Susan B. (0:00:01) – Hello, everyone. Welcome to another episode of the Leverage Report. Really excited today. I’m joined with the team from Berger Montague. And before we dive in, because we’re going to be talking about all things barred port catheter and the litigation. And you guys are going to be giving us updates before we dive in. And I just start peppering you guys with questions. Why don’t I start off with a little bit of an introduction? So we’ve got Shanon Carson that is here with us. He is the managing shareholder and is the co-chair of the Consumer Protection and Mass Tort practice group. Shanon, we appreciate your time and being here with us today. We’re also joined by John Albanese, who is also a shareholder in the firm’s Minneapolis office. And we also have Jennifer Elwell, who’s the senior counsel in the Philadelphia office. And both of you guys, I guess, Jenny and John, you’re both members of the firm’s consumer protection and mass tort practice group. Again, really appreciate your time connecting with me today and sharing all the updates and insights about this litigation. Shanon, we’ll start off with you from a high-level perspective. If you could just provide an overview for the listeners about this litigation, these cases, and for those that may be unfamiliar with the topic and maybe just talk a little bit about the firm’s role in the case.
Shanon C. (0:01:27) – Sure. And first, let me just say thank you for having us today. It’s a privilege to be here and to appear on your show with John and Jenny. In August 2023, a number of lawsuits that had been filed in federal courts around the United States alleging injuries caused by Bard implanted port catheter devices were all consolidated in a multi-district litigation, or MDL, proceeding before senior Judge David Campbell in the District of Arizona for discovery and pretrial proceedings. All of these consolidated lawsuits involve personal injuries arising from Bard’s alleged defective design, defective manufacture, sale, and marketing of their implantable port catheter devices. These devices include the Bard power port device and many other similar devices that are sold under other trademarks and brand names by Bard. The devices that are at issue in this litigation are typically implanted in the patient for the purpose of permitting the intravenous transmission of chemotherapy for cancer patients. And that’s the vast majority of the cases. They can also be used for other types of applications as well, which I think Jenny’s going to talk about in a little bit. The defendants here include Cr Bard Inc. Bard Access Systems Inc. Bard Peripheral Vascular Inc. And their parent company, Becton Dickinson and Company. The lawsuits all allege that Bard has known about the problems with these medical devices for many years, but has failed to provide adequate warnings and redesign their products to make safer for patients to use. And that would avoid the types of injuries that we’re seeing in this consolidated group of lawsuits.
Susan B. (0:03:45) – Thank you for that, Shanon. And would you share a little bit about, Berger Montague, their role in this case?
Shanon C. (0:03:52) – Sure. We’re working with a consortium of law firms in this multi-district litigation that came together in a very cooperative and productive way even before the MDL proceeding was established in the District of Arizona. And that group of firms has been working to put their joint resources to work in terms of serving the plaintiffs in this lawsuit. As is typical in MDL proceedings, there was a leadership application process and an appointment process that was conducted right after the MDL was established in federal court, and I was appointed to the executive committee in the MDL proceedings. My colleague Jennifer Elwell, who’s on with us today, also holds an appointment in the MDL proceedings on the plaintiff’s steering committee. Berger Montague. Our law firm is currently working actively, very actively in the litigation, both in all types of facets, but on the law and briefing side in the litigation, on the bellwether Committee on Science and expert issues. And so we really are fully immersed in the litigation and all that is going on with all the lawyers in the case. We also have an active role in a parallel proceeding where some cases have also been filed in state court, primarily in the state of New Jersey, although there are some cases that have been filed in other state courts as well. And we are working actively with the lawyers who are involved in the state court proceeding. And we have a large dedicated team in this litigation beyond just John and Jenny and myself, who’s been involved since the beginning, from paralegals and investigators and experts and so forth, that we are bringing to bear on this litigation.
Susan B. (0:06:17) – Great. That sounds awesome. And John, I’m interested to hear a little bit from you on the products that are involved in this case.
John A. (0:06:26) – Sure. Well, as Shanon mentioned, this case all involves Bard’s port catheters and what? Port catheters are devices that are used when repeated access is needed to the patient’s vascular system or veins. So instead of getting repeated ivs or other needle sticks, you get a port catheter. These devices are referred to as porticaths, sometimes called, they’re sometimes called metaports, and they’re intended to provide repeated and long term access to the vascular system for patients requiring repeated delivery of medications, iv fluids, nutrition, if they’re unable to take food, orally and blood products. And they’re also used if you need to have blood samples repeatedly. The great majority of port catheters are used for chemotherapy treatment, and the catheter is surgically implanted under the skin. And the port catheter consists of two primary components, an injection port and the catheter. The injection port is typically implanted in the chest, has a raised center where the needle is inserted for medication delivery. The catheter is a small flexible tube that’s attached to the injection port and inserted into a blood vessel.
Susan B. (0:07:53) – Well, they sound like they’re really helpful, but I guess, Jenny, you’re going to tell us what is the problem? What’s the problem with these port catheters?
Jennifer E. (0:08:01) – So all of the catheters are made in part with barium sulfate. And the lawsuits allege that barium sulfate was left exposed on the outer surface of these devices. And when the devices were implanted, the barium sulfate degrades, which causes divots and cracks on the surface of the device. These divots and cracks then become places where the catheter can fracture or break, or where bacteria can hide or where blood clots can form. And so sounds like those are the problems. What exactly are the injuries associated with the catheters?
Jennifer E. (0:08:38) – So there are a few categories of injuries. One involves fracture of the catheter component, the tubing that’s attached to the port reservoir. When that happens, the device malfunctions, which can lead to medication leakage within a patient’s body, pain and damage resulting from a broken catheter. It involves surgical procedure to remove the broken device and then another surgery to implant a replacement. Typically, this can cause a delay in treatment, which is most typically chemotherapy medication. Then catheter fractures become more severe when a fragment of the catheter breaks away and migrates to a patient’s heart or pulmonary artery, causing life threatening situations and possibly internal damage from the migrated fragment piece. That migrated fragment must be retrieved by way of catheterization or an open heart surgery. Possibly another category is poor catheter infections. These infections are often severe, accompanied by a range of symptoms causing patients to present to emergency rooms such as high fever, extreme weakness, pain, swelling, rashes, delirium. The patients are often then quickly hospitalized after they present to the hospital for treatment of life threatening blood infections or sepsis. The hospitalization typically involves emergency removal of the infected port catheter around the clock, antibiotic treatment testing, addressing complications caused by the sepsis, and often then continued antibiotic treatment at home. Like the fracture injuries the patient often requires another surgical procedure to implant a new replacement, and treatment could be disrupted, delayed in this entire process. Another category involves pork catheter related thrombosis or blood clots that could result in pulmonary embolism or deep vein thrombosis in the proximity of the device, such as the heart or internal jugular vein. These clots can also prevent life threatening situations, and treatment often involves long term blood thinners, possibly removal of the port catheter itself. And lastly, an injury that may overlap. Everything I’ve just mentioned involves skin erosion and tissue necrosis around the port catheter site on a patient’s chest.
Susan B. (0:11:11) – Of the cases. Jenny, this is just a follow on question to that of the cases that your firm is handling now, do you see one or more of those injuries more prevalent than others?
Jennifer E. (0:11:23) – There’s been pretty even distribution amongst the fracture cases. Infection and blood clotting. There really has been.
Susan B. (0:11:32) – John, we were talking about this earlier in the level of interest in firms getting into this mass tort, and so know we’ve had lots of discussions about helping firms work up the cases. And so seeing this increase in interest of getting into the tort, what are the factors that are contributing to the rapid growth in the number of plaintiffs?
John A. (0:11:57) – There are a few things. First of all, Bard is by far the market leader in selling these devices. And the great majority of implanted port catheters in the country were sold by Bard. So there are a lot of potential claimants out there. Bard’s port catheter mean they’re used in medical facilities and homes throughout the United States by thousands of patients every day. And the US, the Food and Drug Administration, the FDA has received hundreds of adverse event reports from patients implanted with Bard power ports. But the company just continues to market the products as safe and effective without recalling them, adjusting the product, or adding warnings to the label. And we expect that the number of filed cases will continue to grow as more people discover that the reason they were injured by their port was because it was defective. One thing that’s also leading to more cases being filed is that these catheters were approved by the FDA under the 510K process, rather than the more rigorous pre market approval process. This means that unlike some other medical device cases, we don’t anticipate any significant issues regarding preemption that would limit claims against Bard.
Susan B. (0:13:19) – Well, what’s the current status of the case?
John A. (0:13:24) – There are presently over 113 cases pending in the MDL. The cases, as Jenny mentioned, are diverse as to injury and include catheter related infections thrombosis or blood clots, catheter fractures, and those fracture cases include cases where the catheter fragment has migrated and also where it also has not migrated. The court has approved the short form complaint and plaintiff profile form to be used, and there is a direct filing order so you can just file directly into the District of Arizona. Discovery is underway. The court has entered a case management order regarding the process for the selection and discovery in the first set of bellwether cases. The initial plaintiff pool for the bellwether process includes all cases filed by April 1, 2024. I know leadership is being intentional about what cases get filed prior to the bellwether selection. 24 selected cases will then engage in bellwether discovery process, and final selection will take place in early 2025. We expect that many more cases will be filed before the April 1, 2024 deadline for bellwethers, and then there will be cases that are filed afterwards.
Susan B. (0:14:44) – Thanks for the update, John. Jenny, you were just talking a little bit about some of the injuries and the issues with the catheter. Can you tell us a little bit about what practitioners should be looking for when they’re evaluating the cases?
Jennifer E. (0:14:58) – Yeah, sure. So evaluating the cases does require close review of the medical records to get the product id, the diagnosis, the removal information, possibly replacement device information as well. The timeline between the port implantation and the onset of the injury can be important, too. There are also potential statute of limitations issues for those plaintiffs that were injured outside the standard statute of limitations, which in most states is two to three years. Depending on the state, we may be able to invoke the discovery rule to extend the statute of limitations further.
Susan B. (0:15:38) – And Shanon, I guess just from you started out talking to us about the high level of the tort, what do you see as the future of this litigation?
Shanon C (0:15:49) – Sure. I think one thing is really clear about this litigation, and that is that it’s going to move really quickly. Everyone who attended that initial case management conference with Judge Campbell heard him speak about his intention in terms of moving the case forward promptly. And this is not going to be the type of MDL that languishes for a number of years. Judge Campbell has really taken the reins of this litigation, is holding regular case management conferences, and these cases are going to start to go to trial likely by the end of 2025. So by the end of next year, in terms of when we’re going to start seeing bellwether trials, I believe he has fast tracked the litigation, for example, by not permitting Bard to file certain rule twelve motions, which is a little bit out of the ordinary. And we expect overall that the next 18 months for everybody working on this litigation is going to be incredibly busy. And that it’s very important for those who represent clients who are affected by this litigation to know what’s going on. If they don’t know what’s going on, to get with a firm that knows what’s going on and really take all the necessary steps to make sure that their clients rights are protected and are moving forward as quickly as they can. And so that’s what I expect to see here over the course of the next year or two.
Susan B. (0:17:27) – Well, speaking of firms that know what’s going on, you guys being appointed to the leadership, if firms want to reach out, attorneys want to ask you about the litigation, get advice, hear your suggestions about criteria and such. How do they get in touch with you?
Shanon C. (0:17:45) – Well, it’s super easy. They can reach out to any of the lawyers here, myself, Shanon Carson, my colleagues, Jenny Elwell, John Albanese, any other lawyer who works in our mass tort department at Berger Montague, and we will be happy to talk to them and completely inform them about what’s going on in the litigation in a way that’s very detailed and up to date. One thing that Berger Montague really prides itself on is these appointments are a privilege, and it’s our duty to be up to speed in terms of what’s going on. And it’s an honor to be able to work with many firms who are working with us as cocouncil or referral counsel in terms of talking about representation of potential clients. So please, if anybody has a question about the litigation, do not hesitate to contact any of us and we will be very happy to speak with you.
Susan B. (0:18:58) – Wonderful. Jenny. Shanon. John, I’m just so grateful for your time today, spending some time with me, sharing the updates and the insights on this litigation, and just, again, really grateful for your time. Thank you so much.
Jennifer E. (0:19:14) – Thank you. It’s good to be here. Bye.
