(PRWEB) February 25, 2013

In a filing with the Securities and Exchange Commission on Feb. 22, Johnson & Johnson announced that the U.S. Justice Department and the U.S. Attorney’s Office were investigating the marketing practices of its subsidiary DePuy, maker of the recalled ASR metal-on-metal hip replacement system, according to the Washington Post.* The Rottenstein Law Group, which represents clients in DePuy ASR hip lawsuits, is monitoring the situation carefully and maintains an information website on cases at http://www.depuyhiprecall.us.

DePuy is currently a defendant in more than 10,000 lawsuits nationwide, most of which are part of a multidistrict litigation, which is a consolidation of pretrial proceedings (MDL-2197). The first trial, In re: Loren Kransky and Sheryl Kransky v. DePuy, Inc., et al. (BC456086, Los Angeles Superior Court), is underway in California, involving a 65-year-old retired prison guard who alleges that design flaws, device failure and metal poisoning all have caused him to suffer severe side effects. The Rottenstein Law Group has been following that trial closely since it began in January.

“Evidence from the Kransky trial, such as email communications between employees, indicates that DePuy marketed the device despite full knowledge of its flaws,” said Rochelle Rottenstein, principal of the Rottenstein Law Group. “As we learn more about marketing practices, it is apparent that people who believe their ASR metal-on-metal hip replacement has injured them should retain an advocate who can help them determine if they have a case.”


Read more: Rottenstein Law Group Comments on Report of Federal Scrutiny of Johnson & Johnson’s Marketing of Metal-on-Metal Hips

On December 14, 2011 the New York Times published an article saying that three U.S. senators have proposed a bill reinforcing medical device regulations. The authors of the bill were Richard Blumenthal (D-CT), Herb Kohl (D-WI), and Charles E. Grassley (R-IA). These senators are providing bipartisan support for a “wave of medical device industry-friendly” bills that would restructure regulations of the Food and Drug Administration (FDA), requiring more stern clearances of medical products.
Besides authoring the bill, they also sent inquiries to five major manufcaturing companies of medical devices, consulting them how they track product safety and recall devices. The manufacturers were  Johnson & Johnson, an artificial joint maker; Zimmer Holdings, another producer of artificial joints; Medtronic, a heart and spinal implant producer; Boston Scientific, a heart device maker, and C. R. Bard, a surgical implant maker.

As for Johnson & Johnson’s case in particular, after informationwas out saying that the devices have defects in one out of eight clients, the ASR XL Acetabular System and the ASR Hip Resurfacing System were withdrawn. There are about 93,000 recipients of these products worldwide. Factory production and sale of the two prosthetic items started in 2003. In August 2010, DePuy carried out a worldwide recall.

Problem with Metal-on-Metal Hip Replacements

Design problems with metal-on-metal hip implants, particularly the DePuy ASR hip devices, may cause the metal components to rub against each other and shed microscopic metal particles into the body. Body reactions to these metal particles may cause soft tissue damage, cause inflammatory reactions and lead to bone loss. This may possibly result in a need for a hip revision operation, a more risky and agonizing surgery.

The presence of the metal parts may boost the amount of chromium and cobalt in the blood. This may cause metallosis (blood poisoning) and genotoxicity (genetic damage).
In a statement, a spokeswoman for DePuy, Mindy Tinsley, said, “We believe we made the appropriate decision to recall at the appropriate time given the available information.”
 
Johnson & Johnson Faces Legal Complaints
Johnson & Johnson have been charged with compensatory claims by their patrons, legal specialists say. They were the suffering victims of DePuy product failures and defects, among them displacements, fractures and loosening. According to legal obsevers, the DePuy hip replacement recall should stand as a lesson to other device manufacturers to strengthen and certify the safety of their products.
 
References:
•         nytimes.com/2011/12/15/business/bill-would-require-more-monitoring-of-implants.html?_r=1
•         arthritistoday.org/news/asr-depuy-hip-replacement-recall078.php
•         health.ezinemark.com/patients-implanted-with-defective-mom-hip-devices-at-high-risk-of-metallosis-7d32146a00c7.html
•         usrecallnews.com/2011/01/a-brief-background-of-metallosis-cobaltism-and-metal-on-metal-hip-implants.html
 

Osteoarthritis (OA) is the most prevalent type of joint disorder. It is caused by the breakdown and eventual loss of the cartilage of one or more joints. For cases of OA that do not respond to conservative treatment, surgery, like hip replacement surgery for hip joints, is recommended.  However, an editorial written by a doctor says that many hip replacement surgeries are avoidable. 
 
OA, otherwise known as the “wear-and-tear” arthritis is idiopathic in nature. Several risk factors may cause the condition, doctors say.  However, no single risk factor is enough to cause OA.  Some of the identified risk factors include age, obesity, injury or overuse, genetics, muscle weakness, gender and other underlying diseases.  Having these risk factors does not necessarily mean that one will surely acquire osteoarthritis. 
 
Dr. Louis Pack, author of the book The Arthritis Revolution, clarified the difference between correlation and cause. Though age is believed to be the leading cause of OA, he pointed out in his editorial in CNN, that age only has a correlation to the condition. He added that age was not the reason behind the condition. Dr. Pack said that in almost all cases of osteoarthritis, only one hip or knee joint is affected. 
 
The risk-factor weight also has the same argument. Dr. Pack cited examples showing that some significantly overweight people have no joint problems. Others, who weigh far less, have arthritic joints.   He further stated that only one knee or hip is affected of the many overweight patients. Certainly, not only a single side bears the weight. 
 
What precedes the process of osteoarthritis is misalignment. A study published in the Journal of the American Medical Association in 2001 says that a five-degree misalignment from the ankle to the hip increased the progression of OA three to four times.  The researchers from renowned Mayo Clinic supported this result in 2008. The study showed that a single degree of bad alignment from the ankle to the hip will result to a 55 percent increase on the risk of OA. "Age was only weakly associated with an increase risk," according to the study. 
 
Abnormal alignment is the root cause of osteoarthritis.  Researchers say that if medicine focused more on this than trying to produce other invasive methods of treatment, number of replacement surgeries will be cut to half. There will be reduction in the number of patients needing hip replacement surgery and possibly affected by DePuy hip replacement recall. 


Reference:
ncbi.nlm.nih.gov/pubmedhealth/PMH0001460/
medicinenet.com/osteoarthritis/article.htm
mayoclinic.com/health/osteoarthritis/DS00019
arthritis.org/disease-center.php?disease_id=32http://edition.cnn.com/2011/10/28/health/alignment-hip-replacements-pack/index.html

Orthopaedics Inc. has chosen to sit a new president amidst a worldwide hip replacement recall and an impending mass litigation on its hip replacement systems. Andrew Ekdahl has replaced David Floyd, who resigned as company president, in the midst of lawsuits filed against the company alleging defective hip replacement implants.

Ekdahl who had spent more than two decades with DePuy and its parent, Johnson & Johnson of New Brunswick, N.J. is now expected to be on top of the company’s quality-control issues related to its hip products.

Last August, DePuy voluntarily recalled the ASR Hip Resurfacing and ASR XL Acetabular systems after data from the National Joint Registry of England and Wales showed that within five years, about 13 percent of patients with the acetabular system and 12 percent with the hip resurfacing system needed corrective surgery.

Ekdahl will lead the joint replacement and trauma company’s growing orthopedic operations and serve on the DePuy Franchise Global Management Board of the DePuy Family of Companies. DePuy Orthopaedics employs 1,200 in Warsaw, where it is based.

Danelle Miller, president of the board of directors for the Indiana Medical Device Manufacturers Council and legal counsel for global quality and regulatory affairs with Roche Diagnostics Corp., both in Indianapolis, said Ekdahl must contend with tighter regulatory scrutiny from the government.

Although it may take some time for a resolution on the replacements, DePuy showed resolve this month when it gained approval of a ceramic-on-metal hip implant system from the U.S. Food and Drug Administration.

According to the company, it expects the Pinnacle Complete Acetabular Hip System to offer “durability and stability, along with enhanced low-wear characteristics, that will provide surgeons with an important new option for patients with severe osteoarthritis.”

Read more about DePuy Announces New President Amidst Hip Replacement Recalls

When DePuy Orthopaedics announced a complete recall of their metal hip implants, specifically the ASR XL Acetabular System and the ASR Hip Resurfacing System, the Johnson & Johnson company stated that they are willing to pay for all the expenses and additional costs. These include various laboratory exams, such as that of blood tests, X-rays, MRIs and other indicated procedures. These are expected after it was revealed that the metal-on-metal hip implants produced by DePuy had a unusually high failure rate of 12-13%. In fact, 1 in every 8 recipients of the replacements will be advised for another hip replacement surgery. It is quite unjust, if you should add.

To address this growing issue, the company has organized their own claims process to arrange reimbursements to those affected. Recipients will receive some paperwork, which includes a letter of payment authorization and a medical authorization form. All these documents are sent to DePuy as part of the whole process.

However, they also request the doctors to assist them in collecting the extracted implants from those who underwent the revision surgeries. Apparently, they have authorized third-party laboratories to examine these implants. It is a bit surprising, and even suspicious, that DePuy is actually taking control of the hip implants. What for, exactly? DePuy might be looking for loopholes, searching for details and imploring evidences so that the recipients get the blame instead. Why surrender the implant then? Recipients need not to, if they are unwilling. After all, the hip replacements remain to be under their property, so only them can decide whatever is to do with them.

Think of what you can do before you surrender the extracted hip implant. That can be used to file a lawsuit against the company. Make an informed choice. Before DePuy outsmarts you, you ought to talk to a hip recall lawyer first. In this way, you can make the best decisions through the help of someone experienced in dealing with product liability cases.