According to an article published by Massachusetts Medical Devices Journal LLC, Confidential Witness 2 (CW2) is refusing to supply documents for a shareholder lawsuit against Medtronic, after being ordered by a second judge to produce them. Shareholders are accusing Medtronic of inflating the value of its shares by endorsing off-label uses for its Infuse® Bone Graft protein.
The witness is a former Medtronic employee and has been rebuffing judges’ requests for more than five months to come up with the documents.
Judge Paul Magnuson of U.S. District Court for Minnesota this week upheld a lower court ruling that CW2 must produce the documents.
The documents concern techniques regarding spinal fusion, technical training and bone grafts as well as clinical studies and products for bone grafts.
Shareholders accuse Medtronic of promoting off-label uses to doctors of the bone growth product by:
- Providing literature about off-label Infuse
- Telling doctors what specific amounts to use in off-label work
- Using off-label sales as a key gauge of sales and projections of sales
A number of claims against Medtronic were filed after an entire issue of Spine Journal last summer was dedicated to uncovering problems with studies the company conducted of Infuse. The journal’s inquiry uncovered serious issues about the product’s safety. The publication revealed that 13 studies by Medtronic-sponsored doctors toned down problems or omitted them entirely when discussing the protein.
Resulting problems on Wall Street are not the only difficulties Medtronic face. Both the U.S. Department of Justice and the U.S. Senate are investigating Infuse and the company’s marketing procedures.
Source: MassDevice
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