IVC Filter Company Responsible for 39 Deaths: May Have Forged FDA Application

After surviving a car crash, doctors implanted a device known as an inferior vena cava (IVC) filter in 45-year-old Dodi Froehlich. Froehlich was at an increased risk of blood clots and IVC filters are designed to prevent clots from reaching the heart or lungs, where they can become fatal.

A "Recovery" model filter, manufactured by C.R. Bard, was implanted in Froehlich. 4 months later she experienced an unbearable headache and lost consciousness. The 45-year-old then flat-lined as she was being transported to the hospital.

In order to save Froehlich, doctors performed emergency open-heart surgery. The cause of Froehlic's near-death experience was not a disease or a blood clot, but the very filter that was designed to protect her. A piece of the spindle-like device had snapped off and stabbed into Froehlich's heart, nearly causing her to bleed to death. Surgeons had the difficult job of removing the tiny, sharp piece, draining the excess blood and stitching Froehlich's heart shut.

Froehlich was fortunate to survive, but many other patients, like 55 year-old Gloria Adams, have not had such luck. Adams received the same brand of filter after a brain aneurysm in 2004. Within a week the filter had shifted inside of her arteries and punctured her heart. She left behind a grieving son, Kevin.

IVC Filters Pose Numerous Threats to Health and Well-Being

A recurring and serious problem of C.R Bard filters is their tendency to break inside of the body and damage the heart. However, these are not the only risks associated with these small devices.

IVC filters can also pierce the inferior vena cava itself – the largest vein in the human body – causing massive internal bleeding. The filter may also "tilt" and "migrate" within the inferior vena cava, which can not only cause damage to the artery, but can allow the metal device to be sent towards the lungs or heart. Because they are small, these devices can become lodged inside of one's artery. If the filter becomes too embedded, surgeons can't remove it without the risk of killing the patient.

Medical Company May Have Known It Was Selling Lethal Product All Along

C.R Bard's "Recovery" Inferior Vena Cava (IVC) filter has been associated with 27 deaths in the U.S. Confidential reports commissioned by Bard executives found that "The Recovery" was over 4 times as likely to create a fatal problem than all other IVCs combined, and over 13 times as likely as all other retrievable IVC devices to fracture into pieces once inside of the body.

Despite this alarming data, Bard continued to sell the product for 10 years, during which 27 people died and hundreds of others experienced devastating medical injuries and complications.

In 2005, Bard replaced "The Recovery" with the G2 series. The supposedly new and improved filter also generated hundreds of complaints when the devices fractured and tilted while inside of the inferior vena cava.

Bard May Have Obtained FDA Approval Illegally

C.R Bard first received Food & Drug Administration (FDA) approval in 2002. Bard's application was turned down once, prompting the $14 Billion-dollar company to hire a regulatory specialist, Kay Fuller. Even though Fuller's job is to help companies secure approval from the FDA, Fuller recognized that Bard's filters were simply too dangerous to be placed on the market.

Fuller requested more data on the filters, but the company wouldn't provide them. Eventually, executives told Fuller that she would be fired if she continued to investigate the filter’s safety.

"I was shocked," said Fuller, who refused to sign the company’s FDA application. In a show of true desperation, C.R. Bard allegedly forged Fuller's signature on its FDA application.

In addition to its shady history with the FDA, recent FDA reports show that C.R. Bard has committed several product quality violations that, as of July 1015, it had not addressed.

IVC Filters Are Potentially Lethal: Get Help Before It's Too Late

If you or someone you know has received an IVC filter, it's essential that you speak with a doctor on the dangers and potential complications. Do not assume that the company who manufactures your filter will issue a recall or warn you if your filter is defective. If you suspect that an IVC filter has already caused injuries or health problems for you or a loved one, you should contact Sokolove Law immediately for a free legal consultation.

Sokolove Law Team

Contributing Authors

The Sokolove Law Content Team is made up of writers, editors, and journalists. We work with case managers and attorneys to keep site information up to date and accurate. Our site has a wealth of resources available for victims of wrongdoing and their families.

Last modified: September 28, 2020