A Medical Device Daily

The law firm of Bernstein Litowitz Berger & Grossmann (BLB&G; New York) reported that it filed a class-action lawsuit in U.S. District Court for the District of Minnesota on behalf of its client, Minneapolis Firefighters' Relief Association, and similarly situated investors in the securities of Medtronic (Minneapolis), alleging that during the class period, Medtronic, CEO Bill Hawkins and CFO Gary Elliss violated the federal securities laws by issuing false and misleading press releases, financial statements, filings with the Securities and Exchange Commission and statements during investor conference calls.

The complaint alleges that the company made repeated false statements to the investing public concerning one of its flagship products, the Infuse Bone Graft, representing to investors that it was a valuable and reliable source of revenues for the company.

The complaint alleges that defendants 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 the company's financial condition accurate, truthful, and not misleading to investors.

In particular, the firm said, defendants did not disclose the extent to which revenues from sales of Infuse were dependent on applications of the product not approved by the FDA, via so-called "off-label" uses; 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 hid the fact that the extensive off-label usage of Infuse was the result of an unlawful campaign by defendants to market and encourage off-label use of the product.