By Leah S. Poniatowski, J.D.
Manufacturers of the Cook Celect® Vena Cava Filter prevailed in a bellwether products liability lawsuit on account of the "devastating" testimony from a vascular surgeon who selected, implanted, and removed the device following its fracture and drift in a patient (In re Cook Medical, Inc., IVC Filters Marketing, December 5, 2018, Young, R.).
Background. Cook Incorporated, Cook Medical LLC, and William Cook Europe APS (collectively, the manufacturers) develop, manufacture, sell, and distribute medical devices internationally, and have two products that are used to prevent pulmonary embolism: the Cook Celect® Vena Cava Filter and the Günther Tulip® Vena Cava Filter. A patient with several health conditions, including a history of DVT and multiple abdominal surgeries, was evaluated by the vascular surgeon before she underwent spinal fusion surgery. The vascular surgeon considered the patient’s history and the circumstances of the operation, and chose to implant the Cook Celect® Vena Cava Filter.
A little over two years later, the patient experienced a pain in her thigh and noticed that part of the IVC filter was protruding from her leg. The vascular surgeon observed from a full body scan that the filter had fractured and pieces had migrated to other places in the patient’s body. The filter was ultimately removed four years later when the patient underwent knee surgery. Other individuals similarly affected filed products liability and related lawsuits; the present negligent and strict liability failure to warn case was selected as a bellwether trial in the multi-district litigation against the manufacturers.
Failure to warn. In order for the patient to prevail on her failure to warn claims, she needed to establish under the learned intermediary doctrine that the manufacturers’ warnings to her surgeon were inadequate and that the inadequate warnings were the proximate cause of her injuries. The patient alleged that the "Instructions For Use" (IFU) accompanying the Celect® IVC filter were inadequate because they did not include tilt, progressive perforation, or fracture in the list of "potential adverse events." The patient also asserted that the manufacturers did not inform doctors that: (1) the clinical study mentioned in the IFU contained data that was misleading and inaccurate; or (2) the Günther Tulip® Vena Cava Filter’s lack of perforation limiters reflected a design change from the Celect®.
However, the vascular surgeon testified that he was aware of the tilt, perforation, migration, and fracture risks and that these risks were "not unique to the Celect® filter." He also stated that his knowledge of the risks was based on his education, training, and experience—not the IFU or any other document provided by the manufacturers. Additionally, the surgeon testified that he "had no problem using [the Celect]" in terms of its safety and efficacy and that nothing about the patient’s experience impacted his decision to use IVC filters or the one at issue. The court explained that in light of the surgeon’s "devastating" testimony, the patient could not demonstrate a genuine issue of material fact with respect to proximate cause. Similarly, the patient’s post-sale duty to warn claim failed because she had no testimony or other evidence to offer demonstrating that the filter would have been removed before fracturing by virtue of the manufacturers warning the surgeon after the device had been implanted. Accordingly, the manufacturers’ motion for summary judgment on the failure to warn claims was granted.
The case is No. 1:14-ml-02570-RLY-TAB.
Attorneys: Bentford E. Martin (Hamilton Stephens Steele & Martin, PLLC) for Plaintiffs' Lead Counsel. Ben C. Martin (Law Offices of Ben C. Martin) for Tonya Brand. Christopher D. Lee (Wooden & McLaughlin LLP) for Defendants' Lead Counsel, Cook Medical Inc. and Cook Group, Inc. Andrea Roberts Pierson (Faegre Baker Daniels LLP) for Cook Inc.
Companies: Cook Medical Inc.; Cook Group, Inc.; Cook Inc.
MainStory: TopStory WarningsNews MedicalDevicesNews IndianaNews
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