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FDA Issues Warning About IVC Filter Blood Clot Device

IVC Filter Unsafe Despite Manufacturer’s Push, Associated with Several Wrongful Deaths and Injuries

IVC Filter The IVC filter is a medical device created and manufactured by medical manufacturer CR Bard. The company received FDA approval to offer the device as a treatment to prevent blood clots in patients who were at extremely high risk, where medication would not help or could lead to serious side effects.

However, an investigation into the safety of the IVC filter found that at least 27 patient deaths have been directly associated with the Recovery Filter over the course of a decade.

The apparatus a spider-shaped device of small tubes that, in theory, prevents blood clots from passing into the heart or up to the brain of patients who may otherwise suffer heart attacks, thromboses, or strokes due to their blood conditions.

In practice, the device has made the situation worse for too many patients. In addition to the 27 deaths, government data shows that around 300 other non-fatal but very serious personal injuries occurred because the IVC filter does not function as CR Bard said it did. Several of the surviving patients, along with family members of deceased patients, have filed civil lawsuits against CR Bard for the faulty IVC filter.

Bard IVC filter lawsuits allege that IVC filters are prone to breaking, fracturing, and moving inside the body, allegedly causing damage to the heart and lungs and resulting in stroke and death,” according to court documents.”Bard filter lawsuits also allege the company knew of risks posed by its IVC filters yet failed to warn the public … IVC filter lawsuits allege that Bard officials had a responsibility to warn the public of potential IVC filter complications.”

A South Florida plaintiff, Clare Austin, has a blood condition that makes her very prone to producing blood clots. These were causing thromboses, or painfully and dangerously clogged veins, in her arms. Her doctors implanted an IVC filter in 2010.  Three years later however, the filter stopped doing its job because it turned sideways in her body, perforated an artery, and punctured her pancreas.

“I was in a position of, you can either leave this (in) and maybe die or you can try doing the surgery,” said Austin, who elected to take her chances in surgery.

Another plaintiff, Dodi Froehlich, suffered serious injuries from a 2004 car accident that increased her chances of developing blood clots near her heart and lungs. Her doctors implanted an IVC filter, which nearly killed her when it punctured her heart.

“In that two seconds of being in the ambulance, I started flat-lining,” Froehlich told NBC News in an investigative interview. She had to undergo open-heart surgery.

Patient Gloria Adams was not as lucky as the other plaintiffs; her son is filing a wrongful death lawsuit on her behalf, because her IVC filter killed her. Adams suffered a brain aneurysm in 2004, and her doctors decided that an IVC filter would be the safest course to prevent further clots. Instead of stopping clots from traveling to her heart, however, a clot got caught in the device and pushed the entire IVC filter into Adams’s heart.

“I didn’t get many answers at that point,” her son said regarding her autopsy findings.

“I believe that there are probably at least 100,000 of those filters that were implanted in people,” said a Florida attorney working with Austin. “They have a failure rate of more than 50 percent,” a number he retrieved from Bard’s own documentation.

The FDA now recommends only using IVC filters on a temporary basis to protect against blood clots if medications and other remedies are not effective. Anyone with an IVC filter with questions should consult their physician.

 

About Pete Strom

Defending criminal charges including drug crimes, DUI, CDV, mail fraud, wire fraud, bank fraud, computer crimes, money laundering, and juvenile crimes, Pete also handles Federal and State investigations. Representing individuals in Civil Matters including Class Actions, Personal Injury, Qui Tam Actions, Defective Products, Nursing Home Neglect, and Professional Licensing Defense cases. Joseph Preston “Pete” Strom, Jr., the managing partner at Strom Law Firm, L.L.C., has been fighting for justice since 1984.

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