C.R. Bard IVC Filter Lawsuit

C.R. Bard IVC Filter Lawsuit 2018-09-25T12:28:31+00:00
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C.R. Bard faces thousands of product liability lawsuits filed over its G2, G2 Express and Recovery IVC filters. Patients allege severe injuries, claiming that Bard hid serious risks from the public and medical community.

  • IVC filter fractures, embolizations and perforations
  • Decades of combined legal experience
  • You owe nothing until we secure compensation

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We believe C.R. Bard should be held accountable for patient injuries.

— Laurence Rosen, Esq.

C.R. Bard faces thousands of product liability lawsuits filed over its G2, G2 Express and Recovery IVC filters. Patients allege severe injuries, claiming that Bard hid serious risks from the public and medical community.

  • IVC filter fractures, embolizations and perforations
  • Decades of combined legal experience
  • You owe nothing until we secure compensation

Were you or a loved one injured? Our experienced product liability lawyers can help. Learn more in a free consultation.

24/7 IVC Filter Consultations

(866) 807-4631

We believe C.R. Bard should be held accountable for patient injuries.

— Laurence Rosen, Esq.
"Thank you." Laurence is experienced and knowledgable.
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Prominent medical device manufacturer C.R. Bard is facing thousands of product liability lawsuits filed over the company's Recovery, G2 and G2 Express IVC filters. In their complaints, patients from across the country claim that the medical devices can break apart (or fracture) inside the body, leading to severe and lasting complications that often require additional surgeries to correct.

C.R. Bard is accused of having concealed necessary safety information from the public, while marketing an inherently dangerous medical device as a technological breakthrough.

IVC Filter Lawsuits Consolidated In Arizona

Thousands of patients have filed IVC filter lawsuits against C.R. Bard. The vast majority of these cases are currently awaiting trial as part of a consolidated litigation in the United States District Court for the District of Arizona. As of September 2018, over 4,500 C.R. Bard lawsuits are consolidated in the Arizona federal court, where Senior District Judge David G. Campbell has been appointed to preside over the coordination of claims.

Surgeon Making Incision

Two lawsuits selected from the consolidated litigation have already gone to trial. The results of these test cases could dramatically affect the outcome for thousands of other claims. In one case, Bard was found liable and was ordered to pay $3.6 million in compensation to a woman who alleged a G2 IVC filter had broken inside her, causing severe injuries. At trial, a former Bard engineer testified that the G2 filter's design had been defective.

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Plaintiffs Allege Filter Side Effects, Complications

As plaintiffs claim in their lawsuits, IVC filters have been linked to a host of severe side effects. Hundreds of severe complications have been reported to the FDA, even as the federal agency has struggled to understand the extent of the problem.

Case reports and medical studies have associated Bard's G2, G2 Express and Recovery IVC filters with numerous problems, including the risk of fracture, in which one of the implanted device's breaks apart inside the body. Fractured device components can be carried along with the flow of blood to internal organs.

G2 & Recovery Filters

Multiple FDA reports have warned about the risks of IVC filters. Even so, many of the devices remain on the market. Where complications are concerned, Bard's G2 and Recovery series IVC filters stand at the top of the list. The Recovery filter alone, a 2015 report from NBC News revealed, is linked to at least 27 deaths and hundreds of non-fatal personal injuries.

The company's G2 filter, designed to replace the Recovery, was marred by similar problems almost immediately after its 2005 release. Since then, Bard has been accused, both in lawsuits and investigative reports, of concealing the problem from the US Food & Drug Administration and patients everywhere.

NBC News Finds Evidence Of Risk Concealment

Much of what we now know about C.R. Bard's questionable conduct comes from a landmark investigative report released in 2015 by NBC News. The report concerns Bard's Recovery filter, which the company released "to gain a new foothold in the lucrative filter market" in 2002.

Unfortunately, and tragically for patients, injury reports soon began to pile up. In response, Bard commissioned a confidential internal study on the problem; Dr. John Lehmann, an outside doctor hired to study the device, found that the Recovery filter "had higher rates of relative risk for death, filter fracture and movement than all of its competitors."

Ever since, Bard has fought tirelessly to keep Lehmann's report confidential, but a copy briefly became public, allowing NBC News to cover the story for the first time.

As Side Effect Reports Mount, Bard Resists Recall

The Recovery filter, by all accounts, was more dangerous than any other filter on the market. But Bard chose not to recall it. Instead, the company decided to stand behind the filter for another three years. In 2005, Bard replaced the Recovery filter with the G2 series, but already, high-level officials within Bard were expressing concerns over the new model's safety.

Bard Executives Question G2 Safety

Within months of releasing the G2 filter, a Bard vice president wrote internal corporate memorandums expressing his concern over the G2's propensity to migrate, tilt and perforate the inferior vena cava. After voicing his doubts about the G2's safety, the executive went on to note a similar Bard filter, already on the market, that did not seem to be associated with adverse events. "Why," the vice president asked, "shouldn't doctors be using that one rather than the G2?"

Despite these concerns, Bard continued to promote the G2, allowing thousands of units of the device to be purchased by physicians across the country. In fact, the company never forwarded any of this information to the FDA, investigations have found. Instead, Bard hired a  public relations firm to create a "crisis management plan" to help deal with any further revelations.

That only changed in 2010, when Bard quietly removed the G2 filter from the market. That year, a second review had been conducted to evaluate the rate of adverse events reported for the G2. Like Dr. Lehmann's initial report on the Recovery filter, this second assessment found that the G2 series filters were associated with "more fractures, migrations and reported problems than any of its competitors," NBC News writes.

IVC Filter Expert Says G2, Recovery Should Have Been Recalled

According to Dr. William Kuo, an interventional radiologist who heads up Stanford Health Care's IVC Filter Clinic, Bard should have issued a recall for the Recovery and G2 series filters long before the devices were actually taken off the market. "All of the data that we've seen in our own studies," Dr. Kuo told reporters for NBC News, "is that this device consistently fractures, consistently causes major complications."

In 2015, Dr. Kuo estimated that he and his team at Stanford have removed at least 1,000 fractured and injury-causing filters. The G2 and Recovery filters, Dr. Kuo maintains, are the worst of the bunch. "The number of complications," he says, "the frequency of severe failures makes it obvious that it was never safe to be implanted."

Dr. Kuo also places blame on the FDA, which he believes should have initiated a mandatory recall for the filters long ago. Over the last decade, the FDA has released multiple safety warnings about IVC filters, noting the devices' marked tendency to fail after extended periods of implantation, but Dr. Kuo says that, when public health is at issue, concerted action is necessary.

"What we've learned the hard way," Dr. Kuo says, "is that we can no longer rely on medical devices companies to do what's in the best interest of the patient. And we can no longer rely on the FDA to properly regulate these devices."

C.R. Bard May Have Forged Regulatory Advisor's Signature

Even more troubling allegations arise from a September 2015 report, published by NBC News, on Bard's Recovery series filters. In 2002, the report suggests, Bard was having trouble receiving FDA clearance for its new line of IVC filters. After an initial clearance application was denied, the company hired Kay Fuller, a "veteran regulatory specialist," to help. But Fuller soon became concerned.

As she told NBC News, a small clinical trial "raised red flags" about the device's safety - and the company was hesitant to provide her with the data from additional safety studies. When Fuller raised her concerns with Bard officials, she says the company didn't want to hear them. "It was basically," Fuller says, "if you continue to pursue these questions, that I was going to be asked not to be on the team."

Fuller says she was "shocked," and refused to sign off the FDA clearance documents until all of her concerns were addressed. Today, Fuller says she never signed those documents. Even so, Bard submitted its application to the FDA - with what appears to be Fuller's signature on it. When shown a copy of the paperwork during her interview, Fuller stated, "that's not my signature."

Fuller's explosive revelation has yet to be resolved. C.R. Bard says that any suggestion that the company forged Fuller's signature to gain FDA clearance is "flatly untrue." The FDA has refused to comment publicly on the case.

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