Last month, Schering-Plough's lawyers filed a motion in federal court in New Jersey arguing that a former medical director at Organon, which the drugmaker recently paid $14.3 billion to acquire, wasn't qualified to bring a whistleblower lawsuit alleging Organon covered-up serious side effects prior to launching two drugs several years ago.
The employee, Jeff Feldstein, alleges Organon failed to disclose to the FDA concerns about serious adverse events involving bronchospasm that were cited by clinical trial investigators studying Raplon, a neuromuscular blocking agent, prior to its 1999 launch (back story). The drug was withdrawn in 2001. He also charged Organon allegedly diluted data in an NDA submission showing excessive bleeding caused by the Arixtra blood thinner before it was approved in December 2001 (back story).
Yesterday, Feldstein's lawyers fired back, belittling claims he wasn't an original source of the info upon which his lawsuit is based and denied he relied on news accounts or product-liability lawsuits against Organon. They also argued the former Organon employee successfully cleared a legal hurdle known as rule 9b, a controversial provision of the False Claims Act, which requires a whistleblower to provide specific info about false claims submitted to the government for payment.
These are, in fact, standard points of argument in whistleblower lawsuits, although important ones that can easily determine whether a case proceeds. You can read Feldstein's motion here. The outcome may have serious implications for Schering-Plough, which already raised a troubling point in its own motion last month. The drugmaker charged Feldstein failed to prove the “successor (company) had notice of the claim before the acquisition.”
In other words, Schering-Plough’s lawyers suggest the drugmaker may not have known about the lawsuit, despite the potential for a sizeable liability. This raises an embarassing due diligence issue. We looking forward to reading the next motion filed by Schering-Plough and its lawyers to see if are able to come up with an explanation for this interesting revelation.