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Ethicon 5/19
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Design Defect Claim Survives Summary Judgment Motion in Obtryx Transvaginal Mesh Case
May 18, 2015 | HarrisMartin Publishing
A West Virginia federal judge has denied Boston Scientific Corp. summary judgment on a strict liability design defect claim in a transvaginal mesh case, finding there are issues of fact as to whether the manufacturer acted unreasonably in designing the Obtryx device. -
Gynaecological Mesh Maker Appeals Deregistration Ruling
May 18, 2015 | Newcastle Herald
By Joanne McCarthy
Former Australian champion basketballer and Newcastle Falcons player Paul Zadow is taking the federal health minister to the Administrative Appeals Tribunal to appeal against the deregistration of his company’s gynaecological mesh products... -
Botched Surgery Claims Led to $7.6m Payout
May 18, 2015 | Newcastle Herald
By Joanna McCarthy
...The woman has alleged she did not sign a consent form for the use of the mesh, which was later removed by another surgeon after the woman alleged she had ‘‘lost confidence in the defendant’s medical skills’’... -
Conflict of Interest on Medical Boards Abounds
May 18, 2015 | Mesh Medical Device News Desk
By Jane Akre
Thanks to Joleen Chambers, a patient advocate a tireless champion of a patient’s right to know. She writes to Mesh News Desk about important issues you can be involved with to help resolve the major conflicts that exist on your state medical boards.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
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Design Defect Claim Survives Summary Judgment Motion in Obtryx Transvaginal Mesh Case
May 18, 2015 | HarrisMartin Publishing
A West Virginia federal judge has denied Boston Scientific Corp. summary judgment on a strict liability design defect claim in a transvaginal mesh case, finding there are issues of fact as to whether the manufacturer acted unreasonably in designing the Obtryx device.
However, in the May 7 order Judge Joseph Goodwin of the U.S. District Court for the Southern District of West Virginia ruled that the learned intermediary doctrine defeats the plaintiff’s claim of negligent failure to warn because the implanting surgeon did not read the device’s Directions For Use.
Karen Hembree was surgically implanted with ..
Subscription required, please see link for full article: http://harrismartin.com/article/19499/design-defect-claim-survives-summary-judgment-motion-in-obtryx-transvaginal-mesh-case/
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Gynaecological Mesh Maker Appeals Deregistration Ruling
May 18, 2015 | Newcastle Herald
By Joanne McCarthy
Former Australian champion basketballer and Newcastle Falcons player Paul Zadow is taking the federal health minister to the Administrative Appeals Tribunal to appeal against the deregistration of his company’s gynaecological mesh products.
Mr Zadow’s South Australian company, TFS Manufacturing, lodged an appeal on March 27 after the Tissue Fixation System mesh product was deregistered by the federal Therapeutic Goods Administration on November 5 – one of the first mesh products in Australia to be deregistered.
The company is appealing to the Administrative Appeals Tribunal after losing an appeal to the Therapeutic Goods Administration against its decision.
Mr Zadow’s company failed to substantiate how its ‘‘tissue fixation system’’ mesh device, developed by
Dr Peter Petros and used in prolapse surgery in women, complied with relevant standards.
The Therapeutic Goods Administration and the American Food and Drugs Administration deregistered more than 60 mesh products after concluding there was ‘‘little evidence to support the overall effectiveness of these surgical meshes as a class of products’’ following a large number complaints.
In an email on Wednesday, Mr Zadow said the TFS device was deregistered for ‘‘technical reasons’’.
‘‘The TGA has not found or alleged that the TFS device is unsafe,’’ Mr Zadow said.
‘‘TFS Manufacturing is taking all necessary and reasonable steps to have the TFS device re-registered.’’
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Botched Surgery Claims Led to $7.6m Payout
May 18, 2015 | Newcastle Herald
By Joanna McCarthy
A GYNAECOLOGIST under investigation by the Health Care Complaints Commission was able to resume work in Australia in 1997 without having to notify authorities he faced suspension in the United States after serious complaints against him.
Those complaints included a $7.6million compensation payout to a patient in her 20s after an American court was told she could never have sex again because of permanent and severe damage caused by the Australian doctor.
Former University of Newcastle associate professor Richard Reid, who was suspended by the NSW Medical Council last year and later reinstated, and is barred from performing major surgery after urgent Medical Council action in March, was required to complete a non-identifying questionnaire that was filed with the Department of Health for statistical purposes in 1997 when he returned to Australia after 19years in the US, the NSW Medical Council has said in a letter to an Australian complainant.
Dr Reid was not required to advise Australian authorities when the Michigan Board of Medicine fined him $10,000 in April 1998, more than a year after he returned to Australia, and suspended him for three months for incompetence and violating his duty to ‘‘safely and skilfully’’ practise medicine, based on complaints from three American women.
‘IF I HAD KNOWN THE PRICE, THE INTRUSION ON MY HAPPINESS, THE STRESS IT HAS PLACED ON MY FAMILY, THE TERRIBLE BURDEN ON MY CAREER I PROBABLY NEVER WOULD HAVE BEEN INVOLVED IN ANY OF THIS ... IF I CAN BE BLAMED FOR ANYTHING, IT IS THAT I WAS TOO NAIVE.’- DR RICHARD REID
It was not until an amendment to the Medical Practice Act in 2000 that doctors were required to record if they had been suspended in Australia or elsewhere in the previous year, the Medical Council said.
The NSW Medical Board (which became the Medical Council) did not become aware of the Michigan Medical Board action against Dr Reid until 2006 after a complaint from an Australian patient, the Medical Council said.See your ad here
This contradicted a statement by Dr Reid to the Newcastle Herald in September last year that he advised the Medical Board of the suspension.
‘‘The Medical Board took this information into account in dealing with Dr Reid,’’ the Medical Council said.
Dr Reid did not respond to emails and messages from the Herald to clarify his actions on returning to Australia. When reached by phone, he said ‘‘I can’t talk to you’’ and ended the call.
Dr Reid’s solicitor later emailed the Herald to say that ‘‘any allegations or inferences of inappropriate conduct on the part of Dr Reid will be strenuously defended at the appropriate time’’.
The American woman, who was 23 when she first saw Dr Reid in 1989, was one of three women whose complaints to the Michigan Medical Board were substantiated and led to his suspension.
In her civil case before a jury, which led to large settlements for a number of other patients of Dr Reid, the court was told eight surgical procedures had left her permanently mutilated so that she could never again have sex, could not use tampons and had difficulty urinating.
The Herald understands the conduct of the American proceedings and decisions on settlements were made by Dr Reid’s insurers.
The second of the three women, who spoke to the Herald, was left with a mutilated vaginal area, unable to have sex, has problems urinating and has spent periods unable to sit. She received a substantial settlement after alleging ‘‘wrongful, excessive and inappropriate surgery of the vaginal area’’ in a civil action against Dr Reid.
She alleged she was told Dr Reid was using an ‘‘experimental’’ type of laser ‘‘hexascan’’.
She alleged she was not informed of the serious risks of some of the treatments she received and had not consented to some treatments.
The Michigan Medical Board heard evidence the woman, aged 50 at the time of the complaint, received three laser procedures from Dr Reid and his associate based on an incorrect diagnosis by Dr Reid.
The evidence included that Dr Reid had not performed a biopsy to confirm his diagnosis.
The woman told the Herald she was surprised Dr Reid was treating women in Australia, but not surprised the Health Care Complaints Commission was investigating complaints from a number of patients.
The third woman whose allegations against Dr Reid were substantiated by the Michigan Medical Board received a large settlement after undergoing eight laser procedures and other treatments by Dr Reid over an extended period that impaired her ability to have sex or urinate. Her husband received a settlement for loss of normal sexual relations with his wife.
In American media reports after the $7.6million settlement, Dr Reid blamed the legal system for a case that ‘‘was decided by layer upon layer of lies’’ prompted by a ‘‘small splinter group of chronically angry women’’ who made claims against him.
‘‘If I had known the price, the intrusion on my happiness, the stress it has placed on my family, the terrible burden on my career I probably never would have been involved in any of this,’’ Dr Reid was quoted saying in a November, 1995 article in the Detroit News. ‘‘If I can be blamed for anything, it is that I was too naive.’’
In another article, he was quoted saying: ‘‘After this, my advice to other physicians is to put your own interests first.’’
One 1995 article after the $7.6million court case noted that Dr Reid’s American surgery carried a sign advising he no longer had liability coverage.
This month, a Central Coast patient will seek to have her claim against Dr Reid heard by the Supreme Court, not the District Court, which is restricted to civil claims payouts of $750,000. In a statement of claim, the woman, 56, alleged severe physical and emotional damage after surgery by Dr Reid in 2010 that included the surgical placement of mesh grafts to treat a gynaecological condition.
The woman has alleged she did not sign a consent form for the use of the mesh, which was later removed by another surgeon after the woman alleged she had ‘‘lost confidence in the defendant’s medical skills’’.
Dr Reid’s solicitor said the woman’s allegations were denied.
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Conflict of Interest on Medical Boards Abounds
May 18, 2015 | Mesh Medical Device News Desk
By Jane Akre
Thanks to Joleen Chambers, a patient advocate a tireless champion of a patient’s right to know. She writes to Mesh News Desk about important issues you can be involved with to help resolve the major conflicts that exist on your state medical boards. This is important to everyone and is something you can do something about! Thank you Consumers Union for your Safe Patient Project!
Dear Fellow Advocates/Activists,
Please help me share these two links with your networks:http://www.reportingonhealth.org/2015/05/08/overlooked-court-case-puts-industry-friendly-state-medical-boards-notice#comment-70396http://safepatientproject.org/wordpress/wp-content/uploads/2015/05/FINAL-NC-Press-Release-5-4-15-1.pdfAsk them to follow up by contacting their State Attorney General to support this letter and to change the composition of the state Medical Board to a supermajority of non-conflicted public members or provide state supervision to prevent anticompetitive conduct. A personal story of how a harmed patient had been affected would be appropriate.Public Citizen provided this report several years ago about the conduct of state medical boards:http://www.citizen.org/ranking-of-state-medical-boards-serious-disciplinary-actions-2009-2011
My best,
Jo
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