The Current Status of the IVC Filters Lawsuit

If you have suffered an adverse event after implantation of an IVC filter, including deep vein thrombosis, pulmonary embolism, organ damage, stroke, or hemorrhage, please contact our team of personal injury lawyers today. You may be entitled to compensation for your injuries

About IVC Filters Litigation

About 250,000 patients a year have an IVC filter placed to prevent blood clots from becoming pulmonary embolisms, which can travel from lower extremities to obstruct blood flow in the lungs. The small (1.5”) metal device is designed to trap and hold clots until they dissipate. Retrievable IVC filters are an alternative to anticoagulant medications, such as Xarelto®, which may not be advisable for certain patients. Doctors may recommend this device to patients who have suffered a serious accident or as a post-surgery precaution for at-risk patients.

There are currently hundreds of individual claimants against Bard and Cook, and at least 27 deaths have been connected with IVC filters.

Beginning in the early 2000’s, reports of serious complications began to arise related to IVC filters that demonstrated a tendency to become dislodged or break apart. Displaced metal struts can penetrate the inferior vena cava (IVC) vein, where the device is implanted, or migrate throughout the body and perforate nearby organs. There have been cases of severe heart damage, as well as an increased incidence of pulmonary embolism when the device slips out of place.

The products named in numerous lawsuits include Bard’s Recovery and G2 filters and Cook’s Gunther Tulip and Celect filters. There have also been claims involving the Bard Eclipse and Meridian, as well as devices made by a few additional companies. Bard has never initiated a recall for their IVC filters, though they discontinued the Recovery model in 2005. More than 34,000 Recovery filters were sold, and over 160,000 of the redesigned G2 series.

Status of the IVC Lawsuits

There are currently hundreds of individual claimants against Bard and Cook, and at least 27 deaths have been connected with IVC filters. The first settlement was reached in Nevada in February 2015, awarding an undisclosed amount to plaintiff Kevin Phillips. Mr. Phillips required open heart surgery after his Bard Recovery IVC filter fractured and a metal strut perforated his heart.

With so many actions now pending, the U.S. Judicial Panel on Multidistrict Litigation (MDL) decided in 2015 to consolidate most cases. This means individual IVC filter cases are now being consolidated for oversight by one judge for Bard and another judge for Cook. MDL serves to simplify the discovery process and avoid conflicting rulings from numerous courts. For product liability plaintiffs, MDL is often preferable to participation in a class action lawsuit. In class actions, claimants are legally bound to accept the verdict and settlement for all, but MDL claims can remain independent.

One of the most recently filed cases involves a South Dakota woman who initiated legal action against Bard on January 12, 2016. Her IVC filter migrated and became embedded in an internal organ, and doctors cannot remove it without risking potentially life-threatening consequences. She is seeking damages for disability, disfigurement, and psychological trauma.

If you have been injured by a defective medical device, Speak with an Attorney

As of February 15, 2016, the MDL lawsuit against Cook had 255 plaintiffs, and the Bard suit had 85 separate claims. The Bard MDL will be overseen by U.S. District Judge David G. Campbell in Arizona, and the Cook case is under Indiana Southern District Court Judge Richard L. Young. Judge Young has reportedly selected 10 cases for trial later this year.

As the IVC filter lawsuit continues to expand, it is moving into new territory. In February, two Canadian class action suits were filed against Cook Medical.

Recent Discovery Developments

NBC investigative news recently televised a multi-segment investigative report on IVC filter complications. One of the sources interviewed was Dr. William Kuo, a Stanford surgeon who specializes in removing IVC filters. He criticized the manufacturers for poorly designed medical products as well as the U.S. Food and Drug Administration (FDA) for clearing the devices for use in patients.

Citing the high number of complications and failures associated with Bard’s G2 series filters, Dr. Kuo said they were “never safe to be implanted.” He further commented that medical device manufacturers cannot be relied upon to act in the best interest of patients, and “we can no longer rely on the FDA to properly regulate these devices.”

An NBC reporter also spoke to Charles Grassley, Chairman of the Senate Judiciary Committee, who sent a challenging letter to the FDA regarding IVC filters. Dated September 24, 2015, the letter questioned the FDA’s follow up practices once new product safety issues and discrepancies are brought to light. Senator Grassley referred to a claim by regulatory specialist Kay Fuller, who said she had alerted the FDA to her concerns about Bard’s IVC filters over a decade ago.

Fuller told NBC she was once hired by Bard to help secure FDA approval for the Recovery device, which was initially denied clearance in 2002. She had safety concerns based on a small clinical trial and lack of safety performance data, but claimed that Bard told her she would be let go if she continued to pursue the questions. She said she chose to resign, and privately reported her concerns to the FDA.

Previous evidence has indicated that Bard was aware of the inherent dangers for patients using their IVC filters.

The most startling part of Fuller’s story implies that Bard may have committed forgery to obtain the FDA’s stamp of approval. Her name and apparent signature appear on the application form, but she maintains that she didn’t sign it, and notes the handwriting differs from hers. “That is not my signature,” she said.

The FDA did recently send a warning letter to C.R. Bard, dated July 13, 2015. Inspectors in the company’s facilities found injury and death reports related to IVC filters that were erroneously reported as device malfunctions, and also cited Bard for selling an unapproved Recovery retrieval system.

Discovery evidence also includes reports of 2015 medical studies that question the efficacy of IVC filters in patients using anticoagulation medications, and also demonstrate the Cook Celect product’s high rate of failure compared to competing devices.

Do IVC Filters Claimants Deserve Compensation?

Previous evidence has indicated that Bard was aware of the inherent dangers for patients using their IVC filters. In 2004, they hired independent consultant John Lehmann to look into reports of device failures, yet ignored his written warnings about the dangers. His report noted that Bard’s product had more failures and patient deaths than competitor’s similar filters, and he concluded, “Further investigation of the Recovery IVC filter performance in relation to migration and fracture is urgently warranted.”

Warnings to patients and physicians never came. There is substantial evidence of multiple counts of negligence, breach of implied warranty, and liability for product defects against Bard and Cook. Plaintiffs are seeking significant compensation for medical expenses, lost wages, pain and suffering, loss of consortium, and more.

If you suffered a complication after implantation of an IVC filter, you may qualify to submit a claim for damages. If you lost a loved one because of the failure of one of these devices, you may have a claim for wrongful death.

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