Plaintiffs in this case seek damages to cover the cost of surgery, medical expenses, and the pain and suffering associated with the complications (tissue damage, bone damage, metal ions in the blood, pain) caused by the metal-on-metal ASR hip system and the associated swelling, pain, and difficulty walking. In some cases, patients require revision surgery, which is a second surgery to remove and replace the drugs-medical-devices/depuy-hip-recall-lawsuits/">defective DePuy hip implant.
Plaintiffs claim that DePuy’s ASR hip system was defectively manufactured and that DePuy Orthopaedics knew the ASR hip system suffered from problems including higher than average numbers of revision surgeries needed and failed to warn patients and surgeons of these risks.
In August 2009, the FDA sent DePuy a letter asking for additional information and notifying the company that the FDA would not be approving DePuy’s premarket approval application for a companion or sister version of the hip replacement system used in traditional hip replacementsthat was voluntarily recalled in August 2010. The letter also noted that some patients had a high concentration of metal ions in their blood that was “concerning.” This companion system was also a metal-on-metal system, but it was meant for hip resurfacing. DePuy had been selling this companion version of the hip implant system overseas since 2003.
Following the FDA’s letter, in August 2009, a Johnson & Johnson executive and vice president of DePuy Orthopaedics, Pamela Plouhar, sent an internal company email to three other executives including DePuy’s then president, David Floyd. Her email reported that the FDA had refused to approve the companion version of the hip implant system. She went on to explain further that providing the FDA with the information it requested might take years for new studies and still might not change the FDA’s position. Ms. Plouhar reported that the FDA turned down the hip implant device because it required revision surgeries in a significant number of cases. Despite continuing to assert that the device was safe, the company decided to sell its remaining inventory and phase out the device in September 2009.
The FDA, in 2005, did approve DePuy’s other hip implant device used in traditional hip replacement surgeries, the same device that the company voluntarily recalled in August 2010. The FDA did not require this hip system to undergo clinical trials due to regulatory pathways. DePuy Orthopaedics first started marketing its ASR hip system in the United States in 2005. The existing hip implants were used in patients until DePuy’s voluntary recall in August 2010.
The fact that the FDA had reached out to DePuy years before the voluntary recall regarding the safety of a sister device is one factor that the courts will look at in determining if DePuy did in fact know that the ASR hip system suffered from problems and failed to warn both patients and doctors.
A case management order following a July 25, 2012 status conference established that counsel for Plaintiffs and Defendants were to select cases as bellwether trial candidates for trial by the MDL judge, Judge Katz. A bellwether trial is an indicator of future trends and act to determine what will happen for the other plaintiffs’ trials, which can aid in settlement. The first bellwether trial is set to start on May 6, 2013 with a backup case to start on July 8, 2013. These will be the first federal cases going to trial.
For the state cases, a Nevada state case that had been set to go to trial in December 2012, Rundle, et al. v. Precision Orthopedics, settled in August 2012 for a reported $200,000 for each of the three plaintiffs in the case. A Maryland case with three plaintiffs, Jackson, et al. v. Chesapeake Orthopaedics, Inc. and DePuy Orthopaedics, Inc., is set to go to trial in January 2013.
Overall, DePuy faces about 8,000 lawsuits over its recalled ASR hip implant system. The future of the DePuy recall cases will largely depend on the federal bellwether cases, which will either strengthen or weaken Plaintiffs’ position for settlement and additional trials