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Edwards Pelvic Mesh Trial Delayed, Huskey Trial Verdict Will Stand, 200 J&J Cases Readied for Trial
Aug 20, 2015 | Mass Medical Device News Desk
By Jane Akre
Tonya Edwards, 43, a Georgia resident, was implanted with a TVT-O by Dr. Harold Wittcoff. She is represented by Mark R. Mueller, an Austin, Texas attorney. According to a Judicial Order (Doc #222) filed August 12, the Pretrial and Final Settlement Conference is moved from August 17, 2015 to December 22, 2015... -
Bard Reaches $200 Million Transvaginal Mesh Settlement
Aug 20, 2015 | Surgical Watch
By Laura Woods
C.R. Bard has reportedly agreed to pay more than $200 million in a transvaginal mesh settlement for at least 3,000 lawsuits brought against the company. The settlement will resolve approximately one-fifth of the outstanding lawsuits the manufacturer is currently facing related to its transvaginal mesh products. -
Giving Birth Ruined My Vagina, So I Got a New One
Aug 20, 2015 | Jezebel
By Jane Marie
It was at my six-weeks-postpartum appointment that someone in the birth world finally admitted what we all fear to be true: vaginal birth can ruin your vagina, even might ruin it—and, in my case, did. The doc inserted the type of speculum she’d always used on me in the past, then took it back out, turned to the nurse, and said, “The other one.”
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
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Edwards Pelvic Mesh Trial Delayed, Huskey Trial Verdict Will Stand, 200 J&J Cases Readied for Trial
Aug 20, 2015 | Mass Medical Device News Desk
By Jane Akre
Tonya Edwards, 43, a Georgia resident, was implanted with a TVT-O by Dr. Harold Wittcoff. She is represented by Mark R. Mueller, an Austin, Texas attorney. According to a Judicial Order (Doc #222) filed August 12, the Pretrial and Final Settlement Conference is moved from August 17, 2015 to December 22, 2015, pushing the trial back to Monday, January 11, 2016.
BACKGROUND- What’s Ahead with this Trial
Johnson & Johnson defense attorneys Christy Jones and David Thomas (document #74) wanted to exclude the expert opinion of Dr. John T. Steege. He would testify the TVT0-O was defective and caused her present day pain. Ms. Edwards had delivered three children vaginally and experienced stress urinary incontinence (SUI) before being implanted with pelvic mesh as a treatment.
The mesh explanted from Edwards was not properly preserved by Dr. Vladimir Iakovlev, argues Defense. For their part Defense used Dr. Elizabeth Kavaler, previously seen in the Linda Gross trial, to issue an expert report as well as Dr. Stanley Zaslau.
Defense planned to raise the usual defenses, Edwards was obese, had experienced hip and back pain prior to her mesh implant and had a small rectocele and cystocele as well as urethral hypermobility all prior to her implant. Treatments such as injections had not treated her SUI. She had had about 60 occasions to consult with various medical providers and did not report pelvic pain until more than six years after her implant, says the Defense. It was only after seeing a television ad for pelvic mesh litigation that she filed her case.
Eventually she sought treatment with Niall Galloway, MD with complaints of repeated urinary tract infections and pelvic pain.
JO HUSKEY TRIAL -VERDICT WILL STAND
Pending before Judge Goodwin was Defendant Ethicon, Inc.’s (Johnson & Johnson) Motion for Judgment, or a directed verdict in its favor in the Huskey v. Ethicon trial, which Judge Goodwin denied. (See Husky #441 Motion for Judgment, August 19 2015).
The Huskey case (2:12-cv-05201) was the first bellwether jury trial for Ethicon before Judge Goodwin in this Multidistrict Litigation. At the present time the MDL contains over 26,000 cases filed against the subsidiary of J&J. Jo and her husband Allen Huskey, filed the action after she was implanted with the TVT-O (Obturator) used to treat incontinence. Her implanting physician was Dr. Gretchen Byrkit and the date was February 23, 2011. The mesh eroded and caused her pain. Another physician, Dr. Sohail Siddique attempted a mesh removal on November 18, 2011. He removed about one-third of the mesh from what he described as a “chronically infected space.” An athlete, Ms. Huskey now has limited ability to participate in physical activity and still experiences SUI, pain in her bladder, dyspareunia and joint pain.
Judge Goodwin could have granted the judgment as a matter of law, essentially setting aside the jury verdict. He did not.
On September 5, 2014, a West Virginia jury decided the TVT-O was defectively designed and awarded Ms. Huskey $3.27 million. Judge Goodwin wrote “While courts should not simply rubber stamp a jury’s verdict, judgment as a matter of law is a remedy to be applied sparingly and only in the most extraordinary circumstances.”
Because the state is measured under Illinois law, her home state, the design defect decision must conclude the design made the product unreasonably dangerous and it injured the Plaintiff. Illinois Civil Jury Instructions say,
“When I use the expression ‘unreasonably dangerous,’ I mean that the risk of danger inherent in the design outweighs the benefits of the design when the product is put to a use that is reasonably foreseeable considering the nature and function of the product.” See Ill. Pattern Civ. Jury Instructions § 400.06A.3
Ethicon says no reasonable juror could conclude the TVT-O is unreasonably dangerous, but Judge Goodwin recounts the evidence in the case in a very compelling manner. It’s worth a read.
“From this evidence, a reasonable jury could conclude that the high risks of the TVT-O are not justified by the benefits, and as a result, the TVT-O cannot, as a matter of law, qualify as an unavoidably unsafe product. Ethicon, having failed to meet its burden, cannot save itself from the jury’s verdict on design defect by appealing to comment k’s exemption.”
On design defect the Plaintiffs presented evidence that the polypropylene mesh material had a tendency to erode, that laser-cut mesh was defective and that the placement in the obturator space of heavyweight mesh. Judge Goodwin says,
“I FIND that the plaintiffs demonstrated sufficient circumstantial evidence to support proximate causation for at least one of these defects such that a reasonable jury could find in their favor on the design defect claim.”
The IFU was inadequate a jury could reasonably conclude and Dr. Byrkrit said to the jurors she would not use a TVT-O in an athletic woman, said Judge Goodwin, allowing those jury decisions to stand. Judge Goodwin also allowed to stand the negligent design and negligent failure to warn claim.
Ethicon has not made the required showing to warrant a new trial, Judge Goodwin writes.
200 CASES READIED FOR TRIAL
In a pretrial order, Judge Joseph Goodwin orders TWO HUNDRED Ethicon cases to start the pretrial process.
The oldest cases filed before Judge Joseph Goodwin in the Ethicon MDL will now become Wave 1 cases. Judge Goodwin has just outlined a schedule to bring these cases to court. The discovery process, expert depositions must be completed by March 28, 2013 and the cases should be trial-ready.
Because there are so many Plaintiffs, the Defense is limited to ten Interrogatories or questions put to the Plaintiff and there will be a limit of 10 requests for admission per Plaintiff. There will be a limit of no more than five experts per case. Both sides will meet by January 11, 2016 and decide the venue which other federal court the case may be tried or in the Southern District of West Virginia.
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Bard Reaches $200 Million Transvaginal Mesh Settlement
Aug 20, 2015 | Surgical Watch
By Laura Woods
C.R. Bard has reportedly agreed to pay more than $200 million in a transvaginal mesh settlement for at least 3,000 lawsuits brought against the company. The settlement will resolve approximately one-fifth of the outstanding lawsuits the manufacturer is currently facing related to its transvaginal mesh products.
Plaintiffs claim they sustained serious injuries as a result of the company’s allegedly defective devices. The women share many common allegations, including that the transvaginal mesh products shrink after they’re implanted, causing severe pain and major damage to their organs. Bard transvaginal mesh settlement
Under the terms of the agreement, the women will reportedly receive a settlement of approximately $67,000 per case. This is notably smaller than the $2 million verdict a West Virginia jury awarded one woman in 2013, but larger than the $43,000 average received by plaintiffs in another Bard settlement in 2014.
The Honorable Joseph Goodwin of the U.S. District Court for the Southern District of West Virginia is overseeing the Bard multidistrict litigation and several more of a similar nature involving other transvaginal mesh manufacturers. He has encouraged Bard to consider settlements of a larger scale, as the company risks a total payout of billions in jury awards. Bard continues to maintain the safety and efficacy of its products in court filings.
According to a July 24 filing with the U.S. Securities and Exchange Commission, Bard has added $337 million to its $660 million reserve to resolve product liability cases. The company also admits to resolving 2,800 cases involving “Women’s Health Products.”
In May 2015, a jury in Delaware ordered Boston Scientific to pay $100 million to a woman who sued the company over transvaginal mesh complications. Boston Scientific has settled some cases, but continues to stand behind the safety of its products. Johnson & Johnson has also reached settlements with a number of plaintiffs...Pelvic mesh linked to organ damage
In 2012, the U.S. Food and Drug Administration ordered Bard, Boston Scientific Corp., Johnson & Johnson and other transvaginal mesh manufacturers to carefully examine the rate of organ damage associated with their pelvic mesh devices.
Transvaginal mesh products threaded into the vagina to treat pelvic organ prolapse or stress urinary incontinence. Many patients have accused manufacturers of poorly designing these devices and constructing them with materials that are unsafe for the human body. Surgical mesh made of synthetic materials is found in both knitted mesh and non-knitted mesh forms. Synthetic materials may be either absorbable, non-absorbable or a combination of the two. Some mesh is also animal-derived, composed of animal tissue that has been processed and disinfected to be suitable for use in the human body.
“The FDA has identified clear risks associated with surgical mesh for the transvaginal repair of pelvic organ prolapse and is now proposing to address those risks for more safe and effective products,” said William Maisel, M.D., M.P.H., deputy director of science and chief scientist at the FDA’s Center for Devices and Radiological Health. “If these proposals are finalized, we will require manufacturers to provide premarket clinical data to demonstrate a reasonable assurance of safety and effectiveness for surgical mesh used to treat transvaginal POP repair.”
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Giving Birth Ruined My Vagina, So I Got a New One
Aug 20, 2015 | Jezebel
By Jane Marie
It was at my six-weeks-postpartum appointment that someone in the birth world finally admitted what we all fear to be true: vaginal birth can ruin your vagina, even might ruin it—and, in my case, did. The doc inserted the type of speculum she’d always used on me in the past, then took it back out, turned to the nurse, and said, “The other one.”
“Other what?” I squeaked out, the fluorescent lights suddenly casting an accusatory light on my splayed legs.
“Oh, I just need the other speculum. Childbirth… changes things.”
YOU HEARD IT HERE FIRST.
Here are all the other ways I’d noticed a change. At the gym, I couldn’t tell if I was doing crunches right because I’d lost the mind-body connection between my brain and pelvis. During sex, I’d try to tighten up around the penis (one of my specialties prior to baby) and didn’t feel like I was accomplishing anything. I’d stick a finger up there and it felt okay from the finger’s perspective but like nothing from the vagina’s. Sometimes, when I’d laugh or cough or pick my baby up too fast, a little bit of pee would spill out. The last straw came when I peed my pants at Coachella this year, unable to make the trek to port-a-pottys across a mile-wide field after a few glasses of white wine. I remember thinking, “I’m only 37, for fuck’s sake. I can’t live like this.”
So I did what any of us would do: called Brandi Glanville’s vagina repair dude. Brandi—star of The Real Housewives of Beverly Hills, ex-wife of LeAnn Rimes husband—talks about the miracle Dr. Matlock performed on her pussy in her bestselling memoir, Drinking & Tweeting. She took now-infamous revenge on her cheating ex, Eddie Cibrian, by charging the procedure to his credit card. “A brand-new vagina would be an Eddie-free vagina.... I decided that since Eddie had ruined my vagina for me, he could pay for a new one.” Go Brandi. Get it girl.
Dr. Matlock is an OB/GYN who pioneered the procedure in the late ‘90s. You may remember him from early episodes of E!’s Dr. 90210—he’s the doc who operated on his own wife. Matlock initially developed what is now called Laser Vaginal Rejuvenation to cure urinary stress incontinence, but a happy side effect was that it tightens up the muscles and “restores youth” to your hoo-ha. This video, now 10 years old, is a good primer on the surgery:
I’m lucky enough to live in Los Angeles where he is based, so heading to his Beverly Hills office for a consultation was easy.
Here’s the scene in the waiting room: there are two beige—BEIGE—leather—LEATHER—couches for seating, and framed press clippings cover the walls. Brandi’s book is propped up on the window sill, pertinent pages marked with Post-Its. The first two times I visited, the only other women waiting were in hijabs. One had who I assumed to be her sister and either a brother or brother-in-law with her; both women were draped in black while the dude wore a polo shirt and jeans and talked on the phone the whole time. I overheard the nurse chatting with all three of them about re-hymenization, an even newer procedure that’s being used to re-virginize religious women in order to turn them back into marriage material. As the patient was filling out forms, she came to one that asks if she would allow the doctor to use photos of her procedure for educational purposes. She showed it to her male chaperone and he said “No, absolutely not,” so she didn’t sign it. I got a little sad at this whole scene, but my mood was about to change drastically.
Let me just say that I wish Dr. Matlock were my regular gyno. He had the best bedside manner of anyone who’s ever used a speculum on me: soft-spoken, he gave plenty of warnings before he touched me about where his hands were going and what temperature they would be. He was also surprisingly… light? I don’t know about you, but the majority of my gynecologists have been more on the “brooding” end of the spectrum. We chatted a bit about which procedure I wanted—he does vaginal rejuvenation, labiaplasty, rehymenization, etc. I said I like the look of my shit so don’t mess it up, but that I’d lost feeling and control.
“You’ve had a child, correct?” he asked. “Around 30 percent of women who’ve given birth vaginally have these exact same issues, and we’re going to fix it, okay? It’s going to be better, I promise you.” I was not expecting such a confident diagnosis that quickly. Perhaps, I had feared, my vagina was the only unfixable one on earth. Or perhaps I didn’t injure it during childbirth but instead I had a rare case of vaginal atrophy (a disease I hope I’m making up but I don’t want to Google it to check). But Dr. Matlock was sure he could help and that I’d have a great outcome—boo ya. I only had two decisions to make, said the doc: what kind of anesthesia we’d use, and how tight I wanted to be in the end. (!)
“We can make it like it was just before the baby, go back to 20, 18 or 16. Up to you.”
I chose 18, with a definite uptick in my voice that left other possibilities open. He said he’d take a look and help me decide.
Dr. Matlock did this nice temperature test on my inner thigh with the gel; said things like, “I’m going to touch you here [touches my knee], I’m going to touch you here [lightly taps my thigh], and now I’m going to touch you here [taps my vaginal opening before inserting the speculum].”
It was actually delightful. When he was done, he told me I could sit up, took his gloves off, and said, “Let’s go 16.”
The worst part about how bad childbirth fucked up my vagina was the fact that, to begin with, I hadn’t even necessarily wanted to give birth that way.
The reason I did was this: Five weeks into my pregnancy, I’d gotten a bad pap smear result. Not only did I still have all the HPVs humanly possible, but now something called atypical glandular cells showed up. My doctor called and said she couldn’t tell me what they meant—could be all sorts of cancers or nothing at all, further tests would determine that—but that we could wait 35 weeks until the baby was born to move forward on it.
Apparently, she added, the kind of biopsies I’d have needed couldn’t be performed on a pregnant person, but the kind of cancers I could have were typically slow-growing. (I still can’t believe no one suggested I abort the pregnancy and get that shit taken care of, but that is for another essay.) She presented me with two options: One, if I did end up having some horrible cervical cancer and wanted to have another baby after this one, they could always remove the cancer, implant an embryo in my uterus and sew me shut behind it, a procedure called cervical cerclage. I said, “Nah, I’m cool.” And two, if I could manage to have a vaginal birth, it’s possible I could push all the bad cells out with the baby. Seriously. You shed a lot of tissue giving birth and there was a chance I could flush out whatever was wrong. Challenge accepted.
So I watched The Business of Being Born, I read all the Ina May Gaskin natural childbirth books I could get my hands on. I went to the hippie-dippiest birthing class I could find in Los Angeles. Natural childbirth advocates all tell you generally the same thing, which I’ll sum up here while leaving out all the important scientific info that backs up their claims: if you get an epidural or pitocin (a drug that induces contractions), your chances of having a C-section go through the roof. I did not want a C-section, because I wanted to flush out this possible-cancer by pushing my child through my birth canal, remember?
So I went hard in the natural childbirth paint.
Having a doula has shown to decrease the likelihood of getting an epidural, so I got one of those. (Sort of. She was barely certified, but that’s who I could afford.) Eating seven dates a day increases the chances of going into labor on your own, thus avoiding the pitocin trap, so I got way into dates. Getting acupuncture in the final weeks of pregnancy is also shown to support a natural birth, though when I asked my acupuncturist if I had to believe in acupuncture for it to work, she said, “It helps if you believe.” The repurposed back room of a dance studio on the top floor of a barren strip mall, it turns out, was not the place for me to have a spiritual conversion. Oh well.
Still, when I went into labor at 2 A.M. the night after my due date, I felt pretty positive, like I’d done a good job so far. Then shit got real.
I did all the hippie crap all day—bounced on a yoga ball, had a glass of wine and a bath, labored in the tub, got massaged by my doula, tried to get orgasmic with my partner—and by about 8 P.M. I’d had enough. The contractions were 3-1-1—three minutes apart, one minute long, for one hour—so it was time to head to the hospital. Except when I got there and they examined me, they said I was only 4cm dilated and 70 percent effaced. I almost punched someone, but let out a wail instead. The midwives I’d chosen to see instead of an OB/GYN because of that whole trying to rid my vagina of cancer thing told me I could go home or “lean into the pain” if I wanted to make progress. Maybe I said “LOL, FUCK YOU!” or maybe I just thought it? But I was trapped so I decided to try the leaning in.
For four hours I leaned in as far as I could. Walked the halls, danced in the shower, screamed at everything. And that’s when we all kind of noticed something was awry. I was not getting any relief between contractions; I was in constant, excruciating pain. They said I was experiencing “back labor” and that my baby was in the wrong position. The phrase that kept coming to mind to describe the agony was “I’m shattering.” At one point I wondered to myself, “We’re on the fifth floor. Is that high enough to kill me and the baby or just maim me and kill the baby or just kill me and maim the baby?” That’s when I asked for a progress report. And that’s when Polly, my midwife, told me I’d made no progress since arriving at the hospital. And that’s when I asked for the epidural, 24 hours in.
Seven hours later they manually broke my water. One hour after that I began to push. Three and a half hours later, my daughter finally got in the right position and came tearing through my body. Literally. I tore in three places, requiring over 30 stitches. Pushing that hard for that long apparently wrecks you. Shit got really, really fucked up.
The worst part was: it didn’t even work! I still had to have a LEEP procedure to rid me of the HPV six weeks after giving birth. (I’ve since gotten my first clean pap in five years, WOO HAH!)
The vaginal rejuvenation procedure itself only takes one hour. As I understand it, they go in and open up all four walls of your vagina using a laser. They trim off some excess tissue and then stitch your muscles up tight and close you back up. I chose general anesthesia, but some people do this under local, which sounded crazy to me—although, so did going under risky general anesthesia in order to have a tighter pussy. I agonized over that part: was I going to Donda myself for this? Well, yes. I like peeing on toilets and having good sex, so, yes. If my daughter grew up without a mother because I flatlined on the operating table, at least she’d know I had my priorities straight.
The day of surgery was pretty chill. My anesthesiologist chatted about the line at Starbucks while he injected me with that first woozy shot. I got pretty high. Then a nurse came in and covered me with a blanket that had hot air running through it. I loved it. Then Dr. Matlock came in and shook my hand and we rolled out to the operating room. I woke up a few hours later still super stoned and I don’t remember much of that first day.
The recovery sucked, though. I had a catheter—that’s right, a tube up my pee hole and a bag strapped to my leg—for five days. It was kind of cool, not thinking about peeing for a week; I just had to remember to empty the bag, which was a little troublesome since I couldn’t feel when I peed, so I had no idea if it was full unless I looked. I was also on Valium and Percocet, making the world very fuzzy (which was awesome). All in all, it was a week before I was really up and around. I couldn’t pick up my toddler, but that was a nice break. She was very sweet about the whole thing, checking on me regularly and bringing me supplies. Brandi said the recovery was worse than childbirth. Dr. Matlock explained that the baby distracts you from the pain so this can seem worse. I disagree with both of them: this was way easier than what I went through with my daughter, probably mostly because of all the cool drugs, but still.
As with childbirth, the recovery is said to take six weeks, but mine has been a little longer. I tend to scar badly, so my perineum is taking awhile to soften up. But Dr. Matlock said in another few weeks he can inject it with a steroid that’ll fix things, if it doesn’t chill out on its own.
“But did it work?” you wonder. Hell yes, it worked.
I haven’t peed my pants even a little bit in the two months since surgery. And I can feel things down there again. I can suck in my stomach and feel it. Crunches are a thing once more. And I hear I’m “tight as fuck” but who cares what anyone else thinks, what matters is that I have a neural connection to my pussy again. It feels wonderful.
You want to know how much this cost and whether insurance covers it, yeah? It’s $10,000—the price of a used car—and no, insurance does not cover it. This is how cool our health care system is: if I just wanted to fix the bladder incontinence part, I’d have to have a pretty severe case for insurance to step in, and then they’d just do some bladder sling or vaginal mesh-type thing that you hear about in radio ads for class action lawsuits. Having scarring from tears during childbirth and atrophied muscles from pushing do not count as real medical issues, but instead are considered cosmetic complaints. Meanwhile, there’s Viagra. Fuck the patriarchy.
But! There are payment plans and credit lines available for those of us who can’t just plop down 10 Gs all at once. It was worth it for me, as worth it as the used Chevy Malibu I bought in 2002. I have no regrets. I’m sure as hell never birthing another child, though.
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