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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.

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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?

By Andre Sullo

SULLO & SULLO, LLP

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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.

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, including coverage of the cost of treatments such as the ARPwave. Call us at 1-800-730-7607 or visit our website at www.sullolaw.com for a free legal consultation today.

By Megan Breckenridge, Staff Writer
SULLO & SULLO, LLP

HOUSTON—If you are one of more than 93,000 people worldwide affected by the recent recall of DuPuy, Inc.’s ASR Hip Replacement System, you may be in more danger than you realize. Countless patients have already come forward with horrific stories of pain and suffering as a result of the defective devices; the most common of which are related to metal poisoning, or metallosis, which is a reaction to the chromium and cobalt metal debris that is shed when components of the device rub together.

If you have experienced symptoms of chromium and cobalt toxicity, which include pain, inflammation, tumors and difficulty walking, it is imperative that you seek medical attention immediately. Specialized blood tests can be used to detect levels of these toxic metals in ASR Hip Replacement patients. In some cases, patients with DePuy ASR implants have been found with 100 times the normal levels chromium and cobalt in their bodies.

One method of treating ASR Hip Replacement patients with high levels of chromium and cobalt in their blood is chelation therapy. The process involves the administration of chelating agents—the most common of which is ethylenediaminetetraacetic acid (EDTA)—to remove the poisonous metals from the body.

Chelating agents may be administered intravenously, intramuscularly, or orally, depending on the agent and the type of poisoning. They bind to heavy metals in the body and prevent them from binding to other agents, creating a compound that can then be excreted from the body.

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.

At present, the Food and Drug Administration (FDA) has not approved chelation therapy, though both traditional doctors and alternative medicine practitioners do offer this service. A single chelation treatment usually lasts from two to four hours and costs between $50 and $100. In the first month, patients receive between five and 30 treatments (with 30 being most common), and are often advised to continue preventive treatment once a month.

Individuals must pay for the treatment themselves. Because chelation therapy isn’t a medically accepted procedure, standard medical insurance and Medicare do not cover it. It is believed to be safe for patients of all ages, including children and the elderly, but no scientific data currently exists to support this claim.

Side effects of chelation therapy include a burning sensation at the injection site, fever, a sudden drop in blood pressure, headache, nausea, vomiting, inability to create new blood cells, and mineral deficiencies. Some patients have experienced permanent kidney damage or failure, and deaths have occurred in some chelation studies. Because of the known risks and unknown benefits of chelation therapy, talk to your doctor before trying it as a treatment chromium and cobalt poisoning.

Although a full recovery from chromium and cobalt toxicity is possible with early detection and removal of the defective DePuy ASR implant, many people suffer the effects of metallosis 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 the full compensation that you deserve. Call us at 800.730.7607 for a free legal consultation today.

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Early this year, DePuy issued their recall for the ASR XL Acetabular System sold in the United States. Doctors began recommending revision surgery to those of their patients who reported pain or an overall failure of the DePuy hip implant. In many cases, the doctor was wise enough to run a blood test to determine whether there was excess metal in the bloodstream, as many medical studies have shown that elevated levels of metal are common for patients with metal-on-metal hip implants.

Patient after patient with the ASR Acetabular DePuy hip implant began turning up with cobalt and chromium levels that were well over 100 times normal.

Cobalt poisoning has been getting a great deal of attention and for good reason: the symptoms of cobalt poisoning include many serious side effects including neurological (brain) damage, heart irregularities, and seizures. Cobalt poisoning has also been linked to cancer. It’s small wonder that many people, when they first learn that the DePuy hip implant leaks metal ions into the body, are primarily concerned about cobalt poisoning.

However, chromium poisoning is equally dangerous. And the symptoms are just as troubling.

What is Hexavalent Chromium?

When discussing chromium poisoning, the most significant problems have been linked to a particular compound, hexavalent chromium (Chromium (VI)). Hexavalent chromium is the agent that turned up in the water supply of the California town of Hinkley, later made famous by Erin Brockovich’s activism work. Many people remember the Erin Brockovich story – if not for the event itself, certainly for the award-winning movie based on it. They remember that there were many cases of cancer in the town; 196, to be precise.

Few of them remember that the problem with the water was hexavalent chromium.

Hexavalent chromium has been deemed a cancer-causing agent by the World Health Organization, which means that both chromium and cobalt can elevate a DePuy hip implant patient’s cancer risk. In fact, studies show that elevated levels of any heavy metal increase the risk of cancer.

Our research indicates that hexavalent chromium is the type of chromium being released by the ASR Acetabular system; it degrades in the body into trivalent chromium, or Chromium (III). Anywhere from 18-30% of a typical metal-on-metal implant is composed of chromium; we do not have current numbers on the amount of chromium included in the DePuy hip implant.

Patients with elevated chromium levels show similar symptoms as those with elevated cobalt levels. There are notable differences; cobalt poisoning can cause cardiomyopathy, for example, while elevated chromium levels do not appear to cause heart problems but can cause problems with the reproductive system. The table below gives an overview of the symptoms shown by patients with elevated chromium levels vs. those with elevated cobalt levels.

If a particular type of chromium or cobalt has been specifically linked to a symptom, it is noted in parentheses next to the symptom. For example, mutated DNA is noted as being linked specifically to Chromium III.

What Does This Mean for My Health?

Chromium poisoning and cobalt poisoning are both very serious; however, there is no way to tell if you have either problem without getting a blood test to find out what your chromium and cobalt levels are. Even if you have elevated levels, you may still not have chromium or cobalt poisoning; slightly elevated levels are normal for patients who have metal-on-metal hip implants and among the doctors we’ve consulted, they do not consider slightly elevated levels to be cause for alarm.

For those DePuy hip implant patients who have presented with 100 and 500 times the normal level of these two metals in their systems, however, doctors are quite concerned. Cobalt and chromium can both be retained in the bodily tissues for a long period of time, and if the body is subjected to excess levels, it will have a more difficult time processing the metal ions through the normal elimination process, especially if the kidneys are damaged – a problem sometimes caused by chromium poisoning. Little research has been done on the long-term effects of elevated metal ion concentrations.

When speaking to your doctor, we have a medical crib sheet that may be prove useful if you are uncertain what to ask about or worried you may forget important questions. We would also highly recommend you read this article on DePuy trying to get patients to agree to give the company access to their medical records; if you are thinking of pursuing a legal case against DePuy, signing away your medical records can be severely detrimental to your case.

If you have received a DePuy hip implant and are concerned about the effects chromium and cobalt poisoning may have on your health, please give us a call at 1-800-730-7607 or send us an email through our online system. We’re here to answer your questions and help you build a case against DePuy if you think that is the best course of action for you. The health risks you’ve been asked to shoulder are immense and surely very upsetting; we will do our best to help in any way we can.

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DePuy ASR Hip Implants Are a Serious Risk

A person with 1 microgram of cobalt in their bloodstream has nothing to worry about.

Someone whose blood contains more than 25 micrograms has cobalt poisoning.

And a patient whose blood contains more than 100 micrograms? Probably has a DePuy ASR hip implant.

As more and more patients who received DePuy ASR Acetabular hip replacement systems ask their doctors for blood tests, the numbers of people who have extraordinarily high levels of cobalt in their bloodstreams become staggering. Several of our own clients have received the worrying news that their cobalt levels are far above normal, and at least one doctor has published a case study of two DePuy hip implant recipients who have cobalt levels that are 100 to 500 times normal.

How Much Cobalt Is Normal?

If you go to a doctor and get a blood test, the amount of metal (including cobalt) in your bloodstream will be calculated in micrograms per deciliter. A healthy person has approximately 0.019 micrograms per deciliter – about one microgram for their entire body. The metal in your bloodstream only presents in very, very small amounts; someone with normal cobalt levels could gather all the cobalt in their system together and come up with an amount smaller than a grain of sand.

Even at highly toxic levels, the actual amount of cobalt looks very, very tiny. 0.5 micrograms per deciliter of cobalt is considered toxic. That’s about five grains of sand in a giant bucket of water. Seems small – but those tiny grains of metal can throw the entire chemistry of your body wildly out of order.

In Britain, there are regulations for keeping close observations on patients who have metal-on-metal bearings in any hip implants, including the ASR hip implants. At cobalt levels of 0.7 micrograms per deciliter, patients must be kept under observations. Symptoms at those levels include hip pain, dying tissue, and pseudotumors – masses under the skin. Generally doctors recommend revision if a patient with a hip implant has a cobalt concentration of 1.9 micrograms/deciliter or above.

Revision isn’t suggested until cobalt concentrations are one hundred times the mean average – even though levels are considered toxic at twenty-five times the average.

One patient with severe cobalt poisoning had levels of 6.6 micrograms/deciliter. That’s nearly three hundred and fifty times the mean average. The dangers of cobalt levels so high were quite apparent: in addition to hip pain, the patient showed declining cognitive function, was losing control of his senses like hearing and sight, suffered from seizures, heart failure, and multiple other problems.

The amount of cobalt that patient had in his blood was still small enough that it wouldn’t have filled a teaspoon. But the damage was great enough to threaten his life.

What is Cobalt Poisoning?

Cobalt is one of the many metals that is found naturally in the body, but as with all other metals, in excess amounts it becomes toxic and leads to many harmful and potentially permanent side effects. Cobalt poisoning has caused cardiomyopathy, hypothyroidism, and neurological damage as well as impairing the senses. It can cause neuropathy, seizures, blindness, headaches, and liver damage. Cobalt has also been linked to cancer.

For DePuy hip implant recipients, it can also mean that future hip revisions have a lower chance of success. Excess amounts of cobalt in the bloodstream lead to metal sensitivity and metallosis, which can seriously damage surrounding tissue and make a second implant less likely to succeed.

Doctors Unaware of Risk

For many patients with DePuy ASR hip implants, the symptoms of cobalt poisoning either go unnoticed initially or are chalked up to other pain and problems related to the hip implant failure. For example, a patient might have deteriorating mental function, mood disorders, or vertigo – but if the patient is also in a great deal of pain because the hip implant is failing, it is very possible that he might assume the other symptoms are related to his pain and will go away if he has a revision surgery.

Meanwhile, doctors who are fully aware that DePuy ASR XL Acetabular System is failing at inordinate rates may recommend a revision surgery to solve problems of pain and inflammation. Those doctors may not know that the friction of the hip implant is releasing excess amounts of metal ions into the bloodstream and causing potential problems with far more long-reaching effects.

A patient could walk out of surgery with heavy metal poisoning – and not be aware until the symptoms become extreme enough to return to the hospital.

What Should You Do?

If you have a DePuy ASR Acetabular hip implant and are concerned about cobalt poisoning, see your doctor as soon as possible to discuss your options and express your concerns. Our medical crib sheet for DePuy ASR hip implant patients can give you some guidance on questions you may want to ask your doctor and tests you may wish to request.

If you’d like some advice on any legal case you may have against DePuy because of the danger this implant may present to your current and future health, we’re here to answer any questions you may have. Call our offices at 1-800-677-7095 or use our online contact form, and we’ll do everything in our power to get you the answers you need.

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In a recent article, we explained the difference between bringing an individual lawsuit against DePuy vs. becoming part of a mass action lawsuit. In this article, we’re delving into the differences between mass action and class action.

Historically, class action lawsuits are the stuff that give lawyers a bad name. The senior partner at our firm, Jim Moriarty, likes to say that class action lawyers represent people who don’t know they’ve been harmed and don’t care.

He’s not just speaking metaphorically. It’s entirely possible in a class action lawsuit to represent people who have no idea a lawsuit is being conducted in their name. Statistically, it’s likely that you yourself have been involved in a class action lawsuit without ever knowing it.

In the case of the DePuy hip recall, it’s extremely unlikely that any judge would allow the case to be brought as a class action. Here’s why:

Advantages of a Class Action Lawsuit

When a class action lawsuit is filing, it must name one or several plaintiffs on the behalf of a proposed “class” of people. The “class” of people are individuals or business entities who have suffered a common injury or injuries.

The rules vary by state (in Virginia, for example, there are no class action provisions) but in general the idea is that the group is so large that individual lawsuits are impractical, and the claims are so similar that they can be considered by the judge as a single problem that many people have in common.

Class actions have several advantages. As we noted in our article on the advantage of bringing a mass action lawsuit against DePuy, any lawsuit that involves many people working under a single lawyer or collaboration of law firms has distinct financial advantages, since it will cost far more to bring each case individually than it will to bring a group of cases with similar problems. Another oft-cited advantage of class actions is that there is no advantage to plaintiffs who file early as opposed to plaintiffs who file late, and a third advantage is that class action suits have often been used historically to purposely change the behavior of a group of individuals such as physicians or companies.

Of course, all of these advantages only apply to lawsuits that are brought with the plaintiffs’ best interests in mind. Unfortunately for our legal system, class action lawsuits have been used repeatedly to benefit unethical lawyers rather than plaintiffs.

The Missing Money

The biggest problem in class action lawsuits is that the plaintiffs often do not receive a share of the money recouped – or the share they receive is so small as to be negligible. Lawyers often take a large share of the awarded compensation while leaving plaintiffs with coupons of little or no value.

Lawyers are required to inform members of the “class” for whom they are filing suit that those individuals are now a part of a class action lawsuit. In theory, this means the people whose names are being used in the class action lawsuit have an opportunity to opt out of being a part of the lawsuit. In practice, most people either do not read such notices, viewing them as junk mail, or do not understand them.

Even if the notices are read and understood, it is extremely unlikely that the individual can do very much to forestall the class action lawsuit unless that person has significant personal funds. It is possible to sue a lawyer who uses your name without your consent in a class action lawsuit, but it would require significant funds and the lawyer often wins such cases, claiming that he brought a suit in the plaintiffs’ best interest and had nothing but good intentions.

Meanwhile, the lawyer pockets much of the settlement. For those willing to spend their careers in such shills, it’s a process with great rewards and little risks.

Why Can’t the DePuy Hip Recall Be Filed as a Class Action Lawsuit?

Lawyers must seek approval to bring a case as a class action lawsuit, and as we’ve already explained, class actions must include a group of individuals with similar damages. Though all the people who received an ASR XL Acetabular System and a notification of the DePuy hip recall have the same hip implant, the injuries they have suffered are extremely wide and varied.

The future consequences, and the damages they are due for pain, suffering, and loss of wages will also vary widely. One person may receive a hip revision that fails as a direct consequence of the faulty ASR Acetabular System he originally received. As a result, he may be completely incapable of doing his former job as a construction worker.

That person will have an entirely unique case from someone who had a few minor medical consequences as a direct result of the ASR Acetabular System and whose hip revision was successful. The latter case still has merit and that person should still be compensated, but the evidence, the harm done, and the consequences for which the plaintiff should receive compensation will be very different.

In a case where the injuries to the plaintiffs are this varied but it is still to the plaintiffs’ disadvantage to bring an individual lawsuit, a mass action lawsuit is best. A mass action suit means that plaintiffs will have all the advantages of a class action suit (lower costs to bring the case, no advantage to early filers, etc.) without the disadvantages of receiving a negligible sum for their grievances.

It is extremely unlikely that any judge would allow the DePuy hip recall case to be brought as a class action lawsuit, since it clearly does not fit the parameters for such a suit.

Why Mass Actions Don’t Dip into Plaintiffs’ Pockets

In a mass action lawsuit, most lawyers will agree to bring the case on a contingent fee basis, which means that you owe nothing if the case is lost. The lawyer takes the risk of funding the case up front in exchange for a portion of the awarded compensation at the conclusion of the case.

This is also true for class actions, with one significant difference: there are limits on the percentage of the compensation a lawyer is permitted to recoup at the conclusion of the case. In most states, the limits are between 30-40% of the total compensation. Though that number may seem high, recall that the lawyer is funding the case throughout the time period it is being brought, which may be years. The lawyer is taking significant risk and asking for no fees until the case is successfully concluded.

And, of course, the lawyer earns nothing if the case is lost. In fact, the lawyer is out of pocket if the case is lost, since there is no way to recoup the money already spent on bringing the case in the first place. This gives the lawyer strong incentive to bring the best case possible.

In a class action, lawyers often retain the majority of the funds awarded. In a mass action, that number is limited to a reasonable fee and the plaintiffs are assured of proper compensation for their injuries.

One More Significant Advantage to Mass Action Lawsuits

In a class action, plaintiffs are treated like numbers. In a mass action lawsuit, plaintiffs are treated as individuals. This is both a personal and professional choice for us at Moriarty Leyendecker. Every plaintiff’s story and personal experience is valuable to the case, so it is only logical that we should want to hear every word and learn all about the client’s history.

We also do it simply because it is important that these stories be heard. Every story we’ve heard so far from our clients has been heartbreaking. It isn’t enough to say “some people got hurt and we settled the case.” It’s important that your story is heard, and that the compensation you receive is directly tied to your life and your losses.

If you’d like your story to be heard and you have questions about your particular situation or about becoming a part of the lawsuit against DePuy, we’re here to listen and to give you the best answers we have. Give us a call at 1-800-730-7607 or contact us online. We’ll do everything we can to help.

Two weeks ago, the U.S. Panel on Multidistrict Litigation conducted a hearing to discuss where the DePuy Hip Implant MDL should be placed. Today, the Panel announced that the litigation will take place in the Northern District of Ohio.

Complaints about the DePuy ASR hip implants have been reported throughout the United States, which prompted a hearing to consolidate the cases into multidistrict litigation. Counsel for DePuy Orthopaedics, Inc. did not object to doing so. The Multidistrict Litigation (MDL) Panel determined that the DePuy cases qualified for consolidation and created DePuy Mulitdistrict Litigation.

There were many different courts in the running for the federal district in which the pretrial proceedings would take place, including Kentucky, Indiana, New Jersey, Ohio, and Florida. Counsel for DePuy and several Plaintiffs’ lawyers who represent people harmed by the DePuy devices submitted arguments to the Panel as to which court they felt was most appropriate for these cases.

As we’ve explained in previous articles, consolidating a case conserves resources for the attorneys as well as the judiciary, and bringing individual lawsuits for each case can make the costs so prohibitive as to present an obstacle to getting a fair settlement for the plaintiffs. The fact that DePuy Multidistrict Litigation has been formed creates a more efficient way for our legal team to pursue claims for our clients and ensures we are better able to give them the individual attention they need.

To better serve our clients in this case, Moriarty Leyendecker is working in conjunction with The Law Offices of Sullo & Sullo and The Law Offices of Howard L. Nations, the latter of whom was among the lawyers who proposed the Northern District of Ohio as the best venue based on that court’s current docket and the speed and efficiency at which they move cases to resolution; the convenience of location for all parties; and the experience of the presiding judge.

The Honourable David A. Katz is highly experienced with a successful MDL track record. Judge Katz is exceptionally well qualified to handle a matter of this size and complexity. Mr. Nations and his legal team were recently before Judge Katz in litigation regarding Ortho Evra Products Liability, a matter which was successfully resolved in the same Ohio court.

At Moriarty Leyendecker, we are looking forward to working with Judge Katz and his staff on this important matter, and we are confident that this choice of district is in the best interest of our clients.