Answers to Metal-on-Metal Hip Questions Come Slowly but Surely

In many ways, the rise and fall of metal-on-metal hips has been like an uncontrolled experiment. Manufacturers performed minimal testing on the devices prior to releasing them into the marketplace. As metal-on-metal hips began to fail in patients, manufacturers took measures to delay – or avoid altogether – any acknowledgement that there was a problem with the metal-on-metal design. Doctors had little information to rely on and were forced to put the pieces together based on their experiences with patients. As a result, patients and doctors alike have been waiting for answers to their questions regarding the effects of metal-on-metal hip implants.

A recent information statement released by The American Academy of Orthopaedic Surgeons (AAOS) helps answer some of those questions and provides up-to-date recommendations on how to monitor these devices. The document is not intended to dictate the exact method of treatment, but it serves as a guideline that is based on the state of the published literature available.

In it, the authors discuss the intrinsic (caused by the implant) and extrinsic (something outside of the implant) causes of painful total hip arthoplasty (THA). In any case of painful THA, a thorough clinical history, a detailed physical examination, and select radiographic and laboratory tests are all essential to determining the cause(s) of pain.

The statement also provides a systemic risk stratification recommendation, which can be used to determine if a certain patient is at high-, medium-, or low-risk for hip failure. The data is consistent with some other studies in the past, which have reported trends such as a higher risk for females with metal-on-metal devices that have large-diameter femoral heads. However, this statement goes into more detail on what doctors should look for in determining a patient’s risk level and treatment options.

Having a metal-on-metal device in you can cause significant anxiety.  At GoldenbergLaw, we understand that the most important thing to anyone who has been affected by metal-on-metal hip failure is feeling better and getting back to normal life. We will continue to update our clients and others about important developments in litigation and in treatment of metal-on-metal hip failures.

Should I be worried if I have a metal-on-metal hip but no symptoms of hip failure?

The most common symptoms of hip failure include severe pain, aching and swelling in the hip area. Upon examination, doctors will often find that these symptoms started due to the release of metal particles that can damage the surrounding tissue.

What if I have a metal-on-metal hip but do not have any problems right now?

If you have a metal-on-metal hip but no symptoms of hip failure, you should keep yourself informed. Metal-on-metal effects are still being studied, and more information will continue to come out.

This month, The Lancet reported a case study of a 55-year-old German man who had been diagnosed with severe heart failure caused by cardiomyopathy. He was deaf and almost blind. He also had a fever, hypothyroidism, and reflux oesophagitis. The doctor suspected cobalt intoxication based on these problems and the fact that his medical history indicated he had undergone hip replacement surgery a few years back. The radiograph of his hip showed evidence of metal debris. He also had enlarged lymph nodes on his left hip. A blood test confirmed that the levels were high, and he underwent revision surgery soon after.

Upon examining the explanted devices, doctors found damaged areas of the chromium and cobalt femoral head. They concluded that the high cobalt levels were due to the metal wear on the hip device. After revision surgery, his cobalt and chromium concentrations decreased, and the patient stabilized and everything but his hearing and vision improved.

Importantly, according to the publication, the symptoms the patient reported did not include hip pain or swelling. The doctor made the diagnosis based on the known effects of cobalt intoxication.

It is important to note that the scientific effects of metal on the body are still inconclusive. This man’s case may be an isolated event. Regardless, staying alert and receiving needed care is an important step to staying healthy.

So What Do I Do?

Bring up any concerns with your doctor. If you have not discussed monitoring your metal-on-metal device with your doctor, we suggest you make an appointment to do so.

Recently, the FDA released guidelines for physicians to follow when monitoring metal-on-metal hip recipients. Those guidelines identified various imaging tests that can be useful for doctors to identify problems. X-ray imaging was not listed as a reliable way to detect metal-on-metal damage, so do not assume your doctor is monitoring your device if he or she is only taking x-rays!

In addition to the imaging tests, the FDA recommends that metal-on-metal patients receive blood tests that record metal ion levels in the body. Although the FDA concluded there is not sufficient evidence that blood tests are needed for patients who do not have symptoms of hip failure, we recommend that anyone with a metal-on-metal device requests these tests. We have personally seen many cases in which high ion levels were recorded long before symptoms of hip failure presented. Additionally, a study published last year in the British Medical Journal found that high metal ion levels predicted hip device failure, even in symptomless patients.

Should I get an attorney if I do not have symptoms?

You should at least talk with one. There are statutes of limitations on product liability claims that can bar your case regardless of its merit. Our firm is pursuing these cases throughout the country. Our attorneys and staff are extremely knowledgeable and can answer any questions or concerns you may have. Contact us for a free consultation before it is too late to pursue your case.

Warning: DePuy Lawsuit Funding Sites May Mirror Official Settlement Site

The recently-announced DePuy settlement has gathered plenty of media attention, which has generated many questions regarding DePuy lawsuit funding. No matter how well-executed or -organized a settlement announcement may be, there will still be a decent amount of confusion and/or misinformation as the word rapidly spreads. Unfortunately, there is no shortage of rogue websites and soliciting companies that are ready to capitalize on claimants’ confusion. It is very important for DePuy ASR claimants  to be aware of some of the practices that companies may use in order to involve themselves in the litigation and/or distribution processes.

Here are some things to consider if you are contacted regarding DePuy lawsuit funding:

1.)    Be careful who you give your information to. Lead counsel in the DePuy ASR litigation has already warned that rogue DePuy lawsuit funding and structure websites may pop up and intentionally look very similar to the official site. If you have an attorney, he or she will address all that needs to be done on the official DePuy settlement site.

2.)    Be wary of any parties, other than your attorney, who contact you directly regarding settlement. If anyone other than your attorney/his or her legal assistant asks you questions regarding your case, it is best that you politely decline to answer any questions and give them the number to your attorney’s office.

3.)    If you are considering accepting advanced settlement funding, we strongly encourage you to seek the advice of your attorney first. Legal funding (loan) companies often charge excessive interest rates. The temptation to get your money sooner is understandable. However, GoldenbergLaw (along with many other firms) rarely recommends accepting these types of loans.  Often, the interest can accrue to the point where all of (or even more than) your settlement amount is owed to the funding company.

4.)    Any concerns about DePuy lawsuit funding should be directed to your own attorney, as they are the most familiar with the specifics of your case. There have already been complaints of internet advertisers or direct solicitors (who usually do not work for a law firm but hope to sell your information to one) who are trying to get people to switch firms. Often, the solicitors will try to convince you to switch by making false claims, such as guaranteeing they can get your claim settled faster, for more money, etc. The settlement will have pre-arranged methods for distribution of funds;  no firm will receive special treatment. Some solicitors will say almost anything to get you to agree to give your information to them.

These practices are an unfortunate byproduct of highly-publicized settlements, and by warning against them early we hope to minimize the impact they have. If you have any questions about DePuy lawsuit funding or do not currently have an attorney, please do not hesitate to contact us.

Johnson & Johnson Will Pay $2.475 Billion in DePuy ASR Settlement

DePuy ASR Settlement Confirmed

In 2010, DePuy Orthopedics (a Johnson & Johnson subsidiary) recalled its ASR hip implants. This marked the beginning of an extensive litigation for those injured by the defective device. Yesterday, Johnson & Johnson announced they’ve reached a settlement for DePuy ASR revision cases.

Several news sources – many of which are considered to be reliable – reported details they got from “anonymous sources” prior to the DePuy ASR settlement agreement being finalized. As we warned in previous posts, those details were based on speculation and should not be confused with the official reports from yesterday.

Didn’t have a DePuy ASR hip? Click here for an explanation of what this could mean for your case.

Now that a formal announcement of a DePuy ASR settlement has been made, this is what we know:

A settlement fund valued at approximately $2.475 billion, assuming approximately 8,000 patients participate, will be set aside for patients who had the DePuy ASR hip and meet certain criteria. Among the criteria for eligibility, patients must have had the DePuy ASR implanted in the U.S. or at a U.S. military hospital. In addition, they must have undergone a revision surgery on or before August 31, 2013. The revision surgery must have been related to the recall and performed at least 180 days after the original surgery.

If I qualify for this DePuy ASR settlement, how much money will I get?

We cannot speculate on individual amounts at this time. There are many factors that could affect individual amounts, including how many people apply for the settlement.  Settlement awards will also vary based on health issues, length of product use, and other factors.

In addition to the agreed-upon DePuy ASR settlement amount, DePuy will be responsible for negotiating and resolving “certain liens by qualified lienholders” associated with revision surgery and other types of treatment.

I had a DePuy ASR hip but have not had revision surgery. What does this mean for me?

Thousands of non-revision cases are still being litigated. Broadspire, the third-party claims administrator that has been paying medical bills for patients, is still available to people who did not have revision surgery prior to August 31, 2013 (including those who have not undergone revision). Although this particular DePuy ASR settlement does not apply to non-revision cases, it does not mean you do not have a claim. Non-revision claims will be preserved under this agreement, and we remain dedicated to resolving them.

When will people who qualify for this DePuy ASR settlement receive their money?

Unfortunately, that is not a question we can answer at this point. In settlements of this size, distribution is a slow-moving process. Deadlines are spaced out over a large period of time in order to accommodate such a large number of cases. Fortunately, it seems that leaders in the litigation have taken important steps to eliminate some of the obstacles that have historically caused the biggest delays.

What Does it Mean to Have Elevated Metal Levels?

Hip devices containing cobalt-chromium parts have been used successfully in orthopedics for years and have been known to produce slightly elevated metal levels in patients who receive them1. Over the past decade, however, the profit-driven flurry of new metal-on-metal hip devices has left thousands of patients with much higher levels than previously observed.

Specifically, the inherent design of metal-on-metal devices often results in metal wear, which releases metal ions into the body and causes elevated metal levels. An unacceptable proportion of metal-on-metal hip recipients have needed revision surgery due to implant loosening, tissue necrosis, and pseudotumors – all of which have been attributed to elevated metal levels.

Since the DePuy ASR recall in August 2010, surgeons have been moving away from metal-on-metal implants. Many device makers have taken their metal-on-metal implants off of the market, either by issuing a recall or by “phasing them out.” It is apparent that the metal-on-metal design is causing high failure rates.

However, in relation to how widespread a problem this is, experts have come up with few definitive answers as to how interpret elevated metal levels found in patients.

Elevated metal levels can lead to hip necrosisWhy Don’t We Know More by Now?

Most metal-on-metal devices gained FDA approval through a regulatory shortcut known as the 510(k) approval process. This process requires the manufacturer to prove that the device is “substantially equivalent” to another that is already on the market. They are not required to conduct pre-market studies to prove safety and efficacy.

Since the manufacturers of MoM devices did not study the effects of metal wear, people have likened the advent of metal-on-metal hips to a large, uncontrolled experiment. Thus, the studies that are now underway are reactive in nature and have minimal foundation to build from.

As Nick Freemantle, professor of clinical epidemiology and biostatistics at University College London, pointed out, the studies should have been done before the product is used – not after.

“We shouldn’t be in this position where we don’t know and there’s so much uncertainty. The stability of a compound should have been ascertained before it was used widely in people. As yet, we don’t know the consequences of this.”

What do we know about elevated metal levels?

According to the Medicines and Healthcare products Regulatory Agency (MHRA), patients whose levels are above a threshold level of 7 μg/L should be further monitored and tested. However, it is unclear where they got this number, or if it is reliable.

Earlier this year, BMJ published a study that examined the association between elevated metal ion concentrations and early failure of hip devices. They did so by documenting the clinical course of patients who had elevated cobalt and chromium concentrations but were not experiencing symptoms of a failed device.

The results of the study provided the first real evidence that blood metal ion tests can be used to measure the risk of early joint failure. They also suggested that elevated metal levels, regardless of symptoms, warrant concern.

The study also noted differences in failure rates between men and women. Of men and women who had the same metal ion levels, women appeared to be at greater risk of joint failure than their male counterparts. This is not the first time that higher failure rates have been observed in female patients. Previously, however, the theory was that women were more prone to elevated metal levels due to heavier wear of smaller implants.

However, since the failure rates were still higher in women than men who had the same metal levels, the differences must also have a biological explanation. That is, females may be more likely to have an adverse immune response to the ions. Indeed, the prevalence of a number of immune conditions is higher in women, which, according to the study, further suggests that woman may be more likely to have problems than men.

An important conclusion to the BMJ study is that metal ion concentration levels are a useful clinical tool in predicting device failure. The data presented in the study will help doctors to develop standards and guidelines for future treatment and evaluation of metal-on-metal patients. The data also strengthens the link between the metal-on-metal design of a device and device failure, which manufacturers have contested by pointing to other potential reasons for failure.

If you have questions or would like to speak with an attorney about a potential case, contact us for a free consultation.

 

1BMJ

 

http://www.medpagetoday.com/MeetingCoverage/AAOS/37997

http://www.bmj.com/content/344/bmj.e1410#xref-ref-4-1

http://bmjopen.bmj.com/content/3/3/e001541.full

Is this considered a class action?

No, we are not pursuing any class action cases involving defective knee and hip devices. A class action assumes all damages are essentially the same, and then divides the money up evenly across the class.  The types of knee and hip injuries experienced by each person are unique.  Therefore, it would be unwise to resolve each claim for the same amount of money.   Defective knee and hip cases have been filed in federal court and many state courts. Most of them will be resolved in a consolidated action either at state or federal (multidistrict litigation) level. In consolidated state and federal actions, the cases are combined for pre-trial proceedings, such as discovery and depositions but are resolved as individual cases based on individual merits.

Statute of Limitations: Are there time limits to make a claim?

Yes, there is a statute of limitations that will bar your claim if it is not brought within a certain period of time. Many people want to know about their statute of limitations before they talk to us. Unfortunately, there is no universal answer. Setting the statute of limitations for these claims involves a very complex calculation, which we can only make after we have had time to investigate your case. Factors can include which state you are in, when your surgery was, when you found out there was a problem, etc.

The most important thing to take away is that time is of the essence. The statute of limitations is the date by which you must file your claim. Before we can do that, we need adequate time to open your file, order necessary records, go through and extract needed documents, and have them reviewed by an expert. It can take several months for hospitals to even get the records to us. Therefore, it is best to speak with us as soon as possible to avoid possible statute of limitations issues.

Why choose a GoldenbergLaw knee and hip attorney to handle my hip device claim?

Choosing a defective knee and hip attorney is an important decision. When you are speaking with a firm about you case, ask if they have other knee and hip cases. Ask what their plan is, and what you can realistically expect them to do for you. Most importantly, make sure to ask if the attorney is experienced in mass tort.

Mass tort is a very specialized area of law. Do not make the mistake of assuming that any attorney who agrees to take your case will achieve the same result. Many product liability attorneys do not necessarily have the experience or the resources to take on mass tort claims. Since this is not a class action litigation, outcomes of cases will vary.

GoldenbergLaw has been involved in many mass tort litigations and has been representing victims of defective medical devices for almost 30 years. We work with some of the top experts in the country and stay on top of developments in the litigation that can affect the outcome of your case. We carefully and efficiently review each case, taking time to give realistic expectations and updates to our clients. Before we expect you to retain us as your defective knee and hip attorneys, we will make sure all of your questions are answered to your satisfaction. Please contact us for a free consultation.

Who is Broadspire?

If you have a DePuy ASR Hip or a Stryker Rejuvenate or ABG II Hip, you may have already heard from Broadspire. Many people are confused by who they are and wonder if they should trust them.

Broadspire is a third-party claims administrator that helps manage out-of-pocket expenses for recipients of the recalled hips. They track down recipients of the hips and enroll them in the medical programs funded by the manufacturer (DePuy or Stryker, in this case).

While the opportunity to have the company cover out-of-pocket costs is a good thing, it is important to proceed with caution. Keep in mind that Broadspire is on the manufacturers’ payrolls, and they are not paid to advocate for hip recipients. Do not sign anything with them before speaking with an attorney.

You DO NOT need to forfeit a lawsuit in order to participate in Stryker or DePuy’s medical programs, although they would like you to believe that. You do, however, need to be careful of what you give Broadspire access to. Anything you give Broadspire can be used in a defense against you, which is why we work to make sure that 1) your out-of-pocket costs are submitted to them properly and are paid and 2) Broadspire is not privy to information beyond what is required/necessary.

See also:

Seeger Salvas Warns DePuy Hip Replacement Recall Victims that Recorded Phone Calls Could be Used Against Them

Judge Katz Issues Preservation Order for DePuy ASR Devices

Stryker Hires Broadspire Services Inc. as Third-Pary Claims Administrator

 

 

Should I sign anything?

If you have a recalled device and/or have been contacted by the manufacturer of your metal-on-metal hip, do not sign anything until you explore your rights with an attorney. While the manufacturing company may offer to “pay your medical bills,” you may be entitled to additional damages for wages lost, lost earning capacity and the effects this defective product has had on your life and activities of daily living due to problems caused by your metal-on-metal hip device.

Stryker and DePuy have both hired a company called Broadspire to help them minimize costs associated with their recalled hips (see: Who is Broadspire?).