Novartis Sued in Whistleblower Case over Off-Label Elidel Use

Whistleblower lawyers at Pintas & Mullins Law Firm report that a federal judge recently denied Novartis Pharmaceuticals’ request to appeal a whistleblower over eczema medication Elidel. The suit claims the drug manufacturer defrauded the government in its off-label promotions of the dangerous medication.

The whistleblower, Donald Galmines, alleges that Novartis violated the False Claims Act when it marketed Elidel for uses not intended on its labels. As a result of such promotion, physicians throughout the country prescribed Elidel for long-term eczema treatment in children under two years old. The FDA, however, only approved Elidel to treat mild eczema for a short period of time, only if other prescriptions do not work, and only for adults and children over two years old.

Galmines, a former Novartis senior sales consultant, filed the qui tam lawsuit in 2006, however, qui tam suits have a first-to-file rule that allows only the first person to file a False Claims Act (FCA) claim to proceed. The first FCA case was brought by Gina Moyer, who alleged that Novartis received kickbacks from the illegal, off-label prescriptions of Elidel.

Novartis attempted to dismiss Galmines’ claim citing the previous Moyer case, which contained the exact same allegations. Although the first-to-file rule barred Galmines from filing a qui tam suit, it did not prohibit him from filing a lawsuit based on off-label marketing allegations. Galmines’ case reportedly contains much more detailed evidence than Moyer’s, and refers to a different disease. Moyer’s complaint alleged that Novaritis promoted Elidel for treatment of psoriasis and seborrhea, though it is only intended for eczema treatment.

This is not the first time Galmines has filed a qui tam suit against Novartis, where he worked between 2001 and 2006. In late 2012, he filed a lawsuit against the company that settled for about $20 million, though the details of the case are sealed. The case did, however, contain similar allegations about the off-label use of Elidel.

In the settlement, Texas officials stated that Novartis’ unlawful and deceptive marketing campaigns did include recommendations for Elidel treatment in children under two. Not only this, the campaigns also failed to disclose the severe risks associated with the topical treatment. Elidel has a black box warning – the FDA’s most severe caution – due to the chance of developing cancer after using the cream.

In light of this, Novartis’ promotions of Elidel for long-term, chronic treatment in children under two does appear to be malicious, and clearly demonstrates the companies’ prioritization of profits over patients. Novartis is currently conducting studies to determine the actual link between Elidel and lymphoma and skin cancer. Proptic, a similar drug manufactured by Astellas Pharma, also contains a black box warning of cancer risks.

Elidel Cream may also cause an increased risk of getting certain viral infections, such as chicken pox, shingles, and skin warts. Other side effects include throat or nose redness or soreness, fever, and flu symptoms.

Several lawsuits have been filed against Novartis concerning Elidel’s excessive risks, including two cases of cancer development. One of these cases was filed by the parents of a girl who was prescribed Elidel and later died from lymphoma. Another case involves a 22-year-old who was prescribed Elidel and developed Non-Hodgkin’s Lymphoma, resulting in three surgeries and four months of chemotherapy.

It was revealed during these trials that Novartis knew about the potential for cancer development as far back as 2001, during the first animal trails for Elidel. The FDA expressed concern about the possibility of systemic malignancies in children that year, however, Novartis did not provide a warning until 2006.

Elidel lawyers at Pintas & Mullins Law Firm have decades of experience advocating on behalf of those harmed by dangerous medications such as Elidel and Proptic. If you or a loved one developed cancer from Elidel or Proptic, you have important legal rights, and may be entitled to significant compensation for your medical bills, lost wages, and emotional distress.