Depuy Congress Faulty Hip Implant Issue

Congress Wading Into Faulty Hip Implant Issue

Democratic members of the House of Representatives Committee on Energy and Commerce recently asked the committee’s chairman to hold hearings on the dangers posed by metal-on-metal implants.

In a letter to the chairman this month, the members state that metal-on-metal implants — like the Pinnacle hip implant manufactured by Depuy Orthopaedics — are “examples of devices that were found to be associated with major health problems after being approved or cleared by the FDA.”

You can read the full letter here, "Energy and Commerce Democratic Leadership Calls for Further Examination of FDA Medical Device Regulations - October 12, 2011"

The request comes as the FDA is continuing to receive complaints about the implants and scores of lawsuits against manufacturers are being filed.

Number of DePuy Pinnacle Implant Complaints Continues To Rise

Complaints about the DePuy Orthopedics Pinnacle hip implant are continuing to roll into the U.S. Food and Drug Administration.

According to FDA figures, 709 Adverse Event Reports were filed with the agency in July, August and September of this year. Of those, 201 were specific to the Pinnacle metal-on-metal version of the implant.

So far this year, 1,266 complaints have been filed with the FDA on the Pinnacle implant, 450 of them on the metal-on-metal version.

The DePuy Pinnacle Acetabular Cup is a metal-on-metal hip implant, similar to the ASR system recalled by Johnson & Johnson. The Pinnacle implant has not been recalled but has also received similar complaints about failure rates as the ASR system.

More Than 50 DePuy Pinnacle Lawsuits Consolidated in Federal Court

It was announced Tuesday August 23, 2011, that more than 50 individual lawsuits against DePuy Orthopedics regarding the DePuy Pinnacle hip implant have been consolidated into the DePuy Pinnacle multidistrict litigation (MDL). The cases are to be heard in front of U.S. District Court Judge James Kinkeade in the Northern District of Texas.

The DePuy Pinnacle Acetabular Cup is a metal-on-metal hip implant, similar to the ASR system recalled by Johnson & Johnson. The Pinnacle implant has not been recalled but has also received similar complaints about failure rates as the ASR system.

New York Times Highlights Implant Dangers

The New York Times October 12, 2011 shone the spotlight on the growing problem of faulty hip replacements.

The paper singled out implants that use a metal-on-metal components, such as the implant produced by DePuy Orthopaedics. It cited a European study that found that metal-on-metal implants fail early at three times the rate metal-on-plastic implants.

The Times also described the danger of implants that rely on metal-on-metal components:

“All orthopedic implants, regardless of their composition, shed debris as they wear. But researchers say they believe that the particles released by some all-metal hips pose a special threat because scavenger cells dispatched by the body to neutralize the debris convert it into biologically active metallic ions. In some patients, a chain reaction begins that can destroy tissue and muscle.”

Read The New York Times report, "Remedy Is Elusive as Metallic Hips Fail at a Fast Rate"

The paper’s account comes as the U.S. Food and Drug Administration is continuing to receive complaints about the implants and scores of lawsuits against manufacturers are being filed.

DePuy Parent Prepping To Pay Millions For Bad Implants

The parent company of Depuy Orthopaedics, maker of the Pinnacle hip implant, is acknowledging that it will be on the hook for millions of dollars in damages because of the harm caused to patients by the implants.

In a filing with the Securities and Exchange Commission in November 2011, Johnson & Johnson reported that it anticipates facing some 3,500 lawsuits related to the faulty implants, which use a metal-on-metal system and have proven to cause significant medical problems for patients.

The company anticipates facing liability costs as high as $223 million for the DePuy Pinnacle implant.

The company’s acknowledgement comes on the heels of calls by members of the U.S. Congress for investigations into the implants.