AUTH/2260/9/09: Boehringer Ingelheim rep emailed misleading/disparaging claims about Xarelto (rivaroxaban)

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Key facts

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Case number	AUTH/2260/9/09
Company	Boehringer Ingelheim Limited
Type	Voluntary admission (treated as a complaint)
Complaint received	01 September 2009
Case completed	01 October 2009
Appeal	No appeal
Applicable Code year	2008
Products	Xarelto (rivaroxaban) (competitor); Pradaxa (dabigatran) (BI)
Channel	Email from representative to consultant orthopaedic surgeon
Core issue	Misleading, unsubstantiated and disparaging statements about competitor product safety/formulary status; lack of high standards; company responsibility for representative conduct
Breach clauses	7.2, 7.4, 7.9, 8.1, 9.1, 15.2
No breach clauses considered	Clause 7.3 (no breach); Clause 2 (no breach)
Sanctions	Undertaking received
Notable fact	Panel noted 12 other similar emails sent on 30 July; later email suggested rivaroxaban had never been on the named town formulary

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

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Boehringer Ingelheim voluntarily admitted that a representative emailed a consultant orthopaedic surgeon with information about Bayer’s Xarelto (rivaroxaban) that could be seen as misleading and disparaging.
The email stated that in a named town “Rivaroxaban has been removed from the formulary” and that orthopaedic surgeons had “concerns about the bleeding rates with Rivaroxaban”.
Pradaxa (dabigatran) and Xarelto were both indicated for prevention of venous thromboembolic events in adults after elective total hip or knee replacement surgery.
BI said the email contravened company policies/SOPs; the representative was immediately suspended, investigated and dismissed.
During BI’s internal investigation, it uncovered 12 other similar emails sent by the representative on 30 July.
The Panel noted a later email suggested rivaroxaban had never been on the named town formulary, making the original claim false.
The Panel considered the emails should have been certified as promotional material and was extremely concerned about the representative’s behaviour.

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Breach rulings: Clauses 7.2, 7.4, 7.9, 8.1, 9.1 and 15.2.
No breach of Clause 7.3 (the email was not a comparison).
No breach of Clause 2 (Panel did not consider the circumstances warranted particular censure).
Sanction recorded: Undertaking received.

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