In a startling revelation about apparently caught both
prosecution and defense in confusion, a former Johnson & Johnson has
testified that the company failed in its own safety test in designing sn
all-metal hip implant, media reports say, quoting insights from legal observers
familiar with the manufacturing industry. George Samaras claimed that
artificial hip designers at DePuy Orthopaedics changed the protocol instead of
fixing the flaw. According to a New York Times editorial, Johnson & Johnson will have a lot of explaining to do with this latest disclosure.
Samaras testified for complainant Loren Kransky, who has
failed a lawsuit against Johnson & Johnson, claiming that the ASR XL hip
design implanted her was defective and the company failed to warn her against
the complications.
The company had voluntarily recalled its 93,000 ASR hips
Systems in 2010 after saying 12 percent failed within five years. It was
actually the National Joint Registry of Wales that has discovered the alarming
growth in number of defective implants and triggered the recall.
Samaras told jurors in the Los Angeles federal court that
DePuy failed the safety standard it set up for the ASR hip cup, in which a
metal ball atop the femur rotates. He cited an internal document showing the
ASR produced 16 times more chromium and cobalt debris in the body than another
DePuy product. While DePuy’s review standards said the ASR should have failed,
the company said it passed, Samaras said.
According to Samaras, a biomedical engineer who runs a
consulting firm near Pueblo, Colorado, that the practice was horrible and that
it was not the work of good engineers.
However, Johnson & Johnson denied Kransky’s claims,
including failure to warn against defective design and negligent recall. In his
opening statement, Alexander Calfo, a lawyer for Johnson & Johnson, said
the ASR was properly designed. He said claims by Kransky, 65, of elevated metal
levels in his body can be traced to his many other health problems, including
diabetes, coronary artery disease, high blood pressure, kidney disease, strokes
and cancer.
Samaras said DePuy’s original design criteria said the ASR
had to be at least as good as predecessor devices at the company. When that
failed, DePuy found other devices for comparisons that put the ASR in a more
favorable light, he said.
Samara also said that DePuy changed the test but did not consider certain modifications in
the design which has caused thousands of DePuy ASR hip problems.
URL REFERENCES:
bloomberg.com/news/2013-01-28/j-j-failed-its-own-safety-test-in-hip-design-witness-testifies.html
njrcentre.org.uk/njrcentre/default.aspx
