"It is never acceptable for the health care industry to place the profit motive over people's well being," said Patrick Doyle. "The FDA review process was put in place to protect the nation's citizens. Should these companies and executives ultimately be found guilty, they will have to pay a price for placing at risk the very people for whom they purported to provide relief."

Summary of the Charges


The indictment charges that from the beginning, the intended market for Norian XR was for an unapproved use, i.e., in surgeries to treat VCFs. According to the indictment, the company recognized early on that there were two possible solutions to this problem: (1) the legal solution, which was to disclose to the FDA the intended use of the product and then to try to secure FDA approval of XR for use in surgeries to treat VCFs after obtaining an investigational device exemption ("IDE") to investigate the safety and efficacy of the product, and (2) the illegal solution, which was to promote XR for use in VCFs through a limited so-called "test market," during which the company would evaluate the safety and efficacy of the product in unapproved clinical trials and judge their success according to its own standards. The indictment charges that the company and its coconspirators consciously and deliberately chose the illegal solution. That is, according to the indictment , the company intentionally bypassed the requirement that it obtain permission from the FDA to conduct clinical trials of the XR device on human beings for an unapproved use - permission that it knew it needed. With the so-called "test market," the company allegedly tried to save time and money by cutting out the FDA's oversight of clinical trials of its device. The indictment charges that the company did this for two principal reasons: to rush XR to the market first, before its competitors, and to generate published studies that it could use later to convince other surgeons to use XR off-label to treat VCFs.

Starting as early as late summer 2002, the company allegedly approached selected spine surgeons and asked them to use a predecessor device, SRS, in VCF procedures as part of an initial Synthes "test market" for SRS. Despite a June 2002 plea from one of Synthes's own surgeon consultants that conducting such a "test market" would "amount to human experimentation whose only defense seems to be that it will be a small study [,]" Norian and its coconspirators allegedly embarked on the SRS "test market." According to the indictment, the company taught the selected surgeons the recipe for mixing SRS with barium sulfate to make it more radiopaque, a process called "back-table mixing," and trained two groups of surgeons in the use of SRS to treat VCFs. After training the two groups of surgeons as initial "test market" sites, the company allegedly enlisted these "test market site" surgeons to train other surgeons on how to use XR to treat VCFs.

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