A new FDA Rule has declared that all warning labels must now be clearly highlighted and easy for the average consumer to understand. While this might sound like a noble notion, it appears that the FDA really is doing this to benefit the drug manufacturers. The rule would insulate the drug manufacturers from liability even if the drugs were defective and cause injury as long as the side effect was disclosed. There are, however, still a number of law firms fighting the FDA and the pharmaceutical manufacturers who represent aggrieved and injured people.
The new rule goes into effect on June 30, 2006; until then, ATLA (Association of Trial Lawyers of America) plans to continue to fight the rule.
How are they fighting the new rule*?
- ATLA Public Affairs is looking into options for oversight of the FDA from Congress, who has not given the FDA statutory authority to promulgate rules which preempt state tort law in this area.
- Using a litigation strategy, thorough analysis of the action on warning labels is already proving unconstitutional. ATLA uses the example of Medtronic v. Lohr, 518 U.S. 470 (1996) to show the same analysis, as the case upheld state tort law claims against a medical device manufacturer.
- Reaching out to coalition powers and pursuing an aggressive media strategy will draw attention to the drug industries’ unfair benefit and put pressure on the FDA.
To find more information about the FDA’s new rule or for more depth on the problems sure to unfold, read the articles on ATLA’s website. For consultation on these or other important legal issues, feel free to contact Stipe Law Offices in Oklahoma City, Tulsa, and McAlester, Oklahoma.
*Information paraphrased from www.atlanet.org.
