Patient Safety News: Bard to Pay $3.6 Million in First IVC Filter Trial
C.R. Bard, maker of the inferior vena cava (IVC) filter G2, will pay plaintiff Sherr-Una Booker $3.6 million for injuries she suffered from the device and for failure to warn about its dangers. Out of the total, $2 million was awarded in compensatory damages and $2 million in punitive damages. A radiologist was found at fault for $400,000 of the punitive damages for failure to bring attention to a separated filter piece on an x-ray in 2009 before Booker’s injuries required her to have open-heart surgery.
The Bard G2, which resembles a daddy long legs spider wasn’t required to be tested in patients before U.S. Food and Drug Administration approval because it was submitted through a “pre-market Section 510(k)” process. This process allowed Bard to certify that the device was similar to one already approved, the Recovery.
Like the Recovery and similar Bard filters with high failure rates, the G2 was designed to be inserted into the inferior vena cava, the largest vein in the body, to stop blood clots from flowing to the lungs. It was intended to be removed if it was no longer necessary for treatment.
The metal legs of the devices, however, can break and travel to other parts of patients’ bodies, mainly the heart and lungs, threatening their lives. Symptoms of a filter fracture can include chest pain and shortness of breath. Internal bleeding, constant and severe pain in the heart, chest, and elsewhere are among the complications. Emergency medical treatment can involve cardiac catheterization or a CT scan to find where the filter is located.
The Booker trial is the first “bellwether” case to go to trial. More than 3,600 IVC filter cases have been filed. The next Bard IVC filter trial will start mid-May 2018 and is expected to last two weeks.
In response to reports that the device caused complications, with some serious, one of Booker’s lawyers, Mark O’Connor, said “The simple fix was there. Don’t put it on the market.”
The company also didn’t say to doctors, “Whoever and wherever you are in the medical community, we gave you something dangerous and we need to fix it before it causes irreversible damage,” said O’Connor.
In response to the March 30 verdict, Bard associate general counsel for litigation Greg Dadika stated “We, of course, believe these are important life-saving medical devices whose failures far outweigh the risks.”
Berman and Simmons has an experienced team of lawyers who focus on representing victims of dangerous drugs and medical devices, including IVC filters.
“This is the first major case to go to trial and win. We expect more,” said Berman & Simmons attorney Susan Faunce. “If you or someone you know has experienced injuries or complications from Bard or other IVC filters, contact us immediately. You may be entitled to compensation and we can help you file a suit against the manufacturers.