IVC Filter Lawsuits: Bard & Cook Face Legal Action Over Severe Risks

IVC Filter Lawsuits: Bard & Cook Face Legal Action Over Severe Risks 2017-05-11T10:26:00+00:00

IVC filters are narrow net-like medical devices that can be implanted in a vein to catch roaming blood clots before they reach the lungs. The devices are frequently used by physicians treating patients suffering from deep vein thrombosis, or at risk of pulmonary embolism.

But IVC filters can break apart after implantation, releasing shards of wire into the bloodstream and presenting significant risks to internal organs. IVC filters can also puncture the vein in which they are implanted, the inferior vena cava, leading to severe complications.

New research has even found that IVC filters may actually increase the risk of deep vein thrombosis, a condition they were designed to treat.

Hundreds Of Patients File IVC Filter Lawsuits

In the wake of several major US Food & Drug Administration Safety Communications, patients harmed by IVC filter breakage, migration and perforation are filing personal injury lawsuits against the manufacturers of these dangerous medical devices.

To date, more than 120 IVC filter lawsuits have been filed by injured patients in Federal Courts.

Over one hundred of these claims, filed against manufacturer Cook Medical Inc., have already been centralized as a Multi-District Litigation. Several Plaintiffs have brought claims against another company, C.R. Bard, and recently petitioned the Judicial Panel for Multi-District Litigation to consolidate at least 25 Federal lawsuits in a single Federal Court.

The IVC filter’s risks are now well-acknowledged and a growing body of medical research indicates that the device’s dangers are extraordinarily high. With more than 200,000 IVC filters implanted every year, the legal community expects numerous patients to file claims of their own in the coming days, weeks and months.

Plaintiffs Claim Manufacturers Concealed Evidence Of Risks, While Marketing Defective Device

According to numerous complaints, IVC filter manufacturers marketed their products misleadingly, making unfounded claims of the device’s superiority over traditional blood clot treatments (like blood thinners).

To date, only one study has investigated the potential advantages of IVC filters over traditional treatments in patients at high risk for pulmonary embolism (PE). The eight year research program, conducted in France, found a modest 22% decrease in the risk of PE among patients with an IVC filter, but after only two years, those patients were almost twice as likely to suffer from recurrent deep vein thrombosis. Ultimately, the researchers concluded that IVC filters had no effect on the survival of patients.

In fact, an analysis conducted by Medscape, WebMD’s resource for healthcare professionals, couldn’t even conclude that retrievable IVC filters were as beneficial as “established alternatives” like warfarin, let alone more beneficial.

IVC Filters Fraudulently Marketed, Plaintiffs Say

Patients who received later-generation filters say manufacturers inaccurately promoted new devices as possessing “enhanced features.”

While promotional efforts claimed these innovations would reduce the risks of previous models, Plaintiffs say a growing catalogue of FDA adverse event reports suggests otherwise. Between 2005 and 2010, the agency received over 900 reports of IVC filters migrating, breaking apart, puncturing blood vessels and lodging in heart tissue.

Lawsuits Claim Device Manufacturers Concealed Risks

Perhaps most troubling, patients say IVC filter manufacturers have actively concealed crucial data on the device’s risks from the FDA, health community and public.

At least one company, C.R. Bard has been cited for violating FDA adverse event reporting regulations. After inspecting two Bard manufacturing facilities, the agency discovered numerous cases, including fatalities, that had been improperly classified as “device malfunctions,” rather than serious injuries.

In one patient, the company’s G2 Filter had broken apart, allowing struts to flow from beneath the kidneys to the right lung. While the patient ultimately died, Bard failed to classify its adverse event report as a death.

Companies “Failed To Warn” Patients, Claims Allege

In light of numerous studies suggesting extraordinarily high failure rates, many Plaintiffs have claimed that manufacturers were negligent in failing to either recall the devices entirely, or warn patients of the significant risk that, after implantation, IVC filters can break apart, migrate or “embolize”: travel toward the heart and embed in cardiac tissue.

Problem Products: Lawsuits Focus On Retrievable Filters

The first IVC filter was introduced to the US market in the 1960s. Early devices were designed for permanent implantation, but recent years have seen a wave of “retrievable” filters approved by the FDA.

These “new-generation” filters are designed to be implanted in patients at high risk for pulmonary embolism, but can be removed once the risk has diminished. Unfortunately, “retrieving” an IVC filter seems to be difficult.

Published in the Journal of General Internal Medicine (JGIM), one study reviewed 240 patients who underwent implantation of retrievable IVC filters between 2001 and 2006. For most, a “retrieval” date was never set; more than 74% of the patients continued to live with their filters implanted for the full five-year study period. Out of the 62 patients who were scheduled for removal, 25.8% of retrieval attempts failed.

Recent concerns have been raised by the FDA, among others, that many physicians do not even attempt to remove the devices after a patient’s risks have subsided. In the JGIM study, authors noted that 21.6% of the patients with no set retrieval date “had no clear contraindications to filter removal.” According to Medscape, “in general the longer

[an IVC filter] is left in place, the more difficult it is to retrieve.”

IVC filter lawsuits are currently being filed in relation to retrievable devices, although several of the filters named in complaints were first approved as permanent options and later approved for temporary use.

Have There Been Any Settlements?

Yes.

On February 9, 2015, Plaintiff Kevin Phillips and C.R. Bard came to an undisclosed settlement agreement, resolving Phillips’ claims involving Bard’s Recovery IVC Filter System.

According to his complaint, Phillips was implanted with Bard’s filter in August of 2005. While the product is meant as a short-term measure, and designed to be “retrieved” soon after a patient’s risk of pulmonary embolism has subsided, Phillips claims that he lived with the IVC filter for almost five years.

Phillips wrote in court documents that his IVC filter “migrated” in April of 2010: the device detached from the inferior vena cava wall and, carried by the flow blood, began to approach his heart. Then, one of the device’s wire struts broke off and flowed directly into the vital organ. Phillips’ was forced to undergo open-heart surgery to remove the strut.

Bard settled Phillips’ claim after a full six days of trial proceedings.

C.R. Bard & Cook Medical: Did Two Companies Promote Dangerous Medical Devices?

More than 20 lawsuits have been filed against the manufacturer C.R. Bard. Over its history, the company has made 5 distinct IVC filters:

  • Recovery IVC Filter – this device, a predecessor to Bard’s later models, was voluntarily withdrawn from the market in 2005

Reviewing CT scans of patients implanted with Bard’s early filter, a study published in the Journal of Vascular and Interventional Radiology estimated that after 5.5 years, 40% of Recovery IVC Filters would fracture.

  • G2 Filter System – released to replace Bard’s earlier Recovery filter, Plaintiffs claim that the G2 shares design defects identical to those of its predecessor.

In many complaints, patients say that the G2 Filter System’s material, an alloy developed by the US Navy called “Nitinol,” predisposes the device to failure. Nitinol was designed for mounted artillery, an alloy of nickel and titanium that possesses “shape memory.” Objects manufactured in Nitinol can change shape in response to heat, and then snap back to their original form after returning to a lower temperature.

While Nitinol was used to make IVC filters resilient to dilations of the inverior vena cava, Plaintiffs say the material actually develops “stress fractures” under the dual pressures of the cardiovascular and respiratory cycles, leading to device failure. In their lawsuits, Plaintiffs have argued that Bard’s G2 Filter System should have been electro-polished (as the company did in subsequent models, the Eclipse and Meridian), since the process is known to improve Nitinol’s structural integrity.

  • G2 Express Filter – substantially similar to Bard’s G2 Filter System, the G2 Express is equipped with an extra hook for easier removal.
  • Eclipse – Bard’s Eclipse IVC filter is polished for a smoother finish.
  • Meridian – polished like the Eclipse, Bard’s Meridian IVC filter also features an extra set of anchors meant to prevent device migration.

But the vast majority of IVC filter lawsuits have been filed against Cook Medical Inc., a manufacturer of minimally-invasive devices based in Indiana. Cook produces 2 retrievable filters:

  • Günther Tulip – Cook’s first IVC filter, the Günther Tulip has been in use throughout Europe since 1992.

Reaching US markets in 2000, the device was found to quickly perforate the vena cava in 86% of patients by this 2012 University of California San Francisco study.

  • Celect – approved through the FDA’s 501(k) process, under which device manufacturer’s are not required to provide additional safety data, Cook’s Celect is almost identical to the Günther Tulip.

Several other manufacturers also produce IVC filters:

  • Cordis Corporation, a subsidiary of Johnson & Johnson, manufactured the Optease Retrievable Vena Cava Filter between 2010 and 2013.

The device, which featured a novel design, was recalled over fears that it would be implanted backwards due to insufficient labeling instructions. In its press release, the FDA classified the withdrawal as a “Class 1 Recall[,] the most serious type of recall […] in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.”

  • German corporation B. Braun manufactures the Tempofilter II and VenaTech Convertible, both retrievable IVC filters, along with two permanent options, the VenaTech LGM and VenaTech LP.
  • Pennsylvania-based company Rex Medical manufactures the Option* Retrievable Vena Cava Filter.

Is This A Class Action?

While three class actions were filed against C.R. Bard in the summer of 2012, most claims involving IVC filters have been filed as individual personal injury lawsuits.

But as we mentioned earlier, over 100 claims against Cook Medical have been “consolidated,” using a legal mechanism distinct from class action: Multi-District Litigation (MDL).

How Multidistrict Litigation Works

Multi-District Litigation acknowledges that some form of “streamlining” may benefit parties involved in litigation, but respects the individuality of unique Plaintiffs.

If a number of lawsuits sharing substantially similar allegations and legal questions are filed in Federal Courts, the claims can be transferred to a single court. Under the management of one judge, pretrial proceedings like Discovery (in which a Defendant and Plaintiffs are allowed to obtain evidence from one another) can be conducted in common, improving efficiency and the consistency of expert testimony. After these steps are complete, each case can be sent back to the court in which it was originally filed.

Thus Plaintiffs remain in control of their lawsuits, and can make crucial decisions like whether to accept a settlement offer or proceed to trial for themselves. In class actions, on the other hand, one or more “representative” Plaintiffs file suit on behalf of a wider group. Representatives may make individual decisions, but the results of those decisions are binding on members of the “class.”

Lawsuits against Cook Medical were centralized in October 2014 as MDL No. 2570 IN RE: Cook Medical, Inc. IVC Filters Marketing, Sales Practices and Products Liability Litigation. The cases were transferred to the US District Court for the Southern District of Indiana and assigned to Judge Richard L. Young.

Plaintiffs in a number of claims involving C.R. Bard’s IVC filters have requested centralization in the US District Court for the Northern District of Texas, suggesting Judge James E. Kinkeade as the “ideal” transferee judge.

Banville Law intends to file only individual personal injury lawsuits.

Can I File An IVC Filter Lawsuit?

If you underwent an IVC filter placement and suffered serious complications, you may be eligible to file a claim against the device’s manufacturer.

The experienced attorneys at Banville Law are currently investigating potential claims involving:

Learning more about your legal options is free. Contact Banville Law today to discuss your situation in a consultation, at no charge and no obligation.

We believe that every patient deserves experienced counsel, no matter their personal circumstances. That’s why our lawyers always offer their services on a contingency-fee basis. You pay nothing until we secure a court award or settlement in your favor.

To find more information and learn about case eligibility, call or fill out our online contact form.

Related IVC Filter Pages