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.

Broadspire Reimbursement Program for Hip Devices

As we discussed in a previous post, Stryker Orthopedics and DePuy Orthopedics have both hired Broadspire, a third-party claims administrator, to issue reimbursements for out-of-pocket medical expenses related to the recalled Stryker Rejuvenate, Stryker ABG II, and DePuy ASR hips.

Our office has been pursuing defective hip device cases for several years now. We work with Broadspire on both the Stryker and the DePuy medical programs. These programs are optional, but they have helped our clients cope with the day-to-day expenses of monitoring and/or treating injuries from their failed hips.

What expenses does Broadspire reimburse?

1.            Medical expenses associated with the failed device. This includes prescriptions, such as for pain medication, or copays for a hip-related doctor appointment.

2.            Mileage traveled from home to your medical providers for related treatment.

3.            Other out of pocket expenses such as paying someone for snow removal, lawn care, parking, fitness or rehab facility memberships, in-home health care, etc.

4.            Wage loss. In some circumstances, we are able to make a request for time missed from work, whether a single day off for a doctor appointment or several weeks of recovery following a revision surgery.

Do you need to give them my medical records?

In order for Broadspire to process a reimbursement request, our office must release some of your records to Broadspire. They must see medical records that prove that you have the device. They will also need to see additional relevant documents so they know that the medical needs for which you are requesting compensation relate to the device failure.

It is important that they only get what they need in terms of medical records. Our office releases these certain limited medical records and controls what Broadspire receives at all points in time.

What if I already have health insurance?

Your medical insurance provider will remain your primary insurance on any previous or future related medical bills. Broadspire will be listed as your secondary insurance and will cover any expenses your primary insurance does not cover.

Do people actually get compensated?

We make sure that they do.

Obtaining reimbursement from Broadspire is a complicated matter. It requires persistence, follow-up, and a legal-minded approach toward evidence submission.  Members of our staff touch base with Broadspire several times a week, submitting and pushing through requests for reimbursement. Remember, Broadspire was hired by the defendants to manage these costs. Their program happens to be in the best interest of injured victims, but only because it also aligns with the best interests of the companies who hired them.

How do I participate?

After you become our client, we will give you the option to participate. If you do wish to participate, we will enroll you in the program and you will be assigned a claim number. If you have already been enrolled in Broadspire’s reimbursement program, you can give us your claim number or have us look it up.

Once you are enrolled, we will explain how to proceed.

Regardless of whether you choose to participate in the medical program, neither Broadspire nor the defendant (DePuy, Stryker) should contact you regarding your claim if you have representation. We will serve as the go-between to ensure that your privacy and the integrity of your claim are preserved.

How can I get help?

If you have not yet spoken with our office regarding a claim, contact us as soon as possible. We have been representing defective hip victims for several years and can help you.

FDA Publishes Guidelines for Chromium and Cobalt Testing

It is very important that patients with metal-on-metal implants are monitored and receive the appropriate chromium and cobalt testing. As we pointed out in a post last fall, definitive answers to metal-on-metal questions are difficult to come by:

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.”

The problems that have been reported relating to metal-on-metal wear can undoubtedly generate anxiety and worry for hip recipients and their families. Recently, the FDA released a set of guidelines to help establish uniform chromium and cobalt testing and diagnostic procedures for orthopedic doctors who are treating metal-on-metal hip recipients. This is a step in the right direction, as doctors have been forced to work off of little to no official guidelines when it comes to monitoring metal-on-metal hip recipients and interpreting results of various diagnostic methods.

FDA Guidelines for Chromium and Cobalt Testing

Soft Tissue Imaging

The first method discussed in the FDA report is soft tissue imaging. Depending on the individual circumstances, the FDA recommends one of the following:

  • Magnetic Resonance Imaging (MRI) with metal artifact reduction (MAR)

This technology offers the best visualization of soft tissue surrounding a metal-on-metal hip implant and uses non-ionizaing radiation. Panel members at the June 2012 Orthopaedic and Rehabilitation Devices Advisory Panel Meeting recommended this method over others that were discussed. However, this method is contraindicated for some patients with implants.

  • Computed Tomography Scan (CT) Scan

CT scans offer the best visualization of implant positioning and bony tissue. However, they use ionizing radiation and provide lower soft tissue visualization. Image artifacts from the implant may distort the images.

  • Ultrasound

Ultrasound allows soft tissue visualization without metal artifacts and uses non-ionizing radiation. However, it provides a lower resolution soft tissue image and has a limited depth penetration.

These tests will show the tissue surrounding the implant and any distortions in the imaging will alert your doctor to metal artifacts (particles of metal) around the implant. Your doctor can determine which test is most appropriate for your situation. Keep in mind that his or her decision may also be based on what types of tests insurance will cover.

Chromium and Cobalt Ion Tests

As you likely know, elevated metal ion levels (e.g. chromium and/or cobalt) are a concern for anyone who has a metal-on-metal hip. Ions are not visible on the imaging tests listed above, so a blood sample must be tested in order to detect them.

The FDA says that anyone who develops symptoms should be tested. However, a recent study provided evidence that blood metal ion tests can be used to measure the risk of early joint failure. The study also suggested that elevated metal ion levels, regardless of symptoms, warrant concern. This means that even symptomless patients who have undergone metal-on-metal hip replacement surgery could still have increased ion levels that predict implant failure. For this reason, we recommend that metal-on-metal hip recipients undergo chromium and cobalt testing regardless.

The FDA specifies blood test methods they believe will produce the most accurate results. These tests are rarely done in your doctor’s office; he or she will most likely send you to a lab to have them done. The FDA also specifies the criteria a lab should meet to generate the most accurate results. Many doctors have already been using labs that meet these criteria, but some may be using testing labs that are outside of the FDA’s new guidelines. Before you get tested at a lab, we recommend checking with your doctor to make sure the lab meets the FDA’s criteria for accurate chromium and cobalt testing.

Talk to your doctor

If you have any concerns or questions about your implant, do not hesitate to talk to your doctor. The FDA guidelines are not meant to replace the need to see your doctor; it is important that you keep he or she in the loop when it comes to your condition.

Do you have a Case?

If you have a metal-on-metal hip and have not yet spoken with an attorney, we recommend that you do as soon as possible. There are statutes of limitations that can bar your claim if it is not filed by a certain date. There could also be additional cut-off dates to file your claim based on settlements. Contact us for a free consultation.

Have you been told you need revision surgery?

The explanted device can be a crucial piece of evidence and it should be preserved with the surrounding tissue. We do this for our clients using a company that specializes in device preservation. If you have been told you need a revision surgery, it is best to contact us as soon as possible so that we have time to preserve the device.

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.

Most Metal-on-Metal Hips Banned in United Kingdom

Almost all metal-on-metal hips have unacceptably high failure rates, according to UK regulators:

The United Kingdom’s National Health Service (NHS) has recently decided to ban most metal-on-metal hips in UK hospitals. The National Institute for Health and Care Excellence (NICE), the non-departmental public body that publishes guidelines for the use of health technologies within the NHS, made the recommendation to do so based on an audit of all hip surgery in England and other parts of the UK.

According to The Telegraph, NICE advised the NHS to discontinue use of all hip devices that have failed at rates higher than 5% after five years. According to NICE, the new standard will preclude future use of most metal-on-metal hips, as almost all of them failed at rates higher than that.

Metal-on-metal hips banned in UK

Photo Cred: The Telegraph http://www.telegraph.co.uk/health/nhs/10406198/NHS-hospitals-to-be-banned-from-fitting-metal-on-metal-hip-replacements-after-high-failure-rate.html

According to the report, even metal-on-metal resurfacing procedures had unacceptably high failure rates. Resurfacing hip replacements include the Adept, Durom, Recap Magnum, Conserve Plus and Cormet 2000.

Only two metal-on-metal hips managed to meet the new standards. According to The Telegraph, those devices’ failure rates were still considerably higher than those of traditional implants. Predictably, the DePuy ASR had a particularly high failure rate, which was estimated to be as high as 43% after nine years.

Although the United States has not taken the same measures, many surgeons have stopped using metal-on-metal hips of their own accord. Many manufacturers have discontinued or recalled their metal-on-metal devices, although they do not readily cite problems with metal-on-metal hips as reasons for doing so.

The age of manufacturers profiting off of these dangerous devices may be ending, but thousands of people have been left with the consequences. Many recipients have already undergone dangerous revision surgeries, and many more are left wondering if they will need to do so within the next few years.

If you believe you or a loved one are experiencing problems due to a metal-on-metal hip device, contact our office for a free consultation.

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.

DePuy ASR Settlement? To Be Announced Tomorrow

An “open conference” – potentially revealing ASR settlement – is scheduled for tomorrow, November 19.

According to Bloomberg, Johnson & Johnson will make an announcement pertaining to a possible DePuy ASR settlement tomorrow, November 19. From what we know, it seems likely that the announcement will confirm conjectures that Johnson & Johnson will settle the lawsuits for approximately $4 Billion. If this is the case, the ASR settlement will be the largest defective medical product settlement to date.

However, as we previously warned, these details should not be taken as fact until they are confirmed.

Bloomberg’s anonymous sources say that the settlement will cover more than 7,500 patients who have already had revision surgery, averaging around $300,000 per case. However, the amounts will vary depending on several factors, including the severity of injury. According to the sources, the deal will not bar patients whose hip implants fail in the future from seeking compensation.

Again, it is important to note that this is merely speculation until publically confirmed by leadership in the litigation. We will find out more after the conference tomorrow and will keep you updated if an ASR settlement is announced.

If you have a DePuy ASR hip and have not spoken with an attorney, we suggest you contact us immediately. If you are not sure what type of hip you have but believe it could be an ASR or other metal-on-metal hip, we can help you find out.

Recently Announced: Tentative DePuy ASR Hip Settlement

Is the settlement real?

According to several news sources, Johnson & Johnson plans to pay up to $4 billion in a recently-announced DePuy ASR Hip settlement. Provided these reports are accurate, it would be one of the largest payouts in the history of defective medical device litigation. The pending DePuy ASR Hip settlement will resolve thousands of lawsuits that have been filed by injured recipients of the defective hips.

Although we are optimistic about this announcement, any information about a DePuy ASR Hip settlement that does not come from ASR leadership remains speculation. 

Things to keep  in mind: 

At this point, no numbers you hear should be accepted as fact. In settlements of this magnitude, there are many administrative details to iron out before clients are notified of their settlement amounts.

Remember, this is not a class action. Funds resulting from a DePuy ASR Hip settlement will not be distributed equally. Individual settlement amounts will depend on several factors, including age and medical condition. Revision cases, meaning the hip has required additional replacement surgery, will be given the most value.

Distribution takes time. Again, it is okay to be pleased with the news of potential settlement, but keep in mind that there are tens of thousands of claims.  Lawsuits involving this many people move slowly and have many moving parts.

If you do not have an attorney, speak with one now. If you or a loved one received a DePuy ASR hip device and have not retained an attorney, it is important to speak with us as soon as possible. Those who do not have an attorney may still qualify for settlement, but we must act quickly. Contact us to speak with one of our attorneys right away.

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

DePuy ASR Settlement for Plaintiff in New Jersey

Mass Device reported this week that Johnson & Johnson resolved another DePuy ASR hip case, this time in New Jersey Superior Court. The case, MacDonaled et al v. DePuy Orthopaedics Inc. et al, was previously scheduled to go to trial but has been taken off of the trial calendar. While few details are available in the court documents, we know that Judge Brian R. Martinotti concluded that “all pending motions are withdrawn, [and] the complaint will be dismissed with prejudice upon receipt of a fully executed stipulation signed by counsel.”

While we do not know for sure if this means the case was settled, that has been the common interpretation. The vast majority of DePuy ASR cases are still pending in Federal Court, where Judge Katz is overseeing the MDL in the northern district of Ohio. Recently, the first bellwether trial was rescheduled for the 4th time. There has been speculation into whether we will see a global DePuy ASR settlement anytime soon for those cases, and we are still waiting to see. At this point, the plan is for the first bellwether case to commence in the next few months.