DePuy ASR Metal on Metal Hip Implants were introduced worldwide in July of 2003. These hip Implants were first used in the United States in 2005. DePuy pushed the approval of the DePuy Hip Implant devices through the FDA on what is known as the fast track. This expedited FDA approval process, commonly known as the 510(k) Process, allows medical devices to avoid the rigorous clinical trials if the manufacturer can show that the device is “substantially equivalent” to other medical devices already approved by the FDA. DePuy persuaded the FDA that the ASR XL Hip System was similar to previously approved metal-on-metal hip implants. DePuy claimed that the ASR XL Hip SystemTM did not “raise any new issues of safety or effectiveness.”
The DePuy ASR Hip Implant devices were approved by the FDA because DePuy claimed they were “substantially equivalent” to three other hip implant devices. The three other hip implant devices were all also approved through the 510(k) Process, with the manufacturers claiming their devices were “substantially equivalent” to other approved medical devices. None of the devices had ever undergone the rigorous clinic testing.
Over the following months and years, DePuy and the FDA received hundreds of complaints regarding the DePuy Hip Implant devices. The vast majority of these complaints resulted in early failures of the Hip Implant devices, which required removal of the device.
The typical life expectancy of a metal-on-metal hip implant device is 15 years. However, the DePuy Hip Implant devices are failing at a much higher rate and much earlier than other metal-on-metal hip implant devices.
DePuy had long known of the high failure rate. As early as 2007, the Australian National Joint Replacement Registry had notified DePuy of the high failure rate of the DePuy Hip Implant devices on at least 7 separate occasions.
The surgeon that designed the DePuy Hip Implant device has admitted that both he and DePuy had knowledge of early failure rates due to the design of the device by at least 2008, yet DePuy continued to sell and market the DePuy Hip Implant devices.
In December 2009, the Depuy Hip Implant devices were recalled from the Australian market. The Australian National Joint Replacement Registry Director, Dr. Stephen Graves, stated the following, “It is a complete untruth that DePuy did not have reason to withdraw the ASR before now; we have been telling them since 2007, but they allowed it to be used on thousands of people.”
In March 2010, DePuy first notified doctors in the United States of the high failure rate of the DePuy ASR Hip ImplantTM system based upon the Australian Joint Replacement Registry data. However, DePuy did not issue a recall of the Depuy ASR Hip ImplantTM device. Interestingly, months earlier, in late 2009, DePuy informed doctors that the company was discontinuing the sale of the DePuy ASR Hip ImplantTM devices due to a decline in sales.
The United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) issue medical device alerts on April 22, 2010 and May 25, 2010, warning of the dangers and health complications for patients with the DePuy ASR Hip ImplantTM systems.
On August 26, 2010, DePuy announced the voluntary recall of the DePuy ASR Hip ImplantTM systems.
we have attorneys in: Auburn AL; Birmingham AL; Dothan AL; Gadsden AL; Huntsville AL; Mobile AL; Montgomery AL; Muscle Shoals AL; Tuscaloosa AL; Anchorage AK; Fairbanks AK; Juneau AK; Flagstaff AZ; Sedona AZ; Mohave County AZ; Phoenix AZ; Prescott AZ; Show Low AZ; Sierra Vista AZ; Tucson AZ; Yuma AZ; Fayetteville AR; Fort Smith AR; Jonesboro AR; Little Rock AR; Bakersfield CA; Chico CA; Fresno CA; Humboldt County CA; Inland Empire CA; Long Beach CA; Los Angeles CA; Mendocino (new) CA; Merced CA; Modesto CA; Monterey CA; O.C. CA; Oakland CA; Palm Springs CA; Palmdale CA; Redding CA; Sacramento CA; San Diego CA; San Fernando Valley CA; San Francisco CA; San Gabriel Valley CA; San Jose CA; San Luis Obispo CA; San Mateo CA; Santa Barbara CA; Santa Cruz CA; Santa Maria CA; Siskiyou CA; Stockton CA; Susanville CA; Ventura CA; Visalia CA; Boulder CO; CO Springs CO; Denver CO; Fort Collins CO; Pueblo CO; Rockies CO; Western Slope CO; Eastern CT CT; Hartford CT; New Haven CT; Northwest CT CT; Wilmington DE; Dover DE; Newark DE; Pike Creek DE; Bear DE; Washington D.C. District of Columbia; Daytona FL; Fort Myers FL; Ft Lauderdale FL; Gainesville FL; Jacksonville FL; Keys FL; Lakeland FL; Miami FL; Ocala FL; Orlando FL; Panama City FL; Pensacola FL; Sarasota FL; Space Coast FL; St. Augustine FL; Tallahassee FL; Tampa FL; Treasure Coast FL; West Palm Beach FL; Albany GA; Athens GA; Atlanta GA; Augusta GA; Brunswick GA; Columbus GA; Macon GA; Northwest GA GA; Savannah GA; Statesboro GA; Valdosta GA; Big Island HI; Honolulu HI; Kauai HI; Maui HI; Boise ID; East ID ID; Lewiston ID; Twin Falls ID; Bloomington IL; Carbondale IL; Chambana IL; Chicago IL; Decatur IL; La Salle County IL; Mattoon IL; Peoria IL; Rockford IL; Springfield IL; Western IL IL; Bloomington IN; Evansville IN; Ft Wayne IN; INpolis IN; Kokomo IN; Lafayette IN; Muncie IN; Richmond IN; South Bend IN; Terre Haute IN; Cedar Rapids IA; Des Moines IA; Dubuque IA; Fort Dodge IA; IA City IA; Mason City IA; Ottumwa IA; Quad Cities IA; Sioux City IA; Waterloo IA; Lawrence KS; Manhattan KS; Topeka KS; Wichita KS; Bowling Green KY; Eastern KY KY; Lexington KY; Louisville KY; Owensboro KY; Western KY KY; Baton Rouge LA; Lafayette LA; Lake Charles LA; Monroe LA; New Orleans LA; Shreveport LA; Portland ME; Lewiston ME; Bangor ME; West Scarborough ME; Annapolis MD; Baltimore MD; Cumberland Valley MD; Eastern Shore MD; Frederick MD; Western MD MD; Boston Massachusetts; Cape Cod Massachusetts; South Coast Massachusetts; Springfield Massachusetts; Worcester Massachusetts; Ann Arbor MI; Battle Creek MI; Central MI MI; Detroit MI; Flint MI; Grand Rapids MI; Holland MI; Jackson MI; Kalamazoo MI; Lansing MI; Monroe MI; Muskegon MI; Northern MI MI; Port Huron MI; Saginaw MI; Southwest MI MI; Upper Peninsula MI; Duluth MN; Mankato MN; Minneapolis MN; St Paul MN; Rochester MN; St. Cloud MN; Biloxi MS; Hattiesburg MS; Jackson MS; Meridian MS; Natchez MS; North MS MS; Columbia/Jeff City MO; Joplin MO; Kansas City MO; Kirksville MO; Lake of the Ozarks MO; Southeast MO MO; Springfield MO; St. Joseph MO; St. Louis MO; Billings MT; Missoula MT; Great Falls MT; Bozeman MT; Butte MT; Grand Island NE; Lincoln NE; North Platte NE; Omaha NE; Scottsbluff NE; Las Vegas NV; Reno NV; Manchester NH; Nashua NH; East Concord NH; Concord NH; Derry Village NH; Central Jersey NJ; Jersey Shore NJ; North Jersey NJ; South Jersey NJ; Albuquerque New Mexico; Santa Fe New Mexico; Albany NY; Binghamton NY; Buffalo NY; Catskills NY; Chautauqua NY; Elmira NY; Finger Lakes NY; Glens Falls NY; Hudson Valley NY; Ithaca NY; Long Island NY; New York City NY,Brooklyn,Queens,Staten island,Bronx,White Plains,New Rochelle; Oneonta NY; Plattsburgh NY; Potsdam NY; Rochester NY; Syracuse NY; Twin Tiers NY; Utica NY; Watertown NY; Westchester NY; Asheville NC; Boone NC; Charlotte NC; Eastern NC; Fayetteville NC; Greensboro NC; Hickory NC; Outer Banks NC; Raleigh NC; Wilmington NC; Winston Salem NC; Fargo ND; Akron OH; Canton OH; Ashtabula OH; Athens OH; Chillicothe OH; Cincinnati OH; Cleveland OH; Columbus OH; Dayton OH; Huntington/Ashland OH; Lima/Findlay OH; Mansfield OH; Sandusky OH; Toledo OH; Tuscarawas County OH; Youngstown OH; Zanesville/Cambridge OH; Lawton OK; OK City OK; Stillwater OK; Tulsa OK; Bend OR; Corvallis OR; East OR OR; Eugene OR; Medford OR; OR Coast OR; Portland OR; Roseburg OR; Salem OR; Allentown PA; Altoona PA; Cumberland Valley PA; Erie PA; Harrisburg PA; Lancaster PA; Meadville PA; Philadelphia PA; Pittsburgh PA; Poconos PA; Reading PA; Scranton PA; State College PA; Williamsport PA; York PA; Providence RI; Warwick RI; Cranston RI; Pawtucket RI; East Providence RI; Woonsocket RI; Charleston SC; Columbia SC; Florence SC; Greenville SC; Hilton Head SC; Myrtle Beach SC; Sioux Falls SD; Rapid City SD; Aberdeen SD; Chattanooga TN; Knoxville TN; Memphis TN; Nashville TN; Tri-cities TN; Abilene TX; Amarillo TX; Austin TX; Beaumont TX; Brownsville TX; College Station TX; Corpus Christi TX; Dallas TX; Denton TX; El Paso TX; Fort Worth TX; Galveston TX; Houston TX; Huntsville TX; Killeen TX; Laredo TX; Lubbock TX; Mcallen TX; Odessa TX; San Antonio TX; San Marcos TX; Texarkana TX; Texoma TX; Tyler TX; Victoria TX; Waco TX; Wichita Falls TX; Logan UT; Ogden UT; Provo UT; Salt Lake City UT; St. George UT; Burlington VT; Essex Junction VT; Bennington VT; Charlottesville VA; Chesapeake VA; Danville VA; Fredericksburg VA; Hampton VA; Harrisonburg VA; Lynchburg VA; New River Valley VA; Newport News VA; Norfolk VA; Portsmouth VA; Richmond VA; Roanoke VA; SouthWV VA; Suffolk VA; VA Beach VA; Bellingham WA; Everett WA; Moses Lake WA; Olympia WA; Pullman WA; Seattle WA; Spokane WA; Tacoma WA; Tri-cities WA; Wenatchee WA; Yakima WA; Charleston WV; Huntington WV; Martinsburg WV; Morgantown WV; Parkersburg WV; Southern WV WV; Wheeling WV; Appleton WI; Eau Claire WI; Green Bay WI; Janesville WI; La Crosse WI; Madison WI; Milwaukee WI; Racine WI; Sheboygan WI; Wausau WI; Cheyenne WY; Casper WY; Laramie WY; Gillette WY;