IVC filters were designed to prevent life-threatening blood clots in the lungs, known as pulmonary embolisms. Since 2005, however, hundreds of reports of severe complications and side effects have been filed with the U.S. Food & Drug Administration (FDA).
These problems typically involve device migrations, filter fractures, perforation, embolization, and/or movement of the entire device or fragments to the heart and lungs. As a result, many lawsuits have been filed against the manufacturers of these devices.
Common IVC Filter Lawsuit Claims
IVC filter lawsuits typically claim the adverse events associated with the devices are due to one or more of the following reasons:
- Design and manufacturing defects
- Failure to warn consumers of known risks
- Breach of implied warranty on the medical device
- Negligence on the part of the manufacturing and/or marketing company
Several manufacturers and brands of IVC filters have been subject to individual and class-action lawsuits. Most of these cases have been filed against C.R. Bard (Recovery, G2, and G2 Express), Cook Medical (Celect and Günther Tulip), and Boston Scientific (Greenfield).
According to court documents, each of these companies knew their products were defective but continued to sell them without informing doctors and patients of the risks.
C.R. Bard IVC Filter Lawsuits
Thousands of people partnered with an IVC filter lawyer to file lawsuits against C.R. Bard, claiming the company’s IVC filters cause injuries.
Among other wrongful actions, negligence is the most serious accusation levelled against Bard, with evidence showing that the company likely knew about the risks of its Recovery filter before bringing it to market. Veteran regulatory specialist Kay Fuller recognized and expressed concerns about the filter’s safety when she was hired by Bard to help gain the filter’s FDA clearance, which was initially denied in 2002. After reviewing data from the clinical trials, she refused to sign the clearance request, yet her signature appeared on the application. When shown a copy of the document by NBC News during their investigation of Bard’s IVC filter, Fuller confirmed that it was not her signature.
Shortly after the launch of the Recovery, Bard began receiving complaints of device malfunctions. The company hired Dr. John Lehmann, an independent consultant, to conduct a study. Lehmann found that the Recovery had higher complication rates than its competitors. While Bard attempted to keep the findings under wraps, the report became public during IVC filter litigations. Bard argued and sustained confidentiality under the work-product doctrine in anticipation of future litigation, but the damage was already done.
After 27 deaths and hundreds of reported complaints, Bard eventually replaced the Recovery with a modified version, the G2 series, which had similar potentially fatal defects. During its investigation, NBC News obtained confidential company reports revealing that Bard was concerned about reports of G2 series device failures, but still kept them on the market for a further five years, only removing them in 2010.
At least 12 deaths and hundreds of injuries are linked to the G2 series filters. Bard has already settled a number of IVC filter lawsuits. Over 1,630 cases are still pending.
C.R. Bard IVC Filter Settlements
C. R. Bard has offered settlements to a number of individuals who sued them for defective or problematic IVC filters.
In 2011, Lisa Davis filed a lawsuit against Bard in the U.S. District Court Eastern District of Michigan Southern Division. After being implanted with a G2 series filter in 2006, the device fractured and migrated to Davis’ heart in 2008, causing ongoing heart issues. Her lawyer notified the judge in 2013 that a settlement was reached.
In 2013, Kelly and Chris Vlasvich filed a lawsuit against C.R. Bard in the U.S. District Court for the Northern District of Illinois. Kelly Vlasvich’s implanted G2 filter fractured in 2011, damaging her heart and lungs. The parties filed a stipulation of dismissal in 2015 and the case was closed.
In 2015, C.R. Bard settled a case after just 10 days. The case was brought by Kevin Philips in the U.S. District Court for the District of Nevada after his Recovery IVC filter perforated his heart.
C.R. Bard Class Action IVC Filter Lawsuits
Currently, there are at least three pending class-action IVC filter lawsuits against C.R.Bard in California, Pennsylvania, and Florida. These suits each argue that although some Recovery, G2, and G2 Express filters didn’t fracture or migrate, the plaintiffs are entitled to medical monitoring due to the company’s negligence and concealment of data.
In 2012, the Florida class-action suit was transferred to the U.S. District Court for the Southern District of Florida. More than 100 plaintiffs seek over $5 million in compensation. In 2015, the U.S. Judicial Panel on Multidistrict Litigation ordered all federal cases against Bard to be centralized in the Southern District of Arizona under MDL-2641. At that time, 22 actions were filed in 16 courts.
In 2016, plaintiffs with existing filter implants filed a lawsuit seeking class-action certification, which was transferred to the MDL. As of March 2017, 1,584 actions are pending, with parties in the process of selecting six cases to serve as test cases (known as bellwether cases). According to court documents, bellwether trials will begin in fall of 2017.
Cook Medical IVC Filter Lawsuit
In 2003, the FDA approved the Cook Gunther Tulip IVC filter for permanent and temporary placement. Cook introduced the Celect vena cava filter in 2008, with FDA clearance following trials in other countries. Celect was intended to be an improved version of the Gunther Tulip, but both devices have been at the center of numerous adverse event reports submitted to the FDA.
After 27 actions in 11 districts alleged that Cook’s IVC filters caused injury, the U.S. Judicial Panel on Multidistrict Litigation consolidated them into MDL 2570 in the Southern District of Indiana. When the number of actions continued to grow in 2015, pretrial proceedings moved forward, with the first bellwether cases selected in 2016. Two of the three bellwether cases (Hill v. Cook Medical and Gage v. Cook Medical) will remain in the discovery phase until June 2017. Discovery for the third bellwether case (Brand v. Cook Medical) is scheduled to be completed by November 2017.
As of March 2017, just short of 1,600 cases are pending in the MDL, alleging defective design, misrepresentation, and failure to warn doctors and patients.
Boston Scientific IVC Filter Lawsuit
Boston Scientific, another company that manufactures IVC filters, was hit with a wrongful death lawsuit in 2015 after the family of Cinthia K. Ratliff alleged its Greenfield vena cava filter caused severe injuries that led to her death. According to the suit filed in the U.S. District Court for the Southern District of Ohio, design defects caused the device to fail and perforate Ratliff’s vena cava, resulting in the severe internal bleeding from which she died in 2013. The autopsy report confirmed the allegation, listing the cause of death as “perforation of inferior vena cava by greenfield filter with retroperitoneal hemorrhage.”
The case was dismissed in March 2017 when a settlement agreement was reached.
Filing an IVC Filter Lawsuit
If you or a loved one has experienced complications as a result of an IVC filter, you may be entitled to file a claim. Contact an IVC filter lawyer to find out whether you are eligible to join a class-action lawsuits or to file an individual claim.