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DePuy Pinnacle 2016 Trial Update 17: July 07

Hi, I am Stuart Talley doing another video on the DePuy Pinnacle metal-on-metal hip trials that are currently ongoing. Today, we received a final judgement on the five cases recently tried to a jury that resulted in a $500 million verdict.

If you’ve been watching our videos, you know that the $500 million verdict was made up of two elements. The first: $140 million are compensatory damages (damages that are designed to compensate the individual plaintiffs for their injuries). This includes pain and suffering, economic losses, medical bills, etc. The second: $360 million in punitive damages (damages designed to punish the defendants for intentional conduct. In this case, the jury found that what DePuy and Johnson & Johnson did with these hips was intentional or reckless, and that is why they awarded punitive damages. It is to try and deter these companies from engaging in similar conduct in the future.

Unfortunately, the judgments today reflected the fact that under Texas law punitive damages are capped. There is a complicated formula that caps them. But at the end of the day, the total punitive damage award was reduced from $360 million to only $10 million. In the context of a company like Johnson & Johnson and DePuy, a $10 million punitive damage award is not much.

Johnson & Johnson and DePuy have $68 billion in assets. This is testimony that came out during trial. If you think about how much money you need to award a plaintiff to punish someone who has $68 billion that is difficult to assess. However, if you think about it in the sense for someone who is walking around on the street that has $68,000 in the bank, how much money do you think it would take to punish that person to get them to realize they had done something wrong and alter their behavior? If you think about somebody with $68,000, the punitive damage would be just $100. This is the equivalent of a $10 million punitive damage verdict against Johnson & Johnson.

This case illustrates how caps on any type of damages, and especially punitive damages, really can result in an injustice and allow corporations and large businesses to get away with conduct that normal people would never get away with. This situation is a good example of when those laws go wrong.  The upcoming case is in September with seven individual plaintiffs. All these plaintiffs reside in California. Therefore, California law will apply and there will be no caps on punitive damages.

Stay tuned. When this trial starts, we will provide current updates. We will also be providing updates on the appeal of the current judgments that came out today. DePuy has appealed these judgments.

DePuy Pinnacle 2016 Trial Update 16: July 5

Hi, this is Stuart Talley providing another update on the DePuy Pinnacle metal-on-metal hip cases that are currently being tried in Dallas, Texas. Today, we received an order from the trial court judge indicating that he was denying all of the post-trial motions that had been filed by DePuy to overturn the verdict that occurred in the second bellwether trial.

In the same order, he also addressed DePuy’s request that the litigation be stayed while they appeal the verdict in that second bellwether trial. The judge denied the request to stay the litigation pending their appeal. Specifically, the defendants asked for a stay of the cases that are supposed to go to trial in September. In September, there will be seven cases tried to a jury; a single jury and seven individual plaintiffs, all of whom are California residents.

In the order, the judge was very adamant that he was not going to stay the litigation. He indicated that there are approximately 8,000 cases pending; cases pending more than five years. And if the judge stayed the case every time the defendant lost a trial, the litigation would take an eternity to resolve. In his order, he also noted that the average age of individuals who have a DePuy Pinnacle hip case is 68 years old. The judge was very mindful of the fact that he needed to move the cases forward.

With respect to the numerous evidentiary objections that DePuy raised in the underlying trial, the judge was very dismissive of those objections. In other words, in the order he indicated he did not believe that DePuy really had any chance to win their appeal, which you would expect from a trial court judge whose decisions are being appealed to a higher court. In the order, he referenced the fact of DePuy’s effort to introduce testimony that their product performed well in Europe, that there was good published literature, and that they’re a good corporate citizen. The fact that DePuy attempted to introduce that evidence opened the door to much of the evidence they objected to at trial.

So, the judge was good in explaining his decisions and why he was not going to stay the litigation. As I mentioned, the next trial is coming up in September with seven individual California plaintiffs. This next trial is significant because there are no caps on punitive damages. We could see a big verdict if the plaintiffs do well at trial.

Stay tuned. We still have a decision from the fifth circuit court of appeals who is considering the decision. We will provide another update once we hear from the appellate court to determine if the case will move forward in September or if it will stay the litigation.

DePuy Pinnacle 2016 Trial Update 15: June 24

Hi, this is Stuart Talley. I am doing this video today to provide an update on the ongoing DePuy Pinnacle metal-on-metal hip litigation. As you may know, there was a trial that went to verdict a few months ago. The verdict was for the plaintiffs for several hundred million dollars.

The judge has ordered a new group of cases to go to trial in September this year. The new group will be seven individual plaintiffs all from California. Recently, we received word that DePuy filed a motion with the Fifth Circuit Court of Appeals asking that the next trial not move forward as scheduled. They are asking for a stay of the litigation until their appeal on the last verdict is decided by the court. The argument they are making is that if there were errors committed in that last trial they should be resolved before we go through the time and expense of the next trial.

This is a judicial economy argument. It’s very unlikely that the Fifth Circuit Court of Appeals will grant the motion. There are several thousand cases pending. If the litigation comes to a halt each time there is verdict on appeal, the cases will never resolve. It could be years and years.

At this point, we are still waiting for a decision from the Fifth Circuit Court of Appeals (we anticipate approximately two months). When we get a decision, we will provide another video giving an update on that development.

If you have a DePuy Pinnacle, or underwent revision surgery, contact us for a free case consultation or with any questions regarding the trial.

How are cases selected for DePuy Pinnacle Bellwether trials?

Hi, this is Stuart Talley. I’m the attorney responsible for the DePuy Pinnacle metal-on-metal hip cases. The reason I’m doing this video today is a result of phone calls we’ve received from people asking about the upcoming bellwether trials occurring in September this year. As you may know, there are seven cases that were selected to go to trial. Several months ago we had a verdict on five cases.

People are asking, “How are these cases selected for trial?” It is a complicated process. Typically, what will happen is that the judge will tell the parties to sit down and come up with a group of cases for trial. Normally, the plaintiffs group will select cases and the defendants will select cases. As a strategy, the defense will try and pick complicated cases that are difficult to prove. The plaintiffs want cases that are easy to prove, where there are not a lot of complications or difficulty proving that the hip caused damage. The court wants “representative cases”, run-of-the-mill cases. The idea is that if you get verdicts in several run-of-the-mill cases then the parties should be able to sit down and figure out what all of the other cases should settle for. So, that’s how the process works.

The cases selected by the plaintiffs were vetted extensively. You want plaintiffs that are likeable, that have doctors who are not on DePuy’s payroll, and you want plaintiffs with damages that are similar (representative) to the damages other plaintiffs are experiencing. This is how cases are generally picked. Many of our clients have asked, “How do I get my case set for trial?” It is very difficult to find one case and say I’m going to push this one to the front of the line because there are about 7,000-8,000 people in that line. It’s not an easy process.

We need to get verdicts in these bellwether cases. Hopefully after we get enough verdicts, the defendants will eventually come around and agree to a global settlement program for everyone.

If you have a DePuy Pinnacle, and have any questions, feel free to call us or submit an online form. We are happy to answer questions about the litigation and upcoming trial.

DePuy Pinnacle 2016 Trial Update 14: June 14

Hi, Stuart Talley here to provide an update on the DePuy Pinnacle metal-on-metal hip litigation. We had a significant development yesterday. The Judge issued an order setting a trial date for the next round of trials. Specifically, he entered an order that the next group of trials is going to occur on September 6, 2016. It’s going to be seven individual plaintiffs and their claims are going to be decided in one trial.

All of these plaintiffs reside in California. So, California law is going to apply in the case. The last case that went to trial, where we had a verdict a few months ago, all of those individuals were Texas residents. So, Texas law applied. The big difference between California law and Texas law has to do with punitive damages, intended to punish the defendant to deter bad conduct. In Texas, punitive damages are capped at a certain amount and there is a formula to cap them. The $380 million punitive damages are probably going to be substantially reduced from the Texas trial. California law has no caps and there is an unlimited amount of punitive damages that a jury could award. The only limit would be the Due Process Clause of the Constitution.

This is going to be a different case. The law is going to be slightly different but the big matter is that there are not going to be any caps in this case. The fact that this trial is going forward on September 6 came as a surprise to a lot of us. Many times judges will say that they want a trial date but then for various reasons it gets pushed off, sometimes for over a year or more. I don’t get the impression that this judge is going to push the trial date off. It is going to happen on September 6 and there will be seven plaintiffs.

Of other significance, the Judge has not ruled on the post-trial motions that were filed by DePuy. After the last trial, DePuy filed motions to overturn the verdict to reduce the award of the jurors. They also filed motions for new trial. This judge has not ruled on any of these motions yet he still set a date for the next trial. This is a good indication that he will not undo anything that happened in the previous trial.

Stay tuned. There will be a lot of pre-trial motions that will be filed, no doubt by DePuy to try and get various claims dismissed. We will provide an update when we get the motions and we expect that this trial will go forward on September 6 as planned. We will continue providing updates once this new trial begins.

If you have any questions or concerns, feel free to give us a call. You can reach us at the phone number on the screen, or fill out one of our online forms, and an attorney will call you right back.

DePuy Pinnacle 2016 Trial Update 13

Hi, this is Stuart Talley. I am here to provide an update on the ongoing DePuy Pinnacle metal-on-metal hip litigation currently pending in Dallas, Texas. If you’ve been following my updates, you know there was a recent verdict in a case on behalf of five plaintiffs who were a combined value of $500 million. Since that verdict, a couple months ago, there have been a series of post-trial motions that were filed by the defendant to have the verdict overturned and to request a new trial. I want to go over those motions and discuss them.

The first one is probably the most important in the litigation is a motion by the defendant to limit the damages that the plaintiffs shall receive. The verdict in the case and the jury awarded punitive damages. These are damages that are intended to punish the defendant for their conduct. The award was $360 million combined for the five plaintiffs. Unfortunately, Texas has a strict law that limits punitive damages. All of the plaintiffs in this case were from Texas and the Texas cap on punitive damages applies to their case. The formula for capping those punitive damages is a little complicated. It is based on what your economic damages are and the award cannot exceed two times your economic damages, and they cannot exceed general damages, pain and suffering damages. There is a cap of $750,000 on those types of damages. So, you add two times the economic damages plus the $750,000, which applies to most of these cases, and that’s what you end up with. So, the net result of all of this is that the $360 million punitive damage award will likely be reduced to $8.6 million. In the context of Johnson & Johnson, and DePuy, a punitive damage award that low will have no impact at all on their corporate behavior which is the intent of a punitive damage award, to punish a defendant. These companies combined have a net worth of more than $68 billion. So, $8 million is a very small number for them.

On the bright side, we have another round of trials coming up. The next group of trials will be for five plaintiffs and the Judge has asked for five plaintiffs from California. Those cases are currently being worked up and they are in the system. That is the next group of cases that will go to trial. California has no caps on punitive damages. So, these caps that applied in the most recent verdict will not apply in the next case.
The second motion that was filed is the defendants argued that the jury verdict should be overturned on the grounds of the statute of limitations. The statute of limitations (SOL) is the time period in which you have to bring a case. In Texas, it’s 2 years. What is galling about the argument being made by DePuy and Johnson and Johnson here is that in all of these hip litigations that have been pending, the ASR and Pinnacle litigation, they have consistently taken the position on the issue of settlement that they would never settle a case if the person did not have revision surgery. But now they are telling the court that in order for you to bring a claim, you have to bring it within two years of the date that you first started experiencing pain with your hip. So, they’re arguing that the trigger date for the SOL is not the date that you had revision surgery but the date that you first had any symptoms at all that related to your hip failing. The jury in the case found that this was not the start date for the SOL, and that the start date was the date that they had revision surgery.

Now, the law in Texas is very good for us on this issue. In order for a cause of action to accrue, you have to be aware of your injury and you have to be aware of the cause of your injury. There was lots of evidence given in the case that the fact that somebody’s hip hurts doesn’t necessarily mean that the defect with the DePuy Pinnacle hip is what’s causing your hip to hurt. There are all kinds of reasons a prosthetic hip can cause pain that have nothing to do with the shedding of cobalt and chromium. It could have been implanted incorrectly, there could be a leg length discrepancy, the person could have tendonitis; there are a whole bunch of reasons why a hip can hurt that have nothing to do with metallosis. And in most of these cases, a definitive diagnosis of a failed metal hip does not occur until the surgeon actually goes inside and looks to see what the hip is doing. I am not too worried about this second motion.

The other motion the defendants’ filed was they wanted a new trial because the jury was not instructed on a very specific statute that basically gives the defendants a presumption that their product is not defective if the product is approved by the Food and Drug Administration (FDA), and the defendant can show that the FDA was given all of the relevant information about the product before they got it approved.

The opposition to that motion was that, first of all, these hips were never “approved” by the FDA. The word approved has a specific legal meaning. There are some products that are approved by the FDA. The FDA requires clinical testing in a long process called the pre-market approval (PMA) process. The FDA will look at these tests, look at the design, and decide that the product is not defective and allow its release to the public. The Pinnacle metal-on-metal hips were not approved through the PMA process. They were approved through a “fast track” process in which the manufacturer essentially tells the FDA that the product is substantially similar to something else they already approved, and that’s how this product got on the market. In the past, the Judge has indicated in other motions that the fast track process of getting a medical device on the market is not FDA approval. So, the presumption does not apply. I think this is a sound judgement that is well supported by the case law that has specifically looked at this issue.

The last motion they brought was a motion for new trial that had different grounds in it. The first one was that the jury verdict was too high. The argument was that it was a runaway jury; there’s no way that the damages that these plaintiffs suffered support a verdict that is as high as they received. The standard for overturning a jury verdict, or reducing the jury verdict, in Texas is very high. You have to show that the jury was biased, that they were motivated by passion. It has to be a situation that shocks the conscience. I don’t think that the judge is going to reduce the verdicts in this case other than the punitive damage verdicts.
On the second argument that was made in this motion, the defendants were unhappy with the fact that five cases were able to be tried in one trial. They thought it caused jury confusion and that it influenced the jury because there were five people who suffered similar injuries. So, the standard on that issue is also good for the plaintiffs. The Judge has a lot of discretion especially in a case like this where there are thousands of lawsuits pending and involving the same product. The Judge has discretion to implement mechanisms to make the process go faster. He has the discretion to implement processes so that there’s judicial economy. Trying thousands of these cases could clog the courthouses in this country for years and years. So, by trying five cases at a time it saves everybody money; saves the plaintiffs money, saves the defendants money and saves the court system time and money. So, I don’t think that argument is very well taken.

There were numerous pieces of evidence that were admitted during the trial that DePuy thought should not have been admitted and they want a new trial as a result. Specifically, there were references to the deferred prosecution agreement. This was an agreement that DePuy entered because they were paying bribes to doctors. That was admitted into evidence. There was a reference to cobalt and chromium potentially increasing the risk of cancer. That was brought up during trial as a reason why someone would want to have their hip revised, if they had high cobalt or chromium. The argument was that if someone had high cobalt and chromium it would be reasonable for them to want their hip removed because of the fear it could increase your risk of cancer. There are no studies linking cobalt and cancer but that doesn’t mean there is no increased risk of cancer.

There was argument at trial, or evidence presented, concerning the fact that there were thousands of lawsuits that have been filed against DePuy. There was reference to the DePuy ASR hip which is a hip that’s very similar to the Pinnacle that was recalled. So, all of these small evidentiary issues the defendants had a problem with and they asked the Judge for a new trial. The argument they made is that these pieces of evidence being admitted and presented to the jury bias the jury against them. The Judge in prior motions during the middle of the trial has already ruled that none of these pieces of evidence that were admitted were done so improperly and denied the defendants motions already on numerous occasions concerning these items. So, I don’t expect the Judge to change his mind on these issues.

The defendant has filed a motion to stay the overall litigation. So, they’re asking the Judge not to let any more cases go to trial until the appeal of this verdict works its way through the appellate court system. If that motion is granted, it would put thousands of cases on hold for probably three to four years. Nothing would happen, settlement would be very unlikely to occur during that time period. It is highly unlikely the Judge is going to grant that motion because it would put a screeching halt to the litigation. In fact, the signals we are getting from the Judge is that he is moving the other direction. He wants another round of five cases to go to trial.

So, that’s where we are in the cases. When we get orders from the Judge on these motions, we will do another video. We will try to keep you updated on the appellate process and how that’s progressing. But things are moving along. We all wish things would move quicker but the process takes time.

Jury Awards Plaintiffs $500 Million in DePuy Pinnacle Trial

Hi, this is Stuart Talley.  We have some  breaking news about the DePuy Pinnacle metal-on-metal hip trial currently pending in Dallas, Texas.  We received word the jury has come back with  probably the biggest verdict  in any hip case to date.

The verdict came back at $498  million dollars against Johnson & Johnson and DePuy.  This case was brought on behalf of  five individuals . If you look at the verdict, it was $498 million and approximately $360 million of that was punitive damages, and the rest was compensatory damages for each of the five plaintiffs.  The average compensatory verdict for these five plaintiffs was about $27 million dollars.

With respect to similar cases, that have gone to trial, this is by far the largest  compensatory verdict.  It’s also the largest punitive damage award to date.  Many attorneys, including myself, who have been watching this trial  are not really surprised by this outcome. The trial went very well for the plaintiffs.

The evidence that came out  was shocking  in regards to  what DePuy did with the Pinnacle hip. There were lots of emails and internal documents showing DePuy actively tried to conceal problems  with these hips from doctors . They engaged in nefarious  conduct  in terms of the marketing of  this product. There were allegations that clinical trials  were falsified, and advertising was based on these falsified clinical trials.  A  lot of doctors were bribed and given money to  use this hip and tell other doctors it was a great  deal.  Some doctors received millions of dollars. One of the main witnesses received  for the defense received over $7.5 million dollars in royalties from DePuy.

We have a verdict which is a positive development in the case  for plaintiffs.  Many have asked us, “What happens next?” I can tell you that DePuy has said they would never settle  these cases. This was the position they took  at the very beginning. They took the position that this hip was different than  their other metal-on-metal hip, the DePuy ASR.  The problem with not wanting to settle cases is that if you keeping getting hit with a $500 million dollar verdict, you cannot keep that up.  Johnson & Johnson has to  face that not only was there a $500 million dollar verdict in this case,  but also that there are  8,000 more cases. If DePuy keeps trying cases, and even if they win  90%  of those cases,  if they get hit with a $500 million dollar verdict  (every  one  of a  hundred  cases), that’s a large problem for the company.

So, this verdict puts a lot of pressure on DePuy : shareholders will  start to ask questions and they are under pressure to  resolve this.  The one concern I have is that Johnson & Johnson may have some hope in appealing this verdict and they will certainly appeal it. There were some controversial rulings by Judge Kinkeade, and they are thinking they can get this verdict overturned.  However, the issue for DePuy is that this  is a two year deal. It takes at least  two years for an appeals process of this  magnitude.  In the meantime, there are  upcoming trials.  Judge Kinkeade has indicated  that he wants  another five cases lined up for the Fall.  This puts a lot of pressure on DePuy to come up with a reasonable solution to this problem.

The other problem  is the defense costs.  When you defend one of these cases,  even if  Johnson & Johnson wins one of these  trials,  they are spending millions of dollars on each trial.  They spent millions of dollars on experts for this first trial. They have a team  of lawyers who are billing them $600-$1000 an hour  in the courtroom  everyday for  10 weeks. Those costs add up.

This verdict is very good for the plaintiffs .  It definitely is encouraging and hopefully will bring DePuy and Johnson & Johnson  to the table  to compensate people with  legitimate  claims. If you have a DePuy Pinnacle hip, and have questions about the trial and verdict, feel free to give us a call toll free at 888-817-2527 and we will get back to you immediately.  Thank you.

DePuy Pinnacle 2016 Trial Update 5

Hi, Stuart Talley here, doing another update on the DePuy Pinnacle trial currently pending in Dallas, Texas. We are a couple weeks into the trial now. We have Dr. Pam Plouhar, head of clinical research at DePuy, on the stand today talking about a study and clinical trials that were done on the Pinnacle hip after it was released to the market. She was subjected to intense cross-examination by the plaintiffs’ attorney about the study and clinical trials.  In particular, there was an advertisement released by DePuy that was submitted to doctors, published by medical journals, and published in media directly designed for patients. One of the key phrases in the advertisements for Pinnacle hips reads as follows:

“There were nearly a million [Pinnacle hips] implanted over 10 years. 5 years after surgery, 99.9% are still in place.”

The implications from the ad is that there were millions of hips put in over 10 years, and if you look at all the hips that were in for 5 years, 99.9% of them were still in place. Today, we learned this is not entirely accurate. In fact, it’s blatantly false. The study they used to support that statement was called the PIN study. Dr. Plouhar was responsible for that study. The PIN study didn’t look at the million hips that were implanted; it looked at about a thousand hips that were implanted over a short period of time. When DePuy states the hips are still in place, well, the study doesn’t look at how many hips were still in place. These Pinnacle hips have multiple parts: stem, ball, cup, and inside the cup is a liner. The PIN study only looked at the number of hips that were replaced with respect to the cup. So, if the cup had been removed, that was considered a failure under the study. When they supposedly looked at all these hips, a thousand that were implanted, there was only one hip where the cup had been removed. However, it turns out, there were many hips requiring revision but they did not involve removing the cup. Many times the way a Pinnacle hip is potentially revised if the patient has metallosis is replacing the liner within the cup. So, there were a lot of revision surgeries that took place but they did not involve removing the cup. This study that said there was a 99.9% statistic was only looking at removal of the cup.

As the trial progressed, we learned there were many problems with that study. It was false when the study announced there was only one cup removed. There were lots of cups that were removed, much more than one. Another issue with the study, is DePuy told everyone in the medical community that this was a “prospective study”. A prospective study follows a group of similar individuals who differ with respect to certain factors under study, to determine how these factors affect rates of a certain outcome, over a period of time. In this case, it means you bring potential hip patients into a doctor’s office, you enroll them into the study, they have an initial surgery and you follow their progress.  A prospective study is important because if it is not a prospective study then there is a risk the doctor could cherry pick patients; meaning the doctor could say, “I think this hip works great on this patient. I am gonna put them in the study.” But then if someone comes in who is possibly overweight or has other medical problems, the doctor could say, “I won’t put that person in the study”. So, by informing the public it was a prospective study, DePuy was announcing that it was a reputable study; all patients requiring a hip implant would receive one, despite their different factors, and they would be enrolled in the study. It turns out, many of the patients who were implanted with the hip were not admitted into the study. Rather, DePuy had admitted people into the study who were already implanted months before the study began. This was a serious case of cherry picking.

The other submission made in court was the way this study was drafted. This study was presented at the American Association of Orthopaedic Surgeons (AAOS). However, even though DePuy was the author of this study, there name was not on it. There are emails at DePuy, once the study was completed and the results of the study were drafted, between executives wondering who would be the author of the study.  There are email chains back and forth between DePuy executives where they are wondering who would be the best author for this study that they had already drafted. Once they decided the author, minor edits were made and then it was submitted. This is a classic problem that occurs in the medical device community and pharmaceutical industry where you have companies using scientific literature to sell their products. But the companies do not inform the doctors or the patients that the cited and published studies are actually funded by the companies and the final results are drafted by the company. The plaintiffs made a good showing that this was occurring with DePuy.

From the very beginning, this PIN study was a marketing study. DePuy was not researching and analyzing how good their product was and how they can improve or change it. They did not have some scientific inquiry on how to better their product but instead this study was the brain child of the marketing department. They wanted to do the study in order to gain market share. There are emails from the DePuy marketing department showing them asking how much it would cost to do the study, approximately $400,000, and then there was an analysis of how much the study would increase sales. There is a memo demonstrating the study would cost a certain amount but then generate millions of dollars in sales.

This is currently the progress of the case. We have a situation where the manufacturing of this hip was dominated by the marketers at DePuy. This is not unusual considering the CEO of DePuy was a marketer; he worked his way from marketing to CEO. The culture of this company is one where sales are the driving force.

DePuy Pinnacle 2016 Trial Update 4

Hi, I am Stuart Talley. I am doing another video about the DePuy Pinnacle hip trial that is currently pending in Dallas, Texas. Today, the plaintiffs put on the stand more witnesses for the case. We heard from a Professor Drumwright who specializes in Marketing and Business Ethics. She was called by the plaintiff to give testimony about the way DePuy marketed the Pinnacle hip. She gave testimony regarding how marketing and advertising influences the decision of patients and doctors.

DePuy spent millions of dollars on marketing. Their position in the case is that the marketing is irrelevant, and that it doesn’t matter what the ads say because they are false and fraudulent. They are taking the stance that doctors don’t decide what hip to implant into a patient based off an advertisement. So, Professor Drumwright was called to talk about how marketing does sway doctors and makes a difference in their decisions. She spoke about published literature on this issue. She also talked about DePuy’s overall marketing scheme.

The scheme involved paying a doctor to have a meeting with other doctors in the area, and the paid doctor would then tell the other doctors to promote and talk about the metal-on-metal hips. The problem is many of the doctors promoting the hips were receiving royalty payments upwards of millions of dollars. This was never disclosed to any of the other doctors that showed up to those meetings. There were other issues as well in regards to DePuy having medical journal articles ghost written by doctors (they write the article but remain anonymous).

Most of the day was testimony by Professor Drumwright and there was cross-examination of her. DePuy made the point that the doctors who performed the operations on the five plaintiffs were never present at the aforementioned meetings where the paid doctors were presenting; many said they never saw the advertisements for the hips. Nevertheless, Professor Drumwright pressed the point that when you are talking about devices in the medical community there is a consensus that is reached. The consensus is that when one surgeon in a surgical group starts using a certain product, word spreads to other surgeons that it’s a good product and they start using it. So, it’s the point isn’t whether or not a doctor saw an ad but if a doctor saw another surgeon who saw the ad start using the device, then that doctor might start using it too.

After Professor Drumwright, the plaintiffs called Pamela Plouhar, head of clinical research at DePuy during the Pinnacle development. Dr. Plouhar was in charge of clinical studies. A clinical study is conducted on people starting from initial implantation with a device and following their progress. DePuy used a clinical study called the PIN study. Basically, the PIN study was conducted on 1,100 patients who received metal-on-metal Pinnacles to examine the survival rate of the hips. The data of this study that DePuy paid for was used in marketing. The main statistic from the clinical trial that they reported often in their advertising was 99.9% of the Pinnacles implanted at the beginning of the study were still implanted after 5 years. The plaintiffs’ attorney went to great lengths to analyze and discuss the irregularities with that study.  According to Dr. Plouhar, out of the 1,100 patients only one was revised in order to calculate to obtain the 99.9% statistic. The plaintiffs’ attorney analyzed all the documents and they found there was more than one revision occurring with those hips. At one point in the testimony, there were 8 revisions. DePuy was still using the 99.9% statistic even though they knew there were 8 revisions in this study. The point was clearly made that the 99.9% figure was false. Dr. Plouhar refused to admit it was false; she would say it was inaccurate but would not admit it was fraudulent.

There were many other irregularities with the study. One document was a case report for one of the patients in the study. The study was conducted starting with the implantation of the Pinnacle hip and subsequently the patient would follow up with the doctor at regular intervals after their surgery. The doctor would fill out a form which said the patient was seen on a particular day, the patient was doing well and calculate a “Harris Hip Score”, which essentially tells you how the hip is doing. The doctors would then submit these forms to DePuy. These forms were how DePuy kept track of the hips after they were initially implanted. One of the forms they analyzed was from a patient where the doctor implanted the hip in 2006, and there were several reports revealing the doctor had examined the patient in 2007, 2008 and 2009, and that the hip was doing great. Well, the plaintiffs’ attorney disclosed a document showing that the patient showed up at the surgeon’s office in 2010 and reported that their hip had actually been revised back in 2007, before the doctor said he had examined the patient.

The testimony and documents demonstrated that his doctor falsified data. He had falsely reported he had seen the patient and that the patient was doing well. The patient was not doing well and had the hip revised only a year after it was initially implanted.

DePuy Pinnacle 2016 Trial Update 3

Hi, I am Stuart Talley. I am the partner responsible for the hip litigation. The reason I am doing this video today is to provide an update on the recent DePuy Pinnacle metal-on-metal hip trial. Currently, there are five cases being tried in Dallas, Texas. It’s being tried in a joint trial on behalf of five people. We are providing updates on what’s happening in the trial and we are following it very closely.

Andrew Ekdahl, former CEO of DePuy, was on the stand again. He was CEO when the Pinnacle hip was developed. During cross-examination of Mr. Ekdahl, there was a lot of startling admissions that were made by him throughout the trial and a lot of interesting information was revealed. First, the plaintiffs’ attorney was able to get Mr. Ekdahl to admit that when the Pinnacle metal-on-metal hip was released to the public, DePuy had no idea the health impact of metal ions released from the head. There were a series of documents back in 2000 and 2001 where engineers and doctors working for DePuy were having some concerns about metal ions released from the hip. Mr. Ekdahl admitted they sold the product for many years without knowing what the true health impacts were.

Another line of questioning went into the safety of the Pinnacle. One of the defenses DePuy has brought up is that the reason the failure rate and the revision rate for the Pinnacle is so high is because of lawyer advertising. They’ve painted this picture that there’s ads on television and that people with perfectly good hips ran to their surgeons and asked to have their hips revised because they saw it on television. The plaintiffs’ attorney did a good job defusing that entire line of defense. The reason the hips were being revised and the reason DePuy stopped selling so many was due to so many problems with the hips.

There was a series of articles and medical literature during 2008 through 2010 calling into question metal-on-metal hips. There was also a series of newspaper articles describing problems with these hips and the fact that doctors had to revise them. And so the idea that the Pinnacle was taken off the market because of lawyer advertising and because of people getting unnecessary revision surgeries was invalidated. There was a slew of evidence that the reason doctors stopped using the metal-on-metal hips was because they were having problems with them.

A different line of questions that took place was shocking. It involved DePuy’s conduct with a ball called the A-sphere. The story told at trial was that in 2008 lots of doctors were calling into question metal-on-metal hips. So, 2008 through 2010 articles are released indicating metal-on-metal may not be as safe as the manufacturers would have us believe. Internally, DePuy was concerned about these articles. DePuy came up with a plan to create a new ball and call it the A-sphere. They would then tell the medical community that this new ball was much better than the old ball because it greatly reduced metal wear debris. So, they came out with the A-sphere and there was a series of emails between marketing and engineering where they are discussing the A-sphere ball. In those emails, it becomes clear that the A-sphere was no different than the other ball and it was purely a marketing trick. There is an email from an engineer saying why don’t we take the old balls and change the name because it’s the same thing. That line of questioning was shocking and you were able to see behind the scenes of how marketing and profits drove a lot of the decisions of this company.

During opening statements, the defense attorney made a lot of comments about how DePuy and Johnson and Johnson are great companies. The judge ruled that opened the door for the plaintiffs introducing evidence they aren’t good companies. One of the key pieces of evidence that was introduced with Mr. Ekdahl is called a deferred prosecution agreement. Back in 2006 and 2007, DePuy was in trouble because they were caught paying bribes to surgeons to use their hips. The FBI investigated and eventually DePuy entered into the deferred prosecution agreement. So, they agreed to change their practices and not bribe surgeons anymore. They acknowledged that they were doing it and they took responsibility for it. As a result, the attorney general agreed not to prosecute them criminally. Mr.Ekdahl was asked about the deferred prosecution agreement but he refused to acknowledge any of the facts in there. When he was asked whether DePuy paid bribes to doctors and surgeons he said that they didn’t. And when he was asked why he was not taking responsibility, he didn’t have an answer.

There was a lot of advertising for the Pinnacle about a 99.9% success rate. They were telling doctors and advertising that there was one study where they put in 3,000 of these hips and none of them were revised when this was false. The defense argued during openings statements that these advertisements really don’t matter. They argued doctors do not rely advertising; when they make medical decisions they rely only on the science. During the cross-examination of Mr. Ekdahl, the plaintiffs’ attorney was able to show that DePuy spent millions of dollars on advertising. They had a sales force that would go out and advertise and try to get doctors to use their products. They also spent millions of dollars during the 2008 Olympics on direct-to-consumer advertising; television ads, newspaper ads and magazine ads using Coach K as their spokesperson. Coach K never actually had a DePuy Pinnacle hip but they used him as a spokesperson anyway. So, if advertising doesn’t matter, why was doing spending so much time and money doing it? Mr. Ekdahl was unable to answer these questions.

The final part of the day concerned medical research that had been done. There was a point in time about concern with metal-on-metal and the impact of metal ions on patients. There was a series of emails between the people at DePuy and a surgeon in the medical community who agreed on performing a clinical study. He would do a study with individuals to show how the Pinnacle hip compared to other hips. The interesting part of the emails was how Mr. Ekhdal and the researcher discussed how they would structure the funding of the study so if the study came out negatively, DePuy could claim they had nothing to do with the study; if it is a DePuy funded study, and it has negative results, DePuy has to live with that. But if it’s a study without an association to DePuy, and it is negative, they can criticize it.

These emails and testimony revealed this company is guided by sales and profits more than the safety of their devices and the benefit and welfare of patients.

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