Federal Judge Rules that Medtronic Shareholder Lawsuit, Brought by Three Key Investor Groups May Proceed, Parker Waichman LLP Comments.

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Investors allege that Medtronic misled them about Infuse’s safety profile and potential commercial possibilities.

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“We are happy to see this case brought over the Infuse bone growth product move forward,” said Gary Falkowitz, Managing Attorney at Parker Waichman LLP.

A federal judge in Minneapolis, Minnesota just ruled that a shareholder lawsuit brought over Medtronic’s Infuse bone growth protein may proceed. The lawsuit alleges that Medtronic and its management, which includes its former CEO, William Hawkins, misled investors concerning the safety and potential commercial viability of Infuse. The case is West Virginia Pipe Trades Health & Welfare Fund v. Medtronic, Inc. et al., in the United States District Court District of Minnesota; case number 13-1686. The judge in this case recently denied Medtronic’s Motion to Dismiss. The Court’s denial was made on September 29, 2014.

Judge John Tunheim tossed some claims, but allowed the lawsuit, West Virginia Pipe Trades Health & Welfare Fund v. Medtronic, Inc. et al., in the United States District Court District of Minnesota, case number 13-1686, against Medtronic and a number of its key executives to move forward. In addition to Hawkins, CFO Gary Ellis and CSO Dr. Richard Kuntz are named. Plaintiffs include three institutional investors: West Virginia Pipe Trades Health & Welfare Fund, Union Asset Management Holding AG, and Employees' Retirement System of Hawaii. Allegations include that Medtronic deceived its investors concerning both Infuse's commercial prospects and its safety profile. Other allegations include that Hawkins misled analysts concerning the potential forecast for its planned follow-up, related product known as Amplify, and that the investors purchased Medtronic shares based on these misrepresentations, which led them to become injured when safety issues concerning Infuse became known and were followed by a drop in the stock.

Parker Waichman LLP comments that it is aware that patients may be harmed during medical procedures and as a result of the use of medical devices and is available to assist those individuals who have suffered injuries related to these procedures and medical products.

Infuse is a genetically engineered, synthetic, recombinant human Bone Morphogenetic Protein (rhBMP-2). The product received U.S. Food and Drug Administration (FDA) in 2002 for very specific uses: To stimulate spine growth in patients suffering from lower spinal degenerative disease, for use in one type of spinal surgery, and for use in some dental procedures. Infuse is not approved for use on the cervical (upper) spine; however, the bone graft product is widely used in these off label procedures, Parker Waichman LLP indicated.

The allegations in this lawsuit also include that Medtronic and some of its former and current officers, consultants, and executives were engaged in a scheme meant to mislead investors concerning Medtronic’s financial position, specifically concerning Infuse’s safety and efficacy. Initial studies showing the product’s safety and efficacy were shown to be inaccurate based on newer studies published in May and June 2011 in The Spine Journal, the lawsuit alleges. The journal article revealed that the incidence of Infuse adverse events was 10-50 times the previously published rates. Allegations also include that Medtronic, in collaboration with physician consultants, were involved in a scheme to defraud investors by manipulating Infuse’s initial studies. Because of this scheme to defraud, Medtronic’s stock traded at falsely inflated prices, dropping nearly 25 percent from its highest level once the truth was revealed, according to lawsuit allegations. The lawsuit cited violations of the Securities and Exchange Act; a scheme and course of conduct intended to mislead; and violations of the Exchange Act. (West Virginia Pipe Trades Health & Welfare Fund v. Medtronic, Inc. et al., in the United States District Court District of Minnesota, case number 13-1686)

“We are happy to see this case brought over the Infuse bone growth product move forward,” said Gary Falkowitz, Managing Attorney at Parker Waichman LLP. “Individuals who allegedly suffered a serious, life-altering injury during a medical procedure, or loss over alleged misrepresentations, deserve their day in court.”

On July 1, 2008 the FDA issued a notification warning of serious complications tied to the off-label use of Infuse in cervical spinal fusions. The notification included information on a number of serious complications when Infuse is used in cervical spine fusions. These complications include excessive swelling in the neck, compressed airways, swallowing and breathing difficulties, and nerve damage.

The FDA specifically noted that it received reports of “life-threatening complications associated with” Infuse when used off-label in the cervical spine, and reiterated that, “these products are not approved by FDA for this use.”

Parker Waichman LLP offers free legal consultations to victims of injuries allegedly caused by medical procedures. If you or a loved
one experienced injuries as a result of a potentially inappropriately conducted medical procedure or due to a medical device please visit the Medical Devices pages at YourLawyer.com or call 1-800-LAW-INFO (1-800-529-4636).

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