Miss the Filing Deadline for Your DePuy ASR Hip Case? There May Still Be Hope

Despite the fact that the August, 2010 recall of the DePuy ASR metal-on-metal hip implant caused a significant stir among the medical community, thousands of recipients of the metal implant remained unaware of recall and subsequent warnings. Due to the initial FDA notice which was issued July 17, 2010 and the recall of the implant on August 24, 2010, all those who live in a state which operates under a two-year statute of limitations may have already lost their right to file suit against DePuy and Johnson and Johnson. Over half of the states do operate under that two year SOL, while others extend that time limit to three, four, six or even ten years. A handful of states have a one-year statute of limitations.  If you are the recipient of a DePuy metal hip implant it’s important that you determine your state’s statute of limitations for defective medical products even if you are currently having no problems with your implant.

Although DePuy originally set their metal implant’s failure rate at approximately 5%, they increased that number to 12% at the time of the 2010 recall. Independent studies place the likelihood of a DePuy ASR implant failure much higher—50% at five years following implant surgery and 80% at eight years following implant surgery. Statistically speaking, even those patients who have not yet experienced failure of their hip implant or adverse health effects from metal toxicity will do so in the very near future. It is extremely important that all DePuy ASR implant recipients at least be aware of their options prior to the date the statute of limitations will run.

The DePuy ASR Metal-on-Metal Hip Implant: A Scientific Analysis of its Problems

The last ten years have seen surgical replacement of hip joints with an artificial prosthesis increase significantly. The main reason for this surge in hip replacement surgeries is our aging population. With people living longer, more active lives, degenerating hip joints can put a halt to that activity. From 1997 through 2004, the number of hip replacement surgeries increased nearly 50% and if the trend continues it is estimated that the annual number of hip replacements in the United States will reach 600,000 by 2015.

Factors in Hip Replacement Surgery

Primary reasons for patients undergoing hip replacement surgery include chronic pain, impairment of daily functions and severe arthritis in the hip joint. The most common type of arthritis leading to total hip replacement is osteoarthritis and is generally seen with aging or trauma to the hip joint. In some instances necrosis of the hip can be present, usually caused by a fracture, alcoholism, lupus, or taking steroid drugs such as prednisone. Patients may experience progressively worsening chronic pain which prohibits them from walking, climbing stairs or even getting up from a sitting position.

Types of Hip Implants

There are many different types of hip replacement implant including the metal-on metal, metal-on-polyethylene and metal-on-ceramic as well as the implants which are 100% ceramic or polyethylene. Other than the materials the implant is constructed with, the only other major difference is in how the implant is affixed—it can be cemented to the bone or attached in such a manner that it grows into the patient’s remaining bone. The idea behind the cobalt and chromium metal-on-metal hip implant was to create an implant which would not have to be re-done for fifteen to twenty years—unlike the ceramic and polyethylene hip implants which last approximately 8-12 years. 

First Three DePuy Cases settled by Johnson & Johnson for over $600,000

The DePuy metal-on-metal hip implant, approved by the FDA a mere seven years ago—has been inundated with over 8,000 lawsuits claiming the implant is inherently defective and can lead to costly and painful revision surgery as well as a myriad of other serious health issues. DePuy initially claimed the failure rate of the ASR metal hip implant to be between 4-5%. When DePuy voluntarily recalled the implant in 2010, they upgraded the failure rate to approximately 12% within the first five years. Studies independent of DePuy or Johnson & Johnson place the failure rate of the ASR metal implant at 50% within six years and 80% within eight years. These staggering numbers almost guarantee that this particular metal-on-metal hip implant will fail at some point in the majority of recipients.

Nearly a hundred thousand ASR devices were implanted worldwide prior to the recall with nearly forty thousand in the United States alone. The propensity of the implant to loosen and detach as well as the thousands of reports regarding adverse health effects from high levels of chromium and cobalt have led to over 6,000 lawsuits filed in federal court an another 2,000 filed at the state level in Maryland, California, Nevada and other states. Johnson & Johnson recently settled three Nevada cases for $600,000—an amount considered to be at the low end of the expected $200,000-$500,000 to settle each case.

“ASR” type Chromium and Cobalt Poisoning also being seen in Pinnacle Hip Implant Recipients

The DePuy ASR metal-on-metal hip implant has repeatedly made the news following a voluntary recall on August 26, 2010. While DePuy’s Pinnacle metal hip implant has not suffered under the recall stigma, many feel that it offers the same risks to implant recipients as the ASR. And, in fact, many attorneys are constantly asked by their clients about the differences between the ASR and the Pinnacle. The primary distinction between the two metal hip devices lies in the fact that the Pinnacle uses an insert liner between the acetabular cup and the femoral head while the ASR does not. It has been theorized that the ASR cup was too shallow for the head, leading to the ball hitting the edge of the cup and metal shavings to shear off into the body, also know as edge-loading.

While the Pinnacle’s cup was designed to give greater depth and allow the femoral head to move more freely within the socket, in some cases it still has been know to cause metallosis in implant recipients when the cobalt and chromium ions migrate around the body. Metal poisoning can cause a wide variety of adverse medical events. Many ASR recipients have had cardiovascular, renal, neurological and thyroid issues although studies done in the 70’s do not definitively tie these metals to cancer. Unfortunately, due to the lack of comprehensive studies on safe levels of cobalt and chromium in the body and the effects of toxic levels, nobody really knows just how dangerous these metals can be should they migrate to the bloodstream. The metal shards can also lodge into the surrounding tissues causing degeneration and destruction.

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 26^th 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.

Current Updates on the DePuy ASR Hip Recall

The DePuy ASR metal-on-metal hip implant was approved in 2005 by the FDA, but soon thereafter both DePuy and the FDA began receiving reports of adverse health events. Some believe that the much less rigorous 510(k) approval process which allows manufacturers to skip clinical trials could be at least partially responsible for the adverse health effects in the thousands of ASR recipients. Following a flurry of complaints, DePuy voluntarily recalled the ASR on August 26, 2010. At present there are approximately 4000 DePuy ASR lawsuits consolidated into an MDL in Ohio as well as a smaller mini-state consolidation in Chicago with approximately 600 plaintiffs and another in California containing 1500 or so plaintiffs. Since California is experiencing so many financial problems, the plaintiffs and their attorneys are expected to face problems in getting a trial setting.

The MDL, or multi-district litigation system is meant to streamline the litigation process, taking advantage of the fact that there are similar allegations from all plaintiffs made against the defendants—in this case DePuy and Johnson and Johnson. The first trial regarding the ASR was scheduled to begin in state court in Las Vegas in mid-December although it has been rumored the case settled prior to trial. Should this be true, it would be a positive precedent for all other ASR lawsuits to follow. The metal-on-metal design came about due to its ability to last significantly longer than the metal-on-ceramic or metal-on-plastic hip implants. Unfortunately, the metal-on-metal design allowed the cobalt and chromium ball and cup to shave off microscopic metal ions into the body, entering the surrounding tissues or even the bloodstream. The FDA recently held a two-day panel to discuss the safety of the metal hip implant. 

Is Joining the DePuy ASR Class Action Lawsuit still an Option for Recalled DePuy ASR Hip Implant Recipients With No Pain?

Andrew Sullo, Class Action Lead Counsel & Managing Partner at Sullo & Sullo is working hard to ensure that every single recipient of the DePuy ASRmetal-on-metal hip implant is fully aware of both the recall on August 26, 2010 and the upcoming statute of limitations expiration for those who reside in states which implement the two-year statute. There are over 40,000 people who have received an ASR implant in the United States. The ASR was approved by the FDA in 2005 and began being widely used by surgeons who believed the metal-on-metal design would last much longer than the metal-on-ceramic or metal-on-polyethylene models.

Unfortunately, adverse health reports began pouring in with over 17,000 such reports received by the FDA regarding these all metal hip implants. Of those thousands of recipients, there are only approximately 6,000 who have joined into the MDL lawsuits against DePuy. While this might cause some to wonder if the risks of the ASR have been exaggerated, there are other factors involved. First of all, many recipients may not have heard the device was recalled or may truly have no idea what type of implant was used in their surgery. Second, many recipients of the ASR and other hip implant devices are senior citizens who may believe the symptoms they are experiencing are related to advancing age rather than attributing them to the ASR implant.

Finally, many of those who have not come forward to take part in the lawsuits state they are not having any problems with the ASR at present, so why would they sue the company? This is very flawed logic in this particular instance. Although the failure rate of the ASR was originally stated by DePuy to be in the 12-13% range—still much higher than the average of .5-5% failure rates—experts in the field have estimated that by six years following the initial surgery nearly 50% of the ASR hip implants will have failed and by eight years following the surgery a staggering 80% will have failed. When you look at those numbers you can see that it is highly likely that at least half of those thousands of people who have not joined into the lawsuit will suffer a hip failure. In fact, Andrew Sullo notes that “More than 50% of our ASR hip recipient docket has already received revisions.”

Problems with the DePuy Pinnacle Hip Implant: Current Reports

As of this date the Pinnacle metal-on-metal hip implant device manufactured by DePuy has not followed in the recall footsteps of DePuy’s other hip implant, the ASR. While Johnson and Johnson and DePuy vigorously deny that the Pinnacle has any problems—and, in fact, call it the best metal-on-metal hip implant on the market today—many recipients of the device feel it has some of the same flaws as the ASR. Both the Pinnacle and the ASR are manufactured by Johnson and Johnson’s subsidiary company, DePuy. The Pinnacle made its debut in 2002 as the predecessor of the ASR which followed in 2005. The ASR is strictly a metal-on-metal hip implant device while the Pinnacle name includes metal-on-ceramic and metal on polyethylene models as well.

Nearly 150,000 Pinnacle all-metal hip replacements have been implanted compared to 93,000 ASR’s worldwide—approximately half of those in the United States alone. Both the Pinnacle and the ASR all-metal hip implants were approved under the controversial 510(k) FDA approval process. This particular process allows the majority of medical devices to get to market quickly by showing they are substantially comparable to a device which has already gained approval. The process also allows a product to get to market without expensive clinical trials however in some cases the approval process has been predicated on a device which is no longer marketed—even due to poor performance. 

Chromium and Cobalt Poisoning: What are the Long Term Side Effects of Metallosis?

It is likely that the recipients of a metal-on-metal hip implant have heard about the possible consequences from the metal shavings which can be released into the body when the metal cup and ball rub against one another during normal activities. Tiny ions of cobalt and chromium shear off when the two surfaces meet and those ions can lodge in the surrounding tissues or can end up in the bloodstream. As more and more metal hip implant patients are realizing the seriousness of metal toxicity, blood testing for elevated levels of metals is increasing. In many cases patients have been found to have levels of cobalt and chromium in their bloodstream which are as much as a hundred times normal levels. 

Although slightly elevated levels of these metals are fairly normal for patients with metal-on-metal hip implants, extreme elevations can be very dangerous—and anxiety-producing for the patient. DePuy released a report indicating that concentrations of the metals greater than 7 parts per billion are cause for concern. The Mayo Clinic has set somewhat different reference values, stating that blood serum concentrations of chromium greater than 1ng/mL suggests significant wear of the metal implant while serum concentrations greater than 5.0 ng/mL of cobalt can be considered toxic and also suggest significant wear of the prosthesis. Remember that 1 PPB (part per billion) equals 1.0 ng/mL.

U.S. Drug Watchdog Urges Pinnacle Hip Implant Recipients to Come Forward

Over 130,000 Americans received a DePuy Pinnacle metal-on-metal hip implant between the years of 2005 and 2010. Although its counterpart, the DePuy ASR XL hip replacement system was recalled in 2009, the Pinnacle, while employing the same construction methods and materials, has not been recalled. Because of the recall of the ASR, there is mounting concern that the Pinnacle may also expose recipients to the dangers of metallosis or metal toxicity. The U.S. Drug Watchdog has stated their goal of reaching each and every one of the recipients of the Pinnacle implant to ensure none who have suffered harm are left behind.

Although only about a thousand people have come forward to date, the U.S. Drug Watchdog believes those numbers will grow rapidly, reaching well over 100,000. When the victims are properly identified they will then be provided access to the most knowledgeable attorneys who possess a thorough background in the intricacies of the metal hip implant. The objective of the U.S. Drug Watchdog is to ensure every person who had their health harmed because of a metal-on-metal hip implant receives appropriate compensation for failure of the implant.

DePuy Litigation: Statute of Limitations Depuy Lawsuits

By Independent Staff Writer


In August of 2010 DePuy Orthopedics, Inc. recalled two of its most popular hip replacement systems—the ASR XL Acetabular and the ASR Hip Resurfacing System. The recall came on the heels of a study which indicated the five-year failure rate of these products was as high as one in every eight patients. Severe pain and metal toxicity in the blood have required many of those who received a DePuy hip replacement to have revision surgery to replace the defective implant. Although the DePuy Pinnacle system has not yet been recalled it utilizes the same metal-on-metal design as the ASR, and many of those who received the Pinnacle implant have experienced the same symptoms including loosening of the hip implant, unsafe chromium and cobalt levels in the blood and extreme pain.  

What is a Statute of Limitations?
All lawsuits filed in the United States have an expiration period known as the Statute of Limitations. After this time period has passed an injured party is prohibited from filing a recovery case. These statutes are meant to guard companies from being exposed to lawsuits for long periods of time as well as to ensure the suits are filed while evidence is preserved and memories are clear. Depending on the state you reside in the statute of limitations for product liability can range from two to six years.

DePuy’s “Offer”
Following DePuy’s recall of their hip implants the company stated that patients who met specific criteria might be able to have some of their medical costs covered. Before any type of reimbursement is issued, however, DePuy will review patient’s medical records to determine whether the patient is eligible for reimbursement. The problem with this is that DePuy states the patient’s medical records must confirm a revision surgery is definitively related to the ASR recall rather than another cause such as a “traumatic fall.” In other words, the company is likely to attempt to blame the failure of the hip implant on a pre-existing condition, an underlying disease, physician error or misuse, therefore providing DePuy with sensitive medical records could well mean you would receive no money at all for the defective product implanted in your body.

Reviewing the Safety of Metal-on-Metal Hip Implants

By Independent Staff Writer

According to a recent BBC Newsnight investigation, literally hundreds upon thousands of patients across the globe may have been exposed to potentially toxic substances following the implantation of metal-on-metal hip implants. Even though it is now believed that the dangers of these hip devices—which appear to have been very poorly regulated at best—was well known and documented for decades, recipients of the devices were nonetheless kept in the dark. The implants which are in question are known as “metal-on-metal,” and are constructed via a head at the top and a lining the head fits into which are made of cobalt-chromium alloy.

The Failure Rate of Metal-on-Metal Hip Implants
These hip implants are used in hip replacements and hip resurfacing, and came into wide-spread use in the 1997. The target group for these metal-on-metal hip replacements was younger, still-active patients who expected the hip replacement to last the rest of their life. Unfortunately, the numbers show that the failure rates among both genders are significantly higher than normal—from 11.8% failure in resurfacing to 13.6% for the total hip replacement as compared to rates of only between 3 and 5% for implants made of other materials.

How Many People Have Hip Implants?
Since 2003, the BBC article reports that over 60,000 patients in England and Wales and over a million in the United States have received the potentially dangerous metal-on-metal hip replacement. The metal ions from the cobalt and chromium hip implants are believed to seep into local tissues causing reactions which can not only destroy muscle and bone but can eventually leave the victim with a permanent disability. The fact that cobalt and chromium can lead to such serious health issues was actually documented in scientific journals over three decades ago.

Was There a Cover-up?
DePuy, a major manufacturer of the metal-on-metal hip implant, released an internal memo in 2005 which stated that in addition to possible changes in immune functioning there was additional concern that the metal debris from the device could be carcinogenic. The memo went on to state that the possibility of distant effects of the device was “worrying,” and that one study indicated a three times higher risk of lymphoma and leukemia ten years following the hip replacement. Despite these very real concerns DePuy continued marketing the device and indicated none of the potential health concerns in their subsequent promotional materials.

A Discussion of the Long-Term Health Effects of the Hip Implant
In 2006 the Medicines and Healthcare Products Regulatory Agency convened a meeting to discuss the long-term health effects of the metal-on-metal hip implant made from cobalt and chromium. An advisory board was appointed, however out of the group’s eight members, two were consultants for DePuy and one was the director of product development for Smith and Nephew—obvious conflicts of interest. In the end the group chose to sidestep the potential dangers of the metal-on-metal hip implants, even refusing to warn women of child-bearing age of the potential dangers despite the fact that metal ions had previously been detected in umbilical cord and placental blood among women with the implant. No alert was put out to either surgeons or patients, and it was not until March of 2011 that the British Orthopedic Association sent out a warning advising that the metal-on-metal hip replacements should be “carefully considered and possibly avoided.”

DePuy Litigation: Statute of Limitations Depuy Lawsuits

By Independent Staff Writer

In August of 2010 DePuy Orthopedics, Inc. recalled two of its most popular hip replacement systems—the ASR XL Acetabular and the ASR Hip Resurfacing System. The recall came on the heels of a study which indicated the five-year failure rate of these products was as high as one in every eight patients. Severe pain and metal toxicity in the blood have required many of those who received a DePuy hip replacement to have revision surgery to replace the defective implant. Although the DePuy Pinnacle system has not yet been recalled it utilizes the same metal-on-metal design as the ASR, and many of those who received the Pinnacle implant have experienced the same symptoms including loosening of the hip implant, unsafe chromium and cobalt levels in the blood and extreme pain.  

What is a Statute of Limitations?
All lawsuits filed in the United States have an expiration period known as the Statute of Limitations. After this time period has passed an injured party is prohibited from filing a recovery case. These statutes are meant to guard companies from being exposed to lawsuits for long periods of time as well as to ensure the suits are filed while evidence is preserved and memories are clear. Depending on the state you reside in the statute of limitations for product liability can range from two to six years.

DePuy’s “Offer”
Following DePuy’s recall of their hip implants the company stated that patients who met specific criteria might be able to have some of their medical costs covered. Before any type of reimbursement is issued, however, DePuy will review patient’s medical records to determine whether the patient is eligible for reimbursement. The problem with this is that DePuy states the patient’s medical records must confirm a revision surgery is definitively related to the ASR recall rather than another cause such as a “traumatic fall.” In other words, the company is likely to attempt to blame the failure of the hip implant on a pre-existing condition, an underlying disease, physician error or misuse, therefore providing DePuy with sensitive medical records could well mean you would receive no money at all for the defective product implanted in your body.

Reviewing the Safety of Metal-on-Metal Hip Implants

By Independent Staff Writer

According to a recent BBC Newsnight investigation, literally hundreds upon thousands of patients across the globe may have been exposed to potentially toxic substances following the implantation of metal-on-metal hip implants. Even though it is now believed that the dangers of these hip devices—which appear to have been very poorly regulated at best—was well known and documented for decades, recipients of the devices were nonetheless kept in the dark. The implants which are in question are known as “metal-on-metal,” and are constructed via a head at the top and a lining the head fits into which are made of cobalt-chromium alloy.

The Failure Rate of Metal-on-Metal Hip Implants
These hip implants are used in hip replacements and hip resurfacing, and came into wide-spread use in the 1997. The target group for these metal-on-metal hip replacements was younger, still-active patients who expected the hip replacement to last the rest of their life. Unfortunately, the numbers show that the failure rates among both genders are significantly higher than normal—from 11.8% failure in resurfacing to 13.6% for the total hip replacement as compared to rates of only between 3 and 5% for implants made of other materials.

How Many People Have Hip Implants?
Since 2003, the BBC article reports that over 60,000 patients in England and Wales and over a million in the United States have received the potentially dangerous metal-on-metal hip replacement. The metal ions from the cobalt and chromium hip implants are believed to seep into local tissues causing reactions which can not only destroy muscle and bone but can eventually leave the victim with a permanent disability. The fact that cobalt and chromium can lead to such serious health issues was actually documented in scientific journals over three decades ago.

Was There a Cover-up?
DePuy, a major manufacturer of the metal-on-metal hip implant, released an internal memo in 2005 which stated that in addition to possible changes in immune functioning there was additional concern that the metal debris from the device could be carcinogenic. The memo went on to state that the possibility of distant effects of the device was “worrying,” and that one study indicated a three times higher risk of lymphoma and leukemia ten years following the hip replacement. Despite these very real concerns DePuy continued marketing the device and indicated none of the potential health concerns in their subsequent promotional materials.

A Discussion of the Long-Term Health Effects of the Hip Implant
In 2006 the Medicines and Healthcare Products Regulatory Agency convened a meeting to discuss the long-term health effects of the metal-on-metal hip implant made from cobalt and chromium. An advisory board was appointed, however out of the group’s eight members, two were consultants for DePuy and one was the director of product development for Smith and Nephew—obvious conflicts of interest. In the end the group chose to sidestep the potential dangers of the metal-on-metal hip implants, even refusing to warn women of child-bearing age of the potential dangers despite the fact that metal ions had previously been detected in umbilical cord and placental blood among women with the implant. No alert was put out to either surgeons or patients, and it was not until March of 2011 that the British Orthopedic Association sent out a warning advising that the metal-on-metal hip replacements should be “carefully considered and possibly avoided.”

Excessive Levels of Cobalt Resulting from the Hip Implant
Although there are no current guidelines regarding unacceptable levels of cobalt ions in those receiving implants, a designer and consultant for DePuy theorizes that patients whose device is functioning properly should have cobalt levels of no more than 2 ug/L. Subsequent studies, however, have shown that the cobalt concentrations in the blood of those with a metal-on-metal hip implant have reached over 300 ug/L—approximately 600 times the levels in a person without a cobalt hip replacement device.

DePuy Litigation: Statute of Limitations Depuy Lawsuits

By Independent Staff Writer

In August of 2010 DePuy Orthopedics, Inc. recalled two of its most popular hip replacement systems—the ASR XL Acetabular and the ASR Hip Resurfacing System. The recall came on the heels of a study which indicated the five-year failure rate of these products was as high as one in every eight patients. Severe pain and metal toxicity in the blood have required many of those who received a DePuy hip replacement to have revision surgery to replace the defective implant. Although the DePuy Pinnacle system has not yet been recalled it utilizes the same metal-on-metal design as the ASR, and many of those who received the Pinnacle implant have experienced the same symptoms including loosening of the hip implant, unsafe chromium and cobalt levels in the blood and extreme pain.  

What is a Statute of Limitations?
All lawsuits filed in the United States have an expiration period known as the Statute of Limitations. After this time period has passed an injured party is prohibited from filing a recovery case. These statutes are meant to guard companies from being exposed to lawsuits for long periods of time as well as to ensure the suits are filed while evidence is preserved and memories are clear. Depending on the state you reside in the statute of limitations for product liability can range from two to six years.

DePuy’s “Offer”
Following DePuy’s recall of their hip implants the company stated that patients who met specific criteria might be able to have some of their medical costs covered. Before any type of reimbursement is issued, however, DePuy will review patient’s medical records to determine whether the patient is eligible for reimbursement. The problem with this is that DePuy states the patient’s medical records must confirm a revision surgery is definitively related to the ASR recall rather than another cause such as a “traumatic fall.” In other words, the company is likely to attempt to blame the failure of the hip implant on a pre-existing condition, an underlying disease, physician error or misuse, therefore providing DePuy with sensitive medical records could well mean you would receive no money at all for the defective product implanted in your body.

Overview of the Statute of Limitations for Recalled DePuy Implants
If you received a DePuy hip implant and have suffered medical issues as a result, you must be aware of how the legal statute of limitations may affect your right to pursue legal action for the harm done to you. It is urged that potential claimants exercise a measure of urgency in obtaining legal representation for a potential recovery suit. The DePuy hip implant recall occurred in August of 2010, and it is estimated it affected more than 90,000 devices worldwide. In most states—including Texas—personal injury and product liability statute of limitations are only two years, therefore those who reside in a state where a two-year product liability statute exists may only have until August of 2012 to file a DePuy hip implant suit. In order to ensure you preserve your rights, it is a good idea for any hip implant recipient who has experienced painful side effects to seek prompt legal action in the event revision surgery becomes necessary.

Under Fire: Transvaginal Mesh Manufacturers Defend Device amid Stern Criticism

By Independent Staff Writer

Recent FDA warnings regarding the controversial transvaginal mesh implant have resulted in a staunch defense of the device and its safety by the mesh manufacturers.  Although the FDA has talked of reclassifying the mesh implant from a Class II to a Class III, requiring much more stringent clinical testing as well as human trials, Boston Scientific, one of the makers of the mesh is strongly urging against that potential change. Boston Scientific continues to assert that mesh products are a viable—and valuable—option for surgeons who treat women with pelvic organ prolapse or urinary stress incontinence. Further, they believe that mesh products offer a safe and effective alternative to non-mesh treatments and that the FDA’s current 510(k) requirements for a Class II device are appropriate for the transvaginal mesh.

FDA Warnings
The first warning issued by the FDA came in 2008 and warned of possible complications associated with transvaginal mesh implants, stating such complications were “not rare”. A more recent warning by the FDA went even further when it contended that it was unclear whether pelvic organ prolapse repair using mesh implants had any real advantage over traditional POP surgery without mesh and could expose patients to potentially serious risks.

Mesh Manufacturer’s Concerns
During the FDA advisory meeting, another maker of the mesh, Cook Medical, filed a letter asking the FDA to consider giving different treatment to meshes made from different materials. This request was based on the theory that there are significant differences between non-absorbable synthetic mesh products as opposed to biologic grafts which are not cross-linked. Another maker of the mesh, Johnson and Johnson—who has come under serious fire recently due to complications from their mesh implants—agreed with prior FDA reports which recommended simple label changes could warn women and their physicians of the potential risks of mesh implants.

Both Johnson and Johnson and C.R. Bard have become the target of over 500 lawsuits filed by women who claimed the mesh used in their POP or SUI surgeries caused serious internal injuries and chronic pain. The lawsuits were a direct result of the over 4,000 adverse event reports which have been filed since 2005. Most all the makers of the mesh devices agreed that any new applications for transvaginal mesh products should be subject to clinical testing, but strongly resisted the proposed reclassification of their mesh product. Johnson and Johnson and Endo Pharmaceuticals suggested that new device versions require clinical trials while existing implants have safety tracking controls.  The manufacturers of mesh devices still believe strongly in their product, believing that while it may not be the best resolution for every patient in every case, it nonetheless offers a reliable and safe outcome for many women with pelvic organ prolapse or stress urinary incontinence. 

Does Age Play a Role in Transvaginal Patch Complications?

By Independent Staff Writer

In light of the many adverse events seen among women who have undergone transvaginal mesh surgeries in the past few years, the FDA is considering more stringent controls over approval of the device. Surgeons currently perform as many as 300,000 pelvic organ prolapse and stress urinary incontinence surgeries every year, a large portion of those using mesh in the procedure.

Who Suffers From Pelvic Organ Prolapse?
Women who have gone through childbirth multiple times as well as those who have undergone a hysterectomy or are going through menopause all seem to be more susceptible to pelvic organ prolapse. Additionally, those with a family history of pelvic organ prolapse could be more likely to suffer from POP.  Although pelvic organ prolapse is generally a progressive condition which worsens and causes more serious symptoms, in some cases it does not progress and may actually improve with time. When estrogen levels diminish during and after menopause, pelvic organ prolapse is more likely to occur due to the fact that estrogen assists the body in making collagen, a protein which strengthens the supportive pelvic tissues. When there is less collagen in the body, the supportive tissues in the pelvis are more likely to appear, therefore when estrogen decreases, POP becomes more likely.

Is A Woman’s Age a Factor in Pelvic Organ Prolapse?
While older women will be more likely to suffer from POP simply by virtue of the fact that the connective tissues in the pelvic region have had more time to stretch and they have likely gone through childbirth and possibly even menopause or a hysterectomy, the surgery is also performed on women in their forties after giving birth multiple times. One particular study—done in 2002 which involved nearly 700 participants who received the transvaginal mesh patch—resulted in almost universal satisfaction following the procedure.  

Some questioned the validity of these results since over four-fifths of the participants were post-menopausal and the average age was nearly 64. This is considered a relatively narrow group of study participants, especially in light of the fact that the procedure is often done on women of childbearing age following the stress of multiple pregnancies. It is likely that the older women were having much more serious symptoms of pelvic organ prolapse as a result of many years of downward gravity on the pelvic ligaments, therefore the relief they received from the surgery could have been more significant.

Who is Most Likely to Have Problems Following a Transvaginal Mesh Implant?
In one of the most comprehensive studies done to date, including nearly twelve thousand women, nearly ten percent of those had some sort of erosion of the implanted mesh within twelve months of the surgery, regardless of whether synthetic or biologic mesh was used in the surgery. It was found that factors which could predispose women to erosion problems included being a smoker or having a hysterectomy simultaneously with their POP surgery. Overall health is also a significant factor in surgery results. When a vaginal approach was used to place the mesh—as opposed to an abdominal incision—there tended to be more adverse results. Older women tended to have more incidences of mesh erosion, even though they were the group who reported the greatest satisfaction with the surgical results. Low estrogen levels—which typically occur in older women—were a factor in erosion as were the size of the mesh implant and the surgical technique variations or skill of the surgeon. Women who kept their uterus during the procedure appeared to have a lowered risk of erosion complications.

New Data From Britain About DePuy ASR Acetabular Hip Replacement Devices

By Independent Staff Writer 


Is Johnson & Johnson Telling the Truth About the Failure Rate?
Johnson & Johnson claimed the failure rate was 13% when it recalled the DePuy product in 2010, according to its press release. Johnson & Johnson started using the device in the United States in 2005 and based its failure rate on five years of research.  However, England has a hip registry dating back well before 2005.
This week a report by The British Orthopedic Association revealed the DePuy ASR XL hip replacement unit fails as often as 49% of the time. This is an astounding four times what Johnson & Johnson reported stated when it recalled the device last year.

Dr. David Beverland, an Irish orthopedic surgeon who does massive numbers of hip and knee replacements reported that he started implanting the ASR devices in his patients in September 2004 and stopped in May 2007. He declined to say why he stopped the implants, but reported that 32% of his ASR XL patients have been or will need a second hip replacement (revision) and 44% are symptomatic. Only about 22% of his ASR XL patients seem to have achieved a good result and three of his patients died after receiving the implant. This is a serious problem for the defense since Beverland has been a major consultant and product champion for DePuy.
Here are the real facts:

Patients With Defective DePuy ASR Hip Implants

By Andrew Sullo SULLO & SULLO, LLP HOUSTON — In the wake of DePuy Orthopedics, Inc.’s recall of defective ASR hip implant devices, patients and their physicians have been searching for ways to mediate the potential health risks involved. With complications ranging from dislocation of the implant components and bone fractures at the hip, to metal poisoning, or metallosis, finding an accessible, effective treatment is imperative.   Enter the Accelerated Recovery Performance Wave (ARPwave) System, a revolutionary method that has been used by professional athletes and weekend warriors alike to treat muscle-related injuries and speed post-surgical rehabilitation for years. The invention of Denis Thompson, an exercise physiologist based in Burnsville, Minnesota, the ARPwave uses a patented bio-electrical current, simultaneously with active range-of-motion and other exercise techniques, to significantly speed up the body's natural recuperative ability.   The ARPwave is a Class 2 medical device that is FDA authorized for muscle re-education; relaxation of muscle spasms; increased local blood circulation; prevention and retardation of disuse atrophy; and maintaining and increasing range of motion. Protocols can also be specifically used with the ARPwave to accelerate post-surgical muscle rehabilitation of the shoulder, elbow, wrist, hip, knee, ankle, foot, and cervical and lumbar spine. For this reason, the device would be useful to patients experiencing complications related to a defective DePuy hip implant device. Treatment of the affected area could significantly lessen long-term damage to muscles and bone surrounding the faulty implant.   To use the ARPwave, a valid prescription is required. The devices are licensed only to medical practitioners and select athletes for personal use. Treatment is not currently covered by most insurance plans, and individual sessions cost about $100. The number of sessions required depends on the severity of the damage to the muscles being treated.   A typical ARPwave session requires the patient to move, so wearing loose, comfortable clothing is recommended. Because the device is used to find the origin of the injury, the physician providing treatment moves electrodes around the affected area to search for “hot spots”. These are areas of electrical disturbance in the muscle tissue that represent the root of the injury. Sessions can be intense and physically demanding, so it is recommended during the course of treatment that patients take measures to ensure their bodies recover properly. Typically, this means getting a good night’s sleep, eating healthy meals with adequate protein, avoiding/limiting alcohol consumption, etc.

DePuy offers to remove ASR XL Acetabular System - in exchange for waiving your right to compensation.

By Independent Staff Writer

If you received an ASR XL Acetabular System, your doctor has probably already informed you that DePuy is offering to pay for hip revision surgery.

What they may not have mentioned - and what they may not themselves realize - is that agreeing to DePuy's hip revision offer means that you must agree to sign a waiver that essentially waives your rights in litigation and allows the Johnson & Johson-owned company to access your medical records.

They want to use your own medical records to show that they don't owe you anything for the serious repercussions of the faulty hip implants they allowed to get to market without sufficient testing. 

Hip Revision Dependent on Loss of Patient Rights

DePuy sent a letter to health care professionals explaining the recall and informing the doctors and surgeons that they needed to contact their patients about the problems with the ASR XL Acetabular System. In the letter, DePuy said they intended "to cover reasonable and customary costs of monitoring and treatment for services, including revisions, associated with the recall of ASR."

Laying aside for the moment that "reasonable and customary" probably does not mean the same thing to DePuy as it does to the patients, the real problem comes in the next paragraph.

Eligibility for this medical treatment, DePuy says, is dependent on the patient having "consented to provide DePuy with x-rays, explants, and any other requested medical information after the revision surgery."

In other words: DePuy won't pay for your revision surgery unless you sign away your private medical records so they can examine them.

What do they plan to do with your medical records? DePuy states that they will use this information "to process claims efficiently and to help DePuy to better understand the causes of the problems with the ASR Hip System." 

If this were true, then the information would surely be scrutinized by their engineers to determine exactly what went wrong with the design of this hip implant. That's commendable, but unfortunately it is far from the most likely scenario, as the history of DePuy's previous encounters with faulty implants shows.

The DePuy professionals that will be scrutinizing your medical information aren't engineers, nor even doctors.

They're lawyers.

What's Wrong With DePuy Having Access to Your Hip Implant Records

To give you an idea of what you can expect from DePuy in litigation about the ASR XL Acetabular System, it may help to look at a previous case about another medical device: the DePuy Limb Preservation System. It's a knee replacement approved by the FDA using the same loophole in the 510(k) process that the ASR hip implant slipped through: DePuy claimed the knee replacement to be "substantially equivalent" to another product.

It later transpired that the product to which the knee replacement was supposed to be substantially equivalent was completely different. The LPS system was never tested. It also had serious design defects.

If all of these problems sound familiar, it's because they are identical to the issues with the ASR XL Acetabular System: cleared through the 510(k) process, claimed "substantially equivalent" to a device that was nothing like the new hip implant, clinically tested by the FDA, and serious design problems.

In the knee replacement case, DePuy's defense avoided talking about any of these issues.

Instead, they pointed the blame at the patients.

The device failed because the patient was overweight. Because the patient was over-active. Because the patient had fallen. Sometimes, they also blamed the surgeon - for improper implementation.

But mostly, they blamed the patient. 

What are they going to do with your medical records? They're going to use them to build a case that they did nothing wrong.

They're going to claim that you did. 

Where Is This Form Going to Come From?

DePuy sent copies of their Medical Release Form, also called the Authorization to Use or Disclose Information, to each medical professional who implanted an ASR XL Acetabular System.

The form signs over all medical records, explants and x-rays from the original surgery that implanted the ASR XL Acetabular System, the hip revision surgery, and "all follow up visits and records." Records include "telephone message slips," "copies of lab work," "physical therapy reports," "progress records," and other private medical information. 

This means your surgeon is likely going to be the one who asks you to sign the form, which in turn means you must stay alert. There is a lot of paperwork surrounding any surgery, and it is important that you make sure you don't accidentally sign a form that loses you legal rights.

There are accusations that DePuy has offered the surgeons money for every Medical Release Form they can get signed. They have good reason to offer incentives: all of this information can be used to build a case against you. More importantly, giving DePuy the explant means that your lawyer no longer has access to it and cannot use that evidence to build a solid case against DePuy. 

The surgeon who placed the implant may not be aware that these are DePuy's intentions. In fact, all the communications we have seen between DePuy and the medical professionals who implanted the ASR XL Acetabular System claim that the only reason they want this information is to improve their medical devices. This means your surgeon may have no idea that by encouraging you to sign the form, he or she is also encouraging you to sign away your chance for legal compensation.

Please don't blame your doctor. We certainly don't. They're doing their best to make sure you get the hip revision surgery you need right now. 

We're doing our best to make sure you get everything else you need - including just compensation. 

Have You Already Signed a Medical Release Form for Your DePuy Hip Implant?

You may have already signed one of these forms. If you have, please don't panic. There are measures we can take to help you get your medical and legal rights back. For example, we can put out a revocation of authorization to use or disclose your medical information, which compels DePuy to stop asking for new information and to return the information they've already received.

If they don't comply, we can use that refusal to respect your rights in the case against them.

If you have questions about the ASR XL Acetabular System hip recall or you're concerned that you may have already signed a form giving DePuy access to your medical records, give us a call at 1-800-730-7607 or contact us online. We're here to help.