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Medtronic Lawsuit Witness Must Testify, Judge Says | cialis online

Medtronic Lawsuit Witness Must Testify, Judge Says

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A confidential Medtronic Infuse lawsuit witness must testify in a shareholder class action case, said the judge hearing the case.

A Minnesota federal judge upheld the motion compelling the witness to testify in a shareholder class action, which alleges that Medtronic Inc.’s stock price fell over its off-label touting of the Infuse spinal graft product, said Law 360. U.S. District Judge Paul A. Magnuson’s ruling affirmed a magistrate judge’s prior order that the witness—known as CW2, a former Medtronic employee—must testify and provide a document he attempted to withhold when he cited Fifth Amendment protection, wrote Law 360.

The confidential witness signed a declaration supporting an earlier Medtronic court filing, thus disqualifying him from Fifth Amendment protection. “Given the conclusion that CW2 testified as to the subject matter of the document in question in his declaration, Chief Magistrate Judge Boylan’s conclusion that he waived any Fifth Amendment privilege as to that document is indisputedly correct,” Magnuson said, wrote Law 360.

The lawsuit was first brought about in 2008 against Medtronic and alleged it intentionally touted Infuse off-label and failed to disclose that sales revenues were mostly dependent on unapproved uses. The complaint stated that Medtronic’s stock suffered a 13 percent drop following news that the U.S. Department of Justice was investigating the alleged off-label Infuse promotion, explained Law 360.

It seems that CW2, who left Medtronic in 2008 and backed Medtronic in the declaration, also opposed the motion for class certification, said the ruling. The class followed with a subpoena asking the witness to testify and turn over documentation. The witness did comply, in part, said Law 360; he did not testify and withheld eight documents citing confidentiality and self-incrimination, according to court filings.

In December, Magistrate Judge Arthur J. Boylan ruled that Fifth Amendment protection was moot for five of the eight documents because Medtronic had previously turned them over to the class; two documents were not covered under protection, as they were Medtronic corporate documents; and the last document was not protected and, because CW2 declared his support of Medtronic, he, in essence, waived his Fifth Amendment rights, said Law 360. CW2, who was ordered to provide the document, appealed the decision in district court, claiming the magistrate’s ruling was in error.

Serios questions about Infuse have been raised in recent years over concerns of its cancer links and other serious adverse reactions. Made from the genetically engineered rhBMP-2 (recombinant human Bone Morphogenetic Protein-2), Infuse stimulates bone growth. First approved in 2008 by the U.S. Food and Drug Administration (FDA), Infuse received clearance for use in anterior approach lumbar fusion surgery and two types of dental procedures.

But, Infuse has often been used in unapproved procedures and, in 2008, the agency warned that Infuse and similar rhBMP-2 products caused serious problems when used off-label in cervical spine (neck) surgeries, said NewsInferno. The many controversies have seen a drop in Infuse sales as physicians have minimized or stopped use of the product.

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