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Living donor liver transplantation
A V Srinivas

There was some debate within the editorial board about the appropriateness of carrying the following exchange in an ethics journal. At one level it is a 'complaint' from a patient's relative and an institution's defence of the allegations. However at another level the story raises some larger issues, which are relevant to contemporary ethics.

The field of organ transplantation is no stranger to ethical controversy. A particularly complex issue involves living related transplantation where a healthy donor is at some risk, including the risk of death. In other words in an attempt to save one life two lives can be lost. It is obvious that such a potentially dangerous situation needs the highest level of informed consent. And if things do go wrong there must be a sound and transparent mechanism of dealing with the situation.

This journal has previously carried an editorial on the issue of living related liver transplantation (1).

This unfortunate incident also points to the potential danger of an increasing trend, in the globalised world, of foreign doctors performing procedures and flying back leaving their local counterparts to face the complications.

Hence we finally decided to put before you the story of a family bravely facing a tragedy of immense proportions. It also highlights the problems of high technology medicine where high-risk, complicated and costly procedures are marketed and performed with a promise of cure.


Mr AV Srinivas wrote to IJME describing his parents' experiences. Mr Srinivas' father was diagnosed as suffering from liver failure and advised a liver transplant. The transplant was carried out in April 2003, in Global Hospital, a private hospital in Hyderabad. The donor was Mr Srinivas' mother. The transplant was done by a team of surgeons headed by Dr Nigel Heaton and Dr Paolo Mueisan from King's College Hospital, UK. The Global Hospital team included Dr Kancherla Ravindranath, managing director of Global Hospitals and head of its department of surgical gastroenterology, Dr Dharmesh Kapoor, hepatologist, Dr PBN Gopal, anaestheologist and intensivist, Mrs Lalitha Raghuram, chief liver transplant co-ordinator, and the support staff.

Mr Srinivas' father died within two weeks of the transplant, in the hospital ICU. His mother suffered a cardiac arrest within 48 hours of the surgery and has been in a persistent vegetative state since then.

Mr Srinivas feels strongly that the hospital and staff behaved unethically in promoting adult-to-adult live transplants without the necessary experience. The hospital and staff did not indicate that adult-to-adult live liver transplants are more risky than those from adults to children. Further, Mr Srinivas states that he was not made aware that this was the first adult-to-adult live donor liver transplant in India. Finally, he notes adult-to-adult live donor liver transplants are not permitted within the UK National Health Service (NHS) because of the risks to the donor. Kings College, with which Dr Nigel Heaton and Dr Paolo Mueisan are associated, is part of the NHS. Such transplants are done in the UK only in the private sector, mostly on foreign nationals.

Mr Srinivas provided IJME with replies to letters he wrote to the BBC, the UK General Medical Council and Professor Roger Williams, director of the Institute of Hepatology, Royal Free and University College Medical School. The BBC's reply notes that it had a policy of not releasing untransmitted footage but would consider his request if he would indicate what was contained in the footage that might be of his interest. The GMC replied that his complaint had been forwarded to Drs Heaton and Muiesan. Professor Williams indicated that adult-to-adult live donor transplants are not done in the UK under the NHS, but UK doctors do make this available in the private sector, mostly to people from outside the UK. He added that as a person working with the doctors named, he could not comment further but suggested the names of others who could.

Mr Srinivas also provided the journal with a photocopy of an advertisement by Global Hospitals (undated, apparently published in the Hindu, December 2002), calling for people to "register fast for liver transplants to be done by UK doctors".

The following account is based on Mr Srinivas' statement as well as some documents sent by him.

My father's health problem – cirrhosis of the liver -- was identified in late 2001. Over 2002, we visited Dr Nageshwar Reddy at the Asian Institute of Gastroenterology. Dr Reddy spoke about the transplant option but said the success rate was not good in India.

Towards the end of 2002, we saw media reports that experienced liver transplant surgeons from King's College Hospital, UK, would be doing liver transplants at Global Hospital, Hyderabad. In December 2002 we visited Global Hospital for the first consultation with Dr Dharmesh Kapoor of Global Hospital, who told us to continue the previous medication with a few changes. We were told that Dr Mohammed Rela, a liver transplant surgeon from King's College, UK, would be visiting Global Hospitals and took an appointment with him. Dr Rela examined my father and also went through his medical records. He said the only option was a liver transplant, and that he was a suitable candidate.

Both Dr Kapoor and Dr Rela said many transplants were being done in the West and that in the UK they had a good success rate.

In early March 2003, we consulted Dr Hector Vilca Melendez, also of King's College, during his visit to Global hospital. This was shortly after the media reported on the first liver transplant done there, by Dr Melendez. Dr Melendez went through the medical history and told us transplant was possible, and described the success rate in the UK. We discussed the matter again with Dr Dharmesh Kapoor and on his advice my father went for pre-operative investigations for which we paid Rs 95,000.

On March 28, 2003, Mrs Lalitha Raghuram, chief transplant coordinator in Global Hospital who also heads the Hyderabad branch of the MOHAN foundation (an NGO promoting organ donation/ harvesting), called us to say there was a prospective (cadaver) donor available. She asked us to make a deposit of Rs 10 lakh immediately, and indicated that the surgery could be done any time as the surgeon from the UK was in Hyderabad. She also said that unless the patient was operated upon immediately, his condition could worsen and he could become unfit for surgery. We borrowed the money from various people and deposited it but then we did not hear anything more on the matter. Some days later, we were informed there was a cadaver liver available in Chennai. We were told to decide within half an hour if we could pay Rs 7 lakh for the chartered flight from there. We said we could not afford it.

In the meantime my father's health deteriorated and we took him back to the hospital. This was when we were first advised to consider a live donor transplant, from a family member. My mother was counselled. My parents did not consider my brother or me as potential donors, I suppose because of our career and marriage future.

I do not have any documents on the informed consent process. Family members were also spoken to, but I do not recollect much counselling. They explained that the donor's liver would grow back to normal size within two weeks, and she would be back to her normal self in 4-6 weeks. They did not describe any risks. They did not mention the difference in risk between an adult-child live liver transplant and an adult-adult live liver transplant. They used the term 'live liver transplant' only.

They also said the search for a cadaver liver would continue and if it were found the live donor transplant would be cancelled. We were also assured that we would not be charged for the donor's expenses and my mother was asked to undergo investigations. My mother was hesitant but she saw this as my father's only hope. She was found to be fit for the transplant.

The surgeons were Dr Nigel Heaton and Dr Paolo Mueisan of King's Hospital, UK. Dr Heaton checked on my mother before the surgery. He said it would be major surgery for the donor – this was the first time we heard the word – but that everything was fine. He also said he had done about 55 live liver transplants and none of the recipients had died. The doctors also said my father was in good shape for surgery and would survive the operation. No one used the term 'adult to adult live donor liver transplant'. They described it as 'live liver transplant' We did not know that there are different success rates – and risks -- for partial liver transplants from live donors and total liver transplants from cadavers.

Dad's was the third liver transplant at Global Hospital; the previous two were cadaver transplants.

In the early hours of April 22, 2003, both our parents went into the operation theatre. We were told the surgery went well. It took 22 hours. Then on April 24, within 48 hours of the surgery, my mother had a cardiac arrest in the ICU. By the time they got her heart beating again, she had suffered brain damage. We believe this happened because a delay in resuscitation led to irreversible brain damage. They kept telling us that she would recover, but the extent of damage could not be known until she regained consciousness. It is now more than two years.

My father died in the ICU within two weeks of surgery. The death report, signed by Dr PBN Gopal, anaesthetist, states that the cause of death was multi-organ failure due to fungal septicaemia. We believe that he was operated upon when he was unfit for surgery.

A team from the BBC had accompanied the UK doctors. They interviewed my parents before the surgery; they videotaped the surgery and also interviewed the family after the surgery. The hospital and BBC termed it the first Indian related live donor liver transplant (my parents are related). The BBC team left a few hours after my mother went into coma.

The UK doctors are aware that my father died within two weeks of the transplant and that my mother went into a coma. One of them was there when my father passed away. Neither of them has called back to ask how she is.

We had been told that the total cost would be Rs 12 lakh. In March 2003, we paid Rs 10 lakh and another Rs 95,000 in pre-operative tests for my father. The doctors indicated that they would not charge for the donor's expenses. When she was being taken into the operating theatre we were asked to sign a form committing to pay Rs 23 lakh, including donor expenses. We objected but Mrs Lalitha Raghuram advised us to sign so the surgery could proceed, and this would be settled during the final billing. Even as our parents lay in a coma we were repeatedly pressurised for the payment, including with threats that medication would have to stop. Later they indicated that they would bear the cost of treating my mother. In January 2005 they sent us a bill of Rs 45 lakh, towards the cost of mom's treatment for the previous 20 months.

Did the Global Hospital have staff skilled and experienced to perform the surgery and advise the patient's family on whether the patient is suited for the transplant? I believe that they advocated a complicated and expensive surgery without giving the family sufficient information on the risks associated with the transplant, especially for adult donors.

In the US, there are regulations and some action is taken when things go wrong. Should hospitals in India here not have the same level of scrutiny?
House No 167/A, Sripuram Colony, Malakpet, Hyderabad, 500036 INDIA e-mail: av_srinu@yahoo.com

From the Times of India.

MUMBAI: Union minister Vilasrao Deshmukh died of cardiac failure, said renowned doctor Mohammed Rela of Chennai's Global Health City Tuesday even as he drew attention to the urgent need for organ donations.

In a statement, Rela, director of Institute of Liver Surgery & Transplantation at the GHC said that Deshmukh was rushed from Mumbai to Chennai on Aug 6 with "rapidly progressing liver failure".

Deshmukh was unstable and required intensive treatment, according to Rela.

"At the time of transfer, Deshmukh, in addition to having liver failure, also had circulatory failure requiring support for his heart, respiratory failure requiring mechanical ventilation and renal failure requiring continuous dialysis," Rela said.

"However, in the first 48 hours, he responded to treatment and his vital signs stabilised even though he was still critical requiring support for his heart, lungs and kidneys," Rela added.

This was the time Rela felt there may be a small window of opportunity to consider Deshmukh for a liver transplantation.

Accordingly, he was listed to receive a liver within the super urgent category which gave him priority to receive a suitable organ urgently.

Deshmukh's three sons also expressed a wish to donate a part of their liver, but Rela felt that with his (Deshmukh's) condition being so poor, it would be better for him to receive a whole organ from a cadaver as it would aid recovery faster in such situations.

Unfortunately, Deshmukh waited four days with no suitable cadaver organ available.

"This morning, his condition started deteriorating rapidly with oxygen requirement of 100 percent with very poor tissue oxygenation, an intense acid build up in the body with lactic acidosis of over 20," Rela said.

Despite best efforts by the medical team attending on him, Deshmukh suffered a cardiac arrest and died at 1.40 pm.

"Deshmukh's case shows us how vulnerable we are when we require an organ on an urgent basis. I hope that this death will improve public awareness of organ donation and stimulate governments across the country to do more organ donation. His death would then not be in vain," Rela said, expressing sympathies to the bereaved family.
Jaya Prada's husband underwent a live liver transplant. The donor died. The world has forgotten his death or perhaps the indian medical profession would be happier if the death was forgotten.

The Times of India cleverly archived the event.

"The case of the dead liver donor just got murkier. According to the Indraprastha Apollo Hospitals, Subhash D, 23, who donated part of his liver to actress-turned-politician Jaya Prada's husband Srikant Nahata, died due to pulmonary embolism on July 4"

The Times of India quite rightly questions how this man died while the medical establishment shut the case down. There was no investigation, no report, no efforts to learn from the matter and no recommendations made.

Strangely, Apollo did not see the need to conduct a post-mortem even though death is extremely rare in case of donors in a liver transplant. This is only the second known liver donor death in India. Director medical services, Apollo Hospitals, Anupam Sibal stated, ''We did not conduct post-mortem because there was no doubt in our minds as to why the donor died. If there was something wrong with the operation, he would have died straightaway and not 10 days after the transplant.''

The question still needs to be asked how Subhash suddenly developed pulmonary embolism, or the lowering of the heart rate, when he had so recently been found ''medically fit'' for the donor procedure?

The Director of Medical Services at Apollo raises an issue that has no scientific basis. Perhaps he believes that the world does not understand medicine. Many individuals die much later than 10 days following complications that have arisen during surgery. An example is an infection - there is no 10 day limitation to death :). While the Director of Medical Services at Apollo needs to go back to his surgical books, we ask the question - why is the medical establishment failing to scrutinise failing procedures?

Experts though are calling for changes in the law as examined by this article.

"Dr Harsh Jauhari, Chairman Department of Renal transmission, said: ‘‘Nobody can be sure about that. The Act states that the hospital has to set up an authorisation committee which can verify if there has been a possibility of some monetary transaction’’.Supreme Court lawyer H.S.Phoolka is of the view that the term is very wide and needs to be restricted. ‘‘This leaves a major loophole in the law and needs specification,’’ he said"
The next question that was asked - was the donor selling his organ?

So, the mystery continues...... but everyone has stopped asking questions. It is important to ascertain current statistics on how many donors in India have died due to intra-operative or post operative complications.

Nigel Heaton has been in the news again. See the Daily Mail here.

"Updated regulations were introduced last October after an outcry that foreign patients were being given organs donated by NHS patients – despite the fact there is a critical shortage of organs for the more than 250 Britons awaiting transplants.

But King’s College Hospital, in South London, is ignoring the rules and has carried out a liver transplant on a fee-paying patient, believed to be from Greece.

It emerged last year that almost 800 transplants had been performed by the NHS on non-UK patients over the past decade.

Some surgeons are making up to £20,000 a time by accepting private overseas patients for transplants"

Family members allege negligence; hospital official denies charge

# Woman donates part of her liver for husband's liver transplantation
# But her husband dies just two weeks after the surgery due to sepsis

HYDERABAD: A. Prameela, a 60-year-old woman, who donated a part of her liver for liver transplantation of her husband four years ago, died on Tuesday at Global Hospitals, amidst accusations of negligence by family members.

Her husband A. Jagannatham, who underwent the transplantation in April 2003, died two weeks after the surgery due to sepsis, said to be a common cause of death in such cases.

He was among the first few patients in the State to have undergone the transplant. His family members had lodged a complaint then with the police alleging gross negligence on the part of the hospital.

Team of specialists

Managing Director of the Hospitals K. Ravindranath denied any laxity and said the best possible care was provided to Prameela. He maintained that the liver transplantation was done by a team of specialists led by Dr. Nigel Heaton of King's College Hospital, London that had followed all the standard protocols.

He said that Prameela suffered cardiac arrest two days after the surgery and the heart was immediately revived. Since the brain did not get proper blood supply, she had slipped into an almost "coma-like" condition and the hospital had taken care of her since then.

He said that complications normally arise in 10 per cent of live donor cases in liver transplants and one death occurs in every 100 live donors.

He said that the Global Hospitals had so far carried out eight `live donor' liver transplants, but Prameela was the first donor to have died.

Source - The Hindu.
HYDERABAD: It is a story of sacrifice, the kind you read in books of the yore. A Jagannatham, a middle-class resident of Malakpet in his mid-50s was admitted to Global Hospitals with his liver all but damaged in April 2003. The docs said that they could try and save him by experimenting with a liver transplant. But somebody had to donate the liver. His wife, A Prameela volunteered. The operation was conducted with the larger right half of the liver taken away from Prameela and transplanted in the body of Jagannatham.

But a tragedy was in the making. Two days later donor Prameela suffered a heart attack and went into coma. And 15 days later, the husband died of sepsis (infection). Prameela never came out of coma to see him die. She died on Tuesday after lying comatose for 44 months. That's not the end of the story. The family sometime after the death of their father filed a police complaint charging the hospital with negligence and filed a compensation claim with the consumer court. A ruling is still awaited. Meanwhile, the hospital slapped a Rs 44 lakh claim on the family as charges for the failed operation and other services. The family has coughed up Rs 10 lakhs already to the hospital.

Because of the police case, when Prameela died on Tuesday her body was not handed over to her two sons, but was taken for post-mortem. Kin of the deceased assert that although Jagannatham was too weak for the surgery, that they were cajoled and reassured by the doctors that donor and recipient would recover completely. Uday Bhaskar, donor's younger son, said: "We were not clearly informed of the risks of the surgery.

The doctors were confident and wanted to go into surgery immediately. Of the five such surgeries in consecutive years in Global, only two have been successful." His elder brother A Srinivas says: "They said my mother would be normal in five weeks and that my father would recover in six weeks. The doctors have to date not told us exactly why my mother suffered a heart attack".

Doctors at Global Hospitals said they spared no effort to give Prameela the best care. Dr K Ravindranath, MD of the hospital, said: "We are not gods. We did everything we could. The surgery was successful, his liver was functioning well enough. Sepsis affects 20 per cent of transplant patients. The drugs we gave also numb the immune system further". He added: "If not for our efforts, Prameela would not have lived so long."

Source - Times of India.
The Late Mr Prafulla Chandra Pal Consultant Surgeon [Left]

The Late Mr Prafulla Chandra Pal, Retired Consultant Surgeon was consulted regarding this case. He supported the case until his death in 2005. In his view, Informed Consent had not been obtained. Mr Heaton had been reckless to carry out such a risky Live Liver Transplantation at Global Hospitals. He stated that Global Hospitals did not have the facilities or equipment required and should never have undertaken to do this operation. The surgeon responsible for the conduct of the operation is Mr Nigel Heaton. While he will remain unaccountable in the British Medical System - because they protect their own, Mr Pal was of the view that no Indian or Foreign nationals should ever agree to be operated by Heaton or his team.

Mr Pal was a extremely experienced consultant surgeon, winning the gold medal in surgery at Nilratan Sarcar Medical College,Calcutta. He went onto pass his FRCS in the UK and subsequently worked abroad in Africa as a Consultant Surgeon. It was his view that human experimentation in vulnerable people should be legislated against. He was aware of a number of British surgeons who had gone abroad to practice new untested techniques to avoid legal liability. This remains unacceptable. He felt that the needless loss of life in two vulnerable people should never have happened. Heaton took advantage of two desperate people. This will always be unethical and he felt that every surgeon should ensure Mr Heaton never works in India, in the UK or abroad again.

Egypt Unimpressed by Heaton

Nigel Heaton is apparently in Egypt. A message was left by an anonymous poster. They stated

"I attended a lecture for Dr Nigel Heaton today in Cairo University teaching Hospital.Egypt...and I searched for his name and found this article...which unfortunately did not shock me as I've already heard of foreigner surgeons coming to Egypt and operating liver transplants in new untested techniques thus avoiding legal consequences"

Of course, Nigel Heaton's last transplant patient appeared to be a little too wrapped up to make any further comment. The question we have of course is how many transplants has Heaton done in Egypt?