Recent research has found that younger artificial hip or knee patients may be at greater risk for revision surgery to remedy implant failure. Research recently published in The Lancet medical journal embodied a study which identified 63,158 patients who had undergone total artificial hip replacement (arthroplasty) and 54,276 who had knee replacement surgery, between January 1, 1991 and August 10, 2011, and followed up with these patients for a maximum of 20 years. Researchers found that the lifetime risk of requiring revision surgery in patients more than 70 years old was about 5 percent with no difference between male and female patients. Artificial hip or knee recipients younger than 70 years old, had an increased risk up to 35 percent for men in their early 50s with large variances between men and women. Women in the same age group had a 15 percent lower risk than men.
This research reflects the increased concern about the long term safety of newer joint replacement systems that have been marketed for use by younger patients, which have already been recalled leading to thousands of product liability lawsuits throughout the United States.
As covered in our December 22, 2016 blog post, one of the most recent recalls was the Stryker LFit V40 femoral head in August 2016. The recall involved femoral heads manufactured before 2011 experiencing higher than expected taper lock failure in their artificial hip systems. The femoral heads, made of cobalt and chromium, as are other components of the hip system, fret and corrode and the metal materials rub against one another as patients move. The rubbing can ultimately lead to a weakening of the metal, which can cause the femoral head to disconnect and break off of the femoral stem, causing the hip joint to dislocate or disassociate. This failure often leads to pain, loss of mobility, heavy metal poisoning, adverse local tissue reactions, and the need for revision surgery, as well as other complications.
Recently, the United States Judicial Panel on Multidistrict Litigation (JPML) announced it would hear oral arguments on March 30th to consider consolidating present and future lawsuits against Stryker arising from the LFit V40 femoral head defect into a multidistrict litigation (MDL) to consolidate lawsuits from federal district courts around the country into in the United States District Court for the District of Massachusetts to streamline discovery and pre-trial proceedings (MDL No. 2768 – IN RE: STRYKER ORTHOPAEDICS LFIT V40 FEMORAL HEAD PRODUCTS LIABILITY LITIGATION).
In product liability cases, many patients nationwide often suffer similar damages from the same drug or medical device. Consolidated plaintiffs have the benefit of group negotiating power during the important pre-trial phase of a lawsuit. The JPML, which is comprised of seven federal district court judges, decides whether to consolidate certain lawsuits with other similar lawsuits. The JPML also decides to which court and judge to transfer the cases.
In response to Styker’s motion to oppose the proposed MDL, plaintiffs filed an oral argument request stating:
“Uniformly, patients in whom these products were implanted suffered from excessive metal wear debris, adverse tissue reaction, loss of mobility, inflammatory response and the need for premature removal of the offending device. …Far more troubling however, is the undue emphasis Stryker places on the LFIT V40 recall by suggesting its metal head failure problem is related to the recalled devices. Nothing could be farther from the truth. In fact, patients are experiencing metal wear disease failures across Stryker’s LFIT V40 metal head line.”
The Stryker LFIT LFIT V40 femoral heads are used with a number of hip implant femoral stems, including the Accolade TMZF, Accolade 2, the Meridian, and the Citation. Lawsuits continue to mount against Stryker alleging damages from the LFIT V40 femoral head caused by negligence, defective design, manufacturing defects, and failure to warn.
Stryker is one of several major global hip implant manufacturers facing recalls and MDLs, including Zimmer Biomet, Johnson & Johnson, and Smith & Nephew. Together, these companies maintained a 85.2% share of the global hip implant market in 2015. Global hip replacement implant methods are divided into the total hip replacement implant, hip resurfacing implant, partial hip replacement implant, and revision hip replacement implant. The total hip replacement implant can be fixed bearing or mobile bearing. North America has been leading the global hip implant market and recent research suggests that the North America hip replacement implant market is expected to acquire a share of 52.7% in the overall market by 2024.