North Carolina Product Liability Lawyer Blog
Victims of C.R. Bard’s IVC filters got some great news two weeks ago. An Arizona jury in the first bellwether trial awarded a woman $3.6 million for injuries she suffered after Bard’s “G2” IVC filter broke into pieces in her inferior vena cava vein, requiring open heart surgery to remove the broken pieces.
The plaintiff, Sherri Booker, was implanted with Bard G2 IVC filter to prevent blood clots from reaching the heart and lungs. The problem was, the G2 moved inside her inferior vena cava (it is not supposed to move), then it broke apart. In 2014, she had to undergo open heart surgery. The surgeon was not able to retrieve all the broken pieces.
The Jury’s Verdict
After a lengthy trial the jury found that Bard was liable for a negligent failure to warn patients about the risk factors in using the G2 IVC filter. The jury also determined that Bard was not liable to the plaintiff for strict product liability design defect, strict product liability failure to warn, or negligent design.
The jury awarded Ms. Booker $2 million in compensatory damages and $2 million in punitive damages. The court was utilizing comparative negligence law, which assigns proportional blame for the harm caused. The jury found that Bard as the device maker was 80% responsible for the injuries, and that a radiologist who failed to discover a broken piece of IVC filter in a 2009 X-ray. Under comparative negligence law, therefore, Bard became liable for 80% of the compensatory damages award, for a total of $3.6 million. Punitive damages are not affected by a comparative negligence analysis, so the $2 million punitives award will stand.
Even with the reduction, it was a good result for Ms. Booker, and the verdict was promising for the thousands of IVC filter victims still awaiting trial or resolution of their cases. A second bellwether trial is slated to begin in May.
A C.R. Bard representative said he was “disappointed” in the jury’s verdict, but still maintained that the G2 IVC filters are useful medical devices that have saved lives.
Some History on the Bard IVC Filters
Bard began selling the “Recovery” IVC filter in 2002. This after Bard received approval to sell the device under the “510(k) process.” The name comes from a section of federal regulations that allows companies to sell products that are closely related to products already on the market. The 510(k) pathway, as I’ve discussed often, can lead to disastrous results. Anyway, the Recovery started causing serious problems pretty quickly, the main two that the Recovery filter would move or “migrate” in the inferior vena cava vein, and that it had a tendency to break apart. Bard conducted a study on the Recovery, found higher incidents of injury and death, and finally pulled the Recovery IVC filter from the market around 2005.
That same year Bard introduced the G2 IVC filter. The G2 was engineered from the Recovery technology, and it turned out that the apple did not fall far from the tree. An internal Bard memorandum noted serious issues with safety and function of the G2. Despite these internal concerns, Bard continued to sell the G2 filter and later the G2 Express filter.
Finally in 2010 Bard stopped selling the G2 IVC filters. One report estimated that 160,000 G2 filters were implanted in patients. One of those was implanted in Plaintiff Sherri Booker.
On May 18, 2015 the MDL involving Bard IVC filters was approved for federal court in Arizona, and injured people from all over the country can place their individual lawsuits in this MDL (MDL 2641).
I have written often on the problems associated with IVC filters, which you can read about here. If you have any kind of IVC filter implanted and are having problems, give me a call to discuss your legal options (919.546.8788). Good luck.