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New Data from Britain about DePuy ASR Acetabular Hip Replacement Devices

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Is Johnson and Johnson Telling the Truth About the Failure Rate?

Johnson and Johnson claimed the failure rate was 13% when it recalled the DePuy product in 2010, according to its press release. Johnson and 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 and 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:

-        August 2010 - Johnson and Johnson recalled the ASR XL Acetabular System and DePuy ASR Hip Resurfacing System used in hip replacement surgery due to the number of patients who required a revision.

-        April 2011 - Johnson and Johnson agreed to pay $70 million in civil and criminal fines for bribing European doctors to induce them to prescribe their drugs or implant medical devices in patients unaware of their doctors’ financial incentives, according to The New York Times.

-        May 2011 - The British Orthopedic Association and British Hip Society released data that the DePuy ASR XL hip replacement unit fails as often as 49% of the time - four times more than reported by Johnson and Johnson in 2010.

Based on the evidence there are thousands of patients that appear to be healthy now, yet likely will have complications in the next 3-5 years as a result of the ASR XL device.

What Does the U.S. Food and Drug Administration’s Letter to Hip Makers Mean?

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The U.S. FDA ordered 21 manufacturers to collect information from patients.

The U.S. FDA ordered 21 manufacturers to collect information from patients in a recent letter to hip manufacturers. Click here for report. The three-page letter demands blood tests and other studies within thirty days. Here is a summary of the information and questions the FDA is requiring from manufacturers:

• The harmful events observed in patients with Metal-on-Metal (MoM) total hip replacement (THR) systems.
• The levels of serum and chromium in patients prior to THR.
• The patient population’s average levels of chromium and serum in the blood for a minimum of eight years after the implant (patient population is the demographics and other particulars of a particular population).
• Do the average levels of chromium and serum in the blood increase during the first eight years (or the length of time on the market)?
• Reasons for revision (alteration of a medical device) and patient population’s average levels of chromium and serum in the blood at the time of the revision.
• The number of patients with pain and biological and psychological symptoms associated with the THR.
• The quantity of harmful reaction of body tissues in patients who did not have a revision.
• How differences in revisions vary over time after the initial implant?
• What demographics have higher metal ion concentrations in their blood?
• What demographics have higher risks of needing revisions?
• What causes the THRs to fail?

Gary Schwitzer writes on his blog “Health News Review” that he was “jolted” by a television commercial he saw recently for an artificial hip joint sold by medical device-maker Smith & Nephew.

The ad features athletic, fit, male body forms engaged in all sorts of strenuous pursuits; playing soccer, surfing, rock climbing up a craggy peak (!). The figures are rendered as stylized silhouettes but if I had to guess, I’d say they were designed with highly active men, age 40 to 50, in mind. Triatheletes and Ironmen wouldn’t be a stretch.

As Schwitzer notes, “it struck me that this younger demographic was the sole focus of the figures depicted in the commercial.” Read more about this post>>

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Standard protocol for receiving FDA approval is the premarket approval process (PMA), which involves an extensive review of the product in question, including rigorous clinical trials. The process often takes nearly two years to complete and can cost the manufacturer upwards of $250, 000. It seems understandable then, that companies might seek a less involved option if one were available.

Enter premarket notification, or 510(k) Clearance, which requires manufacturers to notify the FDA of their intent to market a medical device at least 90 days in advance. If, during that period of time, the FDA determines that the “new” product is substantially similar to one that is already on the market, it will be approved without having to go through the normally required clinical trials.

Shockingly, only about 10 percent of 510(k) applications are referred back to the manufacturer for further testing; which means that roughly 90 percent of devices made available through this process have scarcely been studied, and may never have undergone a single clinical trial.

One such product that has recently come under fire for gross failure is the Depuy Orthodics, Inc. hip implant system, which includes the ASR XL Acetabular System and ASR Hip Resurfacing System. Approved through 501(k) Clearance in 2005, the device has since been implanted in more than 93,000 patients across the globe, and was originally anticipated to last for 15 years.

The ASR implant, a metal-on-metal ball-and-socket device used in hip replacement surgery, was touted by manufacturer Johnson & Johnson as a “high performance” replacement system that had significant advantages over other brands. However, the FDA began receiving complaints from patients and doctors regarding problems associated with the device as far back as 2008, and finally ordered a recall of the product in August 2010. A British study has since confirmed that nearly 12 percent of those who received the implants required corrective procedures, called revision surgeries, within five years.

While DePuy considered the metal-on-metal feature of the ASR device a notable attribute, some experts believe that it is to blame. The metal-on-metal contact of the ball and socket creates microscopic metal debris that damages nearby muscles and soft tissues. Some experts also believe that the design of the ASR hip replacement cup was too shallow making the system more difficult to position during surgery.

The premature failure of a hip implant can result in considerable physical, emotional, and financial hardship, none of which should become the patient’s responsibility. The fact that DePuy’s products were approved via an expedited FDA process means that defects the company may have been aware of were easily swept under the rug.

If you or someone you know received a defective DePuy ASR hip implant, you should also 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 the compensation that you deserve. Call us at 800-730-7607 for a free legal consultation today.

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As we try to describe the reasons the DePuy ASR XL Acetabular System present such a danger to your health, we occasionally use terms you may be only vaguely familiar with. This is an ongoing series of articles on the medical terms related to the DePuy hip recall and hip revision surgeries.

When undergoing hip surgery, there are generally two options for a hip implant: cemented and uncemented. Cemented implants, which involve attaching the implant directly to the surrounding bone by means of a specially constructed bone cement, have been used since the 1960s. Uncemented implants were introduced in the 1980s. The ASR XL Acetabular System is an uncemented implant.

The idea behind an uncemented implant is that healthy bone can grow into its surface, thus holding the implant in place by means of the body’s own materials instead of a foreign cement. Medical professionals hoped that this design would mean the patient could have a more active life since the concern of gradually wearing away the cement would be eliminated. Cementless total hip replacements are recommended for younger, more active patients and have shown, so far, better results in long-term studies.

Obviously, healthy bone is essential for an uncemented hip implant. Without healthy bone growth, the hip implant will not be secured into the rest of the skeleton and will not function as a replacement for the removed hip.

Evidence is showing that the DePuy ASR XL Acetabular System may cause serious bone deterioration in a number of ways. One of the most significant is osteolysis, which occurs when the body reabsorbs bone as part of an autoimmune response. Osteolysis has been noted as a side effect of many total hip replacement systems; the more debris that is released into the body, the more common osteolysis becomes. Metal-on-metal hip implants were thought to have less likelihood of debris because they are made of harder materials, but the ASR XL Acetabular System’s poor design caused significant friction and a great deal of metal debris, raising the risk of osteolysis.

Another problem is the surgery itself. An uncemented implant requires the surgeon to insert the cup of the hip implant into the hip socket, called the acetabulum. This means some of the bone in the socket must be scraped away to make room for the implant. This is part of any hip implant surgery, but since the DePuy implants only lasted a few years before they were recalled, patients are now forced to undergo hip revision surgery before that bone has had enough time to recover from the initial surgery’s trauma.

Hip revision surgery is much less likely than initial hip replacement surgery to succeed. With damaged bone mass, the chance of success is even lower.

In essence, the weaker the bone, the less likely it is that each successive hip replacement surgery will succed. With complications of metal poisoning, metallosis, and trauma to the surrounding bone and tissue, the circumstances for a revision surgery are far from optimal.

If you have a DePuy ASR XL Acetabular System and you are concerned about compensation for the medical trauma you’ve experienced, we’d like to help answer your questions and advise you of your legal rights. Please give us a call at 800-730-7607 or simply fill out our online contact form.

By Lacy Boggs

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Since 1976, all medical devices must be classified and approved by the U.S. Food and Drug Administration (FDA) before they can be legally marketed to the public. It is the fond belief of many Americans that FDA approval is a ringing endorsement of a product’s safety, a guarantee that the device has been tested and re-tested by professionals who are presumably trained to put the device through all kinds of rigor to triple-check its safety and effectiveness before allowing it anywhere near our fragile human bodies.

It is, as we say, a fond belief, but not an accurate one. It seems that many medical devices – including the recently recalled DePuy ASR XL Acetabular System – are given an FDA approval and subsequently placed inside people’s bodies without ever going through a single test at the FDA.

The FDA department responsible for the regulation and review of medical devices is the Center for Devices and Radiological Health (CDRH). CDRH divides medical devices into three classes: life-sustaining, life-supporting or implantable devices are designated as Class III.

Hip replacements, including the ASR XL system, qualify as a Class III device and are considered high risk to the patient’s health.

Class III devices can be approved by the FDA through one of two processes. The first, the premarket approval process (PMA) is more or less what we think of when we imagine our device being tested by the FDA: an extensive review including rigorous clinical trials that show it to be safe for use in humans. The PMA is quite detailed, lengthy, and expensive, usually costing the manufacturing company upwards of $250,000 and taking as much as two years to complete.

A quarter of a million is a large chunk of change – but thankfully for companies with a firm eye on their bottom line, there’s always the second FDA approval process.

The premarket notification approval process, also known as the 510(k) approval process, is a sort of shortcut to approval that lowers the price point considerably – and also, conveniently, doesn’t involve any pesky testing that might reveal a flaw in the product that would then have to be revamped and retested for another quarter-million.

The 510(k) process basically pre-approves any product that is deemed “substantially equivalent” to another product already legally approved for sale. It costs less than $5,000, requires no clinical trials, and only takes an average of 3-6 months to complete. It’s a good shortcut for products that are essentially identical to their forebears. After all, it hardly makes sense to waste the FDA’s time when they could be helping get new, innovative, life-saving products to market. But what’s to stop companies from claiming their products are “substantially equivalent” to other FDA-approved devices even if they’re not remotely the same?

What, indeed.

The ASR XL Acetabular hip replacement system got its seal of approval from the FDA using the 510(k) process, claiming that its product was substantially equivalent to other hip replacement devices already on the market. The FDA official in charge of approving the device would have gone through a checklist that included the following questions (simplified; the actual document is fairly dense):

• Does the new product treat or solve the same problems as previously approved products?
• Does the new product have the same design, materials, and energy sources as previously approved products?
• Could any new characteristics or combinations of characteristics affect safety or effectiveness?

The first question is easy: there are dozens of hip replacement devices on the market, all designed to help people walk even after their bum hip throws them out of commission. The second question gives us a bit of a hiccup: the ASR XL Acetabular hip replacement system had two parts, a ball and socket

The ball was equivalent to an approved product; the socket was equivalent to an entirely different approved product; and the materials were equivalent to still a third approved product.

Thankfully for DePuy, the FDA had thoughtfully included a caveat that allowed for such an eventuality. Which brings us to question three: could any new characteristics affect safety?

In Depuy’s 501(k) application, it declared that the “subject device does not raise any new issues of safety or effectiveness.” A brave statement, though one wonders how the company confirmed such a diagnosis without going through any clinical trials. Perhaps if it had, the problem of metallosis would have become evident before the hips were implanted into approximately 93,000 people.

With such prerequisites for FDA approval, it is perhaps not surprising that only 10% of 510(k) applications are referred back for supporting human, clinical or animal testing.

Which is to say that 90% of claims require no clinical testing whatsoever before being sold to patients?

That’s not to say that there is no testing at all. If a mechanical test is available, 510(k) approval process requires that the new product show that it yields similar results to a previously approved product. The DuPuy ASR hip replacement system took a few spins on a robot that went through simulated movements. In a legal suit brought against DePuy for a different hip implant last year, the mechanical test did not include the full range of motion of which a human being is capable.

If we assume that a new product truly is “substantially equivalent” to previous products and if the new product has the same safety and effectiveness-regardless of any new materials or technologies-then the 510(k) system might work just fine. But that’s presuming the device’s manufacturer put the product through enough testing to determine independently that the device could withstand the same circumstances as other products.

What’s more, products are allowed to be “substantially equivalent” to products that are themselves “substantially equivalent” to other products, which are in turn “substantially equivalent” to still other products. It’s a dangerous game of telephone, particularly when you recall that it is permissible to combine two or more products and claim your new device is “substantially equivalent” to all of them.

The DePuy ASR system was approved because it claimed to be substantially equivalent to threeproducts which themselves claimed to be substantially equivalent to other products. None of the products in the chain was ever subjected to clinical trials before being brought to market.

Many people note that the 501(k) process amounts to an enormous loophole, through which many companies bring under-tested products to market. With better testing, the DePuy hip recall might have been avoided altogether.

The DePuy ASR XL Acetabular system was approved through this FDA loophole, despite the fact that it had a materially different design than its predecessors. But it was designed to treat the same problem, so it must have been all right. It was made of a metal ball and a metal socket – but other hip implants had successful metal-on-metal designs, so it must have been all right. And it was designed to allow the bone to grow directly onto the implant – but still other hip implants had used this tactic successfully, so it must have been all right.

Except that, when put all together, it just wasn’t.

On August 4, 2010, the FDA issued two reports that recommend sweeping changes to the 510(k) process and procedures. We can only hope they include actually testing the products to which the FDA affixes its seal of approval.

By Megan Breckenridge, Staff Writer

HOUSTON — 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, which is used for total hip replacements, and the DePuy ASR™ Hip Resurfacing system, which is used in a newer kind of bone-conserving procedure. To date, more than 93,000 of the devices have been implanted worldwide.

DePuy said that it was issuing the recall after new data from a British joint replacement registry showed about 1 in 8, or around 12 percent, of those who received the implants needed corrective procedures, called revision surgeries, within five years. Typically, the devices are supposed to last 15 years before requiring any corrective revision.

DePuy’s hip replacement system—a metal-on-metal implant—has been linked to metal poisoning or 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 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.

Metal-on-metal devices gained popularity in recent years among orthopedic surgeons and patients who believed they would be more durable than those made of other materials, such as ceramics. But it soon became apparent that many of the devices were deteriorating quickly, shedding metallic debris that was readily absorbed into the bloodstream.

The New York Times reported in March that it was “not clear whether some makers’ devices are more prone to the debris problem than others. But some experts argue that some manufacturers, in a rush to meet the demand for metal-on-metal devices, marketed some poorly designed implants and that some doctors fail to properly implant even well-designed ones.”

But it appears that DePuy’s ASR devices are more prone to debris problems than other brands. The first lawsuit filed in the United States against DePuy over the defective ASR hip implants was in March 2009—almost 18 months before the device was recalled. In fact, the Food & Drug Administration (FDA) had received over 500 complaints about the devices through the years leading up to the recall, but no action was taken as a result.

Countless patients are now left to struggle with the serious side effects of receiving a faulty hip implant, including pain, inflammation, metallosis, and costly revision surgery to correct these problems. And while DePuy’s recall notice stated that, “DePuy intends to cover reasonable and customary costs of testing and treatment if you need services, including revision surgery if it is necessary,” the company did not elaborate on what it perceives is “reasonable” or mention compensation for injury, such as the damages to overall physical and mental health, pain and mental anguish, disfigurement and scarring, or future medical expenses.

If you or someone you know received a defective DePuy ASR hip implant, it is imperative that you obtain the counsel of an experienced personal injury attorney. The litigation team at Sullo & Sullo, LLP will aggressively defend you and make sure you receive the finest legal representation in the country. Call us at 800-730-7607 or visit our website at www.sullolaw.com for a free legal consultation today.

By Megan Breckenridge, Staff Writer

SULLO & SULLO, LLP

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 HOUSTON — Millions of women across the country rejoiced in 2002 when a new, convenient alternative to daily oral contraceptive pills hit the market.

Ortho Evra, a hormone-containing patch, was praised by public health experts and consumers alike because it eliminates one of the major barriers to perfect birth control use: Remembering to take a daily pill. The patch can be placed on the arm, back or abdomen—anywhere it adheres well and won’t be damaged—and needs only to be changed once a week. Since it’s introduction, over 40 million prescriptions for Ortho Evra have been written, and TIME Magazine named it one of the best inventions of 2002.

            But in 2005, the Food and Drug Administration (FDA) warned that women using Ortho Evra were exposed to approximately 60 percent more estrogen than those who use oral contraceptive pills. It is believed that the difference in exposure is related to the delivery mechanism of the birth control patch. Hormones in birth control pills are partially diluted by the digestive system, while those in the patch are absorbed directly into the patient’s blood stream. The latter causes a higher concentration of medication, specifically estrogen, to enter a patient’s body, increasing the risks of pulmonary embolism—a specific type of blood clot—as well as stroke and heart attack.

            The first fatality publicly blamed on Ortho Evra occurred in April 2005, when a Manhattan fashion student collapsed in a New York City subway station. An autopsy found that a blood clot had moved into the victim’s lung, which the medical examiner ruled a side effect of the birth control patch.

            By November of 2005, the FDA had received 21 reports of life-threatening blood clots and other ailments associated with Ortho Evra. But it wasn’t until 2006, when a study was published that confirmed women using the patch were twice as likely to suffer from venous thromboembolisms (VTEs) as those taking oral birth control pills, that the FDA requested that the Ortho Evra label be changed to include a stronger safety warning.

According to an NBC news report, broadcast September 22, 2010, leaked patient reports from Johnson & Johnson show that the company knew users of the patch were 12 times more likely to suffer stroke and 18 times more likely to have blood clots than Pill takers. Further, NBC revealed, a vice president of research at Johnson & Johnson, Dr. Patrick Caubel, quit over frustration that the company ignored his data showing elevated levels of complications and mortality associated with the patch.

Another former vice president, Dr. Joel Lippman, claimed in a lawsuit that he was fired by Johnson & Johnson because he expressed concerns about the patch’s dangerously high estrogen levels prior to its coming to market. The company, he says, “disregarded his concerns and launched the product anyway.”

According to NBC, 24 deaths have been attributed to blood clots induced by the patch, and more than 2,400 women currently have personal injury lawsuits filed against Johnson & Johnson. To date, the company has spent $68 million to quietly settle Ortho Evra lawsuits.

Unfortunately, Ortho Evra remains on the market, despite countless calls to have it pulled. In spite of its risks, the patch is still a big money maker for Johnson & Johnson, which has earned $1.6 billion on its sales.

In response to NBC’s news report, the company issued the following statement:

Thank you for your inquiry to Ortho Women’s Health & Urology, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. We believe it is inappropriate to comment on the details around ongoing litigation and therefore are not providing responses to your individual questions beyond the statement below:

ORTHO EVRA has been a safe and effective birth control option for women and their healthcare providers since 2002. It addresses a birth control need and provides another choice for women who, with the counseling of their healthcare provider, do not want or are unable to take a birth control pill every day. Ortho Women’s Health & Urology has regularly disclosed scientific data regarding ORTHO EVRA to the FDA, the medical community and the public in a timely manner, and when used according to the FDA-approved label, ORTHO EVRA remains a safe and effective method of hormonal birth control. It also, like all methods of hormonal birth control, has benefits and risks which, as a prescription medicine, should be the subject of discussion between a woman and her healthcare provider. These benefits, risks and other important safety information are contained in the Detailed Patient Labeling, which is part of the ORTHO EVRA® Prescribing Information, and can be found at http://www.orthoevra.com/sites/default/files/assets/OrthoEvraPI_0.pdf.”

— Jeff Christensen, spokesperson, Johnson & Johnson

If you or someone you know were injured while using Ortho Evra, please contact the experienced team at Sullo & Sullo, LLP. We will aggressively represent women who have suffered heart attacks, strokes, blood clots and other serious injuries while using this drug. Call us at 713.839.9026 or visit our website at www.sullolaw.com for a free legal consultation today.

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In August 2005, the FDA approved an application for the DePuy ASRTM XL Acetabular System, allowing DePuy to market the new, metal-on-metal system to patients needing total hip replacement surgery. To those patients, this FDA approval meant one thing: the DePuy ASRTM XL Acetabular System was safe.

But, in its first five years, the ASR System failed at such catastrophic rates that DePuy issued a voluntary recall in August 2010, affecting tens of thousands of patients who have to undergo revision surgery.

How could this happen? Isn’t it the FDA’s job to verify and ensure the safety and effectiveness of medical devices sold in the United States?

The admitted failure rate of the ASR XL Acetabular System is 13%-meaning, this is the number acknowledged by DePuy. Mounting evidence suggests that the failure rate is higher than that, especially if one doesn’t limit the definition of “failure” to DePuy’s narrow view.

The DePuy ASRTM XL Acetabular System gained FDA approval through the 510(k) process, which bypasses clinical testing altogether if the product is “sufficiently equivalent” to other products already on the market.

Which means the ASR System was never clinically tested before it was sold to patients, and it underwent only the most rudimentary safety tests. DePuy only had to state that their new product raised no new safety concerns. The FDA – evidently – took them at their word.

Congress and consumer advocacy groups have been calling for of the 510(k) process,in part due to similar recalls from DePuy and other medical device companies. As of August 2010, the FDA has issued two preliminary reports that recommend sweeping changes.

The reports indicate that consumer advocacy groups had strong concerns about “predicate quality”-that is, the quality of the already approved devices to which DePuy claimed their new product was substantially equivalent.

Per the current 510(k) requirements, a company can claim its product is substantially equivalent to a product that never underwent clinical testing, was made before 1976, or had been recalled. That’s right: the ASR System got through on a kind of loophole, and now another manufacturer can come along and claim their product is substantially equivalent to it-and be approved.

Had this negligence been rectified years ago, the ASRTM XL Acetabular System might never have gone to market.

The preliminary reports also recommend getting rid of the rule that allows a company to base its substantial equivalence claims on more than one product. This change would almost surely have invalidated DePuy’s ASRTM XL Acetabular System application, because DePuy based its substantial equivalence claim on no fewer than three devices.

Perhaps most important, the reports call for an improvement in the quality of the clinical data submitted to support substantial equivalence. How has the FDA justified making an educated decision about a new product’s safety and effectiveness without strong clinical data?

If DePuy had been mandated to conduct clinical studies before the ASR System was sent to market, the terrible fact of a one-in-eight revision rate might’ve been avoided. Tens of thousands of patients might’ve been spared the painful truth that will need to undergo a second hip implant just a few years after receiving the first.

Critics have long argued that companies use the 510(k) process is a loophole that allows companies to get around the more arduous premarket approval process otherwise required by the FDA. While it’s true that the 510(k) process saves companies a lot of time and money, the cost is merely passed on to the patients, who pay with their money, pain, and quality of life.

We can only hope that the proposed reforms to the current process take effect soon and prevent more tragedy from prematurely approved devices like the DePuy ASRTM XL Acetabular System.

If you think you have a DePuy hip implant and would like to know more about this case, give our offices a call at 1-800-730-7607. We have people standing by to answer your questions and explain how we can help.

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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 requiested 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