Bard Opposes Centralization for IVC Filter Litigation

In response to a recent motion filed to establish consolidated pretrial proceedings for all federal Bard IVC filter lawsuits, the manufacturer indicates that it is opposed to centralizing the cases before one judge, suggesting that the litigation is already at a very mature stage.

Last month, a group of plaintiffs filed a motion to centralize the Bard IVC filter litigation as part of a federal MDL, or multidistrict litigation.

Plaintiffs argue that coordinated pretrial proceedings are justified since there are currently at least 25 different Bard Recovery filter lawsuits and Bard G2 filter lawsuits pending in 23 different U.S. District Courts over problems with the retrievable inferior vena cava (IVC) filters. In addition, hundreds of additional complaints are expected to be filed in the coming weeks and months.

All of the complaints involve similar allegations that the small filters, which are implanted into the inferior vena cava to prevent blood clots from reaching the lungs, are defectively designed and unreasonably dangerous. Plaintiffs claim that they suffered various injuries when the legs or struts broke, punctured the vena cava or otherwise failed.

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 (PDF) filed on June 9, C.R. Bard opposed the request, indicating that the litigation is unlike typical product liability proceedings brought before the U.S. Judicial Panel on Multidistrict Litigation (JPML), and that it is not appropriate to establish coordinated proceedings in the federal court system.

Bard has been defending the IVC filter litigation for the last ten years, and indicates that it has settled, obtained dismissals or defense verdicts in at least 121 cases filed in state and federal courts throughout the country.

“This litigation is extremely mature,” wrote the manufacturer in the response. “In the past decade, the plaintiffs have obtained extensive common discovery concerning all aspects of Bard’s IVC filters, including the design, testing, manufacturing, marketing, labeling and post-marketing surveillance of these devices. Bard has produced over 2.5 million pages of documents. Bard has responded to thousands of written discovery requests. Over 80 corporate witness depositions have been taken. Moreover, Bard has repeatedly agreed to make common discovery available to plaintiffs filing new IVC filter cases, and Bard intends to continue to do so for future cases.”

Bard argues 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.

IVC Filter Complications

Concerns over the safety and effectiveness of removable IVC filters have been a subject of much debate within the medical community in recent years, with several different types of filters manufactured by C.R. Bard, Cook and other companies linked to reports of 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.

Over the past three years, Bard has reportedly reached confidential settlements in individual cases, often as trial was about to begin or underway. In recent months, the number of new cases filed throughout the federal court system have increased, as plaintiffs indicate that no progress has been made to reach a large Bard IVC filter settlement.