Preview Newsletter
ethicon 3/2
-
Mesh surgery scandal: Health watchdog accused of backing procedures without fully understanding risks
Mar 1, 2015 | Daily Record and Sunday Mail
By Marion Scott
Health watchdogs were last week accused of defending controversial mesh surgery without properly investigating the risks. -
Shona Robison Calls for Mesh Implants Suspension
Mar 1, 2015 | BBC
...Ms Robison also confirmed that women who have had complications as a result of mesh implants would be able to access specialist support... -
Ethicon Mesh Trial Wraps Up in California Court
Feb 27, 2015 | Reuters
By Jessica Dye
A California jury is poised to decide whether Johnson & Johnson's Ethicon Inc is liable in the first trial over injuries allegedly caused by the TVT Abbrevo -
Closing Arguments: Perry v. Ethicon Mesh Trial
Feb 27, 2015 | Mesh Medical Device News Desk
By Jane Akre
At this writing the Perry v. Ethicon case has gone to the jury. Since court is in recess today, Friday, the jurors will be back to deliberate Monday. That marks the sixth week of this trial!
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
-
Mar 1, 2015 | Daily Record and Sunday Mail
By Marion Scott
Health watchdogs were last week accused of defending controversial mesh surgery without properly investigating the risks.
The Medicine and Healthcare Products Regulatory Agency paid researchers from York University £40,000 to gather evidence on the procedures.
But, quizzed by MSPs on a Holyrood committee, MHRA boss Neil McGuire was forced to admit the 2012 probe had“limitations”.
Dr McGuire and medical device specialist Sally Mounter were grilled by Tory MSP Jackson Carlaw at Holyrood’s Public Petitions Committee on Tuesday.
The MHRA have insisted there is no problem with mesh surgery – used to treat bladder and pelvic organ disorders – despite more than 300 patients with complications.
Carlaw asked why the MHRA had not waited for the outcome of a £2million trial before deciding the benefits of the surgery outweighed any risks. He said the organisation relied “heavily” on the findings of the 2012 York report.
Allan MilliganJackson Carlaw MSP
He asked: “What level of effort was put into this librarian-led review of evidence, costing just £40,000 which formed the basis for the MHRA’s stance despite the number of women with devastating injuries?”
Dr McGuire, an MHRA director, said they had carried out a new report for NHS England, which included evidence from manufacturers and input from clinicians.
He said: “We realised the York report had limitations which is why we went to extensive efforts for the report we produced for the Chief Medical Officer for England.”
But Carlaw responded: “I have to ask whether the MHRA really have the capacity to deal with what is fast emerging as a national health scandal.
“Scotland’s Health Secretary was right to introduce a moratorium on procedures in June.
Mesh product
“The health boards which ignored the suspension and relied upon what the MHRA said, need to think again.”
Former shadow health secretary Neil Findlay said: “The MRHA’s arrogance defies belief. To see all the evidence he needed, Neil McGuire only had to look at the injured women in wheelchairs and using walking sticks, sitting behind him.
“It was telling he couldn’t bring himself to look them in the eye, never mind talk about the experiences which have destroyed their lives.”
US lawyer Adam Slater, lead attorney in over 7000 mesh cases in New Jersey, gave evidence via a video link.
Describing the human and financial cost as “catastrophic”, Slater added: “Scotland did the right thing suspending mesh implants.
“They have the opportunity to lead the rest of the world and show big pharmaceutical companies they cannot get away with this.”
-
Shona Robison Calls for Mesh Implants Suspension
Mar 1, 2015 | BBC
It has emerged that some boards are continuing to perform the procedure.
This is despite a call for a moratorium by former health secretary Alex Neil in June last year.
Ms Robison also confirmed that women who have had complications as a result of mesh implants would be able to access specialist support.
Mesh implants are aimed at treating prolapse and bladder problems, but some women have experienced painful complications.
Ms Robison met members of the Scottish Mesh Survivors campaign group earlier this week.
She said the Scottish government would work with patient groups and NHS inform to develop the practical support service for women experiencing complications or who have concerns regarding their condition.
EXPLAINER - Mesh implantsThe Scottish Parliament's petitions committee recently heard evidence on a petition calling for the suspension of the use of medical mesh devices. Find out how the procedure has blighted the lives of some women.
She said: "I had a very constructive meeting with members of the Scottish Mesh Survivors campaign group.
"I recognise the impact the procedure has had on these women and was keen to discuss with them ways in which the Scottish government can offer support.
"As part of our discussions I was pleased to confirm that the Scottish government will be able to arrange additional support for those affected by the procedure through the NHS inform hotline.
"We will be working closely with patient groups and NHS inform to develop this role."
'Extremely concerned'
She added: "I am extremely concerned that women have suffered complications following their surgery. This is why we have set up an independent review, which is currently considering these issues and will make recommendations in the spring.
"Until then we have requested that all health boards continue to suspend the use of mesh implants, except where clinically advisable and provided the woman, aware of the risks, has fully consented.
"I will be writing again to all medical directors asking them to consider suspension while the independent review is carried out. This is the right thing to do and will allow a thorough assessment of the evidence before next steps are agreed."
The Medicine and Healthcare Products Regulatory Agency (MHRA), which regulates mesh products, published a report in October stating that "whilst some women have experienced distressing and severe effects, the current evidence shows that when these products are used correctly they can help alleviate the very distressing symptoms of SUI (stress urinary incontinence) and POP (pelvic organ prolapse), and as such the benefits still outweigh the risks".
It added: "In line with other medical device regulators worldwide we are not aware of a robust body of evidence to suggest that these devices are unsafe if used properly as intended and therefore should be removed from the market."
-
Ethicon Mesh Trial Wraps Up in California Court
Feb 27, 2015 | Reuters
By Jessica Dye
A California jury is poised to decide whether Johnson & Johnson's Ethicon Inc is liable in the first trial over injuries allegedly caused by the TVT Abbrevo, one of the newer models of transvaginal mesh devices that have been the subject of thousands of lawsuits.
Following a five-week trial, closing arguments took place Thursday before Kern County Superior Court Judge Lorna Brumfield in the 2013 lawsuit brought by Coleen Perry, who was implanted with Ethicon's Abbrevo in 2011 to treat stress urinary incontinence.
To read the full story on WestlawNext Practitioner Insights, click here: bit.ly/17D4V1P
-
Closing Arguments: Perry v. Ethicon Mesh Trial
Feb 27, 2015 | Mesh Medical Device News Desk
By Jane Akre
At this writing the Perry v. Ethicon case has gone to the jury. Since court is in recess today, Friday, the jurors will be back to deliberate Monday. That marks the sixth week of this trial!
The product liability case concerns the Ethicon (Johnson & Johnson) pelvic mesh, the Abbrevo, a sling used to treat incontinence. This is the first defective product trial over the Abbrevo, which remains on the market.
The following transcript outlines much of what was said in closing arguments to the jury by Ms. Perry’s attorney, Tom Cartmell (Wagstaff & Cartmell) of Kansas City, MO. (Editor’s Note* Mr. Cartmell has a pleasant demeanor that might be described as boy scout-like. Having watched the case he presented in Lewis v. Ethicon, he and co-counsel put on a thorough case.)
Remember the preponderance of the evidence is the standard in this product liability case. In other words, the slight doubt goes to the plaintiff.
Thanks goes out to Courtroom View Network for access to the feed in this case. Because of the high number of witnesses presented, Mesh News Desk has reported on a number, not all of them. Judge Brumfield has specified that images and quotes cannot be taken from the proceeding to put on the internet, so the following is a summary from Mr. Cartmell’s closing words to the jury. Please see comments from The Bakersfield Californian and be sure to comment! Here.
February 26, Closing arguments, Thursday, Tom Cartmell (Wagstaff Cartmell)The defense in Perry v. Ethicon (S-1500-CV-279123) tried to show her as a woman who doesn’t work but lives on a golf course community, who enjoys a Hawaiian vacation zip-lining with her firefighter husband when he retired. The defense attorneys ( Ethicon, J&J) showed her to be a woman who relies on natural modalities and goes to many doctors, a woman who suffered painful pelvic conditions before her mesh implant. Very damaging was her own doctor saying she did not complain of pelvic pain, or pain with sex in her recent exams. Her husband, Patrick, added context when he said his wife is not a complainer, even to him.
Coleen Perry had appeared very together and collected on the stand and not in a great deal of pain as some women have, for example, Linda Gross who could not sit in the courtroom due to her mesh injuries. What also has hurt this case are the large numbers of breaks taken and numerous ruling s in favor of the defense by Judge Brumfield. At this writing court is not in session on this Friday or on any other.
During closing arguments, Tom Cartmell thanked the jury for their time over the five weeks. He said it’s the greatest act of citizenship one can do in a democracy. When you vote today you’ll be one of twelve. Your vote counts and you can make a difference. You can be the conscience of the community, he said.
Could you consider her on an equal ground to Johnson & Johnson (J&J)? This is the only place in the country Ms. Perry could be on an even playing field with J&J. Outside of this courtroom she cannot be on an equal field.
Did a witness show bias or prejudice? That is important in this case, said Mr. Cartmell.
We believe when you are done and have heard everything you will speak the truth he said. Burden of proof is 51 percent, not beyond a reasonable doubt like a criminal case, he reminds the jurors. In other words, if the evidence is a feather weight in their favor, you must find for the plaintiff.
Ahead for the Jurors
In reviewing this case, jurors must first consider negligent design case. They have to prove Ethicon and J&J sold the Abbrevo and were negligent in designing the Abbrevo and that led to her injuries. They are negligent if they failed to use the degree of care that a reasonable person would use. What do reasonable manufacturers do? They do a proper study before they invent a permanent implant; they don’t ignore their negative experiences; they don’t ignore the doctor who runs the claims department, they tell the FDA the full truth and they tell their sales reps and doctors the full truth. I think that is fairly reasonable, said Cartmell. The evidence shows they didn’t do any of those things.
The Abbrevo is too heavy, too stiff and it degrades, he said. We believe the evidence showed heavyweight, dense mesh causes increased injuries to women. Ethicon said their mesh was, in fact, lightweight. 105 grams per meter square is a heavy mesh, if not the most heavy mesh on the market, next to Marlex. Scientists testified it was heavyweight mesh, even Dr. Helhammer (Ethicon) said so in a videotaped deposition.
Dr. Bruce Rosenzweig
Dr. Bruce Rosenzweig said with a heavier mesh you have more shrinkage and contraction, scarring and erosions. In 1998 the old construction mesh was put on the market for a hernia product. A document showed there were concerns it could erode, that it was stiff and could protrude through the vagina. In 2004 after the TVT products had come to the market, they were thinking about expanding the applications for mesh in a woman’s pelvic tissues. They tried to use 1974 mesh in the TVT mesh. What happened? Their consultants in France put it in 100 women’s bodies. It increase the erosion rate and vaginal stiffness and they said we’re not doing that. We are not using the 1974 hernia mesh in the pelvic floor application because it cases too many erosions and they took it out. That’s undisputed in this case, said Tom Cartmell.
In 2006 their own scientist, Dr. Jorge Holste said heavyweight meshes increased complications. Prolene mesh causes not as much inflammation as Marlex mesh but Prolene mesh is next in causing inflammation from the heavyweight, dense mesh.
Dr. Douglas Grier
Dr. Douglas Grier goes around the country and teaches other doctors about pelvic organ prolapse mesh. He said lighter weight meshes cause less sexual dysfunction and pain. The theory is the lighter the mesh the more flexible is the mesh the more biologically it is incorporated and has less potential for side effects. Dr. Grier was an expert for Ethicon in this case. Dr. Luu was never told the Prolene mesh was a heavy mesh. Otherwise he and others wouldn’t use it and Ethicon knew that. This company knows lightweight mesh could be used for SUI. There was a TVT-O partially absorbable, Ultrapro lightweight mesh. If the heavy weight mesh was good why would they change? Dr. Helhammer told jurors it was too stretchy and it didn’t work. The cadaver lab results were never shown to the jury. Why not, asked Mr. Cartmell.
What we know from the literature is a study by other investigators, a four-year study, the study had 144 women over four years and those investigators used Prolene Soft and Ultrapro and the purpose was to ask – is lightweight mesh better for the treatment of SUI? Ultrapro had the lowest complication rate. Ethicon never did that study, but others did. I’ve never seen anything like this, said Mr. Cartmell.
On their website (Ethicon) it says it is a lightweight mesh. But that changed. It no longer says TVT is lightweight mesh. Dr. Bruce Rosenzweig noted that on the stand before direct examination. An Ethicon rep said they had started a project two months ago to change the website on the eve of Dr. Rozenzweig’s testimony. If you believe this is heavyweight mesh, then it has been designed in an unreasonable manner and they are negligent because of that.
The mesh is too stiff. When you have a heavyweight mesh already that is stiff and you laser cut the mesh, you make an already stiff mesh stiffer. In 2006 Ethicon decided to go from mechanical to laser cut mesh. Gene Kamerer (Ethicon) answered on the stand via video the reason they did it was to save waste and cost. Dr. Greer said you agree this is the old mesh. He said they tend to be stiff… when you cut it to the laser cut mesh it becomes stiffer. One of the properties of an ideal sling is it’s not too stiff. Yet Ethicon says the mesh is identical, i.e., laser and mechanically cut mesh. The evidence is overwhelming that is not the case, said Mr. Cartmell.
In 2004 Ethicon did internal testing of the laser cut mesh and stretched it 20 percent and fount it was three times stiffer than the mechanically cut mesh. (Ms. Katrin Elbert, Ethicon). They never showed a single study that showed they were the same, he said.
Remember you can ask for documents in jury deliberations and you can ask for mini-me which was the Abbrevo. The shorter mesh like Abbrevo even has less stretch. De Leval’s (the inventor of Abbrevo) product will face similar challenges to the TVT Secur (laser cut short mesh) if produced that way, their engineer (Dan Smith) told them they will have problems. They knew in 2008 it had problems and erosions.
Engineers met with the inventors the consensus was, among the team, laser cut has more rigid edges and is stiffer than mechanically-cut meshes. That was said before lawyers were involved. In 2009, a document Piet Hinoul met with inventor, de Leval. The reason he went was that Ethicon offered the inventors the option of changing the laser cut mesh, to discuss modifications on TVT-O. If they are identical, why is Ethicon making changes to the mesh? So it would mimic the elastic properties of a mechanical cut mesh, answered Mr. Cartmell showing the jury documents. If you make changes, and want to get a product on the market to be paid, they said they will not do that, i.e.,make changes. Look for that document by Piet Hinoul to the inventors, says Mr. Cartmell.
Piet Hinoul thought Professor de Leval liked laser cut. Professor Nilsson only wants mechanically cut mesh. But Professor de Leval felt laser cut was stiffer, had sharper edges and caused more erosions, the inventors told Piet Hinoul the lead director for Abbrevo development. Professor de Leval said half were mechanically cut mesh in his study. But Piet Hinoul went back to the company and told the team professor de Leval wants mechanically cut mesh. It was considered abut the company said no even though the professor and inventor is telling the company to use the mechanically cut mesh to produce fewer erosions. Ms. Elbert, the company representative, said it was the first time she saw that document.
Dr. Nilsson is the founder of the TVT meshes. He also told you he thought there were more erosions with laser cut than mechanically cut mesh. He said in 2008 he will not use laser cut mesh with exclamation points. Ms. Elbert said she had never seen that document either. Professor de Leval sent an email alert in 2012 – I just had four erosions in 2 months – These are quotes from the documents. Abbrevo is less flexible and integrates worse into the tissues, said the inventor in a message to the company in an email alert. Remember it’s all about costs, Cartmell said, manufacturability, called the company representative (another word for saving money).
TVT Secur was taken off the market in June 2012. It’s different from the Abbrevo, it’s shorter. This mesh is the same laser cut old construct heavy weight mesh in the Abbrevo. It lays underneath the urethra like the Abbrevo, but the Abbrevo is 4 cm longer versus 8 cm for the Secur. Secur had high erosions rates. Seven times the erosions the company saw with laser cut mesh, Piet Hinoul found in studies before he joined the company. Hinoul, the worldwide medical director, was not brought in to testify at this trial as he was at the recent Budke case.
Mini-slings have been taken off the market. The company doesn’t want you to know the Abbrevo is a mini-sling also, according to company’s own documents. Even the sales rep Ricky Chahal called it a mini-sling among his colleagues. Story here.
In 2008 and 2009 Dr. Meng Chang (Ethicon) went to her senior management to say something is up. There are more reports of mesh erosions and dyspareunia coming into the company she told Ethicon. Furthermore, in light of the recent burst of report to the FDA we are seeing lots of frequent reports. There have been no studies comparing mechanically to laser cut mesh. You’ve got to do a study. You are talking about women’s health, he said. It is not what a reasonable manufacturer would do.
Degradation
We brought you two doctors – Tom Cartmell said they brought to the stand Dr. Tom Margolis and Bruce Rosenzweig. Both testified the mesh they remove is brittle, contracted and shrinking. Alex Wayne, their own consultant, pulled mesh out of women and concluded it degrades, was brittle and stiff and contracts.
MSDS it says Prolene, supplier from Sunoco, said it is incompatible with oxidizers and peroxides which are present in a woman’s vaginal tissues and can perpetuate breakdown of the mesh. Ethicon hired a consulting company to ask what is causing all these erosions. The document was in this courtroom, PA Consulting concluded pp (polypropylene) mesh degrades including Ethicon’s meshes.
Explants were studied by Dr. Vladimir Iakovlov (seen in Boston Scientific case in Miami) here . One hundred explants all showed degradation, he reported in a study. Seven explants studied by Dr. Phillipe Zimmern from Houston had all degraded linked to increasing pain, shrinkage and erosions. And it continues over time. Eighty percent of Ms. Perry’s mesh is still inside her body. Degradation is happening in women’s bodies and it happens immediately.
TVT-O is mechanically cut mesh. It is the predicate for Abbrevo. At the same time the Ethicon expert said the mesh is identical. Dr Grier has been paid $600,000 and has implanted many women. He said there were no long-term complications. He said he looked at all the studies. I’m not an academic he said. I operate. He said the vast majority of surgeons do not do burches. For a month they are hunched over and can’t get out of bed. The American Urologic Association says it’s still the standard of care. He was impeached with this. He said he had put in 150 to 200 Abbrevos, a credibility issue when compared to his deposition of 50 Abbrevos. The risk of erosion is one or two percent, he said. Then he said four percent. Weigh the credibility.
There are 1.5 million women with TVT’s and they are all doing well, he said on Tuesday. Wednesday he corrected that and said he misstated that. He said the majority are doing very well. 85% are doing very well. 85% is 225,000 women who are not doing well, said Mr. Cartmell, indicating there are more people outside of this case who are suffering the effects of mesh. What’s not allowed in this case or in any of these product liability action, is information on how many lawsuits have been filed. The Abbrevo has 7 or 8 studies, no randomized controlled studies. One was a questionnaire. One had a 40% dropout rate, said Mr. Cartmell. The corporate representative agreed the Abbrevo was not well studied. This case is not about TVT it is about the Abbrevo and there are very few studies on the Abbrevo.
Warning Claim
Mr. Cartmell told the jurors: On the warning claim- what they have to find is the warning goes to Dr. Luu. Ethicon had a duty to warn Dr. Luu. Even Dr Luu said it should have included information on heavy weight mesh, on stiff mesh, that’s what the doctor needs to know about. Sales rep Ricky Chahal didn’t know it was a stiff mesh that degraded and that’s what he told Dr. Luu. Dr. Luu said if he had been told it was heavyweight or stiffer or degraded would he have prescribed it? No, said Mr. Cartmell. Dr. Luu is no longer using the Abbrevo product.
The instructions on law say it’s what Dr. Luu was told, not what Ms. Perry was told. There is evidence from the treating physicians she had an erosion and the erosion was from the mesh, according to Dr. Sing, Luu and Dr. Allen. Dr. Flynn said it was healing issue that caused her complications. He was alone in that opinion.
You will be asked to consider past and future medical pain, suffering, those are damages if the evidence supports it. These are permanent. When you get to the verdict form you will be asked to fill it out. The evidence in this case says you should find for Ms. Perry. On a negligent failure to warn I believe you should find for her. It’s up to you. For future medical expenses $195,000. For past noneconomic damages, that’s pain and suffering and disfigurement, the inability to have comfortable sexual relations, $2 million. She has 33 years going forward and she will have continued pain from this mesh.
You will be asked to access punitive damages is all about the conduct of this company. It’s designed to discourage similar conduct in the future, you may award it for malice, pressure or fraud. Ignoring your inventors all of these things in front of them, Ms. Perry was put in danger and had these terrible injuries as a result. That’s malice. You are allowed to consider, we have a stipulation of parties, that J&J net worth is $75 billion. If you award punitive damages, what can you to make a $75 billion company listen? If you don’t, it’s business as usual. A company this size you should find punitive damages, not listening to the inventors, $15 to $20 million dollars. That’s one percent of the value of this company. Will that make them listen? They are blaming Ms. Perry for this. They are calling her a liar. Is she a liar? Someone who came in here to tell you all about the problems she is having, open and honestly. A liar walks up to the stand with a cane and says I can’t live my life. Does a liar write that success story? Does a lawyer post on her face page she’s out doing things in Hawaii? No, liars say I’m 100% disabled. She’s not a liar. She’s been totally honest from day one. I hope you’ll take that into consideration. You’ve heard from this case, she had a seizure, she had stomach problems, she’s on all kinds of supplements. She drives a new car. She lives on five acres? That’s not true. That is designed to take your eye off the ball and not look at their conduct. Thank you very much. #
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
Add recipients
Suggested