Call Us: 1.800.873.5297


FDA Proposes Order to Close So-Called “Loophole” for Approval of Metal-on-Metal Devices

As a result of the mounting evidence demonstrating early failure and severe injuries associated with metal-on-metal devices, the FDA has issued a proposed order that would now require metal-on-metal (MoM) hip implant manufacturers to submit premarket approval applications whereby the manufacturers must prove device safety and efficacy prior to the time the devices are placed on the market. This move was made by the FDA in order to close the “loophole” in the Medical Device Amendments of 1976, the federal law under which medical devices were first regulated, where metal-on-metal hip devices are approved under the FDA’s 510(k) approval process. Under the 510(k) process, hip implant manufacturers were able to bypass clinical testing if their device was found to be “substantially similar” to a device that was already approved by the FDA. Under the new guidelines issued by the FDA for the approval of metal-on-metal implants, any metal-on-metal implant must now undergo rigorous, comprehensive clinical testing prior to being introduced on the market.

Recently, the FDA has also decided to examine the potential link between corrosion and metal-on-metal hip implants. According to Health Point Capital, the FDA will embark on a new study to better understand the link between the devices’ wear and corrosion, as well as other potential links associated with clinical outcomes. The study will take approximately 2 years to complete and will examine approximately 250 metal-on-metal hip devices that have been explanted – or removed – from patients during revision surgery. The FDA will utilize the American Society for Testing and Materials (ASTM) protocol for corrosion testing in order to analyze the explanted devices. In deciding to embark on this new study, the FDA revealed a “renewed concern of wear and corrosion of conical head/stem taper junctions in modern modular total hip replacements.” The objective of the study will be to publish a peer-reviewed journal article to shed light on the ties between wear and corrosion and relevant factors to consider, such as the length of time the device was implanted, device head size, materials, modularity and lateral offset. This study will further help “develop test methodologies and special controls for preclinical studies of total hip implants.”

One metal-on-metal hip implant that has become the subject of litigation is the DePuy ASR™. Since the withdrawal of the DePuy ASR™ hip device from the market in August 2010, thousands of lawsuits have been filed against its manufacturers, including DePuy and Johnson & Johnson, alleging injuries to persons who had the defective device implanted. Plaintiffs continue to file lawsuits, with the majority of them currently pending in federal court as part of the Multidistrict Litigation In re:  DePuy Orthopaedics, Inc., ASR Hip Implant Products Liability Litigation (MDL 2197) before The Honorable Judge David A. Katz in the Northern District of Ohio. Judge Katz is currently managing nearly 8,000 DePuy ASR™ hip replacement lawsuits that were consolidated in 2010 and are currently pending in MDL 2197. The first bellwether trial in MDL 2197 is scheduled to begin in Toledo, Ohio on September 9, 2013. The Plaintiff in the first bellwether trial has recently designated 95 potential witnesses for the upcoming trial, including surgeons, company employees and product designers.

If you or a loved one has experienced complications with a DePuy ASR™ hip device, including additional surgeries to remove and/or replace the device, please contact the experienced attorneys at Schlichter, Bogard & Denton, LLP toll-free at 1-800-873-5297 for your confidential and free consultation.


Legal Disclaimer: The choice of a lawyer is an important decision and should not be based solely on advertisements.

000-017   000-080   000-089   000-104   000-105   000-106   070-461   100-101   100-105  , 100-105  , 101   101-400   102-400   1V0-601   1Y0-201   1Z0-051   1Z0-060   1Z0-061   1Z0-144   1z0-434   1Z0-803   1Z0-804   1z0-808   200-101   200-120   200-125  , 200-125  , 200-310   200-355   210-060   210-065   210-260   220-801   220-802   220-901   220-902   2V0-620   2V0-621   2V0-621D   300-070   300-075   300-101   300-115   300-135   3002   300-206   300-208   300-209   300-320   350-001   350-018   350-029   350-030   350-050   350-060   350-080   352-001   400-051   400-101   400-201   500-260   640-692   640-911   640-916   642-732   642-999   700-501   70-177   70-178   70-243   70-246   70-270   70-346   70-347   70-410   70-411   70-412   70-413   70-417   70-461   70-462   70-463   70-480   70-483   70-486   70-487   70-488   70-532   70-533   70-534   70-980   74-678   810-403   9A0-385   9L0-012   9L0-066   ADM-201   AWS-SYSOPS   C_TFIN52_66   c2010-652   c2010-657   CAP   CAS-002   CCA-500   CISM   CISSP   CRISC   EX200   EX300   HP0-S42   ICBB   ICGB   ITILFND   JK0-022   JN0-102   JN0-360   LX0-103   LX0-104   M70-101   MB2-704   MB2-707   MB5-705   MB6-703   N10-006   NS0-157   NSE4   OG0-091   OG0-093   PEGACPBA71V1   PMP   PR000041   SSCP   SY0-401   VCP550  

Legal Disclaimer & Privacy Policy
This web site is designed for general information only. The information presented should not be construed as legal advice and does not form the basis for an attorney/client relationship.

The choice of a lawyer is an important decision and should not be based solely on advertisements.
This web site is not intended to be advertising, and Schlichter Bogard & Denton LLP does not desire to represent anyone desiring representation based upon viewing this web site in a jurisdiction where this web site fails to comply with all laws and ethical rules of that jurisdiction. Materials on this web site may only be reproduced in their entirety (without modification) for the individual reader's personal and/or educational use and must include this notice.

We will not disclose, sell, or rent any of your identifiable personal information to any third party, unless approved by you, or required by law.