Manufacturer Refused Recall of Defective Blood Clot Filter

By David Carnes, Staff Writer

Blood clot filters are implanted into a quarter of a million Americans every year, and they are considered generally safe. In fact, IVC blood clot filters are lifesavers for hundreds of thousands of people. Unfortunately, a recent story by NBC News reports that IVC filter manufacturer C.R. Bard may have contributed to the deaths of a number of patients by delaying the recall of its G2 series IVC blood clot filters even after its defects became known to the company.

How IVC Filters Work

IVC blood clot filters look like large metal spiders. When implanted into the inferior vena cava, the largest vein in the human body, these filters can save lives by preventing existing blood clots from moving into the heart and lungs. IVC filters can be implanted temporarily or long-term.

Dangers

The dangers of a defective IVC filter include:

Migration of the filter inside the body,
Fracturing
Perforation
Detached components

Migration of the device is the most common problem reported by IVC implant patients. IVC implants can cause the following complications in the event of migration, fracturing, perforation or detached components:

puncture of the heart, lungs, inferior vena cava or other body tissues
Deep vein thrombosis
Chest pain
Difficulty breathing
Cardiac tamponade (water on the heart)

Any of the foregoing complications can lead to emergency surgery, serious injury or even death.

C.R. Bard’s Misconduct

Bard initially released its Recovery IVC filter in 2002 after approval by the U.S. Food and Drug Administration (FDA). Although reports of injuries and death due to malfunction of the device climbed steadily after 2002, Bard refused to recall the device even after an internal company report concluded that the risks associated with the Recovery filer were higher than those of any other similar device on the market.

Bard created to G2 series blood clot filter (including the G2 and the G2 Express) to remedy the problems with the Recovery filter. After FDA approval, it was put on the market in 2005, FDA complaints and internal company records quickly demonstrated that the G2 series had failed to adequately resolve the device’s problems, and that these problems increased the longer the device remained inside the body.

Once again Bard declined to recall the product, even though one of its equivalent blood clot filters, the SNF, was already on the market and had been the subject of very few complaints. Bard kept the G2 series filters on the market until 2010, the year in which a report estimated the G2’s fracture rate at a whopping 12 percent. The consequence of Bard’s five-year delay include at least 12 patient deaths in addition to the 27 deaths that were caused by the Recovery filter.

The FDA’s Role

In both the Recovery and G2 blood clot filter cases, defects in the devices were discovered only after FDA approval. This naturally raises the question of whether or not the FDA is appropriately monitoring problems that arise after FDA approval of a new medical device. Since medical device manufacturers will probably always place profits over patient safety as long as they can get away with it, the onus falls upon the FDA to strictly monitor post-approval device malfunctions so that medical device manufacturers can no longer afford to ignore these problems.

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