DePuy Pinnacle Study
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:
- Let marketing objectives shape study design
- Let marketing objectives shape data analysis
- Marketing goals are concealed from doctors and patients
- The sponsor company may use unscientific research practices
The researchers criticize J&J and DePuy for deviations from normal scientific rigor, including:
- Violating study protocol
- Manipulating data
- Violating protections for human subjects
- Failing to secure Institutional Review Board approval for sites
- Marketing the seeding trial as a scientific study
DePuy Pinnacle Metallosis
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.
DePuy Pinnacle Information
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