depuy-hip-recall

J&J executive testifies DePuy ASR recalled because of clinical needs, not failure, the ...

Fri, 29 Aug 2014 15:12:33 +0100

(PRWEB) January 31, 2013

The Rottenstein Law Group, which represents DePuy ASR recall clients, is closely monitoring the proceedings of the Los Angeles DePuy ASR hip trial (In re: Loren Kransky and Sheryl Kransky v. DePuy, Inc., et al., BC456086, Los Angeles Superior Court). Most recently, the jury heard testimony from a DePuy executive who denied that the recall occurred because the device was faulty. Andrew Ekdahl, president of Johnson & Johnson’s DePuy, said in videotaped testimony that the 93,000 DePuy ASR hip implants were recalled worldwide because they did not meet the clinical needs of the market and not because they were unsafe," according to a Bloomberg story.

“Thousands of people believe they were harmed by the DePuy ASR,” said Rochelle Rottenstein, principal of the Rottenstein Law Group. “It is important that these allegations are thoroughly explored in court.”

Loren Kransky, 65, of North Dakota, alleges that the DePuy ASR caused him metal poisoning, among other problems, according to court records. DePuy asserts that Kransky’s health problems are unrelated to his now-removed hip implant, according to Bloomberg. There are more than 10,000 DePuy ASR lawsuits pending across the United States, about 7,000 of which are consolidated for pretrial proceedings in multidistrict litigation in the United States District Court for the Northern District of Ohio (MDL-2197). About 33,000 people in the United States received the ASR implant, out of 93,000 worldwide, according to Bloomberg. The DePuy ASR recall occurred in 2010. Previous testimony** from witnesses suggested that DePuy knew of the ASR’s faults several years before the recall.

Read more: DePuy ASR Lawsuit Update: J&J executive testifies DePuy ASR recalled because of clinical needs, not failure, the Rottenstein Law Group reports

Increasing Number of Complaints on Hip Implants

Fri, 01 Feb 2013 18:41:29 +0100

Complaints on hip implants continue piling up at the U.S. Food and Drug Administration (FDA) with 5,000 of them added this year alone. Some 75 percent of those claims involved the hip replacement systems of DePuy Orthopaedics Inc., a subsidiary of Johnson & Johnson. Several of those lawsuits have been consolidated into a multidistrict litigation (MDL), making it easier for initiating a hip replacement case. Due to the growing evidence against them, the British Hip Society has called for an informal metal-on-metal hip replacement imposition.

A hip implant has a typical life expectancy of about 15 years.However, the complaints seem to suggest that many recipients already had their hip replacement devices removed only after a few years of having them. One of the main reasons for the removal is that the devices have failed and has resulted to complications ranging from pain to severe reactions to chromium and cobalt particles that separate from the device as they wear inside the body. A worldwide recall of its ASR XL Acetabular System and the DePuy ASR Hip Resurfacing Platform was initiated by DePuyin August 2010.

The cup of the recalled ASR or the Articular Surface Replacement is so shallow that it is susceptible tothe so-called edge loading, a situation in which the joints ball strikes against the cups edge and causes the implant parts to rub together and chisel off debris that releases microscopic ions of the heavy metals chromium and cobalt into the body, according to Parker McDonald P.C., who represents plaintiffs seeking remedies for medical issues arising from the failure of metal-on-metal hip implant devices. Metallosis, a reaction of the bodys immune system to heavy metals with potential negative effects on multiple organs and organ systems, could result from the elevated levels.

The five-year failure rate of this product was approximately 13 percent based on a study by the National Joint Registry (NJR) of England and Wales, or one in every eight patients receiving one of the hip implants, according tothe DePuys website. In its recall notice, DePuy had assured that it is committed to assisting patients and health care providers by providing information through multiple channels and paying for the cost of doctor visits, tests and procedures associated with the recall. The company further stated that it intends to cover reasonable and customary costs of monitoring and treatment for services, including revision surgeries, associated with the recall of ASR.

With 350 cases filed just last month alone, more and more recipients have opted to file a case against J&J despite the DePuy hip recall assurances. The total number of cases filed since January 2011 has grown to 1,700 with 700 of the cases filed in July and August same year. The realization that DePuys reimbursement plan will not provide them with all types of compensation they deserve, such as unquantifiable damages like pain and suffering and disruption to family life, has probably pushed these recipients press for compensatory claims.

References:
•    businessweek.com/news/2011-05-03/medical-groups-tracking-hip-knee-implants-after-j-j-recall.html
•    nytimes.com/2010/08/27/business/27hip.html
•    tga.gov.au/newsroom/btn-dupuy-recall.htm

Senators propose bill concerning unsafe medical products

Fri, 01 Feb 2013 18:41:03 +0100

Reaching out to fellow Republicans and seeking bipartisan support, US Democrats aim to block of medical devices with safety issues, Bloomberg reports. They mentioned injuries from flawed medical products, including those manufactured and distributed by Johnson & Johnson.

In a statement released by the Democrats led by Representative Edward Markey of Massachusetts, he explained that the bill introduced would close a loophole that lets devices win approval on the basis of their similarityt to a product alreadymarketed and sold in the market.

The bill also requires the Food and Drug Administration (FDA) to review previously cleared products to determine whether any have recalls in their device lineage, as was reported by Bloomberg News.

For the bill to become law, it would need to pass the Republican-controlled House and Democratic-led Senate and then win US President Barack Obama’s signature.

Markey’s bill is one of more than a dozen introduced in Congress to overhaul device reviews, in response to consumer advocates who say products need to be safer and industry group spokesmen who say the process is too strict.

Case of Johnson and Johnson’s Recalled Hip Devices

As for Johnson & Johnson’s case in particular, after information was 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. These devices were manufactured in 2003 by DePuy Orthopaedics Inc., a subsidiary of Johnson& Johnson. There are about 93,000 recipients of these products worldwide, including 40,000 in the US alone.

In November, a legislative panel in Australia issued a report concluding that Johnson & Johnson was possibly well-aware of the serious setbacks of DePuy hip replacement before recalling it in August 2010.

“Many people could have avoided considerable pain, suffering and diminished quality of life if the company had acted in a responsible manner to known problems with these devices,” the Australian media report said.

Included in the list of the complications that may result from DePuy hip implants are loosening of hip device, additional hip replacement surgery, detachment of hip device from the bone, unexplained hip pain, hip dislocation, metal toxicity (metallosis), pseudotumors, genetic damage (genotoxicty), bone fractures, bone loss, tissue damages and cancer due to the presence of chromium and cobalt in the blood.

Increasing Number of Lawsuits against Johnson and Johnson

As of early October 2011, there were already approximately 3,500 DePuy hip replacement lawsuits that have been filed against Johnson & Johnson in connection with their hip replacement devices. DePuy advises their clients to consult a doctor for the evaluation of their hip replacement device.

References:

Australia Takes Stand on the Metal-Metal Hip Implant Crisis

Fri, 01 Feb 2013 18:42:12 +0100

The high failure rate of the ASR hip system was made public through the reports of the Australian National Joint Replacement Registry. The negative feedback thrown at the all-metal hip implant of DePuy Orthopaedics urged the company to recall the devices in 2009.Recent reports say that an Australian government agency might require doctors to report defective implants.

Evidences that point to the recall is being gathered and investigated by Australia, as was done by the United States. The director of the Australian National Joint Replacement Registry, Dr. Stephen Graves, says that the registry has detected a 50-percent, higher-than-normal failure rate in the ASR hip system. The director remarked that “It is a complete untruth that DePuy did not have reason to withdraw the ASR before now; we have been telling them since 2007, but they allowed it to be used on thousands of people.”

The Therapeutic Goods Administration called for the pull out the faulty implant two years after it first knew about the failures. Health advisories were issued by the TGA to doctors but not to general consumers.Dr. Graham Mercer, president of the Australian Orthopaedic Association, says that the TGA should act faster on prostheses shown to be failing at higher rates by the National Joint Replacement Registry, which is operated by the association. Moreover, he calls for a tighter premarket testing of a prosthesis before general use is permitted.

The concern on all-metal hip implant was tackled in the recently concluded Australian Senate Community Affairs Committee hearing.It recommended that the TGA require doctors to report any incidents of defective devices in their patients. The report states that the "The committee recommends the Department of Health and Ageing introduce mandatory reporting for health practitioners to the TGA on relevant issues in certain circumstances including problems with medical devices." Also part of the Senate’s recommendation is the clampdown on incentives given to doctors by pharmaceutical companies and device manufacturers for using their products.

The News Australia reported that in the country, roughly 5,000 patients were given the DePuy ASR hip implant. Even before the issuance of the DePuy hip replacement recall, Australia already had a functioning artificial joint replacement registry. Researches from both Australia and UK’s National Joint Registry helped the consumers become aware of the device-related problems of DePuy ASR recipients.Doctors and patients in the United States now pay close attention to the registry’s findings even if they are tracking patients who are non-US citizens because no such registry exists in the country.

Reference:
news.com.au/breaking-news/doctors-could-be-forced-to-report-faults/story-e6frfku0-1226203054020

mydepuyrecall.com/depuy-hip-implant-recall-history.htm

smh.com.au/national/health/surgeons-happy-to-be-supported-by-companies-behind-hip-implants-fiasco-20111010-1lhmh.html

theaustralian.com.au/news/health-science/medical-devices-in-spotlight/story-e6frg8y6-1226122720529

Hip Replacement Indications: OA and RA

Fri, 01 Feb 2013 18:42:20 +0100

Each year in the United States, about 200,000 to 300,000 hip replacement procedures are done, as tallied by the American Academy of Orthopedic Surgeons (AAOS). A greater number of these patients are older adults, 60 years old and up. In hip replacement, the damaged joint is removed and replaced with a new prosthetic device. Manufacturers of hip implants have marketed various designs of the device. DePuy Orthopedics recently initiated a campaign telling recipients’ stories to potential recipients, as another means of promoting their hip implants. DePuy is a company of Johnson & Johnsons Inc.

The major indicator for hip replacement is pain. According to a study, Indications for Total Hip Replacement dated 2006, surgeons and referring physician both agreed that pain (rest pain) and impairment of daily function like walking, climbing stairs and rising from a sitting position are the main indicative manifestation for them to recommend THR. The most common cause of hip pain and disability is arthritis: osteoarthritis and rheumatoid arthritis. Breakage of the bone’s continuity, more commonly known as fracture, may also require hip replacement.

Degenerative joint disease, also known as osteoarthritis (OA) is the most common joint disorder and is frequently the most disabling. Individuals who are more than 50 years old and with a positive family history of arthritis are usually affected by the condition. Increasing age directly relates to the degenerative process in the joint, as the ability of the articular cartilage to resist repetitive blows diminishes. With reduced cushion, rubbing of bones against each other may happen resulting to pain, stiffness and impaired function.

Rheumatoid arthritis or RA is an autoimmune disease wherein the synovial membranes is inflamed causing articular cartilage dysfunction, leading to pain and stiffness. RA is an autoimmune disease, which means that the body is attacking its own tissues, a condition very different with OA. Women are 2-3 times more affected with the condition than men. Classic symptoms of RA include swelling, erythema, joint pain and decreased function.

Management for both OA and RA generally includes exercise, lifestyle modification and analgesics, and can be a single or combined approach. But in more advanced cases, surgery or joint replacement is advised. As prescribed, patients suffering from osteoarthritis or rheumatoid arthritis of the hips may undergo a hip replacement surgery. The patient, his family, his primary doctor and his orthopedic surgeon should collaborate on deciding whether to have hip replacement or not. They should all discuss and decide what surgical approach to use and what kind of hip device will be implanted. The device manufacturer DePuy Orthopedics has ordered a worldwide DePuy hip recall on their DePuy ASR after it was found out in certain studies that the device was faulty.

Metal Poisoning and Its Symptoms May Be Experienced By DePuy Recall Patients

Fri, 01 Feb 2013 18:42:43 +0100

The ASR XL Acetabular System and ASR Hip Resurfacing System are orthopedic hip replacement devices manufactured by DePuy and both were recalled from the worldwide market in August of 2010. It was discovered by a foreign joint registry that these implants inherently have flaws that contributed to its high failure rate. Components from the hip replacements rub together that cause metal ions such as cobalt and chromium to get scraped off and be absorbed by the body into the bloodstream. Some DePuy recipients experience metallosis or metal toxicity as a result of this occurrence.

Normally, a person's body contain cobalt and chromium but high levels of these could prove deadly. Generally, metal poisoning has these side effects:

Brain fog
Persistent pain
Persistent feelings of malaise
Gastrointestinal problems
Emotional disturbance
Recurring infections
Dizziness
Headaches
Allergies to certain foods
Problems with the nervous system
Cardiomyopathy
Problems with hearing, sight or cognition
Peripheral neuropathy
Skin rashes
Hypothyroidism

You may suffer from metallosis if you are going through some or all of the symptoms mentioned above and if you were implanted with a DePuy hip replacement unit. You should make seeing your physician a priority. Have yourself undergo a complete medical assessment and testings to find out if your health have been affected by the defective hip implants. After doing so, your next move should be to discuss legal options with an experienced product liability lawyer.

DePuy has an obligation to compensate you if you have been made to suffer as a result of using their products. Your condition could worsen if you do not take action as soon as possible. Should you wish to learn more about the case, you may go to the DePuy hip recall information site.

DePuy Hip Recall Should Have Been Issued Years Back

Fri, 01 Feb 2013 18:42:51 +0100

There is definitely no doubt about it. DePuy Orthopaedics should issued a recall the moment they knew that their implants were defective. In fact, they should have never released their ASR implants to the market, because they never underwent clinical testing procedures set forth by the Food and Drug Administration in the United States. It was eventually found out that the ASR XL Acetabular System and the ASR Hip Resurfacing System both had a failure rate of 12-13%. It can also affect 1 in every 8 recipients--quite an alarming figure, if you might add.

The truth is, DePuy was able to spot a loophole in one of FDA’s regulatory policies, and the company was able to circumvent this rule according to their benefit. They should not be surprised that their products yielded nothing but complications, because they were not routinely tested by the FDA. This fact can lead us to think, “What more products do they manufacture, that contain nothing but defects?” This is only a speculation--but quite a valid one, given that they have shown nothing but sheer negligence in manufacturing health care devices.

Now that the DePuy hip recall is at its peak, more victims speak up, and so lawsuit just keep on mounting. In Canada, three class actions are set to face the company, while a multi-district litigation is ongoing in the United States. Let us keep our fingers crossed that the verdicts of these lawsuits will be fair, and will ultimately benefit both sides without compromising justice. After all, the victims of the defective hip implants really do need to be compensated for the damages, including out-of-pocket expenses.

Credits to: DePuy Hip Implant Warnings Issued Many Times Prior to Recall

Settling With DePuy: Reimbursement or Hip Recall Lawsuits?

Thu, 23 Dec 2010 14:00:17 +0100

DePuy Orthopaedics has manufactured their own patented brands of metal-on-metal hip implants, the ASR XL Acetabular System and the ASR Hip Resurfacing System, both of which have been deemed as defective and harmful for human use—at least most of them. Just this year, the controversial company announced a product recall on these hip implants as a response to the angry complaints of the recipients. Above all, DePuy is also willing to provide reimbursements to those who were affected.

The question is, “How can I be so sure with the reimbursement?” What do you think does DePuy consider your injuries worth? In truth, this so-called reimbursement is not enough to compensate for all your out-of-expenses, not even a teeny bit. All they do is gather important information from you, which they can use against you, until your chances of filing a lawsuit become hazy—which is one reason why you should be very careful about disclosing your information. If they unfortunately manage to convince you into settling with their reimbursement plan, it may be too late for you to make effective measures. In fact, they can ask you to surrender your hip implant, which you should never do because it remains to be your personal property—another reason why you should be very careful. They intend to pay you with “reasonable and customary costs of testing and treatment” from the defective implant, yet they cannot even clarify the meaning of this phrase, which defeats the true purpose of reimbursement.

So what should you do to avoid getting hoodwinked by DePuy? Simple—do not settle with their own version of reimbursement, no matter how difficult the DePuy hip recall has been to you. Never play with the enemy. The best move to make is to consult a good hip recall lawyer—your attorney will make matters easier for you to handle.

Doctor, Also A Co-Creator of Recalled DePuy Implants, Sued by Patient

Tue, 14 Dec 2010 17:21:04 +0100

Months have passed since the product recall was issued by DePuy Orthopaedics, a subsidiary of company giant Johnson & Johnson. Within this time frame, thousands have aired out their concerns regarding the defects of their hip implants, the ASR XL Acetabular System and the ASR Hip Resurfacing System, which both had a 13% failure rate. Typically, patients implanted with the faulty devices will experience pain, weakness and swelling in the hip region a few months or years after the hip replacement surgery, indicating that the implants have indeed failed in catastrophic ways one can never imagine. As a result, the recipients filed their own lawsuits against the company. Typically, surgeons do not play crucial roles in the legal complaints, but one doctor may be held liable for co-developing recalled DePuy hip implants.

Just recently, a recipient of a DePuy implant sued a California doctor—an orthopedist, to be specific—who co-produced the ASR devices. The plaintiff alleges Dr. Thomas Schmalzried has received a particularly large royalty amount from DePuy without disclosing his affiliation with the company. With this, one can suspect that Dr. Schmalzried may have something to do with the defects, or at least have some information, because he is also part of the brains of the whole invention. Being a co-developer of the defective implants, he is indeed well interested in the success of the products.

Victims of the DePuy hip recall may find it too difficult to trust their physicians now, which is perfectly understandable. However, it is also a dire need to see a physician, especially when a defective hip implant is causing a lot symptomatic troubles. The worst case scenario is the development of serious, irreversible damage, all because of the faulty prosthesis. If you are unsure of what to do, you might as well consult a hip recall lawyer to help you explore your legal options.

Rehab After Revision Surgery More Difficult Than the First

Fri, 03 Dec 2010 15:42:18 +0100

Surgeries, being invasive procedures, have accompanying risks that are most likely to occur during the post-operative phase, when the patient is most vulnerable. Orthopedic surgeries are no exception, even if no internal organs are harmed. Hip replacements are commonly performed procedures, and the functionality of hip prosthetic devices implanted into the joints determines how a patient will react in the coming days.

The ideal duration for hip replacement patients to undertake rehabilitation therapy is up to three months, long enough to regain the strength in the hip area. Unlike most hip implants, however, those from DePuy Orthopaedics, particularly the ASR Acetabular System and the ASR Hip Resurfacing System, last for six months to a year. This is because of the defects that they carry, and having a failure rate of about 13%. It is important to note that therapy after revision surgery differs significantly from therapy following the first hip replacement.

On the first two days following the hip surgery, the patient is encouraged to gradually sit up, stand up, and walk with assistance.

Three to five days afterwards, the patient is discharged from the hospital, provided that no complications have taken place, otherwise the patient would still have to be monitored.

From discharge to six weeks after, the patient starts learning weight-bearing exercises to gradually develop range of motion, improve physical strength and promote well-being.

From six weeks to three months, the patient continues regular exercising, especially in the hips, trunk and the knees. The use of canes, crutches and walkers is discontinued. Strenuous exercises, like stair climbing, running and biking can be initiated.

After three months, the patient is expected to have regained most of the strength in the hip area without any complications.

This timeline mirrors the progress that the patient is expected to show after the hip replacement surgery. As mentioned earlier, the rehabilitation therapy after a hip revision surgery is a much slower and rather difficult process. Victims of the DePuy hip recall not only get to feel the complications of a defective implant, they also have no choice but to undergo a revision surgery to take out the faulty device. Truly, this is not the usual challenges that you face every day. What you need to do is file a lawsuit against DePuy, with the help of a good hip recall lawyer specializing in cases like these.