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.  ###