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Beltz v. Ethicon Jury Form in her Pelvic Mesh Trial

Prolift, from Sumsuro, Japan

Mesh Medical Device News Desk, June 1, 2017 ~ The jury form in the Sharon Beltz v. Ethicon case shows mixed success in this latest pelvic mesh trial.

Beltz v. Ethicon Jury Verdict Form

Entered into the court May 31, 2017,  is the form that was filled out by the 12 jurors in the case of Beltz v. Ethicon.

See Beltz etal vs Ethicon Women’s Health and Urology, Case ID: 130603835 in the Philadelphia Court of Common Pleas.

While it does show an award in compensatory damages of $2.16 million, it shows mixed results for the plaintiffs, a departure from the overwhelming recent verdicts for the plaintiff outcomes in the Philadelphia Court of Common Pleas.

The jury was asked if the Prolift failed to perform as safely as an ordinary consumer would have expected?  No, said the jurors.

Did the possibility and seriousness of the harm of the Prolift outweigh the burden or cost of making the Prolift safeYes, said jurors. This is the question that goes to defective, finding the medical device defective and that it caused the harm to Ms. Beltz.

Did J&J fail to properly warn Dr. Van Raalte of the risks of the Prolift No, said jurors.   A failure to warn is one of the causes of action which was not proven to these jurors.

Did J&J negligently design the Prolift?  No, said jurors. Design defect is another cause of action, again which was not proven.

While the jurors had an option of awarding punitive damages, they opted not to.

Here is the Beltz Jury verdict form, posted  May 31 2017.

 

IFU TVT-O

J&J  WANTED TO EXCLUDE CHANGES TO THE IFU of PROLIFT AND TVT-O

Defendant mesh manufacturer Ethicon (Johnson & Johnson) wanted to exclude all evidence that it changed its Instructions for Use (IFU), essentially the warning label that comes with each TVT-O packaged mesh kit and the Prolift +M, after Ms. Beltz was implanted in September 2006.

Evidence of post-implant revisions to the Prolift and TVT-O IFUs is irrelevant, confusing and unfairly prejudicial, argued Ethicon.

The request was included in a letter written Judge Arnold New by Drinker Biddle & Reath, J&J’s law firm. See letter from Drinker Biddle Reath.

The TVT-O IFU was revised on several occasions most recently in 2015 when revisions to the IFU were made after an exchange with Health Canada. These were purely voluntary changes not requested by the FDA, stresses Ethicon.

The Prolift IFU was also revised in 2009 when Ethicon added language about potential adverse events after a discussion with the FDA.

The changes to the IFU can be seen in red lined revisions of the warning label included in documents  – Beltz Redlined changes toTVT-O IFU.   

They include adding a host of adverse events including product degradation, foreign body response, acute and/or chronic pain, voiding dysfunction, pain with intercourse which in some patients may not resolve, neuromuscular problems, bleeding including hemorrhage or hematoma, one or more revision surgeries may be necessary to treat these adverse reactions.  Other additions include urinary retention and frequency, urge incontinence, adhesion formation, atypical vaginal discharge, exposed mesh and death.

The court should exclude this evidence for two reasons, says Ethicon. First, this is inadmissible remedial measure, “label revisions cannot serve as substantive evidence of negligence or of a product defect.”

Second – “the post-implant labeling revisions at issue here are irrelevant, and their admission would only confuse and mislead the jury and unfairly prejudice to Ethicon.”

Prolift in 3 shapes

They are subsequent remedial measures. Evidence of such revisions is inadmissible under Rule 407 for purposes of proving that the warnings in the pre-implant version of the IFU were inadequate or that Ethicon was negligent.

Because the changes were made at the request of a foreign regulatory authority – Health Canada- they should be excluded for that reason argues the mesh maker, says Ethicon.

The changes were included in the IFUs included in TVT-O mesh kit boxes September – October 2015.

Ethicon never sent a Dear Doctor letter alerting users to changes of the IFU.  We didn’t feel we needed to because the existing IFU was adequate says, Dr. Weisberg, Medical Affairs Director of Ethicon.

Since the TVT-O never went before the jurors, this argument is moot.  And the jurors decided Prolift was not negligently designed.  ###

6 Comments

  1. daniee says:

    This is an experiment gone wrong
    J&J Ethiecon promoted and marketed this crap. This device/concept violates the principles of physics, chemistry and medicine.

  2. Anon says:

    Strange verdict……….I am confused ☹ ☹ ☹

  3. Diva64 says:

    This is very sad news ideed. Even auto manufactures send out product recall on parts that may be defective to avoid persons becoming injured .Lifes are valuable I would think that all Transvaginal Mesh receipants should have 1, been advised of the possible complications with the product verifiable my their initials by each potential serious complication , a signature at the end of page and witnessed.
    2 If the complications were not known when mesh went on the market , each patient should have been advised as soon as known damages were known. We have SS# , not like we could not have been located.
    Mesh is a great travesty to human lives and shows how little we are valued, that the U.S. is operating on a Capitalist viewpoint . It is really sad where medicine and the legal system have fallen ..

  4. Kitty says:

    It may be OK for her..but the ladies that got the O could be affected. I thought there was a higher propensity for nerve damage with O.

    • D gore says:

      Where will this lead to those of us w tvt o? Insane revisions after I seryins do not count? Lawyering to the max.

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