Congressional Hearings on DePuy Hip Devices

On April 13, 2011, the United States Senate Special Committee on Aging conducted a hearing that focused on the DePuy ASR hip replacement recall and the role the FDA played in allowing this untested and dangerous product on the market.

The first witness to speak was Katherine Korgaokar, who was implanted with a defective DePuy ASR hip device. After learning of DePuy’s recall, Ms. Korgaokar underwent blood tests that found that her metal ions were 1,000% higher than they should be. Because of the extremely negative health effects of high cobalt and chromium levels in her body, her doctor recommended that she undergo a painful revision surgery to remove the recalled hip device.

Ms. Korgaokar’s testimony about the difficulty in recovering from the revision surgery is familiar to the thousands of patients who are in her shoes:

“The recovery from this second operation has been substantially more difficult than my first. The pain is much worse and it has been extremely difficult to get around. Only recently has my mobility improved to the point where I no longer need crutches. For the past three months I have essentially been confined to my home trying to get through this.”

The Government Accountability Office also testified about its findings in a recent report that found that the FDA is lacking in its ability to adequately protect the public from dangerous medical devices such as the DePuy ASR hip replacement. Among other things, the GAO found that:

“shortcomings in FDA’s oversight of the medical device recall process may limit the agency’s ability to ensure that the highest risk recalls are being implemented in an effective and timely manner. These shortcomings span the entire range of the agency’s oversight activities–from the lack of a broad-based program to systematically assess trends in recalls, to inconsistencies in the way FDA ensures the effective completion of individual recalls.”

Since DePuy was forced to recall the defective ASR hip implants in August, an MDL was formed to handle those lawsuits. Attorneys who have filed lawsuits on behalf of clients who have been injured by DePuy’s Pinnacle Hip System have petitioned the U.S. Judicial Panel on Multidistrict Litigation that all of the federal DePuy Pinnacle lawsuits be consolidated and centralized before a single District Judge. If the panel agrees to form a DePuy Pinnacle MDL, a new MDL will be formed that will solely focus on DePuy Pinnacle lawsuits.

This MDL will function in a similar manner as the MDL for ASR’s. All discovery and pretrial motions will be consolidated under one District Judge and the lawsuits will revert back to their original districts for trial, if necessary. Injuries from the Pinnacle Hip System are similar to ASR injuries: pain, swelling, inflammation and metal poisoning. High levels of cobalt and chromium found in blood and urine samples are causing the most alarm as metallosis can cause rashes, soft-tissue damage and pseudo-tumors.

If you or a loved one have had hip replacement surgery and have been implanted with a defective DePuy hip, you may be entitled to compensation for medical bills, pain and suffering, lost wages and other injuries. Our firm is currently investigating claims for those people who have been implanted with DePuy hip replacement devices, both ASR and Pinnacle. If you would like a free case evaluation, please contact Chris Hellums at toll free 1-866-515-8880 or at chrish@pittmandutton.com.

DePuy Hips--Kickbacks, Deferred Prosecution and the role of Surgeons

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In 2007, DePuy avoided criminal prosecution over financial inducements paid to surgeons to use their hip and knee products by signing a Deferred Prosecution Agreement and paying civil settlements to the Departments of Justice and Health and Human Services of $84.7 million.

The Department of Justice alleged that DePuy routinely violated the anti-kickback statute by paying physicians to exclusively use their products.  In announcing the settlement, United States Attorney Christopher J. Christie stated "prior to our investigation, many orthopedic surgeons in this country made decisions predicated on how much money they could make--choosing which device to implant by going to the highest bidder."

The government alleged that these agreements were in place between 2002-2006, which happens to be when many of the now recalled DePuy ASR hips were implanted.  Government officials also stated that surgeons failed to disclose the payments to the hospitals where the surgeries were performed, and more importantly, to the patients the devices were installed.

As the DePuy litigation proceeds, both DePuy and some surgeons are going to have some difficult questions to answer.

Patients who return to the physicians who installed the recalled devices need to be aware these relationships exist, inquire of their physician as to whether or not they engaged in such kickback agreements and never let their physician influence them to sign releases allowing DePuy to obtain their medical records.