IVC blood clot filters may break apart, causing injuries
The third and final bellwether trial over Cook Medical’s blood clot filters has concluded with the jury returning a $3 million verdict Feb. 1 for a plaintiff who claims because of the defendants’ defective product she faces numerous health risks including the risk of death.
It is the first bellwether trial to be decided against the Bloomington-based medical products company. The trials were held as part of the multi-district litigation in the Southern Indiana District Court over the inferior vena cava filters. Plaintiffs allege the filters tend to tilt, perforate, migrate and fracture after being placed inside the patient.
C.R. Bard Inc, which faces more than 5,700 federal lawsuits alleging its deep vein filters are defectively designed, cannot keep evidence partially disclosed in previous trials under seal, the federal judge overseeing the multidistrict litigation ruled on Tuesday.
U.S. District Judge David Campbell in Phoenix, Arizona said the admission of the evidence at trial, even if not actually presented in court, waived a previous protective order.
In patients with blood clots in the veins of their legs a debilitating condition called deep-vein thrombosis physicians sometimes implant miniature filters to prevent the clots from migrating to the lungs.
But the devices can break and perforate blood vessels, and there is little evidence they save lives, leading some medical societies to conclude they are not worth the risk.
The use of vena cava filters in patients with venous thromboembolism (VTE) and a contraindication to anticoagulation is associated with an increase in 30-day mortality, results of a new observational show.
"After adjustment there was a small but significant increase in all-cause mortality at 30 days in the patients who received a filter vs those that did not receive a filter. As our study is observational and has some limitations we would describe the result as hypothesis generating, but we believe our data justifies a randomized controlled trial to answer the question," senior investigator, David L. Brown, MD, Washington University School of Medicine, St Louis, Missouri, told Medscape Medical News.
A company that made a blood-clot filter associated with 27 deaths and hundreds of problems replaced the device with a modified version that it knew had similar and potentially fatal flaws soon after it was put on the market.
A former insider with C. R. Bard claims her signature was forged, resulting in the approval of the medical device despite major concerns about the filter’s safety.
DALLAS – DePuy Orthopaedics and Johnson & Johnson have appealed a trial court decision that would have them pay out $150 million in damages to five plaintiffs.
Two Canadian patients with Cook IVC filters were told the devices could not be removed because the surgery would be too dangerous. They have now filed class action lawsuits against Cook Medical.