Cobalt Chromium Toxicity

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.

DePuy Pinnacle 2016 Trial Update 12



Hi, this is Stuart Talley here to do another update on DePuy Pinnacle metal-on-metal hip trial. As many of you know, there was a verdict in the case a few weeks ago in favor of the five plaintiffs that had their case tried to a single jury. From that point, DePuy and Johnson and Johnson have released statements to the media about their chances on appeal. There is a lot of discussion about the appeal, and whether DePuy and Johnson and Johnson will win. The reason I wanted to do this video was to provide an update and analysis on what the chances are that DePuy and Johnson and Johnson will win on appeal.

It’s very difficult to say what an appellate court will do. I can tell you that the 5th Circuit Court of Appeals, which is where the appeal will be heard in Texas, is notoriously a very conservative jurisdiction. It’s not a very good appellate court for plaintiff’s attorneys or plaintiffs. However, that being said, there are a couple of important things to remember. First, the trial court Judge who decided this case is a well-respected conservative Judge. He was a Judge appointed by George W. Bush and he’s been on the bench for a long time.

Second, one of the arguments Johnson and Johnson makes, and you see this repeated in the media, is about how unfair it was that five plaintiffs got to try their cases in a single trial. There is a lot of authority where Judges have the ability to consolidate cases for trial for judicial economy; meaning if it’s quicker, cheaper and easier for the judicial system to try groups of plaintiffs together in one trial, it is permitted. If you look at the status of the litigation and what would happen if you had individual trials for all seven thousand people, it would take a hundred and thirty years to try these cases. I think the argument that DePuy and Johnson and Johnson are likely to make at the appellate court is probably not going to go very far. An appellate court that determines multi-plaintiff trials are impermissible would basically open the door for unlimited, inefficient litigation that could last years and years in cases like this.

The other information Johnson and Johnson and DePuy have disseminated into the media is the size of the punitive damage award. First of all, under Texas law, those punitive damages will be reduced. The amount and extent of reduction is unclear at the moment but it will be substantially reduced. You have to assess the relationship of the actual damages to the punitive damages. This is the standard the court will use to determine if the punitive damages were too much. In this case, you have a situation where the punitive damages were three times the amount of the compensatory damages. This is not a big number. The US Supreme Court uses “ten times” as a benchmark- where the punitive damages award that is more than ten times is considered too high. The amount of the punitive damage award is only 0.3% of Johnson and Johnson’s net worth. It’s not one of these runaway Juries with a crazy punitive damage award that will far exceed what is rational, so to speak.

Now, a question people have asked is, “Will there be a good argument that the Jury was confused or misled in the litigation?” because there were so many plaintiffs being tried and there was a lot of evidence introduced. It is important to note that this is an intelligent Jury. There were several professionals and PhD’s, people on this Jury that are not going to be confused, they are not going to be bamboozled. This was a Jury that the defendants probably would like before the trial started.

It is difficult to say what will happen next. There were a lot of controversial rulings that were made during the trial, and it is difficult to know how an appellate court will decide. But I think that what people are reading about Johnson and Johnson’s chances of success on appeal may be a little over stated by Johnson and Johnson.

​The next thing that will happen is Johnson and Johnson will file motions for new trial, probably another motion for mistrial (they filed seven or eight of those during trial), and they are going to be filing motions to have the Jury verdict overturned. All of these motions go to the trial court. It is very unlikely these motions will go anywhere. The real decisions will be made at the appellate court.

DePuy Pinnacle 2016 Trial Update 11



Hi, I’m Stuart Talley. I am a partner here at Kershaw, Cook & Talley responsible for the DePuy Pinnacle metal on metal hip cases at our firm. I wanted to provide an update on the current status of the litigation. We just had a big verdict in the second DePuy Pinnacle hip trial. Many people have been calling us with lots of questions about how this verdict will impact their personal case.

There are a couple of matters that need to be addressed. First, the verdict in this case does not mean DePuy will automatically settle these cases, or propose a settlement to everybody who has a case. However, the verdict puts pressure on DePuy to settle. Unfortunately, by no means is DePuy required to settle. It is entirely DePuy’s decision whether or not they want to settle. Until they offer a global settlement, we are stuck in this phase where the plaintiffs will keep trying cases.

The Judge asked for another group of 5 new cases that will go to trial before the end of this year. Many people asked, “Will the new jury be aware of the verdict from this latest trial?” The answer is no, they will not know about the latest verdict. They will not even know there were 5 other cases that went to trial. Each case has to be independently evaluated by the jury. Many people have also asked, “How do I get my case set for trial?” This is very difficult. There are 8,000 cases that are currently on file. The plaintiffs want very good, easy, simple, and straightforward cases to go to trial first. The defendants are looking for cases with lots of weaknesses. The Judge wants run of the mill cases. That is why they are called bellwether cases; they set potential values on other cases.

There is a lot of jockeying that goes on with respect to what cases go to trial and in what order. It is very difficult for one person to say, “I’d like my case to go to trial next” because there are 8,000 other people who also have that same desire. Unfortunately, people have to be patient. It is tough because many individuals are older, experiencing intense pain and a diminished quality of life. People cannot afford to wait another 5 to 10 years for some kind of resolution. Yet we cannot force DePuy to settle anyone’s case. All we can do is keep hitting them with verdicts, and hopefully they will come around at some point.

If you have a DePuy Pinnacle, and you have not filed a lawsuit, or you have any questions about the process and how it works, feel free to give us a call. You can reach us at the phone number on the screen, or visit our website and fill out one of the online forms, and we will get back to you right away. If you have a lawyer, I would highly recommend following up with them. Your attorney should answer your questions. But if you still have any questions, you can always call us.

We hope you are doing well.

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: Jury Deliberations


Tuesday, March 15- Today is Day 3 of jury deliberations and there is no verdict. The jury continues deliberations which began last Thursday, March 10. The Court’s jury charge (a verdict form the jury is asked to fill out regarding the case) is over 40 pages. It includes different questions with many sub-parts involving each of the 5 plaintiffs along with associated consortium claims (claim for damages suffered by the spouse or family member of the plaintiff injured because of the defendant’s negligent, intentional, or otherwise wrongful acts.)

In the first trial against Johnson and Johnson’s DePuy over Pinnacle hips, the jury awarded a verdict in favor of DePuy. After a seven-week trial, the jurors needed about two days to deliberate. However, the complexity of this case, number of plaintiffs, and the court’s jury charge contribute to the length of deliberations. We are hopeful for an outcome in favor of the plaintiffs.

In addition, many  have  asked us if the jury was informed of how many people had been injured by these hips.  Multiple times during the trial, the plaintiffs made reference to the fact that there were thousands of similar lawsuits pending on behalf of people whose hips were revised. The defendants repeatedly objected to this and, on several occasions, moved for a mistrial. The judge denied all of these motions.

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.

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