What did Johnson & Johnson know about their hips and when did they know it?

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According to the New York Times, a year before Johnson & Johnson's Depuy division recalled their ASR hip systems, Pamela Plouhar, vice president of Depuy Orthopedics, reported privately to top executives that the FDA was going to refuse to approve the device after data showed it failed prematurely in "significant" numbers.  The device was on the market overseas starting in 2003 and was marketed in the United States in 2005 under a loophole in the law.

This, of course, is in direct conflict with public statements by Johnson & Johnson which insisted that its internal studies refuted complaints by surgeons and regulators in other companies. Johnson & Johnson maintained that the failures were the result of improper placement of the implants by physicians--a position I continue to hear parroted by uninformed doctors or physicians still on Johnson & Johnson's gravy train.

There is only one problem with this defense----the data came from clinical studies performed by surgeons hand picked by Depuy and who received royalties and consulting fees associated with it.  In other words, Depuy's hand picked surgeons were seeing failures at the same rate as other Depuy surgeons who were using the product.

In addition to this email, documents filed with a Senate committee indicate knowledge of a serious problem in 2008, nearly 2 years before the hips were recalled.

Of course, lost in this discussion were the hundreds, if not thousands of people who are now suffering crippling injuries as Depuy continued to mislead both surgeons and consumers about the condition of its product.

Related articles

• Johnson & Johnson CEO resigns after series of missteps (money.cnn.com)
• Flawed DePuy Hip Implant Had Early F.D.A. Notice (nytimes.com)
• Hip Implant the FDA Rejected Was Marketed Abroad - New York Times (nytimes.com)
• Regulator dithering put hundreds of hip patients at risk (smh.com.au)
• J&J DePuy - Hip Implant that U.S. Rejected Was Sold Overseas (earlsview.com)

DePuy Pinnacle MDL Update

Our firm has four of the first Pinnacle cases filed in the DePuy Pinnacle MDL and anticipates filing more in the coming months. We are seeing rapid failures of the device due to high cobalt levels in blood tests. Excessive levels of cobalt in the blood stream is a sign of metallosis, which can cause rashes, soft-tissue damage, peripheral neuropathy and pseudo-tumors.

The DePuy Pinnacle cases have been consolidated in the U.S. District Court for the Northern District of Texas under Judge James E. Kinkeade. Judge Kinkeade is currently presiding over at least one of the cases, and the Panel determined his current caseload will accommodate the litigation. There are approximately 57 DePuy Pinnacle hip lawsuits currently pending in federal courts nationwide and that number is expected to rise over the next few months. 

DePuy is a subsidiary of Johnson & Johnson, one of the largest corporations in the world. DePuy recalled the ASR XL Acetabular hip system last August, after researchers found 13 percent of patients needed a repeat operation to fix problems with the implant. The company took a $280 million charge in the fourth quarter to pay for the recall. The company faces more than 500 lawsuits by patients who had the hip implants, most of which are consolidated in a separate MDL dealing only with ASR hips. There has been no recall of the DePuy Pinnacle hip.

Johnson & Johnson’s DePuy Orthopaedics division, a maker of artificial prosthetics such as hips and knees, has struggled with product recalls and lawsuits over faulty implants lately. It was announced earlier this year that the worldwide president would leave the company in March. The executive, David Floyd, has been president of the unit since 2007. He is leaving to pursue interests outside the company, a spokesman on behalf of the company, Lorie Gawreluk, said, declining to be more specific.

Our firm is currently investigating claims for those people who have been implanted with the DePuy hip replacement devices, both ASR and Pinnacles. If you would like a free case evaluation, please contact Chris Hellums at toll free 1-866-515-8880 or at chrish@pittmandutton.com.

FDA orders makers of orthopedic hips to do post market studies

     On the front of its Business Day section, the New York Times (5/11, B1, Meier, Subscription Publication) reported on the "unusual move" by the FDA to direct some 20 makers of "metal-on-metal" artificial hips to do postmarket studies because of "high early failure rates and severe health effects in some patients." The companies are being told to find out if the devices "are shedding high levels of metallic debris" that account for cases of disabling "soft tissue damage." Dr. William H. Maisel, deputy director for science at the FDA's Center for Devices and Radiological Health, said the FDA wants to know "about the entire category of implants, not any single manufacturer's device." He added, "Our concern is the product, not about a manufacturer."

        Bloomberg News (5/11, Farrell, Nussbaum) said the FDA order, dated May 6, went to Johnson & Johnson, "which is already facing more than 1,000 lawsuits over hip replacements," as well as companies such as Biomet Inc., Zimmer Holdings, and Stryker Corp., which said it didn't make a metal-on-metal product. Bloomberg News added, "The request comes nine months after DePuy Orthopaedics, a unit of New Brunswick, New Jersey-based J&J, recalled a hip-replacement system that had been implanted in 93,000 patients worldwide. 

      

     

DePuy ASR Congressional Hearings

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 Hip Replacement Cases Consolidated

In what was probably what was the worst kept secret in legal circles, the Judicial Panel on Multi-District Litigation assigned all Depuy ASR hip cases to United States District Judge Katz. The judge will supervise evidence gathering efforts regarding the hip implants which were recalled by Johnson and Johnson's Depuy Orthopedics unit on August 26th.  According to Depuy, the implants were recalled after researchers found many patients needed revision surgery because of design defects.  Recently, receipents have tested positive for toxic level of chromium and cobalt as a result of the implant failure.

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.

DePuy ASR XL Hip Implant Recall -- Frequently Asked Questions

If you or someone you know suffered pain and/or had to undergo additional surgery as a result of having the DEPUY Hip replacement, contact attorney Chris Hellums of Pittman, Dutton & Hellums today.

Johnson & Johnson's artificial joint replacement company DePuy Orthopaedics, Inc. has issued a recall of two hip replacement products because of high failure rates that necessitated second surgeries.
DePuy recalled the ASR XL Acetabular System and the ASR Hip Resurfacing System after data showed that within five years, one in eight patients (12%-13%) needed a "revision surgery," which is required when an artificial joint doesn't properly fit. Serious pain and difficulty walking can result from a faulty hip replacement. The "ASR" stands for articular surface replacements, meant to replace a damaged or diseased hip.

What Hip Replacement Products Have Been Recalled?

DEPUY has recalled the following hip replacement products:

• ASR XL Acetabular System - was on the market since 2004 and sold worldwide.
• ASR Hip Resurfacing System - was on the market since 2003, and sold exclusive outside the United States.

All remaining products on hospital shelves will be immediately removed.

How Can I Tell if I Have a Recalled Hip Device?

By now, your surgeon should have contacted you on behalf of DEPUY to notify you that your implant has been recalled. If not, and you are having the symptoms below, contact your physician or the hospital where the surgery was performed and request a copy of the "chart stick" from your surgery. Most likely, you have the ASR XL Acetabular System. The ASR XL Acetabular System is a 3 component system comprised of: the femoral stem (which is inserted inside the femur), the femoral head (or ball) that connects to the stem, and then fits inside the acetabulum (cup). A unique characteristic of the ASR XL Acetabular system is that it is a metal-on-metal device meaning both the ball and cup portion of the implant are metal.

What are the Common Problems/Symptoms with the ASR Hips

Component loosening, component misalignment, infections, bone fractures, dislocation, loss of muscle mass, unexplained hip pain, thigh and groin pain, pain when walking or rising from seated position, and clicking sounds. X-rays can also reveal metal debris, which can ultimately lead to inflammation of the surrounding tissue.

What Should I Do if I Received a Defective Hip Replacement

Always consult your doctor or physician regarding health-related issues, but if you or someone you care about received defective joint replacement components, we would like to speak with you right away. DO NOT SIGN A RELEASE FROM THE SURGEON OR DEPUY. It is imperative that you do NOT sign the release sent to you by your physician on behalf of DEPUY. These releases will allow DEPUY complete access to your medical records and allow them to obtain possession of the defective implant in the event it is removed.

Who Discovered Problems and When?

The defects were first documented by the Australian National Joint Replacement Registry in early 2008. The evidence presented clearly demonstrated a very high rate of failure concerning this device. Australia withdrew this device from the market in December 2009. Researchers from a British study also reported problems with the metal-on-metal implants causing adverse soft tissue reactions resulting from the friction of the metal-on-metal surfaces. These patients showed higher rates of wear and tear and soft tissue damage. The United States Food and Drug Administration did not participate in a recall despite this information. Hospitals and hip surgeons in the United States had been warned about the defects of this device, but continued to use it anyway, until DEPUY voluntarily recalled the product in March, 2010.