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Patient sues hospital, firm after two pacemakers fail
By Wu Chong (China Daily)
Updated: 2004-12-30 22:09

A heart patient is resorting to the courts after two pacemakers failed, forcing him to have three operations.

Yang Hongfa, 63, is suing both the hospital and the pacemaker producer for 300,000 yuan (US$36,600) for economic and psychological losses he has suffered as a result of their poor-quality pacemakers, the Beijing Times reported.

Yang's first pacemaker, manufactured by St Jude Medical Inc, was put in the Fuwai Cardiovascular Disease Hospital in 1998. Despite an eight-year guarantee, the pacemaker ran out of power only a year later, so Yang had to get another operation at the end of 1999.

In February this year, the second pacemaker, with a five-year guarantee, also run out of power and had to be replaced.

In 2001, the State Food and Drug Administration blacklisted Tempo 2902 pacemakers made by St Jude, saying that series had a welding problem which would result in a quicker power consumption.

The hospital records show the first pacemaker for Yang was in the blacklist.

But the hospital authorities told China Daily they refuse to bear the cost.

"We did all the operations with good will to ease his pain and sustain his life. We have fulfilled our duty as medical staff," said the anonymous doctor who did the three operations for Yang.

He explained the hospital was also in the dark about the problems with the pacemakers when the first operation was done.

"We have changed all faulty pacemakers for another 20 patients when the State delivered the notice," he said.

And it is normal that the third pacemaker fitted in the latest operation stopped working when it reached the end of its lifespan.

Usually a pacemaker can last six to eight years, but that varies largely depending on the patient's health status and other reasons, doctor Wang Yutang from the 301 Hospital of the Chinese People's Liberation Army told China Daily.

"The patient only has to undergo a subcutaneous operation to change pacemakers, which is small and simple," said Wang.

But he did say that two operations in one year may be too much of a mental strain for some patients.

David Han, a senior staff from the Beijing Branch of St Jude Medical Inc, said the firm had not received a court summons.

"We will abide by the legal procedures if summoned," he said.

Han added no pacemaker will run out of power without giving early warnings which doctors can detect during regular checkups.

"The moment we found 0.6 per cent of the Tempo 2902 pacemakers had fatal blunders in 2000, we reported to the State authorities and helped change them," he said.

The hospital confirmed the company did cover all the expenses for Yang in 1999.

Yang paid about 8,000 yuan (US$967) for the last operation. He was only exempted the fee for the new pacemaker.

Tang Weijian, a law expert from the Beijing-based China Renmin University, pointed out any suit on the 1999 operation is already beyond the two-year limit for such actions.

"But the second pacemaker stopped working before the guaranteed duration ended, which may become a strong suit for both the hospital and the manufacturer if they cannot provide a persuasive explanation," said Tang.



 
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