Bard IVC Filter Lawsuits
Several of C.R. Bard’s IVC filter devices have been associated with a high rate of migration and fractures. Patients from across the country are filing lawsuits against the manufacturer, demanding compensation for their injuries. The lawsuits allege, among other things, that C.R. Bard hid serious risks from the public and medical community.
Have you developed health complications after receiving a Bard IVC filter implant? Contact Rosen Injury Lawyers to learn about your legal options. You may have the right to file a product liability lawsuit against C.R. Bard, the company behind your defective medical device. Our attorneys are prepared to help you fight for the money you deserve. Your first consultation is free, so call for help now.
Bard IVC Filter Lawsuit Settlements and Awards
A growing number of IVC filter lawsuits have been filed against Bard in state and federal courts across the country. Plaintiffs argue that Bard negligently manufactured and marketed defective inferior vena cava filters and failed to warn about potential risks.
Many of these lawsuits are based on similar facts and arguments. These lawsuits have been consolidated into multidistrict litigations (MDLs) and will be tried before a single federal court judge. Unlike class actions, plaintiffs in an MDL reserve the right to have their individual lawsuit go to trial.
IVC Filters Lawsuits Consolidated in Arizona
As of September 2018, over 4,500 C.R. Bard lawsuits have been consolidated into an MDL in the United States District Court for the District of Arizona. One of the first bellwether trials in the MDL has yielded positive results for plaintiffs.
$3.6 Million Verdict: A federal court judge ordered Bard to pay $3.6 million in damages to a woman for injuries caused by a defective G2 filter. The award included $1.6 in compensatory damages and $2 million in punitive damages.
The first verdict in the Arizona MDL may encourage Bard to settle the remaining cases. The next two bellwether trials are scheduled to begin in February and May of 2019.
Bard Settles IVC Filter Lawsuits Privately
Bard has also settled several IVC filter cases privately. The settlement amounts awarded to injured IVC filter patients are unknown. However, the company’s willingness to settle claims involving its defective filters is encouraging. The evidence used in these early cases may help to pave the way for meaningful settlements for other IVC filter victims.
Which Bard IVC Filters Are Problematic?
Three Bard IVC filters have been linked to a host of serious side effects and long-term health risks.
- Bard Recovery IVC Filter
- Bard G2 IVC Filter
- Bard G2 Express IVC Filter
Bard Recovery IVC Filter
Bard’s Recovery IVC filter was first approved by the FDA in 2002. The Recovery filter is unique because it has 12 individual struts – 6 short and 6 long. Struts are thin metal legs that extend from the center of the device. The struts serve two distinct purposes. First, they secure the filter into the inferior vena cava. Second, they catch blood clots as they travel through the vein.
Studies have shown that struts on the Recovery device are prone to fracture. In fact, the failure rate for the Bard Recovery IVC filter is believed to be between 21 and 32 percent. In 2015, an NBC report revealed that the Recovery filter was linked to hundreds of injuries and at least 27 deaths.
Once the strut fractures, it can migrate through the body and cause serious harm, including internal bleeding, pulmonary embolism, and organ perforation. The consequences can be deadly if the small metal shards reach the heart or lungs.
Bard G2 IVC Filter
The Bard G2 IVC filter, which was first approved by the FDA in 2005, was designed to replace the controversial Recovery device. C.R. Bard advertised the retrievable G2 filter as having enhanced fracture and migration resistance. Despite these claims, G2 filters have also been linked to unreasonably high rates of failure. One study found that approximately 12 percent of all G2 filters fractures or broke after implantation.
Bard G2 Express IVC Filter
The Bard G2 Express IVC filter was first approved by the FDA in 2008. The G2 Express was designed with a hook at the top of the filter, which was intended to reduce the risk of migration. Despite this small change in design, the G2 Express filter has also been known to migrate and fracture at alarming rates.
Complications Associated With Bard IVC Filters
Patients have reported a wide range of health issues after receiving a Bard IVC filter implant. According to the FDA, adverse events, related to the fracture, migration, and tilting of defective devices, include:
- Internal bleeding
- Organ perforation
- Puncturing of the inferior vena cava
- Deep vein thrombosis (DVT)
- Chest pain
- Chronic pain
- Shortness of breath, and
The risk of complications associated with retrievable IVC filters increases the longer the device remains in the body.
Bard Accused of Concealing Evidence of Device Failure
Bard released its Recovery IVC filter in 2002 to “gain a new foothold in the lucrative filter market.” The company was able to take advantage of the FDA’s 510(k) pre-approval process, allowing it to bypass safety and clinical testing requirements. After the Recovery device was on the market for a few years, it became clear that it was causing more harm than good.
According to an NBC News investigative report, Bard launched a private internal study on the problem. The company hired Dr. John Lehmann and a team of medical experts to study the device.
Lehmann found that the Recovery filter “had higher rates of relative risk for death, filter fracture, and movement than all of its competitors.”
Bard did not release this information to the public or recall its dangerous IVC filter. Instead, the company fought tirelessly to keep the report confidential. It was only after NBC News obtained a copy of the study that the information became public.
Bard Executive Question Device Safety
Internal memos written by high-ranking Bard officials confirm that the company knew its IVC filters were dangerous. Shortly after the G2 device was released, a vice president noted his concerns about the filter’s propensity to migrate, tilt, and perforate the vein. He even questioned why doctors weren’t encouraged to use a different Bard device that was not associated with adverse health events.
Information about the dangerous of Bard’s G2 device was never forwarded to the FDA, medical professionals, or patients. Instead, the company continued to promote filters that it knew could cause serious harm. Bard only began to quietly remove G2 filters from the market after the FDA released an advisory opinion about the dangers of IVC filters in 2010.
Have Bard IVC Filters Been Recalled?
No. Despite hundreds of reported adverse health events, Bard’s Recovery, G2, and G2 Express IVC filters were never recalled. Medical experts blame medical device companies like Bard and the FDA for this shortcoming.
According to Dr. William Kuo, an interventional radiologist at Stanford University, Bard should have issued a recall for its Recovery and G2 filters long before the devices were actually taken off the market. In an interview with NBC News, Kuo discussed the dangers of Bard devices. “The number of complications,” he explained, “the frequency of severe failures makes it obvious that [these devices were] never safe to be implanted.”
Kuo doesn’t just blame the lack of a recall on Bard. He also contends that the FDA should have issued a mandatory recall for the filters long ago. The agency released safety warnings about the devices but failed to go any further. When the public health is at issue, concerted action is needed. The FDA failed to perform a primary function of its job.
Bard May Have Forged a Signature to Get FDA Approval
A 2015 investigative report revealed that Bard might have had difficulty getting FDA approval for its Recovery filter in 2002. In fact, its initial application for clearance was denied. The company turned to Kay Fuller, a veteran regulatory specialist, for help.
After studying the device and reviewing the results of a small clinical study, Fuller became concerned. She explained that the trial results “raised red flags” about the device’s safety. She also claimed that Bard refused to provide her with results from any other clinical trials.
When she raised her concerns about the device, the company didn’t want to hear them. Instead, Fuller was warned that she would no longer have a job if she continued to raise questions about the device. Fuller resisted Bard’s efforts to get her on board and refused to sign the FDA clearance documents.
Bard submitted its application to the FDA – with what appears to be Fuller’s signature on it. Fuller flatly denies putting her name on the application and contends that the company forged her signature. Bard denied these allegations and calls them “flatly untrue.”
Get Help With Your Bard IVC Filter Lawsuit
Several of C.R. Bard’s IVC filters have been associated with adverse health events. The company is accused of knowing about the dangers associated with its filters, but failing to disclose that information. If you’ve been injured because of a Bard IVC filter implant, you may have the right to obtain compensation.
Rosen Injury Lawyers can help you understand your legal rights and options. Contact our law firm today to schedule a free, no obligation case assessment. Our attorneys are prepared to help you fight for the compensation you deserve. Call to get started on your IVC filter injury case today.