IVC Filters Manufactured by C.R. Bard and Others under the Microscope

Washington, DCA stunning two-part exposé rolled out to the airwaves by NBC News earlier this month was a year in the making. Attorneys familiar with the IVC filter portfolio would not be surprised that it took that long to gather information, as there is no shortage of troubling accusations.

Firms such as Karon & Dalimonte LLP in Boston have been gathering information for some time as they process and progress through many an IVC filter lawsuit on behalf of their clients. For example, according to attorney John Dalimonte, 40 percent of Bard Recovery filters fracture after 5.5 years, with 37.5 percent of Bard G2 filters - the successor to the Recovery - experiencing a fracture in the same time frame.

Bard is not the only manufacturer with allegedly inferior IVC filters. According to Karon & Dalimonte, 100 percent of Tulip and Celect Filters manufactured by Cook Group Inc. and Cook Medical perforated after just 71 days. The US Food and Drug Administration (FDA) issued an urgent advisory to physicians and surgeons in August of 2010, strongly recommending removal of IVC filters as soon as possible after the danger from potential blood clots and pulmonary embolism (PE) has passed. That warning was updated on May 6, 2014 with a recommendation for removal of an IVC filter within 29 to 54 days once the danger of a PE had passed.

Many will never have their IVC filters removed. Removal can be complex and potentially dangerous.

The IVC filter, or inferior vena cava filter, is a spider-like device that is inserted into the vena cava, the largest arterial, into which the filter deploys with thin, spider-like appendages spreading out to rest against the arterial wall, and designed to capture and trap blood clots passing through the artery, preventing the clots from reaching the lung. On paper, the IVC filter appears to offer a good hedge against a potentially devastating event.

However, IVC filters have been found to migrate away from the initial insertion site. They have also been found to perforate not only the arterial wall, but also organs. A woman profiled in the NBC report narrowly missed death when one of the spider-like legs of her Bard IVC filter had broken away from the filter, migrated through the artery and actually pierced her heart.

Dodi Froehlich required the IVC filter following a car accident in 2004. When a tiny piece of the Bard Recovery IVC filter she received broke away and pierced her heart, Froehlich’s only means to survive was emergency open-heart surgery in an attempt to remove the fragment from her heart, and save her life. She was lucky. Many do not survive. NBC reported no fewer than 27 deaths attributed to defective IVC filters, with 300 additional reports of other injuries that were not life-threatening but serious nonetheless.

Gloria Adams was 55 when a brain aneurism in 2004 prompted doctors to install an IVC filter to trap blood clots. In Adams’s case, the device was not successful in trapping the clot, but was rather pushed by the clot itself up into the heart, which was then perforated.

Adams died just a week after her IVC filter was implanted.

According to NBC, Bard hired a public relations firm to help with the fallout stemming from failures involving the Bard Recovery IVC filter, and a doctor was brought in to conduct an impartial study on the device and its design. According to the confidential report obtained by NBC for purposes of its investigation, the Recovery IVC filter was found to have had higher rates of relative risk for death, migration and fracture than those products of other manufacturers. “Further investigation…is urgently warranted,” the investigating physician wrote.

Bard eventually changed the design and replaced the Recovery IVC filter with the Bard G2 IVC filter - which itself appears to have deficiencies. NBC reported that in the time it took to develop and release the G2 filter, Bard did not issue an IVC filter recall and in fact continued to market the Recovery filter, vending 34,000 units over a three-year period.

NBC reported the Bard IVC Recovery filter was brought to market with a 510(k) Clearance through the FDA - and the first attempt was unsuccessful. Bard then, it was reported by NBC, brought in regulatory expert Kay Fuller to help with a second attempt at securing a 510(k) Clearance, the FDA’s fast-track approval. She soon had reservations as to how Bard handled the application process, and was concerned about the safety and efficacy of the IVC filter based on results from a small clinical trial.

“I was pretty concerned there were going to be problems with this product,” she said, in comments to NBC. Rather than take her comments at face value, Fuller claims she was muzzled.

The Bard Recovery IVC filter was soon approved on the second try.

Fast-forward to July 13, 2015 when the FDA sent a warning letter to C.R. Bard, taking the medical device manufacturer to task for failing to properly establish and maintain procedures for reviewing and evaluating complaints relating to its G2, G2X and Eclipse IVC filters.