According to court records, one manufacturer in particular, C.R. Bard, actually hired a litigation consultant to compare the rate of device fractures and migrations to a previous IVC filter model it had manufactured. However, lawsuits allege that even though Bard was aware of these problems, it did not disclose them to the U.S. Food and Drug Administration (FDA). The consultant’s report has become known as the Lehmann Report after its creator, John Lehmann.
Bard received the report in December 2004. Court records show that the purpose of the report was to provide the company with legal advice regarding ongoing and anticipated lawsuits due to defective IVC filters. The document was supposed to be confidential, but it was mistakenly disclosed during the discovery process in an IVC filter lawsuit against Bard.
So Who Knew What – and When Did They Know It?
This is one key question regarding IVC filter litigation, and there are very few tangible answers to this point. What is known, however, is that the plaintiffs in IVC filter lawsuits are alleging that Bard knew about the risk of fractures as early as 2003. But not only did Bard fail to warn the FDA, plaintiffs allege Bard also did not warn doctors or patients of this risk. To that extent, nearly 1,000 reports of complications associated with IVC filters manufactured by Bard and other companies have been reported to the FDA since 2005.