Tag: Johnson & Johnson

OM in the News: J&J’s Hip Implants Run 40% Defective

hip implantFor 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?

OM in the News: Tylenol, J&J, and a Quality Disaster

A timely topic to bring to your students when discussing quality (Ch.6) is an embarrassing and expensive problem currently facing Johnson & Johnson. It’s a tale that has been making news for months now,  but just ended with the US government taking over 3 Tylenol plants a few days ago (New York Times,March 10,2011). This follows a blizzard of drug recalls and an FDA criminal investigation into safety issues at the factories. The government also indicted two execs, the VP-Quality and the VP-Operations, for failing to comply with manufacturing standards.

The scathing report on 20 manufacturing violations and criminal investigation follows eight recalls of Tylenol, Benadryl, and Motrin that have been ongoing since  2009. J & J was warned over a year ago about the unsanitary and unsafe practices in the plants (one in Puerto Rico and two in Penn.), but the company was slow to fix them. Now, all drugs recalled must be destroyed, a “consent decree” allows independent experts to control the plants until safer manufacturing processes are in place, and one of the Penn. plants will remain closed until the FDA stamps its approval. Fines will also be levied at $15,000 per day up to $10 million annually until the FDA clears the company.

Production is expected to be hurt while the corrective actions take place. But as Philip Crosby wrote in his 1979 classic, Quality is Free, “What costs money are all the actions that involve not doing it right the first time”.

Discussion questions:

1. What happened in Tylenol’s 1982  famous recall?

2. What did Crosby mean when he wrote “quality is free”?

3. What is the role of OM in this dilemma?