Preview Newsletter
Ethicon Media Monitoring 6/2/2017
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Beltz v. Ethicon Jury Form in her Pelvic Mesh Trial
Jun 1, 2017 | Mesh Medical Device Newsdesk
The jury form in the Sharon Beltz v. Ethicon case shows mixed success in this latest pelvic mesh trial. -
June Welcome to Mesh News Desk
Jun 1, 2017 | Mesh Medical Device Newsdesk
By Jane Akre
The summer is almost upon us and pelvic mesh trials have been heating up in Philadelphia after a very long lull. -
Johnson & Johnson Under Fire Again for Defective Hernia Mesh Product
Jun 2, 2017 | The Global Dispatch
By Jacob Maslow
Johnson & Johnson’s subsidiary Ethicon is under fire once again for its defective hernia mesh product Physiomesh. A man from Illinois has filed a lawsuit against the company after he experienced serious complications after ventral incisional hernia repair.
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Beltz v. Ethicon Jury Form in her Pelvic Mesh Trial
Jun 1, 2017 | Mesh Medical Device Newsdesk
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 safe? Yes, 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.
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.”
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. ###
http://www.meshmedicaldevicenewsdesk.com/beltz-v-ethicon-jury-form-pelvic-mesh-trial/
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June Welcome to Mesh News Desk
Jun 1, 2017 | Mesh Medical Device Newsdesk
By Jane Akre
The summer is almost upon us and pelvic mesh trials have been heating up in Philadelphia after a very long lull.
Recently there have been $12.5, $13.5, $20 million and $2.16 million jury awards of compensation and nearly $35 million in punitive damages all leveled against J&J.
After attending a shareholders meeting where “sustainability” was the theme, it is tough to square with the continuing losses in court. How tough will healthcare giant J&J play this game of chicken with the plaintiffs’ law firms?
A long time if the media blackout continues.
Meanwhile in Australia, Scotland and the UK, mesh campaigners are making front-page news, and not surprisingly, that is getting the attention of regulators who in Australia will conduct a Senate inquiry this summer to try and determine how many women are injured by mesh in Australia. There is currently no surgeon in AU who can do a complete mesh removal according to campaigners.MND has been reporting on the issues for five years and longer on this site. It remains the only website dedicated to following this mesh litigation and the latest medical news, media reports and insider reports as well.
Clock on the headline “Legal” or “Medical” to find a list of stories filed under that topic. If you comment please do so anonymously or at the very least do not use your last name. Use the Search Bar to research your topic.
The news stories here do not substitute for legal or medical advice. This is not a legal referral service but news and information site supported by advertising.
There are 990 pages of content here. YOUR ESSAYS are welcome! Please consider writing. Please consider advertising. June Welcome to Mesh News Desk
Jane Akre, editor MND
The summer is almost upon us and pelvic mesh trials have been heating up in Philadelphia after a very long lull.
Recently there have been $12.5, $13.5, $20 million and $2.16 million jury awards of compensation and nearly $35 million in punitive damages all leveled against J&J.
After attending a shareholders meeting where “sustainability” was the theme, it is tough to square with the continuing losses in court. How tough will healthcare giant J&J play this game of chicken with the plaintiffs’ law firms?
A long time if the media blackout continues.
Meanwhile in Australia, Scotland and the UK, mesh campaigners are making front-page news, and not surprisingly, that is getting the attention of regulators who in Australia will conduct a Senate inquiry this summer to try and determine how many women are injured by mesh in Australia. There is currently no surgeon in AU who can do a complete mesh removal according to campaigners.MND has been reporting on the issues for five years and longer on this site. It remains the only website dedicated to following this mesh litigation and the latest medical news, media reports and insider reports as well.
Clock on the headline “Legal” or “Medical” to find a list of stories filed under that topic. If you comment please do so anonymously or at the very least do not use your last name. Use the Search Bar to research your topic.
The news stories here do not substitute for legal or medical advice. This is not a legal referral service but news and information site supported by advertising.
No harmful comments are allowed – no disparaging one another or in-fighting. Thank you. There are 990 pages of content here. YOUR ESSAYS are welcome! Please consider writing. Please consider advertising.
Hernia mesh, transvaginal mesh, pelvic mesh – it’s all made of polypropylene. Women today are told all sorts of things about mesh, that “it’s not the same mesh” for example. Here are some other things women are told.
If you are told you need polypropylene mesh to correct prolapse or incontinence, you will need to direct your own medical care and be a truly informed consumer. Ask if the doctor can do a non-mesh repair as a first line of treatment. Stay well.
http://www.meshmedicaldevicenewsdesk.com/june-welcome-mesh-news-desk/
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Johnson & Johnson Under Fire Again for Defective Hernia Mesh Product
Jun 2, 2017 | The Global Dispatch
By Jacob Maslow
Johnson & Johnson’s subsidiary Ethicon is under fire once again for its defective hernia mesh product Physiomesh. A man from Illinois has filed a lawsuit against the company after he experienced serious complications after ventral incisional hernia repair.
The complaint – filed on May 22nd with the U.S. District Court, Southern District of Illinois by Gary Goodson – alleges that the Physiomesh received by the plaintiff was defective and not reasonably safe for hernia repair.
Goodson claims he now requires revision surgery due to complications with the device. He alleges that the mesh’s coating, designed to help the body absorb the mesh, creates a breeding ground for bacteria.
The lawsuit states: “The multi-layer coating prevented adequate incorporation of the mesh into the body and caused or contributed to an intense inflammatory and chronic foreign body response resulting in an adverse tissue reaction including migration and damage to surrounding tissue in the form of sclerotic, granulomatous and/or fibrotic tissue and improper healing.”
The lawsuit is not the first for Ethicon, which withdrew its Physiomesh Flexible Composite Mesh in 2016. The company made the decision to remove the product from the market after two hernia registries in Europe alleged that the product was associated with high revision and recurrence rates compared to other meshes.
While the withdrawal was not deemed an official recall in the U.S., hospitals were advised to return unused hernia patches.
Lawsuits related to Ethicon’s other mesh product, Prolift, has cost the company $120 million. More than 40,000 lawsuits over Prolift are still pending.
Physiomesh and Prolift are two more examples of dangerous medical products that made it to market thanks to the FDA’s 510(k) Pre-Market Approval process, a controversial program. Ethicon’s mesh products were able to make it to the market without safety testing because it could demonstrate that its products were “substantially similar” to another product on the market.
When Ethicon removed its Physiomesh product from the market last year, the company stated that it believed the higher rates of failure were “a multifactorial issue” and they were unable to “fully characterize these factors.”
Plaintiffs allege that Johnson & Johnson and Ethicon were aware of the problems with the meshes, but failed to disclose this information to medical providers and patients.
In addition to the thousands of lawsuits filed in the U.S. over Ethicon’s defective hernia products, Canada is joining a class action suit against the company.
The Canadian plaintiffs joining the suit allege that they experienced severe pain and had to undergo surgery to repair the mesh. Plaintiffs had their hernias return with “greater severity.”
Ethicon says it plans to defend against the lawsuits, which now amount to nearly two dozen in Canada.
Another manufacturer, Atrium, is at the center of many suits in Canada. Atrium’s mesh has a fish oil coating that is designed to prevent it from adhering to the bowel. Plaintiffs allege that coating does just the opposite, sticking to the bowels and organs. Some plaintiffs experienced ulcers, bowel obstructions, infections and other serious complications.
https://www.theglobaldispatch.com/johnson-johnson-under-fire-again-for-defective-hernia-mesh-product-71211/
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