AUTH/1888/9/06: Bayer voluntary admission after failing to withdraw a leaflet covered by an undertaking (BAUS conference)

📊

Key facts

⌄

Case number	AUTH/1888/9/06
Company	Bayer plc, Pharmaceutical Division
Product / campaign context	Levitra; SortEDin10 campaign; “10 minute” efficacy claim (context from Case AUTH/1813/6/06)
Material	Leaflet ref 6LEVI13
Issue	Leaflet covered by an undertaking was displayed at BAUS after it should have been withdrawn
Event / setting	BAUS conference exhibition stand
Date of display	29 June 2006
Approx. copies on stand / taken	~50 placed; ~10 taken (exact figures not available)
Complaint received	03 September 2006
Applicable Code year	2006
Breach clauses	Clause 2, Clause 9.1, Clause 22
Appeal	Yes (by Bayer); unsuccessful
Sanctions	Undertaking received; Advertisement; Audit of company’s procedures; Re-audit
Key dates (from report)	Proceedings commenced 4 September 2006; Undertaking received 18 December 2006; Appeal Board consideration 22 February 2007
Publication	May 2007 Code of Practice Review

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

📋

⌄

Bayer had given an undertaking (from Case AUTH/1813/3/06) to withdraw materials containing a “10 minute” efficacy claim (Levitra/SortEDin10 context).
A leaflet (ref 6LEVI13) that should have been withdrawn was displayed at the British Association of Urological Surgeons (BAUS) conference on 29 June 2006.
The leaflet had been dispatched for BAUS in early May, before the relevant Panel ruling (19 May) and before the undertaking (30 May), but it was still displayed after the undertaking.
Other materials caught by the undertaking were not displayed; this leaflet was displayed “in error”.
An internal email (9 June) instructed withdrawal of 13 items, including the leaflet, but the Panel/Appeal Board considered the email unclear and downplayed the seriousness (framed as “agreed to remove” after discussions, not as required following a ruling).
The agency setting up the stand was given a list of items not to use; the leaflet was missing from that list.
About 50 copies were placed on the stand and about 10 were taken (exact figures not available).
Lilly wrote to Bayer on 19 July about the leaflet being on the stand; Bayer’s voluntary admission to the Authority was dated 1 September (over six weeks later). The Appeal Board considered the explanation for delay inadequate.

⚖️

⌄

Bayer accepted that the omission constituted a breach of Clauses 2, 9.1 and 22.
The Panel ruled breaches of Clauses 2, 9.1 and 22.
Bayer appealed the findings under Clauses 2 and 9.1; the appeal was unsuccessful.
The Appeal Board required an audit of Bayer’s procedures in relation to the Code and later required a re-audit (July 2007) due to urgency and the amount of work needed on SOPs.

🔒

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