SC holds Medical Negligence during Appendicitis Surgery, rejects NCDRC’s Application of Eggshell-Skull Rule

New Delhi: Setting aside the order of the National Consumer Disputes Redressal Commission (NCDRC), which had reduced the compensation awarded to a patient for medical negligence during appendicitis surgery, the Supreme Court has enhanced the amount to Rs 5 lakh. The apex court noted that the patient suffered persistently post-surgery due to a deficiency in service by the doctor and the hospital.

The treating hospital based in Mandi, Himachal Pradesh and its doctors were held negligent for leaving a needle during the surgery back in 2005. While considering the matter, the Apex Court bench of Justices Sanjay Karol and Aravind Kumar restored the order passed by the District Consumer Court after it rejected NCDRC’s decision to apply the ‘Eggshell-Skull Rule’ in the case.

“A person who has an eggshell skull is one who would be more severely impacted by an act, which an otherwise “normal person” would be able to withstand. Hence the term eggshell to denote this as an eggshell is by its very nature, brittle. It is otherwise termed as “taking the victim as one finds them” and, therefore, a doer of an act would be liable for the otherwise more severe impact that such an act may have on the victim,” the Supreme Court noted.

“In regard to the application of the Eggshell-Skull Rule, we may observe that the impugned judgment is silent as to how this rule applies to the present case. Nowhere is it mentioned, as to what criteria had been examined, and then, upon analysis, found to be met by the claimant-appellant for it to be termed that she had an eggshell skull, or for that matter, what sort of pre-existing condition was she afflicted by, making her more susceptible to such a reaction brought on because of surgery for appendicitis,” the Supreme Court bench observed.

The history of the case goes back to 2005, when the petitioner patient was admitted to Suket Hospital, Mandi, Himachal Pradesh and had her appendicitis removed by a senior surgeon of the hospital Dr. Chauhan. After the surgery, she was discharged. However, following this, she suffered continuous pains near the surgical site and had to get readmitted after around one month. She was discharged the next day with the assurance that no further pain would be suffered by her.

Later, she was treated by another Dr. Vaidya of Mandav Hospital, Mandi, on the reference of Dr. Chauhan. However, allegedly her suffering did not end and it continued for a period of four years.

Eventually, the patient approached the Post Graduate Institute of Medical Science, Chandigarh and after investigation, it was found that a 2.5 cm foreign body (needle) was “present below the anterior abdominal wall in the preveside region just medial to previous abdominal scar (Appendectomy)” for which a further surgery was required for its removal.

Thereafter, alleging negligence by Suket Hospital, the patient filed a consumer complaint and claimed compensation of Rs 19,80,000 for the “huge pain and spent money on treatment”.

While considering the case, the District Consumer Forum, Mandi noted that the patient had to suffer physical pain for more than five years due to negligence and noting this, the Forum awarded Rs 5 lakh lump sum compensation to the Complainant.

The order was challenged before the State Commission, which noted that the “needle was not left at the site of surgery, at the Hospital of the appellants, when the complainant was operated for removal of appendicitis, yet from an overall reading of the pleadings and evidence on record, it can be said that surgery conducted at the clinic of the appellants, was the cause of pain…”

Therefore, the State Commission reduced the amount of compensation and directed the hospital and its doctors to pay Rs 1 lakh compensation for the physical pain, mental agony and expenses incurred by the appellant.

Consequently, the matter came to be considered by the NCDRC bench, which observed that the post-operative care provided by the hospital and doctors was casual and fell short of the standard of medical care. It opined that they had failed to investigate the non-healing surgical wound thereby constituting a deficiency in service. 

The egg-skull rule was applied to hold an individual liable for all consequences of their act. The compensation awarded by the State Commission was enhanced to Rs.2,00,000. Therefore, challenging the NCDRC order, the appellant approached the Supreme Court bench seeking enhancement of the compensation.

Taking note of the earlier orders passed in the case, the Supreme Court bench observed, “The factum of negligence on the part of the respondent Hospital as well as respondent No.2 has not been doubted, across fora. Although the State Commission had differed with the District Forum on the presence of the needle, the NCDRC, in para 5 of the impugned judgment and order, found the medical record to testify to the presence of a needle in the abdomen and also found that the respondent Hospital was found wanting in terms of post-operative care.”

The Apex Court noted that the primary ground alleged, in submitting that the finding of medical negligence is unjustified, was that there has been a recorded gap of time where the appellant did not suffer from any pain (1½ years). However, the bench noted that NCDRC observed her period of suffering to be more than 5 years,

“implying thereby that the gap in suffering aspect has not been accepted. No material has been placed before us to take a different view therefrom…we are only required to examine the sufficiency of compensation as awarded by way thereof. The same, though, cannot be appositely done without having appreciated pronouncements of this Court on the scope and purpose of the Consumer Protection Act; medical negligence; and compensation in such cases as also, the rule of tort law known as the ‘eggshell skull’ rule.”

In respect of the eggshell skull rule, which was applied by NCDRC, the Supreme Court bench noted that this rule holds the injured liable for damages that exceed the amount that would normally be expected to occur. It is a common law doctrine that makes a defendant liable for the plaintiff’s unforeseeable and uncommon reactions to the defendant’s negligent or intentional tort.

To put it simply, a person having an eggshell skull would be the one who would be more severely impacted by an Act, which an otherwise “normal person” would be able to withstand. “Hence the term eggshell to denote this as an eggshell is by its very nature, brittle. It is otherwise termed as “taking the victim as one finds them” and, therefore, a doer of an act would be liable for the otherwise more severe impact that such an act may have on the victim,” explained the Supreme Court.

The Supreme Court bench noted that in order to invoke and apply this rule appropriately, the person in whose case an adjudicatory authority applies must have a pre-existing condition falling into either of the four following categories.

It was noted by the Apex Court that the jurisprudence of the application of this rule, as has developed, (needless to add, in countries other than India) has fit into four categories- first, when a latent condition of the plaintiff has been unearthed; second, when the negligence on the part of the wrongdoer re-activates a plaintiff’s pre-existing condition that had subsided due to treatment; third, wrongdoer’s actions aggravate known, pre-existing conditions, that have not yet received medical attention; and fourth, when the wrongdoer’s actions accelerate an inevitable disability or loss of life due to a condition possessed by the plaintiff, even when the eventuality would have occurred with time, in the absence of the wrongdoer’s actions.

“As these categories and, the name of the rule itself suggest, the persons to whose cases this rule can be applied, are persons who have pre-existing conditions,” noted the Supreme Court bench.

Referring to previous legal precedent set by the courts across the world, the Supreme Court bench noted,

“we find the manner in which compensation stood reduced by the State Commission as also the NCDRC, vis-à-vis the District Forum to be based on questionable reasoning.”

The Supreme Court bench noted that the State Commission recognized that the appellant was not treated “with the care expected at a medical clinic”, and she had been suffering from persistent pain right from 2005 until December 2008, and the post-surgical care was deficient and “yet found it appropriate to reduce the compensation to a mere Rs.1 lakh. This clearly is not in line with the balance of interests required to be borne in mind while determining compensation.”

Similarly, referring to the NCDRC judgment, the Apex Court observed,

“The NCDRC observed that the claimant-appellant’s treatment at the respondent-Hospital was ‘casual’; that the excuse of having sought treatment at other hospitals was not available to the respondents and that she had suffered pain for more than 5 years apart from the case having been dragged on for more than a decade, and yet lumpsum compensation was only Rs.2 lakhs.”

“How could such compensation be justified, after observations having been made regarding the service rendered by the Hospital, being deficient, and the continuous pain and suffering on the part of the claimant-appellant, is something we fail to comprehend. Compensation by its very nature, has to be just. For suffering, no part of which was the claimant-appellant’s own fault, she has been awarded a sum which can, at best, be described as ‘paltry’,” it further noted.

In respect of the application of the Eggshell-Skull Rule, the bench observed that the judgment did not mention as to what criteria had been examined, and after analysis, was found to be met by the claimant-appellant for it to be termed that she had an eggshell skull. The NCDRC order did not specify what sort of pre-existing condition was she afflicted by, making her more susceptible to such a reaction brought on because of surgery for appendicitis, noted the Apex Court.

“If we take the rule as exposited by the NCDRC, even then it stands to reason that the record ought to have been speaking of a pre-existing vulnerability or medical condition, because of which the victim may have suffered ‘unusual damage’. However, none of the orders – be it District, State Commission or the NCDRC refer to any such condition,” it further noted.

With this observation, the Supreme Court bench set aside the NCDRC order and the order passed by the State Commission and restored the District Forum’s order of awarding Rs 5 lakh compensation.

The Supreme Court noted, “Considering the discussion as aforesaid, we deem it fit to set aside the Awards of the NCDRC as also the State Commission and restore the Award as passed by the District Forum, meaning thereby that a sum of Rs.5 lakhs ought to be paid expeditiously by the respondents to the appellant for being medically negligent and providing services deficient in nature. The sum of Rs.5 lakhs shall be accompanied by interest simple in nature @ 9% from the date of the award passed by the District Forum. The same be paid within a period of four weeks from the date of this judgment. Additionally, a cost of Rs.50,000/- be paid in terms of the cost of litigation. The appeal is accordingly allowed.”

To view the order, click on the link below:

https://medicaldialogues.in/pdf_upload/supreme-court-eggshell-skull-rule-236841.pdf

Also Read: Mens rea as intent not necessary in Medical negligence cases, Following Established procedure is: Supreme Court

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GSK Gets CDSCO Panel Nod to Study antimalarial drug Tafenoquine

New Delhi: The pharmaceutical major GSK has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the Phase III clinical trial of the antimicrobial drug Tafenoquine Tablets 50 mg /150 mg, used to prevent and to treat malaria.

However, this approval is subject to the condition that GSK should submit Independent data monitoring committee (IDMC) recommendations along with interim analysis reports of pediatric participants 12 to 18 years of age as per the protocol.

This came after the drug maker GSK presented the proposal along with the Phase III clinical trial protocol of Tafenoquine tablets 50mg/150 mg before the committee.

Tafenoquine belongs to a group of medicines, called antiprotozoals. It works by treating malaria, a red blood cell infection transmitted by the bite of a mosquito. It also prevents the development of the blood forms of the parasite, which are responsible for the relapse.

The mechanism of action of tafenoquine is not well established but studies have reported a longer and more effective action when compared to primaquine. The active moiety of tafenoquine, 5,6 ortho quinone tafenoquine, seems to be redox cycled by P. falciparum which is upregulated in gametocytes and liver stages. Once inside, the oxidated metabolite produces hydrogen peroxide and hydroxyl radicals. It is thought that these radicals lead to the parasite’s death.

On the other hand, tafenoquine inhibits heme polymerase in the blood stage of parasites which explains the activity against the blood stages of parasites.

At the recent SEC meeting for Antimicrobial and Antiviral held on 10th April 2024, the expert panel reviewed the proposal along Phase III clinical trial protocol of Tafenoquine tablets 50mg/150 mg before the committee.

After detailed deliberation, the committee recommended the grant of permission to conduct the Phase III clinical trial as per the protocol presented, subject to the condition that the firm should submit IDMC recommendations along with an interim analysis report of pediatric participants 12 to 18 years of age as per the protocol to CDSCO for further review by the committee for extension of the study.

Also Read: Dr Reddy’s Laboratories gets CDSCO Panel Nod To Import and Market Toripalimab 240mg solution for infusion

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Survey finds loneliness epidemic runs deep among parents

A new national survey conducted by The Ohio State University Wexner Medical Center finds that a broad majority of parents experience isolation, loneliness and burnout from the demands of parenthood, with many feeling a lack of support in fulfilling that role.

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The consumption of certain food additive emulsifiers could be associated with the risk of developing type 2 diabetes

In Europe and North America, 30 to 60% of dietary energy intake in adults comes from ultra-processed foods. An increasing number of epidemiological studies suggest a link between higher consumption levels of ultra-processed foods with higher risks of diabetes and other metabolic disorders.

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Perinatal transmission of HIV can lead to cognitive deficits

Perinatal transmission of HIV to newborns is associated with serious cognitive deficits as children grow older, according to a detailed analysis of 35 studies conducted by Georgetown University Medical Center neuroscientists. The finding helps pinpoint the geographic regions and factors that may be important for brain development outcomes related to perinatal HIV infection: mother-to-child HIV transmission during pregnancy, labor and delivery, or breastfeeding.

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Scientists explore the coupling between health span and lifespan in Caenorhabditis

A new research paper was published in Aging titled, “The coupling between healthspan and lifespan in Caenorhabditis depends on complex interactions between compound intervention and genetic background.”

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Social media use linked to tobacco initiation among youth

The tobacco industry has long appealed to youth through targeted marketing that glamorizes smoking with imagery of candy-flavored products, celebrity endorsements, social settings, and other enticing tactics. That marketing approach appears to be particularly effective on social media, according to a new study led by Boston University School of Public Health (BUSPH) researchers.

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USFDA issues EIR for Lupin Aurangabad facility

Mumbai: Global pharma major Lupin Limited has announced that it has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (U.S. FDA) for its Aurangabad manufacturing facility.

The inspection was conducted from March 6 to March 15, 2024.

Read also: Lupin gets one USFDA observation for Aurangabad facility

The U.S. FDA has determined that the inspection classification of the facility is Voluntary Action Indicated (VAI). VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.


“We are pleased to receive the EIR with VAI status from the U.S. FDA as an outcome of the recent inspection of our Aurangabad facility. It is a testament to our commitment to consistently upholding the highest standards of compliance and providing high-quality healthcare solutions to patients worldwide,” said Nilesh Gupta, Managing Director, Lupin.

Read also: Lupin unveils first generic version of Oracea in US

Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.
The Company specializes in the cardiovascular, anti-diabetic, and respiratory segments and has a significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS), and women’s health areas. The company invested 7.9% of its revenue in research and development in FY23.
Lupin has 15 manufacturing sites, 7 research centers.

Read also: Lupin Gets CDSCO Panel Nod to Study Glycopyrronium Bromide, Vilanterol Trifenatate powder for inhalation in capsule

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NEET 2024 Exam City Intimation slip released

New Delhi- The National Testing Agency (NTA) has finally made the National Eligibility cum Entrance Test (NEET-UG) 2024 exam city slip live on its official website.

Candidates can now download the exam city slip from the NTA website. Following are the steps to download the exam city slip-

STEP 1- Visit the official website of NEET UG 2024.

STEP 2- On the appeared page, click on “NATIONAL ELIGIBILITY CUM ENTRANCE TEST (UG).”

STEP 3- Now on the homepage, click on the link that reads, “Click Here for City Intimation.”

STEP 4- Enter your login credentials as asked and then click on submit.

STEP 5- The exam city slips will be displayed on the screens.

STEP 6- Download it and take a printout for future reference.

NEET UG City Slip will contain the name, date of birth and registration number of the applicant along with the subjects and their codes. However, candidates are advised to verify these properly.

NTA has released the NEET UG City Slip in advance to help the candidates plan their travel and accommodation in the allotted cities.

On the other hand, the NEET-UG 2024 exam admit card will also be released in due course of time, so candidates are requested to keep checking the official website of NEET UG regularly.

In case of any discrepancy in the candidate’s details, the candidate should immediately contact the NTA Helpline during working hours i.e. 10 AM to 5 PM.

NEET-UG 2024 exam is being conducted by NTA on Sunday, May 5, 2024, from 02:00 PM to 05:20 PM. The examination will be conducted in pen and paper mode at various centres in India and abroad. NEET UG exam serves as the sole gateway and eligibility criteria for admission to all MBBS and BDS courses across the country. NTA’s preparations are in full swing to ensure the smooth conduct of the examination on the scheduled date.

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Sassoon Hospital Rat bite Case: Medical Superintendent removed, 3 others issued show cause notice

Pune: Taking action against laxity in duty regarding the death of a patient due to alleged rat bites at Sassoon General Hospital, the Directorate of Medical Education (DMER) directed the removal of medical superintendent Dr Ajay Taware from his current position and issued show-cause notices to a nurse, a sanitary inspector and a ward boy. 

The department directed Dr Taware to resign from his position due to administrative reasons and placed the three hospital staff on temporary suspension, granting them time to respond to the show cause notices.   

After Dr Taware stepped down from his position following an order issued by state medical education commissioner Rajeev Nivatkar, the department recently appointed Dr Yellapa Jadhav, associate professor of the Department of Preventive and Social Medicine (PSM) department as the new medical superintendent at the hospital. Dr Jadhav had previously been relieved of this position approximately a year ago.   

Also read- 3 Resident Doctors Of Gynaecology Dept Suspended After Woman Delivers Outside Jaipur Hospital

Speaking to HT, Rajiv Nivatkar said, “We have taken action for the laxity found as per the findings of the investigation report. The charge of the medical superintendent has been removed and a new medical superintendent has been appointed. People who were working in that respective department during the incident have been issued suspension notices.”  

This comes after a probe was ordered regarding the case of a patient passing away while undergoing treatment in the ICU allegedly due to rat bites at the hospital on April 1.     

The patient was admitted to the hospital on March 17 after he had severely injured himself in an accident where he had fallen from a bridge and was later placed under treatment at the ICU located on the ground floor of the old hospital building.

According to the family members, the patient died from rat bites as they claimed that rat bites were visible in two to three places in the deceased body. They further accused the hospital administration of negligence and demanded action against the hospital management and concerned doctors who were monitoring him.

As a result, the relatives submitted a written complaint to Dr Vinayak Kale, dean of B J Government Medical College. The complaint then gained the attention of the DMER who constituted an enquiry committee to probe the allegations. 

The three-member committee then visited the hospital and conducted an investigation. They took records of the statements of the hospital administration and the employees.   

On April 3, they completed the investigation and submitted the report to DMER which recommended that there were rat bites visible on the deceased body. The report further mentioned that the hospital administration also agreed to the rat bite claims during the probe. After the death of the patient, a postmortem was conducted which revealed that the patient died from rat bites as stated by the committee report. 

Dr Deelip Mhaisekar, DMER told the Daily, “Further action against senior officials will be taken by the state government. However, the order to remove the medical superintendent and suspension of three staff was issued late in the evening on Friday.”

“The medical education has taken the action in the purview of their power and state government has powers to take action against senior officials. The suspended staff can submit their response to the suspension show cause notice and if the reply is not found satisfactory, they will be suspended,” he added.

Also read- ICU Rat Bite Case: Telangana Doctors Protest Against Suspension Of Two Doctors, Nurse

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