Fifth Court of Appeals Pinnacle Update
Hi, Stuart Talley here to provide an update on the ongoing Pinnacle metal on metal hip litigation.
After a long time we finally have a decision from the Fifth Circuit Court of Appeals on the first appeal that they have decided and this is the appeal from the verdict of about 500 million dollars that was entered for five individual plaintiffs. All of whom reside in Texas. That was the second bellwether trial and the Fifth Circuit entered an order and unfortunately the court granted DePuy a new trial. So that means that this whole trial will have to be done over again.
There is a lot of information in this decision that is actually very good for the plaintiffs. Though the decision is really broken down into two parts. The first part of the decision addresses many arguments that were made by DePuy that I sort of called “knock out arguments.” These were arguments that DePuy made that would impact not only the case that was before the court but all of the cases. These were arguments that they made that DePuy should have been granted judgment that the plaintiff should have been awarded nothing and judgment should have been entered in favor of DePuy. And the court soundly rejected all of those arguments.
Where we had problems was evidentiary issues. The two points, the two things that the court focused in on was evidence that was submitted what we call character evidence. So in the law if a person or a company puts their character into evidence in the case saying we’re a good company we’re good people we never would have done something wrong that opens the door for the plaintiff or the other side to introduce what we call evidence of past bad acts. So if you show that they’ve done something bad in the future our sorry something bad in the past that can be used to impeach their position that they’re a good company or that they’re good people.
Normally evidence like that can’t come in. It only comes in if the other side sort of puts their character into evidence makes it part of the case. So in this case the court found that DePuy had done that they had testimony of their good character they took the stand and said that they were a great company and they were trying to help people. And so what the plaintiff’s were able to introduce was evidence that the company had what’s called a “deferred prosecution agreement.” So what happened was many years ago there was a subsidiary of Johnson & Johnson that was paying bribes to doctors and hospitals throughout Europe. And they were also paying bribes to individuals of Iraq when Saddam Hussein was president. And so when that information came out the federal government entered what’s called a deferred prosecution agreement with DePuy and so what the defendants did or what the plaintiffs did at trial was they were able to impeach the good character of Johnson & Johnson by introducing this deferred prosecution agreement. And they were actually able to call a witness to the stand of J&J; witness who was there to testify only about the deferred prosecution agreement. So there was a lot of testimony on that issue what the appellate court said was that that evidence should not have been admitted that it was too prejudicial. That the the conduct was so remote from J&J; that it wasn’t really probative. So this was a company that was owned by J&J; it was one of their 260 subsidiaries that was involved in this the bribe payments. So the court found that that was just too prejudicial and it really wasn’t that important.
The second ground that the court indicated the new trial was needed had to do with the expert witnesses. If you’ve been following our blog you know that one of the things that happened in this case was there was an expert witness who the plaintiffs attorneys met with who indicated that he initially would be willing to testify at trial for free that he was so upset with what DePuy had done that he would volunteer his time to help the plaintiffs in the case. After that discussion, the plaintiff’s attorney thanked him and said that I need to pay you something is there something I can do for you. And the plaintiff’s attorney said no. He said well do you have a charity that I can donate money to and so the expert indicated that there was a charity and the plaintiff’s attorney donated ten thousand dollars to that charity before the trial. That in of itself may not be that bad but what happened was at trial there was testimony an argument that was made that the plaintiff’s attorney or the plaintiffs expert weren’t being paid anything, that they showed up for free. They volunteered which was true but the fact that the payment was made to the charity and the fact that that was never disclosed made that argument misleading according to the appellate court. So that was the second basis for ordering a new trial.
As far as the silver lining here, with respect to this decision, is that the knockout blows that DePuy hoped they would get on appeal we’re all shot down. And so what that means is that DePuy in order to resolve the 9,000 cases that are pending they have to either try every single one of them to a jury or they have to settle one or the other this is not a case. Where they can walk away from this problem by not paying anything. And so the arguments that were made far as these knockout blows there were a couple of them the first one was one which was an interesting argument what they argued was that the plaintiffs in the case took the position that metal on metal hips were defective. And under Texas law, in order to prove a product as defective, defectively designed, you’d have to prove that there’s an alternative design that’s better and the plaintiff said all metal and metal hips are defective and metal on plastic is the alternative design. Well the defendant took the position that metal on metal hips and metal on plastic hips are two entirely different products so you can’t really compare them. So the issue there was for the appellate court was is metal on metal just an alternative design to a metal on plastic are they completely different products. And the court said they’re just an alternative design that argument didn’t go anywhere the other argument that was made was what we call preemption.
So the defendant argued that the verdict of the jury in essence overruled the FDA’s decision to allow metal on metal hips on the market. And when the FDA decides something or makes a decision states and juries can’t overturn those decisions so the court went through the analysis of how this product was approved and because it was approved through something called the fast-track process the Court determined that the FDA never really approved the product they never really entered any kind of decision that the product was safe and effective because under the law all you have to do is show that the thing that you want to sell is substantially similar to something that was already on the market what we call a predicate device. So the way this product was approved was not a stamp of approval by the FDA. So the appellate court rejected that argument pretty soundly the the third argument that they made was that in product liability law there’s this concept of unavoidably unsafe products and the idea is that if you have a product that can’t be redesigned some way because it’s always going to be unsafe to some degree.
You can’t have a design defect claim, you can’t claim that the product is defectively designed, so in some states this this doctrine of unavoidably unsafe product is used in the context of drugs because the drug is a it’s a mixture of different chemicals. And the drug is the drug, the drug works it doesn’t work that has side effects but you can’t redesign the drug and so in the context of drugs several states have found that you can’t pursue a design defect claim. In those cases you can’t pursue a claim that the warning is inadequate but you can’t pursue design defect claims so the court addressed that and said under Texas law there’s no authority for that position that a medical device, even though it’s approved by the FDA, is not an unavoidably unsafe product which makes sense because there are multiple designs that you could have of a hip to make it safer.
And with respect to the Pinnacle, there was a lot of alternate designs the the fourth argument that they made was that as a matter of law the warnings for the pinnacle were adequate. And what they’re talking about is if you look at the “IFU” that’s called the indications for use for the device, it really is sort of this fine print document that’s loaded with a whole bunch of boilerplate warnings or precautions. And the reality is very few surgeons actually read the IFU because it really just does sort of lay out the general issues that could happen with any hip surgery. But they argued that the IFU was adequate because it disclosed the fact could be metal where debris that people could have revision surgeries that complications can happen. And what the court said was that that warning in and of itself was not adequate, that the warning did not discuss pseudo tumors tissue necrosis metallosis. Okay, those who have side effects and problems with the Pinnacle that were not disclosed anywhere in the IFU. Additionally, the IFU didn’t disclose the magnitude of those risks and that’s important so you know if something happens one in a million times that’s one thing but if it happens forty percent at the time that’s another. And what the Pinnacle, you know you have a very high failure rate you had this metallosis problem happening very often and that should have been disclosed in the IFU.
The fifth argument that was made, and this was made for two of the plaintiffs, was that the statute of limitations had run on the claim and this related to two plaintiffs who who began experiencing pain many years before the surgeon actually did the revision surgery. And the defendant argued that they should have sued within two years of when they first started feeling pain that they should have suspected that their hip was defective. And the court said that’s not the standard. The court said that it’s not until your doctor actually makes the link and tells you what the link is between the pain and the defective hip. That’s when the clock starts to run. So that’s a good, that’s a very good decision from this court because there are many many clients who were in pain for a long, long time before the revision surgery because nobody knew what the problem was.
The last thing that came out of this decision that was very good was there was argument that Johnson and Johnson, the parent company, to not be liable for anything that because they’re a separate company, separate from DePuy. That they shouldn’t be on the hook for any of the damages. And the appellate court really did shoot that down so the decision gave DePuy a new trial. But it really gave the plaintiffs a lot.
There’s a lot of good language in this decision. There’s a lot of good rulings on the legal issues and as I mentioned this is not a situation where the someone can just walk away from this problem. So stay tuned. We don’t know what the courts going to do now the options are to retry this case again. Another option is to send cases back to the district courts what we call remand the cases back to the home states of where the plaintiffs lived for trial. I’m not sure what the courts going to do but we’ll find out soon so stay tuned. We’ll update you when we find out what the next step is in the litigation. There’s another appeal that’s going to be decided or that’s going to be argued before the appellate court in June that would be the third verdict and we’ll see how that one goes it will most likely be very similar to this one but we’ll see what happens.
If you have any questions you have a metal-on-metal Pinnacle, please feel free to give us a call. You could reach us at the phone number on the screen. You can go to our website fill out our questionnaire also. If you want to give us a good review if you like these video updates feel free to give us a review online. We have a spot on our website where you can do that but stay tuned.