Recently, the Department of Justice reported that Endo Health Solutions Inc. voluntarily agreed to pay $193 million in settlement for the unlawful marketing of Lidoderm, a shingles treatment medicine for uses that were not approved by the U.S Food and Drug Administration. As part of the settlement, Endo will pay $172 million in penalties and a criminal fine of $20.8 million.
The company admitted to promoting the medication to healthcare providers and distributing it nationwide for uses beyond shingles. The medication was marketed as treatment for pain, including low back pain, diabetic neuropathy and carpal tunnel syndrome, none of which were approved by the FDA.
It is important to note that this is not the first time Endo Health has been involved in an illegal activity. Endo Health Solutions has also been involved in purchasing American Medical Systems which has been associated with the infamous transvaginal mesh products and defective devices that have caused permanent injuries and other health risks to patients. In June 2013, it was also reported that Endo had agreed to pay $54.5 million to settle lawsuits alleging its vaginal mesh implants injured women.
Illegally marketing drugs for unauthorized uses in order to increase sales puts patients health in danger. Information on the authorized use of medications should be clearly stated and followed in order to protect patient health and safety. In spite of settlements and lawsuits, drug companies like Endo Health Solutions have continued to be involved in putting patients at risk. It is essential that the FDA enforce stringent requirements for drug-manufacturing companies that should be held accountable for actions and products that put patient health at risk for revenue and profits.