Guerbet exhibition claim “Dotarem…with the highest Stability” ruled misleading in context

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Key facts

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Case number	AUTH/2091/1/08
Case reference	GE HEALTHCARE v GUERBET LABORATORIES (Dotarem exhibition panel)
Complainant	GE Healthcare Limited
Respondent/company	Guerbet Laboratories Ltd
Product(s)	Dotarem (gadoteric acid)
Material/channel	Exhibition panel (used at a clinical meeting)
Key issue	Claim “Dotarem…with the highest Stability” was considered capable of implying unproven clinical/safety benefit in the context of the NSF debate; misleading by implication despite being factually true.
Dates (received/completed if stated)	Complaint received 29 January 2008; case completed 16 May 2008
Appeal	Yes. Clause 7.4 ruling overturned (no breach), but breaches of Clauses 7.2 and 7.3 upheld.
Code year	Not stated
Breaches/clauses	Breaches of Clauses 7.2 and 7.3 upheld on appeal; no breach of Clause 7.4 on appeal
Sanctions	No explicit additional sanctions stated beyond the required undertaking/corrective actions described in the report

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

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GE Healthcare complained about an exhibition panel used by Guerbet Laboratories Ltd to promote Dotarem (gadoteric acid) carrying the claim: “Dotarem The MR Gadolinium Complex with the highest Stability”.
GE Healthcare alleged the superlative “highest stability” implied a clinical benefit (including safety) over other gadolinium-based contrast media, in a debated area (stability and nephrogenic systemic fibrosis (NSF)), and that the claim was misleading.
The Panel noted regulatory and scientific context: NSF and the role of gadolinium-based contrast media was described as an emerging science; Dotarem’s SPC included a warning that NSF might occur in patients with impaired renal function and that use should be after careful consideration.
Guerbet appealed, arguing the “highest stability” statement was factually correct and substantiated by physicochemical data and that the panel did not make clinical claims.

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Panel: ruled the claim implied an unproven clinical benefit and was misleading; breaches of Clauses 7.2, 7.3 and 7.4 were ruled.
Appeal Board: found the claim “highest Stability” could be substantiated with available physicochemical data; no breach of Clause 7.4.
Appeal Board: nevertheless held that, in context with clinicians and the ongoing NSF debate, the claim could be interpreted as “highest stability” meaning “highest safety”, implying an unproven clinical benefit; breaches of Clauses 7.2 and 7.3 were upheld.

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