According to documents in tportal’s possession, Pliva did not have approval to put the dialysis filters in to use, nor had the company requested approval in accordance with the recommendation it had received on September 27 1999 from the Croatian Institute for Medicine Control.

Thus, Pliva in Croatia is, at the very least, at equal fault with US manufacturer Baxter, who paid out immense sums in damages to families across the globe following the international scandal.

Director of the Agency for Medicine and Medical Products, Sinisa Tomic, in March of this year sent a memo to a hemodialysis association in Croatia in which he detailed the actions from 1999 regarding the registration of dialysis filters in Croatia.

According to Agency documents, on March 8 1999 the producer of Plivadool P-15 and Plivadiol P-18 was Pliva d.d. while the producer (listed in the documents as ‘company’) that produced and sterilized the capillary dialysis filters was Althin Medical of 14620 N.W. 60th Avenue, Miami Lakes, Florida. Baxter’s role is explained further in the Agency memo.

Baxter International acquired the Swedish company Althin Medical in 2000. According to available documents, the business ties between Pliva and Baxter is unclear, the Agency reports.

The Agency director further goes on to say that prior to establishing the Agency in 2003 he had headed the Croatian Institute for Medicines Control, which recommended in 1999 that the said dialysis filters could not be registered nor put into use before the passing of a medical products ordinance. When the ordinance was passed in September 27 of that year, the Institute notified Pliva to submit a request for the quality control and draft report on the quality and adequacy of the medical product and to submit the necessary documents.

‘We can freely say that Pliva failed to submit a request or required documents to the Institute. Accordingly, the Institute did not have legal grounds on which to conduct the process proscribed by the ordinance’, the memo reads.


In late 2001, the greatest tragedy in Croatian medical history occurred as faulty dialysis filters in Croatian hospitals caused the deaths of 23 patients. Pliva CEO at the time Zeljko Covic immediately blamed Baster and denied any Pliva responsibility.

‘Pliva is not the producer, only the importer of the said dialysis filters, and immediately following the Health Ministry’s suggestion, we halted the further distribution of dialysis filters produced by the US company Baxter’, Covic told a press conference then, adding that ‘if it is confirmed that the filters are at fault for the deaths of the patients, Pliva warns that the company is in no way connected to their production nor does the company have possibility of post quality control’.

Due to related deaths in other countries at the time, Baxter readily took responsibility for the deaths in Croatia as well, and paid out multimillions sums in damages. This however did very little to calm the anger of the entire Croatian public towards the multinational company that was seen to be ‘sowing death in Croatian hospitals’.

However, a document in our possession (click link for PDF download), casts new light on the affair as well as on a chain of responsible persons who ignored and knowingly covered up Pliva’s legal responsibility for the dialysis filters, having distributed them without following proper procedure.

In Croatia, the case of the dialysis filters had been investigated by the Ministry of Health, the Interior Ministry and the State Attorney.

These new findings obligate the State Attorney to reconstruct the events of 2001 and to determine the culpability of those responsible for releasing unapproved medical products to the public as well as of those involved in the cover up.