US District Judge Saylor issued an order denying the defendants Summary Judgement Motion without Prejudice on January 26, 2016.
Although the defendant may continue to argue preemption under Wyeth v Levine and Buckman v Plaintiff Steering Committee, their chances of succeeding in these motions are not favorable in our opinion. Arguably, neither Buckman nor Levine is not applicable case law. In Buckman the FDA had not brought a Fraud on the FDA Case. Conversely the FDA did bring a case against GSK and GSK admitted quilt as to the allegations made by the FDA as part of a 3.2 Billion Dollar Settlement involving a number of GSK products.
The Levine arguments made by GSK are also problematic for the defendant. In that Judge Saylor rejected the arguments related to the Citizens Petition, it would be necessary for the defendant to look elsewhere to establish evidence to lead to an absolute conclusion that the FDA would not have approved a stronger birth defects warning for Zofran.
In that Zofran was not approved for use in pregnant women, the FDA had no cause to require strong warnings related to birth defects for the product. The FDA classified Zofran under Birth Defects category B.
Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.
In that GSK has never sought approval for the use of Zofran in pregnant women, the FDA did not require studies related to the use of birth defects in pregnant women. Despite GSK having never sought approval for Zofran use in pregnant women, GSK has admitted to off label marketing of Zofran for use in pregnant women in response to allegations brought by the FDA.
Simply put, GSK seeks to take advantage of its own bad acts. GSK never sought FDA approval for use in pregnant women, (despite wide scale off label marketing) ostensibly to avoid being required to conduct the appropriate studies and clinical trials for such an approval, resulting in Zofran being placed in Birth Defect Category B. “there are no adequate and well-controlled studies in pregnant women.”
GSK now argues that an action or lack of action under FDA rules and governing laws, which they willfully ignored, should insulate GSK from plaintiffs’ claims.
“There are no adequate and well-controlled studies in pregnant women.”
The questions posed by Levine “ would the FDA have refused to allow an increase in warnings related to Zofran had GSK sought such changes? ” is not applicable. Levine does not address what the FDA would or would not do when the product in question was marketed for an off label indication. What the FDA would have likely done had GSK sought to change the Zofran label to include stronger birth defects warning would have been to respond in this manner similar to this:
“This product is not approved for use in pregnant women”
After responding in this manner, the FDA would have most likely opened an investigation into the off label promotion of Zoran.
Oh Wait.. the FDA did investigate the unlawful off label promotion of Zofran, brought a case against GSK and GSK admitted to their bad acts.