The company continued to sell the devices. Although medical device maker C.R. Bard was likely aware of injuries and complications associated with its Recovery and G2 blood-clot filters, the company continued to sell the devices.
In late 2015, in an extensive investigative report, NBC News said that at least 27 deaths were associated with Bard’s Recovery blood-clot filter. The Recovery filter was on the market until 2005, when it was replaced by the similar G2 filter series. But not long after the G2 filter was approved, Bard allegedly learned that the G2 had similar problems to the Recovery filter.
NBC reports that several confidential memos show clearly that Bard knew about the problems with migration, tilting and perforation, that is, when the device pierces the vein itself or other organs.
NBC News reported that just four months after Bard released the G2 filter series, the company was concerned by reports of complications. But Bard kept the G2 filter on the market for five more years, and sold 160,000. The G2 has been connected with over a dozen fatalities and many adverse event reports.
IVC Blood-Clot Filters
When a patient is recovering from surgery or a serious injury, blood clots can form in the body. A blood clot that travels to the lungs—a pulmonary embolism—can be fatal. Blood-thinning medications are the most common treatment but if these drugs are not a good option, the doctor often recommends an inferior vena cava (IVC) filter. The IVC filter is implanted in the inferior vena cava—the body’s largest vein—to prevent blood clots from traveling from the lower body to the heart or lungs. The filter is intended to be removed when the danger of a blood clot has passed.
The IVC filter is a small, spider-like device that traps blood clots and keeps them from travelling to the heart and lungs. The trapped clots eventually dissolve back into the body. But many patients have suffered serious adverse health events and complications after having an IVC filter inserted. Patients have experienced severe pain, bleeding, and further clots, the very thing the filter is supposed to protect against.
After insertion, the IVC filter can move out of position and became lodged in another part of the body. If the filter tilts after insertion it will not be effective in trapping clots. The “legs” of an IVC filter can break off and becoming embedded in the vena cava or in another organ. Clots can form around the broken-off filter fragments. Research has suggested that the constant motion of blood within the vein can cause a local tissue reaction and the filter becomes embedded in the inferior vena cava lining.
When a filter has migrated from its original location or has penetrated an organ, sometimes it cannot be safely removed and must be left in place. A study in the Journal of the American Medical Association noted that more than 18 percent of attempts at removing IVC filters were unsuccessful. When the filter cannot safely be removed, the patient is left at risk for future IVC filter complications.
The risk of IVC filter failure increases the longer the filter is left in the body. In 2014, the FDA recommended that retrievable IVC filters be removed between 29 and 54 days after insertion. IVC filters may actually become more dangerous than beneficial when they are left in the body longer than two months. But sometimes, when a filter has migrated from its original location or has penetrated an organ, it cannot be safely removed and must be left in place. A study in the Journal of the American Medical Association noted that more than 18 percent of attempts at removing IVC filters were unsuccessful. When the filter must be left in the body, the patient is at risk for future IVC filter complications.
Dr. William Kuo, a specialist in removing blood clot filters, told NBC News, “All of the data that we’ve seen in our own studies, as well as other clinician researchers’ [shows] that this device consistently fractures, consistently causes major complications.” Kuo added that the number of complications and the frequency of severe failures “makes it obvious that it was never safe to be implanted.”
Dr. Kuo believes both the Recovery and G2 should have been pulled from the market. Kuo said he has removed more than a thousand filters in the last decade and more of them have been from Bard than from any other manufacturer.
Between 2005 and 2010, the U.S. Food and Drug Administration (FDA) received nearly a thousand reports of adverse events involving IVC filters produced by a number of manufacturers.
IVC Filter Lawsuits
Hundreds of lawsuits involving Bard IVC filters have been consolidated in an IVC filter multidistrict litigation (MDL). Some lawsuits allege that when permanent IVC filter designs were adapted into temporary filters, the new devices were not strong enough to resist breakage and stay in place, leading to many of the complications patients experienced.
A small number of representative cases have been chosen to go to trial first, possibly beginning in fall 2017. Bellwether cases give both sides a sense of how juries will react to the type of evidence and legal arguments that would be presented repeatedly if a large number of cases go to trial. The outcome of bellwether trials can be important to the handling of the rest of the cases in a large litigation. When early jury decisions show a trend, this can either prompt settlement negotiations to resolve the remaining cases or encourage the parties to take additional cases to trial.
Legal Help for Those Injured by an IVC Blood-Clot Filter
If you or someone you know has suffered an injury or complication related to an IVC blood-clot filter, the attorneys at Parker Waichman LLP can help you. To contact an attorney for free, no-obligation case evaluation, fill out the online contact form or call 1-800-YOURLAWYER (1-800-968-7529).