St Jude Medical has reached a settlement agreement with the US Department of Justice (DOJ) regarding a previously disclosed 2005 investigation in Boston related to an industry-wide review of post-market studies and registries.
The settlement agreement with the DOJ resolves the post-market study matter in Boston and the company maintains that its post-market studies and registries are legitimate clinical studies designed to gather important scientific data.
St Jude Medical said it does not admit liability or wrongdoing by entering into the agreement.
St Jude Medical’s settlement agreement is to avoid the potential costs and risks associated with litigation and the settlement brings the previously reported post-market study investigation to a close.
As part of the settlement, the company will make a payment of $16m to the DOJ.
St Jude Medical affirms that the resolution of the matter has no material impact on the company’s financial position or operations.