DePuy Orthopaedics recalled its ASR Hip Resurfacing System and ASR XL Acetabular System in 2010 after studies showed high failure rates in the hip implants. People who received the hips may have legal options.
DePuy Orthopaedics issued a recall for its ASR XL and hip resurfacing devices in August of 2010. The U.S. Food and Drug Administration actually issued a class 2 recall for the devices in July 2010. Numerous patients have since required a second hip replacement surgery to correct issues associated with the DePuy devices, and thousands of lawsuits have already been filed against the manufacturer — a subsidiary of Johnson & Johnson — following the onset of painful and debilitating side effects. In November 2013, J&J reportedly agreed to settle most of the ASR lawsuits for $4 billion. In March 2015, it agreed to a second round of settlements for $420 million.
The company initiated the recall after data from a study conducted by the National Joint Registry of England and Wales revealed that five years following the initial implantation surgery, 12 percent of patients who were implanted with the ASR resurfacing device and 13 percent of those who received the ASR total hip replacement required a second hip replacement surgery to correct problems associated with the devices.
Recipients of the DePuy ASR hip implant devices may be entitled to legal compensation for current and future health issues.
Complications and Possible Design Flaw
The DePuy ASR products have been implanted in more than 93,000 patients internationally.
Prior to the recall, studies and patient accounts noted various painful and sometimes permanent side effects associated with the DePuy ASR hip systems, including:
- Loose ASR cup
- Allergic reaction to metallic debris
- Pseudotumors (soft tissue mass that can form as a result of reactions to excess metallic debris)
- Cobalt or chromium poisoning
- Bone fracture around the implant
- Implant dislocation
- Pain in the hip or groin
- Inability to walk
Additionally, many doctors believe that the DePuy ASR hip cup component is too shallow, which prevents proper implantation and can lead to hip complications.
At the time of the recall, DePuy said it had made the decision because of the number of patients who required revision surgery to remove the devices after they had failed.
But DePuy maintains that the “ASR was tested for years before receiving regulatory clearance” and that “once on the market, we carefully considered all the data and investigated product complaints individually, while also looking for broader performance trends.”
Another DePuy hip implant, called the Pinnacle, exhibits metal-on-metal complications but has not been recalled. The metal liner of the Pinnacle was discontinued in mid-2013.
Events Leading Up to Recall
Some doctors argue that the ASR should have been recalled prior to 2010. More than two years before DePuy pulled the metal hip implants from the market, patients already complained of complications leading to surgery. Australian health officials pulled the ASR from the market in 2009 following data that showed the implant had an abnormally high failure rate. In March 2010, just months prior to the August 2010 recall, DePuy sent letter to doctors advising them of the Australian data showing the high failure rates. The company also informed them that women and people with weak bones were at the highest risk of implant failure.
According to documents that surfaced in lawsuits, DePuy knew about the problems with the device well before the recall. Failure rates in some of the company’s own studies were close to 40 percent, yet the company failed to act. This evidence surfaced at the first ASR trial in early 2013.
Criticism of DePuy’s Recall Process
According to Reuters, DePuy hired a third party company to handle recall claims. The company installed its own physicians to make decisions on whether or not the patient needed revision surgery. In effect, the company ignored the recommendations of the patient’s own doctors. DePuy denied patients who could not afford revision surgery the funds to get treatment, Reuters suggested.
“Doctors who are evaluating these cases are being paid indirectly by DePuy, and research suggests that even when we are very well-intentioned we can be influenced by conflicts of interest,” Kristin Smith-Crowe, who specializes in business ethics at the University of Utah, told Reuters. “This is a bit of a red flag in terms of the way this situation is set up.”
Hip Replacement Recall
If you received either the ASR Hip Resurfacing System or the DePuy ASR XL Acetabular System during a hip replacement surgery, you may have been contacted by DePuy Orthopaedics or Johnson & Johnson in recent months regarding the recall of these devices. It is important to seek the counsel of an experienced lawyer before seeing a doctor or signing any paperwork provided by the companies, as you may be signing a waiver that keeps you from receiving any compensation for future medical expenses that may arise.
Though the companies may offer compensation to you, the compensation may not cover some medical expenses, blood tests or diagnostic exams that may be recommended by a doctor to check for certain complications such as metallosis, or a serious allergic reaction to metal debris in the body. The compensation package also may not cover other expenses such as lost wages, loss of earning capacity or pain and suffering.
It is recommended that patients speak with an attorney about legal options prior to signing any documents provided by DePuy Orthopaedics or Johnson & Johnson.