Presentation given in 2015 : How much does litigation affect our practice of using assisted reproductive technologies for the management of infertility? What do we know and what are the issues surrounding this technology?

1. Dr. Anuradha Katragadda

2. Objective
How to avoid litigations
What to do when things go wrong
To identify the aspects of ART that are
most relevant to „present - day society‟
To discuss the multiple ethical, legal &
social challenges inherent to the
technology

3. Litigations
in our practice

4. Litigations in our practice
Reputation for being a highly litigous
speciality
In USA :-
Annually 11 % obst. & Gyn. face
malpractice suit
2.5 % result in pay out
100 % of obst. & Gyn. Over their medical
career -
Face a claim for medical negligence

5. Time limit for claims
Gynaecology -
Within „3 yrs‟ of injury or
date of knowledge of clinical negligence
Child -
3 yr period reach after their 18th birthday
i.e, until their 21st birthday
In birth injuries -
„ No time limit‟ applies, who lack capacity
Adult death -
With in 3 yrs of date of death

6. Why do doctors get sued ?
Accountability
• When things go wrong someone should be
held accountable for their actions
The need for an explanation
• To know how the injury happened & why
Concern with standards of care :
• The desire to prevent similar accidents in
future
Compensation
• For actual losses, pain & suffering or
• Provision of future care for an injured person

7. Deciding factors for legal action
Failure to provide information and
explanation & an apology
Insensitive handling of injury &
Poor communication after the
original incident

8. Anatomy of a claim
Medical defence organizations – receive several
thousand new claims / yr
Few, 1-2 % reach court
70 % chance that cases are successfully defended
Irrespective of outcomes, being sued is a
distressing experience
Usually 3 yrs. From the point a claim is made for the
case to reach a courtroom

9. Stages of claim

11. Elements of compensation award
Financial compensation :
„General damages‟
• Pain & suffering caused by the injury
• This includes an element to represent
personal inability to do things before the
incident
• Assessed using guidelines given to judges
and precedents from previous cases

12. „special damages‟
• Compensation is for past and future
losses and expenses
Most often, clinical negligence cases are
settled out of court

13. Aetiology of claims
A case of clinical negligence requires four
elements are met:
• Duty arising out of the physician –
patient relationship
• A breach of that duty
• A link between that breach of duty, &
• A specific harm that has occured

14. Common areas of litigation in
Gynaecology
Common cause of claims, 2012
Wrong / failed / delayed diagnosis
Inappropriate / failed / delayed
treatment
Intraoperative problems
Failure to obtain informed consent
Failure to recognise complication
Failure to perform operation / tests
Foreign body left in situ
Others
Claims by injury
Bladder damage / fistula
Unnecessary pain
Additional/unnecessary
operation(s)
Bowel damage / dysfunction
Cancer
Psychiatric / psychological damage
Perforation
Others

15. Consent
Why does
a one-hour
surgical operation
take a life time
to explain

16. Consent
Most patients are healthy with problems relating to
quality of life
Most surgery is elective
Expectations of the patients
• Are high and
• Litigation is often related to whether these are met
Signature on a consent form does not equate to
valid consent
The purpose is to record the patient‟s decision and
also the discussions that have taken place

17. • Ensure she understands –
the nature of the condition -
its prognosis, -benefits and risks inherent to
the procedure
• Likely consequences and risks
• Risks of receiving no treatment
• Realistic expectations following surgery
• Reasonable or accepted alternative treatments

18. „critical element‟ of an informed decision
• Discussion of the risks associated with
a clinical decision
• Uncertainties should be discussed
Performance of procedures that were not
discussed with the patient;
i.e, removal of both ovaries when
consented for one or none

19. Common procedures for litigation
Sterilization –
conception
post
sterilization
Laparoscopy
Colposcopy
• Physician
errors or
• Laboratory
errors
Hysteroscopy
Urogynaecology
• Increasingly, centred on the use of
meshes & related complications
Hysterectomy
• Ureteric injury most common cause –
failure to detect
Foreign body – (SUIs)
retained foreign bodies are – classified
as serious untoward incidents,
result in a payment of negligence
claims

20. Laparoscopy
Allegation of a lack of training, lack of expertise or
wrong choice of surgery
Most common cause is internal injury or delay in
recognition
„Difficult‟ to defend –
• Improper documentation
• Inappropriate management & monitoring
Laparotomy – patients should improve on a daily basis,
• In laparoscopic surgery; should on hourly basis
• Patients expectations should be fully met &
o Early recognition of warning signs

21. Recommendations to avoid
complications
Best possible vision maintained
at all times
Avoid use of sharp instruments
unless absolutely
necessary
Use of diathermy, ultrosonic
devices
• Require knowledge of their use
and utmost care
Rule out bowel injury after
primary trocar insertion
Check all areas of tissue
injury or bleeding on
completion
All trocar sites should be
inspected
Use a drain when
necessary
Appropriate contact
details need to be
given

22. Hysteroscopy
Litigation related to
• Failure of clinicians to adapt to the
demands of newer technologies
• Lack of adequate expertise when
performing complicated procedures
• Failure to recognise complications
during relatively simple procedures

23. Complications related to uterine perforation
& subsequent internal organ injury
Commonest cause is the failure to recognize
complication
Clinical negligence claims

24. Hysteroscopy
Factors that increase perforation risk
• Cervical stenosis
• Ac. Av / Rv
• Lower segment fibroids
• Intrauterine synechiae &
• Operator in experience

25. Hysteroscopy
„Red alert‟ – (Fatal complications)
• Fluid overload – causing Hyponatraemia
respiratory arrest & seizures
• Air-embolism: leading to collapse & death

26. Good documentation
Good communication
Accurate
representation
Discharge
instructions
Saying sorry
Integrity
Basic
principles
Avoiding
litigation

27. Good documentation
Old saying „if it‟ is not in the record,
It didn‟t happen,
Still hold true
Good record keeping :
• Information provided by the patient that lead to
diagnoses or treatment decisions,
• The physical findings or laboratory results that
factored into decisions,
• Treatment selected
• Anticipated follow-up

28. Restraints of time

29. Good communication
More important than high standards of care
A valid informed consent
• Is a „dialogue‟ , not a lecture
• To discuss
 Risks of treatment
 Benefits of treatment
 Alternatives to treatment
Including nothing &
Pros & cons of treatment

30. Serious long term sequelae, even if
remote must be discussed

31. Accurate representation
A doctor‟s greatest assest is their
advanced training & experience,
but imp. to work with in that remit
Imperative not to misrepresent their
experience
Give patients, realistic expectations
about their outcomes

32. Discharge Instructions
More procedures as day cases & inpatient stay
shorter
Should address all areas of potential concern,
including pain, wound care & signs of
infection
Information regarding contact details in case of
a query or emergency

33. Instructions

34. Saying sorry
Doctors are human
• Errors sometimes happen
Taking responsibility
doesn‟t mean admitting negligence
Acknowledge a complication & minimise
consequences
• May involve transferring care to another physician
When things go wrong :
vast majority want an explanation & an apology

35. Integrity
Own interests to
influence a
patients treatment
Higher standards
of conduct are
placed on medical
profession

37. Ethical issues
73 % feel practice is defensive for fear of
litigation
Additional & unnecessary tests are performed
These can be invasive & potentially harmful for
the patient
Drives up the health care concepts

38. Ethical issues …..
Impact on the health care professional
A malpractice suit has same impact as
• A major illness
• Loss of a loved one
• or a severe career set back
• Additional emotional consequences & involves
stages of grief
• Can cause irritability, headache, insomnia,
difficulty with concentration, clinical
depression & suicide

39. Ethical issues ……….
Increasing reluctance to join specialities
prone to litigation
• Obst. & Gyn. Is one of these
Deterrant for doctors to assist people in
emergency situations

40. Direct conflict of professional obligations &
a reluctance to be involved in a situation that
can land the clinician in a court room

41. Conclusion
In spite of the
best intentions,
high standards of care, &
attention to all issues discussed,
litigation claims may still be made
Individual awareness & adequate support
• Is the basis of coming through these stressful
situations &
• Keeping one‟s enthusiasm & zeal for continuing in
the profession intact

44. * To identify the
aspects of ART
that are most
relevant to
„present-day
society‟
* To discuss the
multiple ethical,
legal & social
challenges
inherent to the
technology
Object
-ive

46. Scope of ART Utilization
Explosion of IVF availability & use
More than 70 million couples with infertility,
worldwide
Use of ART services increased at a rate of 5 - 10 %
annually
USA 1996
• 60,000 IVF cycles
17,000 clinical preg.
14,000 live births
• Currently 1 % of all live births

47. Reporting Regulations
Legislation & professional societies attempt to
address the concerns
In 1980, focus on safe administration of
Gonadotrophins
 Transparency of pregnancy data
 Addressing economic barriers to ART access
Reporting ART
(like no. of ET, in USA)
 but no accompanying legislation defining
practice patterns

48. Centralized mandatory reporting registries
 General estimate of IVF activity
• To define current IVF statistics
• Take make information more transparent &
available
 Fertility clinic success rate & certification act,
1992 – USA
 HFEA
 IFFS – detailed accounting for ART reporting &
regulations across the globe
In 2010, - ART outcome data from 59
countries

49. Indian Legislation

52. Restricting no. of embryos transferred
To reduce social costs & health risks
associated with multiple births

53. Increased
efficacy of
IVF
Increased rate of
multiples
Trend towards „SET‟
Would in future
Decrease maternal &
health risk

54. CBRC
(cross-border reproductive care)
• Variability of legislation regulating IVF
in different countries & even with
in a single nation
• 10 % of total IVF cycles

55. Financial aspect for IVF
treatment
One of the most obvious ethical
challenges
Inequitable distribution of access to care
Significant economic barriers to IVF in
many countries

56. Highly variable funding structure
• USA –
o No federal Govt. funding
o Insurance mandate in certain states
• Many countries -
full or partial coverage
• Long waiting lists
• UK; 25 % of IVF cycles – funded by NHS

57. Pre-Implantation genetic
testing
PGS & PGD
• Offer unique ability to
„characterize
genetic composition‟
of embryos
Likely broader
implementation in future

58. PGS for sex-selection
• Controversial
• May offer substantial health benefit to
avoid sex-linked disorder
• Preferential PGD
May skew the gender proportions

59. Regulations to prevent tampering of the
scientific advances
• „Designer babies‟
 Refinement of microarray technologies to
define genetic sequences associated
with certain physical or mental
characteristics
• Manipulation of genetic material with in an
embryo
• Concerns on ethical & practical levels
Pre-Implantation genetic
testing (cont.)

60. Fertility preservation
Fertility declines with age
Oocyte cryopreservation
 Before advanced age
 For individuals affected with cancer
o Chemotherapy toxic to ovary
Techniques for freezing sperm & embryos
are well established

61. Lower pregnancy rates
• Oocyte cryopreservation using IVM
• Preservation of ov. cortex strips with
subsequent reimplantation & stimulation
Fertility preservation measures
• Should be offered before cancer treatment
Poses financial, ethical & social issues

62. Oocyte donation
• Introduced in 1980
• Visible increase
• Donor need to undergo IVF
 Inherent risks
• Medical, OHSS,, Surgical
 Informed consent & counselling
• Donor should participate voluntarily
• Financial compensation
 May lead to exploitation
• „buying or selling‟ of gametes-immoral
 Maintaining „anonymity‟ of Donor -
ability of human beings to know
their genetic roots is
universally important
 Right of Donor & Offspring to meet &
develop relationship – may
become more visible in the future
Use of Donor gametes
common place in ART
 Donor sperm
 Donor oocytes
Sperm donation
Can be traced to 1800
Gamete
donation

63. Embryo Donation
Ovarian stimulation –
Transfer of several embryos &
Cryopreserving other embryos
Surplus embryos –
Sometimes never used by genetic parents
Stored indefinitely
Nearly 4oo,ooo embryos currently cryopreserved
Dealing with these involve ethical & social
issues
Possible fate -
1. Thawing & discarding
2. Donating to research
3. Indefinite storage
4. Donating another couple
Myriad of laws governing -
Fierce debate relating to human stem cells
Varied laws from nation to nation

64. Surrogacy & gestational carriers
Surrogate –
pregnancy using her own oocyte
but sperm of another couple
Gestational carrier
• Carrier of couple‟s genetic
gametes
• More common
Significant medical &
emotional risks
• Extensive counselling
• Meticulous informed consent
• Concerns of “ child-selling” or
“sale of parental rights”
• Rights of birth mother,
regardless of genetic relation
Exploitation &
commoidification of
services
• Because of financial
pressures
International – surrogacy
• Emerging industry in
developing nations
• Difficult ethical l& legal
issues
• Citizenship issues of
offspring
• Largely unresolved
internationally

65. Possible deleterious effects of ART
Questions & concerns regarding IVF
Conflicting data on risks of IVF on developing
embryo

66. Multiple studies – failed to find clinically
relevant association bet. IVF,
embryo cryopreservation &
adverse maternal & fetal effects
Small but statistically significant
increased risk for rare epigenetic
& other abnormalities

67. General consensus –
small but measurable increased risk for
variety of congenital abnormalities –
including anatomic abnormalities &
imprinting errors
This may be secondary to increased baseline
risk
But, small increased risk may not be enough
powerful factor to dissuade infertile
couples

68. Conclusion
One of the most widely adopted and successful
medical technologies, in the last century
Present new ethical, legal & social questions that
society must address
Dynamic & ever changing
New technologies raise more controversies &
debates
Physicians to continually monitor these issues &
ensure that ART technologies are offered &
delivered in a manner that balances patients
care with social & moral responsibility
“ primum-non-nocere” first-do-no harm