Flawed DePuy Hip Implant Had Early F.D.A. Notice
February 22nd, 2012 tmccoy
By: Michael Werner, Esq.
As reported in The New York Times on February 21, 2012, an August, 2009 internal email authored by a vice president of a Johnson & Johnson subsidiary has surfaced, the substance of which calls into doubt the accuracy of previous Johnson & Johnson statements as to the safety of its all-metal hip.
Prior to the 2010 recall of the device, Johnson & Johnson maintained that it was safe and dismissed complaints to the contrary. However, the 2009 email from Johnson & Johnson subsidiary DePuy Orthopedics tells a different tale. In response to the Food and Drug Administration’s (FDA) decision just days prior to withhold approval of a version of the all-metal hip for domestic sales, vice president Pamela Plouhar, on behalf of DePuy Orthopedics, informed other high-level DePuy executives that the FDA refused to approve the device in part because it had “failed prematurely in ‘significant’ numbers, requiring repeat surgeries for patients.”
While sales of the artificial hip were confined to over-sea markets, a companion model—which was used in approximately 30,000 patients—was ultimately recalled in the United States during the same 2010 period. It is believed that a total of approximately 93,000 people received the all-metal DePuy hip, many through a resurfacing hip replacement procedure. However, since these surgeries many devices have failed years before their 15 year intended lifespan. Moreover, it is believed that metal filings and sediment are stripped from the device over time and with use, thereby causing considerable injury and necessitating follow-up surgery.
Notwithstanding the content of the 2009 email, and the presumptive notice it provided to top-level executives at DePuy in 2009, the current President of DePuy, Andrew Ekdahl, stated last week that allegations as to the FDA’s safety and inferiority concerns were “simply untrue.” Although the FDA does not release the findings and decisions contained in a “nonapprovable letter” as a matter of policy, it is notable that DePuy has similarly refused to release the findings at issue.
Source: The New York Times
