A U.S. District Court in Pennsylvania has ruled that updated product warnings concerning the diabetes drug Avandia may not have adequately warned users of the risks of heart attack and stroke. This ruling came when the court denied a motion for summary judgment in a pending case. The judge hearing the motions has been assigned to hear Avandia cases by the federal panel on multidistrict litigation. As we have previously reported, GlaxoSmithKline aggressively marketed Avandia without warning of increased risks of heart attack and stroke compared to other diabetes drugs.
In this case, GlaxoSmithKline sought to dismiss certain Plaintiffs who took Avandia after the drug company updated its product warnings in 2001. In the alternative, the drug company wanted the court to dismiss the claims of certain plaintiffs who took Avandia after revised warnings were issued in 2007. The updated Avandia label adopted in 2001 generally warned users of the risk of congestive heart failure. A new Avandia label introduced in 2007 included similar warnings with more detail concerning risks for specific patient subpopulations. The 2007 label also included a black box warning that Avandia directly causes congestive heart failure in some patients.
The court concluded that it could not be said as a matter of law that the revised Avandia warnings adequately warned users of the drug’s risks. The court said in the ruling:
[GlaxoSmithKline] has stressed repeatedly that a label need only be adequate, not perfect. The court does not require a showing of perfection to find a label adequate as a matter of law; instead it requires a finding that no questions of fact remain as to a label’s accuracy, clarity and completeness regarding the scope and nature of the risk in light of what a manufacturer knew or should have known at the time a cause of action arose. The court cannot make such a finding here. … In short, a reasonable jury could conclude that although the 2001 and 2007 labels warned about [congestive heart failure] risks, they did not do so specifically enough or directly enough.
The ruling is sound and is very important in this litigation. It’s for a jury to decide whether or not the warnings are adequate. GlaxoSmithKline had a duty to warn of the safety risks and the warnings had to reflect what the manufacturer knew about those risks and it must be in language that can reasonably be understood.
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