The second Bard IVC filter case in the sprawling multidistrict litigation (MDL) is preparing to go to trial next week. Thousands of injured patients allege that the company’s blood clot filters are patently defective and unsafe. They claim Bard’s IVC filters are prone to fracturing and migrating, as well as perforating the inferior vena cava (IVC) and vital organs, causing significant harm in their wake.
Currently, there are thousands of product liability cases pending against Bard in MDL 2641. District Judge David C. Campbell is presiding over all federal lawsuits in the District of Arizona to streamline the judicial process in the complex litigation.
IVC filters are small, spider-like devices. Surgeons implant them into the IVC to prevent blood clots from traveling to the lungs and causing pulmonary embolisms (PE). However, several different retrievable Bard filters appear to be dangerously defective. The FDA has received countless reports of severe injuries from the filters moving out of position, puncturing vital organs, or fracturing and sending small pieces adrift throughout the body. Many of these filters are defective to the point that surgeons cannot even retrieve them, sentencing patients to a lifetime of these serious risks. As a consequence, dozens of patients have already died. Now, nearly 4,000 of these injured patients have stepped forward to take Bard to task for its insatiable greed and negligence.
First Bard IVC Filter Trial
In March, a jury awarded Sherri Booker $3.6 million for life-threatening damage caused by Bard’s defective devices. This included $2 million in punitive damages to punish the company for concealing their filters’ substantial risks to protect market share at the expense of people’s lives. Booker was 37 when she received a Bard G2 filter in 2007. The filter broke apart in 2009, causing pieces to lodge in her heart and spine. Consequently, she had to undergo open heart surgery to remove the pieces. However, surgeons could only do so much to repair the damage. Several shards remain and continue to cause complications.
Booker alleges that Bard not only knew that the devices were prone to failure but that the company didn’t even conduct safety testing before unleashing the implants on the medical community. Her attorneys concluded that Bard essentially used patients as guinea pigs, taking their hard-earned money and health in the process.
“This was a medical device put on the market without safety testing,” her attorney said. “Real people in the real world were subjects in a massive experiment and suffered terribly. The device failed terribly. The short story is this was a human experiment that went terribly wrong.”
Second Bard IVC Filter Trial
For the second Bard IVC Filter trial, the court selected Doris Jones’s lawsuit. Her case goes before a jury May 15. Jones began experiencing lightheadedness and arm pain almost five years after receiving a Bard Eclipse IVC filter. When she went to the emergency room, a chest scan revealed that the IVC filter had fractured. The broken filter piece had embolized in the right pulmonary artery. Surgeons removed the main filter. However, they were unable to safely remove the IVC filter limb. Consequently, it remains in place and continues to pose a continual fatal threat.
In March, Judge Campbell clarified which issues the jury will consider at trial. The most prominent of these are Bard’s failure to warn about dangers associated with its IVC filters. Bard is not required to disclose risks directly to patients. So, the trial will be primarily dealing with Bard breaching its duty to warn physicians. Jones concedes that Bard warned doctors about filter complications in general. However, she contends these warnings were inadequate, because Bard did not disclose that the risk of Eclipse filter complications was higher than those of other filters. In support, Jones presented evidence that the Eclipse and other Bard IVC filters involved substantially greater risks than other devices. But, her doctor was unaware of these risks.
In fact, her doctor already testified that his initial understanding was that the fracture rates for Bard filters were extremely low. As a result, the court held that a jury could reasonably infer that the doctor would not have implanted the Eclipse filter if Bard had warned him about the higher fracture rates. The jury in next week’s trial will also consider if Bard’s warnings were grossly inadequate regarding the extent of its IVC filters’ risks.