April 18, 2011
Last week, Kershaw, Cutter & Ratinoff client, Katie
Korgaokor appeared before the Senate Committee on Aging to provide testimony
concerning her experience with the recalled Depuy ASR hip replacement
system. The purpose of the hearing was
to explore whether changes to the FDA’s "fast track” approval process are
necessary in light of several recent high profile recalls involving medical
devices approved through this process.
year, thousands of people are injured or die as a result of defective medical
devices being released to the public. Recent
studies have shown that most of these devices were approved through the FDA’s
fast track process where little or no testing is required.
At the hearing, Katie, who was implanted with a DePuy ASR and later had
to undergo a revision surgery, provided the committee with the perspective of a
patient who has been affected by a defective medical device approved through
KCR partner, Stuart Talley, who appeared with
Katie at the hearing, explained the importance of her testimony: "When people hear about a medical device
being recalled in the news they rarely see the consequences of what occurs when
this happens. Katie’s testimony put a
face on the statistics. Her story
is incredibly powerful.”
After the hearing, Talley also commented on the need for
changes to the FDA approval process: "Contrary to what device manufacturers have
been arguing, most of these fast tracked devices are not revolutionary life
saving inventions. Rather they are
usually slight modifications to existing devices that have been on the market
for years. However, sometimes these
slight modifications can have disastrous consequences.”
For more information on the dangers of the DePuy ASR and other metal-on-metal hip devices, visit a new website we designed specifically to inform our clients and the public about this under-researched topic, at www.cobalt-chromium-toxicity.com.
If you have been implanted with a DePuy ASR hip replacement system, or DePuy Pinnacle metal hip device, you may be entitled to compensation for current and potential future health problems. Fill out the contact form found on this page or call 888-285-3333 for a free and confidential case evaluation.