Martinez Trial Underway - The FDA Debate

Jane Akre
June 11, 2018
boston scientific POP mesh

Mesh Medical Device News Desk, June 11, 2018 ~ The following story is retrieved from the first full day of the Ana Martinez v Boston Scientific trial being heard in Massachusetts Superior Court in Woburn, Mass.

The judge's instruction to the jurors began during day 4, on May 30, 2018, according to the trial transcript.

Martinez hopes to prove that the Pinnacle Pelvic Floor repair system and Obtryx Mid-urethral sling she was implanted with are defective, and the instructions to her doctor were inadequate.

She is also suing for loss of consortium on behalf of her husband.

Judge - The Honorable Thomas Billings
Plaintiff Attorneys - Kila Baldwin and Jim Waldenberger of Kline Specter
Defense Attorneys - Jim Keale, Susan Murphy for Boston Scientific.

Image: Pinnacle Pelvic Floor Repair Kit

Susan Donnelly Murphy


Right off the bat Ms. Murphy renewed a motion for a mistrial. The Motion is Denied, said the court.

Not a good way to start the day.


The next item was Boston Scientific reminding the court that it had agreed that the jury be able to hear language that the devices are cleared and legally sold in the U.S.

That creates a problem, said the plaintiff.

Any suggestion that the FDA had done any sort of “review” and that mesh was “approved," presumes it underwent some assurances of safety. Under the 510(k) “clearance to sell” process that is not true, said the plaintiff. Any suggestion that the FDA has put its stamp of approval on mesh could leave the wrong impression with the jury, Mr. Waldenberger objected.

Jim Waldenberger, Kline Specter

“Your Honor, we don’t agree with this instruction, because it specifically is telling the jury that the products were cleared by the FDA. …I think you are injecting an issue that has been ruled out of the case. You’re raising questions in the jury’s mind and essentially undoing the ruling that you had previously made regarding the preclusion of this evidence.”

Instead, he suggests instead of mentioning “clearance” and the implications it carries say:

"Members of the jury, during the course of this trial, you may be wondering or considering or thinking about what involvement the FDA had relating to these devices. Please know that the FDA and any involvement of the FDA is not evidence in this case and is not to be considered by you during this trial or during your deliberations."

Mr. Waldenberger added that even to mention the FDA’s 510(k) clearance process invites online research, even though jurors are warned against doing so.

“It’s putting the ideas in their head. The whole point of the instruction is to remove the idea of FDA from their heads; and just telling them that it’s not evidence in the case and that it shouldn’t consider it, and any potential involvement of the FDA doesn’t mean that this product was defective – was not defective, is really the point.”

The judge said he would look over it later.


The clerk then brought in 15 members of the jury to listen to Judge Billings’ opening instructions on the law.

Judge Billings, Mass. Continuing Legal Education

“You are the sole and exclusive judges of the facts. That’s why you’re here, to determine, based on the evidence, what the facts are.”

“The Rules of evidence are designed to ensure that the evidence you receive is relevant to an issue or issues and is presented in a form that gives you a fair opportunity to evaluate its worth, its credibility and its weight.”~ Judge Thomas Billings

The Judge reminds the jurors the plaintiffs have the burden of proof. The jurors will get to decide if the evidence presented is credible and how much weight it deserves. The plaintiffs must make their case by the preponderance of the evidence, meaning it's more likely than not the facts are true.

"The Rules of Evidence, their function, for the most part, is to ensure that the evidence you receive will be relevant to an issue in the case and will be presented in a form that gives you a fair opportunity to evaluate its worth."

Obtryx Halo patent

Jurors were told it is their job to determine if a witness appears to be telling the truth and whether they appear to be able to observe an event reliably. They are to determine whether the testimony is probably or improbably and how well it fits with the other evidence in the case. Also to be considered - whether the witness appears to have a bias or an interest in the outcome of the case. this goes for both expert witnesses and lay witnesses.


Jurors are allowed to take notes. The notebooks stay in the courtroom and are shredded at the end of the case.

Jurors are charged with finding whether Boston Scientific's Pinnacle Pelvic Floor Repair Kit and Obtryx Sling System-Halo are defective and whether Boston Scientific was negligent (and that caused her injury), and whether the company failed to adequately warn doctors.

Negligence that was the proximate cause of her injures will result in damages, which includes a monetary award for medical expenses, past and future, lost earnings, past and future. Also, Jose and Ana Martinez are suing for loss on consortium on behalf of her husband.

Given all that, “It will be up to you to decide whether the case has been proved or not proved.” ###

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