAS, S

CI. (Nov. 17, 2017), http://www.

sciencemag.org/about/about-science-aaas [https://perma.cc/V9BL-V95Z]. As opposed to “gene thera-

py”, which also uses CRISPR-Cas9 and other gene editing technology, germline engineering is herita-

ble, thus it passes on the modified genes. Antonio Regalado, Engineering the Perfect Baby, MIT

TECH. REV. (Mar. 5, 2015), https://www.technologyreview.com/s/535661/engineering-the-perfect-

baby/ [https://perma.cc/NA2P-A4QR]. In contrast, gene therapy allows scientists to target defective

cells for repair but the repair is not heritable. See id.; see also Kenneth W. Krause, CRISPR-Cas9 Not

Just Another Scientific Revolution (Special Report), D

OTING SKEPTIC (Feb. 2016), https://thedoting

skeptic.wordpress.com/2016/02/06/crispr-cas9-not-just-another-scientific-revolution/ [https://perma.

cc/W4YY-U78V] (expressing the pros and cons of the rapidly advancing germline editing technolo-

gy). Currently, there is a patent debate on who owns the rights to the recent innovations in CRISPR.

See generally Kristin Beale, The CRISPR Patent Battle: Who Will Be “Cut” Out of Patent Rights to

One of the Greatest Scientific Discoveries of Our Generation?, 2016

B.C. INTELL. PROP. & TECH. F.

1, http://bciptf.org/wp-content/uploads/2016/02/KBeale-CRISPR.pdf [https://perma.cc/TK99-Y63Y]

(analyzing the patent debate over CRISPR-Cas9). The debate is between Jennifer Doudna of the Uni-

versity of California, Berkeley, and Dr. Feng Zhang of the Broad Institute and MIT, who each claim they

developed CRISPR first. See id. at 2.

See Krause, supra note 36 (explaining how CRISPR-Cas9 functions by utilizing the cell’s natural

functions and merely engineers them to cut specific strands identified by the researcher).

Bacteria vs. Virus, DIFFEN (Nov. 18, 2017), http://www.diffen.com/difference/Bacteria_vs_

Virus [https://perma.cc/MX2Z-4BQA].

Id. (explaining that a virus attaches to a cell using its legs and thereafter injects its genetic ma-

terial into the cell to either produce proteins immediately, or to be stored in the RNA or DNA and

triggered at a later time).

Id.

Krause, supra note 36. Scientists observed that bacteria retain small segments of virus DNA it has

previously encountered and separates them to form a repetition of “clustered regularly interspaced short

palindromic repeats”. Id.

Antonio Regalado, Can CRISPR Save Ben Dupree?, MIT TECH. REV. (Oct. 17, 2016), https://

www.technologyreview.com/s/602491/can-crispr-save-ben-dupree/ [https://perma.cc/W69C-H6CP].

Sometimes a protein will incorporate an invading virus’s DNA into its genetic makeup in the form of

non-coding RNA in order to identify and stop viruses attempting to invade the bacteria. Alex B. Berezow,

Bacteria Have Immune Systems, Too, R

EALCLEAR SCI. (Sept. 6, 2012), http://www.realclearscience.

com/blog/2012/09/bacteria-have-immune-systems-too.html [https://perma.cc/RU4B-JLGP]. Non-

coding RNA allows the bacteria to function as usual without performing the detrimental instructions the

2018] The Price Tag on Designer Babies: Market Share Liability 325

As opposed to other gene editing methods, like zinc finger nucleases

(“ZFN”) and transcription activator-like effector of nucleases (“TALEN”),

CRISPR-Cas9 is more precise, simple, and affordable.

Both ZFN and

TALEN require more complicated processes using a customized protein rather

than a short RNA sequence.

By contrast, scientists using CRISPR can encode

a single guide RNA with the proper gene sequence for editing.

The Cas9 en-

zyme will read the RNA and make the genetic cuts.

Unlike traditional gene

editing methods, CRISPR-Cas9 increases efficiency by allowing scientists to

alter multiple genome sites at once.

This technology is both readily available

and simple; a scientist can edit a DNA strand for a mere sixty-five dollars.

2. Current Uses and Regulations of Human Germline Editing

In an outpouring of recent experiments, the CRISPR-Cas9 methodology

has enabled scientists to treat muscular dystrophy in mice, counteract drug-

resistance in insects, increase physical strength in dogs, generate virus-resistant

pigs, and modify crops for greater protection.

In April 2015, Chinese re-

virus inserted. Id. If the same viral DNA is inserted into the bacteria, the non-coding RNA serves as an

alarm system to notify the bacteria that a foreign invader has entered and that it must rid itself of the

material immediately. Id. Specifically, the Cas-9 protein is the enzyme from the bacterium Streptococcus

pyogenes used to initiate the cutting technique that scientists have discovered makes the gene editing

process much easier. Benazir & Abhinayani, supra note 6, at 3338.

See Josiah Zayner, DIY CRISPR Kits, Learn Modern Science by Doing, INDIEGOGO (Nov. 18,

2017), https://www.indiegogo.com/projects/diy-crispr-kits-learn-modern-science-by-doing#/ [https://

perma.cc/4A3Y-KHAF] (selling CRISPR kits online for a mere seventy-five dollars, and advertising

that “everyone” can follow the instructions and genetically engineer bacteria). Other gene editing

methods include zinc finger nucleases and transcription activator-like effector of nucleases. Krause,

supra note 36. The CRISPR-Cas9 methods only require three components: the CRISPR RNA and a

trans-activating RNA which signal the Cas9 enzyme to cut the specific sequence. Id.

Benazir & Abhinayani, supra note 6.

Krause, supra note 36. Deoxyribonucleic acid (DNA) and ribonucleic acid (RNA) both hold

genetic information, but DNA is double stranded while RNA is single stranded, and they have differ-

ent roles in the body. Anne Marie Helmenstine, The Differences Between DNA and RNA,

HOUGHTCO. (Aug. 3, 2017), https://www.thoughtco.com/dna-versus-rna-608191 [https://perma.

cc/DNL8-G4TG]. DNA carry and transfer genetic information throughout the body. Id. RNA codes

directly for amino acids and transfers protein-making information from DNA to ribosomes. Id.

Regalado, supra note 42.

Krause, supra note 36 (explaining the simplicity of CRISPR-Cas9 in that it only requires three

components which can alter multiple sites on the genome from one application).

See Krause, supra note 36 (explaining how a scientist can create a single guide RNA with the

sequence of DNA it wants to splice, order it from a manufacturer for sixty-five dollars, and wait for

mail delivery).

John Travis, Making the Cut, 350 SCI. 1456, 1456–57 (2015) (describing another experiment

where scientists wiped out populations of mosquitos by making them infertile and created malaria-

resistant mosquitos); Fiona MacDonald, 10 Things You Need to Know About the UK Allowing Genetic

Modification of Human Embryos, S

CI. ALERT (Feb. 2, 2016), http://www.sciencealert.com/10-things-

you-need-to-know-about-the-uk-s-decision-to-allow-genetic-modification-of-human-embryos [https://

perma.cc/7PWB-R5DW] (describing a recent regulation by the UK Human Fertilisation and Embry-

ology Authority sanctioning an experiment on germline-editing of human embryos); Regalado, supra

326 Boston College Law Review [Vol. 59:319

searchers shocked the world by becoming the first to use CRISPR-Cas9 to edit

human embryos.

In 2017, researchers in the United States also edited human

embryos using CRISPR-Cas9.

The moral dilemma surrounding human genet-

ic editing has remained a heated issue.

About five hundred scientists gathered

in Washington D.C. in 2015 for the International Summit on Human Gene Ed-

iting.

The Summit established a worldwide consensus to prohibit human

germline clinical trials using this technology.

While the Summit agreed that

research was “clearly needed and should proceed,” it also concluded that it

would be “irresponsible” to create a genetically engineered human at such an

early stage of research, citing safety and moral concerns.

In contrast to this

2015 worldwide consensus, the National Academy of Sciences, Engineering,

and Medicine, in February 2017, expressed its support for editing a child’s

germline under a strict regulatory framework: the circumstances require the

note 6 (highlighting the important nature of genetically edited crops compared to classically genetical-

ly modified crops, like corn, in that Federal Drug Administration (“FDA”) regulations may not apply

since genes from bacteria are not introduced and instead the plant’s genes are spliced themselves).

See Puping Liang et al., CRISPR/Cas9-Mediated Gene Editing in Human Tripronuclear Zy-

gotes, 6 P

ROTEIN & CELL 363, 363 (2015) (detailing a study that replaced the gene for a blood disor-

der (β-thalassaemia) in twenty-eight out of seventy-one non-viable human embryos); Sara Reardon,

Ethics of Embryo Editing Paper Divides Scientists, N

ATURE (Apr. 24, 2015) http://www.nature.

com/news/ethics-of-embryo-editing-paper-divides-scientists-1.17410 [https://perma.cc/8VWE-QDPE]

(commenting on the intense ethical debate surrounding genetically modifying human embryos).

See Hona Ma et al., Correction of a Pathogenic Gene Mutation in Human Embryos, 548 NA-

TURE

413, 414–15 (2017) (editing MYBPC3 mutations from human embryos using CRISPR-Cas9 in

order to eliminate the gene for myocardial disease, HCM); Steve Connor, First Human Embryos Edit-

ed in U.S., MIT

TECH. REV. (July 26, 2017), https://www.technologyreview.com/s/608350/first-

human-embryos-edited-in-us/ [https://perma.cc/4XLW-HMDY] (proclaiming that scientists in Port-

land, Oregon used CRISPR-Cas9 to edit a gene mutation in human embryos that causes a harmful

heart disease).

See generally Michael Gross, Bacterial Scissors to Edit Human Embryos?, 25 CURRENT BIOL-

OGY

MAG. R439 (2015) (reviewing the negative public response to recent developments in germline

editing technology). On March 19, the International Society for Stem Cell Research called for “a mor-

atorium on attempts” to edit the genome in clinical applications. Id. at R441. They reasoned that the

technology was too insecure and that current research “lack[s] an adequate understanding of the safety

and potential long-term risks of germline genome modification.” Id. Also, the International Bioethics

Committee of UNESCO has recently amended their report on the Human Genome asking for a mora-

torium on human germline engineering. See About Human Germline Gene Editing, C

TR. FOR GENET-

ICS

& SOC’Y (July 9, 2015) http://www.geneticsandsociety.org/article.php?id=8711 [https://perma.

cc/W99Y-HJ4Q].

Rob Stein, Scientists Debate How Far to Go in Editing Human Genes, NPR (Dec. 3, 2015),

http://www.npr.org/sections/health-shots/2015/12/03/458212497/scientists-debate-how-far-to-go-in-

editing-human-genes [https://perma.cc/A675-RF6E].

See id.

Id. see also Open Letter Calls for Prohibition on Reproductive Human Germline Modification,

TR. FOR GENETICS & SOC’Y (Nov. 2015), http://www.geneticsandsociety.org/article.php?id=8999

[https://perma.cc/YM6B-PGXZ] (publishing an open letter signed by over 100 scientists calling for a

prohibition on human germline modification because “the creation of ‘genetically modified humans’ or

‘designer babies’” has the potential to “irrevocably alter the nature of the human species and society”).

2018] The Price Tag on Designer Babies: Market Share Liability 327

procedure to be reviewed and the child to be monitored periodically for gener-

ations.

As scientists continue to debate the ethical questions of human genetic

modification, some countries maintain loose regulations on the practice while

at least twenty-five countries have prohibited human germline engineering en-

tirely.

China has created “guidelines”—but not laws—regulating the industry,

and Japan, Mexico, and South Africa, have ambiguous policies about whether

or not human germline editing research is allowed.

In contrast, Canada, Bra-

zil, Germany, and Australia do not allow human germline genetic experimenta-

tion at all.

In 2016, the British Human Fertilization and Embryology Authori-

ty (“HFEA”) granted the first license by a national regulator for scientists to

edit the human germline using human embryos for research.

In the United States, there is no federal ban on germline engineering and

the government only places restrictions on the practice.

In 2015, Congress

passed the United States Federal Omnibus Bill, which prohibits any Federal

Drug Administration (“FDA”) funding to be given to research on human

germline genetic engineering.

The National Institutes of Health (“NIH”)

manages funding of gene transfer research through the Recombinant DNA Ad-

visory Committee (“RAC”).

The RAC’s current stance is that it is too soon

for companies to perform germline gene edits on human embryos.

The FDA

regulates the industry for all gene modifications performed in clinical trials.

Harald König, The Illusion of Control in Germline-Engineering Policy, 35 NATURE BIOTECH-

NOLOGY

502, 503 (describing the National Academy of Sciences, Engineering, and Medicine’s con-

tingent support for germline engineering); Amy Harmon, Human Gene Editing Receives Science Pan-

el’s Support, N.Y.

TIMES (Feb. 14, 2017), https://www.nytimes.com/2017/02/14/health/human-gene-

editing-panel.html [https://perma.cc/S9HD-YJ36] (describing the National Academy of Sciences,

Engineering, and Medicine’s decision to support, in extenuating circumstances, the need to edit a

child’s germline).

Melanie Senior, UK Funding Agencies Weigh in on Human Germline Editing, 33 NATURE

BIOTECHNOLOGY 1118, 1119 (2015) (analyzing the procedures and regulations that countries have

imposed on human germline engineering).

See König, supra note 56, at 504 (charting the different national and international policies on

germline engineering research and clinical trials).

Id.

MacDonald, supra note 49.

König, supra note 56, at 504; see also Heidi Ledford, Where in the World Could the First

CRISPR Baby Be Born?, N

ATURE (Oct. 13, 2015), http://www.nature.com/news/where-in-the-world-

could-the-first-crispr-baby-be-born-1.18542 [https://perma.cc/9VGL-AMB2] (describing United

States policies towards germline engineering).

About Human Germline Gene Editing, supra note 52.

Barnett, supra note 19, at 577.

Id. at 579. The director of the NIH issued a statement that the safety and ethical consequences

of genetically editing human embryos is too uncertain to approve any current clinical trials. Francis S.

Collins, Statement on NIH Funding of Research Using Gene-editing Technologies in Human Embry-

os, N

AT’L INSTS. HEALTH (Apr. 28, 2015), https://www.nih.gov/about-nih/who-we-are/nih-director/

statements/statement-nih-funding-research-using-gene-editing-technologies-human-embryos.

Barnett, supra note 19, at 578.

328 Boston College Law Review [Vol. 59:319

Although the FDA would most likely regulate genetically modifying humans

in the U.S., it does not officially ban potential clinical application.

The biotechnology industry for genome editing is expanding rapidly be-

cause of revolutionary technology like CRISPR-Cas9.

In May 2015, Mar-

ketsandMarkets published a report predicting that the genome editing market

will be worth $3.5 billion in just four years.

In Boston, three start-up compa-

nies have partnered with pharmaceutical companies such as Bayer and Novar-

tis and raised an aggregated $1 billion.

In fact, the pharmaceutical giant No-

vartis has funded and contracted with the biotechnology start-up Intellia to de-

velop CRISPR techniques to treat cancer and to research “limited in vivo” ap-

plications of the technology.

A large concern with gene editing is that companies will exploit CRISPR-

Cas9 to perform risky experiments since it is cheap, simple, and yields high

rewards.

Sir Venki Ramakrishnan, the 2009 Nobel prize winner in chemistry,

echoes the fears of many in the scientific community that “once a technology

is feasible, we may well regulate it, but someone somewhere may start using it

in ways we consider unethical.”

With such technology at their fingertips,

Ledford, supra note 61 (explaining that the FDA does not directly state whether or not clinical

applications are banned).

Genome Editing Market Worth $3,514.08 Million by 2019, PR NEWSWIRE (May 7, 2015),

http://www.prnewswire.com/news-releases/genome-editing-market-worth-351408-million-by-2019-

502930301.html [https://perma.cc/TCS2-N9Q2]. Already, start-up company Editas has made an an-

nouncement that it hoped to use CRISPR technology to edit human DNA to treat blindness in 2017.

Antonio Regalado, CRISPR Gene Editing to Be Tested on People by 2017, Says Editas, MIT

TECH.

REV. (Nov. 5, 2015), https://www.technologyreview.com/s/543181/crispr-gene-editing-to-be-tested-

on-people-by-2017-says-editas/ [https://perma.cc/N75R-GPSB]. While the plans are to perform clini-

cal trials in gene therapy and not germline, they still discuss the rapid development of the industry in

applying CRISPR to modify human DNA. See id.

Genome Editing Market Worth $3,514.08 Million by 2019, supra note 67 (projecting the mar-

ket growth of the genome editing market and listing the following companies as industry leaders:

GenScript USA Inc. (U.S.), Horizon Discovery Group plc (U.K.), Integrated DNA Technologies, Inc.

(U.S.), Lonza Group Ltd. (Switzerland), New England Biolabs, Inc. (U.S.), OriGene Technologies,

Inc. (U.S.), Sangamo Biosciences, Inc. (U.S.), Sigma-Aldrich Corporation (U.S.), Thermo Fisher

Scientific, Inc. (U.S.), and Transposagen Biopharmaceuticals, Inc. (U.S.)).

Regalado, supra note 42.

7 Gene Editing Companies Investors Should Watch, NANALYZE (Apr. 25, 2015), http://www.

nanalyze.com/2015/04/7-gene-editing-companies-investors-should-watch/ [https://perma.cc/8JH2-

2VCQ].

See Amy Dockser Marcus & Joe Palazzolo, Breakthrough Gene Technology Attracts Investors

Amid Patent Dispute, W

ALL STREET J. (Sept. 22, 2016), https://www.wsj.com/articles/breakthrough-

gene-technology-attracts-investors-amid-patent-dispute-1474567512?mod=briefly_more_on [https://

perma.cc/2PNW-BKBB] (explaining the “messy” nature of CRISPR-Cas9’s patent dispute and how

companies are responding by licensing from both sides, or using the gene editing technology without

a license until the issue is resolved).

Ian Sample, Genetic Engineering of Humans Has Great Potential, Says Nobel Winner, THE

GUARDIAN (May 23, 2016), https://www.theguardian.com/science/2016/may/24/genetic-engineering-

humans-great-potential-nobel-winner [https://perma.cc/799L-LT69] (quoting British scientist, Sir

2018] The Price Tag on Designer Babies: Market Share Liability 329

companies may strive to remain ahead of competitors by racing to patent lucra-

tive applications of CRISPR-Cas9 to the human germline and clinically apply

the technology before it is thoroughly tested.

3. Potential Consequences and Risks of Human Germline Editing

As CRISPR-Cas9 techniques advance, off-target consequences for individ-

uals and subsequent generations are of immense concern.

In a 2013 study on

Duchenne muscular dystrophy (“DMD”), which results from a genetic mutation

on the X chromosome and causes muscle deterioration, Dr. Eric Olson success-

fully treated DMD afflicted mice by editing their genome using CRISPR-Cas9.

Although off-target consequences were rare in that specific experiment, Dr. Ol-

son acknowledged that CRISPR genome editing can unintentionally cause life-

long changes to an organism’s DNA.

Many scientists worry that treating a hu-

man with DMD using CRISPR-Cas9 technology may lead to generations of un-

foreseen and possibly irreparable harm—such as removing someone’s protective

gene for cancer.

Thus, scientists worry that human manipulation of the genome

may lead to long-term negative impacts on the gene pool itself.

Venki Ramakrishnan, in an interview about his thoughts on the application of human germline genetic

engineering).

See Genome Editing Market Worth $3,514.08 Million by 2019, supra note 67 (showing the

popularity of the industry by listing the numerous genetic companies trying to take advantage of the

growing market). According to an investment report by MarketsandMarkets, the genome editing in-

dustry is estimated to reach $3,514.08 million by 2019, and expand at a compound annual growth rate

of 13.75%. See id. With such strong incentives to invest in genome editing research, it is only a matter

of time before Pandora’s box is opened and clinical trials are performed around the world resulting in

a race to dominate the market. See id. Already, the following companies have invested heavily in

CRISPR-Cas9 therapies without regard to who wins the patent dispute: Bayer invested $335 million

into CRISPR Therapeutics; Regeneron Pharmaceuticals invested $125 million into Intellia Therapeu-

tics; Vertex invested $105 million into CRISPR Therapeutics; Fulcrum Therapeutics invested $55

million into Horizon Discovery Group; Juno Therapeutics invested $47 million into Editas Medicine.

Amy Dockser Marcus & Joe Palazzolo, Crispr-Cas9 and the Companies Getting on Board, W

ALL

STREET J. (Sept. 22, 2016), http://blogs.wsj.com/briefly/2016/09/22/crispr-cas9/ [https://perma.

cc/6465-L69T].

See Patrick Skerrett, Experts Debate: Are We Playing with Fire When We Edit Human Genes?,

TAT (Nov. 17, 2015), https://www.statnews.com/2015/11/17/gene-editing-embryo-crispr/ [https://

perma.cc/R4LC-KBW8] (compiling comments from renowned scholars on the ethical and safety

concerns of genetically modifying human embryos).

Chengzu Long et al., Prevention of Muscular Dystrophy in Mice by CRISPR/Cas9-Mediated

Editing of Germline DNA, 345 S

CI. 1184, 1184 (2014) (analyzing the impact of using CRISPR-Cas9

to edit out harmful DMD genes on the germline of DMD afflicted mice).

Regalado, supra note 42 (describing the DMD study and Dr. Olson’s thoughts on its success).

See Kozubek, supra note 18 (explaining the potential evolutionary consequences of diluting the

gene pool with mutations); Skerrett, supra note 74 (noting that the secondary effects of removing a

harmful gene may be removal of a protective gene for cancer).

See Kozubek, supra note 18; Skerrett, supra note 74 (noting that excision of a particular gene

may result in removal of both harmful and beneficial genetic characteristics). Nevertheless, Cornell

scientist, Philipp Messer, predicts that natural mutations will disrupt the ability of target genes to cut the

330 Boston College Law Review [Vol. 59:319

In the first reported human germline genetic modification, Chinese re-

searchers replaced the gene for a blood disorder called β-thalassaemia in twen-

ty-eight out of seventy-one non-viable embryos.

In the process, they caused

unwanted alterations in other parts of the genome.

In subsequent research,

Chinese researchers attempted to insert a mutated gene into the germline to

create HIV resistance and were successful in a mere four out of twenty-six

non-viable embryos and again, caused unwanted mutations.

Notably, even if scientists can precisely edit the targeted gene, unintended

causal reactions may still ensue.

This is because genes that increase the risk

for some diseases may actually decrease the risk for others.

For instance, if a

genetic company targets someone’s CCR5 gene, which increases the risk for

contracting West Nile, removal of the gene will also rid her of an important

protection from HIV.

Likewise, altering someone’s MC1R gene in order to

produce vibrant red hair can also increase her risk of melanoma.

In one study,

geneticists who modified a mouse’s gene in order to protect against tumors

DNA, and thus create a limitation to spreading modified genes. See Tina Hesman Saey, Seeing the Up-

side in Gene Drives’ Fatal Flaw, A

CCESS SCI. (July 15, 2016), https://www.accessscience.com/

content/seeing-the-upside-in-gene-drives-fatal-flaw/SN1607261 [https://perma.cc/3NHZ-VTGA]. If

predicted correctly, the mutations would be slowly passed with a fifty percent acceptance rate meaning

after one hundred generations, the mutation would be present in fifty percent of the population. See id.

See Liang et al., supra note 50, at 363 (noting the unwanted changes in gene sequencing and

increased genetic mutations).

See id.; Akshat Rathi, Chinese Researches Have Genetically Modified Human Embryos—Yet

Again, Q

UARTZ (Apr. 9, 2016), http://qz.com/658537/chinese-researchers-have-genetically-modified-

human-embryos-yet-again/ [https://perma.cc/AH2X-MM7S] (describing the Chinese research using

CRISPR-Cas9 and the unsuccessful trials that produced unplanned and unwanted genetic mutations).

Rathi, supra note 80 (assessing the impact of trying to alter the germline to create HIV re-

sistance). Notably, recent developments in CRISPR germline editing technology, called “base edit-

ing,” allow for a single edit to change a letter in a DNA strand, as opposed to CRISPR-Cas9 which

works to deactivate an entire gene or allow gene insertion. See James Gallagher, DNA Surgery on

Embryos Removes Disease, BBC

NEWS (Sept. 28, 2017), http://www.bbc.com/news/health-41386849

[https://perma.cc/PAB8-XQF9] (describing the new advancements to CRISPR technology using “base

editing”). Because base editing is so narrow, it may decrease off-target impacts for diseases caused by

a single mutation. See id. A team of researchers in China has recently demonstrated that base editing

leads to less off-target impacts than CRISPR-Cas9 when they cured the genetic defect of a blood dis-

order by changing the genetic code from a G to an A. See id.

See Emily Mullin, CRISPR 2.0 Is Here, and It’s Way More Precise, MIT TECH. REV. (Oct. 25,

2017), https://www.technologyreview.com/s/609203/crispr-20-is-here-and-its-way-more-precise/

[https://perma.cc/VRJ8-CY62] (describing the recent advancements in CRISPR to use “base editing,”

which results in increased targeted genetic changes with less risk of unwanted mutations). But see

Lander, supra note 12, at 6 (commenting on the significant genetic advancements CRISPR has to

offer and cautioning that the technology is still not ready for human germline trials).

Lander, supra note 12, at 6.

See id. at 6–7 (explaining how these “protective variants” that increase the risk for one disease

and protect against another are also present for type 1 diabetes and Crohn’s disease). Another disease

that looks especially appealing to the germline editing community is Alzheimer’s; however, the tar-

geted gene has also been known to improve working memory in young adults. See id.

Id. at 7.

2018] The Price Tag on Designer Babies: Market Share Liability 331

also had the unintended effect of causing the mouse to age prematurely, com-

plete with osteoporosis, decreased life-span, and organ deterioration.

Even if

perfectly executed, human disruption of genes may have unintended and poor-

ly—if at all—traceable consequences for generations.

B. Product Liability Issues and DES Cases for Comparison

1. DES’s Generational Impacts

Diethylstilbestrol, commonly known as “DES,” was hailed as a miracle

drug that shielded pregnant women from miscarriages, premature labor, and

other pregnancy complications.

DES was manufactured in 1938 by research-

ers who synthesized estrogen into pill-form so that it could be taken orally.

1939, Chicago physiologists discovered that giving DES to pregnant rats and

mice caused damage to a developing fetus and produced miscarriages.

De-

spite these findings, pharmaceutical companies successfully persuaded the

FDA to allow them to continue to prescribe DES to pregnant women.

The drug was routinely prescribed from 1940 to 1971, until researchers de-

tected a strong correlation between DES and cervical and vaginal cancer.

At this

point, the damage could not be undone since about 5–10 million children were

exposed while in utero.

As revealed in later studies, young daughters of women

who took DES while pregnant had cancer risks forty times higher than non-

exposed daughters.

These risks increased as the daughters aged.

Research on

Stuart D. Tyner et al., P53 Mutant Mice That Display Early Ageing-Associated Phenotypes,

415 N

ATURE 45, 45 (2002) (researching the impact of inserting a gene into a mouse to protect against

tumors).

See Lander, supra note 12, at 7 (cautioning that even a flawless gene alteration to protect

against cancer may have unexpected negative impacts like early aging).

Diethylstilbestrol (DES) and Cancer, NAT’L CANCER INST. (Oct. 5, 2011), https://www.cancer.

gov/about-cancer/causes-prevention/risk/hormones/des-fact-sheet [https://perma.cc/T87J-22DA] (ana-

lyzing the compiled data on women who took DES and their children from a variety of studies).

DES History, supra note 20 (describing the history and negative health impacts of DES on

pregnant women). Doctors and researchers believed that the added estrogen would prevent miscar-

riages. Id. DES proved to be profitable in that it could be synthesized from coal tar and was more than

twice as powerful as naturally occurring estrogen and could be taken orally. Bichler v. Eli Lilly & Co.,

436 N.Y.S.2d 625, 628 (App. Div. 1981).

Bichler, 436 N.Y.S.2d at 629.

See id. at 628–29.

See Diethylstilbestrol (DES) and Cancer, supra note 88 (outlining the history of DES and not-

ing that doctors in Europe continued to prescribe the drug for seven years after the FDA issued warn-

ings to physicians about the devastating effects).

See DES History, supra note 20.

Diethylstilbestrol (DES) and Cancer, supra note 88.

Id. (finding that the risks of cancer for women who took DES and their daughters increase once

in their forties). See generally Janneke Verloop et al., Cancer Risk in DES Daughters, 21 C

ANCER

CAUSES & CONTROL 999 (2010) (studying how the risk of certain cancers, like vaginal and melano-

ma, increase with age in a study of 12,091 DES exposed Dutch women). Exposed daughters experi-

332 Boston College Law Review [Vol. 59:319

potential DES side effects has continued as scientists and doctors strive to identi-

fy and treat DES exposed victims from diseases that escalate or appear with

age.

With generations of negative health effects and increased risks for diseases

over time, plaintiffs have struggled to find a legal remedy for their harm.

2. Tort Liability Challenges and Innovations

Because of the extraordinary circumstances surrounding the DES disaster,

including latent health effects and the vast number of unidentifiable defend-

ants, DES victims argued for a novel theory of tort liability.

As the Supreme

Court of California, in Sindell v. Abbott Laboratories in 1980 explained, one of

the greatest predicaments was whom to hold responsible since finding the spe-

cific DES manufacturer for a prescription taken decades earlier was nearly im-

possible.

Drug manufacturers often did not have direct interaction with con-

sumers, so most plaintiffs could not retrace or remember what a specific pill,

taken years ago, looked like.

100

The Sindell court noted that consumer harm

from DES exposure often did not show up for at least a generation, and manu-

facturers did not prescribe its drugs, let alone maintain records of who received

its drug.

101

Therefore, under traditional tort law, a DES plaintiff could not re-

enced a 1.7% greater risk for breast cancer at ages forty or older, and a 35.4% greater risk for preterm

delivery. Robert N. Hoover et al., Adverse Health Outcomes in Women Exposed in Utero to Diethyl-

stilbestrol, 365 N

EW ENG. J. MED. 1304, 1306 (2011) (assessing future DES impacts on women ex-

posed in utero).

See Role of DES Cohort Studies, CTRS. FOR DISEASE CONTROL, https://www.cdc.gov/des/

consumers/research/understanding_cohort.html [https://perma.cc/5X7U-7A2C] (explaining that DES

daughters typically do not need to worry about infertility, ectopic pregnancy, or other endocrinal diffi-

culties until after their thirties). In fact, Cohort studies compiled by the Center for Disease Control, still

monitor about 15,000 exposed individuals since many cancers are not visible until later in life. See id.

(listing the following ongoing Cohort Studies: Diethylstilbestrol Adenosis Project; DES Mothers

Study; Mayo Clinic Sons Study; Connecticut Mothers Study; Dieckmann Cohort; British Research

Medical Council Study; British Randomized Trial; Registry for Research on Hormonal Transplacental

Carcinogenesis).

See Zafft v. Eli Lilly & Co., 676 S.W.2d 241, 242, 247 (Mo. 1984) (dismissing plaintiff’s suit

when they could not identify the specific manufacturer who supplied the DES); Victor E. Schwartz &

Liberty Mahshigian, Failure to Identify the Defendant in Tort Law: Towards a Legislative Solution,

73 C

ALIF. L. REV. 941, 942–43 (1985) (analyzing potential tort and legislative solutions to the prob-

lem of assigning liability for harm caused by a generic drug when the defendant is unidentifiable).

See Sindell v. Abbott Labs., 607 P.2d 924, 937–38 (Cal. 1980) (applying a novel concept of

market share liability in order to compensate women and children suffering from the disastrous health

effects of DES exposure); Sheiner, supra note 21, at 966–67 (declaring that by 1977, hundreds of DES

plaintiffs sought recovery from DES manufacturers).

See Sindell, 607 P.2d at 925.

100

See id. at 930.

101

See id.

2018] The Price Tag on Designer Babies: Market Share Liability 333

cover unless she could identify the specific manufacturer of the pill she ingest-

ed years ago.

102

In response to these DES cases, tort law evolved to allow plaintiffs to re-

cover despite a pill’s generic formula and the inability to find specific defend-

ants.

103

Without a change or compromise in tort law, recovery proved “insur-

mountable” to plaintiffs whose cancer arrived years later.

104

This new tort theo-

ry assigned liability via a company’s DES market share.

105

The Sindell court

was the first to adopt the market share liability theory and held that plaintiffs

could recover against pharmaceutical companies according to their participa-

tion in the market.

106

The principle emanated from the “alternative liability”

theory as expressed in the 1948 Supreme Court of California case, Summers v.

Tice.

107

Summers held that a plaintiff, whose eye was injured by one of two

negligent hunters, could hold them jointly and severally liable despite not

knowing which one was ultimately responsible.

108

This theory relied on a fair-

ness rationale: both hunters were wrongdoers, so the burden should shift from

the plaintiff to the defendants to prove otherwise.

109

102

See Gorman v. Abbott Labs., 599 A.2d 1364, 1364 (R.I. 1991) (holding that tort liability re-

quires an identifiable defendant who caused the injury); Schwartz & Mahshigian, supra note 97 (ex-

plaining the identification problem in tort law for harm caused by a generic drug).

103

See Sheiner, supra note 21, at 994, 996 (responding to the problem of defendant identification

in DES cases with a new concept of tort liability based on market share). This novel theory of tort

liability was proposed in a student comment and adopted for the first time in Sindell. See Sindell, 607

P.2d at 924–43.

104

See Bichler, 436 N.Y.S.2d at 632 (reasoning that courts must adapt the law as fairness de-

mands when “traditional evidentiary requirements of tort law may be insurmountable”); Abel v. Eli

Lilly & Co., 343 N.W.2d 164, 173 (Mich. 1984) (applying a modified version of alternative liability

theory tailored specifically to DES plaintiffs given the unique hurdles surrounding proof of causation).

The court clarified that the policy of alternative liability is not just being applied, but that it is forming

a “new DES-unique version of alternative liability.” Abel, 343 N.W.2d at 173. Several courts have

adopted their own version of market share liability and expanded upon the doctrine as they believed

justice required. See generally Andrew B. Nace, Note, Market Share Liability: A Current Assessment

of a Decade-Old Doctrine, 44 V

AND. L. REV. 395 (1991) (comparing and contrasting various courts’

applications of market share liability).

105

See Sindell, 607 P.2d at 938 (applying market share liability for the first time); Bichler, 436

N.Y.S.2d at 625 (applying market share liability and awarding future damages for children’s increased

risks of cancer).

106

Sindell, 607 P.2d at 937; Nace, supra note 104, at 396 (noting that the Supreme Court of Cali-

fornia “created” the theory of market share liability).

107

See Sindell, 607 P.2d at 928, 936 (building on notions of tort law that allow for recovery be-

cause fairness and common acts of negligence and justice permit it); Summers v. Tice, 199 P.2d 1, 4

(Cal. 1948) (finding that when two defendants are culpable for causing the plaintiff’s injury, the bur-

den shifts to the defendants to prove they were not the party responsible).

108

See Summers, 199 P.2d at 1, 5.

109

See id. at 4.

334 Boston College Law Review [Vol. 59:319

3. Successes and Failures in Providing Remedies to DES Victims

One of the problems with compensating DES victims is the inability to

predict with certainty what damages are sufficient to cover present and future

health complications.

110

The effects of DES correlate with a victim’s age in

that breast and vaginal cancer risks increase dramatically as the victim gets

older.

111

Accounting for such risks when filing a lawsuit can be difficult.

112

Particularly, once a plaintiff is on notice, she risks losing her claim through the

statute of limitations unless a state has instituted revival statutes which allow

DES claims to be brought once effects are experienced, and not just once she

knows she was exposed to DES.

113

On the other hand, with little information

except health impacts, a court may find it necessary to restrict standing to a

specific generation.

114

In Enright v. Eli Lilly and Company in 1988, the Court

of Appeals of New York did not recognize a handicapped grandchild’s claim

against DES manufacturers since the evidence was too obscure and attenuated

to have a jury trial.

115

Courts have been sympathetic to plaintiffs’ concerns about developing

cancer and have awarded damages for future harm.

116

In 1995, the New York

state trial court in In re New York County DES Litigation affirmed a jury ver-

dict awarding damages ranging from $2,500–$58,000 for future health compli-

cations for multiple DES plaintiffs.

117

Notably, the court recognized that future

damages served as valid compensation for the plaintiffs’ “unique, far-ranging

and severe physical and psychological injuries.”

118

As DES exposed children begin to experience latent health effects, there

remain numerous pending DES cases across the country.

119

Nonetheless, many

110

See supra notes 92–96 (explaining the increased risks of diseases associated with DES as one

ages).

111

See Hoover et al., supra note 95, at 1306 (identifying DES health risks).

112

See Enright v. Eli Lilly & Co., 570 N.E.2d 198, 228–30 (N.Y. 1991), rev’g, 553 N.Y.S.2d 494

(App. Div. 1990) (explaining the difficulty of connecting negative health impacts from cancer and

other diseases to DES exposure).

113

See id. at 229–30 (recognizing the constitutionality of New York’s revival statute that allows

DES claims stemming from latent effects or injuries that appear years later, but limiting recovery to

three generations of victims).

114

See id. at 228 (insisting that after three generations of victims, the connection between the

alleged harm and DES becomes too attenuated).

115

See Enright v. Eli Lilly & Co., 533 N.Y.S.2d 224, 228 (Sup. Ct. 1988) (explaining that the

“passage of time and generations obscure such evidence to the extent that a third generation lawsuit”

could only stand on “sympathy and conjecture”).

116

See In re New York County DES Litig., 211 A.D.2d 500, 500 (N.Y. App. Div. 1995) (affirm-

ing the jury verdict awarding damages for likelihood of disease).

117

See id.

118

See id.

119

Settlement Reached in Eli Lilly Pregnancy Drug Linked to Breast Cancer Case, supra note 31

(discussing the current litigation of DES injuries in Massachusetts federal court and acknowledging

there are thousands of similar lawsuits that have been filed across the nation, but many have settled).

2018] The Price Tag on Designer Babies: Market Share Liability 335

of these cases are beginning to settle without much information released to the

public.

120

Recently, four sisters diagnosed with breast cancer, allegedly caused

by their mother’s use of DES while pregnant, settled with the pharmaceutical

company Eli Lilly and Company.

121

Although market share liability may be

inadequate to fully compensate individuals who fear suffering from painful

diseases or who actually suffer from said diseases, this recent settlement indi-

cates that recovery is possible and ongoing.

122

II.

COMPANY LIABILITY FOR GENERATIONS OF

RODUCTS LIABILITY CLAIMS

Beyond the lucrative profits and health benefits resulting from gene alter-

cation lies the potential for generations of health defects.

123

In turn, multi-

generational health defects raise serious liability questions.

124

Market share

liability acts as an alternative theory of tort law appropriate for situations in

which the harm from a defective product does not appear for decades or even

generations.

125

Under traditional tort law, plaintiffs suffering from a genera-

120

See id. One of the problems with settling, as opposed to receiving a verdict at trial, is that the

public does not know the extent of recovery by a victim. See Lilly in a DES Settlement, N.Y.

TIMES

(May 19, 1992), http://www.nytimes.com/1992/05/19/business/lilly-in-a-des-settlement.html [https://

perma.cc/DV35-NEMG] (discussing the 1992 DES settlements outside of the courtroom and noting

that they were sealed). For instance, Eli Lilly and Company, one of the largest DES manufacturers,

has settled repeatedly with DES victims after they file suit. See id. In 1992, Eli Lilly and Company

settled 250 cases in just seventeen months. Settlement offers were sealed, but one claimant reportedly

received $1 million from the company. See id.

121

See Settlement Reached in Eli Lilly Pregnancy Drug Linked to Breast Cancer Case, supra

note 31 (describing how four sisters brought suit against Eli Lilly after suffering from miscarriages,

fertility problems, and breast cancer, and later reached a private settlement with Eli Lilly).

122

See id. (explaining that similar claims have been instigated in Boston specifically, and around

the country, with fifty-one women having lawsuits currently pending in U.S. District Court in Massa-

chusetts).

123

See James Gallagher, “Designer Babies” Debate Should Start, Scientists Say, BBC NEWS

(Jan. 19, 2015), http://www.bbc.com/news/health-30742774 [https://perma.cc/W2CA-QTL9] (quoting

various scientists, ethicists, and regulators that the time for public debate on human germline engi-

neering has arrived).

124

See generally Alicia R. Ouellette, Insult to Injury: A Disability-Sensitive Response to Smo-

lensky’s Call for Parental Tort Liability for Preimplantation Genetic Interventions, 60

HASTINGS L.J.

397 (2008) (analyzing various legal avenues harmed genetically modified children may pursue, such

as for moral harm and physical disability, and whether parents who consent to the modification can

serve as defendants).

125

See DAN B. DOBBS ET AL., DOBBS’ LAW OF TORTS § 194 (2d ed. 2017) (explaining that alter-

native tort liability allows courts to use statistical causation when justice requires and to impose re-

sponsibility for harm when a specific defendant is undeterminable). Market share liability imposes

damages on manufacturers based on their percentage of market share with the understanding that their

product harmed approximately the same percentage of plaintiffs. See id. For the averaging to maintain

the appearance of fairness, the potential number of plaintiffs should be a substantial number so that

there is a likelihood a manufacturer on trial contributed to the specific harm. See id. This is usually the

case when thousands of people are impacted and the repercussions are passed down to offspring. See

id.

336 Boston College Law Review [Vol. 59:319

tional harm are unlikely to recover since they must prove that the defendant’s

product—such as DES, asbestos, a vaccine, or genetic alteration—caused their

individual harm.

126

Courts are often split on whether or not to recognize the doctrine of mar-

ket share liability, thus making its application beyond a narrow category of

“fungible products” uncertain.

127

If a harmful product is interchangeable, then

a court is more comfortable allowing proportional recovery among plaintiffs

since the manufacturers are, in theory, equally culpable for its distribution.

128

Sindell narrowed the scope of the new market share liability theory by suggest-

ing that any future claims must involve products that are 1) interchangeable, 2)

have equivalent risks across company lines, and 3) are controlled in the market

through concerted efforts on behalf of the industry.

129

Thus, courts have largely

restricted use of this doctrine to classic DES-type cases and treated its use as

an exception to normal tort doctrine.

130

This Part analyzes the limitations of extending market share liability be-

yond the DES context.

131

Section A discusses one of the biggest barriers to

market share liability, fungibility of the product.

132

Section B considers diffi-

culties in tracing a product’s harm when the harm is passed down from genera-

tion to generation.

133

Finally, Section C examines the problem of compensating

126

See Gorman v. Abbott Labs., 599 A.2d 1364, 1364 (R.I. 1991) (dismissing the DES plaintiffs’

cause of action by holding that tort liability requires the “identification of the specific defendant re-

sponsible for the injury”); Bostic v. Georgia-Pacific Corp. 439 S.W.3d 332, 346 (Tex. 2014) (requir-

ing the plaintiff to show that his asbestos exposure was a “substantial factor” in developing mesotheli-

oma).

127

See Sindell v. Abbott Labs., 607 P.2d 924, 932–33 (Cal. 1980) (declaring DES to be “fungi-

ble,” meaning various manufacturers sold an interchangeable drug). Compare Sindell, 607 P.2d at 937

(incorporating market share liability into the state’s tort law), Conley v. Boyle Drug Co., 570 So. 2d

275, 287 (Fla. 1990) (same), Smith v. Cutter Biological, Inc., 823 P.2d 717, 729 (Haw. 1991) (same),

Hymowitz v. Eli Lilly & Co., 539 N.E.2d 1069, 1078 (N.Y. 1989) (same), Martin v. Abbott Labs.,

689 P.2d 368, 382 (Wash. 1984) (same), and Collins v. Eli Lilly & Co., 342 N.W.2d 37, 50 (Wis.

1984) (same), with Smith v. Eli Lilly & Co., 560 N.E.2d 324, 345 (Ill. 1990) (refusing to recognize

market share liability), Mulcahy v. Eli Lilly & Co., 386 N.W.2d 67, 75 (Iowa 1986) (same), Zafft v.

Eli Lilly & Co., 676 S.W.2d 241, 246 (Mo. 1984) (same), Sutowski v. Eli Lilly & Co., 696 N.E.2d

187, 193 (Ohio 1998) (same), and Gorman, 599 A.2d at 1364 (same).

128

See Allen Rostron, Beyond Market Share Liability: A Theory of Proportional Share Liability

for Nonfungible Products, 52 UCLA L. R

EV. 151, 165 (2004) (explaining the policy reasons for hold-

ing defendants liable who introduce harmful products into the public).

129

See Sindell, 607 P.2d at 931–37; Rostron, supra note 128, at 163–68 (synthesizing the three

factors laid out in Sindell for a court to analyze before applying market share liability).

130

See Rostron, supra note 128, at 163–73 (noting that courts have restricted the “fungibility”

requirement since the term itself is vague and ambiguous, and therefore exercise considerable control

over the application of market share liability).

131

See infra notes 135–179 and accompanying text.

132

See infra notes 135–153 and accompanying text.

133

See infra notes 154–163 and accompanying text.

2018] The Price Tag on Designer Babies: Market Share Liability 337

victims when injuries are not present for decades and are passed on to subse-

quent generations.

134

A. Fungible Product by Design

In order for liability to be spread among companies based on market par-

ticipation, the distributed product must be interchangeable between compa-

nies.

135

In 1980, the California Supreme Court, in Sindell v. Abbott Laborato-

ries, first applied market share liability when hundreds of manufacturers pro-

duced DES using the same generic formula and then marketed their product to

pregnant women.

136

The court found that each manufacturer contributed

roughly the same percentage of harm to plaintiffs based on market contribu-

tion.

137

The relevant inquiry, in determining whether market share liability is ap-

propriate, is whether a company’s product presents a similar enough risk of

harm to consumers or the public such that their liability can be based on the

percentage of their market involvement.

138

For instance, in a 2005 consolidated

multi-district lawsuit, the United States District Court for the Southern District

of New York in In re Methyl Tertiary Butyl Ether (“MTBE”) Products Liability

Litigation extended the use of market share liability to allow “innocent water

users” to recover from petroleum distributors that delivered gasoline contain-

134

See infra notes 164–179 and accompanying text.

135

See DOBBS, supra note 125, § 194. For market share liability to be fairly administered, a com-

pany must be connected to the harm alleged by the plaintiff. See id. Even if not directly connected, a

company can still be culpable for distributing a product that resulted in harm to consumers. See id. In

the DES cases, the pills were manufactured using the same generic formula, which promoted a fair-

ness rationale for holding each of the manufacturers culpable for how many drugs they had on the

market. See id. In addition to the DES context, the court in Wheeler v. Raybestos-Manhattan found

asbestos concentrations in brake pads to be uniform enough across the industry to hold manufacturers

liable based on market contribution. See Wheeler v. Raybestos-Manhattan, 8 Cal. App. 4th 1152, 1156

(1992). Before holding genetic companies uniformly responsible for future injuries based on market

participation, courts will need to find that genetic companies use the same process for performing the

germline modification to target the same genetic disease. See id.

136

See Sindell, 607 P.2d at 935–36 (justifying market share liability as the means for compensat-

ing plaintiffs by a culpable industry rather than allowing manufacturers to escape liability merely

because they could not be directly identified). The court in Sindell measured market share liability

based on the “likelihood that any of the defendants supplied the product which allegedly injured the

plaintiff by the percentage which the DES sold by each of them for the purpose of preventing miscar-

riage bears to the entire production of the drug sold by all for that purpose.” See id. at 937. The court

noted that plaintiffs could not single out one particular defendant from hundreds of DES manufactur-

ers because they created and sold DES using an “identical formula.” See id. at 936.

137

See id. at 937. Specifically, the court noted that if the defendants, Eli Lilly and Company and

five or six other companies, contributed 90% of the DES that was on the market, then there would be

a 10% chance that the responsible defendant would not be held accountable. See id.

138

See DOBBS, supra note 125, § 194 (describing that for an industry to be accountable, the harm

of each manufacturer’s product must be equivalent in order to assign liability based on production).

338 Boston College Law Review [Vol. 59:319

ing the carcinogenic chemical MTBE.

139

The court was compelled by evidence

that defendants understood the risks of immense groundwater contamination

from mixing gasoline with MTBE and that any contamination could not be

traced to a single source.

140

As a result of active concealment by the defendants

and MTBE being fungible, the court allowed plaintiffs to recover damages un-

der the theory of market share liability.

141

Nonetheless, market share liability has been reserved almost exclusively

to the DES context because most products are not generic across an industry.

142

For example, in 1995 in Bly v. Tri-Continental Industries, Inc., the United

States Court of Appeals for the D.C. Circuit referred to market share liability

as a “last resort” largely limited to DES cases where each manufacturer’s

product is “identical.”

143

As a result, the plaintiff could not show fungibility

since the product at issue, benzene gasoline, was manufactured using different

formulas across the industry.

144

Thus, the harm that each manufacturer contrib-

uted could not be considered equal per product on the market because the vary-

ing concentrations of harmful benzene changed the severity of harm of the

product, making some companies more or less culpable than others.

145

Similar-

ly, allergy-causing latex gloves and harmful lead paint are not recognized as

fungible products since manufacturers assemble them with different quantities

of the harmful products.

146

Courts are hesitant to expand market share liability

when manufacturers use different quantities of a harmful substance in their

products, and/or the injury could be attributed to another product altogether.

147

139

See In re Methyl Tertiary Butyl Ether Prods. Liab. Litig., 379 F. Supp. 2d 348, 376–77 (S.D.N.Y.

2005) (applying market share liability to manufacturers of carcinogenic gasoline).

140

See id. at 365.

141

See id. at 376–77.

142

See Bly v. Tri-Continental Indus., 663 A.2d 1232, 1244 (D.C. Cir. 1995) (finding that gasoline

produced with different formulas was not fungible since the harmful product, benzene, varied in quanti-

ties across the industry); City of St. Louis v. Benjamin Moore & Co., 226 S.W.3d 110, 116 (Mo. 2007)

(refusing to apply market share liability to lead paint manufacturers when the plaintiff could not identify

the specific offender); Goldman v. Johns-Manville Sales Corp., 514 N.E.2d 691, 697 (Ohio 1987) (hold-

ing that market share liability was inapplicable to asbestos-ridden duct tape since the duct tape varied by

15% to 100% asbestos based on weight).

143

See Bly, 663 A.2d at 1243–44 (finding that plaintiffs did not demonstrate that there were similar

enough products such that gasoline exposure constituted one of the “extraordinary circumstances” market

share liability covered).

144

See id. at 1244.

145

See id.

146

Kennedy v. Baxter Healthcare Corp., 50 Cal. Rptr. 2d 736, 739–40, 744 (Ct. App. 1996) (find-

ing that plaintiffs could not recover under market share liability theory for harm resulting from latex

gloves containing allergy-causing proteins because manufacturers vary their protein concentrations);

Skipworth v. Lead Indus. Ass’n, 690 A.2d 169, 173 (Pa. 1997) (refusing to extend market share liabil-

ity to the paint industry since paint containing lead varied in concentration among manufacturers).

147

See Goldman, 514 N.E.2d at 697 (finding market share liability inapplicable to asbestos-

ridden duct tape since the harmful asbestos concentrations varied significantly by brand type); Case v.

2018] The Price Tag on Designer Babies: Market Share Liability 339

In the 1987 Supreme Court of Oklahoma’s ruling in Case v. Fibreboard Cor-

poration, the court found that asbestos would rarely—if at all—be a fungible

product like DES.

148

It found that “asbestos” generally referred to products

with varying concentrations of harmful minerals and the risk of exposure often

correlated with the type of asbestos product.

149

Moreover, courts’ applications of market share liability have important

distinctions.

150

For instance, in Sindell, the court applied market share liability

with an important caveat: if a manufacturer proved it could not have sold the

DES to the specific plaintiff, then it was excused from liability.

151

Alternative-

ly, in 1989 the New York Court of Appeals, in Hymowitz v. Eli Lilly and Com-

pany, ruled that it would apply a national market share liability theory based

on the “overall-risk produced” to the public and not specific causation to an

individual plaintiff.

152

Therefore, under that approach, even companies who

could prove they definitely did not cause the plaintiff’s injury were still liable

based on their national market share so long as they were culpable for the

overall harm.

153

Fibreboard Corp., 743 P.2d 1062, 1066 (Okla. 1987) (emphasizing the diverse risk factors associated

with asbestos products based on type and composition).

148

See Case, 743 P.2d at 1065–66 (contrasting asbestos products and the varying risks in compo-

sition and types of products with DES pills, which were generically administered to pregnant women).

Of note to the court, “asbestos” is the name of a family of minerals and can be a combination of more

than thirty different minerals. See id. at 1065.

149

See id. at 1065; Nace, supra note 104, at 414–15 (explaining that most courts have not applied

market share liability in the asbestos context because of the difficulty in attributing the specific harm

to a product). People are exposed to countless asbestos products in the workplace or at home resulting

in a product identification problem similar, yet different, than DES in that it is not merely one harmful

product. See id.

150

See Nace, supra note 104, at 396. States have adopted varying market share liability doctrines

depending on important notions of fairness and how liability should be determined. See id. at 406. In

Sindell, the court allowed companies to escape liability if they could prove they did not injure the

specific plaintiff with their product so that only manufacturers with some probability of contributing

to the specific injury and a substantial share in the sales could be held accountable. See Sindell, 607

P.2d at 937. Ambiguity in whether market share would be a percentage of the plaintiff’s harm or a

percentage of the national market share resulting in less than a full recovery led to some varying inter-

pretations of Sindell. See Note, Market Share Liability: An Answer to the DES Causation Problem, 94

ARV. L. REV. 668, 672–73 (1981) (analyzing court applications and interpretations of market share

liability). In Martin v. Abbott Laboratories, the court applied a theory of market share recovery that

the California Supreme Court later adopted in Brown v. Superior Court that assessed liability based on

a manufacturer’s harm to a particular plaintiff. See Brown v. Superior Court, 751 P.2d 470, 485 (Cal.

1988); Martin, 689 P.2d at 382. By contrast, the court in Hymowitz v. Eli Lilly & Co. departed from

this structure by focusing on the culpability of each defendant to the public and assigning liability

based on the risk of harm each contributed. See 539 N.E.2d at 1078.

151

See Sindell, 607 P.2d at 937 (refusing to extend market share liability to a defendant if she

proved her product could not have caused the plaintiff’s injuries).

152

Hymowitz, 539 N.E.2d at 1078.

153

See id. (“Nevertheless, because liability here is based on the over-all risk produced, and not cau-

sation in a single case, there should be no exculpation of a defendant who, although a member of the

market producing DES for pregnancy use, appears not to have caused a particular plaintiff’s injury.”).

340 Boston College Law Review [Vol. 59:319

B. Tracing Causation Across Broken Family Lines

While market share liability helps plaintiffs recover when a specific man-

ufacturer of the DES itself cannot be identified, proving that the product actu-

ally caused the injury is one of the greatest hurdles to compensation.

154

In re-

viewing studies on DES’s impact on mothers’ and their children’s increased

risk of cancer, some courts have found in favor of the plaintiffs so long as they

prove DES exposure.

155

Unfortunately, many plaintiffs impacted by DES can-

not recover because the causal connection is often too speculative to prove that

DES itself led to the negative health effects generations later as opposed to

other genetic risks, exposures, or activities.

156

Products that increase someone’s risk for contracting a common disease

or cancer in and of themselves are extremely difficult to associate with a par-

ticular defendant since the defendant can easily cast doubt on whether their

product was a “substantial factor” in causing the mainstream disease.

157

For

instance, a woman’s risk of breast cancer doubles from 2% to 4% if her mother

consumed DES while pregnant; however, countless other factors also increase

a woman’s probability of getting breast cancer.

158

In fact, the Center for Dis-

ease Control (“CDC”) has listed over fifteen risk factors that make a woman

more likely to develop breast cancer such as drinking alcohol and aging.

159

2008, in Borg-Warner Corporation v. Flores, the Supreme Court of Texas

The court sought to avoid a “windfall” scenario where manufacturers could escape liability because

they stayed in a local market or made their product “more identifiable,” yet remained equally culpable to

the public as a whole. See id.

154

See Clayton v. Eli Lilly & Co., 421 F. Supp. 2d 77, 81 (D.D.C. 2006) (explaining how the jury

must weigh the credibility of a witness’s memory for whether she can accurately remember the color

and markings of a DES pill she took decades ago while pregnant); Enright v. Eli Lilly & Co., 533

N.Y.S.2d 224, 228 (Sup. Ct. 1988) (stating that the “passage of time and generations obscure such

evidence to the extent that a third-generation lawsuit” could only stand on “sympathy and conjec-

ture”).

155

See e.g. Sindell, 607 P.2d at 937; Hymowitz, 539 N.E.2d at 1072, 1078.

156

See Enright, 533 N.Y.S.2d at 228 (commenting on the serious hurdles, namely time and gen-

erational harm, that plaintiffs face in obtaining recovery).

157

See Borg-Warner Corp. v. Flores, 232 S.W.3d 765, 765 (Tex. 2007) (holding that the jury

legally could not have found a defendant’s asbestos product was a “substantial factor” in contributing

to the plaintiff’s injury). See generally Brent M. Rosenthal, Toxic Torts and Mass Torts, 62 SMU

REV. 1483 (analyzing the evidentiary hurdles to toxic and mass tort litigation in Texas).

158

See Bonnie Rochman, DES Daughters: Banned Pregnancy Drug Linked to Infertility, Prema-

turity, and Cancer, T

IME (Oct. 6, 2011), http://healthland.time.com/2011/10/06/des-daughters-now-

banned-drug-linked-to-infertility-prematurity-and-cancer/ [https://perma.cc/3K5H-62Q9] (describing

the increased risks for many mainstream health issues faced by daughters whose mothers consumed

DES while pregnant); What Are the Risk Factors for Breast Cancer?, C

TRS. FOR DISEASE CONTROL

(Sept. 27, 2017), https://www.cdc.gov/cancer/breast/basic_info/risk_factors.htm [https://perma.cc/

V4N8-3J3F] (describing sixteen factors that can increase a woman’s chance of getting breast cancer).

159

What Are the Risk Factors for Breast Cancer?, supra note 158 (listing the following factors:

taking birth control, drinking alcohol, having a family history of breast cancer, getting older, genetic

mutations).

2018] The Price Tag on Designer Babies: Market Share Liability 341

found that as a matter of law the jury did not have sufficient evidence to find

that a plaintiff’s lung cancer was caused by inhaling asbestos dust at work

when grinding asbestos-ridden brakes for more than three decades.

160

The

court highlighted that the plaintiff smoked, there existed over one hundred dif-

ferent causes for lung disease, and there was little evidence showing how much

asbestos the plaintiff had been exposed to when grinding brake pads.

161

Simi-

larly, in Case v. Fibreboard Corporation, the plaintiff also could not prove a spe-

cific asbestos product caused the injuries.

162

The court noted that the asbestos-

injuries could have come from any one of the three thousand asbestos products a

typical person encounters at work or at home.

163

C. Compensating a Broken Family Line: Collection

and Liquidity Problems

Compensating victims who suffer detrimental effects from a product that

increases the risk of developing a severe, latent health problem proves chal-

lenging, especially when the risk of harm continues to be passed down from

generation to generation.

164

Courts will have to estimate not only the claim-

ant’s present harm and future medical bills, but also that of potential children

who may suffer from the harm.

165

DES exposure increases cancer risks, which

are passed on through daughters, leading to a litany of negative health reper-

cussions still in existence today.

166

Due to varying court interpretations of market share liability, many vic-

tims could not recover if the manufacturer went out of business or proved it

160

Borg-Warner, 232 S.W.3d at 773–74 (concluding that the plaintiff’s lung disease could have

been caused by many factors and it is not sufficient proof of causation to just state that plaintiff dealt with

asbestos at work).

161

Id. at 766, 768, 774.

162

See Case, 743 P.2d at 1065–66 (refusing to apply market share liability for alleged asbestos

injuries when the plaintiff could not identify the particular wrongdoer).

163

Id. at 1065.

164

See Wood v. Eli Lilly & Co., 38 F.3d 510, 513–14 (10th Cir. 1994) (denying a grandchild

damages for a premature birth allegedly caused by their grandmother consuming DES while preg-

nant); Victor E. Schwartz & Cary Silverman, The Rise of “Empty Suit” Litigation, 80 B

ROOK. L. REV.

599, 602 (2015) (describing the recent increase in litigants seeking to recover for “no injury” claims in

which the product’s harm has not yet manifested itself, but there are emotional and medical check-up

claims).

165

See In re New York County DES Litig., 211 A.D.2d 500, 500 (N.Y. App. Div. 1995) (affirm-

ing the jury verdict for likelihood of disease damages). The court in In re New York County DES Liti-

gation held that “reasonable compensation” could include future damages for an increased risk of

disease and medical appointments. See id. In Bichler v. Eli Lilly & Co., the Supreme Court of New

York affirmed a $492,842.39 jury award to a DES plaintiff, which included damages for her chil-

dren’s future cancer costs. See 436 N.Y.S.2d 625, 625 (App. Div. 1981).

166

See Rochman, supra note 158 (listing the various negative health effects from DES on subse-

quent generations and recapping a study that was published in the New England Journal of Medicine).

342 Boston College Law Review [Vol. 59:319

could not have sold DES to that particular plaintiff.

167

In Brown v. Superior

Court, the California Supreme Court in 1988 noted that it would not assign

liability to DES manufacturers that proved they did not and could not have

caused the injuries of the claimant.

168

By comparison, another interpretation of

market share liability was used in Hymowitz.

169

There, the court reasoned that

manufacturers were culpable to the public as a whole.

170

Thus, under that in-

terpretation, even if a manufacturer definitively proved it was not responsible

in a specific case, victims could still recover based on its contribution to the

national market.

171

Although allowing for recovery is the first step, a critical concern is how

manufacturers will compensate generations of victims for harm.

172

Companies,

like people, can become judgment-proof.

173

Many manufacturers subject to

latent tort liability will run out of money before not only the symptoms mani-

fest, but before the victims in subsequent generations receive compensation.

174

As illustrated through asbestos reorganizations in the 1980s, companies at-

tempted to use Chapter 11 of the Bankruptcy Reform Act of 1978 to shed

overhanging tort liability.

175

167

See Nace, supra note 104, at 396 (outlining the various market share liability theories across

states). In California, courts assess manufacturer market share liability based on their stake in the

relevant market but offer a complete defense if they can show there was no possible way they supplied

DES to the specific plaintiff in the case. See id. at 403–05; Brown, 751 P.2d at 485–87 (resolving an

ambiguity in the application of market share liability by determining that defendant manufacturers

will only be held severally liable).

168

See Brown, 751 P.2d at 485.

169

See Hymowitz, 539 N.E.2d at 1078 (assigning liability based on the risk of harm each manu-

facturer defendant contributed to the public).

170

See id. This is because each manufacturer was at fault for having released a dangerous product

into the public although the exact ramifications were unknown. See id.

171

See id. Because each manufacturer released a harmful product into the public, each was culpa-

ble based on their percentage of the market and should be held accountable on an industry-scale. See

id.

172

See Collins, 342 N.W.2d at 48 (explaining that many DES companies have left the market,

while others have entered, and there were uncertain records concerning the overall national production

of DES).

173

See MARK J. ROE & FREDERICK TUNG, BANKRUPTCY AND CORPORATE REORGANIZATION

336 (4th ed. 2016) (describing the institutional problem with mass tort compensation when companies

declare bankruptcy and future tort victims are unable to collect damages).

174

See id. (analyzing the problem of compensation in mass tort cases for victims who incur medi-

cal expenses at a later time after all possible distributions have already happened).

175

See 11 U.S.C. § 1102 (2012). Chapter 11 essentially lets companies write down their tort debt

and, perhaps more importantly, fix it at a known quantity. See id. One of Chapter 11’s unforeseen conse-

quences is the attempt by companies to use Chapter 11 bankruptcy to skirt massive tort liability by reor-

ganizing. See Note, The Manville Bankruptcy: Treating Mass Tort Claims in Chapter 11 Proceedings, 96

HARV. L. REV. 1121, 1122 (1983) (predicting the future of Chapter 11 proceedings in mass tort claims).

Because there were many potential debtors, since the effects of asbestos exposure had yet to materialize,

asbestos companies, like Manville, tried to limit their future liabilities by having experts and not juries

determine the scope of each tort claimant’s recovery. See id. at 1132.

2018] The Price Tag on Designer Babies: Market Share Liability 343

In order to maintain company liability for DES, to allow for more directly

harmed plaintiffs to recover, and to meet evidentiary concerns, New York

courts applied a policy compromise in favor of limiting liability to the third

generation at the expense of other victims.

176

The Court of Appeals of New

York in 1991, in Enright v. Eli Lilly and Company, reduced the liability of DES

defendants to “manageable limits.”

177

Thus, it limited recovery only to first

generation DES victims and not to daughters and granddaughters despite suf-

fering from “malformations or immaturity of the uterus, cervical abnormalities,

misshapen Fallopian tubes, and abnormal cell and tissue growth.”

178

Evidently,

even if liability is established, court awarded recovery may not be enough in

light of courts’ self-designated restrictions on limiting pay outs.

179

III.

PREPARING FOR THE WORST AND PLANNING FOR THE

UTURE WITH MARKET SHARE LIABILITY

Genetic modification may feel like it is part of the scientific future, but

tests are already being done on non-viable human embryos and the industry is

heavily invested in the new CRISPR technology.

180

Market share liability of-

fers a solution for victims to recover when tortfeasors cannot be readily identi-

fied because of time or drug uniformity.

181

As genetic editing becomes the new

generic vaccine or commonly prescribed medication, states should adopt a

176

See Enright v. Eli Lilly & Co., 570 N.E.2d 198, 203–04 (N.Y. 1991) (finding that the passage

of time and uncertain impact of DES exposure on subsequent generations requires a stopping point in

litigation). The court wanted to avoid measures of “over deterrence” and instead recognize a manufac-

turer’s breach of duty towards those directly impacted by the defective drugs. See id. at 204.

177

See id. at 203 (predicting that “manageable limits” requires limiting litigation to the third gen-

eration). Although the court in Enright did not list the factors for why it believed manageable limits

should be in place, it cited to the New York Court of Appeals case, Tobin v. Grossman, which listed

the following factors to be considered when limiting a defendant’s liability: “foreseeability of the

injury, proliferation of claims, fraudulent claims, inconsistency of the zone of danger rule, unlimited

liability, unduly burdensome liability, and the difficulty of circumscribing the area of liability.” Id.

(citing Tobin v. Grossman, 249 N.E.2d 419, 422 (N.Y. 1969)).

178

See Enright, 570 N.E.2d at 200.

179

See id.

180

See Ewen Callaway, Embryo-Editing Research Gather Momentum, 532 NATURE 289, 289–90

(2016) (explaining that germline engineering is expected to become more commonplace, especially in

countries like Sweden, China, and the United Kingdom which already approve such research); Led-

ford, supra note 10 (commenting on the 2017 germline engineering performed in the United States to

rid an embryo of a heart-disease causing mutation); Marcus & Palazzolo, supra note 73 (explaining

that millions of dollars are being invested in CRISPR-Cas9 without regard to who wins the patent

debate on the technology).

181

See DOBBS, supra note 125, § 194 (explaining market share liability as an alternative form of

tort liability for when the defendant cannot be found). Additionally, companies will be incentivized to

maintain better records and retain adequate insurance for such claims. See Sheiner, supra note 21. As

a result, specific defendants should be more identifiable, resulting in regular awarding of tort damag-

es. See id.

344 Boston College Law Review [Vol. 59:319

form of market share liability so that genetic companies can predict their long-

term legal and liability costs before entering the market.

182

This Part argues that market share liability should be adopted in the ge-

netic modification context.

183

Section A discusses the likelihood of being able

to identify a specific genetic company as the source of harm, and argues that as

the process becomes streamlined, similar DES defendant identification prob-

lems will occur.

184

Section B examines germline engineering using CRISPR-

Cas9 as a fungible product comparable to DES pills and vaccines.

185

Section C

assesses the complications of company identification when a defective

germline procedure may not show itself for decades or generations down the

line.

186

Finally, Section D advocates for market share liability as a means of

compensating generations of victims and serving as a pre-market cost for com-

panies entering this risky industry.

187

A. Courts Should Adopt Market Share Liability for Harm

Arising from Genetic Alteration

Unlike DES manufacturers selling pharmaceutical drugs, one of the big-

gest differences in human genetic alteration is that businesses are in never-

before-chartered territory.

188

Any germline engineering transactions for the

first decade or so are likely to be highly contentious and heavily monitored by

journals, medical records and news reports.

189

Evidently, market share liability

182

See Emily H. Damron, Comment, Reviving the Market for Liability Theories: The “Commin-

gled Product” Theory of Market Share Liability Enters the Judicial Lexicon, 111

PENN. ST. L. REV.

505, 520 (2006) (listing the reasons why defendant manufacturers are in the best position to sustain

the costs of consumer injuries). A corporation that can predict its litigation costs can prepare by main-

taining adequate insurance, aggregating profits and resources, increasing the price for products to

spread costs, and investing in safety. See id.

183

See infra notes 188–242 and accompanying text.

184

See infra notes 188–199 and accompanying text.

185

See infra notes 200–211 and accompanying text.

186

See infra notes 212–222 and accompanying text.

187

See infra notes 223–242 and accompanying text.

188

Compare König, supra note 56, at 504 (displaying a chart showing that currently no country,

not even China, publicly permits germline engineering for clinical trials—in other words, to allow

germline editing in viable human embryos with the intention of bringing them to term), and Skerrett,

supra note 74 (describing scientific, ethical, and health concerns from genetic research experts in this

new and expanding field), with Medicine and Pregnancy, F

OOD & DRUG ADMIN (May 19, 2017),

https://www.fda.gov/ForConsumers/ByAudience/ForWomen/ucm118567.htm

[https://perma.cc/LB58-HDPJ] (recommending online sources and tips for women who want to take

medication during their pregnancy).

189

See König, supra note 56, at 504 (describing one of the National Academies of Sciences, En-

gineering, and Medicine’s conditions for supporting a clinical trial of a genetically engineered human

embryo as requiring “multigenerational follow-up” to understand the long-term impacts); Liang et al.,

supra note 50, at 363 (researching CRISPR germline modification on non-viable human embryos for

the first time by Chinese researchers in 2015); Adam Pasick & Akshat Rathi, Chinese Researchers

Have Genetically Modified a Human Embryo—And Many Scientists Think They’ve Gone Too Far,

2018] The Price Tag on Designer Babies: Market Share Liability 345

may deviate in genetic engineering cases from generic pharmaceutical or as-

bestos cases because of the likelihood that plaintiffs will be able to identify the

proper defendants.

190

If defendants are readily identifiable, then market share

liability—as it is currently understood—would not apply.

191

The very reason

for establishing market share liability was to address the problem of an uniden-

tifiable defendant, and assign a percentage of liability to a market participant

because of its tortious market involvement.

192

On the other hand, if human germline engineering becomes a routine pro-

cedure for families, as predicted, then defendants may not be readily identifia-

ble.

193

Market share liability would be invaluable to victims of a defective genet-

ic procedure whose harm manifests decades later in their children or children’s

children.

194

Presently, prenatal genetic screening is offered to parents who would

like an assessment of their child’s genetic condition.

195

For little to no cost with

insurance coverage, parents can learn of potential chromosomal malformations

QUARTZ (Apr. 23, 2015), https://qz.com/389494/chinese-researchers-are-the-first-to-genetically-

modify-a-human-embryo-and-many-scientists-think-theyve-gone-too-far/ [https://perma.cc/53JC-

GR46] (describing the “bombshell” that Chinese researchers dropped by genetically modifying human

embryos for the first time in 2015).

190

See Celotex Corp. v. Copeland, 471 So. 2d 533, 533 (Fla. 1985) (refusing to apply market

share liability in an asbestos case where the plaintiff could readily identify the manufacturers of the

asbestos products he encountered); Hymowitz v. Eli Lilly & Co., 539 N.E.2d 1069, 1072 (N.Y. 1989)

(holding that the court will apply market share liability expressly because identifying the DES manu-

facturer who sold the plaintiff’s drug was “generally impossible”). Also, the pool of genetically altered

victims must be large enough for the averaging of market share liability to be fair across companies. See

OBBS, supra note 125, § 194 (identifying the potential unfairness for assigning liability to a few

potential plaintiffs based on market share liability since averaging over a larger number of consumers

increases a manufacturer’s likelihood of directly contributing to the harm).

191

See DOBBS, supra note 125, § 194 (describing how market share liability arose because plain-

tiffs could not know for certain who caused their injuries, but defendant companies were equally cul-

pable for contributing the harmful product to the public to be held accountable).

192

See id.

193

See Begley, supra note 14 (commenting on the enthusiasm of over 150 scientists at the Ameri-

can Society of Hematology conference at the implications of using CRISPR-Cas9 to eradicate blood

disorders such as HIV/AIDS and leukemia); Harmon, supra note 56 (“This opens the door to adver-

tisements from fertility clinics of giving your child the best start in life with a gene-editing packet….”

quoting Marcy Darnovsky, the executive director of the Center for Genetics and Society, about her

thoughts on germline editing); Ramsey, supra note 28 (quoting CITI biotech analyst, Yigal

Nochomovitz’s prediction that “the first CRISPR-based medicine could reach the market in ~6 years

or less”). DES manufacturers often did not have direct contact with consumers nor maintain records

about who received their drugs from prescribers. See Sindell v. Abbott Labs., 607 P.2d 924, 930 (Cal.

1980).

194

See Hymowitz, 539 N.E.2d at 1072 (recognizing the predicament of DES victims when the

destruction of pharmaceutical records made finding the specific defendant who manufactured the DES

pill they consumed decades earlier unlikely).

195

See Cari Nierneberg, Prenatal Genetic Screening Tests: Benefits & Risks, LIVE SCI. (Dec. 18,

2014), http://www.livescience.com/45949-prenatal-genetic-testing.html [https://perma.cc/J45Z-K28H]

(explaining that genetic testing can determine or predict a child’s risk for a genetic disorder and can be

conducted after the first ten weeks of pregnancy).

346 Boston College Law Review [Vol. 59:319

such as sickle cell anemia or Down syndrome.

196

Presently, the worldwide pre-

natal testing market is expected to increase, between 2016 and 2022, at a rate of

28.85%.

197

With an expected $7.2 billion dollar market by 2022, the temptation

to use genetic scissors to eradicate chromosomal deformities prior to conception

are likely to mainstream germline modification at a rapid rate.

198

As a result of

widespread popularity and high demand, germline modifications are likely to

become so streamlined and generic that they may be used with such frequency

analogous to the prescription of drugs like DES.

199

B. Genetic Modification as a Fungible Product

To function like a fungible product, genetic companies would need to tar-

get the same genetic disease using the same modification process.

200

This

proves a more complicated inquiry than the DES cases since CRISPR-Cas9 is

a process, not a product like DES pills, and the altered gene may have reper-

cussions distinct to an individual’s genetic make-up.

201

Nonetheless, a court

196

Id.; see also What Is the Cost of Genetic Testing, and How Long Does It Take to Get the Re-

sults?, G

ENETICS HOME REFERENCE (Nov. 14, 2017), https://ghr.nlm.nih.gov/primer/testing/cost

results [https://perma.cc/T68C-Z363] (stating that genetic testing can cost between $100 to greater

than $2000 depending on the test, and that newborn screening usually ranges from $15 to $60 depend-

ing on the state and insurance coverage).

197

Global $7.2 Billion Prenatal Testing Market Analysis & Forecast Report 2016–2022, NASDAQ

GLOBE NEWSWIRE (Oct. 20, 2016), https://globenewswire.com/news-release/2016/10/20/881253/

0/en/Global-7-2-Billion-Prenatal-Testing-Market-Analysis-Forecast-Report-2016-2022.html [https://

perma.cc/5XVS-GW6H] (citing Research and Markets’ recent report on the prenatal genetic testing

industry). This growth in prenatal testing is due to a combination of factors such as affordable testing,

more known treatments for genetic disorders, and increasing cases of genetic disorders in the U.S.,

U.K, Japan, and India. See id.

198

See id. Many countries like the United States and Japan do not have enforceable regulations on

germline modifications. See Ledford, supra note 61. With little to no regulations and the popularity of

in vitro fertilization and genetic testing, the potential for human germline clinical trials does not ap-

pear far away. See id. (predicting that Japan will be the first to apply human germline modification

because of the popularity of in vitro fertilization).

199

See Carolyn Gregoire, How New Genetic Technologies Are Reshaping Pregnancy and Parent-

ing, H

UFFINGTON POST (Feb. 20, 2017), http://www.huffingtonpost.com/entry/genetic-testing-

babies_us_58a5c4bae4b037d17d25664d [https://perma.cc/2ZRA-GF4V] (describing the significant

impact genetic testing has on parents and commenting that although “designer babies may not be here

yet” the field of genetics is expanding rapidly). In the United States, one out of every thirty-three

babies is born with a genetic defect. Facts About Birth Defects, C

TRS. FOR DISEASE CONTROL (Oct.

11, 2016), https://www.cdc.gov/ncbddd/birthdefects/facts.html [https://perma.cc/Q6SE-EK6T].

200

See Rostron, supra note 128, at 163–68 (explaining that fungible products are those that are

“interchangeable” and create a similar risk of harm). For example, if a product from Company B is

considered “fungible” to a harmful product from Company A, then Company B’s product will also be

considered harmful and pose that same risk to consumers. See id.

201

See Begley, supra note 14 (quoting Dr. Joung, from Massachusetts General Hospital, that off-

target impacts “var[y] by ethnic group” and are unpredictable with today’s technology); see also Ce-

lotex, 471 So. 2d at 537–38 (refusing to apply market share liability to an asbestos-related harm in part

because of the different methods for manufacturing asbestos products, unlike DES, which was pro-

duced “pursuant to one formula”).

2018] The Price Tag on Designer Babies: Market Share Liability 347

may analogize the same formula used to manufacture DES, to companies using

the same gene modification process—CRISPR-Cas9—to insert or remove a

specific gene.

202

Moreover, prescribed DES pills often varied by concentration,

which shows that courts allowed for some variance.

203

Unlike asbestos products, where market share liability has not been ac-

cepted, germline modification differs in that CRISPR-Cas9 is likely to be

streamlined among the industries.

204

Instead of thousands of products contain-

ing different variations of a drug or chemical, germline modification is likely

to be the same for individuals who have a specific genetic abnormality that is

fixed using CRISPR-Cas9.

205

For instance, renowned Harvard scientist, David

Sinclair, exclaimed that scientists can use CRISPR to excise a defective gene

that causes Huntington’s disease—a fatal brain disease—from the germline

“before we generate your child.”

206

Thus, the fungible product would be a de-

fective Huntington’s disease germline modification.

207

202

See Hymowitz, 539 N.E.2d at 1072 (discussing the similar formula and use of DES pills pre-

scribed to pregnant women); Beale, supra note 36, at 4 (identifying CRISPR-Cas9 technology as the

“most widely used gene-editing technology” to date).

203

See Rostron, supra note 128, at 166 (describing how market share liability still applied to DES

manufacturers even though the concentrations of some pills were greater than others). In George v.

Parke-Davis, the Supreme Court of Washington grappled with how to spread liability among DES

manufacturers when the plaintiff’s DES dosage was a set quantity. See 733 P.2d 507, 512–13 (Wash.

1987). The court reasoned that it should only hold manufacturers liable that could have caused the

harm. See id. at 513.

204

See Case v. Fibreboard Corp., 743 P.2d 1062, 1065–66 (Okla. 1987) (refusing to apply market

share liability in an asbestos case because the lung disease could have come from any one of the 3000

asbestos products a typical person encounters); McNutt, supra note 36, at 1445 (praising CRISPR gene

editing technology as the 2015 breakthrough of the year that will lead to unprecedented advancements);

Antonio Regalado, U.S. Panel Endorses Designer Babies to Avoid Serious Disease, MIT

TECH. REV.

(Feb. 14, 2017), https://www.technologyreview.com/s/603633/us-panel-endorses-designer-babies-to-

avoid-serious-disease/ [https://perma.cc/M426-RSTN] (comparing CRISPR editing technology’s future

application to that of vaccines and how inserting a protective gene like ApoE can protect people from

developing Alzheimer’s).

205

Compare Case, 743 P.2d at 1065–66 (declaring that there are too many products with varying

concentrations of asbestos that could be the cause for lung disease decades later), with Regalado, su-

pra note 36 (explaining that CRISPR-Cas9 allows scientists to fix a heritable disease, like Hunting-

ton’s disease, by altering the gene defect in the germline). In addition to CRISPR-Cas9, a recent

CRISPR advancement called “base editing” allows for even more specific editing that changes only a

single letter. See Gallagher, supra note 81. Scientists predict this will decrease the likelihood of unin-

tentional edits in the germline since this base edit will prevent diseases caused by a single mutation.

See id.

206

Regalado, supra note 36 (quoting David Sinclair, a scientist and age specialist, that gene edit-

ing can eradicate diseases before symptoms develop).

207

See id.; Rostron, supra note 128, at 163–68 (summarizing what generally constitutes a “fungi-

ble product” as interchangeable, having equivalent risks across the industry, and controlled by the indus-

try).

348 Boston College Law Review [Vol. 59:319

Market share liability requires that the harm be attributable to any one of

the products provided by the industry.

208

For this reason, California courts have

extended market share liability to defective vaccine formulas, but not to negli-

gent administration of vaccines.

209

A CRISPR-Cas9 germline modification pro-

cedure to treat a specific disease may be similar enough to a defective vaccine

for courts to apply market share liability.

210

Whether or not harm will result from

flawed CRISPR-Cas9 applications and/or faulty genetic testing, or from the dis-

ease alteration procedure itself, will ultimately determine if CRISPR-Cas9 is a

fungible product.

211

C. Tracing the Cause of Genetic Defects Across Generations

Off-target impacts of a specific genetic alteration may be obvious and

consistent across victims, similar in nature to defective vaccines.

212

In fact,

proving that a genetic alteration caused cancer or a physical deformity may be

easier than connecting a DES pill to cancer.

213

Because an individual’s altered

genetic make-up is passed on to subsequent generations, a victim generations

208

See Hymowitz, 539 N.E.2d at 1072 (emphasizing the identical nature of the DES products

produced by hundreds of manufacturers).

209

Compare Sheffield v. Eli Lilly & Co., 144 Cal.App.3d 583, 594 (1983) (refusing to extend

market share liability to vaccine products that are not the result of a uniformly defective product, but a

“deviant defective vaccine”), with Morris v. Parke, Davis & Co., 667 F. Supp. 1332, 1342 (C.D. Cal.

1987) (extending market share liability to a vaccine after the plaintiff proved the vaccine itself was

defective).

210

See Morris, 667 F. Supp. at 1342–43 (allowing market share liability for production of a de-

fective vaccine); Regalado, supra note 36 (predicting germline engineering using CRISPR-Cas9 will

be “as important to this century as vaccines were to the last”); Regalado, supra note 204 (analogizing

the future application of gene editing to prevent diseases like Alzheimer’s to the present understanding

and application of vaccines).

211

See Begley, supra note 14 (noting that although many scientists are worried about the unpre-

dictable effect of gene modification on diverse populations, others are optimistic that advancing gene

technology will allow for more accurate risk assessment of off-target impacts). Given the unpredicta-

ble nature of genetic modification, the consequences for mass-consumers of these services are un-

known and difficult to predict. See id.

212

See 42 U.S.C. §§ 300aa-1 to 34 (2012) (creating a system to deal with the negative health

impacts from known defective vaccines in order to streamline victim recovery). Congress passed the

National Childhood Vaccine Injury Act in 1986 to facilitate victim remedies from vaccine injury

claims because specific vaccine injuries manifested themselves similarly in the victims. See The Na-

tional Childhood Vaccine Injury Act of 1986, N

AT’L VACCINE INFO. CTR. (Nov. 18, 2017), http://

www.nvic.org/injury-compensation/origihanlaw.aspx [https://perma.cc/A7QQ-KABF]. Victims only

need to prove by a preponderance of the evidence that they (1) took the vaccine listed on the Vaccine

Injury Table and (2) suffered one of the injuries listed on the table known to have been caused by that

particular vaccine. See 42 U.S.C. § 300aa-14.

213

See David Baltimore et al., A Prudent Path Forward for Genomic Engineering and Germline

Gene Modification, 348 S

CI. 36, 36 (2015) (detailing the groundbreaking combination of DNA se-

quencing and genome engineering, hailed as “precision medicine”); Gallagher, supra note 81 (hailing

the advancements in CRISPR technology which allow scientists to edit a single gene’s letter).

2018] The Price Tag on Designer Babies: Market Share Liability 349

down the line would have a copy of the manipulated gene.

214

Expert testimony

could probably point to the manipulated gene and statistical harm across simi-

larly altered people to prove causation.

215

Whereas DES plaintiffs are often

forced to rely on circumstantial evidence that a woman in their family took

DES while pregnant, which resulted in a mutated gene passed on to subsequent

generations that increased the risk for certain diseases, here the genetic altera-

tion can serve as proof of heritability.

216

For instance, children who underwent

genetic engineering to rid their germline of a defective gene that caused sickle-

cell anemia would continue to pass on that modified gene to subsequent gener-

ations.

217

Still, echoing the concerns of scientists everywhere, some off-target im-

pacts from germline modification may be unique to each individual’s genome

making it hard for plaintiffs to connect the side effects to a defective proce-

dure.

218

Additionally, an individual’s specific genome may interact differently

with the modified gene than in the majority of other users resulting in negative

health effects despite a perfectly executed modification process.

219

Genetic

companies are likely to argue, like DES manufacturers, that their connection to

a negative health defect is too attenuated to prove liability.

220

Without statisti-

214

See Barnett, supra note 19, at 555–56 (noting that changing a human germline is in fact chang-

ing someone’s genetic makeup, thus affecting “every cell in the body”).

215

See Role of DES Cohort Studies, supra note 96 (showing the role of DES studies in identifying

and tracking health repercussions from DES over generations and calculating a woman’s risk for de-

veloping certain cancers).

216

See Enright v. Eli Lilly & Co., 533 N.Y.S.2d 224, 228 (Sup. Ct. 1988) (noting the weak testi-

mony of women who are asked to identify a drug from decades past and show it was the cause of their

daughter’s premature birth); Genetic Testing for Hereditary Cancer Syndromes, N

AT’L CANCER INST.

(Apr. 11, 2013), https://www.cancer.gov/about-cancer/causes-prevention/genetics/genetic-testing-fact-

sheet [https://perma.cc/7NX5-QCT5] (explaining that genetic testing enables scientists to assess

someone’s genetic makeup for abnormalities and identify specific cancer-causing genes).

217

See Regalado, supra note 36 (contrasting germline engineering where the modified gene is

heritable since it is altered in the egg cell, with that of gene therapy, which helps relieve the symptoms

of a person already suffering from the disease, but the benefits are not passed on to future genera-

tions).

218

See Begley, supra note 14 (explaining the unpredictable nature of off-target impacts from

germline modification depending on an array of factors like ethnicity); Fu et al., supra note 13, at 822

(noting the high frequency of off-target mutations using CRISPR-Cas9 on human cells); Lander, su-

pra note 12, at 7 (cautioning that a gene alteration to protect against cancer might interact with other

genes and result in unpredictable consequences like early aging). Algorithms that were created to

estimate the risk of off-target effects from CRISPR-Cas9 gene editing have proven to be inaccurate in

practice. See Begley, supra note 14. Dr. Joung, a gene editing researcher at Massachusetts General

Hospital, commented that these algorithms “miss a fair number” of off-target impacts and “they really

aren’t very good at predicting where there will be off-target effects.” See id.

219

See Lander, supra note 12, at 7 (cautioning that genetic modifications may have unintended

negative health effects when interacting with other protective genes).

220

See Skerrett, supra note 74 (expressing the uncertainty and inability of scientists to predict the

consequences of germline editing on the human genome); Settlement Reached in Eli Lilly Pregnancy

Drug Linked to Breast Cancer Case, supra note 31 (reporting that the defendant told the jury there

was no proof that DES caused breast cancer in the daughters of women who took it, but the plaintiff

350 Boston College Law Review [Vol. 59:319

cal support of similarly altered people experiencing similarly harmful side-

effects, a plaintiff is unlikely to prove causation.

221

Hopefully, algorithms that

predict off-target effects and gene modification impact will become more pre-

cise, but consumers are probably willing to risk negative side-effects to avoid

passing on a deadly disease, such as Huntington’s disease or sickle cell ane-

mia, to their children.

222

D. Market Compensation for Genetic Defects

Compensating victims for a defective gene alteration proves challenging

because of the potential harm to generations of plaintiffs who inherit the defec-

tive gene sequence.

223

Courts will have to estimate not only the claimant’s pre-

sent harms and future medical bills, but also that of potential children suffering

from the genetic harm.

224

Until genetic modification of the germline undergoes

clinical trials, the scale of possible harm remains speculative.

225

Given the unique field of genetic alteration, gene companies are in the

best position to sustain liability without compromising consumer compensa-

tion for defective products.

226

CRISPR-Cas9 is hailed as a multi-million dollar

industry in which companies are investing and expanding rapidly.

227

National

pointed to a 2011 study by the National Cancer Institute that found an increased risk for breast can-

cer).

221

See E.E. Hatch et al., Prenatal Diethylstilbestrol Exposure and Risk of Obesity in Adult Wom-

en, 6 J.

DEVELOPMENTAL ORIGINS HEALTH AND DISEASE 201, 201–07 (2015) (describing that in

addition to dysfunctional reproductive organs, cancer, dangerous pregnancies, infertility, and early

menopause, taking DES while pregnant may also contribute to one’s increased risk of obesity).

222

See Fu et al., supra note 13, at 826 (studying the ability to predict off-target mutations, and

offering suggestions for increasing accurate predictions); Regalado, supra note 67 (explaining how

there are thousands of genetic diseases like Huntington’s disease without cures that CRISPR has the

potential to fix).

223

See Barnett, supra note 19, at 568–69 (cautioning researchers from prematurely engaging in

clinical trials because editing the human germline means those genes will be passed on to subsequent

generations); Begley, supra note 14 (emphasizing the potential devastating health effects from a ge-

netic alteration that goes wrong such as triggering a cancer-causing gene).

224

See In re New York County DES Litig., 211 A.D.2d 500, 500 (N.Y. App. Div. 1995) (affirm-

ing the jury verdict allowing damages for likelihood of disease). The court in In re New York County

DES Litigation found that jury damages awarded for severe and long-lasting diseases, as well as the

increased risk for new diseases, will be accepted if they do not “materially deviate” from a “reasona-

ble compensation.” See id.

225

See Open Letter Calls for Prohibition on Reproductive Human Germline Modification, supra

note 55 (calling for a moratorium on any clinical applications of germline genetic engineering until

further research clarifies its impact on the human gene pool); see also Skerrett, supra note 74 (sug-

gesting that the unintended effects of human genetic manipulation will be little different than when peo-

ple choose sex partners or encounter radiation or chemicals).

226

See Damron, supra note 182, at 520 (explaining why defendant manufacturers are in the best

position to compensate plaintiffs for their injuries: insurance, profit and resource aggregation, in-

creased product price to spread costs, and investment in safety).

227

See Genome Editing Market Worth $3,514.08 Million by 2019, supra note 67 (finding the

following companies to be leading the market: GenScript USA Inc. (U.S.), Horizon Discovery Group

2018] The Price Tag on Designer Babies: Market Share Liability 351

market share liability based on the culpability of the company to the public

ensures that newer companies will continue to compensate victims for harm

caused by older companies that eventually go out of business.

228

Under market

share liability, a company, as a market participant, will effectively assume the

bankrupt company’s tort debts regardless of whether it did so as a formal or

legal matter.

229

Simply by virtue of competing in the same market, new and

growing companies will keep tort collection alive.

230

In such a risk-intensive

and ethically charged industry, older genetic engineering companies will serve

to grow the market and create demand for new companies to enter.

231

Accordingly, successive companies paying for generational liability

stemming from older companies may be a necessary pre-market cost to enter

the genetic engineering business.

232

Without an entrance cost, subsequent

companies would be free-riding off companies who spearheaded a new indus-

try and generated public trust in a hotly debated and ethically disputed field.

233

plc (U.K.), Integrated DNA Technologies, Inc. (U.S.), Lonza Group Ltd. (Switzerland), New England

Biolabs, Inc. (U.S.), OriGene Technologies, Inc. (U.S.), Sangamo Biosciences, Inc. (U.S.), Sigma-

Aldrich Corporation (U.S.), Thermo Fisher Scientific, Inc. (U.S.), and Transposagen Biopharmaceuti-

cals, Inc. (U.S.)). A 2015 in depth report predicted the genome editing market will be worth $3.5 bil-

lion in four years. See id.

228

See Hymowitz, 539 N.E.2d at 1078 (requiring compensation from company defendants based

on the risk of harm each manufacturer defendant contributed to the public); R

OE & TUNG, supra note

173, at 336 (describing the potential insolvency of companies in mass tort compensation cases that

results in future tort victims not being compensated).

229

See Hymowitz, 539 N.E.2d at 1078; DOBBS, supra note 125, at § 194 (describing market share

liability as expressed in Hymowitz to mean that entrants who contributed to the tortious conduct even

if definitively not the particular offenders to the plaintiff individually, are still liable based on their

percent share in the national market).

230

See DOBBS, supra note 125, § 194 (requiring the market industry as a whole, including new

applicants, to be liable because they all have contributed to the public harm, should lead to more con-

sistent recoveries by future tort victims whose latent health effects occur after a company who con-

tributed to the harm has gone bankrupt).

231

See Barnett, supra note 19, at 569 (recounting the charged ethical debates about whether ge-

netically modified humans will result in disastrous gene pool complications or will provide unbelieva-

ble opportunities for genetic cures); Dorothy J. Glancy, Autonomous and Automated and Connected

Cars—Oh My! First Generation Cars in the Legal Ecosystem, 16

MINN. J.L. SCI. & TECH. 619, 657–

58 (2015) (analyzing potentially novel civil claims that “first generation” self-driving car manufactur-

ers must account for when creating this new market for consumers and other companies to enter).

232

See Collins v. Eli Lilly & Co., 342 N.W.2d 37, 48 (Wis. 1984) (explaining that the DES mar-

ket was “fluid” in that companies entered and exited frequently). Before entering a market, business

owners must understand the start-up costs both concrete, like capital expenditures for purchasing

products, and estimations, like expenses for advertising, training, and insurance. See Caron Beesley,

How to Estimate the Cost of Starting a Business from Scratch, S

MALL BUS. ASS’N (Sept. 27, 2016),

https://www.sba.gov/blogs/how-estimate-cost-starting-business-scratch [https://perma.cc/23SN-Y534]

(providing advice to entrepreneurs about how to estimate the costs of starting a business). Importantly,

these costs should be calculated based on the industry and requires a fact-intensive analysis. See id.

233

See Rathi, supra note 80 (noting the distinct change in public reaction between the first and

second Chinese research experiments on the human germline from that which “shocked” the public, to

that of an “annoyed shrug”).

352 Boston College Law Review [Vol. 59:319

Moreover, rather than allow a bankrupt genetic company to discharge its debts

to the detriment of a family who continues to suffer generations of health de-

fects, tort law can ensure that subsequent participants pay for that harm.

234

The

growing pains of this high-risk, high-reward industry will last for generations,

so pre-market costs ensure fairness to those who paved the way for others to

enter.

235

As noted earlier, the harm from a defective germline modification may be

consistent across victims leading to streamlined recovery or the off-target im-

pacts may be uniquely assessed according to each individual.

236

Regardless of

the impact, the repercussions of a faulty procedure can be passed to subsequent

generations resulting in massive medical costs.

237

Unlike the Court of Appeals

of New York’s 1991 decision in Enright v. Eli Lilly and Company, which justi-

fied limiting the liability of DES defendants to the third generation so that com-

panies could stay in business, genetic companies are likely to stay in the lucra-

tive business and be able compensate for multiple generations of recovery.

238

Lastly, gene companies should actively embrace market share liability.

239

First, embracing a broad concept of alternative liability, such as market share

234

See ROE & TUNG, supra note 173, at 336 (explaining the problem with mass tort compensation

in that future tort victims are poorly compensated, if at all, when companies declare bankruptcy).

235

See Barnett, supra note 19, at 568, 571 (noting that even if CRISPR-Cas9 is performed flaw-

lessly, there may still be off-target effects in other parts of the genome, so researchers may not know

the impact of a genetic alteration until after human testing).

236

See supra notes 212–222 and accompanying text (acknowledging the current uncertainty in

the long-term effects on humans from germline editing technology).

237

See supra notes 90–96 and accompanying text (describing the increased risks of cancer for

subsequent generations of DES daughters); Skerrett, supra note 74 (explaining that removing or edit-

ing a gene may have unintended effects like also removing a protective gene for cancer); Arlene

Weintraub, Even Insured Patients Are Overwhelmed By the Cost of Care, F

ORBES (Aug. 10, 2017),

https://www.forbes.com/sites/arleneweintraub/2017/08/10/even-insured-patients-are-overwhelmed-

by-the-cost-of-cancer-care/#1544f2f351c4 [https://perma.cc/KL7L-WUT3] (commenting on the rising

costs of cancer treatments in the U.S. and estimating that a new treatment for leukemia provided by

Novartis will cost $200,000 or more per patient).

238

See Enright, 570 N.E.2d at 204 (seeking to prevent companies from leaving the industry and

not creating beneficial products because of incurring too much liability, and instead recognizing a

manufacturer’s breach of duty towards those more directly impacted by the defective drugs); Genome

Editing Market Worth $3,514.08 Million by 2019, supra note 67 (estimating the genome market to be

worth $3.5 billion by 2019). In the August 2017 study in the United States, researchers successfully

repaired a mutation in a human embryo that if brought to term, would result in a child with none of the

unwanted mutations. See Pam Belluck, In Breakthrough, Scientists Edit a Dangerous Mutation from

Genes in Human Embryos, N.Y.

TIMES (Aug. 2, 2017), https://www.nytimes.com/2017/08/02/science/

gene-editing-human-embryos.html [https://perma.cc/3YD8-V5PK] (analyzing the recent research

advancements in decreasing off-target impacts and how this will affect future applications). Moreover,

the disease would not be passed on to any descendants. See id. This technology provides huge benefits

to families with one of the 10,000 specified heritable mutations, who can then make the choice to

eliminate this disease from their family line by electing to undergo the procedure. See id.

239

See Jim Gorzelany, Volvo Will Accept Liability for Its Self-Driving Cars, FORBES (Oct. 9,

2015), http://www.forbes.com/sites/jimgorzelany/2015/10/09/volvo-will-accept-liability-for-its-self-

driving-cars/#3c4e06973d80 [https://perma.cc/M9NY-8KVL] (describing the recent announcement by

2018] The Price Tag on Designer Babies: Market Share Liability 353

liability, may alleviate public policy concerns that fuel the regulatory road-

blocks preventing the commercialization of gene-editing technology.

240

assuring injured consumers that future recovery is possible, genetic companies

can pre-empt many concerns about liability and fears of leaving potential vic-

tims empty-handed.

241

Second, even catastrophic exposure to liability can be

priced into the technology as a cost of doing business—so long as the risk is

accurately known in advance.

242

ONCLUSION

When the stories of science fiction touch today’s reality, the legal and

health ramifications call for preparation. The exceptional implications of ge-

netically engineering children to be born without predispositions to genetic

diseases prove too beneficial not to be questioned. As companies—and na-

tions—begin to tap into these new markets and sell germline engineering like

they would a prescription drug or vaccine, tort liability must adapt to the unu-

sual circumstances. Entire family lines are at stake from a defective germline

procedure. In order to ensure continued compensation and to incentivize con-

servative entrance into the field, courts and legislatures should adopt the DES-

created market share liability in the context of genetic alteration. Market share

liability is an incomparable method to spread costs for the generational harm

an invaluable industry may inflict onto the public.

Volvo to be held strictly liable for any accidents with their self-driving vehicles). Genetic companies

can learn from another industry entering the unchartered territory of widespread tort liability: manufac-

turers of self-driving cars. See id. Companies that want to commercialize self-driving cars face hurdles

from regulators worried about liability to the public. See id. As a result, they have taken matters into their

own hands and pressured regulators into licensing their cars by taking responsibility for accidents. See id.

Currently the U.S. does not have federal laws or regulations on researchers modifying the human

germline. See Barnett, supra note 19, at 577–78. In fact, while the FDA has the authority to regulate

“human subjects,” gametes and embryos involved in human germline modification do not meet that

identification. See id. at 578. Once the embryos are inserted into a human, then the FDA can regulate

and prevent clinical trials. Id. By taking responsibility for defective procedures in an industry based on

market share liability, genetic companies may be able to further federal support for clinical trials.

Gorzelany, supra.

240

See Barnett, supra note 19, at 580 (stating that regulators and legislatures will most likely leap

into action before any clinical tests of human germline editing are actually performed in the U.S.).

241

See id. at 569, 580 (recounting the fiery ethical dilemmas facing society in whether genetically

modified humans will have consequences for the genome that humanity will regret forever or will

provide unbelievable opportunity for genetic cures).

242

See Jonathan Salem Baskin, What Will Self-Driving Cars Mean for Insurance?, FORBES (Apr.

18, 2016), http://www.forbes.com/sites/jonathansalembaskin/2016/04/18/what-will-self-driving-cars-

mean-for-insurance/#5b152b7db7a5 [https://perma.cc/89RY-A6LN] (answering the question of how

self-driving cars will impact insurance carriers). As one insurance director stated, “the purpose of

insurance is to let people go on with their lives, knowing that they’ll get help if something cata-

strophic happens.” See id. A genetically defective family line from a faulty procedure would certainly

qualify as a catastrophic event, and company insurance to cover off-target injuries, just as most states

require minimum auto insurance for drivers, can lead to greater assurance of victim compensation. See id.