metal hip replacement

Stryker Agrees to Second Settlement of Metal-on-Metal Hip Implants

Today (December 19, 2016), Stryker announced it will participate in a second global settlement agreement with patients who were implanted with either of two of its products. The products are both metal-on-metal neck-stem hip implant components: the “Rejuvenate” and the “ABGII” models. Each of these models was recalled in July 2012.

Both the Stryker Rejuvenate and ABGII hip devices consist of a modular stem and femoral head. Individuals who received a Stryker Rejuvenate or ABGII implant and then required removal of the device due to metal-on-metal failure are potentially eligible to participate in the settlement. The removal, or revision, surgery must have occurred no later than December 19, 2016.

This settlement agreement follows a prior global settlement announced in 2014 where individuals requiring removal of the Stryker Rejuvenate or ABGII device before November 3, 2014 qualified. The current settlement, announced just over two years after the first, is an effort to compensate those individuals requiring removal of the products after the November 3, 2014 deadline.

Stryker has paid over $1 billion in settlements stemming from its Rejuvenate and ABGII hip devices and is now projected to pay another billion dollars or more in the second settlement.

Following a recall of the DePuy ASR hip devices in 2010, it became apparent to the public that metal-on-metal hip devices could cause severe injuries to patients. The acetabular components of the ASR device, the cup and ball were made of metal. These two pieces, positioned next to each other, rubbed together, causing metal ions to be released in the body.

The suspected mechanism of failure in the Stryker Rejuvenate and ABGII products was not of the acetabular parts, but of the neck and stem femoral components. These two pieces, locked together upon implantation, could result in metal-on-metal wear. We began to see the Rejuvenate and ABGII fail at very high rates in 2012 due to corrosion between the stem and neck.

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.

Will We See More Stryker Hip Settlements in 2014?

Stryker Hip Settlements in 2013:

So far, four Stryker hip cases have settled in mediation in New Jersey State Court. These cases were among the ten chosen by the parties and Judge Martinotti for mediation in late 2013. As part of the terms, the settlement amounts will not be disclosed.

Currently, over 500 more cases are filed in New Jersey State Court. There are 4 more cases that are on Judge Martinotti’s mediation schedule for January 2014. If these cases end up settling, it is very possible that the amounts will also remain confidential. We expect to see more cases scheduled for mediation in the near future.

What does this mean for the other 500 cases in New Jersey?

Right now, it cannot be determined. However, it is important to keep in mind is that this litigation is progressing at a promising rate. The fact that we are seeing any Stryker hip settlements only 1.5 years post-recall is positive news. DePuy ASR hips were recalled in 2010 and are just now starting to settle. Stryker recalled their Rejuvenate and ABG II hips in July 2012.

We are encouraged that cases are settling and are committed to pursuing future settlements.

Why speak with an attorney now?

It is vital that Stryker hip recipients who do not have an attorney speak with one as soon as possible. It takes time to work up these cases and conduct an expert review; medical records alone take months to come in.

In addition, people who wait until they start seeing settlement amounts to pursue their claim risk their case being barred by the statute of limitations. Each state has different laws governing statutes of limitations, and recipients should not try to figure out what that date would be on their own. It is a very complex calculation that only an attorney can accurately determine.

If you have not yet discussed your case with an attorney, contact us for a free consultation.

Will the ASR Settlement Affect My Case?

You have another metal-on-metal hip. What should the recent ASR settlement mean to you?

With news of the DePuy ASR settlement, many recipients of other types of metal-on-metal hips have asked us what bearing, if any, the settlement will have on their case. This is a fair question, as the bases for other metal-on-metal lawsuits are similar to that of the ASR.

Other metal-on-metal hips include, but are not limited to:

  • Stryker Rejuvenate
  • Stryker ABG II
  • DePuy Pinnacle (with metal liner)
  • Biomet M2M Magnum
  • Wright Medical Conserve

Indeed, there has been a pattern in the trajectory of various metal-on-metal hip litigations. We are optimistic about the ASR settlement and hopeful that it will encourage negotiations on other metal-on-metal hip cases. However, the ASR settlement does not make other results any more predictable. Each hip device has individual traits and circumstances that can affect the outcome of litigation.

We will continue to pursue compensation for all of our metal-on-metal hip clients.

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 case against Stryker?

When choosing a knee and hip attorney, experience must be a requirement – not a preference. GoldenbergLaw has been representing victims of negligent manufacturing practices for almost 30 years. We have specific insight and experience with knee and hip device litigation through our current involvement in metal-on-metal hip litigations, including DePuy ASR. We have experience dealing with Broadspire, as DePuy hired them to manage costs after the ASR recall in 2010. We refuse to let device companies put profits before safety at the expense of your health. In addition, the federal Multidistrict Litigation (MDL) for Stryker cases is centralized in the District of Minnesota, meaning we will be just blocks away from MDL proceedings. We remain heavily involved in this litigation and will play a leadership role.

See More

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