U.S. House Report Further Confirms Bush Administration’s Preemption Plot

Yesterday the U.S. House Committee on Oversight and Government Reform issued a report saying FDA career staff objected to a change in preemption rules, even saying the central factual justifications for the agency’s new positions were false.  The 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.  Prior to this the FDA had asserted through a rule on drug and device labeling that manufacturers should not be held accountable for failing to update their label with additional risks, if the original label was approved by the FDA. 

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.”

Prior to the rule being issued one FDA career official asserted that the rule “is not as it purports to be, consistent with the agency’s role in protecting the public health…”

A copy of the report can be found at:

http://oversight.house.gov/documents/20081029102934.pdf .

Associated Press story on the issue:

http://ap.google.com/article/ALeqM5h1C2M6_6XJkirIrtYpwjP_02a2pAD944G96G3

LA Times story:

http://www.latimes.com/news/nationworld/nation/la-na-fda30-2008oct30,0,1783486,print.story

Forty-one of the fifty-one rules proposed by NHTSA and FDA Contain Federal Pre-Emption Language

The concept of federal preemption, rooted in the Supremacy Clause of the Constitution, is underlying this bureaucratic version of lawsuit reform. Federal preemption refers to situations in which federal regulation and law trumps state law. The issue at hand is whether or not companies can use the broad preemption language in regulatory preambles to get the case thrown out. An expansive interpretation of the preemption doctrine leaves little room for consumers to sue, and that is what has been taking place recently.

Here is a fact paper offered by the Pennsylvania Association for Justice on Federal Preemption in relation to defective products.

Federal Preemption: Working Against Consumers

The lawsuit filed by actor Dennis Quaid and his wife, Kimberly, after a hospital unintentionally gave their newborn twins the wrong dosage of a blood-thinning drug is being contested by a drug maker on the grounds that it is immune from liability.

Owing to rules that have been or are being rewritten by the Bush administration, any person filing a similar product liability lawsuit could face the same argument, greatly increasing the chances his suit would be lost or dismissed outright.

In articles last week, the Associated Press disclosed that federal agencies are quietly rewriting the language used in regulating consumer products. Before the rewrites, the language included this sentence: ‘The final rule is not intended to preempt state tort civil actions,’ meaning a company can be sued if its products are claimed to be flawed. After the agencies’ rewrites, however, the language says federal preemption questions can indeed arise for a number of reasons. The Quaids’ case is an example of how companies can use the new language.