What would you do if you knew that the product you were selling killed the people who bought it? Would you stop selling the product altogether?
While most people with even a trace of morality would say “yes” to the latter question, 2 giant healthcare companies getting even richer from selling Inferior Vena Cava (IVC) filters are proving that they’ll stop at nothing to make a profit, including killing their very own customers. The 2 medical device manufacturers in question – C.R. Bard and Cook Medical – have been at the center of an ongoing controversy revolving around the sale of faulty IVC filters.
The IVC Filter: Helping or Harming?
IVC filters are small medical devices designed to help people avoid suffering a pulmonary embolism (blood clot in the lungs), which could be fatal. After a serious accident or an intensive surgery, blood clots are especially common and may form and travel into the lungs, heart, or brain, often with fatal consequences. To prevent this, people with blood clots can get an IVC filter – a metal, spider-like trap – inserted into their inferior vena cava, the largest vein in the human body.
Like a catcher’s glove, the IVC filter is intended to catch and trap the traveling blood clot. Some IVC filters are removed once the risk of blood clots is gone while others remain inside the body permanently.
The procedure of implanting IVC filters is relatively quick and easy, and the logic behind the device seems fairly sound, so what’s not to like? Well, if you’re someone receiving an IVC filter manufactured by Bard or Cook Medical, there’s certainly a lot to be wary about.
One Company’s Shameful Story
In September of 2015, NBC News published a story highlighting a yearlong investigation into medical-device manufacturer C.R. Bard. Their findings were quite simple: Bard allegedly made blood clot filters that they knew killed and injured people and refused to take the dangerous products off the market.
According to the report, adverse effects caused by Bard’s initial “Recovery” model IVC filter resulted in 27 deaths and hundreds of medical problems. Bard’s next model of IVC filter – the “G2” – killed 12 unfortunate patients and injured even hundreds more.
What’s even more shocking, though, is that confidential reports have revealed that the management at Bard knew of the deadly shortcomings of their blood clot filters and continued to sell them for 10 years. NBC’s investigation also turned up evidence that Bard forged an important signature on an FDA application so that their dangerous product could hit the market sooner and when it wasn’t fully ready or safe.
Dr. William Kuo, a Stanford University surgeon who specializes in the removal of faulty blood clot filters, said the majority of filters he has to remove are manufactured by Bard. "Whether it's an ethical reason, a moral obligation, in the interest of public safety and patient safety, absolutely these devices should have been recalled,” Kuo said.
A Myriad of Deadly Problems
Due to the increasing amount of patients claiming to have been injured by Bard IVC filters, lawsuits were consolidated into a multidistrict litigation (MDL) proceeding before one judge in the Court District of Arizona. Cook Medical has also been under attack for its defective IVC filters. In October 2014, lawsuits against Cook Medical were consolidated into an MDL in the Southern District of Indiana.
Defective IVC filters can cause many serious problems. Other than migrating to areas of the body where they can inflict severe or fatal injury, faulty IVC filters can also break apart, causing individual “spokes” to cut or puncture veins, the heart, or the lungs. Other complications may include:
- “Cardiac tamponade,” a life-threatening condition involving bleeding in the heart
- Perforation or puncture in the inferior vena cava
- Hematoma or nerve injury
- Constant, severe pain in the heart, chest, or elsewhere in the body
- Difficulty breathing
- Infection
- Embedding in veins, heart, or lungs so that the broken pieces are difficult or impossible to remove.
Justice for the Victims?
Instead of saving the lives of the men and women who needed medical attention for potential blood clots, it’s alleged that C.R. Bard and Cook Medical instead complicated and/or took their lives away. What’s worse, the betrayal has been lucrative: in 2015, C.R. Bard raked in $135 Million in revenue while the Cook Group, the parent company of Cook Medical, reported revenue of $1.5 Billion.
It is nothing short of tragic that the powerful corporations of an ever-expanding Big Pharma are so focused on profits that they rush products onto the market that are not yet fit for use. Although the lives unnecessarily cut short by defective IVC filters can never be brought back, perhaps at least partial justice can be found if these shameful companies are made to pay compensation to the victims and their families.
