Former DePuy Consultant Affirms Defective Hip Design

In a startling revelation about apparently caught both prosecution and defense in confusion, a former Johnson & Johnson has testified that the company failed in its own safety test in designing sn all-metal hip implant, media reports say, quoting insights from legal observers familiar with the manufacturing industry. George Samaras claimed that artificial hip designers at DePuy Orthopaedics changed the protocol instead of fixing the flaw. According to a New York Times editorial, Johnson & Johnson will have a lot of explaining to do with this latest disclosure.

Samaras testified for complainant Loren Kransky, who has failed a lawsuit against Johnson & Johnson, claiming that the ASR XL hip design implanted her was defective and the company failed to warn her against the complications.

The company had voluntarily recalled its 93,000 ASR hips Systems in 2010 after saying 12 percent failed within five years. It was actually the National Joint Registry of Wales that has discovered the alarming growth in number of defective implants and triggered the recall.

Samaras told jurors in the Los Angeles federal court that DePuy failed the safety standard it set up for the ASR hip cup, in which a metal ball atop the femur rotates. He cited an internal document showing the ASR produced 16 times more chromium and cobalt debris in the body than another DePuy product. While DePuy’s review standards said the ASR should have failed, the company said it passed, Samaras said.

According to Samaras, a biomedical engineer who runs a consulting firm near Pueblo, Colorado, that the practice was horrible and that it was not the work of good engineers.

However, Johnson & Johnson denied Kransky’s claims, including failure to warn against defective design and negligent recall. In his opening statement, Alexander Calfo, a lawyer for Johnson & Johnson, said the ASR was properly designed. He said claims by Kransky, 65, of elevated metal levels in his body can be traced to his many other health problems, including diabetes, coronary artery disease, high blood pressure, kidney disease, strokes and cancer.

Samaras said DePuy’s original design criteria said the ASR had to be at least as good as predecessor devices at the company. When that failed, DePuy found other devices for comparisons that put the ASR in a more favorable light, he said.

Samara also said that DePuy changed the test  but did not consider certain modifications in the design which has caused thousands of DePuy ASR hip problems.

URL REFERENCES:

bloomberg.com/news/2013-01-28/j-j-failed-its-own-safety-test-in-hip-design-witness-testifies.html

njrcentre.org.uk/njrcentre/default.aspx

DePuy Recall Lawsuit Update: Rottenstein Law Group Acknowledges the Role of an FDA Regulatory Shortcut in DePuy Lawsuits

The Rottenstein Law Group, which represents hip replacement recipients in DePuy lawsuits, reacts to a New England Journal of Medicine article that traces the DePuy ASR recall to an FDA regulatory shortcut called the “510(k) process.”

(PRWEB) January 10, 2013

The Rottenstein Law Group acknowledges an article in the New England Journal of Medicine that pinpoints key problems with an FDA [regulatory shortcut that was a precursor to the DePuy ASR recall and DePuy lawsuits because of the device’s severe side effects.

The 510(k) process allows devices to be fast-tracked for approval that are similar to those that have already been approved. The devices can go to market without having to demonstrate safety and effectiveness through clinical studies. The DePuy ASR, a metal-on-metal hip replacement system, was one of those fast-tracked devices when Johnson & Johnson subsidiary DePuy began selling it in July 2008 after receiving FDA clearance without any clinical study, according to the NEJM article.

“Recipients of the DePuy ASR who believe they have been injured by the device’s serious side effects need a strong advocate,” said Rochelle Rottenstein, principal of the Rottenstein Law Group, which represents hip replacement recipients in DePuy lawsuits. “Our regulatory bodies are supposed to protect patients, not possibly put them into more danger.”

Read full story on PRWeb.com: DePuy Recall Lawsuit Update: Rottenstein Law Group Acknowledges the Role of an FDA Regulatory Shortcut in DePuy Lawsuits

Johnson & Johnson Faces Billions of Dollars In Costs for Compensatory Claims

DePuy Orthopaedic, a business unit of Johnson & Johnson, will be facing billions of dollars in costs for compensatory claims over artificial hip recall lawsuits, legal experts say.  The DePuy ASR hip implants is one of its two recalled artificial hip devices that is facing about 8,000 lawsuit, for which the litigation schedule has already been laid out.

The company pulled back its metal ASR hip system a year ago after it failed at a higher-than-expected rate, with some patients experiencing pain, swelling, joint dislocation and sometimes systemic damage to the central nervous system, thyroid and heart which triggered them to file a lawsuit.

However, DePuy lawyers are taking an unusual approach to managing the crisis—one that could limits financial exposure. Just recently, the company paid $200,000 for each of its three complainants to resolve the lawsuits before they were scheduled to go to trial later this year (although some of the schedule has already been announced).

Over the years, nearly all orthopedic implants were made from plastic or ceramic. But in the last 10 years some surgeons began to support implants made with metal stems and sockets. Laboratory examinations recommended that the devices may be more resilient to wear and may reduce the chances of dislocation. But recent data gathered by surgeons in the United Kingdom appear to show just the opposite.

  

People who are suffering the excruciating pain of osteoarthritis usually undergo hip replacement. It is an age-related “wear and tear” type of arthritis. Like other chronic conditions, It has no single, specific cause. Instead, there are several factors involved in the disease, including heredity and lifestyle. It usually occurs in people 50 years of age and older and often in individuals with a family history of arthritis.

The gravity of pain in men and women suffering from osteoarthritis may vary, depending on which joint are affected and how seriously they are being afflicted. The most common indications are experiencing stiffness, particularly, first thing in the morning or after resting, and pain. The most commonly affected joints are the lower back pains, feet and knees. When those joints are in pain, the person may have difficulty in doing simple tasks such as walking, climbing stairs and lifting objects. To know more about related issues check the DePuy hip ASR lawsuit.

URL REFERENCES:

mentalhealth.org.uk/help-information/mental-health-a-z/E/exercise-mental-health/msnbc.msn.com/id/47951057/ns/health-health_care/t/fda-probes-safety-issues-metal-hip-replacements/#.UGEczI3ibxEarthritistoday.org/conditions/osteoarthritis/all-about-oa/what-is-oa.php

bloomberg.com/news/2012-08-21/j-j-said-to-pay-600-000-to-settle-first-suits-over-depuy-hips.html

History of the DePuy ASR Hip Replacement Recall

The Depuy ASR Hip Replacement System was recalled by its own maker- DePuy Orthopaedics Inc. on August 26, 2010 because of the reported increase of patients experiencing unpleasant consequences and revisions immediately following the procedure. However, this move by its manufacturer is believed to be a delayed reaction since it has learned about the potential dangers of these devices years prior to its voluntary recall. In 2006, they found out that their products were causing problems among women and those whose bones are too weak. But instead of addressing these problems immediately, the manufacturer waited until thousands have already been affected with its complications.

After Depuy ASR Hip Replacement System gained approval to be marketed for healthcare use through the 510 (k) evaluation system, surgeons were immediately impressed at how much these devices have improved patients’ conditions, not knowing about its long-term side effects. Being approved by the 510 (k) process means these products did not have to be clinically tested on actual patients. Without adequate testing, there is no way these complications would have been predicted.

In 2008, the Food and Drug Administration received patient concerns on ASR hip implants with 13 percent of its recipients needing to experience painful and complex implantation corrective procedures. One year later, these products were discontinued in Australia. DePuy Orthopaedics has also announced that the removal of these defective health items will soon be implemented worldwide. However, the company has relayed public information that it has recalled the ASR hip replacement from the Australian market due to declining sales.

In March 2010, orthopedic surgeons were warned of the products’ increasing failures within only a few years after its placement. By June of the same year, the first ASR hip replacement recall lawsuit was filed. Two months later, DePuy Orthopaedics finally issued out a global recall of the ASR hip replacement system, together with the ASR Hip Resurfacing System which was only made available outside the United States.

To date, thousands of lawsuits have been directed at the DePuy ORthopaedics Inc. mainly because the manufacturer was not too careful in assessing the safety of their hip replacement products before bringing it forward for thousands of people to use. In case you are one of these unfortunate people who were implanted with the defective DePuy ASR hip replacement system and your surgeon has not contacted you yet, you might want to find out about the necessary medical interventions you may undergo, or better yet, ask for more information on the latest DePuy hip recall news. Although these controversial side effects do not manifest in all patients who have acquired the metallic hip implants, it is highly recommended that you visit your doctor for assessments from time to time especially if you start experiencing something out of the usual. To know more on hip replacement click this DePuy ASR Lawsuit site.

References:

tga.gov.au/newsroom/btn-dupuy-recall.htm#recall

hiprecalllaw.com/a-timeline-of-the-catastrophic-failure/

fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/MetalonMetalHipImplants/ucm241604.htm


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