AUTH/2107/3/08: Baxter Healthcare v Johnson & Johnson Wound Management – Quixil promotion and aprotinin (Trasylol) safety alert | PMCPA Case

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Key facts

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Case number	AUTH/2107/3/08
Case reference	Code of Practice Review August 2008, Case AUTH/2107/3/08
Complainant	Baxter Healthcare Ltd
Respondent/company	Johnson & Johnson Wound Management
Product(s)	Quixil (human fibrin sealant); Trasylol (aprotinin) referenced; Tisseel Kit referenced
Material/channel	Representatives’ briefing materials (email/PowerPoint); exhibition banner stand; customer promotional letter (early January 2008)
Key issue	Use of a regulatory safety alert for Trasylol in a way that implied Quixil had a safety/clinical advantage because it was aprotinin-free, without supporting data; misleading by implication
Dates (received/completed if stated)	Complaint received 18 March 2008; case completed 30 April 2008
Appeal	Not stated
Code year	Not stated
Breaches/clauses	Clause 7.2
Sanctions	No explicit additional sanctions stated beyond the required undertaking/corrective actions described in the report

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Reviewed by Dr Anzal Qurbain (FFPM) — ABPI Final Signatory

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What happened

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Baxter Healthcare alleged Johnson & Johnson Wound Management used a regulatory safety alert about Trasylol (aprotinin) in the promotion of Quixil (human fibrin sealant) in a misleading way.
Baxter said that after worldwide marketing of Trasylol was suspended in November 2007, the EMEA issued a statement (21 November 2007) clarifying that aprotinin used locally in sealants (glues) was not affected.
Baxter reported receiving enquiries in early December 2007 about the licence status and appropriateness of use of Baxter’s Tisseel (which contains bovine aprotinin).
Baxter alleged one customer from a cardiac surgery centre was told by a Johnson & Johnson representative to stop using Tisseel and switch to Quixil because Quixil did not contain aprotinin.
Baxter wrote to Johnson & Johnson asking what action had been taken to prevent recurrence; Baxter said it received no response.
It became evident Johnson & Johnson’s salesforce had been officially briefed on the aprotinin withdrawal; Baxter said Johnson & Johnson refused to supply a copy of the briefing material (offering to show it at a meeting).
Baxter also alleged Johnson & Johnson wrote to consultant haematologists stating there was a fibrin sealant available that did not contain aprotinin; Baxter questioned the appropriateness given Quixil use was almost exclusively in surgical operations.
A UK exhibition banner stand for Quixil included the claim “Completely free of animal sourced components – Aprotinin free”.
Johnson & Johnson said there was confusion among health professionals following the worldwide suspension and MHRA statement (29 November 2007) and it sought to reassure customers that Quixil did not contain bovine aprotinin and that Trasylol regulatory action did not affect fibrin sealants.
Johnson & Johnson sent a promotional letter in early January 2008 to approximately 28,000 customers (mainly surgeons and pharmacists, including 160 haematologists and 2,100 clinical directors) stating the Trasylol actions were Trasylol-specific and did not affect fibrin sealants.

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Outcome

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The Panel ruled that Johnson & Johnson’s representatives’ briefing material was misleading by implication and likely to lead to a breach of the Code; a breach of Clause 7.2 was ruled.
The Panel ruled that the exhibition banner claim “Aprotinin free” implied a benefit/clinical advantage versus aprotinin-containing sealants without supporting data and was misleading; a breach of Clause 7.2 was ruled.
The Panel did not consider the early January 2008 customer letter misleading as alleged; no breach was ruled in relation to that letter.
Complaint received: 18 March 2008; case completed: 30 April 2008.

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AUTH/2107/3/08: Baxter Healthcare v Johnson & Johnson Wound Management – Quixil promotion and aprotinin (Trasylol) safety alert

Key facts

What happened

Outcome

Clauses

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