Pacira BioScience: Exparel claims in sales emails (day-case TKR, “pain-free mobility” and “social & economic issues”)

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Key facts

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Case number	AUTH/3624/3/22
Company	Pacira BioScience
Complainant	Pharmacy manager (registered pharmacist) at a named health group
Medicine	Exparel (liposomal bupivacaine)
Channel	Emails from a sales representative working on behalf of Pacira BioScience
Main issues	Day-case TKR/early mobilisation claims; “pain free mobility” and other efficacy statements; “social & economic issues” claim; omission of PI/AE info noted
Applicable Code year	2021
Complaint received	16 March 2022
Case completed	23 March 2023
Appeal	Appeal by the respondent; successful on one Clause 11.2 point (adductor canal block wording)
Sanctions	Undertaking received; Additional sanctions: Not stated

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

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A UK pharmacist complained about promotional emails sent in March 2022 by a sales representative working on behalf of Pacira BioScience about Exparel (liposomal bupivacaine).
The emails included claims that Exparel could be used as either infiltration or an adductor canal block; that it enabled same-day total knee replacement (TKR) discharge; and that patients could have 48/72 hours of “pain free mobility”.
Additional claims included: “48hrs+ pain relief” with “no middle of night / waking up in pain”; reduced need for additional pain medication including opioids; reduced need for catheters/pumps; and that opioid side effects bring “additional social & economic issues”.
The emails did not include prescribing information (PI) or adverse event information; the Panel noted this but assessed the complaint under Clauses 6.1 and 6.4 (not Clause 12.1).
Pacira stated the emails were sent in contravention of its procedures (no internal approval) by an employee of a third-party sales provider; the individual was removed from the account and additional controls/training were implemented.
Pacira was not an ABPI member but accepted PMCPA jurisdiction for this matter.

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Breach: Clause 5.1 (failure to maintain high standards).
Breach: Clause 6.1 (making misleading claims) in relation to certain efficacy/day-case/pain-free and “social & economic issues” claims.
Breach: Clause 6.2 (making unsubstantiated claims) in relation to “social & economic issues”.
Breach: Clause 11.2 (promotion inconsistent with the SPC) for two claims promoting same-day discharge/early mobilisation in TKR.
Breach: Clause 14.4 (making exaggerated claims) for “pain free mobility”, “no middle of night / waking up in pain”, and “social & economic issues”.
Appeal: Pacira successfully appealed one Clause 11.2 ruling; the Appeal Board ruled no breach of Clause 11.2 for the statement that the indication allowed use as “either infiltration or an Adductor Canal block …” (narrow point only).
No breach findings included: Clause 6.4 (adverse reactions), Clause 14.1 (comparisons), Clause 17.9 (representatives’ briefing material), and certain aspects of Clauses 6.1/14.4 for specific claims (see Clauses section).

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Breach of Clause 5.1 Failure to maintain high standards
Breach of Clause 6.1 Making misleading claims
Breach of Clause 6.2 Making unsubstantiated claims
Breach of Clause 11.2 Promotion inconsistent with the SPC [One ruling successfully appealed]
Breach of Clause 14.4 Making exaggerated claims
No breach of Clause 6.1 Requirement that claims must not be misleading
No breach of Clause 6.4 Requirement that claims must reflect the available evidence regarding possible adverse reactions
No Breach of Clause 11.2 Requirement that promotion must not be inconsistent with the SPC
No breach of Clause 14.1 Requirement that misleading comparisons must not be made
No breach of Clause 14.4 Requirement that exaggerated or all-embracing claims must not be made.
No breach of Clause 17.9 Requirement that representatives’ briefing material must comply with the relevant requirements of the Code

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