In it’s first use of power granted by Congress, the FDA (Food and
Drug Administration) is intending to close a loophole in the 1976 federal
law under which medical devices were first regulated. The FDA is proposing
that “makers of artificial hips with all-metal components would
have to prove the devices were safe and effective before they could continue
selling existing ones or obtain approval for new all-metal designs.”
An estimated 500,000 patients in the United States alone have received
a type of artificial hip that failed early. Making the FDA’s proposal
a forefront of discussion. Currently, companies have to show that their
devices resemble ones already on the market, they are not required to
conduct clinical studies before selling them. The FDA’s proposal
would require makers of all metal hips to produce clinical data to justify
their use because of the “large number of patients who received
these products and the number of adverse events associated with them.”
said, Dr. William H. Maisel, deputy director for science at the FDA.
Metal hip implants in which the ball and cup component are made from metallic
alloy, were used in one of every three joint replacement procedures preformed
in the U.S. annually. These all metal hips are not only failing at a high
rate not long after implantation, but they are causing severe tissue and
bone damage in hundreds of patients due to tiny particles of metallic
debris released as the artificial joint moves. As a result, thousands
of patients have been forced to undergo painful and costly operations
to replace the all metal implants. Incidentally, hip implants made of
materials like plastic and metal, typically last 15 years before wearing out.
When medical devices were first regulated in 1976, it caused all metal
hips to fall into a sort of regulatory limbo. High risk devices underwent
clinical trials to obtain FDA approval, where devices considered less
risky had only to show that a new product resembled one already on the
market. All metal hips were lobbied as moderate risk products by implant
companies. Resulting in the sale of a new generation of all metal hips
without running clinical tests.
Today, thousands of patient lawsuits involving all metal devices, sold
by the DePuy division of Johnson & Johnson, have started to come to
trial. It is estimated that Johnson & Johnson may have to spend billions
of dollars to resolve the litigation.
If you believe you or a loved one has suffered injury or death due to a
defective medical device, we invite you to
contact our trial tested lawyers today. The Maher Law Firm represents you and your loved ones, we do not represent
insurance companies or the manufacturers of medical devices.
We represent victims across the country, and are convenient to clients
in or near: Florida, Atlanta, Chicago, Alexandria VA, Arlington VA, Farifax
VA, Prince William VA, Loudoun VA, Northern Virginia, Washington DC, Philadelphia
PA, Scranton PA, Wilkes-Barre PA, New York, New Jersey, Los Angeles CA,
San Francisco CA, California, Arizona, Phoenix AZ, Tucson AZ.