Martinez Trial Underway – The FDA Debate

//Martinez Trial Underway – The FDA Debate

Martinez Trial Underway – The FDA Debate

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

MARTINEZ V. BOSTON SCIENTIFIC

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 FDA APPROVAL/CLEARANCE – IN OR OUT?

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.

JUDGE THOMAS BILLINGS

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

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.” ###

By | 2018-06-12T11:31:33+00:00 June 11th, 2018|News|5 Comments

About the Author:

I’m National News Editor, Jane Akre and I began Mesh Medical Device News Desk aka Mesh News Desk (MND) in the summer of 2011 just after the Food and Drug Administration issued an explicit warning to the public that complications associated with surgical mesh used for prolapse repair (POP) and incontinence (SUI) are NOT rare! That was the starting point for the litigation you see today and thousands of lawsuits have been filed by women whose lives have been altered, some permanently, by the use of this petroleum-based product.

5 Comments

  1. Robin June 12, 2018 at 8:53 am - Reply

    Been trying to find another women whom has had an neo-vagina BECAUSE of damage from mesh.Have met and talked to at least thirty women,none so catastrophic. So why can’t I get someone to represent me,read other cases.Still no one that I can find has lost six inches of their colon to make a vagina, and have no real medical help in my state for aftercare.

    • Jane Akre June 12, 2018 at 9:02 am - Reply

      Robin- I will write you privately to see if there is someone in your area who can help you medically. I’m so sorry.

    • MD June 15, 2018 at 9:01 pm - Reply

      Please call. Dr. Milklos and Moore in Atlanta Georgia . Good luck. And God bless you♥️🙏👍🏼

  2. Still Standing June 12, 2018 at 10:18 pm - Reply

    Robin, im so sorry for your complications. I have had a similar experience. My vagina was so damaged that my doctor removed half of it and put in a pig bladder graft. First time a pig bladder had been used to construct a vagina in the world. My doctor truthfully said there was a 25% chance that it would take. He used a camera through a probe to monitor the healing process. I actually had a friend with a bona fide hyperbaric oxgen chamber they bought after her husbands stroke, so I went in it for two hours three times a week. I also went to holistic MD who helped wtih nutritional needs for optimal wound healing. That was in 2015 and it is holding up well. One time when I went in he asked me if I wanted to see the most famous vagina in the world on the screen. I said, yeah, right and he said really, I have sent pictures to collegues all over the world. It was that significant. I told him to send pictures, but I would not sign autographs.

    I went to Mayo clinic this week to consult with doctors there about my colon. My enteric neurons have been attacked and destroyed through an autoimmune disorder, starting after the mesh implant. I have no bowel function at all and have to do gallon enemas every day just to keep from blowng up, The only option I have so far is they will remove my entire colon and attach my small intestines to my rectum unless, and this is the scary part, my rectum cant be attached. They said there is mesh embedded all around my rectum and that would force me to have a permanent ileostomy, which I will not agree to do. They also predict dense adhesions after All the mesh surgeries. Mesh has claimed too many body parts already. I have sacrificed all I can on the quality of life scale. I am going back in a couple of months for some more testing then I will have to decide. They said I cant keep doing what Im doing forever. I have given up meat, dairy, mst sugar and have to limit fresh fruit and raw vegetables because nothing is digested.

    I don’t understand why no one will take your case. Are you outaide the statute of limitations in your state? Did you have preexsting conditions that would impact it? Did whoever did your vagnal reconstruction not refer you back to a local doctor for follow up care ? You need a good urogyn AND a good gastroenterologist to manage any complications from the colon resection.

  3. Blindsided June 13, 2018 at 1:03 pm - Reply

    To Still Standing, I too have severe bowel disfunction and nerve damage from mesh. I would like to talk to you if possible. Jane can you arrange a swap of phone numbers or email address? Robin I will pray you find the legal representation you need. I’m afraid we the mesh injured all have the short end of the stick in this entire medical and legal process. Mesh complaints have obviously disturbed the courts and the courts is rushing to get rid of them which is making attorney’s shy away from them. The chance of any of our cases to make it to jury in this life time is slim to none! So the message this sends to our Justice system is the more harm one does to many the less chance they will have to answer to the courts on their wrong doings. This doesn’t correct or prevent any further harm. The FDA, medical and Justice system is flawed. There will only be more to come because our system is not changing! While my Mother always said prevention is the key, what is the system doing to prevent these reoccurrences! Stay strong and rest assure everyone will answer to God. God forgives but he too expects change!!!

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