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Rock Star Urogyn on Stand in Pelvic Mesh Trial

Dr. Anne Weber, from Linda Gross trial. Cameras are now allowed in this Mo. case.

Dr. Anne Weber, from Linda Gross trial. Cameras are now allowed in this Mo. case.

She was calm, personable  and very knowledgeable. Dr. Anne Weber appeared on the stand this morning in Day Four of the Butke v. Ethicon (Johnson & Johnson) defective product trial. The family claims the Prolift system pelvic mesh implant in Joan Budke led to her deaths sixteen months later from massive infections caused and encouraged by the polypropylene mesh.

The case is being heard in the Camden Co. near Lake of the Ozarks, Mo. where she was a resident. It was brought by her husband Donald and the three adult Budke children. Two daughters were in the courtroom.

Dr. Weber brings enormous credibility to these proceedings.  She did a residency in obstetrics and gynecology and was an advanced surgical resident at the Cleveland Clinic.  Dr. Weber was one of the originators of the specialty of urogynecology, working and training others at the Cleveland Clinic.  There students, residents and fellows trained in the specialty that would become urogynecology after a four year residency in Ob/gyn.

Eventually at the National Institute of Health she would direct funding and studies in the specialty field of women’s health – pelvic floor disorders which included prolapse and incontinence. She helped form the Pelvic Floor Disorders Network as program director. That became a collection of eight institutions around the country doing data analysis.

Dr. Weber didn’t stop there.

I realized the research training I had to that point was not sufficient so I attended the University of Michigan at the School of Public Health to receive a masters degree in clinical research design and statistical  analysis.” What is that?   Basically, it’s clinical research designed to determine how you set up and perform studies so you can answer the question you set out to answer.  First you set up a question you want to identify, pick the patient population, determine what kind of questions will you ask, analyze and condense and summarize into a report to ideally answer the question you started out with.

She has published abut 100 peer reviewed articles on the topic of pelvic floor disorders.

Predicting a defense question in advance, plaintiffs’ attorney  Adam Slater asked her how many hours Dr. Weber had spent on this case.  Many hours had brought her about $88,000 in compensation.

prolift box 200Thanks to The Mesh Warrior Foundation for the Injured for coverage support…..Thanks to Miklos and Moore for their support ! And to all of you who help bring this coverage in the public interest! You are much appreciated. Write janeakre@meshnewsdesk.com 

 

Remember the ACOG Practice Bulletin?  Earlier we reported on the use of the word “experimental” in describing mesh to do pelvic surgery.

It was Dr. Weber who authored that bulletin with the focus of protecting women and letting the end user doctors understand mesh repair was not a firmly accepted practice yet.  She started talking about one of the reviewers noticing the word “experimental”… objection said the defense team, one of perhaps two dozen objections we would hear this day.

We know from past testimony that was Dr. Vincent Lucente (see last week’s testimony) who eventually had the word ‘experimental’ removed from the bulletin that doctors would read.  That would encourage more use by doctors who would have fewer concerns about liability, and give the green light to insurance coverage.

But the objection meant that Adam Slater, the attorney for the Butke family, couldn’t continue.

Adam Slater

Adam Slater

$88,000 Consulting Fee

Knowing the other side would ask, Slater established that Anne Weber has been paid about $88,000 for the 240 hours she has put in to researching and reading to prepare her expert testimony for this case.  Those questions are always asked of both side’s expert witnesses.

Dr. Weber

Dr. Weber

Slater asked her what was an available treatment to treat a mild case of incontinence. 

Various options, said Dr. Weber – first, you could do nothing; then you could use a pessary; do a suture repair (Colporrhaphy) or a biologic or synthetic graft augmented repair. Lastly, you could use a mesh kit like the Prolift.

All of those traditional repairs would be reasonable considering her condition, said Dr. Weber, besides the Prolift was intended for a stage 3 or 4 prolapse, while Ms. Budke had stage one or two. Yes, prolapse might reoccur with a traditional repair, but one has to consider how the woman is feeling, in other words, her quality of life. And more often than not, an older patient with mild prolapse frequently did not see it return. Reoccurrence more often happened among younger patients.

Meanwhile, documents shown to the jury indicated industry-generated data showed a high rate of failure using a traditional repair, therefore the reason for pushing the Prolift.

Dr. Weber said, “In my opinion it was unnecessary.

Bettina Strauss

Bettina Strauss

 

During one of the many objections this day, your editor was asked by defense attorney Bettina Strauss of St. Louis,   “Is there no power on that side?” indicating I shouldn’t be sitting so close to the defense side, near the screen and on their half of the courtroom but also near the only power strip.  She asked with a smile, but I don’t think she was kidding. 

 

Go to the Videotape

The plaintiffs then showed an Ethicon-created animation of a prolapse procedure as well as an actual videotape of surgery.  The defense objects again which ends in a sidebar. The jury leaves the courtroom.

The screen shows the roping of the arms in the animation as the cannula leaves the body. Judge Hass almost always granted a defense objection.

Slater argued, “The video shows roping in real life we are being severely prejudiced and we should have the right to put it in front of the jury. They don’t want the jury to see what they sold.”

After stipulated that Dr. Weber had never seen this procedure in person and had never performed a Prolift surgery, they continued.  Dr. Weber is very professorial and comfortable explaining to the 15-person jury who seem engaged.

Pelvic organs, FDA

Pelvic organs, FDA

She shows the space where the Prolift mesh is going to be implanted between the front of the vagina (anterior) and the bladder.

About the Prolift implant she said, “The involvement of the hip and the groin would never be involved in a typical repair. In the Prolift, a whole new area is involved that has nothing to do with the prolapse.”

While a company animation showed the mesh arms laying flat, in real life they curled through the cannula, said Dr. Weber, making impossibly small the pore size of the arms in the process.

 

The Gynemesh PS study

Ethicon had sponsored a study to see what happens when Gynemesh PS is implanted abdominally or through the vagina. It was conducted to encourage doctors to be mesh users. In preparation for her expert testimony, Dr. Weber took the time to revisit the study protocol, study collection forms, raw data and information that had been transcribed from a medical chart.

Her results showed a drastic difference from what Ethicon reported to a scientific committee.

Dr. Anne Weber, from Linda Gross trial

Dr. Anne Weber, from Linda Gross trial

*1 year mesh exposure, same as erosion  – Ethicon reported 9.4%

                                                                                            Actual  – 15.4% erosion

 

“That’s a very high rate,” said Dr. Weber.

1 year prolapse recurrence rate      24%             Actual  – 33.8%

1 yr vaginal surgery prolapse recurrence rate    (not reported)        Actual -27.3%

 

Not only that, but doctor consultants working for Ethicon  – Dr. Lucente, Dr. Miles Murphy and Dr. Dennis Miller, reported different results at different medical societies, said Dr. Weber.

At the same time the plaintiff side showed a document of another mesh being studied with favorable results.

Of the UltraPro (UP) the LIGHTning Human Cadaver Wet Lab participants said:

*Preferred Ultrapro over Gynemesh PS

*Better handling of UP with Prolift instruments

*Feels very soft in place

*No crumpling of the arms

Ethicon knew there was a better mesh. The document is dated September 6, 2006, 17 months before Ms. Budke received her implant.

Referring to the French inventors of the Prolift TVM group, Dr. Weber said they were not comfortable with having the Prolift used in widespread clinical practice. They felt the erosion rate was too high. “They felt it needed to be under 5% and they were not even close to that.”

Charlotte Owens

Charlotte Owens, from Linda Gross trial

Charlotte Owens, from Linda Gross trial

Ethicon relied on the expertise of Charlotte Owens, a medical doctor just four years out of her residency.

Slater- Was it Owens who signed off on Prolift?

Objection – no foundation. 

Slater – Have all of the witnesses in the case expressed whether the medical affairs director had to sign off? 

Jones objects again jumping up from a half standing position.  

Sustained, said Judge Hass, again. 

Slater tries again – Do you have an opinion whether Ethicon should have been selling Gynemesh?

Objection.

Another sidebar marked around 20 this day. Still the jury was attentive.

Slater tries again.

Do you have an opinion whether medical affairs knew?

 “Ethicon was knowledgeable medical affairs was about the complications. Yes.  Is that the basis deposition testimony and internal documents from the company?  Yes.

Budke family

Budke family

 

What happened to Joan Budke?

What happened to Joan Budke followed her mesh implant? A series of events, said Dr. Weber.

First, she experienced mesh contraction and mesh eroded through the vaginal wall.  The vaginal implant naturally picks up bacteria and eventually the infection formed an abscess. The mass was so large it blocked off her ureters, the tubes that run from the kidney to the bladder. With the blockage, she developed acute kidney failure.

In the chronic phase, the white blood cells are fighting the foreign body, there is ongoing cell death and tissue damage. Dr. Weber described a “cascade of events ” – infections, erosions, extrusions, mesh shrinkage, vaginal granulation tissue, sinus formation abscess, fistulas or osteomyelitis (an infection in a bone).

It’s my opinion she suffered all of these complications,” Dr. Anne Weber.

Ms. Budke lost more than 30 pounds. A foley catheter at one point was implanted to help her urinate. A fistula had developed between her bladder and vagina causing urine to escape that route.  Her body began wasting away as she was bed bound. One month before her death in August 2009, doctors considered permanently removing her bladder because it was too destroyed to repair, but Ms. was determined to be too weak to withstand the surgery.

Dr. Weber told the jurors the downhill spiral cannot be reversed unless the mesh is removed, but with a Prolift mesh kit and its many arms, it’s nearly impossible to do so. The mesh was intended to become integrated with the tissue making removal difficult if not possible to remove.

“That’s a design defect.”

At this point the family appears to be crying. The two daughters have their heads down. At least one  juror appeared to be tearing up.

The Prolift was so defectively designed and so unsafe it should never have been on the market” said Dr. Anne Weber.

Defective design is the key to this product liability case as is a failure to warn doctors.

Dr. Simpson, the implanting physician, is also facing medical malpractice in this trial. She will return to the stand Wednesday. #

31 Comments

  1. Tammy says:

    God be with her family. The truth will stand when all else falls. Praying for her family.

  2. Tracey says:

    Wow, I am so sorry for this family’s loss. I actually have this particular product in me, and suffer constant infections. I really wish more people were aware of this dilemma. It’s a tragedy actually. I also live in Missouri. Johnson & Johnson decided, after my deposition, to not take my case to trial. I was a bellwether case chosen by them. I’m disgusted at their arrogance to attempt to try every case. Actually disgusted by the entire process.

    • Jane Akre says:

      Please come by Camdenton if you can. You will not be disappointed. You will learn a lot and see how hard lawyers work in these cases… really. It is grueling. I don’t think they sleep. It is a real battle… please come by if you can to the Camden Co Court. Thank you. I’m sorry you have the Prolift..and hope you find an expert doctor to consult with. ~ ja

  3. linda says:

    Jane, thank you so very much for your excellent reporting.

    Your hard work, incredible energy and dedication to reporting this tragedy

    is sincerely appreciated by mesh injured women everywhere.

    In 2011, my Doctor implanted the Ethicon +M mesh kit for my pelvic organ prolapse.

    Little did I know that my life would never be the same. I have suffered severely from infections, erosion, migration,

    permanent nerve damage etc. and of course, depression. After two failed explant surgeries, I am still in chronic pain.

    Even with the help of a good pain management Doctor, I spend most of my time alone at home and in bed. I am only 67 years old and until ….”mesh” ruined my life, I was in excellent health..this has truly been my worst nightmare!!!!

    I pray this trial will result in making certain poly. mesh is never used again.

    This has been a very dark, dark event in women’s health care…and a permanent scar for our justice system.

    My prayers are for Adam Slater and the Budke family.

    In 2011

    • Jane Akre says:

      Thank you Linda, I know you are suffering so and with the “improved” +M mesh… the Ultrapro. Maybe not such an improvement. You all deserve your day in court and a face-to-face with the jury.

  4. stopmeshimplants says:

    I try to imagine myself in that courtroom listening to this testimony. I would want to hug these family members and tell them how many of us feel for them and feel so badly they have lost their wife and mother. I would want to scream at everyone there that this woman did not have to die. Obviously, I have so much rage that this death has occurred and I am so fearful how many others will die because of this mesh crap. I am so grateful for Mr. Slater to try to help this family through this lawsuit. Thank you Jane for all of your coverage. I don’t know how you do what you do.

    • Aaron Leigh says:

      I agree ‘stopmeshimplants’! Jane is awesome, and I wish I could say I can only imagine how it feels to sit in court and listen to the manufacturers mince words; change topics; play the shell game; repeat half truths like a broken record and on an on… but I can’t say that. Sitting in on a trial and THEN going home to write about it at night is exhausting, and of course so emotional, as you see the hurting innocent people. It’s literally like the courtroom is divided in half between good and evil. I believe Joan will leave an amazing legacy and our community will find a way to honor her, even in death.

  5. Debbie says:

    Well said stopmeshimplants: It’s so so sad and it angers most of us I think and also scares us too.God Bless this family and thank you for your dedication for us Jane.

  6. Connie says:

    I am so sad about this ladies death Jane. Her poor husband, children & family , the doctors that tried to help her . My own family doctor put me in the hospital for strong antibiotics . He begged me to go back to Vanderbilt & I begged him to PLEASE DON’T MAKE ME GO BACK !! I told him just follow his heart & give me the antibiotics he felt I needed. Jane we couldn’t afford another trip yo Vanderbilt . Dear God have mercy & touch this woman’s family. The living hell they must have saw her go through. I only wish my family could express what they have saw me go through . The things her family will never get out of their minds . This trial hopefully can help bring them some comfort just to get to exited their broken hearts. I wish I could testify for her & share the same issues of staff infection twice . This isn’t about me but I can relate to my own fear of dying from infection . It’s a never ending story it’s almost always there in your body . Urinating on yourself in the Walmart line or in your sisters front yard because you just can’t make it . She was so much older than me I can see how she would loose her fight to live . I have been at that point and I am 58 now . She was on a roller coaster down hill or a snow ball headed to hell !!

    • Jane Akre says:

      I’m sorry for your suffering Connie. It isn’t right. I hope you find an expert mesh removal doc and do not have a series of partials since they do not seem to lead to improvements. Thank you commenting. Let’s hope the family sees and finds some comfort. ~ ja

      • Jan Urban says:

        Joan’s downhill spiral is absolutely horrifying to me. How could this device get on the market? Just looking at the device throws me for a loop. How in the world could these developers and manufacturers think this much mesh is needed and would not cause harm. It’s insane. It is so tragic.

    • abandoned says:

      My polypropylene bladder implant PROCEDURE was at the end of 2010. I was 54. I suffered with urine retention, pelvic, lumbar and tailbone pain, as well as chronic fatigue and terrible depression. The cause was unidentified for at least two years of traveling back and forth to doctors. They treated me as a mental case, my children treated me as a manipulative, lazy attention seeker. I have been told by neighbors that my father spread rumors that he didn’t even know if I had the mesh. He thought I may have seen it on TV and made it up so I wouldn’t have to work, thinking he and my mother would support me. I use a massage pillow on my abdomen, under my thighs, and legs to encourage blood circulation on the days I can’t get out of bed for more than a few minutes. I learned this as a hospital chaplain when we had brain deaths wanting to donate organs. I use wintergreen essential oils as aromatherapy to induce the need to eliminate, take Flomax and bethenachol, drink lots of water, try to self catheter, and used to go to the ER for catheterization. The muscle and tissue death has caused toxicity in my kidneys. I have steroids and antibiotics on hand, along with cold jell pack, tens unit, and heating pad, My last visit to the ER resulted in my son calling them ahead of time to do a psych evaluation on me. The ER doc ignored my medical records I had presented, the social worker talked to me and then told my son I was stable and not in danger of hurting myself. He told her they wanted me treated for psychiatric illness against my will, she told the ER doc, who said well, let’s call a police officer to come do an evaluation on her. The police man came and talked to me (I AM IN UTTER DISBELIEF THAT THIS IS HAPPENING). He told my highly educated 40 year old son (also my HCPOA then) that he really felt I was stable and could go home, my SON insisted and they injected me with something and took me to an understaffed psychiatric unit with out a court order, without addressing my abnormal lab results, without my glasses, lumbar pillow, tailbone pillow, cane or back brace. If you are on this site reading, then you know the horror, the pain, the helplessness, the losses, continued new diagnoses every time you get new blood work, CT, new MRI, NCS, Urodynamics study…

      I can no longer go to the ER when my abdomen is extended and I can feel the sepsis coming on. I live alone with my emotional support animal, I leave huge bowls of water for her, food and an unopened food bag she can easily turn over, she has a doggie door, so if I bleed out and die…she can survive for at least two weeks.

      My children hate me, the adult children that all my friends envied me for and for years. My going from a vibrant, congenial, gregarious and compassionate person ended in 2010. They turned on me, refuse to believe a little piece of mesh could have turned me into a helpless, hurting, tired cranky woman. My family tells me to get a job, go to church, pray more….really? I pray to get out of bed, get dressed, leave the house and my toilet is my temple.

      I truly am sorry for this poor family, yet, I am so happy she is no longer living in pain and fear. I know her family is devastated, it is so difficult to watch anyone suffer, especially a loved one. I wish I could figure out how to get in a support group for this.

      Not sure this reply is appropriate for this forum. God speed to all of you and those you support. Please pray God will send this abandoned and tortured mom some kind people to offer support.

      • Jane Akre says:

        Please let us know where you are located. It appears you need a consult with a mesh removal expert. !

        • abandoned says:

          I live in Austin, Texas. However, will travel anywhere if I can get there in 5 hours by air. Finally, in April…I stopped fighting the idea of “no narcotics”. My pain doctor who had already been treating me for more than a year via injections, licensed professional counseling, acupuncture, PT, etc. knew my reluctance, and seemed to be relieved when I told him I was ready for the real stuff. He agreed to use blood work instead of Ur to get me started, he had my neurogenic bladder report and put me on oxcycontin 12 hour time release. It has been a welcome relief, it has no Tylenol in it (I have liver cysts with debris), diverticulosis, and kidney cyst). I can sit now, but only for a limited time…even with the pain gone, there are consequences the following days and my stomach starts bloating out like a hard basketball (I keep sterile gloves in my temple too). It has not stopped the tissue destruction, infections, or emotional pain and loneliness.

          Three surgeons here have said it has to come completely out…every bit, as it is killing me, causing muscle and tissue death, abnormal labs. However, they won’t touch it, never used it, are against it and terrified of what it may happen during removal.

          Yes, please help me find someone and feel free to give my email out. I don’t have money, but, I have medicare and one credit card with a high limit that I have been holding onto just for this BOSTON SCIENTIFIC midline orbturator pp mesh sling.

          Thank you and Blessings

          • Dr. Bobby Shull in Temple, Texas an hour from Austin has handled mesh removals. Your story breaks my heart. I’ll drive you myself if no one else will. I live in Houston.

            Dr. Bobby Shull

            2401 South 31st Street, Temple, TX 76508

            (254) 724-2150

          • Jane Akre says:

            Thank you Richard for jumping in with those helpful doc….

          • Dear abandoned,

            I’m terribly sorry to hear your sad story. Nothing seems worse than your family’s turning on you. Dr. Philippe Zimmern in Dallas may be your best man for mesh removal near you. Otherwise Dr. Bobby Shull in Temple, Texas does removals, I believe. Even though Zimmern is further away, you may be able to get an appt. to see him more quickly, and he may be more experienced than Dr. Shull in mesh removals.

            Philippe Zimmern, M.D. – Faculty Profile – UT Southwestern

            University of Texas Southwestern Medical Center

            Dr. Zimmern is also Director of the Bladder and Incontinence Treatment Center at UT Southwestern Medical Center

            5323 Harry Hines Boulevard

            Dallas, TX 75390

            (214) 645-8765

          • Lori says:

            I feel and can understand your pain and suffering, I too have Boston scientific mesh for pop and hernia, I do know that keeping the blood clean helps and the inflammation down is a must. I use dandelion, red clover and pau D arch, herbs for cleansing the blood, also I alternate using Essiac formula and that has been a major aid. using anti inflammatory herbs such as turmeric, garlic(a natural antibiotic property herb) for the bloating us a strong PRO-biotic, it is pro body not against the body. the best I have found is ultimate flora, max it helps greatly with replacing friendly bacteria to help against all that bad bacteria taking over, just keep holding on and moving toward the light which is in you, You are worthy. Love and best care, Lori

  7. justme says:

    Dear Jane,

    I am real not a catfish. I am a real J&J Pro lift mesh patient and I am suffering too. You take off my comments a lot, and if you keep doing that, how will other mesh victims understand that the problems they are having are real and we are all experiencing most of the same health issues that very well could kill us.

    It is bad enough that the court won’t allow most of what’s wrong with us to be noted, but you taking off comments is harder. Do you think I am fake? I am not. I don’t understand. I don’t have long to live either if something does not change soon. I am 57 years old. I have lost everything. Just like many others. I have no quality of life at all. I had the robot surgery and the doctor cut my back and disc muscles while installing the mesh. He too, had only been out of residency for TWO YEARS, when he implanted the mesh in me. He said he would tack me up and I would be good to go. He lied and lied. I have found that doctors all lie for each other and in this day and age, they find reasons to hate on the patients and call them names, dismiss them, write on their records they are a liability and not to accept them as patients when the truth is right in front of them. There is no HIPAA. No one wants a mesh patient. Not doctors, not dentists, not hospitals. They look at you really strange and pass you on to the next merry go round doctor.

    Why won’t the judge let the truth be told? The truth keeps getting lost and that is why no one in media really covers mesh. Thank you for being there in the courtroom.

    • Jane Akre says:

      just me- I have not removed your comments, promise. Only comments that are mean spirited or bash others or are obscene are removed. You have not done that have you? Please let me know what you are talking about if you’d like to inquire further, but rest assured, you are not being edited. Why would I do that? ~ja

    • abandoned says:

      I still have not men anyone in person who has had this experience but one dear little lady on the next street. She has had three surgeries, mesh was implanted with out her knowledge or consent. She is in constant pain and mental confusion, her husband does not leave her side for a moment. This older couple has been told they can not file a suit because her surgery and implant were 5 to 6 years ago…so unfair.

      If you want to chat with me about your issues which aren’t being published….I will listen and put it out there if I can.

      • Jane Akre says:

        I dont know what kind of legal advice she is receiving, but if its transvaginal mesh there may not be a limitation to filing…. hernia mesh patients have a much harder time to find an attorney. Please consult farther if you want to proceed..ja

  8. David says:

    It is a testament to what is good in humanity that there are still physicians left like Dr. Weber who are willing to take a stand against this grave industry wrong. As Dr. Weber indicated by her testimony, upon a physician’s ethical classification of the severity of an individual patient’s condition (a “stage one or two [prolapse]” in Ms. Budke’s case), relational to the patient demographic consideration (“one has to consider how the woman is feeling, in other words, her quality of life. And more often than not, an older patient with mild prolapse frequently did not see it return”), “traditional repairs would be reasonable considering [Ms. Budke’s] condition.”

    And, although “prolapse might reoccur with a traditional repair,” it could also with Prolift (at a 1 year actual 33.8% prolapse recurrence rate as indicated by the cited Gynemesh PS Study). But traditional repairs do not carry the numerous, life-long, high risks associated with a permanent surgical mesh implantation (and this defect of design has no “plan b” to address the in vivo performance of the understood non-inert, polypropylene surgical mesh device). If the “best interest of the patient” is to be considered first and foremost, how is a physician’s failure to not stratify the severity of a patient’s condition between applicable treatment alternatives – to mitigate unwarranted “treatment” risk – not physician medical malpractice?

    The very foreseeable failure of Prolift was at best – to sentence a woman to a life-time of torture and at worst – the unwarranted, tragic death of Ms. Budke. While Dr. Vincent is quoted in the March 14, 2014 + MassDevice article, by Arezu Sarvestani, entitled: Unveiled emails raise eyebrows about J&J’s ties to consulting docs, as “[boasting]” “‘Note, no further use of the word experimental!”…“Well, this is one I’m taking credit for. I led the charge on this and never thought we would get a complete replacement of the earlier bulletin” – I wonder if the good doctor feels any responsibility for his direct role in this particular mesh manmade “treatment” plague, which has been deceptively raged against women’s healthcare, with intent to exploit a profit opportunity in an unsuspecting woman’s body?

  9. Hal says:

    Dr. Weber is a real life HERO!!

  10. kitty says:

    I’m scared to death fighting another exacerbation of asthma

  11. jaque says:

    Hi Abandoned,

    If you want a fellow mesh friend You can email me if you like, Jane has my email address so I am sure she wont mind passing on mine to you.

    Bless you.

  12. Tammy says:

    Abandoned, please call me 859- 421-3998 or Jane can give my email to you. I’m praying your strenght. God bless you. If you call. I can call you right back. Keep praying….Jane, great work as always.

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