News Updates on DePuy Recall

The recall made by one of the biggest device manufacturers in the United States has raised concerns over the safety of their products, news reports say. DePuy Orthopedics voluntarily recalled their DePuy ASR TM Total Hip System due to higher than expected failure rate that have resulted to a secondary surgery, according to the Food and Drug Administration. The recall was made on August 24, 2010 after the unpublished data from the United Kingdom joint registry indicated that there is 13 percent chance for revision among patients with this prosthesis within five years. For this reason, the number of cases participating in the DePuy ASR multidistrict litigation continues to grow.

The recall of the said product from DePuy was due to the problems that were experienced by a number of individuals who have had the implant. The design for the ASR system may prove to be the downfall, even though the use of an all-metal ball and cup was thought to be more durable than using metal and ceramic or polyethylene. Orthopedic experts believe that the risks faced by patients are more unique when they have this all-metal hip implant because of the metal particles released from the wear and tear of the prosthesis. The metal used for these implants were chromium and cobalt.

Patients may or may not react to the high concentrations of chromium and cobalt in the blood. However, there are several documented adverse effects that may occur because of the metal toxicity. There are even studies that link chromium and cobalt as possible carcinogenic metals. The possible occurrence of adverse local tissue reaction is possible and the release of metal ions may also lead to other systemic effects. The FDA has even listed the following possible systemic reactions that patients may experience:

-      Skin rash or general hypersensitivity reaction

-      Heart muscle problems

-      Sensory and neurological changes

-      Change in physiological status like depression

-      Impairment of renal function

-      Thyroid problem

Men and women who do not experience the abovementioned problems and there are no evidence that there is a problem with the hip, then the surgeon may not require blood testing for metal ions or soft tissue imaging, as recommended by the FDA. However, if these reactions are present, then patients may need to follow-up these symptoms with their orthopedic surgeon. The FDA continues to monitor these problems in order to update the existing information. The DePuy hip recall was initiated by the manufacturer to avoid the number of cases filed by patients to rise.

URL References:

medscape.com/viewarticle/777801

fda.gov/medicaldevices/productsandmedicalprocedures/implantsandprosthetics/metalonmetalhipimplants/ucm241770.htm

bmj.com/content/344/bmj.e1410

Will J & J Settle Depuy ASR Hip Replacement Lawsuits?

In just less than ten days, Depuy Orthopedics, the makers of the ASR hip replacement systems, has agreed to settle a second Depuy ASR hip implant lawsuit before it can go into trial. After deciding in early October to settle a claim in California which was supposed to be the first bellwether case in a California state court, the Johnson & Johnson subsidiary was reported to have resolved an ASR hip implant lawsuit in New Jersey.

While it may be too early to tell, legal observers have suggested that this may be the course of action Depuy may take in resolving claims which exceed 11,500 in the United States alone. With product liability lawsuits being filed in other countries such as Canada, Australia, and the United Kingdom and the expected increase of claims in the United States in the coming months, this controversy may yet become one of the biggest product liability lawsuits in history.  

Two months ago, it was reported through online sources, that Johnson & Johnson was in the process of weighing the possibility of resolving liability lawsuits involving the ASR hip replacement system on a global scale. According the sources, the company was considering paying more than $3,000 for the Depuy hip implant claims. At this figure, total settlement may exceed $3 billion making it one of the biggest settlements in the medical device industry.

The first lawsuit settled by Depuy Orthopaedics was the claim of Robert Eugene Ottman who alleged that he experienced severe adverse complications after being implanted with an ASR hip replacement system in August 2008. In addition to the several side effects, he had to undergo revision surgery to address his injuries. Originally scheduled for a mid-October trial, it was learned that the claim has been settled with the filing of the notice of settlement before the San Francisco Superior Court.

In a court order issued on October 8, 2013 by the Superior Court in Bergen County, New Jersey, it was learned that the claim filed by Deborah and Kenneth MacDonald was settled after the case had been removed from the trial calendar. No details were released in the settlement of this claim which was supposed to start hearing on October 21, 2013.

Whether Depuy decides to settle the product liability lawsuits or proceed with the trials may become clearer in the coming months with the scheduled hearings of other ASR hip replacement lawsuits. Settlement that is fair may be beneficial to both parties. Depuy may realize huge savings in terms of expenses associated with the recall and litigation expenses which may run into millions. For the injured hip recipient, a settlement may mean he or she may be compensated for the injuries without waiting for a trial which may turn out to be a long process.

References:

fiercemedicaldevices.com/story/jjdepuy-settles-ca-metal-hip-lawsuit/2013-10-03

bloomberg.com/news/2013-08-21/j-j-said-to-weigh-3-billion-settlement-of-its-hip-implant-cases.html

Risk for Osteoarthritis may be Traced through Genes

Osteoarthritis is believed to affect millions of American, thus, making it one of the largest bone diseases in the United States today, revealed by online sources. However, researchers conducting the large-scale studies said that a person’s genetic factor may play a role in developing osteoarthritis, says an article at ncl.ac.uk/press.office/press.release/item/new-study-finds-genetic-causes-of-osteoarthritis. This discovery may be regarded to be a significant development in understanding the link between the genetic factor and the development of the disease. Osteoarthritis is a medical condition which is represented by breakdown of the cartilages.Inherited genetic factors may increase your risk of developing osteoarthritis by 50 percent.

Because osteoarthritis is considered to run in families, the osteoarthritis genes are continued to go on to the next generation, rather than their shared environment, Researchers, who are studying the many genetic features, may easily recognize the people at higher risk of developing osteoarthritis, such as those people whose risk factors include family history of osteoarthritis, hormonal changes, injury or obesity. The genetic regions, which may be the potential major risk factor that causes the development of osteoarthritis, are identified with great confidence by the researchers in the study.This considered as an essential first step.

Although the precise function of many of these genetic risk factors remains unclear, it seems that they largely act by altering the function of chondrocytes, which are the cells involved in the production and maintenance of articular cartilage. It is considered that during the start of the formation of the cartilage, these alterations are observed; when subtle alterations in cell function may affect characteristics such as overall joint shape.Further work is now needed to pinpoint the actual DNA changes within the genetic regions to establish exactly how these changes lead to osteoarthritis. Moreover, other genetic variants remained to be discovered, according to researchers, and that it involved far more genes in susceptibility to osteoarthritis than was thought.

There are only limited to non-surgical treatment options, such as pain relievers and physiotherapy until joint replacement becomes a viable option. The brand DePuy is one of the most popular hip replacement devices.Specifically, experts say, tiny fragments of metal shear off from these artificial joints, causing chronic pain or infection and raising levels of metal in the bloodstream. To understand more about this matter, more information are offered at depuyhiprecallnewscenter.com

References:

news-medical.net/news/20130702/Osteoarthritis-associated-genes-an-interview-with-Professor-Jonathan-Tobias-University-of-Bristol.aspx

arthrolink.com/en/osteoarthritis-folders/all-folders/genetics-and-osteoarthritis-0

arthritisresearchuk.org/news/press-releases/2012/july/major-new-study-finds-clues-to-the-genetic-causes-of-osteoarthritis.aspx

ncl.ac.uk/press.office/press.release/item/new-study-finds-genetic-causes-of-osteoarthritis

sciencedaily.com/releases/2010/09/100921084539.htm

manchester.ac.uk/aboutus/news/archive/list/item/?id=8463&year=2012&month=07

bbc.co.uk/news/health-18676893