Johnson & Johnson Chose Inventory Selloff Over Patient Safety

After FDA Denied Approval of the DePuy ASR Hip Resurfacing System, Johnson & Johnson Decided to Sell Off the Remaining Inventory Explains Ennis & Ennis, P.A.
By: Jami Angelini Haggerty
 
March 29, 2012 - PRLog -- Mere weeks after the U.S. Food and Drug Administration (FDA) denied approval for the DePuy ASR Hip Resurfacing System in 2009, Johnson & Johnson decided to “phase out” and “sell off” all remaining inventory of the problematic devices. This is despite the fact the FDA advised the company that blood tests of various patients who received the all-metal hip showed a “high concentration of metal ions” that it found “concerning,” according to a recent New York Times report. [http://www.nytimes.com/2012/03/23/business/fda-asked-depuy-for-safety-data-just-before-hip-implants-phaseout.html]

The FDA confidentially notified Johnson and Johnson that it was turning down the company’s application to sell the device in the United States and requested additional safety data from DePuy if it wanted to pursue its US application for the all-metal hip resurfacing system.  DePuy, a subsidiary of Johnson and Johnson, did not recall this defective device or a companion model that was already in use in the US, until August 2010, a full year after it received notice from the FDA. Instead, it chose to phase out the rejected device and sell the entire remaining inventory for use in patients abroad.

It is estimated that over 30,000 patients in the US have received a DePuy ASR metal hip replacement, which suffers from a failure rate as high as 12% according to the National Joint Registry of England and Wales. [www.depuy.com/usmedia.com]  Additionally, many patients suffer crippling injuries caused by particles of metallic debris generated as the all- metal implant wears and erodes.

As recently as March 13, 2012, a study published by the Lancet Medical Journal confirms that all-metal hip implants fail more often than other types of hip implant devices. This study analyzed data of more than 400,000 hip replacements, of which 31,171 were all metal ones implanted between 2003-2011. There is a 6.2 percent chance patients with all-metal hips will need a replacement within five years, which is three times greater than the revision rate seen with older patients.  The authors of the study indicate, “Metal-on-metal stemmed articulations give poor implant survival compared with other options and should not be implanted.” [www.thelancet.com/journals/lancet/article/]

Ennis & Ennis, P.A. recommends that anyone with a DePuy Hip Replacement or any other all-metal hip implant system, who is experiencing pain in the groin, hip or leg, swelling at or near the hip joint, or a limp/change in walking ability, first seek medical attention.  Then file an adverse event report with the FDA at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-....  Lastly, consult with an experienced attorney.

Ennis & Ennis is offering free, nationwide, confidential consultations to anyone who has an all-metal hip replacement system by calling toll free 1-800-856-6405 or by going to www.ennislaw.com and completing an online case evaluation form.

Ennis & Ennis, P.A. is a nationwide law firm with offices in Ft. Lauderdale, Miami and Washington D.C. that concentrates its practice in mass torts and represents individuals against pharmaceutical companies and medical device makers.

Ennis & Ennis, P.A. has been representing clients individually since 1986 and has recovered over $100 million in settlements for its clients.

Ennis & Ennis, P.A. is also investigating cases involving Accutane, Actos, Avandia, Fosamax, Paxil, Plavix, Pradaxa, Zoloft/Birth Defects, Prozac/Birth Defects, Zimmer Hip Recall, Wright Conserve Hip Implant, Wright Profemur Hip Implant, any all-metal hip implant, Depakote, Reglan, SJS/Dilantin, Yaz, Yasmin and Ocella Birth Control Pills.

Remember the law limits the time in which you can file a claim, so don't wait to explore your legal rights.  Call today toll free 1-800-856-6405 or visit www.ennislaw.com.
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Source:Jami Angelini Haggerty
Email:***@ennislaw.com Email Verified
Zip:33301
Tags:Johnson Johnson, Depuy, Asr, All-metal Hip, Metal Hip, Ennis and Ennis
Industry:Health, Legal
Location:Fort Lauderdale - Florida - United States
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