FDA Issues Another Warning Letter to Bard Over Defective IVC Device

17327-a-doctor-and-couple-talking-pvAlthough medical technology has worked wonders when it comes to helping us heal certain ailments or cope with other conditions, some medical products turn out to cause far more harm than good. Medical device maker Bard recently came under scrutiny after reports surfaced that its inferior vena cava (IVC) filters pose significant risks to patients. A few months ago, the FDA issued another warning letter to Bard, informing it of several violations associated with the IVC devices.

The filters were originally developed to help patients facing a high risk of pulmonary embolisms, which can lead to death if not treated properly. One of the most common treatments for pulmonary embolism sufferers is anti-coagulant medications, which prevent the blood from becoming too thick and coagulating. Some patients, however, are unable to take these blood thinning medications for a variety of reasons.

The IVC filter was designed as an alternative for those pulmonary embolism sufferers who cannot take blood thinners. The IVC device is implanted into the inferior vena cava, and it prevents embolisms by collecting any clots before they can travel into the patient’s lungs. Shortly after the IVC was released into the market, a number of reports indicated that the device degrades over time, resulting in pieces of the filter breaking off inside the patient’s body. The deteriorating IVC device can cause serious injuries or even death. Other types of injuries linked to the defective IVC devices include internal bleeding, internal perforations, respiratory problems, deep vein thrombosis, heart attack, and severe pain.

The IVC devices were approved pursuant to the FDA’s fast track approval process as a low-risk, Class II medical device. This process permits so-called low-risk devices to become approved without first undergoing the clinical tests and safety trials ordinarily required. Presented as retrievable filters, Bard was able to secure fast track approval by underscoring the supposed temporary nature of the IVC filters. In a 2013 study produced in the JAMA Internal Medicine journal, researchers found that retrieval was only possible in roughly 8.5 percent of patients who received the IVC filters.

Now, over 900 adverse event reports involving the filters have been filed with the FDA. In 2010, the FDA issued a warning letter highlighting the risks associated with the use of the filters and the possibility of death that can result due to filter fracture and migration. The FDA issued a second warning letter last year and threatened to take a series of regulatory actions against Bard.

Medical device manufacturers can be held liable for injuries caused as a result of the manufacturer’s failure to design a reasonably safe medical device, or for any injuries that result from a device that deviated from its intended design during the manufacturing process. At the Law Offices of John S. Moffa, our skilled product liability lawyers know what it takes to investigate a claim involving a defective medical device and to fight for the settlement or judgment that you deserve.

We have helped many Massachusetts residents bring a product liability claim against a device manufacturer and are ready to do the same for you and your family. The last thing you should have to face when suffering through this difficult time is navigating the complex legal system on your own. Call us now at 1-800-446-4485 or contact us online to set up your free consultation.

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