The outcome of this intense and lengthy litigation made headlines this week after 37 days of testimony from both parties as well as multiple expert witnesses. The jury in this bellwether trial – which involved 5 plaintiffs who had received the company’s allegedly defective DePuy Pinnacle hip implant device – returned a verdict for $142 million in compensatory damages and another $360 million in punitive damages. The award will likely impact other pending lawsuits for some 7,000 patients across the country.
Opening arguments for the 10-week trial started January 11th in U.S. District Court in the Northern District of Texas with federal Judge Ed Kinkeade presiding. This bellwether trial focused on 5 plaintiffs. Their cases best represented “common issues of law and fact” shared with other plaintiffs in the MDL. Consolidating a large action with multiple plaintiffs in this way allows the court to adjudicate on the merits. It also informs the interested parties about the likely outcome in the remaining cases and the likelihood of settlement agreements.
The issue at the heart of this high-stakes litigation were the injuries suffered by patients who received Johnson & Johnson’s DePuy Pinnacle metal-on-metal hip replacement devices. These implants, designed for patients who require total hip replacements, replace both the hip socket and the top of the thighbone. In devices like the Pinnacle system, these components are both made of metal. According to allegations made by the plaintiffs, these components can rub against each other and release metal debris inside the body. Thereby producing elevated levels of cobalt and chromium ions in the blood. In addition, the implants have also been linked to mechanical failures that compromise the structural integrity of the device. Numerous patients who have received Pinnacle’s devices have had to undergo revision surgery to remove the implant because of these complications.
Due to its allegedly high failure rate, plaintiffs have claimed to experience injuries such as implant loosening, extreme pain that sometimes spreads to the groin and back, difficulty standing or walking, metal poisoning of the blood, shedding of metallic debris inside the body, and intense soft tissue damage. Though Johnson & Johnson has not issued a recall for the DePuy Pinnacle hip implant, they did issue a global recall of a similar device in 2010 because of higher than expected failure rates. This device – the ASR hip implant – was also a metal-on-metal hip replacement device. In 2013, DePuy established a settlement program to resolve issues involving the ASR hip implants. Metal devices were originally designed to address the failures of older hip implant designs. Metal-on-metal devices were believed to be more durable than their predecessors.
During the trial, both sides called a number of expert witnesses to testify. Plaintiff counsel called orthopedic histopathologist Dr. Nicholous Athanasou, who is also a professor of musculoskeletal pathology at Oxford University. Dr. Athanasou’s testimony was related to his studies on cellular mechanisms of bone resorption. He was permitted to use a microscope in the courtroom over defendant’s objection.
Plaintiffs also called Dr. Bernard Morrey and Dr. Matt Morrey, a father-and-son pair of orthopedic surgeons. Dr. Bernard Morrey has served as a professor at the Mayo Clinic for over 30 years. He was called to testify on the nature of metal-on-metal hip implants in a general capacity. On the stand, Dr. Morrey told the jury that he has never used metal-on-metal implants on his patients. The judge then asked his son, Dr. Matt Morrey to prepare a report for the court. Both of these doctors were designated as non-retained experts for plaintiffs.
Likewise, a number of experts with various specializations were called to testify for the defense. Defendants called Dr. Pat Campbell who specializes in implant retrieval analysis of joint arthroplasties with specific focus on biological factors that impact how these hip implant devices work inside the body. The defense also called Dr. Cato Laurencin to the stand, who was accepted as an expert in orthopedic surgery, implants, history, and evidence based medicine. Dr. Laurencin graduated from Harvard Medical School and has a degree in Biotechnology from MIT.
Another expert witness, Dr. Edward Boyer – an ER doctor and medical toxicologist – was called to testify on cancer-causing agents in the implants, as well as cobalt and chromium toxicity. Defendants also called an FDA regulatory expert to testify about the regulation of medical devices. Like DePuy’s ASR device, the Pinnacle hip replacement device bypassed the standard procedure for testing a new medical product before hitting the market by utilizing the 510(k) process and obtaining doctor approval.
The outcome of this trial will likely influence the thousands of remaining cases with plaintiffs injured by Johnson & Johnson’s DePuy Pinnacle hip implant.