Although recalled globally in 2010, patients are still not always aware of the alleged dangers tied to the ASR metal-on-metal hip implant device marketed by DePuy Orthopaedics, a unit of global health care giant, Johnson & Johnson.
For example, less than 10 percent of some 4,500 patients in India have contacted Johnson & Johnson’s so-called “redressal” agency, according to The Times of India. In response, India’s Food and Drug Administration commissioner, Mahesh Zagade, suggests that non-governmental organizations (NGOs) start educating patients. “We also need specialized courts and compensation laws in the country to tackle these emerging issues better,” Zagade told The Times of India.
Physicians informed the 280 patients of the premature and unexpectedly high failure rates associated with the ASR, not the other way around, which was surprising given that researchers had been discussing the unusually elevated revision surgery rates tied to DePuy ASR devices before the recall, according to The Times of India. In fact, prior to the recall, some surgeons continued to implant patients with the ASRs. Now, experts are wondering if patients should be so trusting about the medical devices they receive.
In one case, a banker explained to The Times of India that his mother was implanted with the ASR; no options were given for other devices. “I was told this was the best implant in the market. I had known the surgeon for over five years, so I did not even consider taking a second opinion,” he said. He said he never considered conducting his own research on the ASR. A senior doctor from a Mumbai public hospitals told The Times of India, “It is ironical, but people do more research before buying a mobile phone or television set than for an implant that will remain inside them.”
The metal-on-metal hip devices have been the focus of increasing controversy over unusually high and premature failure rates, mounting litigation, and alleged adverse medical reactions such as increased blood metal levels. In addition to increased blood ion levels, injury reports also allege dislocations; pain; metallosis (metal poisoning); fracture; difficulty ambulating, rising, standing, and balancing; noise emanating from the joint; and pseudotumors, among others.
Patient allegations that metal debris shed from the chromium and cobalt hip device leads to tissue death and increased blood metal ion levels are of particular concern. Many believe that it is the devices’ metal components that are to blame and that the components rub against one another during normal, daily activities, such as walking. The movement releases tiny metal shards into patients’ blood streams and area tissue, which is believed to raise blood metal levels and cause metal toxicity.
When the August 2010 recall was implemented, 93,000 ASR hip implant devices were recalled internationally. The firm then reported that 12 percent of the devices failed within five years; internal Johnson & Johnson documents, however, indicated a 37 percent failure rate after just 4.6 years. The ASR received U.S. Food and Drug Administration (FDA) approval in 2005.
The DePuy ASR devices were marketed to last for at least two decades and were also marketed as providing increased range of motion over traditional hip devices, which are constructed with plastic or ceramic components.
Today, Johnson & Johnson faces some 12,000 lawsuits that were filed in federal and state courts in Ohio, California, and New Jersey, according to a recent Bloomberg.com report. The device maker recently reached a $2.47 billion settlement to resolve thousands of these lawsuits; the settlement amount could reach as high as $4 billion. U.S. District Judge David Katz, in Toledo, Ohio, is coordinating the federal litigation and the settlement requires Judge Katz’ approval. Prior to this accord, J&J lost one trial, won one trial, and scheduled seven additional trials over the ASRs, which were constructed in two similar models—the ASR XL Acetabular System and the ASR Hip Resurfacing System.