Showing posts with label ASR hip implant. Show all posts
Showing posts with label ASR hip implant. Show all posts

July 29, 2012

Attorneys of Sullo & Sullo Seeing DePuy Hip Implant Lawsuits Increasing


While many other firms have seen a drop in the number of metal hip implant clients, Sullo and Sullo attorneys have actually seen those numbers climb. Andrew Sullo, Class Action Lead Counsel & Managing Partner notes that “Although many firms have noticed a slowdown in the number of clients hiring them for DePuy ASR and Pinnacle lawsuits, our firm has not. I believe that is because we are constantly offering our clients new and updated information. Our job is to inform all metal-on-metal hip recipients that even though their hip may not have failed yet, it could and after August 26th they may lose rights to recover compensation from Johnson and Johnson.”

With the statute of limitations coming up soon on the ASR metal-on-metal hip implant lawsuits, Sullo & Sullo is experiencing an increase in the ASR recipients who are coming forward and asking to be a part of the lawsuit. Many clients in the lawsuit have experienced adverse health effects as a direct result of having an ASR all metal hip implant put into their body.  On the other hand, many have experienced little or no pain with their ASR hip implant but have elected to join the lawsuit that they can be financial protected at a point in the future should their ASR device fail. Through no fault of their own, these people have become victims of a heavily flawed system which allows harmful medical devices to be sold to the public. The ASR was approved in 2005 by the FDA under the controversial 510(k) process which allows medical devices to essentially ride in on the coattails of other medical devices which have come before them. In some cases approval is granted based on a device which has actually been discontinued because of the number of problems associated with it.

January 10, 2011

Depuy Hip Implant Side Effects

 Hip Implants To Blame For Metal Poisoning, Metallosis and Other Long Term Health Effects. 

 Home | Personal Injury | DePuy Hip Recall | Traffic Tickets | Family Law | Criminal Defense |Get Informed

 

DECEMBER 2, 2010 - HOUSTON — If you have undergone hip replacement surgery and are experiencing any amount of pain as a result, you may be in more danger than you realize. Recent findings concerning certain types of metal-on-metal hip implant devices show that they are prone to early system failure and may even cause metal poisoning, or metallosis, which is a reaction to the metal debris that is shed when components of the device rub together. 

On August 26, 2010, DePuy Orthopedics, Inc., a subsidiary of Johnson & Johnson, announced it is voluntarily recalling two types of hip implants due to high early failure rates. The recall affects the ASR XL Acetabular System, and the ASR Hip Resurfacing system. To date, more than 93,000 of the devices have been implanted worldwide. 

In the wake of the recall, countless patients have come forward with horrific stories of pain and suffering as the result of receiving a faulty DePuy ASR implant. If you or someone you love has been implanted with one of these devices, you must understand the risks and repercussions if you fail to seek medical help immediately.
Among the problems reported, some of the most common are:
  • Swelling or pain in the effected hip or surrounding areas
  • Difficulty walking or pain in the hip when doing so
  • Grinding or popping noises originating in the hip area
  • Inflammation or infection in the affected hip
  • Dislocation or improper positioning of the implant
Perhaps the most dangerous side effect of all is metallosis, which, according to the Journal of Bone & Joint Surgery, is “aseptic fibrosis, local necrosis or loosening of a device secondary to metallic corrosion and release of wear debris.” Design problems with the devices cause the metal components to rub against each other and shed microscopic metal particles into the body, which can result in soft tissue damage, inflammatory reactions, blood metal poisoning and bone loss. 

Symptoms of metallosis from metal-on-metal hip replacement devices can include pain, inflammation, tumors and difficulty walking. Specialized blood tests can be used to detect levels of toxic metals in patients experiencing these symptoms. In some cases, patients with DePuy implants have been found with 100 times the normal levels chromium and cobalt in their bodies. 

Chromium and cobalt toxicity has been linked to cancer, and can affect the nervous system, gastrointestinal system, cardiovascular system, blood production, kidneys, liver and reproductive system.
Symptoms of heavy metal toxicity include confusion, pain in muscles and joints, headaches, short-term memory loss, gastrointestinal upsets, food intolerances/allergies, vision problems, chronic fatigue, and others. The symptoms are so numerous that it is difficult to diagnose based on symptoms alone.
The first step in treating metallosis or heavy metal toxicity is to identify the toxic elements and begin the removal process. With the DePuy ASR hip replacement system, this means a painful, costly “revision” surgery, which about 1 in 8, or 12 percent of those who have received the implants have been shown to require within 5 years. Originally, the devices were predicted to last 15 years before requiring any corrective revision. 

For many patients, intravenous Vitamin C and replacement mineral infusions are also recommended to support the body through the metal removal process. Symptoms will often begin to improve within weeks of commencing treatment, but some may linger, indicating residual organ damage. Therapy may last as long as six months to two years. 

Although a full recovery from metallosis is possible with early detection and removal of the defective DePuy ASR implant, many people suffer the effects of heavy metal toxicity for extended periods. Some of the damage, for instance to the liver or brain, may not be fully reversible, and many find that their food intolerances are never completely remedied. Unfortunately for those affected, only time will tell. 

If you or someone you love received a defective DePuy ASR device, it is imperative that you obtain the counsel of an experienced personal injury attorney. The skilled team at Sullo & Sullo, LLP will aggressively defend your rights and make sure you get compensated. Call us at 1-800-730-7607 for a free legal consultation today.

January 7, 2011

Depuy Hip Recall To The Revision Surgery Enough.

 Home | Personal Injury | DePuy Hip Recall | Traffic Tickets | Family Law | Criminal Defense |Get Informed

DePuy Wants You to Give Your Defective Hip Implant Back

After DePuy issued its recall notice, it sent a letter to the surgeons who had conducted hip replacement surgeries using the ASR XL Acetabular System. In part, the letter informed the surgeons that DePuy was offering to pay for their patients' hip revision surgery.
In exchange, the company wanted just one minor thing: the hip implant. 
On the face of it, this doesn't seem like an out-of-line request. After all, DePuy was offering to replace the faulty hip implants and told the surgeons that it wanted to see the explants to figure out what was wrong with the design and make improvements in future models. Many patients may very well have thought that returning the hip implant to DePuy was actually returning the device to its proper owner. 
Not so. DePuy has no right to your hip implant - emphasis here on your. You bought and paid for the hip implant when you first had a hip replacement surgery. It belongs to you.
The other problem, of course, is that handing over the explant is as bad as handing over the keys to your case. 
Why Your Hip Implant is Valuable to Your Case 
When archaeologists discover human bones buried thousands of years ago, they can discern amazing things about how those people lived, interacted, and died. Sometimes they can even determine the profession or position they held in society depending on the way the bones had been worn down over time. 
Your hip implant tells a similar story. The way that it has deteriorated over time will reveal whether it is your behavior or DePuy's poor design that has caused the medical problems you and others have experienced as a direct result of the implant. DePuy would very much like to prove that your lifestyle since the surgery has caused the breakdown of your hip implant. Failing that, the company would like to prove that the way your doctor placed the implant has made it ineffective. 
If DePuy holds the explant, it can attempt to imply that you caused your hip implant's failure. If you hold it, your legal representation can prove otherwise. 
The Art of Misdirection
 
DePuy offered patients a free hip revision surgery as an enticement. For patients who are fearful that their hip implant is faulty and causing problems like metal sensitivity, metallosis, heavy metal poisoning, and bone deterioration, the offer of a no-cost revision is extremely appealing. Worried that the longer they retain the hip implant, the worse off they will be, those patients are likely to sign the consent forms presented to them without reviewing them properly. Even if they do review the forms, it's not likely the full ramifications will become clear until it's too late. 
If DePuy lacked sufficient talent to properly design and engineer a functioning implant, they've made up for that shortcoming by perfecting the art of misdirection. Distracting patients with the offer of a free hip revision surgery, DePuy is making the removed hip explants disappear into thin air - or, at the very least, into the hands of their legal defense.
It's a clever con, and it is very easy to be taken in by it. Many patients have already signed away their own hip explants to DePuy in exchange for the free hip revision surgery, and have undermined their case by doing so. However, even if you have already signed the consent forms, there are ways to reverse the trick and bring the faulty hip implant out of the shadows and back into the light. 
Bad Intentions 
It is entirely possible that DePuy intends to use the explants to improve on their current model and produce a better ASR Acetabular System. However, the evidence thus far is not in favor of that story. Leaving aside the fact that DePuy never put the hip implant through clinical trials in the first place, in previous litigation on another implant case, the company's defense team used the explants to try to prove the plaintiff caused the problems himself.
In one particularly frightening story recounted to us by an attorney who referred a client to us, a hip explant was "lost" after a revision surgery. The hospital and surgeon's staff insisted that the explant was being held at the hospital after surgery. Another staff member said the explant had been thrown out along with other surgical waste, admitting later that a DePuy representative was present at the hospital on the day of the operation. 
We cannot offer irrevocable proof of this story and we have no reason to believe that DePuy representatives are actively attempting to scoop up explants immediately after surgery. However, it is a troubling story and we have no reason to disbelieve the word of the attorney who recounted it. If nothing else, it would seem to indicate that DePuy's motives are not as benign as they claim. 
Unless, of course, the representative merely wanted the explant to help the company's engineers improve the design. It must be a great comfort to the patient whose personal property was lost to know that her case was undermined for such a worthy cause. 
Don't Sign Your Rights Away 
You are entitled to a hip revision surgery without submitting your explant to DePuy. We believe you should be compensated for all medical costs related to the faulty hip implant, which would include the revision surgery. 
To put it another way, you can allow them to pay for the surgery now and lose a great deal of future compensation in the future - or you can retain your own explant and receive the compensation you are due, including the cost of the revision, after we have used your explant to make a strong case against DePuy in a mass action lawsuit.

If you are asked to sign a document waiving your right to keep your own explant, we strongly advise you not to sign it. If you have already done so, please contact our offices immediately at 1-800-730-7607 or via our online contact form. We may be able to help retrieve the explant or show that DePuy obtained it improperly.

J&J Recalls Depuy Hip Implant

Who Is Johnson & Johnson? 



"No more tears."
"The #1 choice of hospitals."
"Everything in life should be this pure."

Johnson & Johnson's slogans over the years have assured consumers, particularly mothers, that their products are - above all else - safe. However, a recent, seemingly endless stream of recalls suggests otherwise.
Children's Tylenol, Motrin Infant Drops, and Children's Benadryl are among the many medications recalled this year for manufacturing and labeling issues. Those products join recalls of Acuvue contact lenses, the allergy medication Zyrtec, and the ASR hip implant, which was sold to approximately 93,000 adults needing hip replacement surgery. A consistent pattern emerges: the company recalls products only as a last resort, and its quality controls seem to allow an inordinate number of dangerous products to reach the market - and enter the bodies of consumers.
J&J may once have cared that its products were safe. Now, it appears the company only cares if they're sold. The company consistently sells products long after it is fully aware that the products present a danger to the public.
And the FDA is helping. 

Silent Recalls
 
In a report by ABC News,  an inventory company employee named Lynn Walther tells reporters that J&J hired him to quietly purchase specific lots of Motrin IB. His instructions stated that he should, "simply act like a regular customer while making these purchases. There must be no mention of this being a recall of the product. Run in, find the product, make your purchase and run out."
Johnson & Johnson's Head of Consumer Affairs, Colleen Goggins, stated that the company had nothing to do with the buy-back, and that she didn't "believe there was any intent to mislead or hide anything." It's difficult to believe the now-retired Goggins, considering J&J has a long history of "phantom" or "silent" recalls.

In 2007, the Australia joint registry sent seven separate reports to the company identifying specific problems with the ASR device and detailing the high failure rate.  The device was withdrawn for "commercial reasons" in December of 2009 and only officially recalled in March of 2010. Meanwhile, thousands of people received an implant that may cause permanent tissue and bone damage or require a revision, which could mean they will be unable to have a successful future implant.
Other recalls show a similar pattern of attempting to minimize the amount of product recalled - or avoid a recall altogether. Where one might hope that a company would issue a recall as rapidly as possible after being informed of problems, J&J's usual response is to "wait and see", followed by an attempt to remove the product by some other means than a recall. If it does recall the product, the company issues the smallest recall possible, expanding by minute degrees to keep products on the shelves as long as possible.
Hundreds of wrongful death claims were issued over the Duragesic pain-killing patch. The jury determined that J&J was aware of the defects in the Duragestic patches, but neglected to inform doctors and consumers. the company recalled the patch that administered a 75mg/hour dose in 2004 - and waited until 2008 to recall the same patch that administered a 25mg/hour dose.
In Japan, J&J expanded a recall of its Acuvue TruEye lenses five times, from the initial 100,000 boxes to half a million.  The expanded recall was only announced in Japan. At the time of the recall notice, J&J rather cavalierly noted that the recall represented less than 1% of all contact lenses made by the company worldwide.
This fact is surely a great comfort to the 500,000 people who put acidic lenses in their eyes. We're surprised a similar statement was not made about the Duragesic pain-killing patches; surely the hundreds of people who died represented only a small - negligible, really - fraction of the product consumed worldwide.
When it comes to consumer safety, though, Johnson & Johnson would almost always prefer to look at the numbers than the people.

Fine Print in Invisible Ink

Johnson & Johnson has been reprimanded, and occasionally sued, repeatedly over the last ten years for not giving their customers adequate warning about the risks of their products. Many jokes are made about reading the fine print - but the fine print can be rather difficult to read if the warnings simply aren't put on the labels at all.

The antibiotic Levaquin is associated with tendon ruptures, particularly in older patients. The company did not warn doctors before changing its label, which meant doctors with previous lots of the medication (or ones who do not read new labels in every new lot) were unaware of the problem. The label change, plaintiffs say, remains inadequate.

The ASR hip implant may have similarly inadequate warning problems. The company's literature on the ASR implant states that it must be placed at precisely a 45-degree angle, rather than the usual range of between a 30-45 degree angle. Though it has yet to be proven that the company did not make sufficient efforts to inform doctors of the dangerous results of placing the implant incorrectly, our sources indicate that surgeons were largely unaware that this particular implant was so sensitive to proper placement.

The company  recalled 12 million bottles of Mylanta and 85,000 of Alterna Gel  due to insufficient labeling as well: no mention is made of the presence of alcohol in the products from flavoring agents. The company also recalled 9.3 million bottles of Tylenol cold treatments for the same reason, including 40 types of J&J medication specifically made and marketed as being for children.

There's Something in the Water

The range of foreign matter found in J&J products encompasses everything from the aforementioned alcohol to  metal and wood particles to  glass shavings.
Perhaps most disturbing, however, is the  bacteria found at the Johnson & Johnson plant that produced the now-recalled children's medicines. It's called Burkholderia cepacia, and while it produces little risk to healthy people, it can cause serious infections in those with weakened immune systems.
Such as, say, sick children whose concerned mothers gave them Children's Tylenol to combat fever.
The bacteria was found during an investigation by the FDA of the facilities operated by McNeil Consumer Healthcare, a unit of Johnson & Johnson that manufactures many popular medications for the company. J&J executives had previously said that the recall problems were limited to a single plant in Fort Washington, PA, that was shut down for an overhaul. However, the FDA's principal deputy commissioner states that  all of the facilities operated by McNeil Consumer Healthcare have deficiencies that could affect the qualtiy of the products being sold.
"The company had an inadequate quality system," Dr. Joshua M. Sharfstein said.
It's a mild rebuke for a serious problem. Johnson & Johnson's quality control system has allowed multiple dangerous products to get to market over the last 10 years - some of which have caused permanent physical damage or even death.
But then, the FDA has never been all that inclined to look closely at Johnson & Johnson's proceedings.

Getting Cozy with the FDA 

The House Committee on Oversight and Government Reform recently investigated the "phantom" recall of Motrin as well as individual manufacturing issues that led to the recall. They found that the FDA had visited the McNeil plants multiple times and characterized the relationship between J&J and the FDA as " too cozy."
This isn't the first time that we at Moriarty Leyendecker noted that the  FDA seems to be doing an inadequate job of ensuring quality controls are met on Johnson & Johnson products that they endorse. The FDA approved the ASR medical devices too - without asking the manufacturers to put the product through clinical testing and without seeming to notice that of the multiple devices to which the J&J company DePuy claimed the ASR was "substantially equivalent", not a one had ever actually been clinically tested by the FDA.
The FDA also claimed that it was unaware J&J was re-purchasing defective Motrin without informing consumers - a claim that was later refuted in a report by ABC News. In emails obtained by ABC, the company's employees  appear to be in cahoots with FDA officials who agreed to allow the company to buy back their product instead of issuing a formal recall
Cozy, indeed.

Cutting Corners Where it Counts

In November,  J&J announced that it intended to cut 8,000 jobs globally. It also decided to give its chief executive, William C. Weldon, an 11% increase on his salary. His new paycheck? $25.6 million. Weldon is currently the worldwide chairman of Johnson & Johnson and is currently testifying to Congress about the recent medication recalls.

Of the 8,000 employees cut by Johnson & Johnson, no mention is made of their official job titles. However, we'd like to propose that Weldon's salary might be better spent in hiring some of those employees back - to manage quality control.

Perhaps then Johnson & Johnson might be able to keep dangerously faulty products like the ASR hip implant from reaching the market. Of course, such a proposal precludes the assumption that J&J executives care more about the safety of real people than about lining their own pockets - and there isn't much evidence to support that theory.