Internal Records Suggest Bard Knew of IVC Filter Problems
C.R. Bard knew that a modified version of its IVC filter was as flawed as the product it was intended to replace, according to recently surfaced internal memos obtained by NBC News. An investigative report claims that confidential company records detailed potentially fatal problems with the G2 Express IVC filter, suggesting that C.R. Bard knowingly kept the device on the market for five years after its defects were allegedly known.
C.R. Bard has been named as a defendant in lawsuits filed by plaintiffs who claim that the company designed and manufactured unreasonably dangerous medical devices. This recent report is likely to add more fuel to the fire.
Problems with the IVC filters
C.R. Bard has sold more than 160,000 IVC filters. These medical implants, which are also designed and manufactured by 10 other companies, are spiderlike devices that are surgically implanted into the inferior vena cava, which is a large blood vessel. The filters are designed to catch blood clots as they move through the inferior vena cava to the hearts or lungs. If a blood clot travels to the heart, it can cause a heart attack. Similarly, pulmonary embolism is a life-threatening condition that occurs when a blood clot travels to the lungs.
Although about 250,000 people in the U.S. receive IVC filters each year, some models have been under fire for causing life-threatening complications. Specifically, the spiderlike arms of the filters can sometimes break off and travel to the heart or lungs.
In 2002, Bard received FDA approval to introduce its Recovery filter. Not long after, there was a rise in adverse events reports associated with the device, including serious injuries and deaths. The Recovery filter was not recalled. Instead, it was replaced by the G2 series, which has also had a checkered history and is the center of IVC filter lawsuits.
Internal documents regarding the G2 series
One of the recently obtained confidential documents was an internal memo from December 2005. In this memo, a Bard vice president expressed his concerns about potential safety issues. He specifically noted problems such as migration, tilting, and perforation. The unnamed vice president went on to note that there was another IVC filter by Bard available on the market that did not appear to have these problems. “Why shouldn’t doctors be using that one rather than the G2?” asked the vice president.
An internal document written much later revealed data through 2010 that suggested the G2 series had more migrations, fractures, and other adverse events associated with it than any other IVC filter available. Bard responded to this investigative report by pointing out that “all medical devices carry some level of risk” and that Bard filters are “an important clinical option for physicians.”
Senator questions FDA oversight
In response to the rising concern over IVC filters, Sen. Charles Grassley (R – Iowa) submitted a letter to the FDA that asked some very pointed questions about the FDA’s approval process. The senator, who is the chairman of the Senate Judiciary Committee, noted that Bard had hired a veteran regulatory specialist, Kay Fuller, who was responsible for getting the Recovery device approved by the FDA. The FDA had previously denied approval for the device.
The senator asked the FDA to comment on allegations that Bard withheld the results of a safety performance test from both the FDA and Kay Fuller, and that the company allegedly did not share the results of a small clinical trial that revealed problems with the Recovery device.
Additionally, the senator has asked the FDA whether an investigation was launched regarding the allegations that Fuller’s signature was forged on a petition from 2002 seeking FDA approval for the Recovery filter.
- NBC News, Why Did Firm Keep Selling Problem Blood-Clot Filters? http://www.nbcnews.com/health/health-news/why-did-firm-keep-selling-problem-blood-clot-filters-n488166
- NBC News, Senator Grassley Letter, http://msnbcmedia.msn.com/i/MSNBC/Sections/NEWS/Grassley.pdf