On March 12, 2015, a North Carolina man named Keith Allen Waters, aged 61, entered the Catawba Valley Medical Center, where he received an Interior Vena Cava (IVC) filter in order to protect him against the possibility of a stroke due to embolism. The attending physicians implanted the device according to manufacturer’s instructions for the purpose intended.
Three weeks later, Keith Waters was dead. In life, he was a devout Methodist and loving husband and father, well-liked by the community. In death, he has become another statistic – part of a growing list of victims who have suffered serious injury and death because of a defective medical device that was poorly-tested and understood.
According to the complaint filed by his widow, Waters’ premature death was due to “complications related to the defective IVC filter, including but not limited to, filter thrombosis, multiple pulmonary emboli and cardiac arrest.” Specifically, the device fractured not long after it was implanted, after which migrating fragments lodged in his heart and lungs, resulting in blood clots that caused his death.
The complaint further alleges that the defendants in the case, B. Braun Medical,
“…so negligently and carelessly developed, designed, licensed, manufactured, prepared, packaged, maintained, labeled, compounded, assembled, processed, tested, inspected, examined, sold, distributed and/or marketed the IVC FILTER that it was dangerous and unsafe for the user and purpose for which it was intended.”
Waters’ widow, Lorraine, is seeking compensation for loss of income, medical and legal expenses in addition to loss of consortium and other damages.
Waters was neither the first, nor the last to be killed by a product that was supposedly designed to save his life. Currently, another manufacturer of IVC filters, C.R. Bard, is a named defendant in nearly 1,600 lawsuits alleging injury or death due to the device.
These devices have been the target of FDA scrutiny for the past seven years. At that time, the agency issued a warning to the medical community that almost 1,000 cases in which IVC filters had fractured and migrated to other parts of patient’s bodies had been reported. The recommendation at that time was that IVC filters be removed as soon as the danger of blood clots was over.
Removal, however, of these supposedly “retrievable” devices has proven to be difficult. Few doctors have the skill or knowledge to successfully remove IVC filters, particularly once they have fractured and/or migrated. Furthermore, a recent study published in the JAMA Surgery found “no statistically significant difference in overall survival between trauma patients who did and did not receive an IVC filter.”
The B, Braun Medical IVC filter, which the company calls the “Vena Tech LP,” differs from the C.R. Bard version of the product in that it is intended to be permanent. According to the corporate literature, the Vena Tech LP represents “the new standard in vena cava filtration.” So far, these have been implanted in over 200,000 patients around the world.
It turns out the “new standard” is no better than the old. Despite the company’s claims, the Vena Tech LP has the same problems as other IVC filters. It is something that executives and designers at B. Braum Medical were either aware of, or should have known. However, due to oversight or willful concealment, this information was not made available to medical professionals – and patients like Keith Waters are paying the price.