DePuy ASR Hip Replacement Lawsuits

Both the FDA and DePuy voluntarily recalled more than 93,000 ASR hip replacement systems in 2010 after receiving information from the National Joint Registry of England and Wales, the British Orthopaedic Association, and the British Hip Society, which reported higher-than-average failure rates, metal ions being released, and potential risk of the condition metallosis. Metallosis can lead to neurological, cardiovascular, renal, and thyroid problems, as well as destroying soft tissue, muscle and bone. Studies have reported that almost 30 percent of patients reported some implant dysfunction. Within four years, 21 percent of patients would require revision surgery, and within six years, that figure rose to 49 percent. Artificial hips are supposed to last 15 years.

The lawsuits claimed that DePuy was aware of the faulty design but continued to keep it on the market, even against surgeons’ advice to withdraw it. It is also alleged that DePuy has aggressively tried to settle with patients who do not have a full understanding of their legal rights or the extent of future medical costs.

The rise in lawsuits led to multidistrict litigation (MDL) in 2010. MDL involves consolidating cases with similar legal issues to one court, where a judge familiar with the technical details of the case can rule on the them. By 2012, 3,000 lawsuits had been filed and Johnson and Johnson budgeted a total of $3 billion to settle.

According to Reuters, this is one of the most expensive medical device failures in US history with over 10,000 lawsuits were filed against the ASR. Approximately 9,000 lawsuits have been settled in the value of $4.4 billion between 2013 and 2015.

DePuy’s Pinnacle Revision Acetabular Cup System, was designed as a successor to the ASR hip replacement system. This system was approved by the FDA in 2000 on the basis that it was a very similar product to DePuy’s Ultima Metal-on-Metal Acetabular Cup. This Pinnacle had a number of surfaces available, including metal-on-metal, and were chosen based on the needs of individual patients. This system was implanted in more than one million patients and is also subject to litigation because the design was also found to be faulty, resulting in similar complaints as the ASR: pain, swelling, limited mobility, dislocation and also releasing metal ions which could lead to metallosis. The Pinnacle device wasn’t recalled, rather all of its metal-on-metal devices were discontinued, in 2013.

The New York Times reported that in November 2016, six New York patients won a $247 million trial verdict for serious harms caused by the Pinnacle hip replacements and for failing to warn doctors and patients about its dangers.

In total, DePuy has been subject to verdicts and settlements relating to both of these hip replacement systems totalling $6.2 billion.

The litigation is not limited to the US, with the BBC reporting that 56,000 UK patients have been implanted with metal-on-metal hip replacements. 312 patients implanted with Ultima are suing DePuy in the High Court, claiming they had to have remedial surgery after it failed prematurely and that they were affected by the release of metal ions. According to the BBC, this hearing is thought to be the largest product liability group actions ever heard in the UK.

The lawsuits are filed against DePuy Synthes (Johnson & Johnson).

DePuy Synthes, a subsidiary of Johnson & Johnson, is the world’s largest medical device manufacturer. Even though DePuy have a history of safe and effective orthopedic products, since 2010 the company has been subject to legal controversy over its metal-on-metal hip replacements. More than 10,000 patients who received DePuy’s ASR™ (Articular Surface Replacement) XL Acetabular Hip System, have filed lawsuits against DePuy for the devices’ early failure, malfunction, and potentially dangerous complications. Patients have alleged that DePuy knowingly sold defective and dangerous products. While initially DePuy cited surgeon error for the malfunctions, the company later settled, or a jury awarded, thousands of lawsuits worth several billion dollars.

The ASR device has been recalled and discontinued.

Patients have filed lawsuits against DePuy and its ASR device, alleging that ASR failed early, caused severe complications and/or dislocation, and required revision surgery to replace it. The plaintiffs are suing for damages, including lost earnings, medical expenses, pain and suffering, punitive damages, and loss of consortium.