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Ethicon Media Monitoring 11/19/2018
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After a Lull, Philadelphia Readies for JNJ Prolift Mesh Case
Nov 19, 2018 | Mesh Medical Device News Desk
By Jane Akre
Suzanne M. Emmett, from Lancaster Pennsylvania is getting ready for the trial that will determine her future. -
Nats promise surgical mesh register while Govt 'drags chain', say advocates
Nov 18, 2018 | Stuff
By Stacey Kirk
A surgical mesh crisis is "not being taken seriously" by the Government, which has all but reneged on a promise to establish a register for the controversial product, advocates say. -
Hundreds of women given mesh implants despite ‘ban’ on procedure
Nov 19, 2018 | The Press and Journal
By James Wyllie
Women in Scotland are still being given controversial mesh implants, more than four years after health boards were told to stop offering the procedure. -
Kelp ban could see Scotland lose £300m industry, warns biotech firm
Nov 19, 2018 | Mail Online
Scotland could lose out on a £300 million industry if MSPs vote to ban the industrial harvesting of kelp in its waters, company bosses have claimed.
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After a Lull, Philadelphia Readies for JNJ Prolift Mesh Case
Nov 19, 2018 | Mesh Medical Device News Desk
By Jane Akre
Suzanne M. Emmett, from Lancaster Pennsylvania is getting ready for the trial that will determine her future.
Suzanne is in her 60s and is married to Michael. Their defective product case is filed in the Philadelphia Court of Common Pleas before Judge Arnold New [No.1307-014975] and involves some names familiar to readers of Mesh News Desk.
The defendant is Ethicon Women’s Health and Urology along with Secant Medical, Prodesco, Johnson & Johnson, Gynecare. Ethicon is the medical device division of Johnson & Johnson.
Emmett has a Prolift implant as well as a TVT-O, 10 mesh erosions, 9 revision surgeries, and several Botox injections, and multiple silver nitrate applications. She continues to work in the insurance industry. Prolift is one of the largest meshes ever put in a kit complete with trocars used to implant it in a blind procedure. In mid-2012 it was removed from the market.
On May 14, 2007, Ms Emmett was implanted with Prolift by surgeon Patricia Reddy, MD, board certified in obstetrics and gynecology, at Pinnacle Health in Harrisburg, Pennsylvania. On the same day she also received a TVT-O. She had delivered two large babies vaginally and was suffering from prolapse.
By the next year she had corrective surgery to remove one of more the products with Dr. Vincent Lucente at St. Luke’s Hospital in Allentown, PA.
On or about January 2012, she underwent another corrective surgery to remove pelvic meshes during a third surgical procedure conducted by Dr. Nils Stenman at May Grant Associates in Lancaster, PA. She had another revision in 21012, again by Dr. Lucente in Allentown. By the spring of 2012, Emmett underwent another corrective surgery to revise or remove the mesh during a fifth surgical procedure conducted by Dr. Vincent Lucente. There was a sixth procedure, again done by Dr. Lucente, and then a seventh one year later.
Today she suffers permanent injury, mental and physical pain, economic loss says her complaint.
BACKGROUND
Prolift was introduced into the market in early 2005 without any FDA clearance. The defendants felt it was unnecessary because the mesh made of Prolene, already had clearance, even though The Prolift system was an entirely new product, pre-cut, prepackaged with tools in one-size fits all, for the repair of pelvic floor prolapse.
Contrary to its claims, there was a high vaginal mesh erosion rate of 15.6 % in one multi-center randomized controlled trial in August 2010. It concludes there was “no difference in overall objective and subjective cure rates. This study questions the value of additive synthetic polypropylene mesh for vaginal prolapse repairs.”
Prolift, and three other problematic meshes were quietly removed from the market by Ethicon after the Food and Drug Administration announced it would order the company to conduct randomized, controlled clinical testing of pelvic mesh products. It remains off the market in the U.S.
HER LAWSUIT
Ms Emmett is represented by Kila Baldwin and Elia Robertson of Kline Specter. Ethicon the medical device division of J&J, defectively designed the manufactured Prolift, the complaint alleges and failed to warn doctors of all of the potential dangers. The company was negligent in its manufacture, design labeling, warnings, instructions, sale and marketing and it had a duty to exercise reasonable and ordinary care in the recruitment and training of physicians and surgeons to implant mesh products. A failure to do so has resulted in catastrophic injury.
The complaint also alleges common law fraud; there were other products and procedures; mesh was not adequately tested; the defendant deliberately failed to follow-up on adverse results coming into it and from clinical studies; the company failed to monitor implanted patients and was negligent in its misrepresentations to the medical community and assurances the mesh was safe and effective; breached an express warranty; breach of implied warranty; and the defendant violated state consumer protection laws; and expressed a grossly negligent disregard for the rights of others , the public and plaintiff Emmett. Also the Emmetts’ have entered a claim for loss of consortium impacting the marital relationship.
Melissa A. Merck of Drinker Biddle & Reath, Joseph O’Neil of Lavin, O’Neil Cedrone & Disipio, Julie Callsen of Tucker Ellis and Nils Burt Snell of Butler Snow and Tarek Ismail of Goldman Ismail Tomaselli Brennan & Baum represents J&J/Ethicon.
MOTION FOR PROTECTIVE ORDER
In October, Ethicon filed a protective order to prevent lawyers to re depose Dr Patricia Reddy. Ethicon argued that since Dr. Reddy hadn’t treated Ms. Emmett since 2007, and since Kline and Specter fully participated in taking her deposition that she shouldn’t be required to undergo another deposition.
The original deposition was conducted June 21, 2018. In it, Reddy said she was she was trained on how to do a Prolift implant by Dr. Lucente at his facility in the Lehigh Valley. She was also trained on the transobturator tape or TVT-O. Altogether she was trained on four Gynecare devices by Dr. Lucente.
Documents from the Linda Gross trial show Dr. Lucente was compensated millions of dollars to be a “preceptor” or trainer of doctors encouraging their use of J&J pelvic mesh products. He also trained the implanting physician in the Joan Budke’s wrongful death case in Missouri in 2014.
During the deposition Dr. Reddy affirmed that today she would stand by her decision to use mesh to treat Ms. Emmett.
The order was granted by the court Judge Arnold New. Dr. Reddy but on October 29, attorney Baldwin re-issued a subpoena for Dr. Reddy to testify live at trial instead of via videotape. Instead Dr. Reddy agreed to another videotaped deposition November 8th.
Dr. Reddy, continues to practice medicine in York county, Pennsylvania.
This will be the first pelvic mesh case tried in this Philadelphia court since, McFarland v Ethicon which resulted in a deadlocked jury September 24. That case will be reset for trial.
So far, of seven trials conducted in this venue, all but two have been decided for the plaintiffs amounting to more than $105 million.
https://www.meshmedicaldevicenewsdesk.com/after-a-lull-philadelphia-readies-for-prolift-mesh-case-against-jnj/
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Nats promise surgical mesh register while Govt 'drags chain', say advocates
Nov 18, 2018 | Stuff
By Stacey Kirk
A surgical mesh crisis is "not being taken seriously" by the Government, which has all but reneged on a promise to establish a register for the controversial product, advocates say.
And political roles on the issue appear to have reversed, with the National Party doing its own about-face to promise it would not only establish a register to record every use of surgical mesh, but it would do so retrospectively to capture past procedures as well.
The National announcement has been welcomed by leading advocacy group Mesh Down Under, which said the Government had promised big when it was in Opposition but its response since, had been disappointing.
Surgical mesh is a commonly-used product to treat a number of gynaecological issues like pelvic organ prolapse and stress urinary incontinence, as well as some hernias. However it's use has left significant numbers of women with debilitating and chronic pain - in some case unable to sit or walk, or have intercourse, comfortably. A number of other countries had suspended its use completely.
Sufferers have been campaigning for years, for tightly regulated and recorded use of mesh. The then-National Government made no moves to establish a national register, however it did begin some work to review its use.
A number of enhanced safety measures had already been introduced, across both governments. Most recently, the Ministry of Health has required all hospitals to guarantee their surgeons had specialist credentials to perform trans-vaginal mesh procedures, work to provide patients with better information was underway, and 13 District Health Boards had suspended certain surgeries involving mesh.
Medsafe had also moved to ban some brands of mesh entirely.
It did not go far enough.
One of the Mesh Down Under founders, Charlotte Korte, said a major problem was the lack of specialist expertise in New Zealand to remove the product. More qualified surgeons were coming onstream, performing more surgeries, but there was no training for removal, which mean the issue would only get worse.
Government engagement had become a "box-ticking exercise" and Associate Health Minister James Shaw had not met with advocates outside of highly-populated roundtable meetings.
National's associate spokeswoman for health Maggie Barry accepted her party had been reluctant to move while in Government. But said significant research developments in the past eight months had shown action was needed, and urgently.
“The Health Minister and the Prime Minister were both strident in their calls for a surgical mesh register when in Opposition. However, more than a year after going into Government they have made no decisions and have instead released a series of meaningless recommendations."
Not only were they "timid" there were not sent out to all of the relevant organisations performing these procedures, missing out private hospitals which carried out a significant proportion of the procedures, said Barry.
She said Greens Acting Associate Health Minister James Shaw was refusing to meet with Mesh Down Under.
Shaw only held the role while Julie Anne Genter was on maternity leave. But he said Genter had met with Mesh Down Under twice since the election, "following four formal requests for meetings to the Associate Health Minister".
"Although I was unable to meet with MDU during my time as Acting Associate Health Minister, my office has emailed the group approximately 30 times in response to issues and queries."
The Ministry of Health was also in close and regular contact with them, he said.
And setting up a national register was not so simple.
"Establishing a national register will take five years of operation until the benefits begin to be seen. At current rates of usage for surgical mesh, the cost is estimated at $15 million over 10 years. During this time, it is clear that regulatory action will see the usage of mesh decline significantly."
A national registry remained "under consideration".Korte said National had come to the right realisation.
"We've come to the stage now where we all need to act together and I applaud National for stepping up now. I think it's time that all parties stood up like National and actually supported the patients.
"Because we're dealing with people's lives, that have been absolutely ruined, absolutely destroyed," Korte said.
https://www.stuff.co.nz/national/politics/108643432/nats-promise-surgical-mesh-register-while-govt-drags-chain-say-advocates
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Hundreds of women given mesh implants despite ‘ban’ on procedure
Nov 19, 2018 | The Press and Journal
By James Wyllie
Women in Scotland are still being given controversial mesh implants, more than four years after health boards were told to stop offering the procedure.
Hundreds have been left in constant pain after being given the treatment for stress urinary incontinence or pelvic organ prolapse.
Both conditions are common occurrences after childbirth.
In 2014 then-Health Secretary Alex Neil said the procedure should be suspended pending the outcome of an independent review into the practice.
Prior to this around 1,500 people were being given mesh implants every year.
Some of these hardened, however, and the women affected have been left in constant pain since. Many of them have also been told they will never be able to have sex again.
Despite the Scottish Government orders and the widespread campaign which followed to have the procedure banned, The Press and Journal has obtained figures showing that more than 600 women across six Scottish health boards have had the procedure in recent years.
Numbers taking it up are falling rapidly, however.
In September Mr Neil’s successor, Jeane Freeman, said health boards have been told to “immediately halt” all procedures until new protocols can be put in place.
She added that the use of mesh should only be carried out in the “most limited” circumstances and subject to “rigorous process”.
Stonehaven mum Nikki Lawrence was left in so much pain after having the procedure in 2010 that she had to quit her job.
Last night she said the new figures were “shocking”.
“The mesh procedures are cheaper and quicker than the original operations so that’s why they do it,” she said.
“But it’s shocking there are health boards still putting women in this position.”
All of the health boards in the north-east confirmed they suspended the use of transvaginal mesh implants following the Scottish Government’s advice in 2014.
A spokeswoman for NHS Grampian said: “We halted the use of transvaginal mesh in the 2014/15 following the suspension announced by then Cabinet Secretary Alex Neil. We have not used it since.
“Other types of mesh – eg those inserted abdominally – are still permitted and we continue to use those in line the Chief Medical Officer’s guidance.”
https://www.pressandjournal.co.uk/fp/news/aberdeenshire/1608874/sun4mon-hundreds-of-women-given-mesh-implants-despite-ban-on-procedure/
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Kelp ban could see Scotland lose £300m industry, warns biotech firm
Nov 19, 2018 | Mail Online
Scotland could lose out on a £300 million industry if MSPs vote to ban the industrial harvesting of kelp in its waters, company bosses have claimed.
Ayr-based Marine Biopolymers (MBL) wants to harvest 30,000 tonnes of kelp off the west coast before using a revolutionary process it has developed to create a product which could be used to make “invisible armour” or slow release cancer drugs.
The nanocellulose it produces from the seaweed is the “best in the world”, it claims, and could have a whole host of possible applications – including an alternative to the vaginal mesh implants which have left some women in crippling pain.
But this hi-tech new industry, which MBL estimates could be worth £300 million a year to Scotland’s economy, will be halted if MSPs pass new legislation that bans dredging for kelp.
After more than 14,000 people signed a petition against such dredging, Green MSP Mark Ruskell successfully amended the Scottish Crown Estate Bill to ban the removal of entire kelp plants.
Veteran naturalist Sir David Attenborough has also spoken out in support, saying it is “absolutely imperative that we protect our kelp forests”.
But MBL co-founder David Mackie insisted its plans to harvest the seaweed laminaria hyperborea are “entirely sustainable” – pointing out there is an estimated 20 million tonnes of it in Scotland’s waters.
The kelp, which he described as “the daddy of the seaweeds in Scottish waters”, grows up to 8ft long, with the plants attaching themselves to rocky surfaces
He said: “People say we intend to dredge. Well you can’t dredge a rocky bottom, so we’re not doing that.”
He insisted the seaweed is “really abundant” in Scottish waters, adding that its special properties come from the “tough conditions” it is subjected to as it is battered by underwater currents.
As MBL developed its processes to remove alginate from the seaweed, it found marine cellulose was also produced.
Mark Dorris, a senior research fellow and lecturer in material science at Edinburgh’s Napier University, has been working with that to create new bioplastic materials, the starting point of which are fibres which are 1,000th of the width of a human hair.
Wood pulp is already used to produce nanocellulose, but Dr Dorris said when kelp is used the end result is “better than any nanocellulose in the world” – with it also being produced using a more environmentally friendly process, without harsh chemicals and cutting CO2 outputs by 80%.
This raw product can be turned into bioplastics to be used in food packaging for products such as sandwiches and ready meals, but work has also been taking place with the Ministry of Defence to develop a “transparent armour” which could be used for helmet visors and body shields by police and the armed services.
Unlike existing products, these do not go cloudy after impact, and will “actually even have aspects of self-repair”, the scientist said.
The nanocellulose could also be used to develop slow release drugs for treating colon cancer, as well as to help conserve fragile, historic documents and artefacts.
Dr Dorris said: “There’s loads of applications for this, medical implants, meshes. This stuff, because it is made from seaweed, is biocompatible, the wood cellulose isn’t.”
But Mr Mackie said he fears plans to develop such products could be halted if MSPs vote through the legislation as it currently stands on November 21.
He said: “We worked long and hard to develop our process, basically we have turned the whole alginate processing upside down, to get to what is absolutely unique, nobody else does it.
“We’ve got this brilliant raw material, we do a wee bit of magic with it.
“This is the thing I am most proud of that we have done, and when I see what these guys can do it is just incredible.”
He added: “We are entirely sustainable, we would not in any way endanger the natural processes.”
Dr Dorris added: “Not only is it sustainable, we’re reducing energy demands, we’re reducing toxic waste.
“I would ask and expect the green lobby to get right behind it – this is a green technology, it is a green project and it will be worth an awful lot of money to the Scottish economy.
“It is estimated in five years’ time the global market for nanocellulose will be a billion dollar industry, and it’s a simple stark choice – either we lead the world or other people do it and we chip in from the sidelines.”
https://www.dailymail.co.uk/wires/pa/article-6404137/Kelp-ban-Scotland-lose-300m-industry-warns-biotech-firm.html
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