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Ethicon Media Monitoring 9/6/2018
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Ethicon Tries Unsuccessfully to Have Hammons’ Issues Revisited
Sep 5, 2018 | Mesh Medical Device News Desk
By Jane Akre
The Philadelphia Court of Common Pleas has been a problem venue for Johnson & Johnson in its pelvic mesh litigation. So far, the device maker has won just one pelvic mesh product liability case with one hundred more to be heard. -
Mesh implant listed as ‘cause of death’ for first time
Sep 6, 2018 | The Scotsman
By Kevan Christie
A woman who underwent controversial mesh implant surgery is believed to be the first in Scotland to have the procedure listed as an underlying cause of death.
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Ethicon Tries Unsuccessfully to Have Hammons’ Issues Revisited
Sep 5, 2018 | Mesh Medical Device News Desk
By Jane Akre
The Philadelphia Court of Common Pleas has been a problem venue for Johnson & Johnson in its pelvic mesh litigation. So far, the device maker has won just one pelvic mesh product liability case with one hundred more to be heard.
The basis for the latest appeal is venue, but that too has not been successful for the healthcare giant.
Johnson& Johnson wanted another bite of the apple.
A Pennsylvania appeals court has denied Ethicon’s request for an enbanc rehearing (typically with a panel of three judges), on issues raised in a June appeals court decision.
In December 2015, Hammons was awarded $12.85 million, which included $7 million in punitive damages due to the injuries she suffered from the Prolift pelvic mesh device which was implanted with in 2009.
Ethicon, the division of J&J that makes medical devices, argued that the Indiana woman’s case should never have been heard in Pennsylvania claiming it was the wrong jurisdiction for Hammons to bring a civil lawsuit
A Pennsylvania appeals court has denied the company’s request for another en banc rehearing on jurisdiction, on statute of limitations, and on causation.
PATRICIA HAMMONS
In an 82-page decision, filed June 19, 2018, Superior Court Judge Victor P. Stabile told the company to pay the damages.
Hammons was represented by Shanin Specter of Kline Specter, a Philadelphia law firm.
Her complaint, filed in May 2013, included not just Ethicon, but Secant Medical and Secant Medical LLC, a manufacturer of surgical mesh located in Perkasie, Pennsylvania.
In November 2015, when the trial court granted summary judgment to Ethicon on the manufacturing defect claim, saying there was no evidence that Prolift deviated from its intended design.
That left a design defect and failure-to-warn claim for the plaintiffs to prove at trial.
THE TRIAL
At trial, Dr. Daniel Elliott was one witness who testified that the Prolift mesh contains too much suture for implantation through the vaginal wall and approximately 260 yards of a plastic material foreign to the body. The mesh is over-engineered, too heavy and dense with small pores to perform as intended, he said.
Dr. Uwe Klinge, M.D. testified Ethicon should have used a mesh with pores larger than three millimeters. He said the the Prolift pores collapse with any movement of the pelvic organs. Dr. Elliott testified that mesh causes a chronic foreign body reaction and inflammatory response and Prolift does so in direct proportion to the large amount of plastic used.
The inflammmatory response and scar formation bridge the mesh, making it contract and become rigid. When that happens, it can erode layers of vaginal tissue and neighboring organs, can expose in the vagina in an open wound, and damage the bladder, intestines and other organs. Pulling or contracting mesh causes pelvic floor muscle spasms and chronic muscle pain.
At trial, Drs. Anne Weber and Elliott concluded the Prolift is unsafe.
Ethicon argued that Pennsylvania is not the correct jurisdiction because Ms Hammons is from Indiana and J&J or Ethicon have no business in Pennsylvania. This is important because of a U.S. Supreme Court decision in 2017. Bristol-Myers Squibb v. Superior Court of California held that non-residents could not bring an action against a non-resident drug manufacturer unless they were prescribed the drug in that state, lived there, or purchased the drug there.
PROPER JURISDICTION
In Bristol- Myers, the decision to contract with a California company to distribute Plavix, did not provide enough basis for personal jurisdiction.
Ethicon was hoping Bristol-Myers might knock Ms. Hammons out of court. However, Ethicon supervised the manufacturing and design in Pennsylvania with Secant Medical of Bucks County, providing the polypropylene filament to Secant and material specifications for the weaving of the mesh as well as specs on the elasticity, mass, and density of the mesh.
E-mails show the company communicated repeatedly and Ethicon empoloyees visited Secant’s plant in Pennsylvania to observe the mesh-making process.
Ethicon worked closely with Dr. Vincent Lucente, MD from Allentown, Pennsylvania in developing Prolift. He was retained as an investigator for three clinical studies, funded by Ethicon on Prolift (Gynemesh PS study of Prolift mesh materials, the US TVM study of Prolift prototype, and Lucente IIS study).
Additionally, Lucente was consulted on marketing and development strategy for Prolift including lifting the word “experimental” from an American College of Obstetricians and Gynecologists publication, opening up the way for insurance coverage, according to trial testimony.
For his work, Ethicon paid Dr. Lucente more than $1.7 million.
Interestingly, according to the appeals court document, Dr. Lucente “advised it would be a “disaster” for women to need revision surgery with Prolift.”
All of those factors supported the exercise of specific jurisdiction over Ethicon in Pennsylvania, writes Judge Stabile in June.
In July, Ethicon requested the Superior Court consolidate Hammons with the Carlino case ($13.5 million) to hear arguments about jurisdiction following the Bristol-Myers decision. The application (here) was denied.
At this writing, McFarland v Ethicon is underway in the Philadelphia Court of Common Pleas, while Emmett v Ethicon is due to go to trial in the same court, November 19, 2018.
https://www.meshmedicaldevicenewsdesk.com/ethicon-tries-unsuccessfully-to-have-hammons-issues-revisited/
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Mesh implant listed as ‘cause of death’ for first time
Sep 6, 2018 | The Scotsman
By Kevan Christie
A woman who underwent controversial mesh implant surgery is believed to be the first in Scotland to have the procedure listed as an underlying cause of death.
Eileen Baxter, 75, died on 27 August after being admitted to hospital the previous week with internal bleeding, sickness and diarrhoea.
Multiple organ failure is listed as directly leading to her death, with sacrocolopexy mesh repair – an implant to fix a pelvic organ prolapse – listed as an underlying cause.
Last night, Mrs Baxter’s son Mark, 52, said he was given the number for the legal department of the Royal Infirmary of Edinburgh by medical staff after he asked for a copy of his mother’s death certificate, which The Scotsman has seen.
He said: “I’ve told them I’m going to take things as far as I can. They said they were very surprised where the tear in the bowel was – I mentioned my mother’s mesh implant to the doctor but we never got a straight answer.
“I’m really angry that my mother is not still here and I’m really annoyed she went through all of this. “They didn’t bother about her – they didn’t seem to care about her.”
He added: “She was feeling unwell in July and was taken to the hospital by ambulance and they basically told her it was a ‘pain thing’.
“They advised her to speak to a counsellor to get advice on how to manage pain and they sent her away.
“I thought ‘they must be joking, my mum’s not well’.
“I would like to legally pursue this but I don’t know if we can get legal aid. We’re so annoyed and my poor dad Chic is lost, he’s completely devastated because they were so close, they did everything together.”
More than 20,000 women in Scotland have had the implants over the past 20 years but some have suffered painful and debilitating complications.
The Scottish Government recommended suspension of mesh implants in their use by the NHS in 2014 while an independent safety review was carried out but since then around 400 procedures have been completed.
Mrs Baxter, a mother-of-two and a great-grandmother from Loanhead in Midlothian, underwent mesh surgery five years ago.
Her death certificate lists this as an antecedent cause of death that caused chronic pelvic inflammation and possible sepsis leading to anterior rectal perforation and finally the multiple organ failure that ultimately led to her death.
Scottish Labour MSP Neil Findlay who has campaigned vigorously on behalf of the Scottish Mesh Survivors group, called on health secretary Jeane Freeman to launch an investigation into Mrs Baxter’s case to “ensure no further harm” is done to women across the country.
He said: “The news that a repair to a mesh implant carried out by NHS Scotland was a contributing factor in the death of Eileen Baxter will deeply distress not only her family but the many hundreds of women in Scotland who underwent this procedure.
“Many women who have undergone this procedure say they have experienced infections, bleeding and even paralysis.
“Mesh implants should be consigned to the history books and those manufacturers who potentially broke the law should be prosecuted.”
The Scottish Mesh Survivors campaign said in 2014 that 12 women had reported cases to the UK-wide Medicines and Healthcare Products Regulatory Agency (MHRA), while it is believed more than 400 women have undergone repeated operations in an attempt to resolve the problems.
Mesh survivor Elaine Holmes, from Newton Mearns, said: “It’s absolutely shocking, what concerns me is the possible sepsis – this woman suffered terribly, has she become antibiotic resistant? Has she been dismissed and ignored? There are so many questions needing asked in this case.”
A Scottish Government spokesperson said: “Our condolences go to the family and friends of Eileen Baxter.
“The Scottish Government does not hold information on individual patients or their treatment, but we will give any information supplied to us on Ms Baxter’s case very careful consideration.”
https://www.scotsman.com/news/mesh-implant-listed-as-cause-of-death-for-first-time-1-4795723
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