Endo Pharmaceuticals Pays Settlement for Off-Label Marketing of Lidoderm Pain Patch
Endo Health Solutions Inc and its subsidiary Endo Pharmaceuticals have agreed to pay $171.9 million to settle False Claims allegations for off-label marketing of their pain patch, Lidoderm.
Endo Pharmaceuticals is also a subsidiary of American Medical Systems, and recently settled another personal injury allegation for their transvaginal mesh devices for $54.5 million. The settlement agreement covered some, but not all 5,000 of the transvaginal mesh lawsuits in the Endo multidistrict litigation (MDL).
According to the US Government, Lidoderm was approved by the FDA to treat pain associated with post-herpetic neuralgia, which is a painful condition that affects certain people with a history of shingles. However, Endo Pharmaceuticals marketed the drug to treat more general types of pain, including chronic pain and lower back pain. The off-label marketing was not approved by the FDA, although it occurred between 1999 and 2007, according to the US Attorney’s Office in Philadelphia.
Because the product was not approved for pain outside of shingles cases, Medicare and Medicaid could not cover those prescriptions.
Endo Pharmaceuticals has agreed to pay $137,700,172 to the U.S. Government and a total of $34,209,981 to various states and the District of Columbia, the U.S. Attorney’s Office announced.
“Off-label marketing can undermine the doctor-patient relationship and adversely influence the clear and honest judgment of doctors that their patients rely on and trust,” Zane David Memeger, the U.S. Attorney for the Eastern District of Pennsylvania, said in a statement released Friday. “Pharmaceutical companies have a legal obligation to promote their drugs for only FDA-approved uses. This obligation takes precedence over the company’s bottom line.”
In addition to the financial repercussions of the Lidoderm whistleblower lawsuit, the company has agreed to enter into a Corporate Integrity Agreement which will require Endo to implement measures to avoid or detect off-label marketing. The company has also agreed to create an internal risk assessment and mitigation program, and conduct public reporting of information about Endo’s financial agreements with doctors who might prescribe Lidoderm or other Endo Pharmaceuticals medications and devices.
The agreement resolves all criminal charges against Endo Pharmaceuticals for off-label marketing of Lidoderm.
“We are pleased to resolve this matter and are confident that we have robust programs in place to assist us in satisfying our legal and regulatory agreements,” Endo’s president and chief executive office, Rajiv De Silva, said in a statement.
The Strom Law Firm Can Help with Dangerous Drug Cases
The Strom Law Firm, L.L.C. is a leader in the consumer protection battle against dangerous prescription drugs and medical devices promoted for off-label uses, like Lidoderm or Risperdal. We represent individuals who have been killed or injured by dangerous or defective pharmaceuticals. If you or a family member have been injured or killed after using a dangerous drugs or medical products such as Lidoderm, contact our dangerous drug lawyers as soon as possible so that we can begin taking steps to preserve evidence and your claim immediately. We offer free consultations to discuss the facts of your case. 803.252.4800