Bard is back in the news regarding its IVC filters and it’s looking pretty bad for the medical device manufacturer. Recent discoveries show that when it comes to Bard blood clot filters – company chose profits over patients. NBC News recently got confidential company records that show Bard was aware of potentially deadly problems with one of its products, but kept it on the market anyway. This is the first of two posts on the subject.
These filters, shaped like spiders, are implanted in the inferior vena cava. The IVC is the largest vein in the human body and the filters were designed to keep blood clots from reaching the heart and lungs. If clots make it to these areas, patients can die. Currently, there are 11 companies that make IVC filters and roughly 250,000 U.S. patients per year receive them. Most of the filters function without problems.
Bard had high hopes for its original IVC filter, the Recovery. The company wanted to capture a good chunk of the market, but instead released a product that caused 27 deaths and hundreds of other serious issues after its 2002 FDA approval. Reports of deaths and other injuries, both connected to device migration and fragmenting began surfacing.
Bard began a confidential study that ultimately showed the Recovery filter’s risk factors for death, fragmenting and migration were higher than any of its competition. The outside doctor hired to run the study wrote, “Further investigation…is urgently warranted.”
Here’s where Bard went off the rails, in my opinion. Rather than do the responsible thing and recall the Recovery filter, the company created a similar replacement for it the G2 series, released in 2005. Confidential Bard records, as well as hundreds of reports submitted to the FDA, serve as evidence that the G2 series not only didn’t fix the problems caused by the Recovery, but also was just as bad.
At the time of the G2’s release, the Recovery filter had been on the market for three years. New Jersey-based Bard’s internal records show that the company had concerns about G2 series failures a mere four months after it was given FDA clearance. So, did Bard learn from its mistake with the Recovery? Nope. It didn’t recall the G2, either. Instead, the G2 was kept on the market until 2010, by which point Bard had sold over 160,000 filters. According to Bard and the FDA, hundreds of serious problems and at least 12 deaths have been connected to the G2 series IVC filters.
Dr. William Kuo, interventional radiologist and head of Stanford Health Care’s IVC Filter Clinic said, “All of the data that we’ve seen in our own studies, as well as other clinician researchers’, is that this device consistently fractures, consistently causes major complications. The number of complications, the frequency of severe failures makes it obvious that it was never safe to be implanted.” Kuo’s clinic specializes in the removal of failed IVC filters.
It gets even better… er, worse. A December 2005 confidential memo from a Bard vice president, written shortly after the G2 series was OK’d by the FDA clearly shows he has issues with the new filter. The memo spells out his concerns regarding, “problems with… migration,” “tilting,” and “perforation.” He even asks the logical question, based on the fact that Bard manufactured another, almost complaint-free filter, “Why shouldn’t doctors be using that one rather than the G2?”
It was a very good question indeed. Sadly, it was also one that never got answered.
Based on all of the adverse event reports, the FDA issued safety alerts in 2010 and 2014 advising doctors to consider removing IVC filters as soon as patients were no longer at risk of developing blood clots.
On September 24, 2015 (ironically the same day the FDA was holding a public hearing regarding the dangers of Bayer’s “permanent” birth control product, Essure), the chair of the Senate Judiciary Committee, Senator Charles Grassley (R-IA) sent a letter to the FDA asking questions about the agency’s handing of the Bard products. He was specifically concerned about what steps the FDA takes (or doesn’t) when new data becomes available regarding a previously cleared medical device’s performance.
As Sen. Grassley pointed out to NBC, “FDA’s only got one responsibility. It’s not the company, it’s John Q. Public — to protect the American public from two standpoints: safety and effectiveness.” The senator also told NBC that the agency’s response to his letter was incomplete and that he had further questions before formulating a plan.
The FDA declined to talk to NBC about Sen. Grassley’s letter, but did issue a statement saying that it “investigated the risks of all of these devices,” [including those from companies other than Bard] and “issued safety communications” covering the “risks associated with IVC filters.” These were the safety communications issued in 2010 and 2014.
In the next installment, we’ll take a closer look at the personal impact Bard’s choice of profits over patients had on one man. We’ll also examine the similarities between the corporate and FDA responses to Bard’s IVC filter issues and those from Bayer and the agency regarding the Essure product. Similarities that are more than just a little disturbing.