Elidel (generic name: pimecrolimus) is manufactured and marketed by Novartis. In December 2001, the Food and Drug Administration (“FDA”) approved Elidel to treat eczema, an allergic reaction that causes skin inflammation. Unfortunately, millions of Americans used Elidel not knowing that it was linked to severe side effects, including skin cancer and lymphoma. In January 2006, the FDA ordered Novartis to add a black box warning to Elidel’s label detailing the increased cancer risk.
Elidel Lawsuits: Pre-Emption Ruling
In January 2007, the U.S. District Court for the Eastern District of Pennsylvania ruled against FDA pre-emption in an Elidel lawsuit. The principle of pre-emption mandates that federal law trump state law if federal and state law conflict. Therefore, Novartis, Elidel’s manufacturer, argued that plaintiffs could not file a lawsuit under a failure to warn theory because the FDA did not require warnings for skin cancer and lymphoma when Elidel was approved in 2001. Plaintiffs’ lawyers argued that Novartis knew about the skin cancer and lymphoma risks before Elidel was approved and the FDA did not specifically pre-empt the warning. The court ruled that FDA pre-emption applies only if the FDA addresses the specific warning. In fact, the FDA did not specifically address the skin cancer and lymphoma warnings in 2001 when it approved Elidel. Therefore, the court ruled that the Elidel lawsuit could proceed against Novartis.
Elidel New Jersey Lawsuits
Two Elidel lawsuits were filed against Novartis in the Atlantic County Superior Court in New Jersey. In one case, Haley Thomson’s parents filed a wrongful death lawsuit after Haley died from cancer after exposure to Elidel. In the other case, the plaintiff filed a personal injury lawsuit after developing lymphoma, undergoing three surgeries and four months of chemotherapy treatment after using Elidel. Both Elidel lawsuits allege that:
- Novartis aggressively marketed Elidel even though it knew Elidel may cause serious side effects
- Novartis failed to warn the public that increased Elidel use may cause severe skin cancer and lymphoma
- Novartis failed to warn about the increased cancer risk children face from Elidel use
Filing an Elidel Lawsuit
If you would like more information about Elidel lawsuits, or if you or a loved one has developed serious side effects from using Elidel, contact us to discuss your potential lawsuit today. Recovery from a lawsuit may include compensation for:
- Medical bills
- Lost income
- Pain and suffering
- Mental anguish