Bayer v Actavis: Levosert leavepiece ruled misleading on breadth of suitability and “25% saving” cost claim

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Key facts

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Case	AUTH/2794/9/15
Parties	Bayer v Actavis
Product	Levosert (complainant marketed Mirena)
Material	Four-page leavepiece (ref UK/LE/0001/01-15b)
Main issues	Implied broad suitability claim; acquisition cost “25% saving” claim vs Mirena; high standards
Key claims challenged	“Can a single IUS be suitable for so many women?”; “Levosert is available at a low acquisition cost. 25% saving compared to Mirena”
Panel findings	Claims misleading/unsubstantiated; did not encourage rational use; high standards not maintained
Breach clauses	7.2 (x2), 7.4, 7.10 and 9.1
Sanction	Undertaking received
Complaint received	11 September 2015
Case completed	21 October 2015
Appeal	No appeal
Applicable Code year	2015

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

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Bayer complained about a four-page Levosert leavepiece (ref UK/LE/0001/01-15b) issued by Actavis UK Ltd.
The leavepiece headline asked: “Can a single IUS be suitable for so many women?”
The leavepiece also stated: “Levosert is available at a low acquisition cost. 25% saving compared to Mirena”, alongside “All these benefits at a competitive price”.
Bayer argued the “so many women” message implied Levosert was suitable for more/most women versus other IUSs, despite Levosert having fewer indications and a shorter licensed duration than Mirena.
Bayer argued the “25% saving” comparison was not like-for-like and could mislead because Mirena’s licensed duration is longer (5 years vs 3 years) and Mirena could be cheaper per year if used for the full licence.

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The “Can a single IUS be suitable for so many women?” claim was ruled misleading, unsubstantiated, and not encouraging rational use.
The “25% saving compared to Mirena” acquisition cost claim was ruled misleading because it implied Levosert would always be 25% cheaper and lacked sufficient context given different “usage rates” (licensed duration).
High standards were ruled not to have been maintained due to the above breaches.
No appeal.

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