New documents unveiled during trial proceedings don’t bode well for Johnson & Johnson (NYSE:JNJ) subsidiary DePuy Orthopaedics.
Emails and internal memos suggest that the metal-on-metal hip maker for years hid concerns about the failure rates of its ASR implants, which are now the subject of a high-profile recall and thousands of patient injury lawsuits.
Evidence provided during the trial further suggest that the DePuy knew as far back as 2007 that the ASR designs failed faster than other hip implants and the company began looking at a possible redesign, but a recall wasn’t initiated until 2010.
DePuy’s attorney’s maintained during opening arguments that the ASR implants had performed well in patients in the years and that "DePuy acted as an extremely responsible manufacturer," the New York Times reported.
The medical device maker has said in the past that when it began phasing out the ASR devices in 2009 it did so because interest in the product was waning, not due to warnings from physicians.
Read more of MassDevice.com’s coverage of metal-on-metal hip implants.
Newly unveiled documents suggest, however, that DePuy consultants began raising red flags as far back as 2005. One doctor wrote the company that she was "quite concerned" about the failure rate of the hip implants after receiving reports from the Middle East and Spain, according to a June 2005 email unveiled during the trial.
A DePuy engineering test conducted in 2007 found that the ASR implants weren’t as durable as another metal-on-metal hip implant. Other internal reports and emails show that the company began looking at a possible product redesign but abandoned that initiative in 2008 when "the business case for the project could no longer be justified."
DePuy voluntarily recalled the ASR in August 2010 "due to the number of patients who required a second hip replacement procedure, called a revision surgery," according to a company report. A report passed around internally in 2011, in the midst of the high-profile recall, concluded that 37% of DePuy’s ASR hip implants would require revision or replacement in less than 4.6 years.
The lawsuit, filed by patient Loren Kransky who claims his ASR hip failed less than 5 years after he received it, is the 1st to go to trail against J&J. The healthcare giant in August 2012 paid as much as $600,000 to 3 patients in the 1st settled lawsuits against the company’s metal hip implants.
