Blog Post

Subpoenas Issued against Prodisc Company


February 07, 2008
Topic: Pharmaceutical Liability

The New York Times reports that the New Jersey Attorney's Office has issued subpoenas to two companies, the Swiss medical technology group Synthes and Viscogliosi Brothers, a New York based investment group. The subpoenas are related to the ties that researchers and surgeons who approved the use of Prodisc had with the financial success of the product.

Prodisc is an artificial spinal disc that's especially indicated in cases of spinal arthoplasty in patients who have degenerative disc disease and who have no relief from pain medication for at least 6 months prior.

When the findings of the research conducted into its benefits was made public in 2006, doctors like Jack E. Zigler were effusive in their praise for the artificial disc, claiming it gave patients a new found mobility, and that it was "gratifying" to watch patients return to some semblance of their normal life after the insertion of the disc.

As it turns out, all that "gratification" might have been heightened by the lure of greenbacks - doctors at at least half of the 17 research centers involved in the study had invested in the product, it was later revealed. While doctors promoting a product or device with some expectation of rewards is not that uncommon, this case is strikingly different because the doctors here were supposed to be impartial and objective observers studying the benefits of a new product. It doesn't take a PhD to figure out that when researchers have a financial stake in the object of their study, the conclusions might mirror their own financial ambitions rather than the actual benefits of the product.

This is exactly what seems to have happened in the Prodisc case. Later investigations revealed that data from a disproportionately high number of subjects was ignored or left out of the conclusions. As many as 21 subjects or 10 percent of the total number of subjects were left out of the conclusions. Medical research experts say 10 percent is an unusually high number of people to be excluded from the results.

Many of these subjects, it now turns out, did not do well with the artificial disc at all. One patient, Calvin Timberlake, had the disc implanted after it got FDA approval. The disc came apart right after implantation, necessitating another surgery. He has filed a lawsuit against Synthes.

The influence of commercial and financial interests is so prevalent in the spinal surgery field that a bunch of doctors have grouped together to form the Association for Ethics in Spine Surgery. They see relations between the spinal surgeons and the device industry getting progressively friendlier, and fear that doctors seem to be swayed by profits and shareholder prices, rather than the medical efficacy of the device.

The FDA allows doctors to have a financial stake in the devices they are studying as long as these relationships are fully disclosed. As of now, it's still not clear if all details of these financial ties in the Prodisc case were revealed to the FDA.

If you have been injured by a defective medical product, then you need the help of an experienced California personal injury law firm. Contact a lawyer at The Reeves Law Group for a free consultation.


The California personal injury attorneys at The Reeves Law Group represent victims of accidents, injuries and wrongful death throughout California from our offices in Los Angeles County, Orange County, San Diego County, Riverside County, San Bernardino County, Ventura County, Fresno County, Kern County, Sacramento County, San Fernando Valley, Long Beach, Antelope Valley, Torrance, Glendale, Bakersfield, Santa Ana, San Jose, San Francisco, Oakland, Ontario, and Victorville.