LOS ANGELES (CN) – A saleswoman claims Sanofi-Aventis made her the scapegoat for its illegal, off-label promotion of an injectable facial reconstruction treatment called Sculptra.
Terran Lamp says she worked in sales for the drug company from March 2005 until she was fired in October 2010.
She claims that in June 2008 the company instructed her and other sales reps “to promote a new product, Sculptra … [which] was undergoing laboratory studies at the time and had not yet been approved by the Federal Drug Administration (‘FDA’) for use for non-HIV patients. Plaintiff and other sales representatives were advised by Sanofi-Aventis to promote Sculptra to facial plastic surgeons, cosmetic physicians and dermatologists for non-HIV related medical treatments for facial rejuvenation, despite the fact Sculptra had not been approved by the FDA. Such conduct was commonly referred to selling ‘off label.'”
Physicians are allowed to prescribe drugs and medical devices for off-label uses, but pharmaceutical companies are not allowed to promote them for that.
Lamp sued Sanofi-Aventis and her supervisor, William Malcolm Parker, in Superior Court.
According to the complaint: “Plaintiff grew increasingly uncomfortable with the promotion of Sculptra prior to its FDA approval. Although supervisors in her region and sales representatives were aware that Sculptra had not been approved by the FDA for non-HIV patients, they were still encouraged by Malcolm Parker and Sanofi-Aventis to promote its use to physicians to increase sales revenues.
“Plaintiff expressed her concerns to her supervisor, Malcolm Parker, during ride-alongs and staff meetings, about the off-label promotion of Sculptra.”
In July 2009, the FDA approved Sculptra for use on non-HIV patients, the complaint states. In June 2010, “Sanofi-Aventis was subpoenaed by the Department of Justice,” Lamp says.
She says a Sanofi-Aventis manager instructed her by email “that an investigation was taking place,” and told her not to discuss the issue with anyone.
“Malcolm Parker informed plaintiff that he had received a similar email,” the complaint states.
Lamp says that she “and all employees of Sanofi-Aventis” received an email from the company’s legal department on Sept. 21, 2010: “The email was labeled ‘Privileged and Confidential’ and dealt with a legal hold being on Sculptra pending governmental investigation.”
On Oct. 11, Lamp says, she was fired “for off label promotion and for violating the expense policy.”
Lamp claims: “Sanofi-Aventis used plaintiff as a ‘scapegoat’ for its policy of promoting an unapproved use of Sculptra and in an attempt to save its own reputation, terminated plaintiff for doing what plaintiff was instructed her to do – promote Sculptra off-label, and when she complained defendant Sanofi-Aventis accused her of selling off-label.”
Lamp says the real reason she lost her job was because she knew of Sanofi-Aventis’ “unethical business practices.”
“During the time defendant was promoting the off-label selling of Sculptra to the medical community, and primarily to dermatologists and facial plastic surgeons, defendant was realizing significant monies from federal and state programs, including Medicare and California’s Medi-Cal program through the sale of Sculptra as an HIV medication,” the complaint states.
It adds: “Plaintiff engaged in protected activity when she complained to her employer that selling ‘off-label’ violated the FDA rules and regulations, but defendants Sanofi-Aventis and Malcolm Parker insisted on plaintiff continue to sell Sculptra [sic] off-label and primarily to dermatologists and facial plastic surgeons, having little or nothing to do with treating AIDS patients or those with HIV.”
Lamp seeks punitive damages for wrongful termination, retaliation and violation of the Business and Professional Code.
She is represented by Dale Fiola of Anaheim.