According to the Complaint filed in Federal Court, nine of the plaintiffs had the device installed as part of an experimental trial conducted by Stryker. Four additional plaintiffs are spouses of the original nine and have suffered as a result of their husband’s or wife’s suffering.
The CerviCore device is an experimental metal-on-metal device that was implanted in between two cervical spine vertebrae. Stryker bills the device as an alternative to traditional fusion surgery.
Study documents show that up to 400 people may have been part of the study, with around 200 of them receiving the CerviCore device. It’s not known how many of those are suffering because of it.
All nine plaintiffs in this suit say the CerviCore device has caused them grave harm. Most or all are suffering metallosis symptoms and they allege Stryker either will not conduct proper metal exposure testing or conducted testing and will not release the results. The symptoms are very similar to the metallosis alleged to be caused by Stryker replacement hips.
Additionally, all nine say Stryker/Howmedica abandoned them. In most cases, the company sent a representative saying Stryker wanted to continue the CerviCore study, then, shortly after they signed new waivers, it abruptly ended the entire study and stopped monitoring their conditions.
The suit seeks damages for all the medical expenses, the lost work time, and the pain and suffering each person has endured. It also asks the court to punish Stryker/Howmedica and send a message that the way it treated these people is unacceptable.
Stryker/Howmedica has yet to respond to the allegations.
READER COMMENTS
Philomena CappaBianca
on
The FDA did not approve the application for the legally required investigational device exemption (IDE) that had been submitted by Stryker Howmedica Osteonics in 2004.
Without an order from the FDA granting a valid IDE to the sponsor, Howmedica Osteonics, dba Stryker Spine, the CerviCore device was absolutely prohibited for use on human subjects in clinical trials.
see ClinicalTrials.gov Search CT-002-04 / Stryker Spine CerviCore
Stryker Spine registered the CerviCore CT-002-04 as a Trial Device NOT PREVIOUSLY APPROVED or cleared by the US FDA for any use.