IVC Filter Litigation
Strokes, heart attacks, and other medical complications caused by blood clots are extremely serious and a major concern for many families. Fact is, some people are simply at a higher risk of suffering from blood clots, and if something isn’t done, the risk of a clot making its way to your brain, heart, lungs, or another vital location can be extremely high.
Many people have turned to Inferior Vena Cava (IVC) filters, which are medical implants that can help catch clots before they make it to a vital organ, such as your lung and heart. The surgery to have these filters inserted can be expensive and dangerous, and recovery times can be long. But when done right, the costs are worth it.
IVC filters are implanted near the kidneys in the inferior vena cava, and are designed to capture blood clots that have broken away from veins deep in the legs and that are heading towards the heart or lungs. If the clot reaches the heart or lungs, serious medical conditions can arise. These blood clots are also referred to as embolisms, which are capable of causing heart attacks and strokes.
Unfortunately, many people have come to find out that they’ve had faulty IVC filters inserted in their body. These faulty filters can actually pose even greater dangers than the risk of blood clots. In some cases filters have migrated through the body, puncturing vital organs and veins. These complications can not only cause immense pain and suffering, they can also result in death.
If you or a loved one has suffered from a faulty IVC filter, legal recourse is available.
The Facts About IVC Filters
- Starting in 2010, the FDA warned that certain removable IVC filters were malfunctioning and should be removed as soon as the risk for blood clots has passed.
- According to the FDA, these filters should be removed at some point after the 29th day, but before the 54th day.
- Unfortunately, the warnings by the FDA came too late for many. Countless patients had already suffered serious medical complications and some had even died.
- The FDA’s 2010 report found more than 900 different instances of adverse events, including 328 device migrations, 70 filter perforations, and 146 embolizations.
- It is believed that at least 27 people died due to complications associated with Bard’s IVC filters.
- The filter have also fractured and embed in veins and other organs.
- Various lawsuits have been filed against IVC manufacturers, including Bard.
NBC Nightly News Investigation
In early September 2015, a yearlong investigative report by NBC uncovered potential fraudulent activity by Bard. The company hired a public relations firm to analyze and develop a plan for possible fall out from the problematic filters, though it continued to sell the filters that were causing serious problems like death. To watch the NBC Nightly News Investigative Reports click below:
SEP 4 2015, 11:55 AM ET
Numerous lawsuits have been filed against both Bard and Cook based on various charges, including failure to warn, breach of implied warranty, negligence, design and manufacturing defects, and negligent misrepresentation.
Bard is currently facing lawsuits in Florida, Pennsylvania, California and Arizona. Several other cases against Bard and Cook are still pending in the courts. All federal court cases have been transferred to the District Court of Arizona.
Bard Knew but Ignored the Risks
The case against Bard isn’t based simply on an accidental but unanticipated design flaw, but instead what appears to be willful negligence on the company’s part. Back in 2004 Bard hired Dr. John Lehmann, an independent consultant, to examine whether the company’s IVC filters were more prone to risks and failure than competing products.
Lehmann’s study found that Bard’s products were indeed more likely to fail that competitors’ products. The company chose not to disclose this information either to the FDA or the general public, instead choosing to continue selling its products.
There are also reasons to believe that Bard knew of its faulty products even before the 2004 Lehmann report. In 2002 the FDA actually rejected the company’s efforts to get its products cleared. Lehmann then tried to hire regulatory expert Kay Fuller, but she claims she declined to represent the company after reviewing its clinical trial data. Her name and signature did appear on application forms, however, raising the possibility that Bard actually falsified her name on documents that were filed with the FDA, according to NBC Nightly News.
It also appears that Bard knowingly misbranded and sold products without the proper clearance or approval.
The Companies and Products Involved
So far, most of the complications have been associated with IVC filters produced by C.R. Bard and Cook Medical. Specific IVC filter models that have been found to be faulty include:
- The Bard Recovery filter
- The Bard G2 filter
- The Bard G2 Express filter
- The Cook Gunther Tulip filter
- The Cook Celect filter
What You Can Do
If you or a loved one has suffered from a medical complication resulting from a faulty IVC filter, you need to take action right away. Don’t suffer at the hands of these companies that cut corners and ignored risks posed to their patients.
Given the seriousness of the allegations against Bard, Cook, and others, as well as the apparent intentional negligence involved, people who have suffered due to faulty IVC filters can seek legal recourse. Get in touch today so we can review your situation and help provide you with guidance.