A front page article in the January 23 New York Times, Maker Aware of 40% Failure in Hip Implant, revealed that Johnson & Johnson knew of widespread failure with the troubled all-metal hip joint it had recalled in 2010. Even as the company became aware of the extent of the products failure, it continued to publicly play down similar findings from the British implant registry.
The internal study, conducted by Johnson & Johnson, is just one of hundreds of documents expected to be made public as the first of over 10,000 lawsuits begins this week in California superior court in Los Angeles.
In the analysis, Johnson & Johnson found that nearly 40 percent of the patients who received the now-recalled Articular Surface Replacement, or ASR joint, would experience failure within five years. It also found that thousands more patients will likely experience premature failure in up-coming years and be forced to undergo painful and costly replacement surgery.
The trial is expected to uncover what officials of Johnson & Johnson’s DePuy Orthopedics division knew about the device’s problems, both pre- and post-recall, and what actions they took. This episode represents one of the biggest medical device failures in decades and these early documents bring into question how forthright DePuy was in dealing with the problem. Even after the company recalled the device in 2010 it continued to challenge the validity of the British registry findings, which had found a failure rate in at least one-third of patients with the device.
Metal hip implants made by all manufacturers have been failing at an unacceptable rate for years. The DuPuy ASR joint was only the first to be recalled. Since then the Smith & Nephew R3 and the Zimmer Durom Cup have also been recalled. The Stryker Rejuvenate was recalled in 2012 for metal contamination as well but in that case the metal was leaching from the modular neck joint.
As a result of these failures the FDA recently posted a proposed order addressing metal hip implants. The new order, if approved, will require all hip implant manufacturers to go through Premarket Approval Process to keep any existing metal-on-metal hip implant on the market or to put a new metal on metal product on the market.
Metal on Metal joints still on the market such as The Biomet Magnum, the Encore and the Wright Profemur Converse, Dynasty, and Lineage are also failing at unacceptably high rates. Ironically the new order and PMA process faced by these manufacturers might allow them to avoid recalls. By citing the prohibitive cost of preparing a PMA application they can simply cease production without ever acknowledging an admission of failure in the joints.
So, as the trial prepares to begin in California this week, the early release of documents showing that DePuy long knew of the high failure rate while simultaneously trying to downplay the situation would indicate the company was more concerned with limiting its financial liability than being forthright with patients. Even after the company instituted its own recall of the suspect joint in 2010 it methodically continued to challenge medical findings that indicated a high failure rate.
Continued public disclosure of documents from the civil lawsuits and the data collected by the FDA will help protect the public from companies that put their own profits ahead of safety.

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 888
[Docket No. FDA-2011-N-0661]
Effective Date of Requirement for Premarket Approval for Two Class III Preamendments
Devices
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed order.
SUMMARY: The Food and Drug Administration (FDA) is proposing to require the filing of a
premarket approval application (PMA) or a notice of completion of a product development
protocol (PDP) for the following two class III preamendments devices: Hip joint metal/metal
semi-constrained, with a cemented acetabular component, prosthesis; and hip joint metal/metal
semi-constrained, with an uncemented acetabular component, prosthesis. The Agency is also
summarizing its proposed findings regarding the degree of risk of illness or injury designed to be
eliminated or reduced by requiring the devices to meet the statute’s approval requirements and
the benefits to the public from the use of the devices. In addition, FDA is announcing the
opportunity for interested persons to request that the Agency change the classification of any of
the aforementioned devices based on new information. This action implements certain statutory
requirements.
DATES: Submit either electronic or written comments on the proposed order by [INSERT
DATE 90 DAYS AFTER DATE OF PUBLICATION IN THE FEDERAL REGISTER]. FDA
intends that, if a final order based on this proposed order is issued, anyone who wishes to
2
continue to market the device will need to file a PMA or a notice of completion of a PDP within
90 days of the publication of the final order. See section X of this document for the proposed
effective date of a final order based on this proposed order.
ADDRESSES: You may submit comments, identified by Docket No. FDA-2011-N-0661, by any
of the following methods:
Electronic Submissions

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New FDA Proposed Order Will Take Metal on Metal Hips Off the Market
The FDA released a proposed Order today that will likely remove most metal on metal hips from the marketplace. Metal on metal hips had been grandfathered in and allowed to be sold for a decade because they were similar to polymer hips and ceramic hips.
Today’s proposed FDA Order, if finally approved, will require that “anyone who wishes to continue to market the device” (metal on metal hip) will have to submit an application for Premarket Approval called a PMA. A PMA application requires very expensive clinical studies that the manufacturers are unlikely to spend the money to complete. The metal on metal hip manufacturers are unlikely to spend the money for the PMA studies because it is unlikely that a PMA for a metal hip implant would ever be approved. There is enough evidence out there already that these hips are failing at a high rate to indicate that they are not safe or effective.
The hip implant products affected by this proposed Order are: the Biomet Magnum, the DePuy Pinnacle, the Wright Profemur Conserve, the Wright Dynasty, the Wright Linaege, the Zimmer Trabeculer, and the Encore. These products are currently on the market.
The DePuy ASR and the Smith & Nephew R3 have already been recalled. The Smith and Nephew Birmingham hip, the BHR, which is a resurfacing device has already received a PMA approval and will likely stay on the market.
Today’s action by the FDA is a step forward in patient safety and an acknowledgement that these metal on metal hips should never have been placed on the market without an adequate study of the dangers of cobalt and chromium in the blood.

Metal Hip Implant Lawsuit Settlements

How Much and When?

Thousands of metal hip implant patients are suffering and undergoing painful revision surgeries as a result of the irresponsible marketing of these poorly designed and manufactured products. So far, the companies that promoted and profited from the sale of these metal hips have refused to offer any fair compensation to those that have been injured.

The metal on metal hip implants are failing at an unacceptably high rate. The manufacturers told doctors that these hips would last more than twenty years and perhaps for a patient’s lifetime. Many of these metal implants now have to be replaced through complicated surgery after only a few years. The marketing claims that the manufacturers made were not based upon any science or clinical studies they were just sales puffery. The greedy hip implant manufacturers put their own profits ahead of the safety of their customers and sold these implants without adequate testing or study. The companies used the public as their test guinea pigs and it is now evident that these metal hip implants are defective and inferior products.

All Metal Hip Implants are Bad Products

All of the metal on metal hip implant products, no matter which manufacturer, are inferior to the polyethylene and ceramic hip implants that have been on the market for years. Some metal implants have higher failure rates than others but they are all too high. The failures are caused by chromium and cobalt ions leaching from the metal on metal interface of the metal acetabular cup and the metal ball on the femur and damaging the tissue in the hip compartment.

Orthopedic Surgeons Now Reject the Use of Metal Hips

Over the last two years the community of orthopedic surgeons and the AAOS, the American Association of Orthopedic Surgeons, have concluded that the implant of any metal on metal hip is a bad idea. The only exception to this is that the Smith & Nephew Birmingham metal resurfacing device may be appropriate in some large male patients.

Only the DePuy ASR and the Smith & Nephew R3 have been officially recalled. However, the high failure rates are showing up across all metal on metal product lines. Metal on metal hip implants include the DePuy Pinnacle Ultimet, the Wright Profemur Converse and Dynasty, the Zimmer Durom Cup and Trilogy, the Biomet Magnum M2 and the Biomet M2-38, and the Encore.

Manufacturers Have Refused to Settle Lawsuits

Thousands of lawsuits have been filed across the United States and thousands of claims have been made around the world by patients who had these hips implanted over the past ten years when the hips were aggressively advertised and marketed. None of the manufacturers have made any effort to provide fair compensation or settlements to patients suffering from metallosis from these hip implants. Interestingly, Zimmer has had a campaign for several years now to settle Zimmer Durom Cup lawsuits for a different design defect that caused some of the Zimmer cups to come loose and fail.

The wave of lawsuits started in 2010 after the public recall of the DePuy ASR implants. The DePuy ASR has the worst failure rate of any of the metal implants. DePuy Pinnacle, Biomet, Wright, and Smith & Nephew metal hip failure rates are slightly better than the DePuy ASR but still are unacceptably high compared to polyethylene and ceramic implants.

Hip implant product liability lawsuits are complicated scientific cases that take several years to fully prepare for trial. So it is expected that the first jury trials will take place in 2013. It is likely that there will be an increasing number of jury trials in 2013 unless massive settlements take place.

How are Lawsuit Settlement Amounts Determined?

If these jury trials do take place they will set ranges for monetary amounts that influence settlement decisions. A settlement decision in a lawsuit is almost always based to some degree on each sides’ estimate of what a jury might do if the case went to trial. The current deadlock on settlements is due to some degree on the corporate defendants believing that jury verdicts will be low and the injured peoples’ attorneys believing that the verdicts will be much higher.

If juries return multimillion dollar verdicts then the settlement values of the cases will certainly be higher than if the juries come back with defense verdicts that the companies are not responsible for the hip implant failures or if the verdicts are for small amounts. Usually settlement figures for lawsuits are lower than the best verdicts by juries and higher than the lowest jury verdicts. Settlements are in essence a compromise of the predictions of the plaintiff and defense lawyers about what a jury might do. Jury trials are very expensive for both sides and that influences both sides to compromise to avoid the expenses and risks of trial.

A trial verdict is usually not the end of a case. Whichever side loses a jury trial has a right to appeal and ask for a new trial or a reduction or an increase in the verdict. Some lawsuits are tried more than one time and many are settled during the appeal process in some type of compromise of the jury verdict.

Another factor that may influence settlement decisions are the amounts of past settlements. There have been no settlements of any metal on metal implant cases with any degree of the details about the few cases that have been settled. However, there was a significant class action settlement involving a recall of the Sulzer hip implants about a decade ago. The Sulzer class actions settlement included values of about $240,000 for each failed hip that required a revision with supplements up to $400,500 for cases with extraordinary complications or high monetary losses.

There were three reported DePuy ASR cases settled before trial in late 2012 in Nevada for a total of $600,000 but the details are confidential. We don’t know if the three cases were settled for $200,000 each or $500,000 for one and $50,000 for the other two or some other amounts so those settlements don’t give us much data to predict other settlements.

It is my opinion as an experience trial and medical device and pharmaceutical attorney that few plaintiff attorneys nationwide would recommend a settlement of a revised DePuy ASR case for less than $300,000-$500,000. The ultimate decision of settlement is up to the client and I know some of my clients have been waiting for years for a reasonable settlement offer and are in such financial circumstances due to complications from their bad hip that they would settle for less than those amounts. Cases in which there were complications from the revision such as infection, re-revisions, blood clots, strokes, or death would warrant larger settlement amounts.

Further, in my opinion, no amount of money is fair for what these companies have done to people by marketing these defective hip implants. However, legal settlement evaluation is an assessment of what a jury might do with a case not an assessment of what is fair.

Juries are allowed to consider amounts of past and future medical expenses, lost wages or income, and pain, suffering, and loss of enjoyment of life to calculate a monetary verdict figure. Some states allow punitive damages to punish a corporate wrongdoing that showed a conscious disregard for the safety of patients or were reckless as opposed to merely being negligent or careless.

The conduct of the companies in selling these metal hips without testing them and putting their own profits ahead of safety should qualify for punitive damages to punish them. However, in practice punitive damages are rarely collected because of a feeling among judges and politicians that they are unfair to business. In cases where jurors award punitive damages judges frequently reduce or take them away completely. I don’t agree with this but it is a fact in the legal system.

When will the Lawsuits Likely be Settled?

I expect that the scheduling of the jury trials in the DePuy ASR cases will result in some movement towards settlement of those cases in 2013. I think it will be another year or two before there is settlement activity or a number of trial settings in the DePuy Pinnacle cases. The Pinnacle has not been recalled and DePuy appears to still believe that this is a good product. I think it may be several years before there is significant settlement activity in the Biomet or Wright Medical cases because those are a year or two behind the DePuy cases in the litigation process.

In my opinion, these metal hip manufacturers should all be making fair settlement offers to the injured consumers to assist them in getting their lives back on track and compensate them for their suffering and financial losses. Unfortunately, these corporations are continuing to put their own profits ahead of justice for the thousands of people they have injured with by the marketing of these bad products.

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Rather than do what’s right and settle the lawsuits filed against the company in relation to its DePuy Hip Implant Products. Johnson and Johnson has instead chosen to prolong litigation in the matter. As a result, what would have been the first DePuy hip case to head to trial has instead ended with a dismissal.
The dismissal order was entered on January 8th 2013 and was signed by Prince George County (Md.) Circuit Court Judge Crystal Dixon Mittelstaedt, who was to preside over claims
DePuy continues to litigate these cases in court and refuses to fairly compensation hip implant patients who have suffered. DePuy is still putting their own corporate profits ahead of compensating the ASR implant patients who have now been waiting for two and a half years since the recall for justice. The Company should have settled this case rather than prolonging the litigation process.

First Jury Trials Set in DePuy ASR Hip Implant Lawsuits
The first trials in the ASR hip implant multidistrict litigation will take place in May and July of 2013. These trial settings should push settlement negotiations for the other six thousand cases that have been filed against DePuy Orthopeadics and Johnson & Johnson for the failed ASR hip implant design. This product was recalled in the summer of 2010 and the companies have refused to make settlement offers to the thousands of suffering hip implant patients who have filed lawsuits.
The Order setting these trials was signed Friday December 28, 2012 by United States District Court Judge David Katz in Toledo, Ohio. Judge Katz is has scheduled the next case management hearing to take place in January in Palm Beach, Florida.
It is expected that many more lawsuits will be filed against J & J and DePuy Orthopaedics as the ASR implants are continuing to fail at an extraordinary rate. The ASR is a metal on metal implant that has the worst failure rate of any metal on metal hip implant. The metal on metal design for hip implants has been almost totally discredited for use in any patients because they are all showing high failure rates due to metallosis. Metallosis is a metal poisoning of the tissues in the hip from metal ions that are leaching from the metal on metal articulation of the hip implants.
Other metal on metal implants that are failing and which are the subject of lawsuits are the Biomet Magnum, The DePuy Pinnacle Ultimet, the Wright Converse, the Sith & Nephew R3, and the Zimmer Durom Cup. So far there have been no jury trials in any of the metal on metal hip implant lawsuits.
These first DePuy ASR lawsuit trials should measure a jury response to the conduct of these companies and the lawsuits against them. If the verdicts are high that will likely influence the settlement value of other cases. The reverse is also true: if the verdicts find no liability or are for low money damages then that will likely be reflected in settlement offers in other lawsuits.
All of the companies that made these metal on metal hip implants competed against each other to rush these defective and dangerous products to market. I expect that when juries hear how these companies put their own corporate profits ahead of people’s safety they will award substantial damages to those who have suffered failure of their hip implants.