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Wednesday, February 13, 2008

He's suing the device maker: Prodisc artificial spinal disk lawsuits

Calvin Timberlake, a 50-year-old former forklift operator who lives in Texas, had a Prodisc implanted in his spine four months after the US Food and Drug Administration approved it. Prodisc is an artificial metal and plastic spinal disk that is meant to relieve lower back pain by replacing a damaged disk between vertebrae of the spine. Calvin's surgeon was not involved in the clinical trial, though he apparently had invested in Prodisc. The Prodisc soon came apart, requiring an emergency operation to remove it. Calvin remains in extreme pain, and has to take medication to control the pain.

Calvin is suing Synthes, the Prodisc's maker, but not his surgeon, whom he does not blame for the problems.

Many of the surgeons who co-authored articles in peer-reviewed medical journals had major investments in the Prodisc, and at least some of them did not disclose their investments to the journal editors when they submitted their manuscripts for publication. They stood to profit financially if the Prodisc succeeded in the market, according to confidential information from a patient's lawsuit that was settled last year.

Advice to people who may have surgery to implant a medical device: Ask your surgeon's office manager if the surgeon has a financial stake in the device.

Browse for related stories in the index at the very bottom of this page, or read another Texas spinal surgery lawsuit story.

Thanks to Reed Abelson for the source article in the Jan. 30 issue of the NY Times.

1 comment:

Matt said...

My wife had to have one of these things taken out, after spending 1 horrific year in bed. The surgeon, who has a large financial interest in the device, denied there was a problem. Six other surgeons clearly pointed out the 4 obvious contraindications.

People who are considering getting ADR should first browse http://spinesupport.org/simplemachinesforum/

This site objectively presents research on ADR (artificial disc replacement). You may find that ADR is not nearly so amazing as some surgeons would have you believe.

Now we discover, the whole FDA trial of the Prodisc is tainted. Half of the surgeons involved had a large financial interest. A inordinately large portion of the trial cohort are missing.


-M