The first bellwether trials over medical devices that are designed to prevent blood clots during surgery have failed to carve out a clear winner, with another trial set to begin this week.

About 9,000 lawsuits allege that various types of inferior vena cava filters, or IVC filters, which doctors implant in patients, have perforated or fractured in their bodies, causing pain and leading to removal surgeries. Among the several device manufacturers listed in the lawsuits, C.R. Bard Inc. and Cook Medical Inc. face the largest number of cases, clocking in over 4,000 each.

So far, trials have failed to identify a clear victor. Cook won the first IVC filter trial last year, but it lost a $1.2 million verdict in Texas state court on May 24. Bard lost a $3.6 million verdict on March 30, but followed up with a defense win on June 1. Judges also have granted summary judgment motions in at least two key cases slated for trials.

The next trial is set to start against Bard on Sept. 18 in Phoenix, where a federal judge is overseeing the multidistrict litigation over its IVC filters. Ramon Lopez, plaintiffs attorney in the case, noted, “You might consider this the tiebreaker of the trials. The score is 1 to 1.”

“This case is representative of a number of other cases in the MDL, and the outcome of it is very important to the entire process. I think it will have an impact on what might happen thereafter in the MDL,” Lopez said.

Bard's lead counsel, Richard North, a partner at Nelson Mullins Riley & Scarborough in Atlanta, declined to comment, and a Bard spokesperson did not respond to a request for comment. North is working with James Condo of Snell & Wilmer in Phoenix on Bard's defense.

In the Cook cases, a federal judge in Indiana is set to discuss on Sept. 20 whether to change the trial plan. A team from Faegre Baker Daniels is handling Cook's defense of the IVC filter lawsuits.

“Cook's IVC filters are clinically successful devices critical to patient well-being, and no court or jury has identified a defect in the design of Cook's IVC filters,” wrote Indianapolis partner Andrea Pierson, who is working with partner J. Stephen Bennett in Fort Wayne, Indiana.

There are lawsuits against other manufacturers of IVC filters. Those include more than 300 cases pending in Alameda County Superior Court in California against Cortis, and nearly 100 cases in Philadelphia Court of Common Pleas involving devices made and distributed by Rex Medical and Argon Medical.

IVC filters prevent pulmonary embolisms that occur when blood clots travel to an artery in the lungs. Houston attorney David Matthews, who has suits against all four manufacturers, likened IVC filter cases to those over transvaginal mesh devices, which make up the largest mass tort in the country, with more than 50,000 cases pending against half a dozen manufacturers, including Bard and Cook.

“The similarities are striking,” said Matthews, of Matthews & Associates. “They're dangerous, there's no benefit, and they don't work.”

All the IVC filter cases against Bard in federal court are in a multidistrict litigation proceeding in Phoenix, where U.S. District Judge David Campbell of the District of Arizona has set an aggressive schedule of bellwether trials, designed to pin down the value of the cases to get both sides closer to settlement. He has identified six bellwether cases and, after those trials are completed, could remand the rest of the lawsuits to the courts in which they were filed.

“If this case doesn't settle after the first four or five, he's going to shut down the MDL,” said Lopez, who is co-lead counsel in the Bard MDL. “He's going to send all the cases back, and there's 4,000. He's not going to hold onto these cases, waiting for them to settle.”

Lopez and Phoenix-based Gallagher & Kennedy shareholder Mark O'Connor have spearheaded the bellwether trials in the MDL along with Joseph Johnson of Babbitt & Johnson in West Palm Beach, Florida, and Julia Zaic of Heaviside Reed Zaic in Laguna Beach, California.

On March 30, a federal jury in Phoenix awarded $3.6 million to Sherr-Una Booker, a Georgia woman who had open-heart surgery in 2014 to remove pieces of a Bard IVC filter that had fractured. Plaintiffs attorneys had picked that case for the first bellwether trial. Bard has appealed that verdict to the U.S. Court of Appeals for the Ninth Circuit.

Another federal jury in Phoenix gave Bard a defense verdict on June 1 in a case brought by Doris Jones, another Georgia woman. Her lawyers appealed that decision on Aug. 1.

“This was the No. 1 defense pick case,” Lopez said of the Jones trial. “And we had a hung jury after a day and half. The judge was going to declare a mistrial, and both sides agreed to allow the jury to deliberate for at least two more hours. And after two hours, the jury came back with four people crying.”

On Aug. 17, Campbell tossed out another bellwether case on summary judgment, concluding that Carol Kruse, from Nebraska, filed her lawsuit too late. Bard had selected that case for trial.

Lisa and Mark Hyde brought the case that goes to trial next week. In that case, Lisa Hyde had a Bard IVC filter implanted that doctors removed three years later after it perforated near her heart.

According to Lopez, another Bard trial, in a case in Delaware Superior Court, begins on Oct. 1. Matthews said he has a case against Bard set for trial on Oct. 21 in Dallas County District Court.

The Cook Cases

The Cook cases, however, have progressed much more slowly. U.S. District Judge Richard Young of the Southern District of Indiana has scheduled three cases for trial, but only one has reached a verdict.

A Nov. 9 verdict came in a defense pick: a case brought by Elizabeth Jane Hill, who had an IVC filter implanted in preparation for spinal surgery in 2010. After her doctor was unable to remove the filter, Hill began to suffer gastrointestinal symptoms that she attributed to the IVC, which doctors removed in 2013.

“It was a very difficult case,” said Matthews, who is working on the cases with co-lead counsel Dallas attorney Ben Martin of the Law Offices of Ben C. Martin and Michael Heaviside of Heaviside Reed Zaic. “She was a sweet lady, but the jury found, we think, there was something else that caused the problems.”

On March 9, Young tossed out another bellwether case on summary judgment, concluding the claims were time-barred.

Cook Medical vice president Mark Breedlove said of that summary judgment ruling: “This outcome is consistent with Cook's verdict in the first bellwether trial.” Matthews called the entire case, which Bard selected, a “worthless endeavor.”

A third trial, the first plaintiffs' pick, was set to start this week. Tonya Brand alleged that she pulled a part of her Cook IVC filter out of her thigh in 2011. Last month, Young vacated that trial.

“The primary reason for continuing the case was the fact that there were dozens of motions pending and the court and the parties did not have sufficient time to address the issues prior to the September setting,” Joseph N. Williams, of Indianapolis-based Riley Williams & Piatt, liaison counsel in the Cook MDL, wrote in an email. “The court figured that by continuing the trial until January everyone will have enough time to address the motions.”

Among those are summary judgment motions and Cook's request to toss more than 200 cases in which the plaintiff has alleged “frivolous, no-injury claims.” In court documents, Cook estimated that half of the MDL now consists of such cases. As a result, Cook's lawyers wrote, Young should reassess the bellwether trial plan. Young's hearing later this month plans to address that motion as well as a request by the plaintiffs to have trials of more than one plaintiff at a time.

Matthews called Cook's motion “ridiculous.”

“Their position is there should be a process by where we have to show an injury,” he said. “They call it a 'screening' order, which is unprecedented and ridiculous.”

In court documents, he noted that, his own case that landed a $1.2 million verdict in Texas would never have happened under Cook's proposed bellwether plan.

In a statement, Cook said it planned to appeal that verdict, which Cook Medical general counsel Cynthia Kretz said was not “supported by the facts or the law.”