Manufacturer Negligence and Failure to Warn Public of Known Risks
The medical device manufacturer, C.R. Bard of Murray Hill, New Jersey, is fighting bad publicity from media reports that it knew about problems with its blood clot filters but continued selling them to the unsuspecting public.
The series of reports on NBC News raise serious questions about what Bard knew about the risks of its IVC filters, whether the company was negligent in putting defective products on the market and whether Bard should have issued a recall rather than keep right on selling the problematic blood filters for profit.
Since these actions resulted in deaths and permanent injuries, it raises questions about the ethics of Bard and whether it puts profits over patients.
NBC News broadcast a series of stories at the end of 2015 after obtaining internal company documents. Bard was the manufacturer of the Recovery IVC blood clot filter. The IVC stands for inferior vena cava, the largest vein in the body that delivers blood from the lower extremities to the heart or lung. Unfortunately when a blood clot is in the mix, it can cause a pulmonary embolism or heart attack.
The Recovery is put in the inferior vena cava, with its daddy long legs spider-like extremities dangling below a basket top designed to trap any blood clots that could be fatal if they reach the heart and lungs.
Bard told NBC that its filters go through testing and are in compliance with federal law and the U.S. Food and Drug Administration (FDA) before they are ever sold. Patients are carefully selected for implantation by doctors and only those are chosen for whom the benefits outweigh the risk.
That is what the company says which is a far different picture from what it did.
The Recovery was just one model of the IVC filter. A confidential study commissioned for Bard showed Recovery had resulted in 27 fatalities in the one year it was on the market. The deaths were blamed on the IVC filter’s migration, fracturing and perforating and detaching device components.
Bard continued to sell Recovery despite the fact it had noted a statistically significant rate of death reports related to filter movement and filter embolization. Bard sold 34,000 Recovery IVC filters until it created the replacement, the G2.
It was designed to be a new and improved model that was launched on the market in 2005. Between 2005 and 2010 the company sold 160,000 G2 units.
Neither one met its promises. In fact, four months after the G2 made it to market, it too showed an unusually high failure rate and the company was concerned. There are 12 deaths associated with G2, according to the FDA.
Both Recovery and the G2 are now off the market. Neither was recalled.
Not only did the internal company report raise questions of corporate negligence, but there are real questions whether the Recovery ever met safety and efficacy goals. We know this because of how it made it to market.
In a follow up story, NBC reports that Bard knew it had a problem with the FDA in convincing the agency the Recovery was safe and effective. Initially, Bard was denied FDA approval for Recovery. This was around 2002 during its first application to the agency. A small clinical trial had raised some questions about the Recovery and its safety for patients.
So the company hired Kay Fuller, a regulatory specialist, to try and get FDA approval. Fuller told NBC that she asked for safety performance results on the Recovery. She grew concerned when company failed to give her results. They told her to if you continue to pursue these questions you would be asked not to be on the team. She said she would not sign the FDA application until her concerns were addressed. But Ms. Fuller’s signature appears on the application to the FDA, pointed out the reporter. “I did not sign it,” Fuller said.
Fuller resigned from the company but reported her concerns to the FDA. The implication is clearly that her signature was forged by company officials who had the most to gain.
Another red flag was seen in the Lehman report issued December 15, 2004, written by John Lehman, MD and MPH. Bard wanted to understand why the Recovery was receiving adverse events reported to the FDA and its MAUDE database (Manufacturer and User Facility Device Experience Database), the place citizens and doctors are supposed to report problems with medical devices. Lehman looked back to adverse event reports starting in January, 2000 and ending in September 2004. The report compared the Bard Recovery with other vena cava filters.
The Lehman report concludes the Recovery filter “has relatively high reporting rates of total death, filter movement, filter embolization and filter embolization death reporting.” Specifically Recovery had an adverse event reporting rate almost twice as high as other VCFs combined.
Its rate of filter fracture was 5.6 times higher than all other VCFs and 13.6 times as high as other retrievable VCFs. Recovery had a rate of vena cava perforation 3.8 times higher than all other VCFs. Recovery had a four times higher reporting rate for filter movement compared with all other VCFs and 2.6 times higher rate when compared to other retrievable VCFs. Recovery had a three times higher reporting rate for filter embolization compared with all other VCFs. Recovery had an 11.5 times higher reporting rate for filter embolization deaths compared with all other VCFs.
When considering the relative risk of death and other adverse events, Lehman concluded that “further investigation of the Recovery VCF filter (vena cava filter) performance in relation to migration and fracture is urgently warranted.”
The report urged an analysis of the design of all VCFs.
This was in 2004. Bard continued to sell 34,000 more units of Recovery and modified it slightly before introducing the G2 IVC filter. But four months after its 2005 launch, the G2 also was malfunctioning. The spindly device would fracture and migrate. It would break inside the major vein where it was difficult if not impossible to retrieve.
That didn’t stop Bard. The company continued to sell G2 and the slightly modified G2 Express. The company reports it sold 160,000 of these units between 2005 and 2010.
In 2010, the Food and Drug Administration attributed Recovery and G2 with 900 adverse events. The agency recommended the filters be removed and not left in the body permanently. However, the Journal of the American Medical Association reports only one in ten cases has led to an IVC removal.
The longer an IVC filter remains in the body, the more complications it potentially can cause.
Recovery is now blamed for at least 27 deaths and 300 injuries. Bard, knowing it has a problem, hired a public relations company to fix any damage to its reputation that could cause its stock price to fall. That move does nothing for the patients walking about with these IVC filters in their body.
Product liability or defective product lawsuits are being consolidated in multidistrict litigation located in the Southern District of Indiana for IVC maker Cook, and in Arizona for C.R. Bard.
The two companies at the center of litigation will be facing claims of negligence in these product liability or defective product lawsuits. In other words, Plaintiffs claim the companies were reckless and careless in bringing the IVC filters to market and in letting them remain on the market.
Other charges include a failure to warn doctors, manufacturing and design defects, a breach of implied warranty and negligent misrepresentation if the plaintiffs can show enough evidence to the jury that the company could have done more to avoid these deaths and injuries resulting from their problematic IVC filters.