Protopic (generic name: Tacrolimus) is manufactured and marketed by Astellas Pharmaceuticals. In December 2000, the FDA approved Protopic to treat eczema, an allergic reaction that causes skin inflammation. Protopic is a popular drug with millions of users in the United States. Unfortunately, Protopic is linked to severe side effects, including skin cancer and lymphoma. In January 2006, the FDA ordered that a black box warning be added to Protopic’s label detailing the increased risk.

Protopic Lawsuits: Pre-Emption Ruling

In November 2006, the U.S. District Court for the Eastern District of Kentucky ruled that FDA pre-emption is inapplicable to Protopic lawsuits. The principle of pre-emption mandates that federal law trump state law if federal and state law conflict. Therefore, Astellas Pharmaceuticals, Protopic’s manufacturer, argued that

the FDA did not require warnings for skin cancer and lymphoma when Protopic was approved in 2000 and, therefore, the plaintiff’s lawsuit was preempted. Plaintiffs’ lawyers argued that Astellas Pharmaceuticals knew about Protopic’s skin cancer and lymphoma risks before it was approved by the FDA and the FDA did not explicitly reject including warnings about cancer in the label. The court ruled that FDA pre-emption applies only if the FDA specifically addresses the warning. The FDA did not specifically address skin cancer and lymphoma warnings when it approved Protopic. Therefore, the Court held that FDA pre-emption was inapplicable to the lawsuit.

Protopic Lawsuits Claims

Many injured victims and their families have filed Protopic lawsuits against Astellas Pharmaceuticals. Protopic lawsuits include personal injury lawsuits (brought by injured victims) and wrongful death lawsuits (brought by deceased victims’ families or estates). Many Protopic lawsuits allege that Astellas Pharmaceuticals:

  • Aggressively marketed Protopic even though it knew Protopic may cause serious side effects
  • Failed to warn the public that increased Protopic use may cause severe skin cancer and lymphoma
  • Failed to warn about the increased cancer risks that children face from Protopic use

Filing a Protopic Lawsuit

If you would like more information about Protopic lawsuits, or if you or a loved one has developed serious side effects from using Protopic, 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

Published November 17, 2011 by