Legal Issues Mount for Intuitive Surgical after Surge of Adverse Event Reports

Intuitive Surgical's problems with its da Vinci robot are in the spotlight again. In its latest legal wrangle, the company is alleged to have concealed legal claims that were filed over its robotic surgical system.

Intuitive Surgical had seen a significant jump in reports of adverse events tied to its da Vinci robot. In early October, the company said that an analysis based on the FDA MAUDE database demonstrates a drop in overall adverse events. The company notes that "any assessment of safety trends based on Reporting Dates rather than Event Dates in the MAUDE database will be fundamentally flawed and misleading, and is likely to seriously misrepresent the true performance of a device." Such reporting may see an uptick as a result of media attention or an advertising or legal campaign. This was the case here: in August, there were 105 injury and death reports, 73 of which were part of a legal mediation effort. Last week, the Illinois Union Insurance Company filed a lawsuit, alleging that the company only revealed 25 legal claims associated with its flagship robotic surgical system. The lawsuit was filed in the United States District Court for Northern California.According to court documents, Intuitive agreed to a lawsuit extension deadline for a series of lawsuits filed over the da Vinci system starting in 2012. However, these "tolling agreements" were not disclosed to the Illinois Union Insurance Company."Plaintiffs did not know of the existence of the tolling agreements prior to the issuance of the policy, and had no means of learning of the existence of the tolling agreements and the increasing number of claimants being added to the tolling agreements because that information was known only to the defendant, defendant's counsel, and the claimants' attorneys," noted court documents.