Here are four things to know:
1. Medtronic has faced several lawsuits related to Infuse in recent years, and this could be among the last. The product, which received FDA approval in 2002, has been used in thousands of spinal fusions for on-and off-label applications.
2. The institutional investor sued Medtronic for allegedly hiding adverse events from the clinical studies used to achieve FDA clearance and promote the product, as well as overstating the disadvantages of alternative treatments, according to the report. Medtronic denied “all allegations of liability and wrongdoing related to the case” in a 1,000-word disclaimer as part of the settlement agreement. The company also denied that the shareholders were harmed as a result of the incident.
3. The two sides agreed to a $43 million settlement to resolve the allegations. The most recent settlement comes after the company agreed to pay $12 million to settle legal complaints in December, as well as the federal racketeering lawsuit Humana brought against the company last June.
4. If the judge approves, Medtronic will pay the $43 million settlement to cover shareholders acquiring company shares from Sept. 8, 2010 to June 28, 2011.
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