By Wendy Biddle, J.D.
A patient who had an inferior vena cava (IVC) filter implanted that subsequently caused her harm failed to present evidence that an inadequate warning caused her injuries, the district court in Arizona held, granting the device manufacturer’s motion for summary judgment on the patient’s negligent and strict liability failure to warn claims. The court, however, denied summary judgment on the patient’s strict liability design defect claim, finding that the patient had provided sufficient evidence of a factual dispute over whether there was a design defect in the IVC filters (In re: Bard IVC Filters Products Liability Litigation (Hyde v. C.R. Bard, Inc.), July 26, 2018, Campbell, D.).
The patient, who had a history of deep vein thrombosis, had a Bard G2X IVC filter implanted while she lived in Wisconsin. She subsequently moved to Nevada, and while there, a CT scan indicated that the one of the filter’s struts had fractured and lodged in her heart. She followed up by having both the strut and filter removed. The patient’s case is part of a large multidistrict litigation (MDL) case and was selected as a one of the bellwether cases set for trial in September. The patient asserted various claims against Bard, including strict liability and negligent failure to warn, and strict liability design defects. Bard moved to dismiss these claims, as well as those for failure to recall, misrepresentation and fraud, and breach of implied warranty.
Choice of law. Although both Wisconsin and Nevada had significant contacts in the case, after reviewing the "choice-influencing factors" under Wisconsin’s conflict of laws rules, the court held that Wisconsin’s law applied.
Design defect claim. The patient asserted a strict liability design defect claim. Bard responded with several defenses, which the court considered. The first defense Bard raised was that the device was presumed to be non-defective because Bard complied with the Food and Drug Administration’s (FDA) 510(k) review process. But the court rejected this defense, holding that the 510(k) process is a clearance process focused on equivalence, not safety. The FDA does not make a determination that the device is safe or approve it during the 510(k) process, it merely finds that the product is substantially equivalent to a previous device.
Bard also claimed that the complications associated with IVC filters, like migration, fracture, and perforations, are inherent characteristics of the device and well known. The court rejected this defense as well, holding that the patient raised issues of fact that showed that Bard’s filters have a higher rate of adverse events than others and those increased risks were not known.
Lastly, Bard raised the defense that the plaintiff did not show that an alternative design or warning could have reduced or avoided injury. The court, in rejecting this contention, held that the patient provided expert testimony that showed specific and reasonable design changes were available when Bard developed the G2X filter. The patient offered enough evidence to survive summary judgment.
Failure to warn claims. The patient asserted both strict liability and negligent failure to warn claims. Because the patient did not present any evidence that an inadequate warning caused her injuries, the court determined that she could not satisfy the element of causation as required by Wisconsin law. The doctor who implanted the device into the patient testified that he trusted the FDA more than individual companies, and because the devices were meeting the FDA’s expectations, he had no issue with using the devices. The patient failed to provide any testimony or other evidence that an enhanced warning would have affected the doctor’s decision to use the G2X filter. Therefore, the court granted Bard’s motion for summary judgment on the failure to warn claims.
Other claims. The court ruled that the patient’s misrepresentation and fraud claims failed for lack of reliance and causation. The patient’s manufacturing defect and breach of express warranty claims were dismissed because the patient withdrew them before the manufacturer moved for summary judgment.
The case is No. 2:15-md-02641-DGC.
Companies: C.R. Bard, Inc.; Bard Peripheral Vascular, Inc.
MainStory: TopStory DesignManufacturingNews WarningsNews DefensesLiabilityNews MedicalDevicesNews ArizonaNews WisconsinNews NevadaNews
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