By Deena Beasley
LOS ANGELES, Feb 1 (Reuters) - Toxicity caused by debris
from a metal-on-metal hip implant meant that the device had to
be removed from a 66-year-old man who is suing manufacturer
Johnson & Johnson, according to expert testimony heard at the
trial on Friday.
"I concluded that his hip failed because of the toxic
exposure," said Robert Harrison, an occupational medicine
specialist at the University of California, San Francisco, who
was not involved in treating plaintiff Loren Kransky but did
review the medical records.
The testimony was heard in Los Angeles Superior Court in the
first lawsuit to go to trial involving all-metal hips made by
J&J's DePuy unit. More than 10,000 U.S. lawsuits have been filed
since the hips were recalled from the market in 2010.
As many as 500,000 Americans are estimated to have received
metal-on-metal hip replacements.
Lawyers for Kransky argue that J&J was aware of the defects
in the ASR hip implants, including the risk of poisoning from
cobalt and chromium metal debris, even before it started selling
the devices in 2004.
Kransky's blood tests showed that his levels of cobalt and
chromium reached as much as seven times normal after he received
the ASR hip.
The Food and Drug Administration last month proposed that
companies making all-metal hip replacements provide additional
information proving they are safe and effective before being
allowed to continue selling them.
The agency said it was not recommending a specific level of
metals in the blood as a trigger for revision surgery because
there was not enough evidence to demonstrate a correlation
between those levels and patient outcomes.
J&J attorney Alex Calfo said the amount of cobalt measured
in Kransky was not enough to cause any adverse systemic health
effects.
Trial testimony earlier in the week included DePuy
executives explaining that the ASR hip was tested in the
laboratory at a single angle of implantation. Plaintiffs'
lawyers contend that they should have tested it using multiple
angles.
All-metal hip implants were developed to be more durable
than traditional implants with ceramic or plastic components,
but have been shown to fail at a higher rate than traditional
implants.
A J&J study presented at the trial showed that the company
had estimated that 37 percent of the devices would fail within
about five years of implant surgery.
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