The suits say the companies negligently designed and made Boston Scientific Greenfield Vena Cava Filters and Cook Celect Vena Cava Filters. The IVC filter devices were implanted in women to treat or control pulmonary embolisms.
Boston Scientific IVC Filter Case
In her suit against Boston Scientific, Katherine Milan says that after being implanted with a Boston Scientific inferior vena cava filter, she not only suffered pain in her thigh and lower abdomen, but also extensive clotting. Her complaint says that a CAT scan showed her IVC filter had become occluded.
Ms. Milan’s suit says that she was admitted to a hospital in Paducah, Kentucky, with a diagnosis of deep vein thrombosis in her right leg in May 2005. After she had undergone a clot extraction, surgeons implanted a Boston Scientific Greenfield Vena Cava Filter in her inferior vena cava.
The very next month, Ms. Milan was taken to the emergency room with pain in her left thigh and lower abdomen. She was then admitted to a hospital with extensive clots in her right leg and acute deep vein thrombosis in her left leg. According to her lawsuit, a CAT scan showed occlusion of her IVC filter. Consequently, her suit says, she must take blood thinners the rest of her life.
Cook Medical IVC Filter Case
In her lawsuit against Cook Medical, Olenda Homes says that she had chronic back and lower extremity pain after being implanted with a Cook IVC filter. Ms. Homes says an angiogram showed a lot of clotting.
Ms. Homes’ complaint says she was admitted to a hospital February 2013, diagnosed with deep vein thrombosis in her right leg. After then being implanted with an IVC filter, she experienced progressively worsening lower back pain. Ms. Homes made an emergency room visit in July 2015 for chronic back and lower extremity pain. According to her lawsuit, an angiogram showed what appeared to be fresh thrombus in her pulmonary vasculature.
An angiogram showed her IVC filter had tilted, causing acute deep vein thrombosis in the left lower extremity. A doctor then placed another inferior vena cava filter above the Cook one, and Ms. Homes also received right and left vein catheter placements. She says in her suit that she will now need to take long-term anticoagulation medication.
Negligent, Reckless, Wanton Charges
The lawsuits both say that, “Defendants negligently, recklessly, wantonly, and carelessly failed to properly design and manufacture the [IVC filters]”.
IVC Filter Warning from FDA
The FDA (which cleared but never approved IVC Filters) advised health care professionals in 2010 to be vigilant of the risks associated with the long-term use of IVC filters. At that time, according to Law 360, the agency had received more than 900 adverse event reports involving the devices since 2005.
Both of the women’s lawsuits exonerate the doctors who inserted the IVC filters, arguing that they properly followed the defendants’ instructions, guidelines and directives.
Each of the lawsuits makes product liability, warranty, strict liability, negligence, gross negligence claims against the device manufacturer, and then seeks unspecified damages and further relief.
Boston Scientific, Cook IVC Filter Lawsuits Filed
The cases are Katherine Milan et al. v. Boston Scientific Corp., case number 5:16-cv-00065, and Olenda Homes et al. v. Cook Medical Inc. et al., case number 5:16-cv-00066. Both were filed in U.S. District Court for the Western District of Kentucky.