The research article “Grave Fraudulence in Medical Device Research: A Narrative Review of the PIN Seeding Study for the Pinnacle Hip System” was published in December 2017 in the journal Accountability in Research.
The title of the article makes it clear what it discusses: that Johnson and Johnson (J&J) and DePuy Orthopaedics (DePuy) initiated a seeding study for the DePuy Pinnacle hip implant and failed to maintain ethical standards.
According to the authors, seeding studies differ from real medical studies in that they:
The researchers criticize J&J and DePuy for deviations from normal scientific rigor, including:
A FDA recall of metal on metal DePuy ASR hip implants occurred in 2010 due to large scale failures of the device in patients. Cobalt and chromium coated metal on metal systems by DePuy including the ASR and Pinnacle were causing metallosis, pain, and the need for revision surgery to remove the device. In 2012 DePuy stopped selling Pinnacle hip implants with metal liners, a product called Ultamet. While J&J never officially recalled the DePuy Pinnacle hip implants, they stopped selling this version of the medical device and did not replace the product with a new metal on metal version.
To read the published article, follow this link: https://doi.org/10.1080/08989621.2017.1405259
Article: Joan E. Steffen, Ella A. Fassler, Kevin J. Reardon & David S. Egilman (2018) Grave fraudulence in medical device research: a narrative review of the PIN seeding study for the Pinnacle hip system, Accountability in Research, 25:1, 37-66