AUTH/2015/7/07: Lilly v Bayer Schering Pharma – Levitra claims ‘works first time’ and ‘many men prefer’ ruled misleading | PMCPA Case

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Key facts

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Case number	AUTH/2015/7/07
Parties	Eli Lilly and Company Limited v Bayer Schering Pharma
Product	Levitra (vardenafil)
Materials	Journal advertisement (ref 7LEVI05); leavepiece (ref 7LEVI07)
Main issues	“Works first time in 9 out of 10 men” (SEP2 vs SEP3; open-label challenge phase; arithmetic); “Levitra lets them wine and dine” (SPC context); “Levitra is the one many men prefer” (abstract evidence; lack of statistical evaluation; fairness)
Applicable Code year	2006
Complaint received	09 July 2007
Case completed	17 August 2007
Breach clauses	7.2, 7.3 and 7.4
Clause 2	Not upheld
Sanctions	Undertaking received; Additional sanctions: Not stated
Appeal	No appeal

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

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Eli Lilly complained about a journal advertisement (ref 7LEVI05) and a leavepiece (ref 7LEVI07) promoting Levitra (vardenafil) by Bayer Schering Pharma.
Both items claimed: “Works first time in 9 out of 10 men”, referenced to Valiquette et al (2005), with small-print qualification referring to SEP2.
Lilly argued the cited study showed first-time SEP2 success of 87% (520/600), but first-time SEP3 (maintenance sufficient for intercourse) success of 74%; therefore “9 out of 10” implied successful intercourse and was misleading.
Lilly also noted the one-week challenge phase was open label and this limitation was not stated in the materials.
The leavepiece also included: “Levitra lets them wine and dine” (referenced to the SPC) and “Given a choice of PDE5 inhibitors, Levitra is the one many men prefer” (referenced to a 2005 congress abstract by Sommer et al).

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“Works first time in 9 out of 10 men”: ruled misleading and not substantiated (implied SEP3/successful intercourse; 520/600 did not equal 9/10; footnote qualification insufficient).
“Levitra lets them wine and dine”: ruled misleading because insufficient information was provided about food and drink effects given the SPC content (including potential delay with high-fat meals).
“Given a choice of PDE5 inhibitors, Levitra is the one many men prefer”: ruled misleading and unfair (abstract provided little design/analysis detail; no apparent statistical evaluation; small differences such as 39% vs 38% at maximum dose questioned).
Clause 2 was alleged for the preference claim but not upheld (Panel did not consider censure warranted).
No appeal.

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