The Pinnacle Litigation Documents collection is comprised of documents produced during the MDL lawsuit DePuy Orthopaedics Inc. Pinnacle Hip Implant Products Liability Litigation, MDL 3:11-MD-2244-K; Herlihy-Paoli v DePuy Orthopaedics, Inc et al (2014).
From 2002 to 2012, DePuy Orthopaedics, a subsidiary of Johnson & Johnson (J&J), manufactured metal-on-metal (MoM) hip implants sold under the brand name Pinnacle. The lawsuit charged the hip implant was defectively designed and fraudulently marketed and that DePuy failed to warn patients and doctors about the risks of the devices. Prosecutors claimed that DePuy, in an effort to gain and keep a large share of the hip replacement market, rushed the Pinnacle metal-on-metal hip implant to market without ever testing it in humans. Instead, the company used a loophole known as the FDA's 510(k) regulatory pathway. The 510(k) allowed manufacturers to skip clinical trials and test the implants only on mechanical simulators if they could show the implants were 'substantially equivalent' to other devices already in use.
The plaintiffs in the Pinnacle lawsuits experienced high levels of cobalt and metal ion in their systems, a condition called metallosis, due to the wear from the surface of the implant’s femoral head. Ultimately, many of these hip implants failed and had to be replaced. In addition to defective design and health risks, the suit charged DePuy fraudulently marketed the Pinnacle hip replacement system by using a team of 'design surgeons' as a sales force. Called KOLs (key opinion leaders), these surgeons signed off on ghostwritten articles, hosted speaking engagements and large regional sales meetings, and taught other surgeons how to use the Pinnacle system. In return, documents show these design surgeons received millions of dollars in royalties from the sales of the Pinnacle hip replacement system.See the Opening Statements in Volume 2 of the case for context and specific complaints.