Grave fraudulence in medical device research: a narrative review of the PIN seeding study for the Pinnacle hip system

ABSTRACT

In 2001, DePuy, a wholly-owned subsidiary of Johnson & Johnson (J&J/DePuy), initiated a seeding study called the “Multi-center, Prospective, Clinical Evaluation of Pinnacle Acetabular Implants in Total Hip Arthroplasty” (PIN Study). J&J/DePuy designed this study to develop new business opportunities during the launch of their Pinnacle Hip System (PHS) and generate survivorship data for marketing. This article, the first review of a seeding trial for a medical device, examines internal company documents relating to the PIN Study; the analysis herein focuses on the integrity of J&J/DePuy’s research practices in conception, implementation, and analysis. J&J/DePuy violated the study protocol and manipulated data; consented participants in violation of standards protecting human subjects; and did not secure Institutional Review Board approval for all study sites. J&J/DePuy used PIN Study results as the “fundamental selling point” for the PHS. Medical device seeding trials are distinct from previously-documented pharmaceutical seeding trials because companies can profit directly from device sales and because these studies may be the first clinical evaluation of the device (as was the case for the PIN Study). Seeding trials are malleable marketing projects, not rigorous scientific studies. Regulatory bodies, physicians, and others should be vigilant for persuasive marketing accounts disguised as science.

KEYWORDS:

• DePuy
• FDA
• Johnson & Johnson
• Pinnacle hip system
• medical ethics
• research ethics
• seeding trial
• total hip arthroplasty

Conflict of interest

David Egilman served as an expert witness in litigation at the request of people who were injured as the result of having total hip replacement with the Pinnacle Metal on Metal Hip System. Joan Steffen and Kevin Reardon worked for Dr. Egilman on this litigation. Ella Fassler served as a consultant on the same litigation. None of these authors were compensated for work on this paper and the lawyers for the injured plaintiffs did not review this paper and had no input into the content of the paper. The authors provided J&J/DePuy lawyers a draft copy of this manuscript one month before publication with a request for comments and corrections; no response has been received.

Notes

¹ Although the vast majority of documents reviewed for this study remain confidential, an author’s expert report (DSE) in this case has become public. This article cites the author’s expert report in instances where the source documents remain confidential.

² In many cases, these “predicate” devices also have not been assessed for safety and efficacy or may even have demonstrated poor clinical outcomes. The metal-on-metal configuration of the PHS, for example, relied on a chain of predicate devices leading back to three hip implants (the McKee-Farrar, the Ring, and the Sivash metal-on-metal implants), all of which had been previously removed from the market due to poor performance. The 510(k) process does not evaluate safety and effectiveness of new devices; instead, the 510(k) regulatory pathway evaluates the substantial equivalence of the new device to one previously sold in the United States (a “predicate” device).

³ The PIN Study protocol limited the investigators to a combination of only one line of cemented and one line of cementless implants (“for example: only S-ROM and Luster implants, not S-ROM, Luster, and Endurance”) (Deposition Exhibit Forster-02). The investigator at site two violated this requirement by implanting two types of cementless stems.