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Jakarta Post

Kalbe spared from lawsuits in Siloam incidents

In spite of the accidental deaths of two patients at Siloam Hospital in Lippo Karawaci, Tangerang, the country’s largest pharmaceutical company, PT Kalbe Farma, has been spared from lawsuits that could lead to prison time and hefty fines

Hans Nicholas Jong (The Jakarta Post)
Jakarta
Wed, March 25, 2015

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Kalbe spared from lawsuits in Siloam incidents

I

n spite of the accidental deaths of two patients at Siloam Hospital in Lippo Karawaci, Tangerang, the country'€™s largest pharmaceutical company, PT Kalbe Farma, has been spared from lawsuits that could lead to prison time and hefty fines.

Kalbe Farma corporate secretary Vidjongtius said on Tuesday that the company had settled the cases amicably with the families of the victims.

'€œAs far as we know, Kalbe and the hospital have coordinated and spoken to the victims'€™ families and reached solutions amicably,'€ he told The Jakarta Post.

Therefore, the families will not sue the company for the deaths last month, according to Vidjongtius.

'€œIt'€™s true [that they won'€™t file lawsuits],'€ he said.

The incidents in question occurred on Feb. 12, when the hospital conducted urological surgery on one patient and a C-section on another.

The medical teams injected Buvanest Spinal anesthetic into the patients'€™ spinal cords. However, after the patients started showing physical resistance during the course of their procedures, the medical team began to suspect that the contents of the drug were falsely represented.

Both patients died less than 24 hours later after experiencing painful itching and muscle spasms.

An investigation by the Health Ministry and the Food and Drug Monitoring Agency (BPOM) concluded that the deaths were likely caused by a mix-up in the labeling of Buvanest Spinal and antihemorrhagic Asam Tranexamat Generik during the secondary packaging, specifically during the visual inspection at line production No. 6 for producing injections.

The agency'€™s head, Roy Sparingga, said that it had punished Kalbe properly by suspending its license to distribute and produce the two drugs, as well as 24 other products that were produced in the same production line.

'€œWe revoked the license to produce the drugs at line production No. 6 to eliminate the risks [of further incidents] even though those products have not been reported yet for causing troubles,'€ he told the Post on Tuesday.

In addition, all Buvanest Spinal still on the market had to be revoked and destroyed.

However, he acknowledged that the agency did not have solid proof regarding the alleged mix-up, but had based its finding on observations made during inspection.

Roy said that it was possible for the police to open an investigation as the incidents had claimed two lives.

The investigation may go ahead regardless of the victims'€™ families not filing reports with the police.

That National Police said on Monday that they had suspended their investigation into Kalbe pending mediation between Kalbe and the families.

'€œWe will resume if mediation fails,'€ he said.

Even if mediation was successful, Sularsi of the Indonesian Consumers Foundation'€™s (YLKI) legal affairs division said that it did not mean the police should stop its investigation.

'€œIf we'€™re talking about civil law, then the case may be over. But a crime that claims lives is a matter of the state protecting its people,'€ she said on Tuesday.

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