While most of the media attention in recent months involving Johnson & Johnson’s hip replacement business has focused on lawsuits over the recalled DePuy ASR hip implant, recent court documents suggest that the company also faces more than 4,000 lawsuits over the DePuy Pinnacle hip, which features a similar metal-on-metal design that has also been linked to premature failure and problems caused by the release of metal debris as the components rub against each other.
In the federal court system, Johnson & Johnson’s DePuy Orthopaedics subsidiary faces two separate multidistrict litigations, known as MDLs, involving the hip replacement products. One is centralized in the U.S. District Court for the Northern District of Ohio involving all DePuy ASR hip lawsuits and the second is centralized in the U.S. District for the Northern District of Texas involving all DePuy Pinnacle hip lawsuits.
Following a series of DePuy ASR trials so far this year, substantial attention has been focused on the more than 7,000 lawsuits pending throughout the federal court system involving the ASR implant. However, according to a master case list (PDF) earlier this month, there are now 4,087 lawsuits consolidated in the federal DePuy Pinnacle MDL as well.
Problems with DePuy Pinnacle and ASR Hip Replacements
Both the DePuy Pinnacle and ASR hip replacements involved in the lawsuits feature similar designs. Known as metal-on-metal hip replacements, the systems involve a metal femoral component that rotates within a metal acetabular cup.
According to allegations raised in the hip replacement lawsuits, both implants release microscopic metal particles into the body, which could cause the components to loosen and ultimately fail, often resulting in the need for risky hip revision surgery within a few years of the device being implanted.
The DePuy Pinnacle hip system was introduced in 2001, with some variations containing a metal liner. The metal-on-metal configuration was used as the basis for the approval of the DePuy ASR hip implant in 2005, with Johnson & Johnson obtaining “fast track” 510k approval by maintaining that the DePuy ASR and DePuy Pinnacle metal-on-metal hips feature “substantially similar” designs. However, the DePuy Pinnacle was also approved under the FDA’s controversial 510k system as a substantial equivalent to older metal hips, which has allowed both designs to be implanted in thousands of people without federal regulators requiring stringent clinical trials to examine the safety of the design.
In August 2010, a DePuy ASR hip recall was issued after the manufacturer acknowledged that post-marketing data suggested that about 12-13% of the implants were failing within five years. However, many subsequent estimates have suggested that the DePuy ASR failure rate is really substantially higher.
Although a number of lawsuits allege that a DePuy Pinnacle hip recall should have also been issued, as it has also been associated with an alarming number of reported problems, Johnson & Johnson has kept the device on the market. However, most doctors have abandoned use of all metal-on-metal configurations due to concerns about the safety.
In January 2013, the FDA released new guidance for metal-on-metal hip replacements, indicating that doctors should only use the design if other artificial hip implants are not appropriate. The agency also determined that future metal-on-metal hip designs will be required to undergo extensive human clinical trials before they will be approved.
Metal-on-Metal Hip Litigation and Trials
In addition to lawsuits over the DePuy Pinnacle and DePuy ASR implants, a large number of complaints have been filed nationwide against manufacturers of other metal-on-metal hip systems. In the federal court system, at least two other multidistrict litigations (MDLs) have been established for all Biomet M2A Magnum hip lawsuits and Wright Medical Conserve Cup lawsuits.
So far this year, two DePuy ASR cases have reached a jury, with one case in California resulting in an $8.3 million damage award and a second case in Illinois state court resulting in a defense verdict. Additional trials involving the DePuy ASR MDL are scheduled to begin in the coming months in the federal court system.
In the DePuy Pinnacle MDL, a small group of cases are also being prepared for early trial dates. However, according to a case management order issued last year, the first DePuy Pinnacle trials in the MDL are not expected to begin until at least September 2014.
The outcomes of these early trial dates, known as “bellwether” cases, are designed to help the parties gauge how juries are likely to respond to evidence and testimony that will be presented throughout many of the cases. The outcomes may help facilitate eventual metal-on-metal hip settlement agreements or other resolutions for the litigation.