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New FDA labeling rule is a double edged sword
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. This strategy helped protect companies from allegations that they didn't act quickly enough to inform patients, according to Dan Kracov, an attorney with Arnold and Porter.
"The thinking was 'We need to get this information on the warning label now otherwise we're going to get hit over the head with product liability suits,'" said Kracov, who represents pharmaceutical companies.
The new FDA rule should protect companies from such lawsuits. 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.
"The key point is this rule offers doctors and patients clarity and confidence that labels mean something and can be relied on," said Randall Lutter, FDA deputy commissioner for policy.
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.
"When consumers are harmed they will have no way to get recourse from manufacturers," said Gerie Voss, a director with the American Association of Justice. "This rule is going to be a total shield against all 'failure to warn' claims."
Voss said many of the recent lawsuits against drugmakers, such as the Vioxx case involving Merck & Co. Inc., would not be possible under the new rules. The company has agreed to pay $4.85 billion to settle with patients who suffered heart attack or stroke and alleged the company failed to warn them about those risks.
Voss said the new FDA rule is part of a larger effort across the Bush administration to shield companies from lawsuit.
Since 2005, the 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."
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