The plainiff, Diane Levine, was given a given “push injection” of the drug Pheneragen, manufactured by Wyeth.  She developed complications from an apparent mistake in the injection, and ultimately had to have her forearm amputated.

Although Levine won at the state level, Wyeth, appealed arguing that a 2006 regulation of the Food and Drug Administration should mean that such cases are barred at the state level.  Read more about preemption.

As Levine V. Wyeth gets ready to be argued in front of the Supreme Court on Monday, a report released from the House Oversight and Government Reform Committee: says that top scientists and career employees at the Food and Drug Administration had opposed the agency regulations that weaken consumers’ ability to sue drug makers.

The issue is language in a drug-labeling rule from 2006 that effectively limits when people can sue in state court over injury claims involving medications. The FDA contends pre-emption, which is when federal regulations prevail when there is a conflict with state law. The concept of pre-emption is being used as a way to prevent a person from suing a drug company if they are injured by a drug, as long as the drug had recieved approval from the FDA.

The recently released report highlights internal FDA documents which show high-ranking career officials repeatedly warning about the dangers of not allowing drug companies to add additional warnings to their labels without FDA approval. 
 

The report cites Dr. John Jenkins, the highest official in FDA’s new drug review process, writing:
[M]uch of the argument for why we are proposing to invoke preemption seems to be based on the false assumption that the FDA approved labeling is fully accurate and up-to-date in a real time basis. We know that such an assumption is false.”

 A copy of the report.

For Further Reading: Associated Press story on the issue:

LA Times story: