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What Doesn’t Kill Your Tort Only Makes it
Stronger – Why Not Regulate Too?
Response to Birth Rights & Wrongs by Dov Fox
Harvard Law School, 2019
Katherine L. Kraschel
Lecturer in Law
Executive Director
Solomon Center for Health Law and Policy
Yale Law School
2
• Regulatory Vacuum
• Regulations Strengthen (establish cause of
action, specific breach/liability)
• Regulations are required? (role of licensing)
• Regulations are better? (small damages)
Regulatory Vacuum - Federal
3
Fertility Clinic Success Rate and Certification Act
(1992)
• Report pregnancy rates
• No penalty or incentive
• FDA directive to screen for infectious disease
• CARVE OUT – forbid FDA from supervision or
control over “practice of medicine”
Regulatory Vacuum - States
4
• Stem Cells
• Embryo Disposition
• Surrogacy
• Insurance Mandates
• Utah – access to medical history of genetic
parents
• Louisiana – “possess specialized training and skill”
• Lax medical boards? (Dr. Salem)
Regulatory Vacuum – Professional Organizations
5
• American Society for Reproductive Medicine
o Completely voluntary
o No sanction sanction/audit authority
• College of American Pathologists
o Optional Accreditation
Regulatory Vacuum Drivers
6
1) Libertarian outlook on reproductive life
2) Political economy of reproductive
technology in US
3) Murky electoral implications
4) Limited public outcry
(p 28-30)
Establish Cause of Action: Example HIPAA
7
“When acknowledging new causes of action…we remain acutely
aware of relevant statutes and do not ignore the statement of public
policy that such statutes represent…. HIPAA and its implementing
regulations may be utilized to inform the standard of care applicable
to such claims arising from allegations of negligence in the disclosure
of patients' medical records…”
Byrne v. Avery Ctr. for Obstetrics & Gynecology, P.C., 327 Conn. 540, 557, 175 A.3d 1, 11
(2018)”
Establish Breach/Liability – Tracking/Testing
8
“Plaintiffs can’t point to when their test results get
switched or sperm samples go missing.” (p 37)
Establish Duty – Licensing
9
“Even when there’s no disputing that the reproductive injury is
serious, courts must also determine whether professional
misconduct is what caused procreation to be imposed.” (p 121)
“By contrast, sperm bank operators, fertility doctors, and/or
OB/GYNs all assume just this sort of obligation toward their
patients.” (p 79)
Adoption and handling corpses examples – both licensed!
Establish Duty – Licensing (Or Not?)
10
“Alleged that the defendant discarded ovarian tissue that was supposed to
remain cryogenically stored; no medical treatment or procedure was
occurring at the time. Thus, although the defendant is sued in its capacity as
a medical care provider, the alleged negligence at issue did not require
professional judgment or the performance of any particular medical skill.
Accordingly, because the claims in this case stem from the disposal of tissue
that should not have been discarded—an act that is tantamount to poor
record keeping and which does not require any medical expertise—the court
concludes that the standards governing ordinary negligence apply.”
Witt v. Yale-New Haven Hosp., 51 Conn. Supp. 155, 159, 977 A.2d 779, 783 (Super. Ct. 2008)
Confounded Procreation – Inefficient Litigation
11
“The injury of skin-deep or nonmedical traits, as when
reproductive negligence frustrates efforts to choose an
egg donor who isn’t short, colorblind, or nearsighted – or
a sperm donor without a big nose, male-pattern baldness,
or ‘bat’ ears that stick out to the side…don’t usually
impede normal functioning…modest or negligible harms.”
(p 131)
Wendy, Janet, Xytex, and “Donor” 9623
12
“…brought suits against Xytex for legal claims ranging from
negligence, fraud, and false advertising to products
liability, breach of warranty, and a battery-by-
insemination. Every case that didn’t settle was summarily
dismissed.” (p 166)
How could this result be different bolstered by regulation?
Thank you!
13
Regulatory Vacuum Driver – Political Economy
of Reproductive Technology
14
“Free market origins of infertility treatment insulate it
from the surveillance that government usually conducts
over doctors and scientists…This multibillion-dollar
industry sustains powerful lobbying forces that block
efforts to rein in its operation.” (p 29)
Political Economy of Reproductive Technology
15
Most compelling – but is it insurmountable?
Murky Electoral Implications
16
“Conservatives legislation abortion and contraception all
the time in the name of family values and unborn life. But
reproductive negligence raises hard new questions that go
beyond traditional family values and the sanctity of
unborn life…answers provoke turmoil even in reliably red
or blue districts, because they drive a wedge within core
voting blocks.” (p 30)
Murky Electoral Implications
17
Isn’t this implicated by focusing on damages (tort) but
NOT if we frame as regulating the practice or services of
the industry?
Limited Public Outcry
18
“But there’s no groundswell of civic agitation to replace
even medical malpractice with a no-fault system like the
one New Zealand and the Nordic countries administer for
personal injuries by doctors and hospitals, drugs and
devices.” (p 30)
Limited Public Outcry
19
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Katherine L. Kraschel, "What Doesn't Kill Your Tort Only Makes It Stronger -- Why Not Regulate, Too?"

  • 1. What Doesn’t Kill Your Tort Only Makes it Stronger – Why Not Regulate Too? Response to Birth Rights & Wrongs by Dov Fox Harvard Law School, 2019 Katherine L. Kraschel Lecturer in Law Executive Director Solomon Center for Health Law and Policy Yale Law School
  • 2. 2 • Regulatory Vacuum • Regulations Strengthen (establish cause of action, specific breach/liability) • Regulations are required? (role of licensing) • Regulations are better? (small damages)
  • 3. Regulatory Vacuum - Federal 3 Fertility Clinic Success Rate and Certification Act (1992) • Report pregnancy rates • No penalty or incentive • FDA directive to screen for infectious disease • CARVE OUT – forbid FDA from supervision or control over “practice of medicine”
  • 4. Regulatory Vacuum - States 4 • Stem Cells • Embryo Disposition • Surrogacy • Insurance Mandates • Utah – access to medical history of genetic parents • Louisiana – “possess specialized training and skill” • Lax medical boards? (Dr. Salem)
  • 5. Regulatory Vacuum – Professional Organizations 5 • American Society for Reproductive Medicine o Completely voluntary o No sanction sanction/audit authority • College of American Pathologists o Optional Accreditation
  • 6. Regulatory Vacuum Drivers 6 1) Libertarian outlook on reproductive life 2) Political economy of reproductive technology in US 3) Murky electoral implications 4) Limited public outcry (p 28-30)
  • 7. Establish Cause of Action: Example HIPAA 7 “When acknowledging new causes of action…we remain acutely aware of relevant statutes and do not ignore the statement of public policy that such statutes represent…. HIPAA and its implementing regulations may be utilized to inform the standard of care applicable to such claims arising from allegations of negligence in the disclosure of patients' medical records…” Byrne v. Avery Ctr. for Obstetrics & Gynecology, P.C., 327 Conn. 540, 557, 175 A.3d 1, 11 (2018)”
  • 8. Establish Breach/Liability – Tracking/Testing 8 “Plaintiffs can’t point to when their test results get switched or sperm samples go missing.” (p 37)
  • 9. Establish Duty – Licensing 9 “Even when there’s no disputing that the reproductive injury is serious, courts must also determine whether professional misconduct is what caused procreation to be imposed.” (p 121) “By contrast, sperm bank operators, fertility doctors, and/or OB/GYNs all assume just this sort of obligation toward their patients.” (p 79) Adoption and handling corpses examples – both licensed!
  • 10. Establish Duty – Licensing (Or Not?) 10 “Alleged that the defendant discarded ovarian tissue that was supposed to remain cryogenically stored; no medical treatment or procedure was occurring at the time. Thus, although the defendant is sued in its capacity as a medical care provider, the alleged negligence at issue did not require professional judgment or the performance of any particular medical skill. Accordingly, because the claims in this case stem from the disposal of tissue that should not have been discarded—an act that is tantamount to poor record keeping and which does not require any medical expertise—the court concludes that the standards governing ordinary negligence apply.” Witt v. Yale-New Haven Hosp., 51 Conn. Supp. 155, 159, 977 A.2d 779, 783 (Super. Ct. 2008)
  • 11. Confounded Procreation – Inefficient Litigation 11 “The injury of skin-deep or nonmedical traits, as when reproductive negligence frustrates efforts to choose an egg donor who isn’t short, colorblind, or nearsighted – or a sperm donor without a big nose, male-pattern baldness, or ‘bat’ ears that stick out to the side…don’t usually impede normal functioning…modest or negligible harms.” (p 131)
  • 12. Wendy, Janet, Xytex, and “Donor” 9623 12 “…brought suits against Xytex for legal claims ranging from negligence, fraud, and false advertising to products liability, breach of warranty, and a battery-by- insemination. Every case that didn’t settle was summarily dismissed.” (p 166) How could this result be different bolstered by regulation?
  • 14. Regulatory Vacuum Driver – Political Economy of Reproductive Technology 14 “Free market origins of infertility treatment insulate it from the surveillance that government usually conducts over doctors and scientists…This multibillion-dollar industry sustains powerful lobbying forces that block efforts to rein in its operation.” (p 29)
  • 15. Political Economy of Reproductive Technology 15 Most compelling – but is it insurmountable?
  • 16. Murky Electoral Implications 16 “Conservatives legislation abortion and contraception all the time in the name of family values and unborn life. But reproductive negligence raises hard new questions that go beyond traditional family values and the sanctity of unborn life…answers provoke turmoil even in reliably red or blue districts, because they drive a wedge within core voting blocks.” (p 30)
  • 17. Murky Electoral Implications 17 Isn’t this implicated by focusing on damages (tort) but NOT if we frame as regulating the practice or services of the industry?
  • 18. Limited Public Outcry 18 “But there’s no groundswell of civic agitation to replace even medical malpractice with a no-fault system like the one New Zealand and the Nordic countries administer for personal injuries by doctors and hospitals, drugs and devices.” (p 30)