For a great case study in OM ethics and quality, the New York Times (Jan. 26, 2013) reports that an internal analysis conducted by Johnson & Johnson not long after its 2010 recall of a troubled hip implant (called the A.S.R.) estimated that the all-metal device would fail within 5 years in nearly 40% of patients who received it. J&J never released those projections for the device. And at the same time that the medical products giant was performing that analysis, it was publicly playing down similar findings from a British implant registry about the device’s early failure rate.
The company’s analysis also suggests that the implant is likely to fail prematurely over the next few years in thousands more patients in addition to those who have already had painful and costly procedures to replace it. The J&J analysis is among hundreds of internal company documents expected to become public as the first of over 10,000 lawsuits by patients who got an implant goes to trial this month. The episode represents one of the biggest medical device failures in recent decades. Last year, the company took a $3 billion special charge related to medical/legal costs associated with the device.
The A.S.R. belongs to a once-popular class of hip implants in which a device’s cup and ball component were both made of metal. Surgeons have largely abandoned using such devices in standard hip replacement because their components can grind together, releasing metallic debris that damages a patient’s tissue and bone. Hip implants, which are generally made from metal and plastic, often last for 15 years before they wear out and need to be replaced. The early replacement rate is typically 1% after a year, or 5% at five years.
J&J decided in 2009 to sell off its A.S.R. inventories just weeks after the F.D.A. demanded safety data about the implant. But the F.D.A. said J&J could not dump the device in the U.S. because of concerns about “high concentration of metal ions” in the blood of patients who received it.
Discussion questions:
1. Ask students to follow and report on the current status of the lawsuit.
2. What are the ethical implications of J&J continuing to sell the implant after British and F.D.A. studies warned of its dangers?