Photo: Flickr James Martin
Most companies do everything they can to keep their executives away from court. A case in California helps to demonstrate why.Johnson & Johnson faces more than 10,000 lawsuits over artificial hips it produced that allegedly shed metal debris inside patients.
The case is the first to go to trial and provides gripping television, available on the Courtroom View Network. Lawyers are assailing company employees with accusations (“You knew that cobalt chromium is cyto-toxic to human cells, right?” was a typical question.) J&J is less enthralled.
The company’s subsidiary, DePuy, launched the ASR hips (pictured above) in America in 2005 and recalled them five years later. At that time there were more than 93,000 hips on the market, with 37,000 in the United States. DePuy now faces questions about what it knew about the hips’ problems and whether it hid that information from consumers.
The plaintiff’s lawyer, Michael Kelly, has argued that DePuy should have conducted further studies before putting the product on the market. Internal e-mails show that the company was receiving complaints about ASRs in 2005 and 2006.
A study in 2007 by Chris Hunt, an engineer, explained how the ASR’s exaggerated angle could cause excessive wear. The study was not made public. Mr Kelly questioned Graham Isaac, a DePuy engineer, about those findings on February 4th.
“You need to tell the surgeon everything you know about the safety ramifications of the device, correct?” the lawyer asked Mr Isaac.
“Well, everything we think is relevant,” Mr Isaac responded.
“Well doctor, it’s not up to you to choose what’s relevant, is it?”
“I think it is to a certain extent it is, yes.”
In April 2008 Mr Isaac wrote to his colleagues at DePuy, including Andrew Ekdahl, who is now the firm’s president. He had new data comparing the release of metal ions from the ASR with that of a competitor’s product, the BHR.
The data found that “under certain conditions ASR is susceptible to extreme metal ion levels, whereas in the hands of the same surgeon BHR does not have the same problems…I believe that this data will appear in the journals…and has the potential to seriously affect our business. We need to discuss this at the earliest possible opportunity as I believe it means that we need to start any ASR upgrade sooner than our previous plans had suggested.”
Asked about this in court, Mr Isaac insisted that, “We were making an improvement not correcting a defect”. Rather than alert consumers to the problems, another DePuy employee wrote, in May 2008, that “We will ultimately need a cup redesign but the short term action is manage perceptions.” The redesign never happened. DePuy decided to phase out sales in November 2009. The recall came later, in August 2010. Mr Ekdahl’s video testimony was shown to jurors on January 31st. He did not admit the product was unsafe.
More than 7,000 consolidated cases are due to go to trial in May in a federal court in Ohio. The case in California continues.
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