FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Endo Settles Texas Off-Label Promotion Case for $13 Million

Aug. 7, 2018

Endo Pharmaceuticals has settled with the state of Texas for $13.25 million over allegations of illegal marketing for its drug Lidoderm (lidocaine).

The lawsuit alleged Endo misrepresented the drug’s safety, efficacy and approved uses in its marketing to Texas’ Medicaid program, leading to illegal promotion of the drug. Between 2002 and 2006, Lidoderm was approved only for an indication of shingles-related pain.

The lawsuit alleged Endo deliberately suppressed information about negative results in five clinical trials showing the drug was no more effective than a placebo for lower back pain, carpal tunnel syndrome and neuropathic pain, instead promoting less rigorous studies to bolster off-label use.

The complaint further claimed Endo improperly sought out doctors who were unlikely to prescribe the drug for the approved use and shipped free samples of the drug to formulary executives as part of a push to illegally secure preferential treatment for the drug.

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