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MEDICOLEGAL ASPECTS OF
HEAD AND NECK
ENDOCRINE SURGERY
D r U t k a l M i s h r a
A s s i s t a n t P r o f e s s o r , A I I M S B h o p a l
15/09/2021
LEGAL BASIS
• The legal basis of a malpractice suit rests on four
components.
• The essence of the case is usually the question “Did
the surgeon deviate from the standard of care?”
• The legal doctrine most commonly used by plaintiffs in
malpractice cases involving RLN injury is “res ipsa
loquitur”
The surgeon has entered into a relationship obligating
provision of care to the patient.
The surgeon violated the
“standard of care.”
The “substandard care” resulted in injury
to the patient.
This resulted in compensable damages to
the patient
Statistics of Medical negligence cases filled in various consumer
courts in India
https://www.researchgate.net/publication/335868242_Duty_to_ensure_quality_d
esign_and_safety_of_IOL_Manufacturer_Dealer_or_Treating_Doctor
THYROIDECTOMY
• The most common reason for litigation was vocal cord paralysis 51%
• Of those, 43% of cases (n = 12) were due to unilateral recurrent laryngeal nerve ( RLN) injury,
• and 39% (n = 11) were due to bilateral RLN injury.
• Of thyroidectomy-related claims, 11% went to trial and a third resulted in an indemnity
payment.
• 2nd – Spinal accessory nerve injury
• 3rd – Hypocalcaemia
• The most common nontechnical cause for malpractice suits related to the thyroid is the delayed
diagnosis of cancer.
• In USA standard of care for thyroid related procedures is defined by ATA guidelines.
Swonke ML, Shakibai N, Chaaban MR. Medical Malpractice Trends in Thyroidectomies among General
Surgeons and Otolaryngologists. OTO Open. 2020 May 13;4(2):2473974X20921141. doi:
10.1177/2473974X20921141. PMID: 32435722; PMCID: PMC7223205.
RLN
• Rates of permanent injury to the recurrent laryngeal nerve - 1%
• Identification of RLN in its entire course - is less likely to result in nerve injury and
represents the standard of care
• Preoperative laryngoscopy.
• Intraoperative recurrent laryngeal nerve monitoring
Malpractice Claims and the Parathyroid Glands
• Permanent hypoparathyroidism alone is rarely a reason for a malpractice suit.
• Failure to mention the parathyroids and maneuvers to preserve them in the operative
notes of a patient who ends up with permanent hypoparathyroidism is a difficult case
to defend.
• Parathyroid adenoma surgery –
Preoperative imaging,
Intraoperative parathyroid hormone (IOPTH) measurement.
CASE EXAMPLES
• https://mega.nz/file /ThpUHBRb#mlx4rDdimS8 tsjNpLe_2lK8crIoiKPRtauggqmjQzyg
• https://mega.nz/file /Wk4mDR5Q#1-zz2eEp-8jHIKQcNS3u7oOlIjbU6BkBlzSHcit3erw
• https://mega.nz/file /e5piUJCA#EhyOIvLGhIu637vLL4z95ikwzgctSli2OLiObLWkQhM
Points to note
• Lack of informed consent was cited in most number of malpractice suits.
• Frequently, the patients did not know their operating physicians.
• Although, most of the surgeons had a pre-operative discussion with their patients and
relatives, only rarely is this discussion documented.
• Official recommendations for obtaining informed consent for elective procedures -
more than 24 hours prior to the procedure.
• Wrong technique used for treatment is the next frequent complaint followed by
complications of the operations.
Bastia BK. Litigation suits in otorhinolaryngology - Areas of concern. Indian J Otolaryngol Head Neck Surg.
2006 Oct;58(4):370-3. doi: 10.1007/BF03049598. PMID: 23120351; PMCID: PMC3450379.
SURGEON–PATIENT RELATIONSHIP
• Patients must be willing to place so much trust in their surgeons that they are willing
to risk disfigurement and potentially permanent disability or even death at the hands of
the surgeon.
• A successful surgeon-patient relationship therefore requires a deep level of trust -
developed in a relatively short period of time of the preoperative visits.
• Surgeon must take this opportunity to teach patients regarding the anatomy, nature of
disease, treatment options, complications and quality of life.
Bastia BK. Litigation suits in otorhinolaryngology - Areas of concern. Indian J Otolaryngol Head Neck Surg.
2006 Oct;58(4):370-3. doi: 10.1007/BF03049598. PMID: 23120351; PMCID: PMC3450379.
INFORMED CONSENT
• In the current era of shared decision making, surgeons must approach the informed
consent process as a means of educating the patient on his/her condition so that the
patient can participate in the decision about whether to have surgery or not.
• Consent is explicit i.e. both person-specific, and procedure-specific.
• All the relevant information of the disease and treatment needs to be informed to the
patient.
• All significant and material risks are to be disclosed.
• The patient should also be informed about other alternative treatments available and
the consequence of no treatment at all.
• The entire conversation should be documented and signed by the patient or his
representative in presence of witness.
Bastia BK. Litigation suits in otorhinolaryngology - Areas of concern. Indian J Otolaryngol Head Neck Surg.
2006 Oct;58(4):370-3. doi: 10.1007/BF03049598. PMID: 23120351; PMCID: PMC3450379.
TECHNIQUES USED FOR TREATMENT
• A surgeon should try continuously to improve medical knowledge and skills.
• A surgeon should use one of the accepted methods prevailing at that time in medical
world.
• However, if there are two or more accepted views on a particular point, a surgeon is
free to accept any one depending upon his skill and expertise.
Bastia BK. Litigation suits in otorhinolaryngology - Areas of concern. Indian J Otolaryngol Head Neck Surg.
2006 Oct;58(4):370-3. doi: 10.1007/BF03049598. PMID: 23120351; PMCID: PMC3450379.
POST OP CARE
• It is accepted in the court of law that every operation has certain risk and known
complications which are sometimes beyond the control of the surgeon.
• The surgeon can not be held responsible for this natural phenomenon.
• But, if the surgeon is aware of the post-operative complications and does not attend
when it occurs, it is negligence.
• The operating surgeon is responsible for the postoperative care of the patient.
• A surgeon, after operation can not, without patient’s consent, hand over a patient to
some other doctor having lower qualification to take post-operative care.
• The surgeon is responsible for determining when the patient should be discharged
from the hospital.
Bastia BK. Litigation suits in otorhinolaryngology - Areas of concern. Indian J Otolaryngol Head Neck Surg.
2006 Oct;58(4):370-3. doi: 10.1007/BF03049598. PMID: 23120351; PMCID: PMC3450379.
OPERATIVE NOTES
• It has to be legible and comprehensive.
• It should include diagrams, if this explains the procedure.
• It must contain
– The names of the surgeon, assistants and the anesthetist who conducted the procedure.
– The indication for the operation
– Name of the procedure.
– Description of the position of the patient.
– Describe the site, shape and length of the incision and the structures that were divided to obtain access.
– The pathology needs to be described as seen in the operating field.
– The exact procedure should be described step by step.
– Any special procedure done or any special instruments used should also be documented.
– The method used for closure needs to be mentioned.
– Instructions regarding postoperative care are an important part of the note and must be clearly written.
– Any complications that may follow must be documented clearly.
– At the end of the operating note, the surgeon must sign it with his name and date.
• Like all the medical records, the operating note has to be preserved for at least three years.
TO REFER
• It is a basic duty of the doctor to handle only those cases which are within the limit of
his skill, knowledge and experience.
• He must take into consideration the availability of equipments, staff, medicine and
other circumstances also.
• Once a patient is under his care, it is negligence to leave the treatment halfway
especially when patient's condition is deteriorating.
• If a doctor finds on preliminary examination that, the case is beyond his capacity, it is
better to refer it to the consultant or a hospital at the earliest after giving primary
treatments only.
TAKE HOME MESSAGE
• Good communication
• Obtaining appropriate informed consent for treatment
• Keeping accurate and appropriate medical records
THANK YOU

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Medicolegal aspects of head and neck endocrine surgery

  • 1. MEDICOLEGAL ASPECTS OF HEAD AND NECK ENDOCRINE SURGERY D r U t k a l M i s h r a A s s i s t a n t P r o f e s s o r , A I I M S B h o p a l 15/09/2021
  • 2. LEGAL BASIS • The legal basis of a malpractice suit rests on four components. • The essence of the case is usually the question “Did the surgeon deviate from the standard of care?” • The legal doctrine most commonly used by plaintiffs in malpractice cases involving RLN injury is “res ipsa loquitur” The surgeon has entered into a relationship obligating provision of care to the patient. The surgeon violated the “standard of care.” The “substandard care” resulted in injury to the patient. This resulted in compensable damages to the patient
  • 3. Statistics of Medical negligence cases filled in various consumer courts in India https://www.researchgate.net/publication/335868242_Duty_to_ensure_quality_d esign_and_safety_of_IOL_Manufacturer_Dealer_or_Treating_Doctor
  • 4. THYROIDECTOMY • The most common reason for litigation was vocal cord paralysis 51% • Of those, 43% of cases (n = 12) were due to unilateral recurrent laryngeal nerve ( RLN) injury, • and 39% (n = 11) were due to bilateral RLN injury. • Of thyroidectomy-related claims, 11% went to trial and a third resulted in an indemnity payment. • 2nd – Spinal accessory nerve injury • 3rd – Hypocalcaemia • The most common nontechnical cause for malpractice suits related to the thyroid is the delayed diagnosis of cancer. • In USA standard of care for thyroid related procedures is defined by ATA guidelines. Swonke ML, Shakibai N, Chaaban MR. Medical Malpractice Trends in Thyroidectomies among General Surgeons and Otolaryngologists. OTO Open. 2020 May 13;4(2):2473974X20921141. doi: 10.1177/2473974X20921141. PMID: 32435722; PMCID: PMC7223205.
  • 5. RLN • Rates of permanent injury to the recurrent laryngeal nerve - 1% • Identification of RLN in its entire course - is less likely to result in nerve injury and represents the standard of care • Preoperative laryngoscopy. • Intraoperative recurrent laryngeal nerve monitoring
  • 6. Malpractice Claims and the Parathyroid Glands • Permanent hypoparathyroidism alone is rarely a reason for a malpractice suit. • Failure to mention the parathyroids and maneuvers to preserve them in the operative notes of a patient who ends up with permanent hypoparathyroidism is a difficult case to defend. • Parathyroid adenoma surgery – Preoperative imaging, Intraoperative parathyroid hormone (IOPTH) measurement.
  • 7. CASE EXAMPLES • https://mega.nz/file /ThpUHBRb#mlx4rDdimS8 tsjNpLe_2lK8crIoiKPRtauggqmjQzyg • https://mega.nz/file /Wk4mDR5Q#1-zz2eEp-8jHIKQcNS3u7oOlIjbU6BkBlzSHcit3erw • https://mega.nz/file /e5piUJCA#EhyOIvLGhIu637vLL4z95ikwzgctSli2OLiObLWkQhM
  • 8. Points to note • Lack of informed consent was cited in most number of malpractice suits. • Frequently, the patients did not know their operating physicians. • Although, most of the surgeons had a pre-operative discussion with their patients and relatives, only rarely is this discussion documented. • Official recommendations for obtaining informed consent for elective procedures - more than 24 hours prior to the procedure. • Wrong technique used for treatment is the next frequent complaint followed by complications of the operations. Bastia BK. Litigation suits in otorhinolaryngology - Areas of concern. Indian J Otolaryngol Head Neck Surg. 2006 Oct;58(4):370-3. doi: 10.1007/BF03049598. PMID: 23120351; PMCID: PMC3450379.
  • 9. SURGEON–PATIENT RELATIONSHIP • Patients must be willing to place so much trust in their surgeons that they are willing to risk disfigurement and potentially permanent disability or even death at the hands of the surgeon. • A successful surgeon-patient relationship therefore requires a deep level of trust - developed in a relatively short period of time of the preoperative visits. • Surgeon must take this opportunity to teach patients regarding the anatomy, nature of disease, treatment options, complications and quality of life. Bastia BK. Litigation suits in otorhinolaryngology - Areas of concern. Indian J Otolaryngol Head Neck Surg. 2006 Oct;58(4):370-3. doi: 10.1007/BF03049598. PMID: 23120351; PMCID: PMC3450379.
  • 10. INFORMED CONSENT • In the current era of shared decision making, surgeons must approach the informed consent process as a means of educating the patient on his/her condition so that the patient can participate in the decision about whether to have surgery or not. • Consent is explicit i.e. both person-specific, and procedure-specific. • All the relevant information of the disease and treatment needs to be informed to the patient. • All significant and material risks are to be disclosed. • The patient should also be informed about other alternative treatments available and the consequence of no treatment at all. • The entire conversation should be documented and signed by the patient or his representative in presence of witness. Bastia BK. Litigation suits in otorhinolaryngology - Areas of concern. Indian J Otolaryngol Head Neck Surg. 2006 Oct;58(4):370-3. doi: 10.1007/BF03049598. PMID: 23120351; PMCID: PMC3450379.
  • 11. TECHNIQUES USED FOR TREATMENT • A surgeon should try continuously to improve medical knowledge and skills. • A surgeon should use one of the accepted methods prevailing at that time in medical world. • However, if there are two or more accepted views on a particular point, a surgeon is free to accept any one depending upon his skill and expertise. Bastia BK. Litigation suits in otorhinolaryngology - Areas of concern. Indian J Otolaryngol Head Neck Surg. 2006 Oct;58(4):370-3. doi: 10.1007/BF03049598. PMID: 23120351; PMCID: PMC3450379.
  • 12. POST OP CARE • It is accepted in the court of law that every operation has certain risk and known complications which are sometimes beyond the control of the surgeon. • The surgeon can not be held responsible for this natural phenomenon. • But, if the surgeon is aware of the post-operative complications and does not attend when it occurs, it is negligence. • The operating surgeon is responsible for the postoperative care of the patient. • A surgeon, after operation can not, without patient’s consent, hand over a patient to some other doctor having lower qualification to take post-operative care. • The surgeon is responsible for determining when the patient should be discharged from the hospital. Bastia BK. Litigation suits in otorhinolaryngology - Areas of concern. Indian J Otolaryngol Head Neck Surg. 2006 Oct;58(4):370-3. doi: 10.1007/BF03049598. PMID: 23120351; PMCID: PMC3450379.
  • 13. OPERATIVE NOTES • It has to be legible and comprehensive. • It should include diagrams, if this explains the procedure. • It must contain – The names of the surgeon, assistants and the anesthetist who conducted the procedure. – The indication for the operation – Name of the procedure. – Description of the position of the patient. – Describe the site, shape and length of the incision and the structures that were divided to obtain access. – The pathology needs to be described as seen in the operating field. – The exact procedure should be described step by step. – Any special procedure done or any special instruments used should also be documented. – The method used for closure needs to be mentioned. – Instructions regarding postoperative care are an important part of the note and must be clearly written. – Any complications that may follow must be documented clearly. – At the end of the operating note, the surgeon must sign it with his name and date. • Like all the medical records, the operating note has to be preserved for at least three years.
  • 14. TO REFER • It is a basic duty of the doctor to handle only those cases which are within the limit of his skill, knowledge and experience. • He must take into consideration the availability of equipments, staff, medicine and other circumstances also. • Once a patient is under his care, it is negligence to leave the treatment halfway especially when patient's condition is deteriorating. • If a doctor finds on preliminary examination that, the case is beyond his capacity, it is better to refer it to the consultant or a hospital at the earliest after giving primary treatments only.
  • 15. TAKE HOME MESSAGE • Good communication • Obtaining appropriate informed consent for treatment • Keeping accurate and appropriate medical records

Notas del editor

  1. which in Latin means “the thing speaks for itself.”
  2. The standard of care cannot mandate that the nerve actually be identified but rather that every attempt should be made to do so and that these attempts should be documented in the operative notes. If the nerve cannot be identified, the reasons for this and whatever other strategies were employed to minimize the risk of nerve injury should be similarly documented.
  3. and should make available to their patients by participating in professional meetings as part of continuing medical education programmes.