AUTH/1836/5/06: Johnson & Johnson Wound Management v Baxter Healthcare (Tisseel) – No breach | PMCPA Case

📊

Key facts

⌄

Case number	AUTH/1836/5/06
Parties	Johnson & Johnson Wound Management v Baxter Healthcare Ltd
Product	Tisseel Fibrin Sealant Kit
Main issue	Alleged promotion outside the marketing authorisation / inconsistent with SPC (promotion in burns and plastic surgery; interpretation of “haemostasis” in indication)
Complaint received	08 May 2006
Case completed	19 July 2006
Applicable Code year	2006
Clause(s) considered	Clause 3.2
Decision	No breach
Appeal	No appeal
Additional sanctions	Not stated

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

🤖

Got a question about this case?

Ask one of our 13 specialist ABPI advisors — instant answers, 24/7.

Ask AskAnzal AI

🎬 Expert Video Walkthrough

🎬

Video walkthrough — coming for members

Subscribe now and get expert video analysis for every case as we publish them.

Subscribe — from £299/yr

📋

⌄

Johnson & Johnson Wound Management complained that Baxter promoted Tisseel Fibrin Sealant Kit across multiple hospital departments, including burns and plastic surgery, as a haemostat and sealant.
Because there had been prior confusion about Tisseel’s licensed indication (referencing Case AUTH/1751/8/05), Johnson & Johnson asked the MHRA to clarify the meaning of: “Tisseel is intended to complement good surgical technique in achieving haemostasis, or obtaining a watertight seal of the dura mater”.
Johnson & Johnson said the MHRA replied that “haemostasis” could only reflect benefit in relation to neurosurgery and could not be used to promote a general haemostasis indication; the comma should not be used as justification.
Baxter disputed the allegation, stating its promotion was appropriate and in accordance with the marketing authorisation/SPC, and questioned why MHRA guidance would be shared with a competitor but not with Baxter.
The Panel reviewed the SPC wording and noted it could be interpreted in two ways due to punctuation (general haemostasis vs haemostasis only in relation to dura sealing), and considered the context in the following SPC paragraph (cardiopulmonary surgery and adjunct to dura sealing).
The Panel considered the promotional material provided and the allegation that promotion occurred in departments other than neurosurgery and cardiovascular surgery.

⚖️

⌄

No breach of the Code was ruled.
The Panel did not consider the promotional material, nor promotion in hospital departments other than neurosurgery and cardiovascular surgery, to be inconsistent with the SPC as alleged.
No breach of Clause 3.2 was ruled.

🔒

Members get the complete breakdown — Clauses, Sanction, Signatory Lens, Audit checklist, and 3 Key Questions.

Best value

£249/year

Annual — save £99

£29/mo

Monthly

Join Now — Instant Access