Cyrus Dugger

Major Victory Against Immunity for Drug Manufacturers

An important victory was just won for supporters of access to the courts by Trial Lawyers for Public Justice. This organization's Access to Justice Campaign just won a major victory in its first challenge to federal preemption of state law claims against a prescription drug manufacturer.

This decision is especially important because the U.S. Food and Drug Administration (FDA) has recently attempted -- in the preamble accompanying new prescription drug regulations -- to dramatically expand federal preemption, threatening to prevent victims of dangerous drugs from holding the manufacturers accountable under state law.

As further described by Trial Lawyers for Public Justice:

The court in Perry v. Novartis Pharmaceutical Corporation held, as Trial Lawyers for Public Justice and our co-counsel the Center for Constitutional Litigation (CCL) urged, that the FDA's approval of a drug's label does NOT preempt claims against a drug maker for failing to warn consumers of known risks. We represent the parents of a two-year-old boy, Andreas Perry, who developed cancer after he was prescribed the topical immunosuppressant Elidel to treat his eczema, a skin condition. His parents were not warned that Elidel would increase their son's risk of developing cancer. Six months after treatment, Andreas was diagnosed with lymphoblastic lymphoma, a rare form of cancer. Only after Andreas developed lymphoma did the FDA ultimately require Novartis to add to Elidel's label a "black-box" warning of the cancer risks. The Perrys sued Novartis, alleging that it had failed to adequately warn of Elidel's known risks. Novartis moved to dismiss the case, arguing that the claims conflict with -- and thus are preempted by -- the FDA's approval of Elidel's label.

In a ruling issued yesterday, October 16, 2006, U.S. District Court Judge Stewart Dalzell of the Eastern District of Pennsylvania denied the preemption motion and found that the FDA's new "Preamble is not entitled to any special consideration in our analysis." The court ruled that, because FDA regulations already permit manufacturers to supplement labels with warnings of newly discovered risks without prior FDA approval, state law tort suits do not conflict with FDA regulations. Thus, a failure-to-warn claim may only be preempted in cases where the FDA has rejected the specific warning proposed by the plaintiffs. That didn't happen here, so there is no preemption. The court also emphasized that, "given the recent concerns about the effectiveness of the FDA's safety monitoring of recently approved drugs, . . . the availability of state law tort suits provides an important backstop to the federal regulatory scheme."

If you or your organization is interested in learning more about or working on these types of civil justice issues, please feel free to contact me at

Cyrus Dugger
Senior Fellow in Civil Justice
Drum Major Institute for Public Policy

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Posted at 5:34 PM, Oct 17, 2006 in FDA | Federal Preemption
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