Boehringer Ingelheim: Actilyse press release implied unequivocal mortality benefit (AUTH/2026/7/07)

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Key facts

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Case number	AUTH/2026/7/07
Complainant	Hospital consultant in elderly/stroke medicine
Company	Boehringer Ingelheim
Product	Actilyse (alteplase)
Material	Press release on corporate website (originated from German corporate colleagues)
Main issue	Mortality discussion implied unequivocal effect on death; misleading/unsubstantiated vs SPC limitations
Applicable Code year	2006
Breach clauses	7.2, 7.4, 9.1
Clause 2	Not breached (not ruled)
Complaint received	24 July 2007
Case completed	31 October 2007
Appeal	No appeal
Sanction	Undertaking received

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

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A hospital consultant complained about an Actilyse (alteplase) press release placed on Boehringer Ingelheim’s corporate website by German corporate colleagues.
The press release related to a UK NICE appraisal and included statements about outcomes including “death and dependency” and a comparison of mortality rates in routine practice vs pooled randomised trials (11.3% vs 17.3%).
The complainant alleged the release made alteplase appear “life-saving” and criticised non-disclosure of UK-specific mortality data (20.6%) said to have been presented to NICE.
Boehringer Ingelheim UK said it did not place the release on the UK website and did not direct UK doctors/media to it; it was prepared for a global audience and included an international-markets disclaimer.
The Panel held that UK companies are responsible for acts/omissions of overseas affiliates within scope, and that this press release (UK NICE document; benefit to UK patients) was subject to the UK Code.
The Panel found the release’s discussion of mortality implied the data were unequivocal, despite the SPC stating the data did not allow a definite conclusion on effect on death.

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No breach was ruled in relation to the specific allegation that the press release stated mortality was “reduced from 17.3% to 11.3%” (the Panel found it was presented as a comparison of mortality rates in routine practice vs randomised trials and was clear on that point).
The press release was ruled misleading and unsubstantiated regarding mortality implications.
Breaches were ruled of Clauses 7.2, 7.4 and 9.1.
No breach of Clause 2 was ruled (Panel did not consider the circumstances warranted that level of censure).

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