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Preemption: What it is, why state lawmakers don’t like it and why you shouldn’t like it either

By Robert A. Schwartz, Attorney at Law

In our legal system, preemption generally refers to the displacing effect that federal law will have on a conflicting or inconsistent state law. The origin of preemption is found in the Supremacy Clause (Article VI, section 2) of the Constitution, which states that the (federal) laws of the United States, (which shall be made in pursuance to the Constitution), shall be the supreme law of the land. So, when there is a conflict between a state law and a federal law, the federal law (subject to the Fifth and Tenth amendments and other Constitutional law) trumps, or “preempts,” the state law. As a general rule, there is a presumption in favor of the validity of a state law, and courts will attempt to reconcile seemingly inconsistent state and federal laws with this presumption where possible. If the laws are truly irreconcilable, the federal law will generally preempt the state law only to the extent of the inconsistency. The key here is the existence of an inconsistency between state and federal law.

Unfortunately, the well-settled legal doctrine of preemption is being abused. It is being used when there is no inconsistency between state and federal law. It is wrongfully being used not because of its Constitutional purpose as a shield to prevent inconsistency but as a political sword to promote political agendas. Plainly stated, FDA preemption is the latest tool used by those who seek to close the courthouse doors to those who have suffered serious injuries caused by dangerous prescription drugs.

The issue of FDA preemption has been a hot one since the FDA issued a new drug-labeling regulation in January 2006. At that time, the FDA claimed in the preamble to the rule that federal drug-labeling regulations preempt most state failure-to-warn claims against pharmaceutical manufacturers. This new language on preemption was added to the notice of final rulemaking, even though it was never included in—and directly contradicted—the notice of proposed rulemaking.

It is not a coincidence that this preamble of preemption was inserted at a time when many, if not the majority of, states passed significant tort-reform laws that inserted a “rebuttable presumption” in product liability pharmaceutical litigation that provided if a drug was approved by the FDA, its warnings are sufficient and the drug is safe. It is not a coincidence that this FDA preamble was inserted at a time when Congress could not pass federal tort reform. It is highly unlikely that the FDA decided on its own that there was a need for the insertion of the preemption language in the preamble. More likely, the Republican administration and/or the Republican Congress pressured the FDA to take this unusually bold action to achieve its political agenda to protect the pharmaceutical companies from liability and exposure in failure to warn product liability litigation. Why would they do this? Simple: The pharmaceutical industry is a huge contributor to political candidates and parties that support their political agendas.

Pharmaceuticals/Health Products: Long-Term Contribution Trends

Pharmaceuticals Graph

The National Conference of State Legislatures’ position is that these recently enacted FDA regulations imposing product liability preemption by the FDA regarding prescription drug labeling is wrong. The conference is a bipartisan organization that serves the legislators and staffs of the nation’s states, commonwealths and territories and provides research, technical assistance and opportunities for policymakers to exchange ideas on the most pressing state issues. In January 2006, and as required by Executive Order 13132 (the “Federalism Executive Order”), the FDA contacted the conference to state that preemption language would be included in the preamble to the final rule on prescription drug labeling. This requirement is to make the FDA consult with the conference to determine if the proposed prescription drug labeling changes would preempt state laws and, if so, to consult with the conference and other state and local government groups to eliminate or minimize the preemption. This seems consistent with the preemption doctrine and the Republican platform adopted at the GOP National Convention on Aug. 12, 2000, that stated in part, “We must acknowledge that the federal government’s role should be to set expectations in policies, then get out of the way and let the states implement and operate those policies as they best know how. Washington must respect that one size does not fit all states and must not overburden states with red tape attached to its policies.” However, the FDA informed the conference that it would not reopen the comment period on the rule nor disclose the proposed language.

Contribution Graph

These numbers show how the industry ranks in total campaign giving as compared to more than 80 other industries. Rankings are shown only for industries (such as the automotive industry), not for widely encompassing “sectors” (such as transportation) or more detailed “categories” (such as car dealers).

These figures do not include donations of “Levin” funds to state and local party committees. Levin funds were created by the Bipartisan Campaign Reform Act of 2002.

METHODOLOGY: The numbers on this page are based on contributions of $200 or more from PACs and individuals to federal candidates and from PAC, soft money and individual donors to political parties, as reported to the Federal Election Commission. While election cycles are shown in charts as 1996, 1998, 2000, etc., they actually represent two-year periods. For example, the 2002 election cycle runs from Jan. 1, 2001, to Dec. 31, 2002. Data for the current election cycle was released by the Federal Election Commission on Feb. 19, 2007.

NOTE: Soft-money contributions to the national parties were not publicly disclosed until the 1991–92 election cycle and were banned by the Bipartisan Campaign Finance Reform Act after the 2002 elections.

Copied with permission: Center for Responsive Politics

NCSL understands clearly the problems that the rule creates. The rule affects the states in the following ways:

  • The FDA has usurped the authority of state legislatures and state courts by seeking to preempt state product liability laws by writing this preemption into a final rule, thereby undermining state policy and judicial decisions.
  • The FDA has violated Executive Order 13132 by not consulting with NCSL or any other state or local organization.
  • The preemption provision is contrary to the consumer protection goals of the rest of the rule. The preemption of state product liability laws harms the consumers the rule otherwise protects.

While recognizing that an administrative agency is entitled to great deference in its interpretation of ambiguities in its governing statute and regulations, the U.S. District Court for the Eastern District of Pennsylvania concluded in Perry v. Novartis Pharmaceuticals Corporation that the FDA was not entitled to such deference when it attempts “to supply on Congress’s behalf, the clear legislative statement of intent required to overcome the presumption against preemption.”

The Perry v. Novartis Pharmaceuticals Corporation Court rejected the FDA position that the appropriate test is whether the warning sought by the plaintiffs “would have rendered the drug misbranded” or “would have been rejected by the agency as unsubstantiated.” Instead, the court adopted a far narrower rule: “to allow state law to require the addition of warnings so long as there has been no specific FDA determination as to the sufficiency of the scientific evidence to support a particular warning.” The court noted that “given the recent concerns about the effectiveness of the FDA’s safety monitoring of recently approved drugs, the availability of state tort suits provides an important backstop to the federal regulatory scheme.”

The rule was finalized Jan. 18, 2006, and went into effect June 30, 2006. The NCSL continues to fight it and is working with members of Congress to stop the rule. It is likely that if the current administration and Congress get their way, any litigation you may be involved in will face a preemption challenge. I urge you to contact your elected representatives on the state and federal level and tell them you are not in favor of product liability preemption by the FDA regarding prescription drug labeling and that “the federal government’s role should be to set expectations in policies then get out of the way and let the states implement and operate those policies as they best know how. Washington must respect that one size does not fit all states and must not overburden states with red tape attached to its policies.”

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