Ray Rennell knew he was having a heart attack. Awoken in the dead of a cold November night by searing chest pain, he was, in a word, terrified. Would he make it to the phone to call 911? Would he survive the ambulance ride from his rural home to the nearest hospital more than 30 miles away? Luckily, he did. And of course he was relieved when he arrived at the ER and was told that stents would be placed in short order, saving his life. The doctors rushed him to the cath lab to put in the stents. But there they discovered it was no heart attack at all.
A few years earlier Ray had been laid up for several weeks after an accident. His doctors, fearing potential pulmonary emboli associated with forced inactivity, inserted a clot-catching filter in his inferior vena cava, which carries venous blood from the lower body to the heart. Ray now carried within him an IVC filter, a cage-like device with spidery legs that anchor into the vein. Surely his doctors had thought this IVC filter a protective, perhaps life-saving, device. Instead, it nearly cost Ray his life. And it may still.
Back in the cath lab, Ray was told that his chest pains were caused by pericarditis — swelling of the membrane surrounding his heart. The cause? A small metal shard had pierced his right ventricle. CT scans revealed that his IVC filter had fractured. Two of the spider’s “legs” had migrated from the implant location and one had lodged in his heart. Open-heart surgery was the only option, but the doctors feared Ray would not survive the surgery even if they were able to extract the strut from the wall of his heart.
So they left it alone, and the strut remains there today, a constant source of pain and anxiety. Ray’s doctors are now exploring whether they can safely remove the remnants of the broken filter left in his IVC before further fracture occurs.
Ray is not alone. Filter fractures are but one of the many problems that have come to light with IVC filters. Increasingly popular over the past decade, hundreds of thousands of IVC filters have been implanted. Many now are found to be tilted inside the vein, to have migrated from the implant spot, or to have perforated and pierced the inferior vena cava, threatening damage to surrounding organs and vessels. Indeed, scientific study now reveals that retrievable IVC filters may actually cause pulmonary emboli — the very harm they were intended to address.
The FDA reported in 2010 that 2,000 IVC filters had been used in 1979. By 2007 that number had jumped to 167,000, and FDA projected 259,000 would be implanted in the year 2012. It is (un)safe to say that more than a million filters are now embedded throughout America. Time bombs ticking away. The FDA expressed concern in its 2010 report that temporary, retrievable filters were “not always removed once a patient’s risk for PE subsides,” and it noted long term risks including “lower limb deep vein thrombosis (DVT), filter fracture, filter migration, filter embolization, and IVC perforation.” It recommended that physicians consider removal as soon as the risk for PE subsided. It reiterated these concerns in 2014.
While it was thought that IVC filters might save some lives, it is now unclear whether they have ever actually saved any. We now know that, at the very least, they carry great risks. The public’s awareness of the risks seems to grow by the day. Unfortunately, for many that awareness comes with a diagnosis of filter fracture. With so many potential negative outcomes, litigation was inevitable and it is now under way. To day it has focused on devices of particular concern by two manufacturers: Cook and Bard.
Cook Filters & the Cook MDL.
Filters designed for permanent placement had been around for decades, but the race to develop a retrievable filter began in the early 2000s. Cook’s Gunther Tulip, with a hook at the top, was the obvious leader of the pack; doctors had been retrieving it off-label as soon as they saw it had a hook to grab. Still, Cook barely lost the race to Bard’s Recovery filter, just barely; both filters hit the market by way of the controversial 510(k) process in mid- to late-2003.
Under federal regulation 510(k), a medical device manufacturer can skip rigorous product testing otherwise necessary for approval. The manufacturer need only fill out a short form, tell the FDA there is a substantially equivalent device already being sold, get fast-track clearance, and in short order the devices find their way into the human body. Cook’s Gunther Tulip, initially cleared for permanent use only, was given the go-ahead for retrieval in 2003.
But selling the Tulip as one of the world’s first retrievable filters had its issues. The device, used up until then as a permanent filter, would soon carry an indication that it could be retrieved without any time limitation at all. But the Tulip had never been proven to be safely retrievable for even two weeks. This problem was well-known by Cook before the Tulip was ever cleared for use as a retrievable device. In 2001, physicians in Canada had studied the Tulip for its retrievability. The most that study would prove is that the device had been retrieved safely when in the body for an average of 9 days. Now it would be marketed to doctors in patients as if it had an unlimited window of retrieval.
The first retrievability study following its new indication for that use showed that 16% of Gunther Tulip filters wouldn’t budge after an average placement period of just 34 days. Tulip filters were embedding themselves in the veins of the patients they were meant to protect, some within days of implantation. At that time, the Tulip was being sold worldwide as having no retrieval limitation period. In other words, Cook marketed its filter as infinitely retrievable. The 2004 study showed Cook was wrong, and it was not the last to do so.
A 2007 study showed Tulips proved irretrievable one out of every five times. Seven percent more required a separate attempt to get the filters out. Cook’s Tulip was failing on first attempt at retrieval close to 30% of the time. By the end of the study, its authors were “excit[ed]” by the development of a new Cook retrievable filter — the Celect — presumably as a cure to the “stuck filter” problem.
The Cook Celect was introduced in 2007; but it was no cure for the Tulip’s ills, or those of its victims. The Celect also became embedded. Doctors were creating imaginative ways of removing the Cook filters and began to write about them. They couldn’t get them out with the Cook retrieval device sold for that purpose. There were numerous reports of both the Tulip and Celect filters breaking apart, migrating from their intended position, perforating the vena cava, and penetrating organs and other vessels.
By 2009, enough Cook IVC filters had been put into humans that an insurmountable body of evidence had mounted against them. The embedded filter problem had become a disaster. In 2012, a devastating article was released: “Perforation of the IVC: Rule Rather Than The Exception After Longer Indwelling Times for the Gunther Tulip and Celect Retrievable Filters.” If the title alone was not disturbing for Cook and for doctors using Cook products, its content certainly was. The study showed 86% of Cook retrievable filters perforated the vena cava within a short period of time and estimated that if left in long enough all Cook filters would fail: “All filters imaged after 71 days showed some degree of vena caval perforation, often as a progressive process.” A study published one year later showed only 2% of Greenfield filters perforated while “[a] trend of increasing perforation rates with longer indwelling time was observed for the Celect and Gunther Tulip filters.” Despite all, Cook continues to market its filters.
In August 2014, all Cook IVC Filter cases were consolidated in MDL 2570 by the Judicial Panel for Multi-district Litigation, and the case was assigned to the Southern District of Indiana, with Judge Richard Young presiding. There are more than 400 cases on file with more to come. Trials are expected to begin in early 2017.
Bard Filters & the Bard MDL.
C.R. Bard may be familiar to many readers as a manufacturer of transvaginal mesh. It also produced a number of IVC filters at the center of its own multidistrict litigation, including the Bard Recovery Filter, the Bard G2 and G2X filters and its Eclipse, Denali and Meridian filters. Their story is eerily similar to Cook.
The Bard Recovery filter came on the market in July 2003, just a few months before the Cook Gunther Tulip. Sales already were picking up in the IVC filter industry. Permanent IVC filter sales had been a steady but relatively unimpressive 50,000 or so up through the early 2000s. Once Cook’s Gunther Tulip and Bard’s Recovery filters became available, sales began to skyrocket. By 2008, around 150,000 filters were being sold in the U.S. every year and that number exceeded 250,000 by 2012. Bard and Cook had been right. Doctors loved the fact that they could insert a filter that could be left in the body for good or safely taken out at any time. The package insert said so. No problem, right? Not so fast.
The short life of the Recovery was troubled from its inception. There had been no clinical trials showing that it was safe or that it saved lives (remember this was a 510(k) device). Accounts of it breaking apart and pieces of the Recovery filter migrating throughout the body were being reported. Studies would confirm these reports in alarming numbers later; but studies take time to conduct and even more time to publish. Bard needed no studies, however. Internal documents recently made public show that Bard knew all of this early on. It had begun work then to develop a replacement for the Recovery, which it must have known was doomed. This began the strategy Bard would systematically employ on filter recipients for the next ten years: It would simply put a new filter on the market when its predecessor failed. When the next one failed it would do it all again.
From 2004 until the development of its current filter in 2013, Bard sold and pulled from the market in this order: the Recovery filter, the G2, the G2 Express, the Eclipse and the Meridian — all because of safety problems. Studies on the G2, possibly a filter even worse than its predecessor, showed that one of every eight G2 filters was going to break apart after implant. Bard left the G2 on the market until the next one was ready to go just like it had the Recovery before it.
No matter what Bard seemed to do, when it built a new retrievable filter it became a safety nightmare. The filters broke. They moved. They pierced the vena cava. They damaged adjacent organs and vessels. A 2010 study of 80 patients with Bard filters concluded “[t]he Bard Recovery and Bard G2 filters had high prevalences of fracture and embolization, with potentially life-threatening sequelae.” A 2014 retrospective study reviewed CT scans at a single institution from 2000 to 2011. IVC penetration was observed in 86% of Bard’s G2/G2X filters and in 100% of its Eclipse filters. After eleven years on the market only one Bard retrievable filter is left: the Denali. Though touted as “innovative” with a “completely new design,” the Denali suffers the same failings as its predecessors — it lacks any long-term study showing that it is safe to remain in place for any significant length of time. And given the fact that more than half of “retrievable” filters are never removed, no one can fully predict the future health crisis for filter recipients, whether they have a Bard or Cook.
2015 was a rough year for Bard. In July, the FDA sent Bard a warning letter stating that its “Recovery Cone” filter retrieval system (still in use today) was manufactured “without marketing clearance or approval, in violation of the [Food, Drug and Cosmetic] Act.” The FDA also cited Bard’s “[f]ailure to establish and maintain procedures for receiving, reviewing, and evaluating complaints.” In one example, a fractured G2 filter that embolized to a person’s lung “was filed as a malfunction Medical Device Report [MDR] and should have been filed as a death.” On top of this, two nationally televised NBC News pieces blasted both the Recovery filter and the G2. Stanford physician William Kuo, who has written extensively about the dangers of IVC filters (a doctor with the unenviable task of extracting embedded and fractured filters), told NBC both filters should have been recalled and that the Recovery filter was never safe. And 2015 saw Bard lose its battle to avoid an MDL, which now sits in Phoenix, Arizona, before Judge David Campbell.
In its response to the bad press Bard put up a website called “Filter Facts.” In it Bard talks about its new Denali filter and includes product information on the Denali — never mentioning the Recovery filter that was the subject of the NBC exposé leading to its launch of “Filter Facts.” Clearly the facts will have to come out, as so often they do, through discovery and trial.
The word is getting out on Cook and Bard filters. And surely more concerning facts will be revealed through litigation. Unfortunately these revelations come too late for thousands of people now literally stuck with IVC filters — filters that eventually will cause more of the harms already suffered by so many over the past several years. How many filters have failed? How many more will fail in the future? And how will Cook and Bard finally resolve these issues? Only time will tell.
Ben C. Martin is a trial attorney based in Dallas, Texas. He serves as plaintiffs’ co-lead counsel in the Cook IVC Filter MDL and is on the plaintiffs’ steering committee of the Bard IVC Filter MDL.
Matt Shultz is a shareholder with Levin, Papantonio, Thomas, Mitchell, Rafferty & Proctor, P.A., in Pensacola, Florida. Matt heads up the firm’s IVC litigation department.