Timeline of the IVC Filters Lawsuit
Patients harmed by retrievable IVC filters continue to file lawsuits against the manufacturers, as clinical studies and experts confirm the risk of complications tied to these medical devices. A timeline of the IVC filters lawsuit reveals growing evidence that demonstrates the inherent danger associated with this form of preventive treatment.
Hundreds of patients have experienced life-threatening and fatal complications from certain models of retrievable IVC filters, specifically products manufactured by C.R. Bard and Cook Medical. If you or a loved one suffered a serious complication after having an IVC filter placed, please speak to a qualified attorney as soon as possible.
IVC Filters and Complications
Implanted in the inferior vena cava (IVC), IVC filters are small (1.5”) devices that look like a metal spider. They are designed to trap and hold blood clots, preventing them from traveling to the lungs, where they can be extremely dangerous.
Perforation of arteries and organs by broken filter components have left patients with heart and other organ damage, as well as causing hemorrhages and other adverse complications.
Patients have experienced deep vein thrombosis (DVT) and pulmonary embolisms, which can obstruct blood flow to the lungs. Perforation of arteries and organs by broken filter components have left patients with heart and other organ damage, as well as causing hemorrhages and other adverse complications.
Timeline of Important Events in the IVC Filter Lawsuit
In 2002, C.R. Bard’s initial application for their Recovery IVC filter was denied by the U.S. Food and Drug Administration (FDA). At that time, the company hired a regulatory specialist, Kay Fuller, to help obtain FDA approval. Ms. Fuller told NBC reporters that she had been concerned about unsettling safety data and refused to support Bard’s quest to market the device, even though her signature appears on the FDA application. Fuller maintains that she did not sign the document, and noted that the signature looks significantly different from her own, implying that it had been forged.
The Bard Recovery IVC filter was launched in early 2004, and the company immediately began hearing of adverse events. They received complaints of malfunctions, including device fractures, which caused metal pieces to migrate to other areas of the body. One report concerned the death of a female patient in Michigan, whose cardiac event was caused by a piece of a broken filter puncturing her right ventricle.
Bard did not warn the public or notify the FDA, but instead hired an independent consultant, Dr. John Lehmann, to compare the Recovery’s fracture and migration rate to other models in use. They also hired a public relations firm to help prepare a crisis management plan in response to news coverage about the device.
In December 2004, Dr. Lehmann provided a confidential written report that verified the Recovery filter had higher complication rates than its competitors, including reports of device migration and fracture, with incidents of organ perforation and patient deaths. His conclusions state that further investigation was urgently warranted. Dr. Lehmann’s report was eventually introduced as evidence in a product liability lawsuit against Bard. Attorneys for the company fought to keep the contents of the report confidential under work product doctrine laws. Court rulings have differed on this issue, and the admissibility of the report is still unresolved.
If you have been injured by a defective medical device, Speak with an Attorney
By October 2005, Bard had discontinued the Recovery, and began selling the modified G2 filter. However, they did not recall the Recovery, which was implanted in about 34,000 patients. In December 2005, a few months after the G2 was introduced to the market, an internal memo from a Bard executive shows that there were already concerns about adverse events pertaining to the newly modified device.
In 2010, the FDA issued a warning pertaining to IVC filters, detailing 921 accounts of complications in patients, and urging physicians to remove the filter as soon as the danger from a pulmonary embolism had passed. The FDA updated this warning in 2014, and cited a study that analyzed the risks and. benefits of IVC filters. This panel concluded that the devices should be removed 29 to 54 days after implantation.
The first IVC filter lawsuits were filed in July 2012, three class action suits against Bard in California, Pennsylvania and Florida. Numerous lawsuits were also filed against Cook Medical, manufacturer of the Gunther Tulip and Celect IVC filters. The lawsuits contain numerous allegations including negligence, liability for product defects, fraudulent misrepresentation, concealing evidence, and failure to warn.
There were so many plaintiffs filing claims against Cook that the U.S. Judicial Panel on Multidistrict Litigation (MDL) decided to consolidate cases from 11 districts. In October 2014, the lawsuits were moved to the Southern District of Indiana. MDLs are used to combine a number of nationwide cases under a single judge, creating an efficient discovery process across lawsuits with similar claims. They differ from class action lawsuits because MDL plaintiffs are still considered individually, and no decisions are legally binding on other claims.
In February 2015 the first pending lawsuit against Bard was settled for a confidential amount. Then, in August 2015, The Judicial Panel consolidated Bard cases into an MDL in the U.S. District Court of Arizona.
The litigation now appears to be spreading outside the U.S., as two class action lawsuits were filed against Cook in Canada in February 2016.
Medical Studies and Expert Opinions
In November 2010, the National Center for Biotechnology Information (NCBI) reported on a study of 80 patients with Bard Recovery and G2 filters, where 25 percent of Recovery and 12 percent of G2 devices were found to have fractured. The report concluded that the devices have a high prevalence of potentially life threatening failures.
A report in the October 2013 Journal of Vascular Surgery stated that the risks of complications with retrievable IVC filters increase with time and noted that 50 percent or fewer of retrievable IVC filters are ever removed.
Also in October 2013, ACS surgery news reported on a Columbus, OH, study that said 46 percent of 262 IVC filter patients showed evidence of penetration of the inferior vena cava and adjacent organs. Only 1.6 percent of the temporary filters had been retrieved from patients involved in the study.
As of the publication of this article, there have not been any significant recalls of IVC filters manufactured by Bard or Cook.
An April 2015 article in the Journal of the American Medical Association cited a study evaluating the efficacy and safety of retrievable IVC filters used in conjunction with anticoagulation medication. They concluded that the device did not reduce the risk of recurrent pulmonary embolism at three months, and that the findings do not support the use of this filter in patients who can be treated with anticoagulation.
In late 2015, there were three televised media reports by NBC news regarding the IVC filter lawsuits. Reporters spoke on air with a Stanford surgeon, Dr. William Kuo, who estimated that he had removed 1,000 Bard filters over the past 10 years. He said the Bard G2 consistently fractures and causes major complications, and stated, “Whether it’s an ethical reason, a moral obligation, in the interest of public safety and patient safety, absolutely these devices should have been recalled.”
As of the publication of this article, there have not been any significant recalls of IVC filters manufactured by Bard or Cook. It is estimated that over 250,000 patients have retrievable IVC filter implanted each year. There have been hundreds of reported injuries and over two dozen deaths, with new claims continuing to come in.
As of April 2016, there were 84 U.S. plaintiffs in the consolidated Bard lawsuit and 255 plaintiffs combined in MDL against Cook Medical. The first 10 cases have reportedly been selected to begin trial against Cook later this year. Our legal team is providing updates to the staus of the lawsuit as new details emerge.
Legal Help in Your State
If you or a loved one has experienced an adverse complication from use of an IVC filter, you may be eligible for compensation. Each state has separate time constraints called statutes of limitations that outline the amount of time that claimants have to file before the manufacturers are released from liability. Please contact an experienced attorney to schedule a free consultation today.