Medtronic, Inc. may have misled investors about its financial condition by failing to disclose that revenues from its bone graft product, INFUSE, were generated from non FDA approved uses.

This is a securities fraud class action lawsuit against Medtronic, Inc. and certain of its officers.

Medtronic manufactures medical devices. One such medical device is Medtronic's flagship product, the INFUSE Bone Graft ("INFUSE"), which according to Medtronic INFUSE is a surgically-implanted medical device containing a genetically engineered protein designed to stimulate bone growth.

The class action lawsuit alleges that Medtronic's statements about INFUSE were materially false and misleading because Medtronic concealed and failed to disclose material facts known to or recklessly ignored by them about INFUSE that were necessary to make their otherwise positive statements about the product and Medtronic's financial condition accurate, truthful, and not misleading to investors, including the following:

(1) Medtronic did not disclose the extent to which revenues from sales of INFUSE were dependent on applications of the product not approved by the United States Food and Drug Administration ('FDA'), or so-called "off-label' uses;

(2) Metronic did not disclose that a significant and increasing number of patients subjected to such off-label uses of INFUSE were suffering severe medical complications; and

(3) Medtronic hid the fact that the extensive off-label usage of INFUSE was the result of an unlawful campaign by Medtronics to market and encourage off-label use of the product.

Medtronic's false and misleading statements concerning INFUSE and Medtronic's financial condition artificially inflated the price of Medtronic's publicly traded securities during the Class Period. Revelations concerning Medtronic's false and misleading statements during the Class Period caused significant losses to investors as the prices of Medtronic's securities experienced severe declines as a direct result of these revelations, with Medtronic's stock price closing the day after the end of the Class Period at $31.20 per share, down from a Class Period high of $55.65 per share.