http://www.hiprecalllaw.com Legislators from leading US Democrats aim to prevent approval of unsafe medical products, through a landmark legislation, says Bloomberg They talked about untoward results brought about by medical products of Johnson & Johnson. Due to the increasing negative feedbacks against the DePuy hip system, the British Hip Society has called for an informal metal-on-metal hip replacement ban.
2. Legislators from leading US Democrats aim to prevent approval of unsafe
medical products, through a landmark legislation, says Bloomberg They
talked about untoward results brought about by medical products of
Johnson & Johnson. Due to the increasing negative feedbacks against the
DePuy hip system, the British Hip Society has called for an informal metal-
on-metal hip replacement ban.
There are around 93,000 recipients of the ASR XL Acetabular System and the
ASR Hip Resurfacing System worldwide. After the release of data presenting
defectiveness in one out of eight patients to whom they were implanted, the
two devices were pulled back.
3. Problems with the design of metal-on-metal hip devices,
specifically DePuy’s, may lead to the rubbing of metal
components against each other and casting microscopic metal
bits into the body. The amount of certain metals in the blood, like
chromium and cobalt, may be augmented by the metal bits
transported from the implant device. Furthermore, tumors and
cancer may also arise because of cobalt and chromium in the
patient’s blood.
“A bill introduced this week before the lower house of Congress
would close a loophole that allowed devices to win approval even
when these are similar to a product already pulled out from the
market,” as stated by Representative Edward Markey of
Massachusetts in a statement released to the media.
“If an automobile is recalled for a major safety problem, we
wouldn’t allow future models to repeat this same flaw, and the
same should be true for the medical devices used in our bodies,”
Markey said in the statement.
4. From 2008 until the recall of the products, the Food and Drug
Administartion (FDA) have compiled approximately 400 damning
reports against the devices from patients who needed to undergo
another hip replacement surgery. Presently, numerous clients have
pursued legal complaints against DePuy Orthopaedics Inc. and its
mother company, Johnson & Johnson.These lawsuits claim that the
company was deferring the implementation of DePuy hip recall
although it is aware of the problems of the devices. To facilitate
medical attention for men and women who had bought the devices
from it, DePuy should provide wide-ranging information
dissemination on the flawed hip replacement symptoms.
5. Additionally, on December 14, 2011, the New York Times
published an article saying that three U.S. senators proposed
a bill reinforcing medical device regulations. The three
senators were Charles E. Grassley (R-IA), Richard Blumenthal
(D-CT) and Herb Kohl (D-WI).
According to Senator Blumenthal, “there is clearly a need for
scrutiny once products are implanted or used on patients.”
The Times further noted that “these lawmakers have
proposed a wave of medical device industry-friendly bills that
would further streamline FDA regulations, allowing more
product clearances.”
6. This effort from a group of lawmakers demonstrates that policymakers are
listening to patients, companies, and consumers about their concerns for
potential negative consequences from a stricter medical device regulatory
regime, legal observers say. Additionally, legal observers say that thiseffort
exhibits the concern of the lawmakers to the citizen’s need for better health
and medical care. Aside from DePuy, there are several other manufacturers
who will be affected by these impending bill.