At 3:10 p.m. on September 13, 2001, Biserka Furčić, director of Pliva’s dialysis division, and Jasna Gršković, Pliva’s dialysis product manager received an official letter by email. This same letter was also sent to 6 other individuals in Europe in the pharmaceutical industry. The subject of the letter, stated under the names of the eight recipients, was removing the A18 dialyzers from use. The letter, sent by Alessandro Slama, RZ Manager of EC Europe MEA Drugs, stated who the American company Baxter had done so far and what they intended to do further following the ten fatal dialysis cases in Spain.

Baxter informed Pliva to stop using the dialysis filters made in their Swedish factory, but Pliva neither informed the Ministry of Health nor the Center for Dialysis which had received a shipment of those filters.In this letter, which we present here in its entirety, Slama wishes to confirm prior verbal communication with those individuals, with the intention of informing them that the A18 dialyzers were being recalled. The letter also informs of Baxter’s decision to halt the use of all A series dialyzers worldwide. This decision is described as a precautionary measure, which could be altered following the investigation into those products. A list of the filters and their codes follows, together with an explanation of why the Renal Division of Baxter decided to pull the A18 filters: after ten fatal cases in August 2001 in Madrid and Valencia, their recall was a measure of caution until the final results could be obtained.

Slama’s letter also includes a detailed list of the recalled filter shipments. According to his words, all the filters in two batches coded 2001FO5P and 2001FO5R had already been completed recalled by September 3, 2001. The first shipment had gone to Spain, the second to South America, the US, Greece, Finland and Sweden. Following this is a section on Pliva, which states:

Alternative Dialyzers

“It is my understanding that no products from these two batches have been shipped to Croatia – PLIVA.

“However, all countries receiving these types of dialyzers have been instructed to provide alternative dialyzers to their customer until further notice (until the analysis of this case is over) and a final decision will be taken by Baxter.

“Baxter has informally informed several MoHs (mainly in the EU) of this recall. You may wish please to consider, if appropriate, to inform the Croatian MoH of the reasons of our decision not to distribute these products to PLIVA until a full investigation is carried out.”

Even though the A18 series of dialyzers under codes 2001FO5P and 2001FO5R were never shipped to Croatia, a different code was. Pliva was supposed to have pulled all of the received A18 filters, which they did not do. Baxter suggested that Pliva contact the Ministry of Health, as Pliva was the formal producer of the filters in Croatia. The Baxter filters in Croatia were only repackaged and distributed as a Pliva product under the name Plivadial, which is why Baxter felt it necessary for Pliva to contact the authorities about the problem.

Twenty Three Deaths

The letter ends with a remarkable kind regards, and the laboratory analyses of the filters used in Spain were attached. This analysis was conducted by the Baxter laboratory in Ronneby, Sweden, in the factory which produced the filters, and showed that there were no errors. Regardless of this fact, Baxter decided to err on the side of caution and pull the filters. To this date, it is still a mystery as to what Biserka Furčić and Jasna Gršković did when they received that email on September 13 – did they immediately contact their superiors and did anyone in Pliva take action?

According to the ongoing police investigation following the tragic events in Croatia only one month later, when 23 patients died during dialysis in Zagreb, Pula, Dubrovnik, Požega, Karlovac and Rijeka, it would appear as though no one in Pliva reacted. Not after the verbal warning in early September 2001 about pulling the filters produced in Sweden, nor after the September 13 email or the letter on measures to be taken which, Nacional has learned, was sent to Pliva from Baxter at the end of September.

Admission of Responsibility

The events in the dialysis units last October are truly tragic. As is now well known, following the series of death, the Health Ministry sent all Croatian hospitals a dramatic order on October 18, to immediately stop using all Plivadial filters, regardless of series or code. Behind these labels was the product produced in Baxter’s Swedish factory, even though they were considered to be a domestic product. The first fax was sent from the Ministry to the dialysis centers and was signed by Minister Ana Stavljenić-Rukavina, while the second was signed by her Deputy, Ranko Ostojić. The Minister was soon replaced, as was her deputy, who remained in the ministry for a short time. Also replaced was Dr. Santa Večerina-Volić, director of the Rebro Clinical Hospital, where the first fatal cases occurred.

Two weeks ago, we contacted the County Prosecutor, Krunoslav Canjuga, who promised to respond in writing to several questions we had forwarded him, directly regarding the email sent to Pliva on September 13. Canjuga never responded. As we have learned, even though the County Prosecutor’s office has thrown out all criminal charges against Baxter, which immediately assumed its responsibility and paid compensation to the victims’ families, they are still considering possible action against other actors in last year’s tragedy. This refers to Pliva, for their failure to inform the authorities and the public about Baxter’s decision to pull their products produced in the Swedish factory.

Last week we wanted to speak with the former Health Minister, Ana Stavljenić-Rukavina about whether she had received any word from Pliva in September of last year about the precautionary measures from Baxter. However, obviously still embittered about being fired and angry with the press who blackened her name, as she said, for bigger newspaper sales, she declined to speak with us.

We did speak with the former Deputy Health Minster, Ranko Ostojić, who told us that he had received no information nor seen any letters from Pliva following September 13, 2001, and had any such letter arrived in the Ministry, he certainly would have known about it. He claims to have never heard of this email.

We spoke to the current Health Minister Andro Vlahušić, who said that since his appointment to the minister’s chair, he has neither heard nor seen any trace of proof that Pliva informed the Ministry of the Baxter recall following the deaths in Spain, prior to the fatal cases in Croatia.

Her Personal Business

We tried fruitlessly to discuss the email mail letter with the two Pliva employees. Biserka Furčić, as we were informed, was on official business out of the city. Jasna Gršković was in her office and she answered the phone, however, we were unable to learn anything new about the email message or what she did after receiving the same. In an agitated tone, she said that she did not want to talk about it, as it was her personal business and that we should contact Pliva’s public relations office. This however, was unnecessary as one day earlier we have received the following statement from that office:

“The producer of the filters never contacted Pliva that a certain number of the defect filters had been corrected after production and that these corrected filters had been sent to Croatia. Unfortunately, Pliva also learned about the fatal cases in Spain from the media. Only upon our insistence did Baxter inform us and convince us that the incriminating filter series was not sent to Pliva. Not then, nor after the tragedy in Croatia were we informed as to the causes. As such, Pliva is also a victim of this entire case, even though we cannot in any way compare to the tragedies of the victims and their families.”

Immediately after the affair came to light in October of last year, Pliva CEO Zeljko Čović announced that the company would no longer be distributing the filters, which to that point had brought in revenues of $5 million annually. Though there were many indications that Pliva had violated a number of laws and regulations and despite the tragedy which occurred, to date, no one has been held accountable. According to our source in Pliva, one year ago that company had no documentation on the filters which they began importing eighteen months earlier. Pliva simply stuck their label on the finished product, though they were registered as both the producer and distributor. They lacked the documentation called for in the Croatian regulation, which require information on where the product was produced, its contents, production procedure and whether it has undergone testing. The documentation also failed to note the change in ownership of the factory which for eighteen months supplied Pliva with the filters. Pliva had originally been buying the filters from the Swedish company Althin, which was bought out by Baxter three years ago.

As the Pliva filters were registered as a domestic product to avoid the tariffs, or rather, in order to only pay customs on raw materials, Baxter had no legal responsibility to the Croatian authorities. Pliva never received the two shipments of A series filters which had been used in Spain. But they did receive a different shipment of those filters, on which they placed the Pliva labels. As the producer and distributor of the filters, Pliva was informed of the fatal cases in Spain in order to cut the supply of the tainted product to the Croatian market and to inform the proper authorities. Due to the incident in Spain, all the A series filters in the world are now on hold, meaning that these filters should not have been sent to users either from the Baxter or the distributor warehouses until the investigation was complete. Pliva, however, for as yet unknown reasons, did not follow those directions.

The email sent from Baxter on September 13, 2001

Dear Biserka,
to confirm previous communications with you and your team, I would like to share with you some background information relating to the recall of two batches of Baxter A18 Dialyzers in Spain, which also led Baxter to take the decision to momentarily discontinue the supply of A18 dialyzers worldwide. This, however, is only precautionary and may be changed as soon as the results of the investigations on the products will be over.
Description: Althin A18 Dialyzers
Code: 237018
Lot: 2001FO5P & 2001FO5R

Background
The Renal Division has decided to initiate a recall following the receipt of 10 reports of serious adverse effect from Spain (4 in Madrid and 6 in Valencia) that resulted in patient death. Although there is no evidence to date to link incidents to the dialyzers, this is considered as a precautionary measure.
Other measures taken are as follows:
-A18 dialyzer discontinuation until further details are received
-all necessary investigations are ongoing
Initial testing results performed by our plant show no abnormality of our products and did not reveal any evidence to suggest a link between a Baxter product and the unfortunate deaths of these patients. Investigations will continue, also with the help of TUV. Results from TUV testing are expected at the end of next week.

You may find the results of these preliminary tests on compangnon samples here below.

My understanding it that this recall was completed by Monday September 3, 2001.

Batch 2001FO5P: 460 units shipped to Spain:

-22 units sent to Barcelona (customer with no even reported)
-140 units to Madrid (customer with 4 events reported)
-80 units to Valencia (customer with 6 events reported)
-218 units to Baxter’s Spanish warehouse

Batch 2001FO5R

-4480 (planned for South America) and 2240 (planned for the US were physically in the plant at Ronneby and were put on hold
-2320 were shipped to Baxter Lessines (BDCE)
1.700 shipped to Baxter Swedish warehouse: 300 shipped to 1 customer in Finland (customer informed and confirmed that none of the units were used by patients) – 400 units physically in the Baxter Swedish warehouse
2.1620 shipped to Baxter Greece and then to DIOPHAR (exclusive distributor). None were sent to customers (confirmation received this afternoon).

It is my understanding that no products from these two batches have been shipped to Croatia – PLIVA.

However, all countries receiving these types of dialyzers have been instructed to provide alternative dialyzers to their customer until further notice (until the analysis of this case is over) and a final decision will be taken by Baxter.

Baxter has informally informed several MoHs (mainly in the EU) of this recall. You may wish please to consider, if appropriate, to inform the Croatian MoH of the reasons of our decision not to distribute these products to PLIVA until a full investigation is carried out.

Should you need further information, please do not hesitate to contact me.

Thanks and best regards,

Alessandro Slama
RA Manager EC Europe MEA Drugs

P.S. For your ready reference, the functions to which the message was addressed are:

Biserka Furcic – General PLIVA DDDI
Michele Latini – Managing Director ECE
Ian Pursell – Marketing Manager ECEMEA HD
Diethart Schmidt – Sales Manager Althin
Alfredo Venturini – Sales Manager SECE Renal – Medication Delivery
Nicole Denjoy – Global Renal Viligance Director
Elisabeth Hoechsmann – Director Regulatory Affair Europe and ECEMEA
Jasna Grskovic – Product Manager Dialysis PLIVA