Bard can’t keep internal memos out of pelvic mesh trial

C.R. Bard (NYSE:BCR) won’t be able to keep internal memos out of an upcoming bellwether trial over its recalled Avaulta pelvic mesh, a federal judge ruled last week.

Bard asked Judge Joseph Goodwin of the U.S. District Court for Southern Western Virginia to exclude 6 memos written by Bobby Orr, head of Bard’s Advanced Surgical Concepts division, in 2008 and 2009 discussing various options and materials that could be used to make new pelvic mesh products. The medical device company argued that the memos should not be allowed as evidence in the jury trial of Carolyn Jones v. C.R. Bard because they were written after Jones was implanted with the Avaulta Plus mesh "and are therefore not relevant to Plaintiff’s design defect claim," according to court documents.

Citing a federal provision barring the introduction of evidence showing measures taken to remediate a defect that would have prevented a prior injury, Bard also argued that the memos should be excluded because they referred to measures that might be taken after Jones received the Avaulta Plus mesh.

"Here, the memoranda promulgated a hypothesis for changes to future products. The memoranda were prepared after the Avaulta Plus devices had been designed, after they had been sold, after they had been shipped, and after they had been implanted in plaintiff. They are therefore precisely the type of remedial measure that deserves protection," according to the documents [emphasis theirs].

Finally, Bard argued, the memos should be kept out of the trial because they could unfairly prejudice the jury and delay the trial, court records show.

"The memoranda should be excluded under Rule 403 because any probative value is substantially outweighed by the risk of unfair prejudice and jury confusion," according to the documents. "First, the memoranda do not mention specifically mention Avaulta mesh or any other mesh manufactured by Bard. Mr. Orr had no responsibility for reviewing the safety and efficacy of the Avaulta Plus device. As head of the Advanced Surgical Concepts division within Bard, Mr. Orr’s responsibilities included exploring new technologies for next generation products. It is possible the jury could misconstrue the memoranda’s future design hypotheses as criticisms of the existing Avaulta mesh. Indeed, Plaintiff’s counsel has advanced this argument by labeling Mr. Orr a ‘whistleblower’ during the recent Cisson trial."

Goodwin shot down the argument that the memos should be omitted because they were written after Jones received the Avaulta Plus mesh, writing that "Bard’s very own statement of the governing law, then, recognizes that one of the central issues in the case is what it should have known – and what alternative feasible designs existed – no later than the 2007 Avaulta product launch date," according to the records.

"While the Orr memoranda post-dated that critical point in time, each piece of scientific literature found in the memoranda was published prior to it. The pre-launch, peer-reviewed body of literature referenced by Mr. Orr, and his comments respecting it, may thus relate to what Bard should have known prior to launch and the feasibility of a then-safer alternative. Accordingly, portions of the Orr memoranda may be admissible. A final determination awaits the foundation laid at trial and the specific portions of the Orr memoranda sought to be introduced," Goodwin wrote.

As for the contention that the Orr memos discuss remedial measures after the fact, Goodwin ruled that the documents "are not, in their entirety, devoted to subsequent remedial measures," the records show.

"They include an analysis of Bard’s existing products. That portion of the memoranda, at least, is not within the contemplation of the remedial-measure prohibition," Goodwin wrote.

And Bard wasn’t specific enough about the potential to prejudice the jury to allow the memos to be excluded, the judge ruled.

"Bard has failed to sufficiently articulate why admission of the memoranda would lead to prejudice that is "unfair." As such, the Orr memoranda should not be excluded," Goodwin wrote.

The jury trial is scheduled to begin Jan. 10, according to the court.