Updated to include a response from Cook Medical
A federal jury in Indiana last week awarded $3 million in damages to a plaintiff in a bellwether case against Cook Medical over allegedly defective designs in the company’s Celect inferior vena cava filters.
The plaintiff, Tonya Brand, sued Cook in 2014 alleging that the Celect IVC filter implanted prior to a spinal procedure fragmented and sent broken pieces into her thigh and near her spine.
In her suit, Brand included claims for stricter liability and negligent failure to warn, negligent design defect, negligent manufacturing, negligence per se, breach of warranty, loss of consortium and punitive damages. Cook filed for summary judgement, seeking to have the case dismissed.
But testimony from the surgeon who implanted the Celect IVC device in Brand, Dr. Mark Rheudasil, indicated that he wouldn’t have treated Brand any differently, Judge Richard Young of the U.S. District Court for Southern Indiana wrote, according to prior court documents.
Last December, Judge Young found that Brand was unable to “establish causation in her strict liability and negligent failure to warn claims,” leaving only strict liability and negligent design defect and negligence per se claims intact.
In its recent decision, the jury ruled that the design of the Celect IVC filter was defective and that the defective design “was the proximate cause” of damage and injury to the patient, according to court documents, granting damages of $3 million.
Cook Medical responded to the ruling saying that it plans to appeal the decision on multiple grounds.
“The plaintiff’s attorneys in this case asked for tens of millions of dollars as well as punitive damages. We appreciate the jury’s thoughtful approach and rejection of punitive damages as well as unreasonably high demands for compensatory damages. While we respectfully disagree with the compensatory damages and verdict, we appreciate the time and hard work of the jury. We never want to see a patient with a poor outcome and we’re sorry that this patient experienced a very rare complication,” VP & GC Cynthia Kretz said in a press release.
The company said that its Celect IVC filter has a reported fracture rate of less than 1%, and said that the devices are still chosen for use based on the benefits of the devices outweighing the “small percentage risk for patients that need to prevent potentially life-threatening blood clots.
“We’ve seen clinical success in preventing recurrent pulmonary embolisms. This was a particularly complex patient case with unique, patient-specific factors. This case does not change our position. Cook is committed to continuing the fight for physician and patient access to this life-saving technology. We are dedicated to providing life-saving treatment options for patients. Our filters have saved thousands of lives and are critical to patient well-being,” vascular division VP Mark Breedlove said in a prepared statement.
Cook Medical said that it was successful in its first two multi-district litigation cases on IVC filters, having won a complete jury verdict in the first and a summary judgement in the second.
DeviceTalks Minnesota's leadership track is designed to provide attendees with insights on topics such as:
Use code SAVE15 to save 15%!