Medical Researchers Call DePuy Pinnacle Study “Grave Fraudulence”
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 Lawsuit
The attorneys at Levin Simes Abrams are investigating DePuy Pinnacle Lawsuits and represent dozens of those injured. Our lawyers have successfully settled hip implant recall lawsuits and continue to fight for those injured. If you have questions about metallosis, metal on metal hip pain, hip implant revision or other issues call us at 1-888-426-4156 or email [email protected]
DePuy Pinnacle Information
For more information on DePuy Pinnacle hip implant failures read our page here: DePuy Pinnacle Lawsuit.
For information on DePuy Pinnacle verdicts: DePuy Pinnacle Verdicts.
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