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.

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.

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