Article by guest commentator K.J. Bard
In recent news, the DePuy Orthopaedics division of Johnson & Johnson will be abandoning the manufacture and marketing of its metal-on-metal (MoM) hip replacements. In addition, DePuy will be discontinuing its Ceramic-on-Metal Acetabular Hip System. Both product lines will be unavailable after August of 2013; “related products” will be phased out over next year.
The company cites decreased demand and increased regulation of the devices by the federal government. Earlier this year, the U.S. Food and Drug Administration (FDA), which had approved these devices under the 501(k) Clearance process, informed manufacturers of MoM him implants would have to run the additional studies that had previously been waived if they wanted to continue selling the products.
It's certainly true. According to company representatives, the sale of metal-on-metal hip replacements from all manufacturers has dropped by a whopping 90 percent over the past six years. DePuy spokesperson Mindy Tinsley told Bloomberg that there is “not a viable market for these bearing combinations anymore.”
Could the fact that Johnson and Johnson lost its first injury lawsuit – and is facing many more lawsuits – have anything to do with it?
Despite the outlook for DePuy's impending legal battles and medical evidence that metal-on-metal are causing serious injuries, the company continues to insist that the decision to discontinue its product line has nothing to do with “safety or effectiveness.” It's all about market demand.
The Pinnacle Hip Implant will also be discontinued. Currently, 3300 lawsuits are pending over this particular product – yet Company representatives continue to insist that the Pinnacle is “safe and performing on par with other hip replacements.” Again, they say it's all about falling market demand – not patient safety.
In the U.S., approximately 33% of all hip replacement patients received a MoM implant of some type. Intended to last for an average of 15 years, some of these these devices have been failing after only two or three years.
It is likely that other MoM hip replacement manufacturers will follow DePuy's lead in this matter, phasing out their own product lines in the coming months.
Meier, Barry. “J.&J. Unit Phasing Out All-Metal Hip Devices.” New York Times, 16 May 2013.
N/A. “J&J to Stop Selling Metal-on-Metal Hip Replacements, Citing Drop in Demand.” Bloomberg, 17 May 2013.
Orzek, Kurt. “J&J To Stop Selling Metal Hips, Facing Thousands Of Suits.” Law360.com, 16 May 2013.
Learn more about Depuy lawsuits