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.

Stryker Bellwether Trial Categories Established in Federal MDL

Federal MDL in Minnesota Establishes Stryker Bellwether Trial Categories

A small group of Stryker hip cases are being prepared for early trials, which are known in mass tort as “bellwether trials.” Bellwether trials are a way for the parties to determine how each case might be resolved if it were brought to trial. Thus, the results of a bellwether trial often have a significant impact on the potential value of the rest of the cases in the litigation.

The cases that are selected for bellwether trials must represent the diversity of cases in the litigation. Since the type/severity of injuries can vary, as can the risk factors for those injuries, both plaintiffs’ and defendants’ attorneys typically establish categories into which the test cases will be divided.

On May 9, 2014, Judge Frank, who oversees the Minnesota Stryker MDL, issued a pretrial order that indicated that there will be five categories for Stryker bellwether trial cases. One of the categories will be dedicated to the ABG II system, which was recalled at the same time as the Rejuvenate for similar problems. The other four will pertain to the Stryker Rejuvenate, which is the subject of the majority of the lawsuits that have been filed.

The four Rejuvenate categories will be divided according to the date the Stryker Rejuvenate hip was implanted (before or after January 1, 2011) and whether the revision was complicated or uncomplicated. Judge Frank had already established that only cases that involved a revision surgery (a second surgery to replace the defective hip) would be considered for a Stryker bellwether trial.

According to an order issued in March 2014, the first Stryker bellwether trial will begin during the summer of 2015.

New Jersey Cases

In New Jersey State Court, cases are coordinated under Superior Court Judge Brian R. Martinotti as part of a Multi-County Litigation, or MCL.  Judge Martinotti established a mediation process last year to see if a settlement could be reached before a lengthy and expensive trial process. The first phase involved a group of 10 cases that were selected for early negotiations before a court-appointed mediator. One of the cases was delayed, and eight of the remaining nine cases were successfully resolved.

Now, a “phase 2 mediation” is in the works. The group of cases will involve plaintiffs aged 78 years or older, among other plaintiffs who sustained serious injuries. The Court has selected five cases at random to be included in this mediation, and plaintiffs have identified another five.

Next Steps for Recalled Stryker Hip Recipients

If you currently do not have an attorney, it is important that you speak with one as soon as possible about your options. There are statutes of limitations that can bar you from bringing a claim if you do not do so by a certain deadline. The statute of limitations on your case requires a complex evaluation that only an attorney can accurately provide. Click here to contact our office.

If you are currently our client, please know that we are keeping up on filing deadlines of your case and any Broadspire reimbursement requests that you may be waiting on. If we have any concerns or questions regarding your case we will contact you directly. Thank you for your trust.

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.

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.

Stryker Hip Settlements in New Jersey

Four Stryker Hip Settlements in New Jersey, Attorneys Continue to Mediate Cases

Last week, attorneys negotiated Stryker Hip settlements on four cases that were filed in New Jersey State Court. The cases were among six that were chosen by both parties and by New Jersey Superior Court Judge Brian Martinotti. Negotiations on the other two cases “fell through,” according to reports.

Although the Stryker Hip settlement amounts remain confidential, this news is very encouraging for other plaintiffs involved in the litigation. Attorneys continue to mediate a select few cases as the New Jersey Court permits.

However, it is very important to remember that this is only the beginning stage of negotiations. Over a thousand cases have been filed throughout the country. Litigation of this size often progresses very slowly. Even after a case reaches a settlement, it can take years until funds are distributed.

Currently, there are two main consolidated actions throughout the country. Approximately half of the cases are filed the federal multidistrict litigation (MDL), which is centralized in Minnesota under Judge Frank.  Over five hundred more are filed in the New Jersey multi-county litigation in state court, under Judge Brian Martinotti. About 100 more are filed in various other venues throughout the country.

We will continue to post updates regarding Stryker hip settlements. If you have a recalled Stryker ABG II or Rejuvenate hip and have not yet spoken with an attorney, it is important to do so as soon as possible. Contact us for a free consultation.

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

Stryker’s Q3 Profits Are Down Nearly 71% Due to Hip Recalls

Q3 Stryker decline in profits attributed to Rejuvenate and ABG II hip recalls

In a press release yesterday, Stryker Corp. reported a 71% decrease in profits in Q3 due to costs associated with the recalls of their Rejuvenate/ABG II hip devices and a surgical waste management system. The company’s gross sales totaled $2.2 billion for Q3, showing a growth of 4.8%. Profits, on the other hand, totaled just $103 million – less than one third of 2012 Q3 profits.

The company admitted that hip and waste management recalls cost the company $313 million in Q3 alone and $700 million total so far.

Stryker president and CEO Kevin A. Lobo released an optimistic statement that focused on the sales growth:

“We are pleased with our strong third quarter sales growth of 6.8% in constant currency, and 6.1% excluding currency and acquisitions…We believe these results not only represent gradual improvement in our key markets but also underscore our commitment to delivering above market growth. We are on track to meet our full year adjusted EPS guidance of $4.20 to $4.26.”

However, the press release gave no indication as to whether the company could see similar hits next quarter.

Back in July, Mass Device reported that Stryker’s Q2 profits plunged nearly 35% due to costs related to the recall of the hip devices.