Friday, December 05, 2008

Will Preemption Rules be Introduced?

The clock is ticking for lawyers specializing in consumer safety litigation as they wait to see what "midnight regulations" the Bush administration squeaks through before leaving office in January.

There are dozens of rules now under review by the administration that affect everything from prescription drug labeling to water quality to auto roof safety, according to the Office of the Federal Register, the government's official daily publication for rules, proposed rules and notices of federal agencies.

Midnight regulations are last-minute federal rules and regulations that a president issues before leaving office, usually in the last three months of his term.

Defense counsel are counting on the Bush administration to leave behind regulations that offer greater liability protection to manufacturers and less regulation. The plaintiffs' bar fears just that, warning that as many as 21 possible regulations could be a nightmare for consumer safety and the environment.

Pre-emption is front and center. What may show up in the last days of the current President's term:

• A proposed regulation that would require auto manufacturers - for the first time in 35 years - to increase the strength of vehicle roofs. Plaintiffs' lawyers say the roof strength standards are still too low, and that automakers that meet that rule will be granted complete immunity from all lawsuits, according to the AAJ.

• A proposed rule by the U.S. Food and Drug Administration (FDA) to revise warning labels regarding the use of prescription drugs during pregnancy and breast-feeding, and to update them with more detailed information, including clinical trial results.

This rule includes a pre-emption clause, which the AAJ fears will offer drug makers blanket immunity and give injured women no recourse.

• A proposed FDA rule that would shield companies from liability for potentially harmful over-the-counter drug ingredients. The proposed rule changes the status of some ingredients used in over-the-counter drugs, making them subject to additional FDA approval. Once they were approved, manufacturers no longer could be held accountable should the ingredients cause harm, according to the AAJ.

Stay tuned.

Source: Fulton Daily Report.