AUTH/2634/8/13: Anonymous v Boehringer Ingelheim – Spiriva Respimat ‘perfectly safe’ claim (No breach) | PMCPA Case

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Key facts

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Case number	AUTH/2634/8/13
Parties	Anonymous complainant v Boehringer Ingelheim
Complainant	Anonymous, non-contactable general practitioner
Company	Boehringer Ingelheim Limited
Product	Spiriva Respimat (tiotropium solution for inhalation); comparator mentioned: Spiriva Handihaler
Therapy area / indication	Chronic obstructive pulmonary disease (COPD) maintenance bronchodilator treatment
Allegation	Representative allegedly said a new unpublished study showed Respimat was “perfectly safe” regarding CV events
Key study referenced	TioSPIR (Tiotropium Safety and Performance in Respimat)
Panel finding	No breach; allegation not proven on balance of probabilities
Applicable Code year	2012
Clauses considered	2, 7.2, 7.4, 7.9, 9.1, 15.2, 15.9
Complaint received	07 August 2013
Case completed	02 October 2013
Appeal	No appeal

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

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An anonymous, non-contactable GP complained about statements made by a Boehringer Ingelheim representative at a lunchtime meeting about Spiriva Respimat (tiotropium solution for inhalation).
The GP alleged that, when asked about the Respimat device and cardiovascular (CV) event concerns, the representative said a new “10,000 patient study” showed the device was “perfectly safe”, despite the study not being published.
Boehringer Ingelheim investigated but said the complainant provided no practice details or meeting date, making it impossible to identify the specific meeting.
The representative in the relevant county could not recall a meeting matching the description and denied saying the device was “perfectly safe”; the representative said they would have referred to TioSPIR as enrolling ~17,000 patients.
Boehringer Ingelheim explained it had provided only reactive materials about the TioSPIR study design/rationale (not results) and that TioSPIR results were internally embargoed until after publication in September 2013.

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No breach of the Code was ruled.
The Panel found the complainant had not demonstrated, on the balance of probabilities, that the representative claimed the Respimat device was “perfectly safe”.
No breach rulings were made for Clauses 7.2, 7.4, 7.9, 15.2, 15.9, 9.1 and 2.

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