Judge Refuses to Seal Documents from Bard IVC Filter Lawsuit Following Settlement

As a growing number of Bard G2 IVC filter lawsuits and Bard Recovery IVC filter lawsuits continue to be filed in courts throughout the country, a federal judge indicates that the manufacturer is unable to seal documents that were part of a prior case settled.

In an order (PDF) issued on June 1, U.S. District Judge Robert C. Jones denied a motion filed by C.R. Bard to seal certain trial exhibits and portions of the trial transcript in a lawsuit brought by Kevin Phillips, which settled during trial.

Judge Jones indicated that the public has the right to see records generated from the case, rejecting Bard’s attempt to keep confidential certain records involving the product design and testing, including communications between the manufacturer and the FDA, as well as sales and marketing information and internal quality control measures. The manufacturer also wanted to seal records on how it responded to adverse events involving their controversial inferior vena cava (IVC) filters, what corrective actions it took and device tracking procedures.

Phillips raised similar allegations to those being brought by dozens of individuals throughout the U.S., who indicate that the small filters failed after they were inserted into the inferior vena cava to catch blood clots, preventing them from travelling to the lungs and causing a pulmonary embolism. The retrievable filters have been linked to reports of problems where the legs or struts broke, punctured the vena cava or moved to other areas of the body.

In the decision not to seal the records from the Phillips lawsuit, Judge Jones said the company failed to provide a compelling reason to do so, indicating that the fact that the documents may lead to additional claims was not sufficient justification for withholding the records from the public.

“The only harm that could come to Defendants [from] the release of this information is the precipitation of further lawsuits against it,” Judge Jones wrote. “Preventing lawsuits due to the release of inculpating information is not a compelling reason to seal otherwise public legal proceedings. Indeed, the exposure of facts relevant to the material claims in a lawsuit is the purpose of a trial, and these facts should remain public unless the harm likely to result from their release is unrelated to the nature of the claims.”

Judge Jones also noted that Bard did not object to many of the same records being made public in an earlier trial.

Bard IVC Filter Complications

The decision may have an impact on the growing number of product liability lawsuits being filed by individuals who experienced complications from IVC filters.

Concerns over the safety and effectiveness of removable IVC filters like the Bard G2 and Bard Recovery have been a subject of much debate within the medical community in recent years, with a large number of reports involving severe and sometimes fatal complications.

In August 2010, the FDA issued an alert about the risk of problems with removable IVC filters, indicating that the agency had received more than 900 adverse event reports. Of those reports, 328 involved the IVC filter breaking free and migrating through the body, 146 involved  components breaking loose, 70 involved the inferior vena cava being perforated and 56 involved the filter fracturing.

The FDA recommended that doctors remove the filters once the danger of the clot has passed, to reduce the risk of the filters breaking free and traveling through the body.

In April 2012, a study published in the medical journal Cardiovascular Interventional Radiology indicated that nearly 100% of Cook Celect and Gunther Tulip IVC filters perforated patients’ venal cava wall within 71 days of being implanted. The study also found that 40% of the filters became tilted and out of position.

A study published in the medical journal JAMA Internal Medicine in March 2013 raised questions about the effectiveness of IVC filters, indicating that less than 10% of filters evaluated in the study were successfully removed from patients and 8% of recipients of IVC filters suffered a pulmonary embolism despite the device’s presence.

In May 2014, the FDA urged doctors to remove IVC filters within about one to two months after the risk of a pulmonary embolism has passed, suggesting that many doctors were not adequately warned about the importance of retrieving the devices.

Mounting Lawsuits Over Bard IVC Filters

Over the past three years, Bard has reportedly reached confidential IVC filter settlements in some individual cases, often as trial was about to begin or underway. However, following a failure to reach widespread agreements to resolve large numbers of other cases, the rate of complaints being filed has increased recently.

To avoid the potential for such contradictory rulings in different cases pending throughout the federal court system, a group of plaintiffs petitioned the U.S. Judicial Panel on Multidistrict Litigation (JPML) last month to centralize all Bard IVC filter lawsuits before one judge as part of an MDL, or multidistrict litigation.

Centralizing the litigation before one judge is designed to reduce duplicative discovery into common issues, avoid conflicting rulings from different judges and to serve the convenience of the parties, witnesses and the courts.

In a response filed on June 9, C.R. Bard opposed the request, indicating that the litigation is unlike typical product liability proceedings brought before the JPML, since many cases have been resolved and the litigation is very mature.

Bard indicates that it is not appropriate to establish coordinated proceedings in the federal court system, arguing that centralizing the IVC filter litigation as part of an MDL will delay the resolution of cases underway and result in the filing of unsubstantiated claims.

The U.S. Judicial Panel on Multidistrict Litigation (JPML) is scheduled to hear oral arguments on the motion during an upcoming hearing session in San Francisco, California, on July 30.

In October 2014, the U.S. JPML granted a similar request to centralize all Cook Celect and Gunther Tulip filter lawsuits, which raised nearly identical allegations involving these competing brands of IVC filters. The Cook IVC filter litigation was centralized before U.S. District Judge Richard L. Young in the Southern District of Indiana.