IVC Filter Lawsuit 2017: Blood Clot Device Risks & Complications

IVC Filter Lawsuit 2017: Blood Clot Device Risks & Complications 2017-09-29T16:01:58+00:00

Over 5,000 patients and families have already filed IVC filter lawsuits. In legal complaints, medical device manufacturers C.R. Bard and Cook Medical are accused of producing a defective, dangerous product and concealing safety evidence from the public. Medical research has linked IVC filters to a host of severe complications:

  • Filter fracture
  • Filter migration
  • Vein perforation

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IVC filters carry an extreme risk of severe complications. Thousands of patients have already stepped forward.

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Thousands of injured patients have filed IVC filter lawsuits, accusing major medical companies of manufacturing a defective and dangerous medical device. In these product liability lawsuits, patients and families say C.R. Bard and Cook Medical, two of the country’s largest medical device makers, failed to warn the public about the severe risks posed by IVC filters, a group of medical devices used to trap blood clots in the vein.

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Thousands Of Lawsuits Filed Over IVC Filter Injuries

Most people who get blood clots, or live at risk of a blood clot, take blood-thinning drugs. According to researchers at Rhode Island Hospital, over 100,000 patients die every year due to pulmonary embolism, when a blood clot breaks away from its place in a vein and ends up in the lungs. The standard treatment, warfarin, has saved countless lives. Anticoagulants are extremely effective when used properly, but as in all other cases, some patients slip through the cracks.

IVC filters were designed to help people who can’t take a blood thinner drug due to other medical conditions, along with people who tried an anticoagulant but didn’t see good results. The device’s design is deeply intuitive. Think of a blood clot as a baseball; IVC filters are the catcher’s mitt. A small net, or basket, made from metal wires, the filter can be inserted into a large vein (the inferior vena cava, or IVC) to catch blood clots before they reach the heart and lungs.

IVC Filters Should Work. So Why Don’t They?

It seems obvious, just from this short description, that IVC filters should work. In reality, the device’s efficacy, its ability to prevent life-threatening complications, was simply assumed for decades.

The first IVC filter was introduced in 1972, after a group of cardiovascular surgeons from the University of Miami described their design for an “umbrella filter” in the New England Journal of Medicine. Over the years, the filter’s design was updated to reduce complication rates, growing in popularity from a clinical novelty to a mainstay in the treatment of high-risk patients who respond poorly to traditional anticoagulants. But only once did anyone attempt to evaluate whether or not IVC filters actually work.

Study Finds No Benefit, More Risk

As experts at the Journal of the American Medical Association explain, there has been exactly one randomized clinical trial to investigate the risks and benefits of IVC filters in the nearly 45-year history of this medical invention. In their biting takedown of this questionable technology, the researchers describe PREPIC, a French study that followed IVC filter patients for 8 years and was published in 2005.

The project employed a well-worn study design. 400 patients at risk for pulmonary embolism were gathered together. 200 were treated traditionally, with only blood thinners. The other 200 received IVC filters and completed a course of blood thinners. Then, all 400 were followed for years to see what would happen. Did IVC filters prevent more blood clots from reaching the lungs? Did IVC filter patients live longer?

The answer to both of these questions, as PREPIC’s authors noted in the journal Circulation, was a resounding “no”! Both groups of patients died at exactly the same rate. Even more troubling, IVC filter patients actually developed deep vein thrombosis, blood clots in the legs, more frequently than people who just took blood thinners. In short, IVC filters didn’t save any more lives, but rather, increased the risk of serious complications. IVC filters are used in the absence of empirical evidence. The evidence we have suggests that they are dangerous.

510(k) Clearance Lets Dangerous Devices On The Market

How could this happen? How could a medical device without any empirical support become a staple in the toolkit of cardiovascular surgeons? One problem begins at the US Food & Drug Administration, a federal agency tasked with reviewing medical devices for sale.

The FDA doesn’t really scrutinize medical devices before allowing them onto the market. Tons of time and money are spent analyzing pharmaceutical drugs, but medical devices are treated differently. Most IVC filters were approved for use through the FDA’s 510(k) clearance process, outlined in the federal Food, Drug and Cosmetic Act. 510(k) clearance is almost laughably easy to get. When a medical device manufacturer wants to begin selling a new device, all it has to do is send the FDA a “Premarket Notification” 90 days beforehand. Generally, the Notification will attempt to show that the new device is “substantially equivalent” to one that is already on the market. If it is, the device is instantly “cleared” for distribution and sale.

The consequences of this system should be obvious. Once one IVC filter was on the market, every subsequent filter could reach the market without any further study. 510(k) clearance is a big problem. It’s come under fire in recent years for allowing downright dangerous products to reach consumers and patients without any oversight.

C.R. Bard Hid Filter Dangers For Years, NBC Reports

A second problem? As an exhaustive NBC investigation revealed, at least one major IVC filter manufacturer, C.R. Bard, may have lied to the Food & Drug Administration about the dangers of its device, allowing a model called the G2 filter to remain on the market a full five years after learning of unacceptable failure rates. Dr. William Kuo, a true expert in the field who leads Stanford University’s IVC Filter Clinic, describes the G2 filter as an all-out catastrophe. “The number of complications, the frequency of severe failures,” Kuo told NBC, “makes it obvious that [the G2 filter] was never safe to be implanted.”

Regulatory Specialist: Bard Forged Signature

A previous report, on Bard’s earlier Recovery filter, had gone even further. In another damning NBC article, a regulatory affairs expert who worked for C.R. Bard accused her former employer of forging her signature on compliance documents.

Kay Fuller, who now runs Medical Device Regulatory Solutions, was hired by Bard to help the company get their Recovery filter past FDA reviewers. But after analyzing the device’s safety reports herself, Fuller started to get worried. Patients were getting hurt in clinical trials, but as Fuller tells the story, her employers at C.R. Bard didn’t want to listen to reason.

When she approached company executives with her concerns, Fuller says she was met with threats. “It was basically, you know, if you continue to pursue these questions, that I was going to be asked not to be on the team,” Fuller told a reporter. Ultimately, Fuller refused to sign Bard’s clearance application. But the documents were soon filed, with what appeared to be her signature. “That’s not my signature,” Fuller said after reviewing the application.

Side Effects & Risks

Medical researchers now agree unanimously that IVC filters create a significant danger of device failure; some studies have even found that up to 50% of devices, after being implanted in the inferior vena cava (IVC), will break apart. This complication, known as “fracture,” releases fragments of the metal filter into a patient’s blood stream, flowing toward the heart where they can cause life-threatening injuries.

Migration has been another major problem. Instead of disintegrating, IVC filters can escape from their implantation site and begin to travel, carried along with the flow of blood toward the heart. Emergency surgical operations have found entire filters lodged in a patients’ right atrium, a chamber of the heart. The technical term for this complication is “embolization” – a blood vessel becomes blocked by some obstruction.

The next side effect, which seems to occur in almost every patient, is “perforation.” The most common form of perforation occurs when one or more of the IVC filter’s struts pierce the wall of the inferior vena cava. In some patients, this type of perforation doesn’t really cause any problems, although it does complicate the process of removing the filter. In other patients, perforations result in severe hematoma, leaking blood into the abdomen, accompanied by pain and tenderness. At least one 2012 study, which looked at patients with Cook Medical’s Günther Tulip and Celect filters, found perforations of the inferior vena cava in 86% of patients.

Duration Of Implantation Matters

The rate of perforation is “positively correlated” with the length of implantation; the longer an IVC filter is implanted, the more likely perforation becomes. This is an important point. Most modern IVC filters are designed to be retrievable. Doctors can implant them when a patient is at risk for pulmonary embolism and then remove the device once the risk has subsided.

Research shows, however, that few doctors actually “retrieve” filters when they should. Many implanted devices have been left inside patients for months after removal became indicated. This only increases the risk of severe complications.

Thousands Of Lawsuits Filed

The IVC filter litigation now includes more than 5,000 individual personal injury claims, most of which have been “consolidated” in federal courts in Arizona and Indiana. The litigation isn’t new; the first patients to file lawsuits against C.R. Bard and Cook Medical did so in 2012. Five years later, the number of claims has grown exponentially.

Multi-District Litigation

That’s why a group of federal judges, known collectively as the US Judicial Panel on Multi-District Litigation, decided to “consolidate” the claims. Instead of allowing hundreds or thousands of individual lawsuits to remain scattered through federal courts across the country, the Panel saw fit to centralize them. This makes litigation more efficient, allowing plaintiffs to pool their resources and address the allegations they all share in one fell swoop.

Consolidation also makes things easier for the defendants, Cook Medical and C.R. Bard. Instead of sending defense attorneys to every corner of the nation, the companies can focus on proceedings in a single jurisdiction.

Arizona & Indiana

To these ends, federal lawsuits filed against C.R. Bard were consolidated in the US District Court of Arizona. Now centralized as a Multi-District Litigation, In re: Bard IVC Filters Product Liability Litigation currently covers around 2,600 individual claims. Lawsuits filed against Cook Medical, on the other hand, have been centralized in the US District Court for the Southern District of Indiana. There are now around 2,700 IVC filter lawsuits included in In re: Cook Medical, Inc., IVC Filters Marketing, Sales Practices and Products Liability Litigation. In Phoenix and Indianapolis, these two parallel litigations have progressed through pre-trial proceedings at a rapid pace.

How MDL Proceedings Work

Multi-district litigation focuses on two important phases of court proceedings: motions practice and discovery. Motions, very simply, are requests made for a court order, usually asking for a determination from the Judge on a matter of law. Common in any MDL, for example, is the Motion to Dismiss, in which the defendant asks the Court to dismiss all or some of the consolidated cases at once due to some legal issue.

Discovery, on the other hand, inquires into issues of fact. What information, and evidence, can be gleaned from corporate documents? What can the defendant learn about a plaintiff by reviewing their medical records? During the discovery phase, both defendant and plaintiffs have the right to demand relevant information from their opponent, hoping to develop evidence and build a case in support of their contentions. Witnesses can be deposed, providing sworn testimony on the issues at hand. Reams and reams of internal documents are scrutinized.

Meanwhile, both sides will engage in settlement negotiations, attempting to hammer out a satisfactory agreement that does not require trial. Most MDL proceedings, however, don’t end in settlement at this point. In most cases, a number of lawsuits will go to trial first.

Bellwether Trials

These “bellwether trials,” heard before a jury, are real. The jury’s decision is binding, but only comes to directly affect the individual plaintiff at issue. All of the other plaintiffs, though, receive valuable data. So does the defendant. Both sides have learned, through an actual trial, how their evidence and arguments worked in practice.

This new understanding will, in turn, come to impact IVC filter lawsuit settlement negotiations. Defendants who have lost a series of bellwether trials are probably more amenable to the idea of settlement; plaintiffs, meanwhile, have gained significant leverage. A string of defense verdicts, on the other hand, allow the defendant to gain the upper-hand in settlement talks, or may even convince the company that proceeding to trial in each individual case may be the least expensive option.

Most MDL lawsuits are resolved in settlements. Those that are not can be transferred back to their original federal court for further proceedings.

Learn More About Filing A Lawsuit

As we’ve seen, the IVC filter litigation is gaining steam. Thousands of patients have already filed suit amidst serious and credible allegations of forgery and wrongdoing. Even more important, up to 50% of IVC filter patients may have suffered severe injuries due to the device. Legal experts believe that thousands more patients, along with families who lost loved ones to an IVC filter failure, may be eligible to secure financial compensation.

Our experienced medical device attorneys can help. Our lawyers are actively representing patients who suffered severe IVC filter side effects. We are also offering free consultations to patients and families who have yet to file suit. You can learn more about your legal options at no charge and no obligation. Just contact our attorneys now to speak with an experienced legal representative.

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