As DePuy hip recall attorneys, we have heard many disturbing reports which place the blame for the DePuy hip recall squarely at the doorstep of the United States .
FDA “Approves” Implants by Default
Although most hip implant patients assumed that their hip replacement manufacturer (e.g., DePuy, Zimmer, Johnson & Johnson, Stryker, etc.) received approval from the FDA for their device, this assumption is not entirely accurate. 
For years, the FDA has permitted a regulatory loophole under FDA 510(k) which permits the release of new medical devices like the DePuy hip implant, Zimmer NexGen knee implant, and other medical devices, to be placed onto the market without first receiving a comprehensive review by the FDA. How? Because this loophole permits implant manufacturers, like DePuy, to obtain FDA approval if a medical device manufacturer shows that its device is “substantially equivalent” in safety and effectiveness to another FDA approved device.
Ironically, although DePuy claimed its ASR XL Acetabular or Resurfacing implants were “substantially equivalent” to other hip implants, DePuy was not required to make its product out of the same metals as already existing marketed hip implants. As such, reports have shown that the FDA never considered the effects of the chromium and cobalt metals used in DePuy’s hip implants. As a result, consumer advocates have argued that the FDA allowed DePuy to use – without any FDA testing- potentially hazardous metals in a medical device without proper oversight.
DePuy Hip Recall Attorneys in New Jersey and Philadelphia
The DePuy hip recall shows the potential danger in this process. What is the lesson? All potential hip implant patients should specifically ask whether their hip implant device has received formal FDA approval or was approved through the FDA 510(k) loophole. As a New Jersey and Philadelphia DePuy hip recall lawyer, we strongly encourage and current recipients of a DePuy hip replacement to contact the Mininno Law Office for a free case evaluation, or call for a free consultation at (856) 833-0600 in New Jersey, or (215) 567-2380 in Philadelphia.
Let the team at the Mininno Law Office earn you the compensation you need and deserve.
Dr. Stephen Serlin was summoned at 5am on February 24th, 1993 to perform an emergency C-section for Marlayna’s mother, Dawn Kineke. He did not arrive at the hospital until 7am, and the procedure didn’t begin until 8:14am. In that time, Marlayna suffered fetal asphyxia from umbilical cord compression within the womb, which caused cerebral palsy and a host of additional developmental issues.
In fact, some hip replacement surgeons have argued that hip implant and joint replacement surgery is one of the most important surgical advances over the last century. Because of its popularity, and potential profitability, hip manufacturers such as DePuy, Johnson & Johnson, Zimmer, and others have been competing to capture this potentially lucrative market. Unfortunately, as has been suggested with DePuy, sometimes manufacturers are in such a rush to roll out a “new and improved” implant device, they fail to properly test whether the hip, knee, or other joint implant is better than those that already existed on the market.
The Lincoln Specialty Care Center has had 2 routine inspections between November 2008 and October 2010. During this time period, the facility had 57 cited deficiencies. At an average of 25 deficiencies per visit, the Lincoln Specialty Care Center acquired almost double the amount of citations that some of the other troublesome nursing homes we’ve discussed have acquired.
Martin Chieng Were, M.D., M.S., a Regenstrief Institute investigator and assistant professor of medicine at the Indiana University School of Medicine, has received a $420,000 award from the Harold Amos Medical Faculty Development Program of the 
Silver Care Health Center has had two routine inspections in the two year period from November 2008 through October 2010. During those two routine inspections, the Silver Care Health Care Center was cited for 31 deficiencies. The Silver Care nursing home was cited for numerous violations, i.e. life safety code standard violations, housekeeping, drug regimen not being free of unnecessary drugs, and life safety from fire issues. A number of these deficiencies were considered widespread and able to cause more than minimal harm. 
The report provided by the agents that raided the clinic last February described the clinic as smelly and squalid. It noted pools of blood on the floor, a urine stench, and cat feces on the stairs the day they arrived. Women were semiconscious and moaning, sitting on dirty recliners with blood-stained blankets. 
The Kresson View Center had two routine inspections and 13 complaint inspections in the two year period from November 2008 through October 2010. The Kresson View nursing home was cited for a variety of deficiencies. These included the prevention and treatment of bed sores, medication errors of 5% or more, hazard and accident issues, and not being free from abuse/involuntary seclusion. The bed sore citation, although found to be isolated in nature, did show potential for more than minimal harm. The other above mentioned violations were found to occur in pattersn, and also showed the potential for more than minimal harm.
Recently, the prestigious Washington Post reported on a fairly widespread yet rarely discussed practice of medical device sales representatives to lurk in operating rooms, without patient knowledge or approval, and guide surgeons in the surgical procedure. According to the Washington Post, this practice of sales rep “assistance” is common among medical device companies including Johnson & Johnson, Stryker, Zimmer, and DePuy.
On August 29, 2000, Richard Flagg was admitted to Meadowlands Hospital to have portions of his left lung removed due to a cancerous tumor. His surgeon was Dr. Santusht Perera. When Richard awoke, Dr. Perera informed him that during surgery he found an even larger tumor on his right lung, and that by removing portions of that lung instead, he had saved his life.