St. Louis, MODoes a win by Cook Medical in a recent bellwether IVC filter lawsuit, together with the release of a study suggesting that IVC filter use is beginning to trend downwards after thirty years of growth, point to the beginning of a sea change for the inferior vena cava filter industry, and IVC filter patients?
Earlier this month MedPage Today (11/07/17) reported on the findings of a study conducted by David Brown, MD and colleagues (and published in JAMA Internal Medicine) that suggests the placement of inferior vena cava filters have been on the decline since hitting a peak in 2010.
That peak – and the resulting drop – coincides with a warning issued by the US Food and Drug Administration (FDA) in 2010 against use of IVC filters as a long-term strategy against problematic blood clots.
IVC filters were originally designed as an alternative to blood thinners – especially for patients who had trouble tolerating anticoagulants. The IVC filter is a spider-like device physically implanted in the inferior vena cava, the primary artery returning deoxygenated blood from the legs and lower extremities up to the heart and lungs. Blood clots often form in the lower extremities, and were they to become dislodged and travel up the inferior vena cava to the lungs, grievous health consequences can result.
Thus, the IVC filter is designed to ‘catch’ a migrating blood clot in its spines. Originally designed as a more permanent hedge against blood clots, various problems with some models of IVC filter – including those manufactured by C.R. Bard and Cook Medical Inc. – prompted concern with the FDA as reports to its Adverse Events Reporting System (AERS) revealed struts pushing through the inferior vena cava wall, or struts and spines breaking away and migrating up to the heart and lungs. In some cases IVC filter migration has occurred from the original point of insertion, endangering the patient and contributing to an IVC pulmonary embolism.
Many an IVC filter lawsuit has resulted from the problem. Seven years ago, in 2010 the FDA asserted that while use of IVC filters was still considered to be relatively safe and effective (with the benefit outweighing the risk for the intended cohort of patients), they should be considered as a temporary hedge against blood clots, with removal as soon as reasonably possible once the primary danger of blood clot has passed. That said, the FDA came up with an outside window of about six weeks. “For patients with retrievable IVC filters in whom the transient risk of PE has passed, quantitative decision analysis suggests the benefit/risk profile begins to favor filter removal between 29 and 54 days after implantation,” the FDA said.
Translation: the risk of IVC filter failure increases for every day the filter remains in place beyond 54 days.
The problem: for many patients, the IVC filter is not removed – either due to a lack of follow-up, or the degree of difficulty involved in attempting to remove them. IVC filters are a lot easier to implant, than remove. In some cases, attempts to remove an IVC filter have failed, leaving the patient to deal with a ticking time bomb.
For patients with problematic blood clots – and those who absolutely cannot tolerate blood thinners due to the bleeding risk – the IVC filter is the only option, and there has been no suggestion of banning the devices from the market. However, for the general population it appears as if doctors, since 2010, have begun to view the IVC filter as more trouble than they’re worth. If their use can be avoided for the benefit of the patient, so much the better.
But it is the FDA warning in 2010 that appears to have reversed a 31-year trend of increased use, notes study author Brown of Washington University School of Medicine in St. Louis. With rates of venous thromboembolism (VTE) continuing to be consistent, the drop in IVC filter use since 2010 is not based on shifting indications.
Brown and colleagues noted that according to National Inpatient Sample data, the rate per 100,000 hospitalizations rose from 322.1 in 2005 to 412.0 in 2010, before steadily declining down to 374.1 in 2011 and 321.8 in 2014.
Brown and colleague’s conclusions mirror those of another study that also identified a decline in use, also attributing the decline to the FDA warning on IVC filters.
The reversal of the upward trend in IVC filter use and subsequent decline in implantations does not negate the continued difficulty that patients have been encountering with IVC filters, and lawsuits are continuing to be filed naming – amongst other products – the Bard G2 IVC filter and IVC filters manufactured by Cook Medical. Lawsuits against both manufacturers are consolidated in separate multidistrict litigation files.
Cook Medical, meanwhile, recently came out on top at the conclusion of a bellwether case. In Hill v. Cook Medical Inc. et al., Case No. 1:14-cv-06016, one of several bellwether cases housed in US District Court for the Southern District of Indiana for Cook Medical, a federal jury on November 9 cleared the defendant of liability. The case was the first bellwether trial in the Cook Medical MDL (In re: Cook Medical Inc., Case No. 1:14-ml-02570).
The Reuters News Agency (11/10/17) reports the jury found Cook Medical did not defectively design the IVC filter Hill used, alleged to have caused her injuries. The defective design argument was the lone, remaining complaint asserted by the Florida plaintiff to stand once the bellwether case made it to trial.
Law360 (05/17/17) reported back in May that prior to the bellwether trial Cook Medical won partial dismissal of Elizabeth Hill’s IVC lawsuit based on Hill’s claims of negligence under the federal Food, Drug and Cosmetic Act (FDCA). Cook Medical asserted that wording entrenched in the FDCA requires that all enforcement actions under the FDCA, or associated with FDA rules, must be made by, and in the name of the federal government.
US District Judge Richard L. Young agreed with the defendant, and dismissed negligence claims by bellwether plaintiff Hill based on the FDCA.
Thus, Hill went to trial with only the defective design claim. But it didn’t hold up in front of the jury.
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