Biomet M2a Hip Implants Cause High Metal Levels

Zimmer Biomet (Biomet) is a medical device manufacturer founded in 1977, and  headquartered in Warsaw, Indiana. Its official name was simply “Biomet” until “Zimmer” purchased it in 2015. Biomet M2a hip implants are hurting patients in the US and United Kingdom (UK).

The Magnum M2a Hip Implant Has a High Revision Rate

The M2a Magnum is a metal-on-metal brand of cup and head. This means that both the cup and head implants are made of cobalt-chromium. Studies show that between 6% and 7% of patients who receive the M2a Magnum need revision surgery within 5 years. Those patients needed revision surgery because their implants were poisoning their blood with high metal levels. High metal levels in the blood can cause a host of problems including:

  • Bone death (osteolysis)
  • Tissue death (necrosis)
  • Pain
  • Infection
  • Psuedotumor

One somewhat unique side effect patients experience from the M2a Magnum is clicking. In some cases, as the M2a Magnum wears out it can cause an audible clicking noise. Unfortunately, all of these problems eventually necessitate revision surgery.

Biomet Paid Out Big in the US

On April 15, 2014, Biomet signed a settlement agreement with hundreds of implant patients. Patients are eligible to receive a base award of $200,000 if they meet the following conditions:

  • Had a Biomet M2a Magnum hip implant
  • Filed a lawsuit against Biomet on or before April 15, 2014
  • Had the Biomet M2a Magnum hip implant removed more than 180 days after it was implanted

If you meet those conditions, then you may be entitled to at least $200,000.

Biomet Tried to Cover Its Tracks in the United Kingdom

Biomet hasn’t recalled M2a Magnums in the US, but it has recalled a close cousin of the M2a Magnum – the M2a 38 mm – in the UK. On April 12, 2016, Biomet issued an Urgent Field Safety Notice (FSC) regarding M2a Magnums in England and Wales. An FSC is an official communication in the UK which has two purposes:

  • Warning—tells doctors that something is wrong with the company’s product
  • Recommendation—tells doctors what to do with patients who were or are exposed to that product

Here is a breakdown of Biomet’s FSC.

  • Warning—patients with M2a 38 mms need revision surgery far more often than they should because they are getting high metal levels in their blood.
  • Recommendation—doctors should test patients with M2a 38 mms, and if the test results are abnormal, then the doctors should remove the M2a 38 mms and replace them with different, safer implants.

Biomet M2a Hip Implants Are Dangerous

Here in the US, Biomet is paying out millions of dollars over the M2a Magnum. In the UK, Biomet issued an urgent warning over a similar device. Clearly something is wrong with these dangerous products.

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.

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.

Biomet Hip Settlement – M2a Magnum Hips

We are happy to report some good news regarding a recently-announced Biomet hip settlement. Yesterday, the Court proposed a settlement between Biomet and the Plaintiff’s Steering Committee (PSC) of the multi-district litigation on behalf of all plaintiffs who suffered a metal-on-metal  (MoM) related failure of their Biomet M2a 38 or Biomet M2a Magnum hip device.  As we anticipated and hoped, the settlement structure is in many ways similar to the ASR settlement that we reported in late 2013. However, as we previously warned, each hip litigation varies and might produce slightly different results.

Who is eligible for the Biomet hip settlement?

Plaintiffs who have undergone revision surgery on their Biomet M2a 38 or Biomet M2a Magnum hip more than 180 days after it was originally implanted are eligible for the settlement. Cases that have not undergone revision surgery will be dismissed without prejudice on or before September 12, 2014, if a revision does not take place by that date. The injuries necessitating the revision surgery must have been caused by metal-on-metal wear.  Other reasons for failure, such as infection or trauma, do not qualify.

How much will plaintiffs receive?

We cannot speculate on individual amounts at this time. However, reports say that Biomet will pay at least $56 million to settle the claims in the MDL. The Biomet hip settlement agreement includes a base award of $200,000 for eligible plaintiffs. This amount is subject to deductions based on the date of implantation, amount of time between implantation and revision, and other factors. Notably, the base amounts for the Biomet hip settlement will not be subject to discounts based on age, BMI, or smoking like they were in the DePuy ASR settlement.

In addition, certain factors may “enhance” the compensation a plaintiff can expect to receive. Examples of enhancement cases have not yet been released. Stay tuned for updates.

To our clients:

If you qualify, we will be sending you an update letter as soon as possible detailing the settlement agreement and next steps. Please keep in mind that, 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. Thus, we ask that you follow these guidelines unless you consult with your attorney first:

1.)  Do not spend the money until you have it. Even if we do confirm with you that your case is eligible for settlement, the base value could be subject to discounts based on the facts of your case. In addition, we cannot guarantee a deadline by which you will receive funding. Settlement funding depends on many factors beyond our control, and after we have submitted everything on our end there is little we can do to expedite the process.

2.)  Do not talk to loan funding companies. They charge extremely high interest rates over short periods of time. Again, we cannot guarantee when you will receive funding, and you could end up owing most or all of your settlement back to them.

3.)  Do not post on social media about the settlement. Posting on social media about your case is never going to help it, but it does have the potential to hurt it (see more).

4.)  Be wary of anyone (besides us) who calls you to talk about your claim. The period between a settlement announcement and fund distribution can be an opportune time for scammers to prey on plaintiffs. If you are not sure who is calling you or how they got your information, don’t be afraid to ask.

5.)  Be wary of anyone trying to get you to switch attorneys. Now that people have heard of the settlement, the competition for these cases is fierce. Marketers can make a lot of money selling your name and number to other law firms, and they will often tell you whatever you want to hear to try to get your attention. Sticking with your current attorney is, in most circumstances, the best route specifically because our attorney has already prepared your case for settlement.

If you have not yet hired an attorney:

It is very important that you speak with us as soon as possible. Plaintiffs are not eligible to participate in the settlement unless their case is filed in the MDL on or before April 15, 2014. That does not simply mean that we must hear from you by that date. It takes months to prepare these cases before we can file them. We must hear from you very soon in order to file your case on time for the April 15th deadline.  Further, there are statute of limitation laws that could bar your claim if your case is not filed by a certain date. Statute of limitation laws vary from state to state and are determined on a case-by-case basis.

These cases still depend on our ability to prove that your injuries were related to the metal-on-metal design of these implants. We have some of the top expert physicians reviewing our cases and making sure your case is as strong as possible before we file it. If you have metal-on-metal Biomet hip, please contact us to speak with one of our attorneys. We look forward to helping you.

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.

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

Lawsuits Involving Biomet M2a Magnum Metal-on-Metal Hips will be Consolidated to MDL

Earlier this month, the United States Judicial Panel on Multidistrict Litigation (JPML) decided that Biomet M2A Magnum hip claims will be centralized in the Northern District of Indiana (See Case MDL No. 2391). The pretrial proceedings will be assigned to the Honorable Robert L. Miller, Jr., who is experienced and well-versed in complex mass tort litigation.

The Panel made this decision despite objections from Biomet, whose lawyers argued against consolidation. Specifically, defendants argued that consolidation of the lawsuits was not appropriate because (1) plaintiffs’ injuries were too different, (2) the Biomet M2A Magnum was not subject to a recall, and (3) the system has been comparatively less problematic than similar hip implant products of its competitors.

However, the Panel’s final position stated that, since the cases involved common questions of fact, consolidation would better serve the convenience of both parties and the witnesses involved.

Although the Panel agreed with plaintiffs on the issue of centralizing the Biomet M2a Magnum claims, the JPML had its own ideas pertaining to the appropriate district for the proceedings. The Northern District of California, the Eastern District of Louisiana, the District of New Jersey, the Eastern District of New York, the Southern District of New York, the Southern District of Ohio, and the Southern District of Texas were all suggestions from plaintiffs in support of centralization. However, the Panel decided on the Northern District of Indiana based on its central geographic location, proximity to Biomet’s headquarters in Warsaw, Indiana, and favorable docket conditions.

The Biomet M2a Magnum litigation now joins the DePuy ASR, DePuy Pinnacle, Zimmer Durom and Wright Conserve as the fifth MDL for metal-on-metal hip implant devices. There have also been motions in multiple states to consolidate cases for the recently recalled Stryker Rejuvenate and ABG II hips.

What is an MDL?

When a drug, medical device, or other type of product is alleged to cause injuries and/or deaths, many lawsuits against the manufacturer of the product can be filed in courtrooms across the country.

If these cases are deemed similar enough to each other, they can be merged into a multidistrict litigation for consistency and efficiency purposes. The goal of the MDL process is to avoid duplicate discovery, inconsistent pre-trial rulings and conflicting verdicts.

The MDL process also helps speed up the process of handling numerous (sometimes thousands) of separate civil lawsuits pertaining to the same alleged tort (wrongdoing).

In determining whether consolidation to an MDL is appropriate, a panel considers whether civil actions pending in different districts involve one or more common question of fact. If it is decided that consolidation makes sense, the panel will then decide on the district in which to centralize and the judge to preside over the matter.

Although multidistrict litigations can be confused with class action suits, they have important differences. The cases that are consolidated into an MDL start and remain individual claims throughout the litigation.