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IN THE HIGH COURT OF SOUTH AFRICA

(SOUTH EASTERN CAPE LOCAL DIVISION) CASE NO: 1481/2007

In the matter between:

B BRAUN MEDICAL (PTY) LIMITED APPLICANT

and

FRESENUS KABI SOUTH AFRICA (PTY) LTD RESPONDENT

JUDGMENT

DAMBUZA J:

1. In this matter, the applicant seeks an interim interdict, on an urgent basis, restraining the respondent from distributing certain documents and from otherwise spreading offending information about a medical product marketed and sold by the applicant known as Venofundin which is apparently similar medical product known as Voluven marketed and sold by the respondent.

2. There is also an application, brought by the respondent, for leave to supplement its answering affidavit.

3. The applicant, a wholly owned subsidiary of B Braun Melsungen AG, a private German Company, and the respondent, a South African Company, are competing pharmaceutical companies which operate within the country and internationally. The medical products in question are a colloid plasma volume substitute that is used during surgical operations and in emergency units of hospitals and clinics. Venofundin is a potato based product also known as hydroxyethl starch (HES) 130/0.42/6:1 whilst Voluven is maize or waxy-corn derivative alternatively known as HES 130/0.4/9:1. The respondent’s Voluven product has been used in South Africa since 2002 and internationally since 1999. The applicant’s Venofundin is relatively new, having been registered in South Africa on 2 March 2007 and launched at the end of March 2007.

4. The facts giving rise to this application are largely common cause. On 22 May 2007 representatives of both parties attended a seminar held at 1 Military Hospital in Pretoria. Various other competitors in the same market as the parties also attended the seminar and presented their volume replacement therapy products to senior members of the military. The respondent’s national sales manager, Marlize Haarde made a presentation in respect of the respondent’s Voluven and Armin Junkuhn, a divisional manager in the employ of the applicant, made a representation in respect of Venofundin. In the course of her presentation Haarde referred to the applicant’s Venofundin, stating, amongst others, that:

4.1 Doses of up to 33ml/kg of Venofundin are associated with hyperbilirubinaemia (excessive concentration of bilirubin (a bile pigment) in the blood) ;

4.4 Venofundin is contra–indicated for liver failure in its European package insert whereas in South Africa it is not;

4.2 The potato based HES product is registered for a dosage of 33ml/kg, with a maximum daily dosage of 40ml/kg in acute cases and there is no data for administration of higher doses thereof ; and

4.3 The potato-derived HES has a greater effect on (blood) coagulation than waxy-corn derived .

5. These statements appear in a 36 page document prepared by the respondent titled “VOLUVEN Colloids Overview” (the respondent’s pamphlet or Annexure “E” to the founding papers). This document was distributed by Haarde at the seminar. In this document Volume Replacement Therapy is discussed and a comparison is drawn between Voluven and Venofundin. In the comparison it is also stated that:

A the Amylopectin/Amylase content of the products is 95/5 for Voluven and 80/20 for Venofundin;

B Unlike with Voluven, there is no information available on the safety of Venofundin use in paediatrics; and

C Unlike with Voluven there is no information available in respect of Venofundin regarding tissue storage, renal function, toxicology and compatibility with other drugs.

6. In the founding affidavit Junkuhn states that on 17 April 2007 he received an enquiry from Carole Lawrence of the Life Healthcare Hospital Groups in the country, requesting clarification on queries that she (Lewis) had received concerning Venofundin. According to Lewis there were insinuations that because Venofundin is registered as a hetastarch this could have clinical consequences, particularly regarding coagulation; that because Venofundin contains a fair amount of phosphates it could have more extensive side effects than Voluven; that contrary to the only article used in the applicant's detail aids, written by Lehman et al, a few published studies showed that Voluven has a greater plasma clearance than Venofundin; and that potato-derived HES has a greater effect on coagulation than corn-derived HES. Lewis also enquired whether the applicant had a safety data for use of Venofundin in paediatrics and patients with compromised renal or hepatic function.

7. The applicant received further queries from Entabeni Hospital in Durban, expressing concern about the amylopectin/amylase ratio for Venofundin and Voluven being different; there being no data available for Venofundin regarding tissue storage; Venofundin being contra-indicated for liver failure in the European package insert but not in the South African package insert; Venofundin dosages of up to 33 ml/kg being associated with hyperbilirubinaemia; unavailability of toxicological data for Venofundin; and unavailability of information regarding compatibility of Venofundin with other drugs.

8. The applicant contends that the only conclusion to be drawn from the similarity between the queries raised by Lawrence and Entabeni Hospital and the contents of the respondent’s pamphlet, Annexure “E” is that the respondent’s representatives had been spreading injurious falsehoods and unsubstantiated rumours concerning Venofundin. Such conduct on the part of the respondent, so argues the applicant, constitutes unlawful competition. The applicant’s case is that in Annexure “E”, the respondent has made reference to articles written by medical experts on the products, thus misleading the reader by giving an impression that the statements complained of are supported by medical evidence. Mr Mundell submitted on behalf of the applicant that the respondent has undertaken a deliberate extensive campaign of falsely maligning the applicant’s Venofundin product by suggesting that the product is unsafe and has negative side effects which render Venofundin a less safe and a less acceptable alternative when compared to Voluven whilst on the other hand, claiming unwarranted accolades for Voluven.

9. The respondent denies that the statements in question are false and that its conduct constitutes unlawful competition. It contends that the statements find support in the studies and articles referred to in Annexure “E” and in the package inserts of the products.

10. Requirements for an interim interdict and unlawful competition

It is trite that ordinarily an applicant seeking an interim interdict must prove a prima facie right, a well-grounded apprehension of harm if the interim interdict is not granted and the ultimate relief is ultimately granted, a balance of convenience in favour of the granting of the relief sought and absence of an alternative remedy. See Steel and Engineering Industries Federation and Others v National Union of Metal Workers of South Africa (2) 1993 (4) SA 196 (T) 199 G – 205 J; Setlogelo v Setlogelo 1914 AD 221; L F Boshoff Investments (Pty) Ltd v Cape Town Municipality, Cape Town Municipality v L F Boshoff Investments (Pty) Ltd 1969 2 SA 256 (C) 267.

11. In an action for damages founded on unlawful competition, a party alleging injurious falsehood has to allege and prove that the other party has, by word or conduct or both, made false representations; that it had known the representations to be false; that the plaintiff had lost or would lose customers; that the false representation had been the cause thereof; and the defendant had intended to cause the plaintiff loss by the false representation. Geary & Son (Pty) Ltd v Gove 1964 (1) SA 434 (A). Fault, however, is not a requirement for an interdict directed at prevention of unlawful competition. See Van Heerden and Neethling; Unlawful Competition at 69; Schultz v Butt 1986 (3) SA 667 (A).

12. The applicant's case, as I understand it, is that the respondent's conduct constitutes unlawful interference with its (respondent's) right to engage in its trade and to market Venofundin. It contends that the respondent's conduct of publishing and distributing injurious falsehood and misleading customers about Venofundin constitutes unlawful competition.

13. That the applicant is entitled to the free exercise of its trade cannot be disputed. According to the authors Van Heerden and Neethling (supra at 283):

"The direct infringment of the goodwill of a competitor's undertaking by the publication of disparaging, untrue statements about his business, goods or services, is undoubtedly unlawful. Such a direct attack on a rival is clearly in conflict with the competition principle (and therefore contra bonos mores ):

there is no question of performance (merit) competition because the perpetrator is deceiving the public as to the merit of his rival's performance"

See also Abakor Ltd v Crafcor Farming (Pty) Ltd t/a Riversdale Feedlot 2001 (1) 973 (N).

However, this right to free exercise of trade is not without limitations. There is a general acceptance that because of self-interest, competitors cannot evaluate their performances and products objectively and impartially. Misleading images therefore become an almost inevitable feature of comparative advertising even if only to a small extent. The South African Courts, in line with English and American law, have held that publication of true disparaging statement is lawful. In Post Newspapers (Pty) Ltd v World Printing and Publishing Co Ltd 1970 (1) SA 454 (W) Nicholas J held at 456 F-G that:

" But where a trader does not limit himself to a comparison of his goods with those manufactured by another trader and a mere statement that they are inferior to his own, but makes some untrue statement of fact about his rival's goods - for example, states that they are rotten or contain deleterious ingredients - an action on the case will lie, on proof that such statement was published maliciously and (save in cases falling within the provisions of the Defamation Act 1952, sec 3 (1) that special damage has ensued.

'The general position in our law is: comparison - yes; but disparagement - no' (per Hodson LJ; in Cellacite & British Uralite v Robertson, The Times, July 23rd, 1957 (C.A.)

There can be no doubt, on the authority of Fitchard's case, and subsequent cases that such statements would be actionable in our law."

This principle has been criticised on the basis that where a true disparaging statement is irrelevant to the competitive struggle concerned, it should be wrongful. See Van Heerden and Neethling (supra) at 302. In this case, however, the application is founded on falsity and misleading nature of the statements. Further, I am satisfied that the statements under consideration are relevant to the competitive struggle between the parties.

14. According to the respondent Annexure “E” was prepared in the context of the parties’ mutual clients having requested the respondent to furnish them with medical and scientific information regarding the differences between the two products i.e. the differences between potato based starch and maize starch based HES. The request followed, so says the respondent, the applicant having represented to customers that Voluven and Venofundin are bio-equivalents; that Venofundin is similar to and/or better than or equivalent to or safer than Voluven; that Venofundin is the worlds’ fastest, most efficient, fluid replacement system, is a new technologically improved, chemically modified HES 130. The respondent contends that the first group of statements carries with them the inference that Venofundin is medically superior in a number of respects including that it is safer and/or associated with less risk and/or improved results and that the second group constitutes passing off and/or injurious falsehood on the part of the applicant. The respondent contends that in preparing Annexure “E” it sought to draw a distinction between the two products, to enable its representatives to respond to queries from customers to whom representations had been made on Venofundin. Needles to say the respondent denies that the statements are misleading and/or constitute injurious falsehood. The applicant, on the other hand, denies that it attempted to market Venofundin as a bio-equivalent of Voluven and maintains that it could not have done so given the pharmaceutical differences of the products; one being a potato starch and the other, a maize starch based product. The applicant contends that the rest of the statements attributed to it are nothing more than mere puffery.

15. Against this background I then proceed to consider whether the statements in question constitute injurious falsehoods, were made without basis and/ or are misleading insofar as they relate to the two products.

16. That doses of up to 33ml/kg of VENOFUNDIN are associated with hyperbilirubinaemia

The applicant contends that this statement is false and that it was intended to communicate that doses of up to 33ml/kg of Venofundin are associated with hyperbilirubinaemia, which could indicate possible liver dysfunction. According to the respondent the statement finds support in an article written by medical experts Sander, Reinhart and Meier-Hellmann in 2003. The respondent points that in Annexure “E” reference is made to this and other articles written by experts in the medical field to safeguard against possible misinterpretation of the statements. It is common cause that the article by Sander et al which forms part of the record, is based on a study comparing Venofundin and another potato based product, the 6% HSE 200/0.5. In the article the authors state that:

“A novel potato starch-based HES solution (HES 130/0.4) was developed by B Braun Melsungen AG…..

This trial was designed as an approval study for B Braun Melsungen AG and Serumwer Bernberg AG…..

Amount of colloidal infusions were adjusted individually up to the recommended daily dosage of 33ml/kg bodyweight for pentastarches like 6% HES 130/0.4 and 6% HES 200/0.5 (10,17)…..

A total of 36 equally distributed adverse events (AE) with unlikely or questionable relationship to the study drugs were documented (17AE in the HES 200/0.5 group and 19 in the HES 130/0.4 group, respectively. The most common AE was mild to moderate hyperbilirubinaemia at the morning of the first postoperative day with questionable relationship to study medication ….

In safety assessment, the most adverse event was mild to moderate hyperbilirubinaemia. However this was seen in a few patients of both study groups, with questionable relationship to study drugs.”

17. The applicant contends that the statement, in failing to reveal that the experts concluded that the relationship between hyperbilirubinamea observed in patients and the study drugs, is misleading and that in the light of this inconclusive result the article cannot be valid foundation for the conclusion drawn by the respondent. According to the applicant post-operative hyperbilirubinaemia may be introduced by impaired excretion of bile, "possibly due to lowered intestinal perfusion and aggravated by an increased bilirubin supply from fragmented erythrocytes or certain concomitant medication such as antibiotics".

18. My understanding of this contention is that other factors, (other than the study drugs), may cause post-operative hyperbilirubinaemia. The applicant contends further that the statement compels the reader thereof to draw the conclusion that the safety characteristics of Voluven exceed those of Venofundin in that Voluven is not associated with hyperbilirubinaemia whereas Venofundin is. From the evidence before me, I am of the view that a reader of the statement who has background knowledge of Voluven may indeed draw from the statement, the conclusion put forth by the applicant. But that conclusion may, in my view, be drawn from a mere reading the article. Further, I am not able to find any basis on which to conclude that the statement is false. The applicant does not demonstrate that Voluven is not associated with hyperbilirubinaemia. It does not explain why the statement is false. It does not dispute the assertion by the respondent that despite the numerous tests done on Voluven, there has been no association between the product and hyperbilirubinaemia. Whilst it is true that the Sander article does not conclude that Venofundin causes hyperbilirubinaemia, it is not true that the article does not associate Venofundin or potato starch HSE with hyperbilirubinaemia. Even if the Sander study is inconclusive on the association between Venofundin and hyperbilirubinaemia, that does not make the statement false. Neither does the fact that other factors may cause hyperbilirubinaemia.

19. That in the European package insert Venofundin is contra – indicated for liver failure whereas in the South African version it is not.

The applicant contends that the statement is false and is intended to warn the applicant’s customers that Venofundin can cause liver damage or impairment of liver function. The applicant argues that the South African package insert, under the heading "warnings", does warn of a contra-indication for liver or hepatic dysfunction. It is not in dispute that a contraindication in a package insert of a medical product is the portion thereof which informs the reader that a particular medicine should not be used in patients or persons with a particular medical and/or physical condition as stipulated in the insert.

In the South African version of Venofundin package insert, the following appears:

"CONTRA - INDICATIONS

• Hypersensitivity to hydroxyethyl starch or any of the other ingredients.

• Intracranial bleeding.

• Renal failure with oliguria or anuria.

• Dialysis treatment.

• Sever hypernatremia or severe hyperchloremia.

• Fluid overload (hyperhydration) including pulmonary oedema."

20. The contra-indications in the German European Venofundin package insert have been translated by the respondent as follows:

"Gegenanzeigen [Contraindications]

.....Schwere leberfunktionseinschrankung [Severely impaired hepatic [liver] function [i.e. liver failure]]..."

21. In the English version of the European Venofundin package insert the contraindications appear as:

"Contraindications

- Hyperhydration states including pulmonary edema.

- Renal failure with oliguria or anuria

- Intracranial bleeding

- Severe hypernatremia or severe hyperchloremia

- Hypersensitivity to hydrxyethyl starch or to any of the excipients.

- Severely impaired hepatic function.

- Congestive cardiac failure"

22. By all accounts it appears to be factually correct that contrary to the European version, the South African Venofundin package insert contains no contraindication for severely impaired hepatic function. The warning issued in the South African package insert of Venofundin is that: "[p]articular caution should be exercised in patients with hepatic insufficiency, pulmonary oedema and in those with blood coagulation disorders". This warning, in my view simply means that particular care should be taken when administering the product to patients suffering from the stated conditions. It falls short of advising that the product should not be administered to patients suffering from such stated conditions. I am therefore satisfied that the statement is neither misleading nor false.

23. That the potato-derived HES has a greater effect on (blood) coagulation than the waxy-corn derived HES.

It is common cause that this statement was drawn by the respondent from an article written by M Jamnicki and others titled "The effect of potato starch derived and corn starch derived hydroxyethyl starch on in vitro blood coagulation". At the beginning of the article the authors say:

“The present study was designed to investigate the effects on in vitro blood coagulation of a newly developed potato starch derived hydroxyethyl starch (HES) and to compare those effects with those of the traditional corn starch derived HES, as assessed by thrombelastography (TEG).”

24. The applicant contends that the respondent was not entitled to extrapolate the Jamnicki study to Venofundin and Voluven as the study was not done on these product. It is so that the Jamnicki study did not compare Voluven and Venofunden. It compared a potato-based HES (INFUKOLL HES 6%) and a maize-based HES (HAES - steril 6%) and the authors concluded that “potato starch derived hydroxyethyl starch compromises in vitro blood coagulation more that corn starch derived hydroxyethyl starch.” The applicant's case in this regard, as I understand it, is that data acquired in clinical studies on a potato and maize- based HES cannot be utilised to infer similar properties in Venofundin and Voluven. There is, however, no explanation why such an inference cannot be made either generally or in this particular case. Whilst the Jamnicki study does not specifically refer to Venofundin and Voluven, the products in question are derived from potato starch and maize starch. I find no basis to conclude that the respondent's reliance on the study is not justified as submitted by Mr Mundell on behalf of the applicant.

25. The applicant contends that there is essentially no distinction between Venofundin and Voluven insofar as they are associated with blood coagulation. In this regard the applicant relies on an opinion of Dr Gernot Willy Konrad Marx, an international medical expert whose opinion is that the fact that package inserts for both Venofundin and Voluven indicate that care must be taken when administering the products to patients with severe liver disease or severe bleeding disorders negates the distinction which the respondent seeks to draw between the two products. According to Dr Marx a recent trial comparing Venofundin and Voluven showed a general bio-equivalence. He states that there is no evidence that doses of up to 33ml/kg of Venofundin have been associated with hyperbilirubinaemia and maintains that the study on which the respondent relies in associating Venofundin with liver impairment and/or hyperbilirubinaemia does not justify the conclusion drawn by the respondent. He points out that in the Sander study the authors measured bilirubin which had not been investigated in previous trials on volume replacement therapy. My view is that the fact that levels of bilirubin were not measured in previous studies has no effect on the results of a study wherein bilirubin was measured. Nor does that fact demonstrate that there is no association between Venofundin and hyperbilirubinaemia. It also does not detract from the uncontested assertion that no studies have shown an association between hyperbilirubinaemia and Voluven.

26. Further, as Mr Rowan submitted on behalf of the respondent, Dr Marx's opinion that the two products are bioequivalent and/or their end product is identical, is rendered doubtfully an article co-authored by the same Dr Max, G Lehman and H Forster, in which it is concluded that the two products must be considered as not being bio-equivalent. Another expert, Professor Guy Richards, in a written opinion states that:

"The Lehman study (of which Prof Gernot Marx is a co-author) and the Sommermeyer report (attached) indicate that Voluven and Veonofundin are not bio-equivalent. In fact the raw materials utilized are entirely different waxy maize for Voluven and potato for Venofundin). As a consequence these products have a significant potential effect on their pharmacokinetic profiles".

27. Drs Klaus Sommermeyer, Franz Cech and Richada Scchossow also point out that postoperative hyperbilirubinaemia is a side effect not known in waxy maize starch derived HES. They conclude that "waxy maize and potato starch based hdroxyethyl starch plasma volume expanders differ in their chemical fine structure. Their pharmacological and clinical equivalence remains to be proven with further studies". Dr Sommermeyer's opinion is that in the light of the physio-chemical differences between the two products, the claimed similarity of potato starch based products to waxy corn starch based products is not justified because theoretical arguments and published data indicate a higher inference on coagulation of the potato starch based products.

28. That Venofundin is registered for a dosage of 33ml/kg bodyweight; with the maximum dosage of 40ml/kg for one day in acute cases (and there is no data for higher doses).

In contending that this statement is false the applicant refers to the European package insert of Venofundin and an article written by Dr Marx. The relevant portion on the South African package insert for Venofundin reads:

" ...The maximum daily dosage is 33/ml/kg body weight per day...

In cases of acute and severe bleeding a higher dose may be given for 1 day if indicated after the risk/benefit analysis. However, dosage of more than 40ml/kg bodyweight per day should not be exceeded". (emphasis supplied)

In the European package insert the following appears:

"The maximum infusion rate depends on the clinical situation. Patients in acute shock may be administered up to 20ml per kg of body weight per hour (equivalent to 0,33mlkg/min or 1.2g of hdroxyethyl starch per kg of bodyweight per hour). In life threatening situations 500ml may be administered by manual pressure infusion. Also see "Method of administration and duration of therapy.

Maximum daily dose:

Up to 50ml of Venofundin per kg of body weight (equivalent to 3.0g of hydroxyethyl starch per kg of bodyweight). This is equivalent to 3,500ml of Venofundin for a 70 kg patient."

Dr Marx, in his written opinion to the applicant, states that:

"In the European SPC the maximum infusion rate of Venofundin is 50ml/kg body weight over 24 hours similar to the SPC of Voluven.In the South African SPC of Venofundin it is stated that the maximum infusion rate depends on the clinical situation. There is no scientific reason that the infusion rate of one drug should be different between Europe and South Africa".

The opinion is, however, silent on the instruction in the South African insert that dosage of more that 40ml/kg per day of Venofundin should not be administered. My view is that in the light of this warning in the South African leaflet, the fact that the European package insert provides for administration of higher dosage of the product is irrelevant to a South African reader of the leaflet or user of the product. In this light therefore, the statement cannot, in my view, mislead or constitute injurious falsehood or unlawful competition.

29. To further disprove the distinction drawn by the respondent between the two products, the applicant compares the "almost identical" package inserts thereof. These include identical contraindications for both products; the same maximum infusion rate for both products being 33ml/kg bodyweight; both products being registered for similar side effects, precautions, safety and efficacy in relation to children and use during pregnancy and lactation. The applicant contends that the package inserts reveal minimal meaningful distinction between the products and that the statements are not justified in the light thereof. In my view the comparison of the package leaflets does not prove the falsity of the statement or that the statements are misleading. In any event, as the respondent contends, the package insert used by the applicant in respect of Voluven is outdated, having been used prior to 2004. The scope of Voluven has been widened with the registration of the 2004 and 2007 package inserts for the product; for example the 2004 package insert states that there has been limited use of Voluven in children.

30. I am not persuaded that the statements made by the respondent are misleading or constitute injurious falsehood and/or find no basis in the articles cited by the respondent in Annexure “E”. Even if the criticism by the applicant that the statements are not supported by the articles cited in Annexure “E” is well founded, it does not follow that the statements are false. “It is an error to say that false premises must logically lead to propositions which are false: it is plain that a good cause may have bad reasons offered on its behalf”. Post Newspapers (supra) at 459 H. It is not the applicant’s case that Venofundin is distinguishable from other potato based products and that properties observed in other potato based products should therefore not be attributed to Venofundin. On the other hand expert evidence suggests that the results of studies done on potato derived starches are of relevance to potato based products generally.

It is my view in the circumstances that the applicant has not made out a case for the relief it seeks.

31. Application to file a supplementary answering affidavit.

The respondent wishes to supplement its answering affidavit for three reasons. Firstly it contends that it needs to respond to certain issues raised for the first time in the applicant’s replying affidavit. It further seeks to place before the court certain information that it was previously unaware of. It also seeks to place before court certain expert evidence that it could not file with the answering affidavit because of time constraints.

32. New Matter

In the replying affidavit the applicant attached a document (annexure R 5) titled;

"VOLUVEN vs Venofundin

Internal use only - Arguments for the market"

The document is yet another comparison between the two products. Amongst others, the following appears on the document:

	VOLUVEN	VENOFUNDEN
Studies available #1 in a SAFETY	> 60 VOLUVEN studies proving safety	3 studies (2 published)-use Voluven studies for argument
Dose limit	45ml/kg registration Neff 2003 proved 70ml/kg/day for up to 28 days to be safe with no effect on renal function or coagulation	33ml/kg registration Venofundin SmPC says you can give maximum 40ml/kg for ONE day in acute cases
Blood typing before infusion	No SmPC No influence on blood group serology Voluven scientific info	Yes according in European SmPC but no according to SA SmPC???
Infusion speed	No limitations SmPC	20ml/kg/hour in European SmPC but not included in SA SmPC???
Liver failure	Not contra-indicated	Contra-indicated in European SmPC but no in SA SmPC??? Sander 2003 Venofundin @ 33ml/kg associated with hyperbilirubinaemina
Coagulation	Jamnicki 1998 compared HES 200/0.5 maize vs potato starch and showed potato starch to have greater effect on coagulation than maize starch

33. It is common cause that despite the document being an internal document intended for use by the respondent's representatives, copies thereof were handed to medical staff at hospitals in Vereeniging and at the West Coast Life Hospital in the Western Cape. In the answering affidavit the applicant contends that this document was a further attempt by the respondent to persuade the staff at these hospitals that Venofundin has a greater effect on coagulation than Voluven.

34. A fundamental consideration in an application for filing of further affidavits is that a matter should be adjudicated upon all facts relevant to the issues in dispute. South Peninsula Municipality v Evans 2001 (1) SA 271 (C) at 283 A-H. I am of the view that the contents of Annexure "R 5" are in essence a repetition of allegations already made by the parties in the first two sets of affidavits. They do not constitute new matter. The respondent, in my view, answered to these allegations in the main answering affidavit. That certain minor allegations were not included in the applicant's founding papers (for example, the allegation in annexure R5 that there are in excess of 60 studies proving safety of Voluven whereas there are only three in respect of Venofundin) does not take the matter any further.

35. The respondent further takes issue with allegations made in paragraphs 40 to 45 of the replying affidavit. In these paragraphs the applicant refers to the respondent’s distribution of the Jamnicki article to attendees of an anaesthetic refresher course held at Groote Schuur Hospital from 2 to 5 August 2007. The applicant contends, in the replying affidavit, that the article was distributed by the respondent with the intention to persuade the persons to whom it was given, that Venofundin compromises in vitro blood circulation more than corn starch HES such as Voluven. In paragraph 44 of the replying affidavit Junkhun refers to an incident in which a representative of the respondent, Shelley, presented a copy of the Jamnicki article to a specialist at St Augustine Hospital in Durban and wrote on the article, in her handwriting, that the potato starch HES being referred to in the article is Venofundin and the corn starch HES referred to is Voluven. I am, again, of the view that these allegations are a repetition of what is already contained in the parties' first two sets of affidavits. I can only conclude that the applicant's intention, in citing these incidents, was to demonstrate that the applicant persists with the offending conduct. In view of the respondent’s denial of any wrongdoing, such persistence was to be expected. In any event the incidents referred to in paragraphs 40 to 45 of the replying affidavit are, strictly speaking, not relevant to this application and should be properly struck off from the record.

36. Facts that the respondent recently became aware of.

The information referred to by the respondent is a written comparative analysis between Venofundin and Voluven prepared by the applicant. In this document the applicant states, amongst others, that both products are produced to contain 100% of Amylopectin in the finished product and that all Amylose is removed. The comparative analysis further states that corn starch contains Sulphur and potato starch contains Phosphate, the content of which, in both products, is very small and clinically irrelevant. I can only conclude that all this is intended to disprove the distinction drawn by the respondent between the two products. The respondent contends that the truth is that the degree of esterification (modification) of Phosphate in the potato starch HES derived product is higher in comparison to the waxy maize starch derived product. Lastly the respondent contends that contrary to the Lehman and Marx study, which shows “advantages for Venofundin” in respect of plasma clearance, three other studies conclude that Voluven has a faster clearance rate than that reported in the Lehman study.

Once more, my view is that the applicant’s comparison adds nothing new to the case made by the applicant in the founding papers. The respondent may have only become aware of this document subsequent to the filing of the answering affidavit. But the contents of the document are neither the basis of the application nor the respondent's reason for preparing Annexure “E”. It is therefore irrelevant to this application.

37. The evidence of Drs Gopalan and Joubert

This evidence is contained in reports prepared by the two experts in respect of certain aspects of the Sander study. The reports were prepared on the respondent’s instruction but were not completed in time for filing together with the answering affidavit. The respondent refers to portions of the expert reports which refute the claims that the association between Venofundin and Voluven finds no support in the Sander study. Dr Gopalan remarks that:

“Hyperbilirubinemia is indeed an indication if impairment of liver function. The study in question does indeed describe hyperbilirubinemia in patients included in the study…..While this study does not prove causation with respect to the study medication (Venofundin), it does potentially show an association. From a clinician’s perspective, this would have to be born in mind with respect to drug administration until further evidence either proves or refutes this association. Note the comparator drug in this study was not Voluven (Venofundin) but a 200/0.5 potato derived starch. From a scientific perspective, this raises the question as to whether hyperbilirubinemia is associated specifically with potato derived solutions”.

Regarding contra-indications for liver failure Dr Joubert states that:

“There is a clear distinction between a contraindication with respect to administration and a warning with respect to administration. A contraindication would mandate non- administration of the drug whereas a warning would be seen as a strong cautionary advice with respect to administration of the drug.

It is very surprising that the European package insert for Venofundin carries a contraindication for administration in severe, hepatic dysfunction, while the South African version does’nt. From a clinician’s perspective this is of grave concern.”

38. It would appear that the assertions made by the Drs Gopalan and Joubert in these paragraphs are the main motivation for seeking admission of their affidavits and reports. But the respondent filed, together with its main affidavits, reports and opinions by no less than four other experts, including Drs Sommermeyer and Richards, who also warned that the presence of post-operative hyperbilirubinaemia in patients on whom Venofundin had been administered requires further investigation. Further, the respondent, in the answering affidavit, explains conclusively the difference between a "contraindication" and a "warning" in the package insert of a medical product.

39. Having considered these aspects I am satisfied that the respondent stands to suffer no prejudice if the filing of a supplementary answering affidavit is not permitted. Further, in view of the irrelevant allegations made in the applicant's replying affidavit, to which the respondent sought to respond in the supplementary answering affidavit, I am of the view that the appropriate costs order would for each party to pay its own costs in respect of the application for leave to file a supplementary answering affidavit.

The following order shall therefore issue:

1. The interim relief sought is refused with costs;

2. The application for leave to file a supplementary answering affidavit is dismissed with no order as to costs.

_________________________

N DAMBUZA

JUDGE OF THE HIGH COURT

Applicant’s Counsel: Adv Mundell

Applicant’s Attorneys: Greyvensteins Nortier

St George’s House

104 Park Drive

PORT ELIZABETH

Respondents’ Counsel: Adv Rowan

Respondent’s Attorneys: Pagdens-Stultings

18 Castle Hill

Central

PORT ELIZABETH

Heard on: 1 November 2007

Delivered on: 15 April 2008

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