October 31, 2013

A LANDMARK TURN IN INDIA’S MEDICAL NEGLIGENCE LAW

Posted by The Himalayan Voice:
[The landmark ruling is supposed to remind doctors, hospitals, and nursing homes that they will be dealt with strictly if they do not maintain their standard of care, the Supreme Court said in its judgment on Oct. 24.]

By Gayatri Vaidyanathan

Prashanth Vishwanathan for The New York TimesA batch of drugs being processed at the research and development department of Cipla Limited in Mumbai, Maharashtra, on March 1, 2012.
Anuradha Saha died painfully in May 1998 at the age of 36, her skin sloughed off all over her body, except for her skull. She was encased in bandages meant to prevent infections that had already lodged in her system. Her immunity had been compromised after receiving a high dosage of steroids from some of the top doctors in Kolkata.
For the past 15 years, her husband, Dr. Kunal Saha, has pushed Indian courts to hold at least five doctors and the hospital responsible. Though the lower courts rejected his cases, Dr. Saha persisted, appealing all the way to the Supreme Court, which found the doctors and AMRI Hospital (Advanced Medicare & Research Institute Ltd.) in Kolkata guilty of negligence in 2009.
It took another four years for the Supreme Court to award Dr. Saha an unprecedented amount in a medical negligence case in India — 60.8 million rupees ($1 million), plus 6 percent annual interest for each of the 15 years that Dr. Saha has been fighting his legal battle.
The landmark ruling is supposed to remind doctors, hospitals, and nursing homes that they will be dealt with strictly if they do not maintain their standard of care, the Supreme Court said in its judgment on Oct. 24.
“The patients, irrespective of their social, cultural and economic background, are entitled to be treated with dignity, which not only forms their fundamental right but also their human right,” wrote Justices Chandramauli K.R. Prasad and V. Gopala Gowda.
For Dr. Saha, the verdict is but a waypoint in his fight against medical negligence in India, which began in 1998. At the time, the couple was living in the United States, and Dr. Saha, a medical doctor, was working as an HIV/AIDS researcher at Ohio State University. Mrs. Saha had finished a graduate degree in child psychology at Columbia University in New York. They had bought their version of the American dream, a five-bedroom house in the suburbs.
In the spring of 1998, the couple traveled to Kolkata, where Mrs. Saha’s parents lived, to attend a wedding. Near the end of April, Mrs. Saha noticed rashes on her body, an indication she may be having an allergic reaction.
The couple asked friends who the most prominent doctor in the city was. Dr. Sukumar Mukherjee, they were told. Patients would throng his clinic, the Nightingale Diagnostic & Eye Care Research Centre Private Limited, before the doctor arrived.
The couple visited his clinic on May 7, 1998, when Mrs. Saha’s rash worsened. Dr. Mukherjee prescribed Depo-Medrol to be injected into Mrs. Saha’s muscles so that the long-acting glucocorticoid could suppress her immune system’s inflammatory response, which was presumably causing her rash.
Depo-Medrol’s chemical structure ensures it stays in the blood for a long time. It takes the body six days to get rid of just half the drug. As such, it is usually given to patients who suffer from chronic conditions like rheumatoid arthritis, and even those patients receive just one injection a week.
The maximum dosage recommended by the drug’s Indian manufacturer, Pharmacia India Ltd., is 40 to 120 milligrams once a week. Dr. Mukherjee prescribed two injections of Depo-Medrol at 80 milligrams every day.
That moment haunts Dr. Saha. He realized that prescription did not sound right and asked Dr. Mukherjee to explain his reasoning.
“He said, ‘Kunal, I know what you are saying, and yes, it is a long acting,’ ” recalled Dr. Saha in an interview. “But believe me, I’ve treated at least 100 patients exactly like your wife, and this drug works like magic,” he recalled Dr. Mukherjee telling him.
“He used the word ‘magic,’ ” Dr. Saha added.
Dr. Saha chose to believe him. Although he and Mrs. Saha were living in the United States, they had grown up in India, where doctors are treated with excessive deference. Dr. Saha’s friends had assured him that Dr. Mukherjee was the best. He had an aura about him, Dr. Saha said.
Dr. Mukherjee injected the first dose himself. Four days later, Mrs. Saha’s rashes and fever worsened, and she was admitted to the AMRI Hospital in Kolkata. Dr. Mukherjee examined her there and prescribed Depo-Medrol again before leaving on a trip to the United States.
A dermatologist later diagnosed her with toxic epidermal necrolysis, which is as painful as it sounds. Toxic epidermal necrolysis, known earlier as Lyell’s disease, is an extremely rare drug reaction and it is unclear what triggered the disease in Mrs. Saha. It is fully treatable if doctors carefully monitor the patient, maintain her fluids, ward off infections with antibiotics and ensure proper nutrition.
Some doctors will give the patient glucocorticoids at the initial stages of toxic epidermal necrolysis. But as the disease progresses, steroids make the patient more vulnerable to secondary infections, according to experts consulted during the Supreme Court ruling.
By May 12, 1998, large sheets of Mrs. Saha’s skin had separated from her back and limbs. The Supreme Court noted in its 2009 judgment that she had lesions on her tongue and mouth, which made it difficult to eat or drink. Yet the nursing staff at AMRI hospital did not set up a feeding tube, nor did they give her any painkillers.
The next day, Dr. Mukherjee left for the United States, and Dr. Balram Prasad and Dr. Baidyanath Halder continued her treatment. The core medical team did not pause to question why Mrs. Saha was getting worse despite all the steroids, the Supreme Court noted in 2009. No one wondered if the drug itself could be making her worse.
On May 17, 1998, Dr. Saha evacuated his wife by a private plane to one of Mumbai’s top hospitals. On arrival, doctors noticed a dark green patch on her back, an unpropitious sign of an infection that claimed her life on May 28.
Dr. Saha began fighting that September to hold the Kolkata doctors and hospitals accountable for his wife’s death, filing criminal and civil lawsuits in India’s notoriously slow legal system. He educated himself on toxic epidermal necrolysis and assembled an international panel of experts.
Proving medical negligence in India is difficult, and the burden rests solely with the claimant, said Nagarathna Annappa, an assistant professor at the National Law School of India University in Bangalore.
“It is still difficult in India for a common man, to take up a case to that extent without understanding medical science,” she said. “In this case, because he was a doctor, he could convince the court.”
Dr. Saha shuttled between the United States and India for 15 years, appearing at various trials and racking up attorney fees, which the Supreme Court calculated as 150,000 rupees. His prolonged absences cost him his job at Ohio State University in 2005. He filed for bankruptcy in 2011, and his home was foreclosed.
Dr. Saha said he did consider giving up, but the thought of Mrs. Saha kept him going. He does not believe in life after death, he said, but he cannot help feeling that he will be reunited with her in the future.
As Dr. Saha repeatedly lost criminal and civil cases in the lower courts, the doctors who treated his wife prospered. Dr. Mukherjee became chief adviser to the Health Ministry of West Bengal state in 2012, and the other doctors practiced at the city’s top hospitals.
The Supreme Court’s ruling in 2009 found Dr. Mukherjee, Dr. Prasad, Dr. Halder and AMRI Hospital negligent in the civil case but dismissed the criminal complaint, a point that Dr. Mukherjee emphasized during an interview. The doctors are allowed to keep practicing since the West Bengal Medical Council has not canceled their licenses.
Dr. Mukherjee stressed that the Supreme Court had found him liable only in the civil case, and he was not criminally negligent.
“This is medical negligence, which is much lower in degree than criminal negligence,” he said. “It is the collective responsibility of many other doctors.”
Dr. Prasad said in an interview that he would honor the court’s judgment and that he was glad the long saga was over. “The main thing is that we will all go one day to eternity and have to accept the mistake one has done,” he said. “I accept the verdict.”
AMRI Hospital declined to comment through a spokeswoman. Dr. Halder could not be reached by telephone despite repeated attempts.
The Supreme Court’s 60.8 million rupee award took into consideration the complex socioeconomic conditions of Dr. Saha, the pain his wife endured, the doctor’s loss of income and his copious legal expenses.
Dr. Saha said he planned to keep fighting against medical negligence in India through the courts and through his non-profit, People for Better Treatment, to help others in similar situations. Yet he would never move back to India permanently.
“As a country, it took away the only precious thing I ever had. And that is a lot,” he said.
Gayathri Vaidyanathan is a science writer based in Washington, DC and co-founder of India Hospital Watch, a journalistic initiative tracking medical negligence in India.