Sunovion: RBM urged “you might be sued” messaging to drive Latuda reviews; Appeal Board publicly reprimanded misleading response (AUTH/2935/2/17)

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Key facts

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Case	AUTH/2935/2/17
Company	Sunovion Pharmaceuticals Europe Ltd
Complainant	Anonymous ex-employee
Product	Latuda (lurasidone)
Therapy area	Schizophrenia (adults)
Main allegation	RBM encouraged sales staff to pressure prescribers using medico-legal “you might be sued” messaging; cited barrister presentation as implied authority
Complaint received	13 February 2017
Undertaking received	19 June 2017
Applicable Code year	2016
Breach clauses	15.2; 15.9
No breach clauses	2; 9.1; 15.2; 15.9
Sanctions	Undertaking received; Public reprimand; Audit of company’s procedures (with parent-company interviews); re-audits (June 2018, April 2019)
Appeal hearing	No appeal (Appeal Board consideration of case report and sanctions)
Interim case report first published	30 October 2017
Case completed	11 July 2019

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

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An anonymous ex-employee alleged a regional business manager (RBM) encouraged sales staff to pressure customers to prescribe Latuda (lurasidone) by suggesting prescribers could be sued if Latuda wasn’t considered during patient reviews.
It was alleged the RBM encouraged staff to quote national measures/guidelines (including CQUIN) about reviewing medication when patients had side-effects.
The complainant alleged the RBM cited a barrister’s medico-legal presentation as implied authority to challenge customers’ prescribing and to make customers feel uncomfortable about their medico-legal position.
Sunovion investigated interviews from attendees of a February 2017 regional meeting; initially characterised the interviews as “mixed and somewhat unclear”.
The Panel reviewed interview transcripts and found most attendees recalled the RBM directed the team to suggest legal consequences if patients were not reviewed and alternative options offered (eg “if you don’t do this, you might be sued”).
There was no evidence provided about what representatives actually said to health professionals in the field.
The Appeal Board later found Sunovion’s initial response to the PMCPA was inaccurate/misleading (not a fair reflection of the interviews) after the US parent company altered the UK draft response.

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Breach rulings were made against the RBM’s verbal direction (Clauses 15.2 and 15.9).
No breach was found regarding what representatives said to health professionals (insufficient evidence).
No breach was found for referencing CQUIN/guidelines (on the balance of probabilities, the RBM’s direction on this did not advocate a likely breach).
No breach of Clause 9.1 and no breach of Clause 2 were ruled by the Panel.
The Appeal Board publicly reprimanded Sunovion for providing inaccurate and misleading information to the Panel and Appeal Board and required audits of Sunovion’s Code procedures (including parent company interviews).
Following audit (Nov 2017) and re-audits (Jun 2018, Apr 2019), the Appeal Board noted significant progress and decided no further action was required (case completed 11 July 2019).

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