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<p>[QUOTE="Anonymous, post: 2187998"]<a href="http://www.nytimes.com/2008/02/22/business/22suit.html?_r=1&ref=business&oref=slogin" target="_blank" class="externalLink ProxyLink" data-proxy-href="http://www.nytimes.com/2008/02/22/business/22suit.html?_r=1&ref=business&oref=slogin" rel="nofollow">http://www.nytimes.com/2008/02/22/business/22suit.html?_r=1&ref=business&oref=slogin</a></p><p><br /></p><p>February 22, 2008</p><p>Suit Says Spinal Disk Maker Falsely Won F.D.A. Approval</p><p>By REED ABELSON</p><p><br /></p><p>A patient suing the maker of an artificial spinal disk now says the original maker of the device, Spine Solutions, and the investment firm that financed its development misled patients and federal regulators about the disk’s safety and effectiveness.</p><p><br /></p><p>Earlier this year the patient, Calvin Timberlake, sued Synthes, the disk’s current maker, because he said the device, the Prodisc, had come apart in his back and had to be removed surgically, leaving him in severe pain. On Thursday he added Spine Solutions and the investment firm Viscogliosi Brothers to the suit.</p><p><br /></p><p>Mr. Timberlake and his lawsuit were mentioned in a January article in The New York Times that reported that many of the doctors who had conducted the clinical research for the Prodisc stood to benefit financially if it won approval from the Food and Drug Administration. That approval came in 2006.</p><p><br /></p><p>The amended lawsuit by Mr. Timberlake claims that the Viscogliosi firm, and the three brothers running it — Marc, John and Anthony — “were under tremendous pressure” to sell Spine Solutions and receive F.D.A. approval for the Prodisc because they needed to repay “embezzled funds” and “prevent financial ruin and likely criminal indictment.”</p><p><br /></p><p>Synthes, which agreed to acquire Spine Solutions for $350 million in 2003, declined to comment Thursday on Mr. Timberlake’s lawsuit.</p><p><br /></p><p>Describing the lawsuit as “completely baseless and without merit,” Viscogliosi Brothers said in a statement that it would “aggressively defend themselves” and “take all remedies to defend their reputations and achieve justice.”</p><p><br /></p><p>According to the lawsuit, in September 2002 the Manhattan district attorney’s office became aware of accusations that the firm’s principals had embezzled money from its investors and began an investigation.</p><p><br /></p><p>“At no time, even after intense reviews, did any government agency pursue any action against Viscogliosi Brothers,” the firm said, saying all of the judicial and regulatory bodies reviewing the claims had either dismissed them or did not pursue them.</p><p><br /></p><p>In an earlier interview, Daniel J. Castleman, chief of investigations for the Manhattan district attorney, said, “We examined the allegations and found they lacked prosecutorial merit, as investors recouped their investments and more.”</p><p><br /></p><p>Mr. Timberlake’s lawsuit also contends that Viscogliosi Brothers “intentionally set up an inherent conflict” in the clinical research by finding surgeons who would invest in Viscogliosi funds that financed the Prodisc and who would serve as researchers.</p><p><br /></p><p>Doctors at about half of the 17 research centers involved in the study stood to profit financially if the Prodisc succeeded, according to confidential information from a patient’s lawsuit settled last year.</p><p><br /></p><p>The companies behind the Prodisc have previously said the researchers’ financial interests had no impact on findings of the research, which they say have been published in various peer-reviewed medical journals.</p><p><br /></p><p>In Thursday’s statement, Viscogliosi Brothers said it is “proud of their achievement in this area and with the technology that has given thousands of patients hope and relief from spinal pain.” The Prodisc has undergone two separate assessments by the F.D.A., one for use in the lower back and the other for the neck, the firm added.</p><p><br /></p><p>In light of Wednesday’s Supreme Court decision that would protect medical device companies from many personal-injury lawsuits if the products were approved by the F.D.A., Jim Cole, the lawyer representing Mr. Timberlake, said his case differed from that one in several ways.</p><p><br /></p><p>He said the fact that many of the doctors performing the research had a financial interest in the outcome raised questions about the validity of the data supplied to the F.D.A. He also said that the disk had not been manufactured according to the specifications approved by the F.D.A.[/QUOTE]</p><p><br /></p>
[QUOTE="Anonymous, post: 2187998"][url]http://www.nytimes.com/2008/02/22/business/22suit.html?_r=1&ref=business&oref=slogin[/url] February 22, 2008 Suit Says Spinal Disk Maker Falsely Won F.D.A. Approval By REED ABELSON A patient suing the maker of an artificial spinal disk now says the original maker of the device, Spine Solutions, and the investment firm that financed its development misled patients and federal regulators about the disk’s safety and effectiveness. Earlier this year the patient, Calvin Timberlake, sued Synthes, the disk’s current maker, because he said the device, the Prodisc, had come apart in his back and had to be removed surgically, leaving him in severe pain. On Thursday he added Spine Solutions and the investment firm Viscogliosi Brothers to the suit. Mr. Timberlake and his lawsuit were mentioned in a January article in The New York Times that reported that many of the doctors who had conducted the clinical research for the Prodisc stood to benefit financially if it won approval from the Food and Drug Administration. That approval came in 2006. The amended lawsuit by Mr. Timberlake claims that the Viscogliosi firm, and the three brothers running it — Marc, John and Anthony — “were under tremendous pressure” to sell Spine Solutions and receive F.D.A. approval for the Prodisc because they needed to repay “embezzled funds” and “prevent financial ruin and likely criminal indictment.” Synthes, which agreed to acquire Spine Solutions for $350 million in 2003, declined to comment Thursday on Mr. Timberlake’s lawsuit. Describing the lawsuit as “completely baseless and without merit,” Viscogliosi Brothers said in a statement that it would “aggressively defend themselves” and “take all remedies to defend their reputations and achieve justice.” According to the lawsuit, in September 2002 the Manhattan district attorney’s office became aware of accusations that the firm’s principals had embezzled money from its investors and began an investigation. “At no time, even after intense reviews, did any government agency pursue any action against Viscogliosi Brothers,” the firm said, saying all of the judicial and regulatory bodies reviewing the claims had either dismissed them or did not pursue them. In an earlier interview, Daniel J. Castleman, chief of investigations for the Manhattan district attorney, said, “We examined the allegations and found they lacked prosecutorial merit, as investors recouped their investments and more.” Mr. Timberlake’s lawsuit also contends that Viscogliosi Brothers “intentionally set up an inherent conflict” in the clinical research by finding surgeons who would invest in Viscogliosi funds that financed the Prodisc and who would serve as researchers. Doctors at about half of the 17 research centers involved in the study stood to profit financially if the Prodisc succeeded, according to confidential information from a patient’s lawsuit settled last year. The companies behind the Prodisc have previously said the researchers’ financial interests had no impact on findings of the research, which they say have been published in various peer-reviewed medical journals. In Thursday’s statement, Viscogliosi Brothers said it is “proud of their achievement in this area and with the technology that has given thousands of patients hope and relief from spinal pain.” The Prodisc has undergone two separate assessments by the F.D.A., one for use in the lower back and the other for the neck, the firm added. In light of Wednesday’s Supreme Court decision that would protect medical device companies from many personal-injury lawsuits if the products were approved by the F.D.A., Jim Cole, the lawyer representing Mr. Timberlake, said his case differed from that one in several ways. He said the fact that many of the doctors performing the research had a financial interest in the outcome raised questions about the validity of the data supplied to the F.D.A. He also said that the disk had not been manufactured according to the specifications approved by the F.D.A.[/QUOTE]
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Cafepharma Message Boards | Pharma Sales, Device Sales, Lab Sales
Home
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Medical Equipment/Device Sales
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Synthes
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Class Action Law Suit Against Synthes
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Cafepharma Message Boards | Pharma Sales, Device Sales, Lab Sales
Home
Forums
>
Medical Equipment/Device Sales
>
Synthes
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Class Action Law Suit Against Synthes
>