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Ethicon Media Monitoring 9/21/2018
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McFarland Pelvic Mesh Philadelphia Case with the Jury
Sep 20, 2018 | Mesh Medical Device News Desk
By Jane Akre
Lawyers for McFarland plan to rest their case Monday, September 10th and by this Tuesday, Tracie Palmer (Kline Specter) delivered closing arguments. -
Breaking the Silence: Nancy Gretzinger, Author, Educator, Patient Advocate, Mesh Victim
Sep 20, 2018 | Mesh Medical Device News Desk
By Jane Akre
Like many women, Nancy Gretzinger experienced mild incontinence. -
EU Regulatory Roundup: EMA Starts Revising Guidance on Clinical Trials in Neonates
Sep 20, 2018 | Regulatory Focus
By Nick Paul Taylor
The European Medicines Agency (EMA) has published a draft concept paper on the investigation of medicinal products in neonates. -
Pregnancy is riskier than skydiving -- birth control should be harder to market
Sep 21, 2018 | CNN International
By Caroline Criado Perez
In Australia about half of women who have had more than one child have some degree of pelvic organ prolapse, a condition for which treatment is inadequate. A woman in the UK died after having a mesh inserted to treat her prolapse. Last year it killed a woman in Canada.
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McFarland Pelvic Mesh Philadelphia Case with the Jury
Sep 20, 2018 | Mesh Medical Device News Desk
By Jane Akre
Lawyers for McFarland plan to rest their case Monday, September 10th and by this Tuesday, Tracie Palmer (Kline Specter) delivered closing arguments.
The jurors were deliberating the entire day Wednesday.
Mesh News Desk will deliver a verdict as soon as it is announced.
See McFarland coverage on MND here and here.DEFENSE CASE
Among items the defense, Ethicon ( Johnson & Johnson) presented were:
Ethicon called Katrin Elbert as a live witness.
She was an Ethicon engineer and they called her an expert in the design process of the TVT-O. She was involved in the R&D process, but was not involved in the clinical component of the product development, such as performing clinical trials on the TVT-O.
Ethicon called Elizabeth Mueller as the general expert. She is a urogynecologist in the Chicago area.
Notably, she claimed that the IFU, Surgeon’s Monograph, and Professional Education material were adequate and accurate. She also opined she never reviewed those materials.
Dr. Mueller was brought in to be the Ethicon medical literature expert (saying the literature supports her opinion that the TVT-O is safe and effective). Also, she recently authored a mesh advocacy piece where she questioned the legitimacy of mesh lawsuits and advocated for the use of midurethral slings.
Mueller’s article appearing in the Journal of Urology in October 2017 and in it she says that 57.1% of pelvic mesh lawsuits involve the retropubic or the transobturator mid urethral sling.
“However, settlement amounts, which average around $40,000 per plaintiff, will continue to incentivize aggressive recruitment efforts by law firms.”
In that article, she did not disclose her conflict of interest with Ethicon.
You may recall Dr. Mueller who offered a deposition in the case of Huskey v Ethicon in 2014. She had examined Jo Huskey one time but didn’t remember her. In her deposition, she admits mesh left behind can cause residual pain here.
Elizabeth Mueller, Urogyn Medical Expert for Defense
As part of the Urinary Incontinence Treatment Network, a group of doctors put in 600 slings, including 300 TVT-O, as part of a randomized study of 597 women. She admitted in the deposition with the TVT, “there is more bladder perforations and with the TVT-O there is more groin pain postoperatively.”
She participated in something called the ToMUS trialinto midurethral slings (MUS) which supported their use. More on ToMUS here.
Dr. Mueller considers a fascial sling a “salvage procedure after a synthetic sling.” She says it is easier to make the fascial sling the second procedure in case a woman can’t void after surgery, a mesh sling can be more easily released than a fascia. She also does not operate for chronic pain following a mesh procedure because she doesn’t believe it’s related to the mesh.
“It’s related to a musculoskeletal problem like a back problem or something else, because those are the things that continue for three or four days.”
ProPublica’s Dollars for Doctors on Dr. Mueller here.
Robert M Rogers, MD
Ethicon called Robert M. Rogers is a urogynecologist from rural Montana who works as an Ethicon expert witness, and he worked as an Ethicon consultant for about 13-14 years. He was involved in the development of the TVT-O, including travelling to Belgium to do work on cadavers and training Ethicon sales people.
Dr. Rogers is a case-specific expert in over 25 cases and has always found that the mesh was not the cause of any injuries. He believes that Mrs. McFarland’s symptoms are from atrophy. He has made hundreds of thousands of dollars for his expert work for Ethicon over the last two years.
ProPublica’s Dollars for Doctors on Dr. Rogers here.
Juries typically deliver verdicts on Friday just before the weekend.
https://www.meshmedicaldevicenewsdesk.com/mcfarland-pelvic-mesh-philadelphia-case-with-the-jury/
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Breaking the Silence: Nancy Gretzinger, Author, Educator, Patient Advocate, Mesh Victim
Sep 20, 2018 | Mesh Medical Device News Desk
By Jane Akre
Like many women, Nancy Gretzinger experienced mild incontinence.
Since she was having a pool installed in her Phoenix backyard, she thought it might be a good time to check out her treatment options.
The 66 year-old, with a doctorate in education, is no dummy, however Gretzinger admits today she did NOT do her research. She figured with two spinal cord surgeries this incontinence surgery would be a piece of cake. The doctor said mesh was the answer. The doctor never told her that in 2009 there was an FDA warning about mesh, though it said complications were “rare.”
The doctor did give her a pamphlet and told Nancy she had implanted many meshes successfully. For Gretzinger, the doctor chose two meshes to use that December day in 2009 – the Ethicon Gynecare TVT sling, to treat incontinence, and a Boston Scientific Uphold to treat pelvic organ prolapse.
Gretzinger had already endured a spinal cord surgery and a malignant tumor in the bowel and bladder area removed. She told the doctor about that surgery, but it had no bearing on the mesh surgery.
Unfortunately, from December 2009 until June 2010, Gretzinger could not urinate on her own. The mesh was too tight, restricting her urethra. So the same surgeon attempted to release the mesh in her office. It didn’t work.
Then in 2010, she performed a 7 hour surgery, picking out mesh from the urethra. At this point, Gretzinger was totally incontinent and she decided not to return to her surgeon.
After shopping around for a new doctor, Nancy decided on Dr. Christian Twiss at the University of Arizona Medical Center in Tucson. Dr. Twiss trained under UCLA’s Dr. Shlomo Raz, considered a leading authority on mesh implantation and removal.DR. TWISS
Dr. C. Twiss, Urologist, U of Az.
Nancy called Dr. Twiss “The Man” because he was so thorough and patient. The three-hour round-trip drive completed in a day was well worth it. Even though her outcome was not the best, he was with her every step of the way.
She tells MND he was a very caring doctor. He listened and explained all that could go wrong for least to worse. He did surgery June 2010 and implanted what he called a sling made of Ethicon Prolene Soft mesh. This was the first time she had urinated on her own since December 2009. The bladder did not drain completely, so she had to self-cath.
Gretzinger underwent multiple surgeries for the next four years including medication, nerve stimulation and Botox, all in an attempt to have a normal urination.
Before, during, and after the surgeries, Nancy was administered Cipro to prevent infection. Cipro, in the fluoroquinolone class of antibiotics, is associated with tendon rupture, nausea, vomiting, rash, headache, and an allergic reaction. Researchers are now saying Cipro and Levaquin elevate the risk for Aortic Aneurysm. See the BMJ.
It brought on its own host of problems for Nancy, among them tendonitis, pancreatitis, UTIs, increased resistance to antibiotics necessitating PIC lines for intravenous treatment. The FDA conducted a study and the results can be found here.
She retired in January 2014, believing it was in her best interest for her health. Working with special needs preschool students, she found she caught everything they brought into the classroom. Her immune system was compromised and so was her urethra.
In December 2014, her urethra was removed and closed; the sling/mesh had entwined within the urethra. A suprapubic tube was inserted into her bladder, so urine could be released. A larger tube was also changed to stop any further blockage.
To address the depression that followed she met with a life coach who told her, “You have to say goodbye to the old you and hello to the new you. We have a lot of ladies who are still angry, rightly so, and keeping them from moving forward. The stress is likely causing more damage or increasing the likelihood of immunity problems and other medical complications.”
WRITING FOR RELIEF
Gretzinger started writing a blog, she says for “cathartic reasons” and did contact some mesh sites about tips to living life with mesh. She couldn’t find them, so she tackled that gap too.
Her tips included, triple sheeting your bed with inexpensive plastic waterproof mattress pads and made up with sheets and pillowcases. If you do leak in middle night, strip a layer and go back to sleep; wearing incontinent panties that will hold up to six ounces of urine; anyone with a UTI must have it cultured so they know what kind of UTI it is and what kind of medication to pursue.
The list went on and it, with additional amounts of research, gave Gretzinger enough for a book to share with others facing their new normal.
“Enmeshed – The Truth about Treating Incontinence and Mesh Complications” was published in March 2018 and is available on Amazon. Dr. Twiss wrote the touching Foreword to this book.
She wrote the book to share her experiences with other women who are suffering from complications after having a mesh surgery or from taking Cipro.
It is the latest media attempt to address the hundreds of thousands of mesh injured patients globally as the mainstream media in the U.S. offers scant coverage, unless there is a multi-million dollar jury award. The Bleeding Edge documentary on Netflix is another attempt to break through the silence.
Gretzinger remains positive.
“Our first goal is to get the polypropylene mesh off the market. I know it’s class II (incontinence) and class III (POP), and I’d like to see Cipro off the market too.” She is marketing herself as a public speaker through her website, http://www.drnancyspeaker.com.
Gretzinger sees her future role as a patient advocate.
Her next plan is to take her advocacy, to the urogynecologists who make up AUGS, American Urogynecology Society.
AUGS MEETING IN CHICAGO
The group of nearly 2,000 doctors is meeting in Chicago, October 9 -13 at the Hyatt Regency Chicago for Pelvic Floors Disorder Week 2018.
“I plan to distribute my book with a nice letter about staying current and with sites about mesh. Frankly, I would love for the doctors to purchase the book at cost and give to mesh patients who have already had surgery.”
And if doctors are not receptive to her presence?
AUGS has in the past remained an organization that heavily relies on industry support to underwrite its annual convention, including a trade show by industry showing its latest “innovations,” all for sale to prospective doctor/customers. In 2016, the only panel on litigation that would included a mock trial to discuss the issues being brought forth in litigation, was cancelled at the last minute.
Gretzinger says, “Are they telling us mesh is not harmful and all these lawsuits are false? Each of six pharmaceutical companies set aside one billion to pay off lawsuits, that’s significant.”
At the very least she plans on continuing her advocacy.
“We need to push all mesh victims to register with the FDA their adverse events. It must be done. It is under-reported and until the true numbers are reflected, it will remain an insignificant issue,” she adds.
Gretzinger and a number of mesh-injured woman and their families plan to attend a rally October 11, 2018, 9 am outside the Hyatt Regency Chicago, 151 East Wacker Drive, Chicago. IL 60601 during the AUGS annual meeting.
https://www.meshmedicaldevicenewsdesk.com/breaking-the-silence-nancy-gretzinger-author-educator-patient-advocate-mesh-victim/
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EU Regulatory Roundup: EMA Starts Revising Guidance on Clinical Trials in Neonates
Sep 20, 2018 | Regulatory Focus
By Nick Paul Taylor
MA Starts Revising Guidance on Clinical Trials in Neonates
The European Medicines Agency (EMA) has published a draft concept paper on the investigation of medicinal products in neonates. EMA is revising its stance on testing drugs in newborn babies after interactions with sponsors identified shortcomings in the guidance it published on the topic in 2010.
In its 2010 guidance, EMA set down general principles for the investigation of medical products in term and preterm neonates. The guideline was in development for several years and underwent a public consultation before being finalized. Yet, in the years since the guideline was adopted, the same questions have come up again and again in EMA’s assessments of pediatric investigation plan (PIP) filings for products destined to be investigated and used in neonates.
The draft concept paper is the first step in an effort intended to address these questions and bring the text into line with current thinking about neonatal research and standards. In the draft, EMA lists 14 critical aspects it plans to address in the update to the guideline.
Some of the planned changes affect fundamental aspects of EMA’s position. Notably, EMA is planning to revise how it defines “neonate.” The current guideline defines neonates as “the group of children from birth up to and including the age of 27 days, including term and preterm neonates.” However, that definition is outdated. Today, a system based on postmenstrual age (PMA) that addresses enzyme and organ system development in preterm neonates is more widely used. In this model, the “neonatal age for preterm neonates is considered the age period up to 44 full weeks of PMA.”
Aspects of the rethinking of the neonate classification are reflected in other changes planned by EMA. The agency wants to see more focus on the differences in the maturation of organ and enzyme systems between neonatal subgroups, such as term, preterm and extremely preterm neonates. That subdividing of neonates is evident in another planned change to the assessment of differences in pharmacokinetics (PK), pharmacodynamics (PD) and dose finding between subgroups of newborns.
The way EMA wants sponsors to approach these activities is influenced by broader changes to the thinking about neonate research that have happened since the 2010 guideline. As EMA notes, dose selection, extrapolation of efficacy, modeling and simulation and PK/PD extrapolation have “evolved significantly over the last years and must be correctly addressed.”
Other planned changes include the placing of greater emphasis on the study design. EMA wants sponsors to design clinical trials that try to differentiate between the effect of the treatment and the various confounding factors common in neonates. The agency is planning to tackle challenges related to excipients, the need for long-term outcomes data and the validation of biomarkers, too.
EMA is accepting feedback on the draft until 16 December.
Concept Paper
Scotland Stops Transvaginal Mesh Procedures With Immediate Effect
The Scottish government has stopped the use of transvaginal mesh to treat pelvic organ prolapse and stress urinary incontinence. With one exception, the action bans procedures involving transvaginal mesh until a protocol that limits their use to rare circumstances is in place.
Scotland has been at the forefront of efforts to restrict the use of tranavaginal mesh in the United Kingdom. In 2014, the government asked the National Health Service to stop using the devices. Two years later, another 400 women had undergone transvaginal mesh procedures, prompting Scottish politicians to criticize how the UK Medicines and Healthcare products Regulatory Agency’s (MHRA) was handling the situation.
Politicians in Westminster have since followed the lead of their peers in Scotland, leading to strong temporary restrictions on the use of vaginal mesh in the treatment of stress urinary incontinence across the UK.
Scottish officials have decided the UK-wide action does not go far enough, though, leading them to ban use of the implant in pelvic organ prolapse and stress urinary incontinence procedures. The only exception to the Scottish ban are women who are currently awaiting treatment with mesh under “the treatment time guarantee.” Provided these women give clear informed consent, their treatments can go ahead.
In all other cases, use of transvaginal mesh is on hold until a new protocol is in place. The protocol is expected to restrict the use of transvaginal mesh to exceptional circumstances and otherwise impose limitations that mean use of the implants is likely to be limited even after the ban is lifted.
“Should the halt be lifted, transvaginal mesh would be available in the NHS in Scotland only under the restricted use protocol, which would require the health board’s medical director ... to consider and agree each case individually, taking account of the clinical evidence, and would be subject to evidenced, informed and voluntary consent being obtained from the woman,” Jeane Freeman, the Scottish cabinet secretary for health and sport, said in a statement to parliament.
Government Statement
Denmark Improves Score on Regulatory Agency Benchmarking Initiative
The Benchmarking of European Medicines Agencies (BEMA) has scored the Danish regulator 4.5 out of 5 in its latest assessment of the performance of national competent authorities (NCAs). BEMA gave the Danish Medicines Agency (DKMA) a score of 3.9 when it last assessed it in 2014.
Since 2004, the Heads of Medicines Agencies have periodically benchmarked NCAs against indicators related to management systems, the assessment of marketing authorization applications, pharmacovigilance activities and inspection services. BEMA began its latest cycle of assessments in 2015 and expects to have visited 47 agencies by the end of the month.
The timelines of the previous three cycles of BEMA assessments suggest there will be a lag between the end of the visits and the publication of the final report. However, DKMA already knows its score and is promoting its improvement over the prior assessment.
“The BEMA top score given to the Danish Medicines Agency is a sign that Denmark possesses good assets in an area that is developing rapidly, for example with the use of big data in the development of new medicine, precision medicine tailored to the individual citizen and a new framework for more efficient clinical trials,” Ellen Trane Nørby, the Danish health minister, said.
BEMA’s third and fourth assessments span a period of change for DKMA. Late in 2015, Denmark re-established DKMA and set out to turn it into a leading European drug regulatory agency. That led DKMA to make multiple changes, including the hiring of leaders with international experience and the initiation of a scientific advice service.
DKMA Notice
Other News:
EMA has published a summary of its third industry stakeholder platform on research and development support. At the event in May, EMA and the industry discussed orphan drugs, the review of digital technology proposals in medicine development programs and a framework for the co-development of therapies and companion diagnostics. EMA Summary
EMA’s Committee for Medicinal Products for Veterinary Use (CVMP) has adopted two scientific advice reports. The reports provide initial advice on safety and efficacy issues related to medicinal products for cats and dogs. CVMP also agreed to extend the marketing authorizations for Chanelle Pharmaceuticals Manufacturing’s Inflacam and Rheumocan. EMA Notice
MHRA has issued a notice about Cadiasun Pharma’s Caspofungin 70mg powder concentrate for solution for infusion. The notice relates to an error on the patient information leaflet. MHRA Noticehttps://www.raps.org/news-and-articles/news-articles/2018/9/eu-regulatory-roundup-ema-starts-revising-guidanc
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Pregnancy is riskier than skydiving -- birth control should be harder to market
Sep 21, 2018 | CNN International
By Caroline Criado Perez
When was the last time you did something risky? Went skydiving? Played the stock market? How about downloaded an app that claims to be able to tell you when you can safely have unprotected sex?
If you're a woman on social media between the ages of 18 and 40, you've almost certainly seen an advertisement for a controversial contraceptive app called Natural Cycles.
It claims to offer an effective, "natural, hormone-free and non-invasive" alternative to traditional birth control methods. In this age of jade egg cleanses and vaginal steaming, they've got their messaging just right.
In fact, they've won an award for it: in June, business magazine Campaign awarded Natural Cycles its "Pick of the Month" for a social media campaign that resulted in "a staggering 127% increase in app registrations" and "1,000,000 women influenced."
Beyond traditional advertising, Natural Cycles also uses "influencers" -- a new tribe of online celebs who, with their loyal and engaged social media followings that often number into the millions, are catnip for marketers looking for a more "authentic" way of hawking their products.
This authenticity is largely a sham. In the UK, influencers are legally obliged to mark paid-for social media posts as adverts. But, says criminology professor Natasha Tusikov, "there is research showing that people don't understand the difference between Kim Kardashian posting a picture of herself at the beach and Kim Kardashian hawking a certain product for which she is paid." And surely this confusion is part of the point of using them.
We have long known that celebrities wield a powerful influence over consumers. For this reason, their use in marketing products that carry particular risks has long been regulated in the UK.
Under non-broadcast rules, you can't use a "health professional" or a celebrity to sell a medicine. Broadcast rules are more stringent: celebrities can't recommend "a medicinal product or treatment." This disparity, the Advertising Standards Authority press office informed me, "reflects the long-held view that TV is a more impactful medium necessitating tougher standards."
But in the era of social media, does this "long-held view" remain valid?
There is a dearth of solid research on social media advertising, but Facebook made a huge deal about how much more impactful the Natural Cycles campaign on its platform was than on TV. It claimed a "20% incremental reach on top of TV," "47% more efficient reach per target rating point than TV" and a "higher total reach than TV for women aged 25-34. And all for "3.6x lower cost per target rating point than TV."
There's something unseemly about all this. Natural Cycles is not a harmless toy; it's a medical device. Indeed, the company makes the most of being the only medically "certified" contraceptive app. Natural Cycles is able, it seems, to capitalize on the legitimacy of being medically certified without suffering from any of the drawbacks.
FDA approves 1st birth control app, long-term vaginal contraception ring
Amy Hough, the lead author of a paper about Natural Cycles, told me that one influencer she spoke to found the app time-consuming "and ended up with a coil that she much prefers."
It is unclear if, under the terms of her contract, the influencer would have been allowed to disclose this to her audience: when I contacted Natural Cycles they refused to share any information about what they allow influencers to say.
But negative experience is relevant. Natural Cycles requires a lot of work from its users in order to give accurate readings. You have to take your temperature at the same time (ideally) every morning. You have to input data on when you're having sex and when your period is. For more accurate results, you can input what level of "luteinizing hormone" is in your urine at various times of the month. Your readings may be off if you're ill, if you work shifts, if you're hungover.
This matters, because the more a contraceptive method relies on user input, the less effective it is. This is why condoms are around 82% effective with typical use, while the contraceptive implant is over 99% effective, according to the UK's National Health Service.
But Natural Cycles doesn't have to mention this caveat on their marketing -- and, naturally, they don't.
In the UK, the Advertising Standards Authority (ASA) ruled at the end of August that Natural Cycles was misleading its customers by claiming that the app was as effective as other methods. This is to be welcomed. But it doesn't go nearly far enough in addressing how Natural Cycles markets itself. It can't, because the ASA regulatory powers don't go any further.
This contrasts sharply with financial products, which in the UK and the US are subject to a high level of regulation. And it shows.
The Natural Cycles app
"Banking is traditionally not known to use influencer marketing," explains Holly Pavlika, an expert in social media marketing, because the "legal regulations associated with promoting and endorsing investment products can create a more strict environment that takes away from the authenticity and human touch of an influencer's post."
Influencer marketing, says Pavlika, is for "passion products," not for risky ones, and a company advertising a financial product in the UK and the US must be clear and upfront about the risks. In an advert for an investment product, for example, the company would have to state that your capital could be at risk. It must carry the same prominence as the benefits presented in the advert.
This makes sense. Investment products are risky. But if something goes wrong with Natural Cycles, I run the risk of getting pregnant -- and yet no advert I've ever seen for Natural Cycles (and I've seen many) was accompanied by anything along the lines of "your uterus may be at risk of not being empty."
And my uterus not being empty is no small thing.
Numerous studies have claimed to show that men are more risk-taking than women. Men skydive and gamble; women stay home and look after the kids.
But is having kids risk-free? Not according to academic psychologist Cordelia Fine, who in her award-winning book "Testosterone Rex" points out that "being pregnant is about twenty times more likely to result in death [in the US] than is a skydive."
In Australia about half of women who have had more than one child have some degree of pelvic organ prolapse, a condition for which treatment is inadequate. A woman in the UK died after having a mesh inserted to treat her prolapse. Last year it killed a woman in Canada.
There are financial risks, too. In the UK, by the time a child is 20, mothers earn almost a third less per hour than equally qualified fathers, according to researchers.
So why is it that a spare-change investment app must carry a warning while a contraceptive app can ramble on about how great it is to be hormone-free?
The US Food and Drug Administration (FDA) has specified that Natural Cycles adverts be clear about potential risks, for example, by including "a statement that no contraceptive method is 100% effective."
But there's a chance this stipulation may inadvertently mislead women, since it implies that Natural Cycles is of comparable risk to other birth control methods -- something Natural Cycles again makes the most of in its ads, proudly citing "clinical studies" showing that the app is 93% effective, "which is in the same category as other conventional methods."
There is reason to be skeptical about this claim. Birth control methods like the pill or the coil have been tested numerous times, over decades, in independent trials.
For birth control, what's old is new again
By contrast, two of the lead authors of Natural Cycles' 2017 study were the company's founders, and experts say the data (harvested from users' app inputs) is full of holes.
When I asked Natural Cycles if they would make their data available to other researchers so that their claims could be replicated, they told me that they currently "do not have plans" to do so.
The Swedish Medical Products Agency recently investigated Natural Cycles after 37 women fell pregnant at a single hospital while using the app, but ultimately closed the investigation, ruling that the number was in line with the 93% figure.
This is naturally good news for Natural Cycles. But the ruling cannot be a substitute for the proper randomized clinical trials that have been called for by the Family Planning Association and a 2012 Cochrane Review. And it does not, in any case, address any of the issues about the level of informed consent women who are being influenced online are able to give.
It is clear that we need more data on the efficacy of contraceptive apps and on the impact of social media. And we need to update our outdated views on advertising and on risk.
The distinction between broadcast and everything else was made before the advent of the smartphone and social media. It made sense back then. It doesn't today.
This is a world where celebrities have direct contact with their often-impressionable followers and where anyone can upload a video to YouTube, Facebook or Instagram. And unless we have regulation that recognizes this, well, that seems pretty risky to me.
https://edition.cnn.com/2018/09/20/opinions/natural-cycles-pregnancy-skydiving-caroline-opinion-intl/index.html
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