Suits Target J&J Discs

FDA spokeswoman Heather Howell told TheStreet.com that the agency could offer no details about a panel review for the ProDisc or disclose if one will even be held. Rather, she said, the public must rely on the company itself for any information.

Synthes told TheStreet.com that no FDA panel hearing will be held on the ProDisc and that no study results have yet been published on the device.

Rosen got nowhere with the FDA, either. So he next contacted a powerful senator bent on reforming the agency.

"The process of approval and monitoring of both of these disc replacements by the FDA has occurred under suspicious and secretive circumstances that suggest that this is the work of undue influence by industry," Rosen insisted in a February letter to Senate Finance Chairman Charles Grassley. "I believe this presents a real danger to the American people in a circumstance of money triumphing over patient care."

Rosen, who claims no financial conflicts himself, hopes to one day share his warning with a wider audience through formal testimony before the U.S. Senate.

Weighing the Risks

In the meantime, Rosen continues to do his homework.

After much prodding, for example, he finally got the FDA to send him 67 reports on adverse events involving the Charite. He found the information sorely incomplete and worrisome in nature.

Some "71% of reports were generated by 'company representatives' only, [and] not one report to the FDA concluded any device malfunctioned or was defective -- including the 11 cases where the device intrinsically malfunctioned with the plastic dissociating from the metal plate," Rosen says. Also, "it is striking that only 15% of retrieved specimens [artificial discs] were sent to the manufacturer for analysis. It is accepted widely -- and with little question -- that retrieval and analysis of any implant is critical for both evaluation and research."