C.R. Bard and Cook Medical are facing a growing number of lawsuits over their inferior vena cava (IVC) filters. These filters have been involved in dozens of serious injuries, including deaths. The spider-like devices are implanted into a major vein running into one of the heart chambers. IVC filters were designed to prevent blood clots traveling from the leg and entering the pulmonary system, thus causing an embolism. Instead, these filters have been falling out of place, after which they migrate and fracture, allowing small metal fragments to travel into the heart and lungs.
What physicians and patients have not been aware of is how often these IVC filters fail. IVC filters were intended to be a temporary measure for patients at risk for embolism who could not be treated with anticoagulant medications (“blood thinners”). In the spring of 2014, the U.S Food and Drug Administration (FDA) issued a warning to physicians that IVC filters should be removed as soon as possible once the patient was no longer in danger of suffering a pulmonary embolism. Under no circumstances should they be left in place more than eight weeks. According to plaintiff mass torts firms, neither C.R. Bard nor Cook provided doctors with adequate warnings on this issue.
In the case of C.R. Bard, it appears to be criminal fraud. In 2004, Bard hired an outside physician, Dr. John Lehmann, to evaluate its IVC filter for safety. When Lehmann reported the IVC filter to be dangerously defective, company executives buried the report. It was never submitted to the FDA as required by federal law. Although this report was recently uncovered by NBC News, courts in several states today are barring the “Lehmann Report” from being entered into evidence. On top of this, a regulatory specialist at Bard in 2005 refused to sign off on an FDA application for the device on grounds that it was poorly designed and prone to fracturing. A company executive simply forged her signature.
Even though the FDA has attempted to sound the alarm about IVC filters, the federal regulatory agency also bears some responsibility. The IVC filter was rushed through the approval process, using what is known as 510(k) Clearance. This is literally a regulatory short cut. If a drug maker or the manufacturer of a device can demonstrate that the product for which they are seeking approval is “substantially equivalent” to a similar product already approved and currently on the market, approval for that product is “fast-tracked.” The legislative intention was to speed potentially life-saving drugs and devices to market for the benefit of patients.
Unfortunately, it hasn’t quite worked out that way. As a result, too many defective drugs and devices have been injuring and killing patients. Furthermore, evidence in these cases demonstrates that time and again, the manufacturers were aware of the risks associated with these products. However, in the great tradition of Corporate America, the accountants run the numbers and the executives decide that a few hundred million in fines and judgments – as well as a few human lives – are just part of the cost of doing business (and these fines and judgments are actually written off on company tax returns).
Until the profit motive is removed from health care in the U.S., we can expect more of the same.
Potential injuries from IVC filters include:
- Perforation of the heart
- Perforation of the lungs
- Hemorrhagic pericardial effusion (blood around the heart)
- Cardiac tamponade (disruption of the heart caused by excess fluid)
- Ventricular tachycardia (accelerated heart beat)
- Puncturing of the vena cava
If you or a loved one has been injured by an IVC filter, you should immediately find an IVC filter attorney to file a lawsuit and receive compensation for your injuries.