Processing Magazine

New FDA labeling rule for drugmakers could be a lawsuit shield

August 25, 2008

As reported by the Associated Press on Monday, Government regulators have issued new rules designed to keep drug warning labels clear and concise, though some say the new guidelines would also shield drugmakers from lawsuits. The regulations from the Food and Drug Administration, which were released Thursday and take effect next month, explain when drug and medical device companies are responsible for rushing out safety updates on their products. The Pharmaceutical Research and Manufacturers of America welcomed the announcement, saying it provides much-needed clarity. But trial lawyers who represent consumers said it will provide legal protection to companies that withhold information on their products'' risks. In recent years, drugmakers have added warning information to their labeling more quickly, even when the scope of the risks was unclear. The new FDA rule should protect companies from this kind of lawsuit. It states that companies are only obligated to rush out warnings when they have clear evidence of a serious risk that hasn''t been reviewed by FDA. In all other cases, the rules state that FDA will review the information and consider a new label at its own pace. FDA officials said the changes would help ensure that companies are not haphazardly adding warning information to their products.

However, trial court attorneys said the rule lets companies off the hook on alerting consumers to the risks of their products. The American Association of Justice, a professional group for attorneys, argues the new rule requires an excessive standard of scientific evidence before companies are required to update their labels. The group''s lawyers say the new rule will make it easier for companies to claim they were not obligated to alert consumers. Since 2005, the Bush administration has proposed dozens of regulations that limit lawsuits against pharmaceutical makers, automakers and other companies by ruling that federal regulations trump state laws. Product liability lawsuits are usually filed in state courts, where juries often are more receptive to claims against corporations. The Supreme Court is scheduled to wade into the issue later this year.