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Ethicon 11/2
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Mesh Trials on the Horizon
Nov 1, 2017 | Mesh Medical Device News Desk
Despite what appears to be a lull in litigation concerning pelvic and hernia mesh, a number of cases are set to go before a jury in the coming months. -
‘This operation left me in agony’ says Spalding woman Steph
Nov 2, 2017 | Spalding Today
But when Steph was admitted a surgeon recommended an alternative procedure she’d never heard of – a Laparoscopic Sacrohysteropexy – which involves leaving the uterus in place and supporting it with an artificial mesh implant.
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Nov 1, 2017 | Mesh Medical Device News Desk
Despite what appears to be a lull in litigation concerning pelvic and hernia mesh, a number of cases are set to go before a jury in the coming months. New Jersey, Philadelphia, Charleston, WV and Los Angeles all have transvaginal mesh cases consolidated and waiting for trial.
Mesh News Desk will attempt to keep up to date on the docket. Your updates are very welcome as well!
NEW JERSEY
The New Jersey law firm of Mazie Slater Katz & Freeman, will bring the defective product trial of Elizabeth Alice and Tadeusz Hrymoc v Ethicon, Monday, November 27.
Ms. Hrymoc was implanted with two meshes made by Ethicon, the medical device division of Johnson & Johnson (J&J). The two are Prolift, used to treat pelvic organ prolapse, and TVT(tension-free vaginal tape) to treat stress urinary incontinence. Both have been found defectively designed by previous jury actions.
Opening statements will be heard in Bergen County (Bergen Co Docket No BER-L-13696-14 MCL), before Judge Rachelle Harz. Jury selection will begin before that date. The case was filed September 24, 2009. See Pre-Trial scheduling here.
New Jersey cases only allow you to receive the docket here. You must request by mail to receive documents if you are not an attorney.
PHILADELPHIA
Philadelphia Court of Common Pleas, Philadelphia Co.~ November 6, 2017 / Patricia Blockus et al vs Ethicon Women’s Health and Urology. * Late Breaking ** This trial has been moved to January 8, 2018, with jury selection set for January 4.
Blockus is from Hunlock Creek, Pennsylvania, where she lives with her husband, Eugene. The defendant corporations are Ethicon, American Medical Systems, Boston Scientific and CR Bard Inc. as well as Sofradim Production SAS, Tissue Science Laboratories Limited, Secant Medical and Prodesco, Inc. The trial was moved from June 19, 2017 and the Case No. is 1307-00707 before Judge Arnold New.
See the case list here.
She was implanted with a Prolift pelvic organ prolapse (POP) mesh and a PelviSoft Acellular Collagen BioMesh made by Bard. See Bard brochure here.
Ms. Blockus was implanted with Prolift March 19, 2007, and the PelviSoft July 28, 2008, both at Gesinger Medical Center in Danville, PA to treat pelvic organ prolapse. The implant surgeon is Barbara Plucknett, MD. Ms. Blockus underwent one explant surgery, July 28, 2008 by Dr. Mitesh Parekh, MD.
Bard claims its PelviSoft is highly effective for posterior vaginal wall defects and is “ideal for use in repairing rectocele and cystocele prolapse.” It was developed after Pelvicol, another biomesh, and is made by C.R. Bard in Covington, Georgia. The promotional material does not say where the “natural” mesh is derived but further research finds it is made from porcine (pig) dermis or skin.
*Note* – See this Porcine dermis study, randomized control trial, with 12 month followup. Using a cure definition as anatomic with no pelvic organ prolapse at Stage 2 or greater. 57 patients. Published in Obstetrics and Gynecology January 2013 by Patrick Culligan MD, Division of Urogynecology Atlantic Health System, Morristown, NJ. See Clinical Trials here.
The complaint states negligence, manufacturing defect, failure to warn, defective product, design defect and common law fraud, the first among 16 claims. The Blockus family asks for punitive damages.
BLOCKUS MOTIONS FILED
On May 5, 2017, Johnson & Johnson/ Ethicon filed motions to preclude the testimony of expert Peggy Pence, Ph.D., Uwe Klinge, M.D., Ph.D and Daniel Elliott, M.D.. This was done under Pennsylvania Rule of Evidence 702, known as the Frye Motion. It cites Frye v. United States, 293 Ethicon had filed almost identical Frye motions to preclude testimony in the Hammons case against Ethicon.
With Peggy Pence, for example, Pence is a regulatory expert with more than 40 years experience in bringing medical devices to market. Dr. Pence has testified that the Proliftwas misbranded when brought to market because the manufacturer made false and misleading statements.
Prolift actually was marketed by Ethicon prior to having any FDA clearance at all. It was only when Prolift M+ was submitted for FDA clearance did the FDA even know the existence of Prolift. Then andonly then did the FDA issue it clearance to market, three years after it was already being sold!
Dr. Uwe Klinge is a biomaterials scientist who collects explanted hernia mesh for a decade and examines their properties. Ethicon does not want him to testify about Ethicon’s purported knowledge and state of mind, about degradation of mesh and particle loss.
Ethicon wants to exclude the testimony of Dr. Daniel Elliott that Prolift is defective and had a duty as a medical device manufacturer to make a safe and effective product.
Ethicon motions aim to exclude Bruce Rozenszweig as an expert witness. There is a Motion in limine to eliminate the Chevron MSDS and any discussion of Johnson & Johnson shredding of documents pertaining to its transvaginal mesh production. See MND story here.
There is a motion to eliminate discussions heard in the Budke death trial and the Linda Gross Prolift trial in New Jersey.
Motion for Summary judgment filed by Ethicon October 6, cite that she allegedly filed outside of her statute of limitation. Ms Blockus should have been aware of her mesh injury July 2008 and October 2010 and/or should have been aware of the 2008 and 2011 FDA Public Health Notices.
Ms. Blockus said she was not aware her injuries might be linked to mesh until she saw television commercials after which she filed her lawsuit.
The defendant says “a plaintiff cannot just sit back and wait to see a lawyer television advertisement before filing suit when there is similar, if not more detailed, information from a government source regarding a potential causal connection between a product and certain symptoms that has been accessible and available to the public for 5 years.”
Between March 2007 and November 2011 she says she experienced ongoing pain and urinary symptoms, four mesh erosions and underwent four surgical procedures to correct the erosions. She also had an additional prolapse device implanted.
ALSO IN PHILADELPHIA
Also listed for trial in the Philadelphia court is Hespe v Boston Scientific, Trial date certain – January 22, 2018. Case No. 130700947
Deimler vs. Ethicon Women’s Health and Urology, Trial date certain – May 14, 2018, Case No. 13070136
There are 131 records found waiting for trial in this pelvic mesh mass tort in Philadelphia.
https://www.meshmedicaldevicenewsdesk.com/mesh-trials-horizon/
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‘This operation left me in agony’ says Spalding woman Steph
Nov 2, 2017 | Spalding Today
But when Steph was admitted a surgeon recommended an alternative procedure she’d never heard of – a Laparoscopic Sacrohysteropexy – which involves leaving the uterus in place and supporting it with an artificial mesh implant.
The op has left the once active Steph in constant agony, unable to scoop up her grandchildren in her arms or even carry two cups of tea at one time.
“I feel like I have got barbed wire inside my stomach,” said Steph. “When I get up it’s just painful, it’s painful if I sit too long.”
It’s also too painful for Steph to be hugged and she sleeps with the aid of Night Nurse.
Steph and her district councillor husband, Pete, have been to Westminster with the Sling the Mesh Campaign, founded by Cambridgeshire newspaper reporter Kath Sansom, which has more than 4,230 followers on Facebook calling for the operation to be axed.
Courageous Steph has revealed intimate details about her health to warn women – and men – not to have an operation that campaigners say has left some in wheelchairs and others walking with a stick.
Steph suffered in silence for nine months with a prolapsed uterus before going to her GP and had her first hospital appointment in January. Symptoms include seeing the uterus or cervix pop out of the vagina, a pulling or heavy feeling in the pelvis and feeling like you’re sitting on a ball. Other organs, such as the bladder or rectum, can prolapse (fall out of place) too and the Williams say men have suffered though having similar operations.
One hospital explains the procedure used in Steph’s case as “supporting the uterus using a permanent artificial mesh material”.
Punchbowl pub landlord Pete (63) says the mesh was attached to Steph’s hip bones but one side came away.
“Every time she coughs or laughs or sneezes it doubles her up with pain,” said Pete.
Steph said: “I went in for a hysterectomy in June and an hour before the operation the surgeon came round and said ‘we are going to try the (whatever the long name is for that operation)’. I had waited five months just to get the operation date and I didn’t have time to research it in any way so I agreed to have it done.
“It wasn’t explained. Even when I came round I thought I’d had a partial hysterectomy.”
Steph came away from hospital with a carrier bag full of leaflets “and in it was an explanation of the operation”.
The couple paid privately to see one of two top experts in the country to ask about having the mesh, something that could pose even more risks to Steph’s health.
The reversal operation, together with a hysterectomy, will cost £9,000. Steph expects to wait months with ever worsening pain because the cost is so high and it will have to be done on the NHS.
Pete believes mesh procedures save NHS thousands compared to the cost of hysterectomies, but says they are wrecking people’s health and destroying couples’ sex lives.
Kath Sansom told us: “The mesh operations are given as they are a quicker, cheaper fix to traditional natural tissue repairs. “Lots of women are told they are not having mesh they are having a tape so don’t realise they are suffering from problems on this issue. It is a tape which is made of mesh.
“Steph was not given proper fully informed consent of what operation was being given to her nor of the risks associated with the plastic mesh implant. It can shrink, twist or degrade and cause mayhem.
“I am glad Pete and Steph found Sling The Mesh as it means they know they are not alone as that is how all women affected are made to feel – like they are some kind of mystery patient – but it is sad and wrong that they had to even find the group in the first place. I hope Steph gets her referral soon to a mesh removal specialist to hopefully re-build her previously healthy life.”
Health minister Jackie Doyle-Price rejected MPs’ calls for an inquiry into vaginal mesh implants, but Scottish Conservative Paul Masterton spoke of “women who have lost their careers, their husbands, their homes, their dignity and their lives, who are forced to spend day after day and night after night in agony”.
http://www.spaldingtoday.co.uk/news/this-operation-left-me-in-agony-says-spalding-woman-steph-1-8222252
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