Judge Blocks Juries From Hearing About IVC Filter Problems in Bard PowerPort Trials

According to a pretrial order, attorneys are only allowed to present evidence about prior Bard IVC filter problems if the manufacturer claims it has not been targeted by enforcement actions over failure to report adverse events.

A federal judge has ruled that plaintiffs involved in Bard PowerPort lawsuits cannot present evidence at trial about prior adverse event reporting violations tied to the company’s inferior vena cava (IVC) filters, rejecting an argument that the conduct is relevant to claims involving a different product line.

The dispute centers on plaintiffs’ efforts to show that Bard engaged in a broader pattern of failing to properly report device-related complications to regulators. Attorneys had argued that the company’s handling of adverse event reporting for its IVC filters, which have been the subject of separate litigation for years, helps demonstrate that Bard may have similarly withheld or underreported safety issues involving its PowerPort catheter devices.

The Bard Powerport is a type of port catheter used to deliver medications and other fluids into patients repeatedly, without the need for a new needlestick each time. They consist of a small injection port where the needle is inserted and a polyurethane catheter that delivers the fluid into the vein. However, despite Bard’s version of the port catheters being marketed as safe and effective, a growing number of individuals say it is actually defectively designed, increasing the risk of port catheter infections, fractures and migration injuries.

Becton Dickinson and its C.R. Bard subsidiary currently face more than 3,000 product liability lawsuits, alleging that they knew about these problems, yet failed to correct issues with the design or warn the medical community and patients about the potential for additional complications that could result in pulmonary embolism, blood clots, infections and the need for additional surgeries to remove the failed implants.

Plaintiffs blame the use of barium sulfate in the construction of the catheters for their premature breakdown, cracks, fracturing and failures.

All federal Bard PowerPort lawsuits are currently consolidated in the District of Arizona before Judge David G. Campbell for coordinated discovery and pretrial proceedings as part of a multidistrict litigation (MDL).

The court has been working with attorneys for months to prepare a series of six bellwether trials, which are intended to test key arguments likely to be repeated across thousands of cases. The first trial, involving claims by Robert Cook of Minnesota, is scheduled to begin April 21, with a final pretrial conference set for this week.

Judge Restricts IVC Filter Warning Letter Testimony

As part of preparations for the Cook trial, plaintiffs sought to introduce a July 2015 warning letter issued by the U.S. Food and Drug Administration (FDA) to Bard over its handling of adverse event reports and product complaints involving its IVC filters.

Those filters have been the subject of thousands of Bard IVC filter lawsuits in recent years, with plaintiffs alleging the devices were defectively designed and prone to fracture, migrate or perforate the vena cava. In some cases, fragments have reportedly broken off and traveled to the heart or lungs, causing the very complications the devices were intended to prevent.

Relying on that history, PowerPort plaintiffs argue the FDA warning letter is relevant not because it involves the same product, but because it may show a broader pattern of failing to properly report safety issues to regulators, which they claim also occurred with the PowerPort.

However, Judge Campbell rejected that argument in a court order (PDF) issued April 6, ruling that the IVC filter warning letter could not be used to suggest misconduct related to a different product line. The decision limits plaintiffs from drawing that connection for the jury, even though both sets of claims involve allegations that Bard concealed or failed to disclose device risks.

The judge did leave open a narrow exception, indicating that portions of the warning letter could be introduced if Bard argues at trial that it has consistently complied with FDA reporting requirements or has never been subject to regulatory enforcement actions.

Defendants also asked the judge to block plaintiffs from mentioning a 1994 criminal conviction against C.R. Bard over improper use of the FDA’s 510(k) fast-track approval program, which grants marketing approval to devices that are “substantially equivalent” to existing designs without the need for extensive clinical trials. The program was also used to approve the Bard PowerPort.

The judge denied the motion but warned plaintiffs that the issue must be resolved at trial and to consult with the court before showing such evidence to the jury. He acknowledges that, if handled incorrectly, the evidence could be “highly prejudicial.”

“(T)he 1994 conviction — which in part concerned Bard’s deliberate disregard of FDA requirements and its knowing and willful failure to comply with FDA disclosure rules — could be relevant if Defendants rely heavily before the jury on their past compliance with FDA requirements and suggest to the jury that they have always been exemplary and forthcoming in their dealings with federal regulators. The issue is also factually complex, with Plaintiff submitting more than 70 pages of court records from 1994.”

– U.S. District Judge David G. Campbell

Cook’s bellwether trial will be closely watched. Although the results will not be binding on other claims, its outcome, and those of the following bellwether trials, may help the parties pave the way to a Bard PowerPort lawsuit settlement agreement.

Following the Cook trial, additional bellwether trials are currently scheduled to begin on July 7, August 18, October 13, December 1, and February 2, 2027.

Once the bellwether trials have been completed, if the parties have not reached a settlement or other agreement to resolve the litigation, Judge Campbell may begin remanding the cases back to their original federal district courts for individual trial dates.