St. Louis court clears way for first Infuse jury trial

A St. Louis judge has cleared the way for the first jury trial involving personal injuries allegedly caused by Medtronic's Infuse Bone Graft.

The injury claims of plaintiff Trisha Keim are set for trial in February, after Judge Mark H. Neill of Missouri's 22nd Judicial Circuit declined to dismiss the case or transfer it to another court.

A trial in the case has the potential to make public heretofore sealed records that would be available to thousands of other pending injury cases involving Infuse, a bone-fusion product that has been used on more than a million patients since 2002.

Product liability expert David Prince of the Mitchell Hamline School of Law called Neill's Dec. 2 order "a very big deal."

"They've got all the discovery [documents]," Prince explained. A trial "means all of this information will come into the public record with all of these other plaintiffs standing in line. This is always the point where a defendant has to have a come-to-Jesus meeting with himself. Do I take a chance or do I settle? There's a lot at stake. This is as much a business decision as anything else."

In a statement to the Star Tribune, Medtronic spokesman Eric Epperson said, "Judge Neill's ruling merely permits this case to proceed to trial; it does not decide the merits of the claim. Medtronic believes the claims in this case are baseless, and we are prepared to vigorously defend ourselves in court."

Medtronic cannot appeal Neill's ruling before the case goes to trial. The company has said in regulatory filings that it has already spent more than $100 million settling Infuse injury litigation ahead of trial.

Settlement documents in some cases stipulate that many documents remain secret and that the injured cannot talk about their cases. Medtronic also reached an $89 million settlement in a shareholder suit alleging that improper Infuse marketing hurt the company's stock price.

Among records that could come into evidence in a trial, according to Neill's order, are documents that Keim says prove she "would have received different medical treatment if [Medtronic] had adequately warned of the dangers of Infuse."

These include "marketing materials, studies and papers ... an article that allegedly contained false information distributed to the medical community" and depositions from Keim's doctor, as well as Dr. Richard Kuntz, Medtronic's chief scientific, clinical and regulatory officer.

While the order does not reference the number of documents, including e-mails, that Keim's lawyers have collected through pretrial discovery, a California Infuse lawsuit referenced the St. Louis case and said the number stands at tens of millions.

Medtronic denies all allegations in the lawsuits.

Prince said the case raises the prospect of "reputational damage" that might "affect the company's bottom line and the market's perceived value of the company."

Thrivent Financial senior health analyst David Heupel disagreed, saying Infuse problems are well known and that even if documents "make Medtronic not look so great," he did not "think that issues arising from Infuse will be significant going forward."

Marketing of Infuse and failure to report injuries following non-FDA-approved uses have sparked investigations by the U.S. Justice Department, the Senate Finance Committee and five state attorneys general.

In April, the Star Tribune reported that Medtronic did not report to the FDA more than 1,000 complications revealed in a 2006-2008 company-run Infuse study until 2014, more than five years after the law required.

Medtronic's latest quarterly filing with the Securities and Exchange Commission (SEC), posted last week, states that the company is fighting a second shareholder suit alleging that the stock price was hurt by improper marketing of Infuse for off-label uses. The SEC document also said Medtronic is negotiating settlements on 4,300 of 6,000 potential Infuse injury claims and expects to go to court on the roughly 1,700 outstanding claims in 2017.

The number of outstanding claims could rise as the result of the release of records in a jury trial. One of Keim's lawyers, Jerrold Parker, said he has "retained" 1,900 Infuse clients.

The Keim case survived federal pre-emption arguments by Medtronic. The company asserted that people who allege Infuse injuries cannot sue the device maker for non-FDA-approved uses because the biologic was approved for a separate use by the U.S. Food and Drug Administration (FDA) and the company did not promote nonapproved or off-label use.

While Infuse is used an estimated 85 to 90 percent of the time off-label, that legal strategy has succeeded in preventing numerous other plaintiffs from getting a day in court or even asking questions about Medtronic's design and marketing practices.

Neill said Keim's allegations run parallel to federal law and do not superimpose state laws over U.S. statutes or add new requirements. For that reason he declined to dismiss the case, letting it go to the jury.

Jim Spencer • 202-662-7432