As consumers and patients, we rely on the honesty and integrity of the companies we buy products from. The Golden Rule dictates to most ethical people that you treat others as you would like to be treated.
What’s interesting about lawsuits is you sometimes get to peek into the underbelly of what companies would rather you not know. It’s not a pretty picture.
The Lehman Report is one of those studies that IVC filter maker, C.R. Bard, would rather keep secret.
The Lehman report is so named because Bard hired an independent contractor, Dr. John Lehmann, MD and MPH, to prepare a report about its IVC filters.
IVC filters are so named because they are placed in the inferior vena cava (IVC), the main artery in the body which brings oxygen-rich blood from the lower half of the body to the lungs. Doctors will place an IVC filter when they want to stop the potential flow of a blood clot before it reaches the lungs or heart and causes a pulmonary embolism.
The first Bard IVC filter was the Recovery and it was launched finally in 2003 after initially being denied for approval by the FDA the year before. The Recovery had problems. The spindly, fragile legs of the filter would break off or fracture. Struts, as these fragments are called, had the potential to migrate in the artery and land in precarious places, like the heart and lung or to pierce the IVC.
The company was trying to understand why patients and their doctors were reporting complications to Bard and to the Food and Drug Administration’s MAUDE database (Manufacturer and User Facility Device Experience Database) which is supposed to track medical device complications occurring in the real world.
To compile his report, Dr. Lehman gathered complication reports coming into the FDA from January 2000 to September 2004. Specifically, he was looking at the Bard Recovery IVC filter as it compared to complications reports from vena cava filters manufactured by other companies.
The Lehman report concluded 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 vena cava filters (VCF) 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 caval perforation (perforation of the vena cava wall) 3.8 times higher than all other VCFs.
Dr. Lehmann found Recovery had a four times higher reporting rate for filter movement compared with all other VCFs and a 2.6 times higher rate when compared to other retrievable VCFs.
As far as filter embolization (emboli or strut fragment), 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.
In a memo retrieved during discovery, Bard acknowledged that Recovery was the least able among the IVC filters to “resist migration,” another word for having it travel inside the body where it can pierce the heart muscle or other organs.
When considering the relative risk of death and other adverse events, Dr. Lehman concluded that “further investigation of the Recovery VCF filter (vena cava filter) performance in relation to migration and fracture is urgently warranted. Given the multiple known flaws in the data available, this analysis is insufficient to demonstrate conclusively that any of the VCFs analyzed presents an excess risk.”
This was in 2004. Instead of investigating further, as their own consultant suggested, Bard continued to sell 34,000 more units of Recovery and modified it slightly before introducing the G2 IVC filter.
Today the Recovery filter is associated with 27 deaths, some that no doubt could have been averted if Bard took this red flag seriously and suspended sales of Recovery.
In fact, the company didn’t learn from its mistakes. It launched the G2 when it stopped selling Recovery. This was supposed to be new and improved.
Four months after its 2005 launch, the G2 also was malfunctioning, fracturing and migrating in the body. That didn’t stop Bard. The company continued with G2 and the slightly modified G2 Express, selling 160,000 of these units between 2005 and 2010.
In 2010, the Food and Drug Administration blamed Recovery and G2 for 900 adverse events.
Recovery, and eventually its successor, G2, were eventually taken off the market.
Bard decided to keep the Lehmann document a secret instead of informing doctors who then can inform their patients, part of true informed consent.
We recently learned about its existence from a series of reports done by NBC News. The reporter got hold of the Lehmann report and made its contents public. The report had accidently been included in a 2012 lawsuit but Bard wanted it returned and a protective order requesting the Lehmann report be destroyed.
The U.S. District Court of Nevada allowed the Lehmann report to be used in another product liability case and denied Bard’s request the document be returned.
This was not the first indication Bard had of troubles with its filters.
In 2002, the company tried to have its Recovery filter approved by the FDA, but the application was denied. Bard hired a regulatory specialist, Kay Fuller, who wanted to see more company research before she put her stamp of approval on a new application to the FDA, but Bard would not comply with her request.
In fact, she was told if she kept asking, she would be off the team.
NBC News retrieved the application for the Bard Recovery IVC that had Kay Fuller’s signature on the application. She told NBC she never signed that document. The implication is that someone else had, someone who wanted to get Recovery on the market.