Boehringer Ingelheim press release about Pradaxa appeared to come from Lifeblood without consent

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Key facts

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Case number	AUTH/2118/4/08
Case reference	Pradaxa press release
Complainant	Lifeblood: The Thrombosis Charity
Respondent/company	Boehringer Ingelheim Limited
Product(s)	Pradaxa (dabigatran etexilate)
Material/channel	Press release distributed to media (including Daily Telegraph, Daily Express, Daily Mail, BBC)
Key issue	Unauthorised amended press release appeared to come from Lifeblood; inappropriate use of quotations without permission; misleading/inaccurate public information about authorised indication
Dates (received/completed if stated)	Complaint received 25 April 2008; Case completed 27 June 2008
Appeal	Not stated
Code year	Not stated
Breaches/clauses	Breaches: 11.2, 11.3, 20.2. No breach: 2, 9.1. Clause 20.6 cited (responsibility for PR agency product information).
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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Lifeblood: The Thrombosis Charity complained about a press release about Pradaxa (dabigatran etexilate) which it said had been issued by a media advisor acting for Boehringer Ingelheim.
Lifeblood said the press release appeared to have come from Lifeblood, despite Lifeblood not being given sight of it, not being asked to comment, and not being asked for consent to publish it.
Lifeblood stated it would not issue any press release that endorsed or appeared to endorse a specific product, and it had a policy of remaining independent.
Boehringer Ingelheim said it had approved press materials (including two press releases and fact sheets) under its SOP and that materials were pre-vetted by the MHRA; quotations from Lifeblood’s medical director in the approved releases had been approved and faithfully reproduced.
The agency subcontracted a media advisor who, for unclear reasons, changed the approved press release without reference to or approval from Boehringer Ingelheim or the agency, and sent the altered material to multiple media outlets.
The altered material was headed as if it were from Lifeblood (eg, “from thrombosis charity Lifeblood” / “from Lifeblood”).
After learning of the issue, Boehringer Ingelheim and the agency took steps including removing the media advisor from PR activity and meeting with Lifeblood; Boehringer Ingelheim’s lawyers also wrote to the media advisor disassociating the company from an email sent by the advisor to Lifeblood’s medical director.

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The Panel ruled that quotations were used in an inappropriate manner: they did not reflect the meaning of the author and formal permission had not been obtained.
The Panel ruled that the quotation attributed to Lifeblood’s medical director was not in line with the authorised indications for Pradaxa because it did not state it was for use after elective surgery; the material was misleading and inaccurate in this regard.
The Panel stated that under the Code a company is responsible for the actions of third parties employed on its behalf, even if acting outside instructions, and that companies are responsible for product information issued by their PR agencies.
Given Boehringer Ingelheim’s procedures and that it had been badly let down by a third party, the Panel ruled no breach of the requirements to maintain high standards and not bring discredit upon the industry.

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Clause 11.2 – Breach ruled (quotations used inappropriately; did not reflect author’s meaning; formal permission not obtained).
Clause 11.3 – Breach ruled (quotations used inappropriately; did not reflect author’s meaning; formal permission not obtained).
Clause 20.2 – Breach ruled (public material misleading/inaccurate regarding authorised indication; did not state use after elective surgery).
Clause 9.1 – No breach ruled (Panel considered procedures/processes were in place and company was badly let down by a third party).
Clause 2 – No breach ruled (same reasoning as Clause 9.1).
Clause 20.6 – Cited by the Panel as making clear companies are responsible for information about products issued by their public relations agencies.

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