Written by Rick Busby for Provost Umphrey
As 2015 ends, plaintiffs in the IVC Filter lawsuits against medical devices giant C.R. Bard will likely look back on the year as one of progress. In February 2015, attorneys for C.R. Bard, one of the two medical devices giants at the center of hundreds of lawsuits involving failed IVC Filters, settled a Nevada lawsuit with plaintiff Kevin Phillips after only ten days of trial. The settlement signaled an apparent trend and legal strategy for Bard to settle cases, but only after they have gone to trial.
By midyear, there were hundreds of active lawsuits against C.R. Bard scattered about the nation. Coupled with nearly 100 active suits against competitor Cook Medical for similar failures of their IVC Filter products, the collective weight of the lawsuits threaten to mire the judicial system in a tangle of suits that would take years to unravel at great expense.
As 2015 progressed, many of the suits began to be consolidated into Multi-District Litigations with some reportedly attempting to gain Class Action status. With the vast majority of the suits beginning as single plaintiff pleadings, it will still take a while to sort through, litigate through trial and/or settle the suits along the way. With Bard attorneys apparently demonstrating a tendency to settle after a case actually goes to trial, consolidating cases into MDLs makes great sense in terms of efficiently administrating the legal morass the suits have become. Still, plaintiffs should remain cautious in their optimism. There is still a long way to go.
NBC Nightly News Reveals Findings of Year-Long Investigation of C.R. Bard
If network media attention still wields influence in the outcomes of the course of events, plaintiff suits may yet see an extra boost of momentum from a high profile NBC Nightly News exposé of Bard that aired in September 2015. Over two successive evenings, NBC Nightly News broadcast the findings of its year-long investigation into the C.R Bard Recovery IVC Filter. The in depth investigative feature raised serious concerns over Bard’s alleged mismanagement, negligence and deception in the research, development, manufacturing and marketing of its Recovery and G2 IVC Filters.
The NBC investigation thoughtfully disclosed many of the important facts surrounding the case, including the controversial Lehmann Report, which is sure to remain a contentious piece of evidence moving forward, and also revealed that Bard may have forged the signature of a prominent FDA consultant on one of the applications for FDA approval of its Recovery IVC Filter.
In part one of the two-part investigative series, NBC reported that more than 300 adverse events have been connected to the Recovery IVC Filter device. Of those events, NBC revealed that at least 27 resulted in fatality. At the center of NBC’s revelations was the disclosure of the confidential study commissioned by C.R. Bard in 2004. The study, known as the Lehmann Report, was commissioned by Bard when it first began receiving complaints on the Bard Recovery IVC Filter less than one year after its first uses.
Bard had received complaints alleging that the legs of the IVC filter device were prone to break off from the device and then migrate through the body, perforating interior venal walls in the inferior vena cava making patients susceptible to cardiac events. The Lehmann Report did indeed conclude that the Bard Recovery IVC filter appeared to be connected to higher rates of fracture, migration, and even death compared to devices manufactured by Bard’s competitors. Dr. John Lehmann, the author of the report, advised Bard executives that "further investigation" into the safety of the Recovery IVC Filter was "urgently warranted."
Despite Lehmann’s warning, C.R. Bard chose not to recall the product. Sales of the Recovery IVC Filter continued for nearly three more years. During that span, Bard allegedly sold approximately 34,000 additional Recovery filters before a modified version, the Bard G2, was brought to market. The Lehmann Report evidences that Bard executives knew of the dangers with the Recovery IVC Filter, yet continued to market and sell them while they readied a replacement to go to market. In effect, Bard ignored the dangers to potential users because of the potential negative impact a voluntary recall would have on Bard’s bottom line.
While the Lehmann Report appears to be the smoking gun any plaintiff’s attorney would desire, Bard attorneys are doing their best to suppress use of the report as evidence at trial. Bard’s claims for privilege rest on exempting and protecting the report under “work product” doctrines. However, it has already been allowed in at least one California case, Giordano v. Bard, in which a California state court denied Bard’s motion to return or destroy the documents. Subsequently, the U.S. District Court of Nevada tightened up the California Court’s decision and restricted the use of the report in any other case beyond Giordano v. Bard.
Since then, a number of court rulings have reached conflicting conclusions that leaves in doubt whether the Lehmann Report will ultimately be exempted and protected under the work-product doctrine or allowed into evidence in a broader sense. Clearly Bard attorneys will continue to press for work-product protection, while plaintiff’s attorneys will be fighting hard to use it. Regardless of the outcome, the Lehmann Report will continue to make news as the suits progress.
NBC Report Alleges Forgery By Bard On FDA Application
While the Lehmann Report had been making news with lawyers, plaintiffs and observers of the cases, NBC’s investigative report did bring to mainstream attention a lesser known piece of potential evidence that, if true, could place Bard executives in jeopardy of potential criminal charges. The network news investigative feature disclosed that Bard may have known about the risks posed by potential defects in the device well before the Lehmann Report and even before it had gained FDA approval.
The story goes back to 2002, when Bard’s initial application to the FDA was denied. In order to address the issues and get the Recovery IVC Filter back on track for FDA clearance, Bard retained the services of a regulatory specialist named Kay Fuller. After Fuller took on the consultancy, she became concerned after early findings in clinical trials revealed doubts about the device’s safety. When Bard apparently brushed off her concerns, Fuller refused to further support Bard’s efforts to gain FDA approval to market the device and resigned the consultancy.
For its part, Bard apparently moved forward with its plans for the Recovery IVC Filter and submitted another application for clearance. The NBC report revealed that at least one signature on the FDA application appeared to evidence Kay Fuller’s signature. In an on camera interview with NBC Nightly News, Fuller flatly denied the signature was hers and stated that it was included without her knowledge or consent. If this allegation ultimately proves true, Bard executives could potentially find themselves on the wrong end of criminal charges, including possible fraud, forgery and even perjury before this all plays out.
The effect of these allegations, if any, on the outcomes of active suits remains to be seen, but, the year 2016 promises to be a year of further revelations. Hopefully, it will also see long suffering IVC Filter patients find relief.