After the FDA published the new rule and preamble with the preemptive language in January 2006, Pfizer filed another motion asking the court to vacate the order denying summary judgment, or to certify the question for interlocutory appeal
In opposing the motion, Ms. McNellis said that the preamble amounted to nothing more than the FDA's opinion on preemption; the same opinion expressed previously by the FDA in amicus briefs, and the same opinion already rejected by the court. It is irrelevant that this opinion now comes in the form of a preamble to a regulation rather than an amicus brief, she said.
In her brief filed on March 2, 2006, Ms. McNellis argued that the FDA had also exceeded its authority, stating:
"In this instance, an executive agency, the FDA, has expressed an opinion that Congress has never agreed to. Without notice or comment, the FDA found it within its jurisdiction to go against the wishes of Congress as well as the wishes of those states which have product liability failure-to-warn statutes."
Ms. McNellis also pointed out that the last six courts to decide the issue "have found, consistent with this Court's finding, that the FDA regulations establish minimum requirements such that they do not preempt state tort laws."
She also noted that the preamble was not in effect at the time that her father committed suicide as a result of taking Zoloft.
The court held that regulations allow a drug company to increase warnings when new risks emerge, that the Food, Drug and Cosmetic Act does not contain a preemption clause, and that Congress gave no implicit empowerment to the FDA to preempt State law.
Following the McNellis decision, on October 16, 2006, a federal court in Pennsylvania refused to grant the drug maker's preemption motion on the failure-to-warn claims in Perry v. Novartis Pharma Corp, --- F Supp 2d ----, 2006 WL 2979388.
This case involved Elidel, a drug used to treat eczema, prescribed to Andreas Perry when he was 2-years-old. Six months after he began using the cream, in October, 2003, Andreas was diagnosed with a form of cancer known as lymphoblastic lymphoma.
Elidel belongs to a class of drugs known as calcineurin inhibitors, so called because they reduce immune activity by inhibiting the activity of the enzyme calcineurin. Prior to the approval of Elidel for treating skin conditions in children over 2 years of age, calcineurin inhibitors were used as systemic immunosuppressants in organ transplant patients.
Systemic use of the drugs has long been known to increase the risk of cancer and the labels on the drugs prescribed to organ transplant patients say so. But because Elidel is applied topically for eczema, it was not known at the time of approval in December 2001, whether long-term use posed a risk of cancer.
This case illustrates why drug companies must be made to alert the public of known dangers as soon as they are known. On February 15, 2005, an FDA advisory committee met to discuss calcineurin inhibitors. In particular, reports of "off label" use of the drugs in children under two caused concern for some members of the committee.
At the meeting, the committee voted to add a "Black Box" warning about the possible increased risk of cancer associated with the topical use of Elidel, and the lack of long-term safety data on the use of the drug.
On March 10, 2005, the FDA told the drug maker to add a "Black Box" warning and issued a public health advisory about the possible cancer risk. However, it was nearly a year later when Novartis finally got around to adding a "Black Box" warning to Elidel's label on January 19, 2006.
In their brief in opposition to the preemption motion to dismiss, the plaintiffs said that the FDA's broad claim of preemption is not entitled to deference, "whether it is expressed in the January 2006 Preamble to the Final Rule," or "in amicus curiae briefs filed by the agency in support of drug manufacturers."
"The FDA's claims," the brief wrote, "which are tantamount to an advisory opinion, lack the force of law and contradict the FDA's governing statute, its regulations, and its regulatory purpose."
