Medical device manufacturer C.R. Bard is now facing around 200 lawsuits, all of which claim the company’s IVC filters broke or migrated inside a patient’s body, causing severe injury and, in some cases, death. With hundreds of lawsuits already filed, recent revelations of potential fraud have attorneys across the country saying thousands of other patients injured by C.R. Bard IVC filters may be entitled to financial compensation themselves.
What’s Wrong With C.R. Bard’s Popular IVC Filters?
Bard, at least the company’s executives, have known for decades that these medical devices, small wire “nets” designed to catch blood clots inside a vein, are prone to “failure” – breaking or migrating far from the site of implantation.
One Bard filter, the Recovery model, has been estimated to break in between 25% and 31.7% of patients. Bard’s G2, a model designed to replace the Recovery after concerns were raised over its propensity to harm patients, carries a failure rate of 12%, according to a 2010 study published in the Journal of General Internal Medicine.
Recent investigations have uncovered evidence that high-level executives at Bard were well aware of the IVC filter’s risks, but continued to sell the products for at least five years. One employee, tasked with redesigning an FDA approval application that had been rejected on its first go, was apparently threatened after she brought up the device’s “problems” with her supervisor.
Bard May Be Secretly Settling IVC Filter Cases
Reports have surfaced that Bard has been secretly settling IVC filter lawsuits, but those rumors have yet to be substantiated. We know without doubt, however, that Bard has settled at least one IVC filter lawsuit. Filed in 2012 by Kevin Philips, the lawsuit claims that Philips was implanted with a Bard Recovery filter in 2005. Problems only started five years later, when the filter caught a blood clot, as it was designed to do. But in trapping the clot, one of the filter’s legs snapped off, traveling downstream to Philips’ heart. The man says he required open-heart surgery.
Almost three years after his initial filing, Philips’ case finally reached trial. Six days into court proceedings, Bard decided to settle the case, according to a docket entry registered in the US District Court of Nevada. The amount of the settlement is confidential. It’s likely that news of the settlement only reached the public because Philips’ case had reached trial.
Filters May Not Work At All
Like most patients implanted with an IVC filter, Philips lived at an increased risk of venous thromboembolism, a condition marked by the formation of blood clots in veins. If one of these blood clots detaches, it can travel through the circulatory system and ultimately reach a patient’s lungs, at which point the clot becomes a “pulmonary embolism.” Blood clots in general, and pulmonary emboli specifically, are a leading cause of death world-wide.
IVC filters were designed to trap these traveling blood clots, cutting them off before they reach the lungs. Implanted in the inferior vena cava (hence “IVC”), a large vein carrying blood to the heart, the filters can be retrieved for removal by way of a catheter. These so-called “retrievable” IVC filters were first approved in 2001, replacing a first generation of permanent filters in use since the late 1960s. But as with permanent IVC filters, researchers have been quick to question the effectiveness of newer models.
In 2013, a Journal of the Medical American Association review could find only 1 clinical trial that even tried to investigate the efficacy of filters over more traditional treatments for venous thromboembolism. The study, conducted in France, followed a cohort of 400 patients, half of whom had been implanted with permanent IVC filters, some manufactured by C.R. Bard. 200 of the patients did not receive a filter, but remained on the industry-standard treatment of blood thinners. After 8 years, the researchers found that IVC filters reduced the risk of pulmonary embolism “significantly,” but that those “beneficial findings were offset by an increased occurrence of deep-vein thrombosis.”
Paradoxical results, to be sure. Deep vein thrombosis, a blood clot that develops in the lower limbs, is a key risk factor for pulmonary embolism. In other words, IVC filters seemed to cause the very condition they were designed to treat. Moreover, the study could not conclude that filters had any beneficial impact on the patients’ survival rate.
Despite Risks, Bard “Decided” To Continue Selling
Recent developments have many prominent attorneys saying the future only holds more legal trouble for the manufacturers of IVC filters.
An investigation led by NBC News has found that C.R. Bard, only months before its replacement for the faulty Recovery filter was approved, expressed serious concerns over a new device’s failure rate in internal corporate documents. “But instead of recalling the [new] 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,” NBC writes.
Bard’s vice president, David Ciavarella, apparently took notice, sending out a private memo about his concerns over the device’s propensity to “migration, tilting [and] perforation.” Ciavarella noted a different IVC filter, also manufactured by Bard, which had “virtually no complaints associated with it. Why shouldn’t doctors be using that one rather than the G2,” he asked.
Secret Studies & Red Flags
The investigation even uncovered a study, carried out confidentially, that found the company’s earlier Recovery filter posed greater risks of death, breakage and migration than any of its competitors.
In an earlier report, NBC News investigators questioned whether Bard had been entirely forthcoming about the Recovery’s problems. Among a slew of internal documents obtained by the reporters was a “crisis management plan,” concocted by public relations firm Hill and Knowlton, advising Bard staff that “unfavorable press” could hurt the company’s stock value and “ruin reputations.”
After Bard’s initial attempt to get the Recovery filter approved failed, the company hired Kay Fuller, a specialist in medical device regulation, to help improve the application. But Fuller, who spoke to NBC in September 2015, says Bard actively suppressed her concerns about the device’s safety. Reviewing a small clinical trial, one that “raised red flags” in Fuller’s mind, she became worried that “there were going to be problems with th[e] product.” But when she spoke to her supervisors at Bard, “the message she got was that she would be removed from the team if she continued to pursue the matter.”
“Never Safe To Be Implanted”
Dr. William Kuo, a radiologist at Stanford, has seen those red flags become a reality. Over the last decade, he’s had to remove at least 1,000 broken or migrated IVC filters. Most of them were manufactured by C.R. Bard. His conclusion is even more damning: “the number of complications, the frequency of severe failures makes it obvious that it was never safe to be implanted.”
Kuo now believes “absolutely” that both the G2 and Recovery filters should be recalled. That still hasn’t happened, and Bard repeatedly declined NBC’s requests for comments. Instead, the company released a statement saying it “steadfastly believe[s] in the safety and efficacy of these devices,” and implicitly questioning the news organization’s “commit[ment] to telling the whole story about IVC filters.” But injured patients haven’t waited for Bard to address the allegations of fraud, or issue an IVC filter recall. Instead, they’ve turned to the civil court system, filing personal injury lawsuits in droves and demanding corporate accountability directly.
Lawsuits Consolidated In Arizona
Originally filed in various federal courts across the country, the lawsuits have now been centralized in the US District Court of Arizona.
This process, known as “consolidation,” will allow the numerous plaintiffs to coordinate on legal strategies and evidence-gathering. The Honorable David G. Campbell, the federal judge appointed to preside over the litigation, has set October 28, 2016 as the deadline for “fact discovery,” the phase during which plaintiffs and C.R. Bard can exchange information with one another.
Lawyers are currently deciding on how best to handle a recent FDA investigation into Bard’s manufacturing facilities, which turned up numerous violations, and the testimony of a regulatory specialist who says her job was threatened when she raised questions about the safety of one of Bard’s devices.
Here’s What One Lawsuit Has To Say
In February of 2009, Kelly Vlasvich underwent surgery to have one of Bard’s G2 IVC filters implanted. Vlasvich, a resident of Illinois, lived with the filter for 3 years, until inexplicable chest pains warranted an emergency room visit. She was admitted to the hospital in 2011, and her symptoms quickly progressed, coming to include nausea and vomiting, breathing difficulties and general weakness. Physicians diagnosed Vlasvich with “cardiac tamponade,” a condition in which fluid, often blood, builds up between the heart’s muscles and a sac that encloses the organ.
Four days after receiving treatment for that condition, however, Vlasvich’s chest pain persisted. A CT scan revealed “metallic fragments” lodged in the right ventricle of her heart, as well as the right lung – “struts” from her IVC filter which had broken off. Imaging Vlasvich’s abdomen, her doctors searched for conclusive evidence that the filter had fractured. Manufactured with 12 struts, Vlasvich’s IVC filter only had nine.
Complete Removal “Too Dangerous”
The next day, Vlasvich was prepped for open-heart surgery, a procedure she says “to save her life.” Surgeons were able to remove the strut stuck in Vlasvich’s heart, but decided not to remove the broken wires lodged in her lung. Removing them, they determined, would be “too dangerous.”
Instead, she was transferred to a larger, metropolitan hospital, where the broken IVC filter was removed – not, however, as the manufacturer had intended, through a non-invasive cardiac catheterization procedure. Vlasvich required a second open-heart procedure to get the faulty device out. Two struts remain embedded in her lungs, and will likely remain there forever.
Bard IVC Filter “Defective In Design”
Vlasvich filed a lawsuit against C.R. Bard on October 31, 2013. Her demand for compensation, in part to cover the cost of two open-heart surgeries, was filed in the US District Court for Northern District of Illinois under the case number 1:13-cv-07817.
She notes the G2 filter’s substantial failure rates, demonstrated by numerous studies, but makes an even bolder allegation. The IVC filter was designed and manufactured improperly, she claims. In effect, Bard’s device was built to fail. Made from Nitinol, a material created by the Navy to be used in military ordinance, the G2 IVC filter was designed to respond to the constant fluctuations of human circulatory and respiratory cycles. Nitinol expands and contracts in response to pressure and heat changes. In the minds of Bard’s designers, this capability must have made Nitinol seem the perfect material to be implanted inside a vein.
But according to Vlasvich, the filter’s struts are marked by minuscule gouges, artifacts of the manufacturing process. Under normal metabolic pressures, Vlasvich claims, these gouges become prone to fracture. “Simply put,” she writes in her complaint, “the G2 Filter is not of sufficient strength to withstand normal placement within the human body.”