There is not much legitimate dispute that the CerviCore devices used by Stryker in the CerviCore clinical trial were mismade. Stryker relied on its subcontractor, Hammill Manufacturing, to make the devices and the evidence shows the part measurements for nearly every part in every batch has some quality flaw.
But, who is to blame?
- Did Hammill tell the Stryker team that the parts could not be made to specifications and the Stryker staff told Hammill to make the parts anyways?
- or, did Hammill mis-make the parts and never tell Stryker?
Some evidence suggests Stryker’s team knew about the defects before they were made. But, Hammill’s representative testified that if there are defects it would be his company’s fault.
In any case, Stryker learned about the defects during an audit and review process, but never informed the study participants or their doctors.