New Jersey Plaintiff Sues Cordis for Wrongful Death in IVC Filter Trial
By Lynn Shapiro, Staff Writer
On March 23, 2016, Martino Convertino checked into the emergency room of St. Joseph’s Regional Medical Center in Paterson, N.J., with lightheadedness and severe pain in his back and legs. He went into shock and died from thrombosis the next day.
His autopsy noted “acute inferior vena cava dissection and rupture with evidence of pre-existing microscopic chronic dissection adjacent to IVC filter struts”, Osborne & Associates said in its brief, citing Mr. Convertino’s autopsy in its most recently filed wrongful death suit on behalf of Convertino’s widow, Carmine Convertino, against the Miami Lakes, Fla., medical device maker, Cordis Corporation.
The 37-page, five-count suit alleges Mr. Convertino’s death resulted from a defective Cordis Trap Ease IVC filter, implanted in October 2012, when he was 68 years old.
Mrs. Convertino, also cited Cordis’ earlier Opt Ease IVC filter as a trigger for her husband’s severe pain and death.
Cordis, a former Johnson & Johnson subsidiary, was sold to Cardinal Medical for $2 billion in 2015, before the company’s liability costs began to surge.
“This is among the first death lawsuits in South Florida against Cordis for the product Joseph A. Osborne told the The National Law Journal.
“This is a big step in a growing body of litigation around the country against manufacturers of IVC filters that not only fail to protect people, but place them at greater risk of injury and even death, “he concluded.
Substantial Safety Hazards and No Benefits over Anti-Coagulants.
“While IVC filters have been on the market since the 1960s, from 2000 to 2003 manufacturers raced to bring the first IVC filters to market with the option to remove them.
“The first three cleared were the Opt Ease, made by Cordis; the Recovery Filter by C.R. Bard Inc.; and the Gunther Tulip Filter, manufactured by Cook Medical.
The filters prevent blood clots in the lungs and heart and are considered an alternative to anti-coagulant medication such as heparin or warfarin.
“The medical community has just recently begun to awaken to the fact that despite marketing claims by defendants, there is no reliable evidence that any IVC filter offers a benefit and that these products expose patients to substantial safety hazards,” the suit alleges.
“Not only do Trap Ease and Opt Ease filters fail at alarming rates, but they also fail at rates substantially higher than other available IVC Filters,” the suit says, citing one study showing a fracture rate of 23 percent for Trap Ease filters after 46 months, and another reporting a 64 percent fracture rate after four years.
IVC Filters May Cause Thrombosis, Not Prevent It
The suit cites “alarming results” reported in an October 2015 article in the Annals of Surgery, concluding that IVC filters are not only ineffective in preventing thrombosis, but actually cause it to occur.
The Annals reported that twice the percentage of IVC filter patients died or developed pulmonary thrombosis -- the very condition the device was supposed to prevent -- as those who did not receive the device.
IVC filter use overall peaked in the United States in 2010 and has since declined. A recent article posted by JAMA cited a Food and Drug Administration (FDA) device safety advisory as contributing to that drop-off. A growing body of medical literature and news reports -- including three 2015 NBC broadcasts -- have thrown light on the dangers of these devices.
Most Filters Aren’t Removed, as the FDA Orders
The FDA recommends moving filters as soon as the danger of developing blood clots passes, or between 29 and 54 days after insertion. However, most filters aren’t removed and they’re more difficult to remove than the manufacturers let on.
Even worse, surgery to remove a defective filter can be dangerous and in some cases can’t be removed, according to US Recall News,
According to Wikipedia, fractured IVC filter pieces may migrate throughout the circulatory system or may perforate the duodenum, resulting in severe diarrhea and weight loss.
Filter migration may cause acute myocardial infarction, while a filter lodged in the heart causes arrhythmia.