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Joseph H. Saunders
Joseph H. Saunders
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ASR Lawsuit Trial Shows Executive Covered Up Danger

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When Andrew Ekdahl, a 20-year veteran at Johnson & Johnson’s DePuy Orthopedics, was named in 2011 to head the company, it was widely viewed as an attempt to help move past the troubling A.S.R. hip-joint recall.

But in testimony delivered in Los Angeles Superior Court this week it was revealed that Ekdahl, who had supervised the introduction of the A.S.R. into the U.S. market, had been told by a company consultant in 2008 that the device was faulty.

Just as perplexing, Ekdahl was a senior executive in charge of DePuy’s sales in Europe, Africa and the Middle East when U.S. regulators refused to allow the sale of the A.S.R. in this country. Johnson & Johnson elected not to tell any officials outside the U.S. – including in the regions Ekdahl oversaw – of the problem.

Worldwide, about 93,000 patients received an A.S.R., with roughly a third of those being in the United States. Almost from the beginning there were complaints from patients and doctors about the device. The joint was failing at an unacceptable rate and doctors began discovering tissue damage caused by metal debris from the implant. Common complaints from patients with an A.S.R included pain and joint dislocations, infections and bone fractures. In 2010 these problems led to the hip-implant being recalled in the United States, and since then over 10,000 lawsuits against Johnson & Johnson have been filed in this country regarding the product.

As the first of these lawsuits got underway in Los Angeles this week, previously unreleased documents from DePuy leave little doubt that the company long knew of the troubles with the A.S.R. Rather than disclose them, they chose in every instance to place profits above the welfare of their patients. The testimony of Ekdahl seems to reinforce that pattern and has revealed troubling new information.

In 2005, Ekdahl was tasked with introducing the standard version of the A.S.R. to the United States. Within three years, Ekdahl and other DePuy officials were receiving reports of higher-than-expected failure rates. Ekdahl knew of the high failures and had seen the internal documents indicating that flaws in the implants design were suspected as the cause. However, Ekdahl and other officials denied the design flaw as the cause of the failures and started blaming surgeons for poor implementation of the device.

Later, in 2009, when the F.D.A. asked DePuy for more safety data on the A.S.R., the company chose to phase out the hip-joint and hurriedly sold off existing stock. Ekdahl stated at the time that, “This was purely a business decision.” When questioned by the New York Times regarding concerns raised by the F.D.A., Ekdahl said that any reports of safety issues with the A.S.R. were, “simply untrue.”

When the A.S.R. was finally recalled in 2010 it became part of the biggest medical device failures in decades. Since then, the Smith & Nephew R3 and the Zimmer Durom Cup have also been recalled. The Stryker Rejuvenate was recalled in 2012 for metal contamination as well but in that case the metal was leaching from the modular neck joint. Metal-on-metal joints still on the market such as the Biomet Magnum, the Encore and the Wright Profemur Converse, Dynasty, and Lineage are also failing at unacceptably high rates.

As theses lawsuits begin against Johnson & Johnson, most bothersome is the pattern of misconduct exhibited by the company and its corporate officers. They long insisted that the A.S.R. was safe even after their own internal reports showed it wasn’t. Profits trumped safety concerns and limiting corporate liability became paramount to patient welfare.

The cruel irony is that Johnson & Johnson was once held up as the golden example of how corporations should behave ethically in a crisis. Its handling of the 1982 Tylenol recalls was used as a case model in business schools. The Washington Post said of the company then, "Johnson & Johnson has effectively demonstrated how a major business ought to handle a disaster."

Perhaps it would serve Andrew Ekdahl and other officials at DePuy well if they went back and studied the event and be reminded of a time when ethics mattered and profits were secondary to patients’ safety.

http://www.facebook.com/#!/pages/DePuy-ASR-Hip-Replacement-Survivors/147143978666032

http://www.youtube.com/watch?v=w8_Wg2eobrw