Ottawa, ONWe’re coming up to the one-year anniversary that Health Canada, the Canadian equivalent to the US Food and Drug Administration (FDA), released a guidance review and summaries pertaining to in-depth analysis of the inferior vena cava filter landscape in America’s northern-most neighbor. Akin to the FDA, Health Canada maintains concern for the length of time retrievable filters are left in place.
Over the years the IVC filter has evolved from a primarily permanent device, to one that is designed to be inserted in order to ward against deep vein thrombosis (DVT) and IVC filter pulmonary embolism (PE). While DVT and PE can also be treated with anti-coagulant drugs (blood thinners), not all patients can tolerate blood-thinning medications. While use of an inferior vena cava filter can be a greater risk than blood thinners (especially if the IVC filter is left in too long), the risk is less than leaving a potentially deadly condition untreated. In this way the benefit outweighs the risk – but the risk is palpable nonetheless.
The use of IVC filters, a spider-like device placed into the inferior vena cava artery to entrap blood clots migrating up from the lower extremities before they have a chance to reach the heart or lungs, have swung with increasing frequency to the retrievable filter. However, a host of reports associated with IVC filter side effects have prompted both the FDA and Health Canada to release guidance on device removal, and timelines.
Leaving an IVC filter in for too long can result in compelling, and grievous consequences. Health Canada, in guidance posted July 25 of last year, included in a list of serious consequences “caval perforation, caval thrombosis, filter fracture and fragment embolization, intracardiac migration, cardiac perforation, cardiac tamponade, and death.”
The small, thin tines on the spider-like device have been known to pierce the arterial wall. In other cases, as Health Canada has alluded, the structure of the IVC filter has failed, with fragments breaking away from the device and migrating to internal organs, such as the heart and lungs. In rare cases the entire device has dislodged and migrated along the inferior vena cava, to sometimes disastrous consequences resulting from IVC filter migration.
The Canadian regulator holds that retrievable filters should be removed as soon as risk for blood clot, DVT and PE has passed – optimally at 30 days following insertion, or as soon after the thirty-day mark as is conceivably possible.
“Many of [the above-noted] complications occurred with long-term (greater than 30 days) filter implantation,” Health Canada says.
Amongst the devices referenced in the Health Canada guidance is the Bard G2 IVC filter, a device that was introduced to replace a previously-available product that was alleged to have design defects, but was never formally recalled. There was no IVC filter recall, and given the prevailing belief that the Bard G2 filter is not much better than the product it was designed to replace, many an IVC filter lawsuit has been fought alleging IVC filter side effects. Plaintiffs assert that inferior vena cava filter manufacturers – C.R. Bard and Cook Medical Inc. among them – knew about deficiencies and design flaws with their IVC filters but failed to alert consumers in a timely manner and allowed defective products into the market.
The Cook Celect Platinum Vena Cava Filter System and Cook Medical Vena Cava Filter are two other products identified by Health Canada as remaining under the microscope of the Canadian regulator.
“As of June 6, 2016, Health Canada has received 121 incident reports of serious complications associated with IVC filters,” Health Canada says. “These complications have also been reported internationally.”
Such complication continues to result in IVC lawsuits. A few of the more recent actions are David Hornback et al v. Cook Medical, Inc. IVC Filters Marketing ET AL, et al, Case No. 1:17-cv-01304 filed April 25th, and Donna Walters v. Cook Medical, LLC et al, Case No. 1:17-cv-01305, also filed April 25th in US District Court, Southern District of Indiana.
There are also a plethora of IVC filter lawsuits against C.R. Bard in the judicial pipeline, harbored within multidistrict litigation.
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