After enactment of the FDA Revitalization Act, the next challenge for trial lawyers and their allies is to see that the hard-won language on pre-emption of lawsuits is used effectively in court.

The most important court, of course, is the Supreme Court, which could hear several pre-emption-related cases in the coming sessions, so whatever momentum liability lawyers have from the FDA bill could be short lived.

In the meantime, however, they are savoring the "rule of construction" included in the bill that passed the House Sept. 19 by a vote of 405-7 and, after a bit of drama, passed the Senate by voice vote on Sept. 20 (see ¹ Also see "FDA Bill Passes; Congress Adds $225 Million To Industry User Fee Burden" - Pink Sheet, 24 September, 2007.).

"We are pleased with the House vote ... which maintains the current labeling requirements for prescription drugs and keeps the onus on pharmaceutical companies to warn the FDA and the public of potential drug hazards," American Association for Justice Regulatory Counsel Gerie Voss said in a statement. "The drug companies are in the best position to know about early problems with their products and report those problems to the agency."

In the final bill, the section describing FDA's powers to require labeling changes includes a "rule of construction" stating, "This paragraph shall not be construed to affect the responsibility of the responsible person or the holder of the approved application under section 505(j) to maintain its label in accordance with existing requirements, including subpart B of part 201 and sections 314.70 and 601.12 of title 21, Code of Federal Regulations (or any successor regulations)."

The language is adopted from the bill that passed the House, but is substantially different from the mechanism in the Senate version, which would have created an FDA-controlled mechanism for all labeling changes (² Also see "Preemption Remains Conference Issue In FDA Bill As Both Sides Declare Victory" - Pink Sheet, 23 July, 2007., p. 12).

Legislation Goes A Courting

The plaintiff's bar was concerned that such a system could allow manufacturers to argue that they had no power to place warnings on their products aside from those vetted by FDA, which would undermine the "failure to warn" argument that is at the center of many liability suits in state courts.

The impact of the new bill language, especially when played against FDA's explicitly pre-emptive statements in the physician labeling rule, remains to be seen, but the large number of liability suits against drug firms is likely to present ample opportunity to find out (³ Also see "Rx Industry Faces Wave of Personal Injury Suits; Avandia To Test Honed Skills" - Pink Sheet, 9 July, 2007., p. 19).

More crucial will be decisions by the Third Circuit U.S. Court of Appeals in two pending cases and potentially relevant rulings from the Supreme Court expected next session (⁴ Also see "FDA Preemption Policy Gets First Appeals Court Test With Zoloft, Paxil Cases" - Pink Sheet, 9 April, 2007., p. 24).

Seeking Principles on Pre-emption

Regardless of how the current crop of litigation plays out, the issue of federal pre-emption in general may yet return to Congress, especially as states push their own agendas in areas ranging from physician data access to vehicular carbon emissions.

At a hearing in the Senate Judiciary Committee on Sept. 12, National Council of State Legislators President Donna Stone, a Republican who serves in the Delaware state legislature, argued that pre-emptive powers should be limited.

"If not curbed, [pre-emption] will undermine the genius of the federal system," Stone said. "Agency bureaucrats are unelected and have no real accountability to those impacted by an agency's pre-emptive regulations."

Stone urged that the Executive Order on federalism issued in 1999 be respected. The order requires agencies to consult with state and local elected officials whenever a proposed rule contains pre-emptive provisions. However, Stone said it is often "abused" and "ignored."

NCLS is offering five components it would like to see included in new legislation, including: partnership and enhanced consultation with state and local elected officials; rule of construction with state law; congressional and agency enforcement and accountability checks, legislative reports and federalism assessments; and required agency impact statements.

But advocates of pre-emption say it plays a vital economic role in reducing "the burdens" on interstate commerce and helping to "create unified national markets," as attorney Alan Untereiner told the committee.

"It makes little sense to disregard the views of an administrative agency concerning whether state or local law conflicts with, or frustrates, the purposes underlying a statute the agency is charged with administering," he said.

- M. Nielsen Hobbs (n.hobbs@elsevier.com)

Pre-emption Limits Survive In Congress, Must Now Stare Down Supreme Court

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