In an article that appeared here in mid-September of last year, I reported on a series of reports aired on NBC news discussing the results of a year-long investigation into a blood-clot filter called recovery manufactured by the new jersey-based medical device giant C.R. Bard. The report revealed that the device, (which was) implanted in thousands of people, was associated with 27 deaths and hundreds of other non-fatal problems after it received FDA clearance.
Now there is a new report from NBCs Tim Sandler and Stephanie Gosk released on December 31, 2015, asking the question: Why did C.R. Bard keep selling problem blood-clot filters?
The story reveals that the filters associated with the 27 deaths and hundreds of problems replaced the device with a modified version that it knew had similar and potentially fatal flaws soon after it was put on the market.
According to NBC News: Confidential company records obtained by NBC News show that New Jersey-based medical device giant C.R. Bard was concerned about reports of failures for its G2 Series filters, designed to replace the companys Recovery filter, within four months of being cleared to sell the G2 by the Food and Drug Administration. But instead of recalling the G2 filter, and the virtually identical G2 Express, the medical device manufacturer decided to keep them on the market for five years, until 2010, selling more than 160,000 of them. At least 12 deaths and hundreds of problems are now linked to the G2 Series filters, according to Bard and FDA records.
The report features Dr. William Kuo, an interventional radiologist who runs Stanford Health Cares IVC Filter Clinic, which specializes in removing failed blood clot filters. Kuo notes, the number of complications, the frequency of severe failures makes it obvious that it was never safe to be implanted.
The spider-shaped bard filters, implanted in the largest vein in the body called the inferior vena cava were designed to stop blood clots from moving to the heart and lungs, where they could be fatal.
Blood clot filters are implanted in an estimated 250,000 people in the United States each year, most without incident. In the last decade, millions of filters have been implanted in Americans. Bard is one of 11 manufacturers that make these devices.
After Bard received FDA clearance to market their Recovery Filter in 2002, reports of deaths and injuries associated with it moving and breaking steadily climbed.
Bard continued to market the Recovery Filter despite studies commissioned by Bard itself that showed this filter had higher rates of relative risk for death, filter fracture and movement than all of its competitors. Even an outside doctor hired to conduct the study wrote that further investigationis urgently warranted.
Finally in 2005 the company replaced it with a similar G2 Series of filters. Hundreds of reports to the FDA show that the G2 series did not solve the filters problems.
Dr. Kuo estimates that in the last 10 years he has removed 1,000 failed filters. Many of the cases were referred to him by other surgeons who deemed the procedure too complex and dangerous. Kuo said he has removed more bard filters than any other single make of filter.
The Recovery and G2 Series filters should have been pulled from the market, Kuo said. Whether its an ethical reason, a moral obligation, in the interest of public safety and patient safety, absolutely these devices should have been recalled, he said.
In response to concerns expressed by Senator Charles Grassley of Iowa regarding the FDA oversight of the filter, the agency said in a statement that it has investigated the risks of all of these devices, not just Bards, and issued safety communications about risks associated with IVC filters.
In 2010 and 2014, the agency recommended in those safety alerts that doctors should consider removing the filters from patients as soon as protection from blood clots is no longer needed.
According to another article published just this past January 5, there are currently at least 72 lawsuits regarding Bard filters pending,and other cases pending involving IVC filters manufactured by C.R. Bard in federal court. Since August 2015, the Bard filter lawsuits have been centralizedbefore one judge in the District of Arizona, as part of a federal MDL, or multi-district litigation.
Each of the complaints raise similar allegations that the small devices are unreasonably dangerous, and contain inadequate warnings about the potential risk of problems with IVC filters.
Similar lawsuits have also been filed against Cook Medical involving their retrievable IVC filters, which have also been linked to reports of problems. In a separate MDL, there are currently at least 170 Cook Celect and Gunther Tulip IVC fiter lawsuitspending in the Southern District of Indiana, where a small group of cases are being prepared for early trials that may begin later this year.
As lawyerscontinue to review and file complaints on behalf of individuals who have suffered migration or perforation problems, it is ultimately expected that several thousand cases will be filed against Bard, Cook and other manufacturers of the devices.