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Ethicon Media Monitoring 7/18/2018
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J&J Second Q Report – Rosy Picture for Medical Devices
Jul 17, 2018 | Mesh Medical Device News Desk
By Jane Akre
Amid the reports of a growing company, Johnson & Johnson is facing massive litigation costs it’s required to disclose under the Securities and Exchange Commission. -
Surgical mesh implant suspension welcomed by campaigner Jackie Cheetham
Jul 18, 2018 | Gazette & Herald
By David Mackie
The Government’s decision to immediately suspend the use of surgical mesh when treating incontinence has been welcomed by local campaigners. -
Medical negligence firm raises concerns over government's commitment to mesh ban
Jul 17, 2018 | Medical Plastics News
Thompsons Solicitors has pointed out discrepancies between the recommendations of the Independent Medicines and Medical Devices Safety Review and the government’s ministerial announcement to the House of Commons. -
Pause on the use of vaginally inserted surgical mesh for stress urinary incontinence.
Jul 17, 2018 | GOV.UK
Following a recommendation by the Independent Medicines and Medical Devices Safety Review, the government and NHS have paused the use of vaginally inserted surgical mesh for stress urinary incontinence until a set of conditions to ensure that patients receive safe and high-quality care are met.
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J&J Second Q Report – Rosy Picture for Medical Devices
Jul 17, 2018 | Mesh Medical Device News Desk
By Jane Akre
Amid the reports of a growing company, Johnson & Johnson is facing massive litigation costs it’s required to disclose under the Securities and Exchange Commission.
Litigation Amid Profits
The second quarter report on earnings for Johnson & Johnson reports a rosy picture medical devices and an overall increase of more than 10% compared to this time last year. Noting the “accelerating sales momentum in our Medical Devices business, driven by the continued growth of our market leading products and strategic new launches,” led to sales of $7 billion in the second quarter of 2018, reports Worldwide Medical Devices division.
Medical devices include surgical mesh, artificial knees and hips.
Last May, the company said its outstanding product liability issues surround DePuy ASR hips, the Pinnacle Acetabular Cup System, pelvic meshes, Risperdal, Xarelto, Baby Powder and Invokana.
PERSONAL INJURY
The company tells investors it has settled “a majority of the United States cases,” though acknowledges,
“individual personal injury cases or claims have been commenced in various countries outside of the United States, including claims and cases in the United Kingdom, the Netherlands and Belgium, and class actions in Israel, Australia and Canada, seeking damages for alleged injury resulting from Ethicon’s pelvic mesh devices.”
A decision on the result of more than 700 product liability lawsuits filed in Australia against Johnson & Johnson over its pelvic meshes should be made this year.
Next month, Wave 7 in the Charleston MDL should commence with multi-plaintiff trials consolidated against J&J/Ethicon. Wave 8 will follow later this year, again with multiple plaintiffs consolidated in one action against the healthcare giant.
Last week the company was charged with a $4.7 billion jury verdict over its talc in Baby Powder over an ovarian cancer trial in Missouri. J&J plans an appeal and denies its talc contains any cancer-causing asbestos, however a view of the company website now finds that most baby powders in its personal care family of products are made from corn starch.
The company still fails to put a warning on its powder for feminine hygiene, the theory being that asbestos fibers make their way through the vagina and into the ovaries where over time they initiated cancer. Talc is generally mined near asbestos sources.
MULTI-STATE INVESTIGATIONS
Additionally, Johnson & Johnson is involved in a multi-state investigation with various states seeking compensation for the use of pelvic mesh. In May 2016, California and Washington State filed civil complaints against Johnson & Johnson and its Ethicon Inc. division “alleging violations of their consumer protection statutes. Similar complains were filed against the companies by Kentucky in August 2016 and Mississippi in October 2017. “
“Johnson & Johnson and Ethicon have entered into a new tolling agreement with the remaining 43 states and the District of Columbia.”
OPIOID CHARGES
Since 2014, J&J and Janssen Pharmaceuticals, Inc. has been named in numerous lawsuits brought by certain state and local governments relating to the marketing of opioids including Duragesic, Nucynta and Nucynta ER, all made by J&J.
In all, 23 states allege the company falsely advertised, violated consumer fraud laws cr3eated a public nuisance and deceptively acted for unjust enrichment.
J&J and Janssen Pharmaceuticals have been served with motions to consolidate 66 pending matters into Multi District Litigation in the Southern District of Ohio. In December the MDL was approved and hundreds of cases are now being transferred to Ohio.
https://www.meshmedicaldevicenewsdesk.com/jj-second-q-report-rosy-picture-for-medical-devices/
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Surgical mesh implant suspension welcomed by campaigner Jackie Cheetham
Jul 18, 2018 | Gazette & Herald
By David Mackie
THE Government’s decision to immediately suspend the use of surgical mesh when treating incontinence has been welcomed by local campaigners.
The decision was made by Baroness Cumberlege following her review into the contentious procedure which campaigners say can go badly wrong and cause unending, excruciating pain.
The plastic polypropylene implants, sometimes called “sling implants”, are given to women to support organs in the pelvis. The surgery usually takes less than an hour.
Jackie Cheetham, 50, from Allerston, near Pickering, has been campaigning for a permanent ban on the use of the mesh after her own surgery led to 12 years of agonising pain.
She said she was in tears when she heard the news about the suspension.
“I am delighted that Baroness Cumberledge has acted after receiving lots of emails and hearing women’s stories personally,” she said. “This news has come exactly 12 years since my second implant that destroyed my life.
“I’m delighted no other woman will have to suffer from this incontinence mesh operation, although it might frustrate some to have theirs cancelled. However in the long term I hope that they come to appreciate that it may have saved them from a much worse outcome.
“Rectopexy and prolapse mesh through the stomach has not yet been suspended but I am hoping it soon will be as all mesh can cause mass life-changing damage. All mesh is plastic polypropylene; inert and can slice through organs.
“We also now hope this suspension will lead to a permanent ban on all mesh operations in the UK.
“I would like to thank Kevin Hollinrake for helping to highlight the dangers of mesh and for speaking on my behalf in parliament.”
Mr Hollinrake, MP for Thirsk and Malton, said: “The announcement can’t come soon enough for many women in my constituency and elsewhere who have been injured and suffered agonising pain because of mesh surgery.
“They have shown great bravery and dignity in speaking out and I am delighted that the message has been heard.”
Baroness Cumberlege said: “We strongly believe that mesh must not be used to treat women with stress urinary incontinence until we can manage the risk of complications much more effectively.
“We have not seen evidence on the benefits of mesh that outweighs the severity of human suffering caused by mesh complications.
“At this stage in our review we are not recommending a ban, but a halt to procedures.”
http://www.gazetteherald.co.uk/news/16358782.surgical-mesh-implant-suspension-welcomed-by-campaigner-jackie-cheetham/
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Medical negligence firm raises concerns over government's commitment to mesh ban
Jul 17, 2018 | Medical Plastics News
Thompsons Solicitors has pointed out discrepancies between the recommendations of the Independent Medicines and Medical Devices Safety Review and the government’s ministerial announcement to the House of Commons.
Last week, chair of the review baroness Julia Cumberlege, advised the NHS and the Department of Health and Social Care that mesh surgeries for SUI should be paused until a set of conditions designed to mitigate the risk of injury are met. The NHS and DoH accepted the recommendations that the conditions be met by March 2019.
Thompsons Solicitors state that despite the government agreeing to the recommendations, the statement to parliament does not commit to the immediate ban proposed in the review. Instead, the government introduced the vague concept of a ‘high vigilance programme of restricted practice’.
Within the announcement, health minister Lord O’Shaughnessy said: “Our new approach, with a high vigilance programme of restricted practice, will radically reduce the number of women have vaginal meshes inserted, and ensure that when it does happen, it is only after close consultation with their clinician and with extremely thorough clinical oversight and governance.”
Tom Jones, head of Policy at Thompsons Solicitors, said: “The recommendation for a ban could not have been clearer and yet, whilst saying they accept it the government haven’t introduced a ban at all. The only thing they have introduced is ambiguity where there was none.
“For the Department for Health and Social Care to be backing out of promises made by experts they appointed to advise them is extremely worrying. Baroness Cumberlege wanted no one else to suffer but the government apparently don’t care. It’s worth recalling that Jackie Doyle Price said in answer to a Westminster Hall Debate in October 2017 that she believed mesh ‘is still the best product for treating stress incontinence’ and it appears that her mind is closed and she thinks she knows better than the experts.”
Owen Smith, Labour MP for Pontypridd and chair of the All-Party Parliamentary Group on Surgical Mesh Implants, said: “I am concerned that a rearguard action fought by surgeons who have earned thousands putting mesh into women in private clinics has forced the government to row back somewhat from the clear suspension envisaged by the Independent Review.
“I have submitted questions to Health Ministers to clarify the current position. Crucially, we need to know how many women does the government imagine will still be treated with Mesh under the exceptional cases process and how will those women be selected.”
https://www.medicalplasticsnews.com/news/medical-negligence-firm-raises-concerns-over-government-s-co/
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Pause on the use of vaginally inserted surgical mesh for stress urinary incontinence.
Jul 17, 2018 | GOV.UK
Following a recommendation by the Independent Medicines and Medical Devices Safety Review, the government and NHS have paused the use of vaginally inserted surgical mesh for stress urinary incontinence until a set of conditions to ensure that patients receive safe and high-quality care are met. This pause has been extended to include vaginally inserted surgical mesh for pelvic organ prolapse and will be implemented through a high vigilance programme of restricted practice.
These procedures have not been banned and during this pause, they will continue to be used when there is no viable alternative and after close and comprehensive consultation between patient and clinician.
There has not been any new evidence which would prompt regulatory action and the position of MHRA remains the same on these medical devices. We continue to work with other regulators in the EU and wider, as well as colleagues across the health sector, to monitor and examine evidence as it becomes available.
We continue to work closely with NHS England, NICE and professional bodies, and we are all committed to helping address the serious concerns raised by women who have experienced complications, and we will take action as appropriate to protect public health.
We actively encourage patients and healthcare professionals to report complications associated with these implants through the Yellow Card Scheme.
Please see the DHSC statement on the pause and the letter from NHS Improvement to acute trust CEOs and medical directors.
https://www.gov.uk/government/news/pause-on-the-use-of-vaginally-inserted-surgical-mesh-for-stress-urinary-incontinence
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