In addition to ongoing care for people who have contracted metallosis because of allegedly faulty hip implants, we need more study now to determine the long-term toxic and corrosive effects metal shavings may have on patients’ muscle and bone.
Teaneck, N.J. (PRWEB) March 14, 2013
New Jersey defective medical products attorney Samuel L. Davis voiced support today for a recent U.S. Food and Drug Administration (FDA) proposal that would require manufacturers to submit premarket approval applications before their metal-on-metal hip replacement systems are allowed on the U.S. market.
However, he added, his firm’s concern lies with those who may have been harmed by allegedly faulty hip implants already allowed on the market.
Davis, a partner with the New Jersey personal injury firm of Davis, Saperstein & Salomon, P.C., has litigated knee- and hip-replacement cases since 1998. He also is the founder and chair of the American Association for Justice’s Orthopedic Implant Litigation Group.
“We support the FDA’s proposal, of course, but it won’t provide relief for the thousands of people across the country who are currently facing serious health issues that may be directly linked to metal-on-metal hip implants that were allowed onto the market,” he said.
The FDA describes metal-on-metal hip implant systems as consisting of a ball, stem and shell made from cobalt-chromium-molybdenum alloys. As portions of the implanted joint rub against one another, they can shed metal fibers, the FDA says.
A case report published in the medical journal Acta Bio Medica linked metal-on-metal hip implants to metallosis, or the “loosening of a device secondary to metallic corrosion and release of wear debris.”
Additionally, an investigative report published in BMJ, formerly known as British Medical Journal, connected the all-metal hip implants such as the recalled DePuy ASR XL Acetabular System to the leaking of high levels of toxic cobalt and chromium ions.
“In addition to ongoing care for people who have contracted metallosis because of allegedly faulty hip implants, we need more study now to determine the long-term toxic and corrosive effects metal shavings may have on patients’ muscle and bone,” Davis said.
If the FDA’s proposed rule is finalized, it would change the way metal-on-metal hip systems are currently approved for the U.S. market through the 510(k) premarket submission program.
The 510(k) program, in contrast to the more stringent premarket approval process, allows manufacturers to get their products to the U.S. market by stating that new medical devices are “substantially equivalent” to previously approved medical products.
A recent New York Times report said that about 50,000 hip-implant patients in the U.S. have suffered pain and additional corrective surgery because their metal-on-metal hip implants failed prematurely. The report says problems with metal-on-metal hip implants systems represent “one of the biggest [medical] device-related failures in decades.”
The Times report says industry lobbyists may oppose adoption of the FDA’s proposal to tighten scrutiny of metal-on-metal hip implants or work to modify it, and it will probably be a year before the rules are finalized. Then, manufacturers will have 90 days to submit clinical data to support a device’s safety and effectiveness.
About Davis, Saperstein & Salomon, P.C.
The New Jersey personal injury attorneys and dedicated staff of Davis, Saperstein & Salomon, P.C., provide compassionate and skilled legal help to those injured by harmful medications and medical devices. The firm represents people across the United States who have been harmed or placed at increased risk of harm by dangerous medical products such as allegedly defective hip and joint implants.
For more information, one can download the free 30-page report called, “The Consumer's Guide to Artificial Hip and Joint Replacement Litigation,” available at MyMetalHip.com.
Since 1981, the firm has secured more than $350 million in verdicts and settlements for clients throughout North Jersey and New York, including the communities of Newark, Jersey City, Paterson, Elizabeth, Edison, Toms River, Trenton, Clifton, Camden, Brick Township, Woodbridge Township, Bergen Co., Middlesex Co., Somerset Co., Warren Co., Sussex Co., Monmouth Co., Mercer Co., Ocean Co., Hudson Co., Passaic Co., Essex Co., Union Co., Morris Co., Teaneck, Fort Lee, Paramus, Hackensack, Hoboken, Secaucus, Englewood, Mahwah, Bergenfield, Union City, North Bergen, Ridgewood, Bayonne, Ridgefield, Belleville, Alpine, New Milford, Atlantic City, Princeton, Iselin, Woodcliff Lake, East Rutherford and Freehold.
The firm’s practice areas include personal injury, mass tort, defective medical devices, auto accidents, drunk driving accidents, motor vehicle accidents, medical malpractice, premises liability, product liability, slip and fall, truck accidents and workers’ compensation.
The firm’s Teaneck office is located at 375 Cedar Lane, Teaneck, NJ 07666 (local phone (201) 907-5000). For more information about Davis, Saperstein & Salomon, P.C., call (800) LAW-2000 or use the firm’s online contact form.