Hoping to minimize her risk of suffering serious complications from future blood clots, plaintiff Natalie Johnson underwent surgery to implant a retrievable intravascular filter. Intravascular filters are medical devices that are placed in the inferior vena cava (the major lower vein that carries blood to the heart) to prevent blood clots that develop in the lower body from flowing into the heart and lungs.
Johnson’s doctor selected the Meridian filter, which was supposed to be temporary and easily removeable. It was not. Instead, Johnson’s filter migrated and fractured, leaving shards embedded in the wall of her heart and elsewhere. Her surgeon was unable to remove the device safely and fully. She now faces an ongoing risk of infection, pain, and other complications as a result of the broken filter.
Johnson sued the manufacturers of the Meridian filter—C.R. Bard, Inc., and Bard Peripheral, Inc. (together, “Bard”)—
claiming that they defectively designed the Meridian filter and failed to warn medical providers about the device’s risks, in violation of Wisconsin law. The jury returned a verdict for Bard on both of the defective-design theories and on the negligent failure-to-warn theory, but it returned a $3.3 million verdict for Johnson on the strict liability failure-to-warn theory, finding that the “foreseeable risks of harm posed by the [Meridian filter] could have been reduced or avoided by the provision of reasonable instructions or warnings by [Bard] and the omission of the instructions or warnings render[ed] the [Meridian filter] not reasonably safe.” Wis. Stat. § 895.047(a). Bard moved for a new trial on a host of issues, but the district court denied the motion. Bard appealed.
The United States Court of Appeals for the Seventh Circuit (“Federal Appellate Court”) held in its August 11, 2023 decision, in part: “The district court in the present case concluded that the line of substantial-equivalence findings that Bard’s filter depended on did not demonstrate compliance with relevant federal safety standards. We agree with this reasoning. Bard did not show that the 510(k) clearance of its Meridian filter was based on the FDA’s determination that it complied with any specific safety standards, rather than its similarity to previously approved devices.”
“We conclude that the district court did not err in holding that the evidence that Bard proffered regarding its 510(k) clearance was insufficient to show that it materially complied with relevant federal safety standards. Therefore, the district court did not err by refusing to instruct the jury that there was a rebuttable presumption that the Meridian filter was not defective for failure to warn.”
Source Natalie Johnson v. C.R. Bard, Inc., No. 22-2610.
If you or a loved one were seriously injured (or worse) due to an intravascular filter, you should promptly find a defective medical device claim lawyer who may investigate your intravascular filter claim for you or your loved one and represent you or your loved one in a claim for compensation due to the harm suffered as a result of an intravascular filter, if appropriate.
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