All Posts in Category: Adverse Reaction to Medication

Vaginal Mesh Class Action Won Against Johnson & Johnson in Australia

 A long-running class action lawsuit against Johnson & Johnson (J&J) over vaginal mesh implants has been won by more than 1,350 Australian women.

It was ruled in Australia’s Federal Court J&J subsidiary Ethicon had not issued a sufficient warning to patients and surgeons in relation to the “risks” posed by the products they were using. The vaginal mesh implants were often put in place to address pelvic organ prolapse and incontinence that occurred in the aftermath of childbirth.

Some patients in the legal action said they had suffered chronic pain, bleeding and severe discomfort during sexual intercourse after having the mesh surgically implanted.

Judge Anna Katzmann ruled that much of the information the company provided about the products was “inaccurate” and at times made “false representations”. Damages will be set next year. During he ruling she said: “The risks were known, not insignificant and on Ethicon’s own admission, serious harm could ensue if they eventuated.”

Ethicon defended its record and said it would consider an appeal and released a statement which said: “Ethicon believes that the company acted ethically and responsibly in the research, development and supply of these products.”

The original claimant in the case Julie Davis said: “They have treated women essentially like guinea pigs, lied about it and done nothing to help”. This ruling comes after the Australian government  last year issuing a national apology to women affected by vaginal mesh, acknowledging decades of “agony and pain”.

The case is one of a series of lawsuits J&J faces over the products around the world. Last October, the company committed to paying almost $117m (£90.5m) to settle claims in relation to pelvic mesh in 41 US states and the District of Columbia. There are also a number of lawsuits over the product in Canada and Europe, including Ireland.

US Medical Expert says Vaginal Mesh is ‘Not Safe’

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US Medical Expert says Vaginal Mesh is ‘Not Safe’

Expert Chartered chemist Dr Chris DeArmitt, has assisted over 9,000 women is have their vaginal mesh compensation actions settled, has referred to the that the material as not safe for treating incontinence.

Vaginal mesh is currently not being used due to suspension in the United Kingdom. This will remain so until the results of an independent safety review are revealed. The study was initiated after thousands of women reported harrowing complications. DeArmitt, a leading medical expert in the UK has been called upon during court action against producers of vaginal mesh.

In the United States over 100,000 people are taking legal actions due to injuries and illnesses that the believe arose from the use of vaginal mesh.

In an interview with Sky News Dr DeArmitt said: “There are two main reasons why any plastics material expert will tell you just obviously that this is a bad material and I have never heard anyone who disagrees with me. I see an absolute disregard for proper testing. Testing is way less than you would see on a vacuum cleaner or a washing machine. It’s shocking. I’ve never seen anything like it in my career.”

In Ireland there have been a number of case in relation to use if vaginal mesh in recent years, particularly in 2017. Legal representatives for a number of women, who initiated legal actions in 2017 after undergoing the vaginal mesh procedure, said that they (the women) only became aware of the issue after seeing media reports in the United Kingdom in relation to its use.

The US regulator, the FDA, in 2019 outlawed the sale and distribution of all mesh that was to be used for the treatment of pelvic organ prolapse due to the many safety problems experienced by the general public. In the UK, the National Institute for Care and Excellence (NICE) has stated that it will be offered as a potential alternative form of treatment for women suffering from various injuries once the ban on using it is lifted.

A NICE representative commented: “The benefits and risks of each type of treatment are laid out to ensure every woman is fully informed. Where the evidence is limited, this is also highlighted. There are a number of procedures recommended by NICE, including mesh procedures.”

Due to work of many campaigners, the use of vaginal mesh has come under the microscope once more. Typical problems suffered by  women include chronic pain, not being able to make love, inability to work as normal and walking difficulties. These issues arise from vaginal mesh cutting organs or getting stuck in tissue, leaving permanent nerve damage.

 

 

 

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Medical Negligence Compensation Payouts of €268m Made by State Claims Agency in last two years

The overall amount of compensation paid out by the State Claims Agency (SCA) in relation to medical negligence claims totals over half a billion euro in the past two years.

New figures released by Minister for Health Simon Harris show that the amount of compensation paid out by the State Claims Agency (SCA) in 2018 was €268.45m for medical negligence cases – an increase of €18.6 million – or 7.5% – on the €249.77m paid out in 2017. This brings the total amount of compensation for medical negligence paid out in 2017-18 to €518.2m.

The figures were provided by the State Claims Agency (SCA)  in response to a a written Dáil question by Fianna Fáil’s Finance spokesman, Michael McGrath. It also reveals that the highest sum paid out last year under medical negligence was €15.5m in relation to a cerebral palsy case compensation claim.

Cases linked to birth negligence or cerebral palsy accounted for seven of the top ten medical negligence payouts in 2018. The figures release indicate that, in the seven cerebral palsy cases, a total of €60.3m compensation was paid out in order to provide adequate treatment for the individuals concerned for the remainder of their lives.

The remainder of the top ten was made up of cases that in the top ten payments concerned a pay-out of €6.3 million for a clinical procedure at surgery and a separate payout of €5.9m under the same category.

The lowest payout in the top ten was €4.37 million paid out concerning a clinical procedure in the Gynaecology service.

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Family of 52-Year Woman Who Died Following Hernia Operation Awarded €300,000

Yesterday at the High Court a private medical clinic apologised, for the failures in the care given to a 52-year old woman who died from sepsis after developing a rare infection following a hernia operation, as part of a €300,000 settlement to her family of the deceased Ms Susan McGee

Ms McGee, a mother of two, died eleven days after the hernia operation at the Hermitage Clinic in Dublin on July 24, 2013. Ms McGee had contracted a rare Clostridium Difficile infection in her bowel in the aftermath of the hernia operation. A verdict of medical misadventure was returned at the inquest into the death of Ms McGee.

Ms McGee’s daughter, Melissa Barry, spoke to the court revealing that the death of her mother had a significant effect on the family. She said: “Our mother is missed every day by her entire family and a large circle of friends. We owed it to our amazing mam to seek answers and justice. We hope she can now rest in peace while we can rebuild the rest of our lives.”

Ms Barry went on to say: “The Hermitage Medical Clinic has reassured us new procedures are in place for the handover of patients and we hope lessons have been learned. Patients need to be assured that details of their medical condition and care plan are properly communicated  if they are being put in to the hands of a different medical professional. Hospital staff must also listen to and act on the concerns of a patient’s family.”

Melissa Barry, Grange Rise, Stamullen, Co Meath and her brother John McGee , Bretton Woods, Skerries Road, Rush , Co Dublin had taken the medical negligence compensation case against the Hermitage and consultant surgeons Arnold Hill and Colm Power in relation to the manner of her treatment at clinic in 2013.

The High Court was told that the defendants accepted liability after McGee experienced complications following hernia surgery in July 2013. Ms McGee’s surgeon was on annual leave when she was readmitted to the clinic after becoming ill. The court was told that another doctor was not available to administer care to her as he was on duty in a separate hospital and a third doctor was not advised of Ms McGee’s condition. Following some attempted emergency surgery, she passed away on 22 July 2013.

In approving the medical negligence compensation settlement Mr Justice Robert Eagar offered his condolences to the McGee family.

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Advice about a Lip Implant Injury Compensation Claim

In order to receive legal advice relevant to your specific circumstances, speak with a solicitor about making a lip implant injury compensation claim.

If you have experienced an adverse event due to a poor standard of cosmetic surgery in Ireland, certain conditions have to be fulfilled before you can make a lip implant injury compensation claim. Having experienced an adverse event in itself is not sufficient grounds to claim compensation for a lip implant injury – particularly if you gave your informed consent prior to undergoing the procedure and were fully aware that the adverse event was a possible consequence.

Indeed, the first thing a solicitor will ask you is what information you were given before undergoing the procedure and whether you signed an agreement or contract. If so, your solicitor will need to review a copy to identify any exclusions or limits of liability. This will also help establish whether the adverse event was avoidable at the time and in the circumstances, and if your injury is attributable to a lack of skill or a lack of ability to demonstrate that skill.

If there is sufficient evidence to suggest “on the balance of probabilities” you have a lip implant injury compensation claim worth your while to pursue, your solicitor will write to the negligent cosmetic surgeon with a “Letter of Claim”. The letter will outline your injury and the consequences of your injury, explain why it is believed the injury was caused by negligence and request a proposal settlement of compensation for a lip implant injury.

An application for assessment will not be made to the Injuries Board, as lip implant injury compensation claims fall outside of their remit, and the value of your claim will be settled by negotiation once negligence has been acknowledged by the cosmetic surgeon. How much compensation for a lip implant injury you receive will depend on a number of factors including your age, whether or not the injury can be rectified and the reason for undergoing the procedure initially.

In this respect, your lip implant injury compensation claim will be unique from any other. To make sure you receive legal advice relevant to your specific circumstances, you should speak with a solicitor at the first practical opportunity.

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Class Action for Side Effects of Sodium Valproate Started in France

A class action for the side effects of sodium valproate has been started in France on behalf of children who sustained foetal valproate syndrome in the womb.

Sodium valproate is an active ingredient of the drug Epilim. Epilim was introduced in Ireland in 1983 after successfully treating patients in France for epilepsy and bipolar disorder for almost twenty years. Because it works by stabilising electrical activity in the brain, Epilim has also been prescribed for migraine and chronic pain.

Unbeknown to the medical profession in Ireland, pregnant women taking Epilim break down the sodium valproate and it is absorbed into the bloodstream as valproic acid. The valproic acid travels along the bloodstream and into the womb, where it can have an adverse effect on the development of the foetus. Children who have sustained foetal valproate syndrome in the womb have been born with a wide range of health issues from autism to spina bifida, and from a cleft palate to kidney development problems.

The side effects of sodium valproate during pregnancy were identified before the drug was introduced in Ireland, but the evidence was allegedly covered up due to not being sufficiently conclusive. Small scale studies have also failed to conclusively prove a link between Epilim and the side effects of sodium valproate during pregnancy, but now France’s National Agency for the Safety of Medicines (ANSM) has looked deeper into the issue and produced an alarming report.

ANSM researched the health of 8,701 children born between 2007 and 2014 whose mothers were known to have taken the French-branded equivalent of Epilim during their pregnancies. The agency believes it has identified up to 4,100 children suffering from the side effects of sodium valproate and discovered that hundreds of stillbirths during the period were also attributable to foetal valproate syndrome.

The results of ANSM´s research have prompted a class action against in France against the manufacturer of Epilim – Sanofi – on behalf of the children who sustained foetal valproate syndrome in the womb. The parents of the children claim that Sanofi did not do enough to warn the medical profession of the risks associated with taking Epilim during pregnancy and the side effects of sodium valproate.

 In Ireland, it is not known how many children have been diagnosed with foetal valproate syndrome. A support group – the FACS Forum – has called on the government to conduct an audit to identify the scale of the problem in Ireland and what support measures are needed for families. For further information, the FACS Forum can be reached via the disability-federation.ie website, or you can speak with a solicitor.

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Judge Approves Compensation for an Adverse Reaction to Antisepsis

A judge has approved a settlement of compensation for an adverse reaction to antisepsis in favour of a child who suffered permanent scarring to her back.

On 19th October 2012, Ann Ryan gave birth to a daughter at the National Maternity Hospital in Dublin just twenty-five weeks into her pregnancy. Weighing just 840 grams, baby Sophia was transferred to the Special Care Unit, where various catheters were inserted to administer drugs and help with her feeding.

To prevent skin sepsis, the areas where the catheters were inserted were cleaned with chlorhexidine, rather than povidone-iodine, as part of the National Children´s Research Centre´s “SKA trial”. Ann had previously agreed for Sophia to participate in this trial on the grounds that her child would not experience any discomfort or side effects.

However, the following morning, hospital staff noticed a large area of redness and a small area of ulceration on Sophia´s back. The redness was diagnosed as being an adverse reaction to the chlorhexidine and, because Sophia was displaying signs of distress, was administered morphine intravenously.

Two days after her birth, Sophia was administered Fucidim – a cream used to prevent bacterial skin infections – but this resulted in Sophia suffering a deep dermal skin burn. The Fucidim treatment was discontinued the following day and an alternate cream administered – Duoderm. However, by then, the damage had been done, and – in May 2014 – the hospital´s consultant paediatric dermatologist diagnosed Sophia with a scar consistent with a chemical burn.

Through her father – Tom Ryan of Rathdrum in County Wicklow – Sophia claimed compensation for an adverse reaction to antisepsis, alleging that the National Maternity Hospital had been negligent in her treatment, that due to the hospital´s negligence the affected skin will be permanently discoloured and that she will likely require a skin graft in the future.

Although liability was not admitted, the hospital offered to settle the claim for €100,000. As the claim for compensation for an adverse reaction to antisepsis had been made on behalf of a child, the proposed settlement first had to be approved by a judge. Consequently, at the High Court in Dublin, Mr Justice Richard Humphries was told the details of Sophia´s treatment after her premature birth.

After hearing that Sophia spent 135 days in hospital after her birth, but has suffered no developmental delays due to her experience, the judge approved the settlement of compensation for an adverse reaction to antisepsis plus costs. The settlement will now be paid into court funds until Sophia reaches the age of eighteen.

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Compensation for Hepatitis C due to Infected Blood Increased by Judge

An award of compensation for Hepatitis C due to infected blood has been increased after an appeal against a decision of the Hepatitis Compensation Tribunal.

In 1977, the unnamed plaintiff was one of thousands of women in Ireland who were given an anti-D immunoglobulin blood transfusion carrying the Hepatitis C virus. Twenty years later she was awarded an interim settlement of €298,000 compensation for Hepatitis C due to infected blood by the Hepatitis Compensation Tribunal.

Two years ago, the plaintiff underwent ribavirin treatment when test results indicated the development of cirrhosis. Unfortunately, the treatment resulted in the side-effects of decompensated cirrhosis and encephalopathy – a brain injury that manifests as slurred speech and forgetfulness. Both the decompensated cirrhosis and encephalopathy are irreversible.

Consequently, the plaintiff appealed to the Hepatitis C Compensation Tribunal for a further settlement of compensation for Hepatitis C due to infected blood. The Tribunal awarded her €180,000; but, as a similar case had settled for €250,000, the plaintiff appealed the award of compensation – claiming there was no reason that she should receive €70,000 less.

The Minister for Health opposed the appeal on the grounds that the plaintiff´s case was different to the one in which the higher award was made and that the plaintiff had received treatment for Hepatitis C before her condition was diagnosed. Consequently the plaintiff took the appeal to the High Court where it was heard by Mr Justice Bernard Barton.

At the hearing, Judge Barton was told that the plaintiff´s decompensated cirrhosis and encephalopathy conditions had been triggered by the ribavirin therapy she had undergone. The judge also heard that the encephalopathy in particular had caused the plaintiff great mental anguish because the condition frightened her grandchildren, who are a very important part of her life.

Judge Barton found in the woman´s favour – saying that the High Court had the jurisdiction to compensate her for the pain and suffering arising from the treatment she underwent in 2013. The judge said that it was “only fair and reasonable” that her settlement of compensation for Hepatitis C due to infected blood be increased to €250,000.

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Court Hears Syntocinon Use Resulted in Cerebral Palsy Birth Injuries

The High Court has approved a €2.1 million interim settlement of compensation after hearing that Syntocinon use resulted in cerebral palsy birth injuries.

Just last month, Mary Godfrey – the State Claims Agency´s clinical risk advisor – called for a nationwide consistent set of guidelines for the use of Syntocinon during labour to improve outcomes for mothers and babies, and to prevent more claims for birth injuries due to Syntocinon being made against the HSE.

A little over two weeks after Ms Godfrey raised concerns about how the synthetic drug was being used in Irish hospitals, a case came before the High Court concerning how Syntocinon use resulted in cerebral palsy birth injuries in Cavan General Hospital in 2007.

The case concerned seven-year-old Patrick Brannigan, who was in poor condition when he was delivered by Caesarean Section on 20th July 2007. The court heard that after a CTG trace had shown signs of foetal distress, Syntocinon had been administered to Patrick´s mother to accelerate her labour.

However, the Syntocinon use resulted in cerebral palsy birth injuries when Patrick was starved of oxygen in the womb, and he now suffers from dyskinetic cerebral palsy. Due to his mismanaged birth, Patrick is barely able to communicate and is confined to a wheelchair.

Through his mother – Niamh Brannigan of Castleblayeny, County Monaghan – Patrick made a claim for compensation against Cavan General Hospital and the Health Service Executive, alleging that the synthetic drug should never be use when there are signs of foetal distress in the womb.

Cavan General Hospital admitted that Syntocinon use resulted in cerebral palsy birth injuries and the hospital apologised to Patrick and his family. A €2.1 interim settlement of compensation was negotiated but, as the claim was made on behalf of a minor, it first had to be approved by a judge.

This week at the High Court in Dublin, Mr Justice Kevin Cross heard the circumstances leading up to Patrick´s birth. Judge Cross was also told that Patrick is a cheerful, good humoured boy who is cared for by his parents. The judge approved the interim settlement of compensation and adjourned the hearing for three years so that reports can be compiled on Patrick´s future needs.

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Claim for Compensation for Deltacortril Side Effects Allowed to Proceed

A Cork woman´s claim for compensation for Deltacortril side effects has been allowed to proceed after a hearing at the High Court

Lorna Savage (43) from Cobh in County Cork was given permission to proceed with her claim for compensation for Deltacortril side effects after a motion to dismiss her case brought by one of the defendants was denied at the High Court.

Lorna had first been prescribed the steroid Deltacortril in 1997 to treat the skin condition vasculitis – a disorder which damages blood vessels and causes them to cluster together to form an unsightly and irritable rash on the surface of the skin.

After taking Deltacortril for several years, Lorna´s developed Avascular Necrosis – an uncommon but known side effect of Deltacortril – a disorder which stops blood reaching the bones of the knee and hip joints with the resulting effect that the bone tissue dies and the bone ultimately collapses.

By the time Lorna was thirty one years old, she had both knees and one hip replaced, and the Avascular Necrosis disorder had spread to such an extent that she was reliant on a wheelchair for her mobility and was permanently on morphine to control the pain.

After seeking legal advice, Lorna made a claim for compensation for Deltacortril side effects against the two doctors who had prescribed the steroid tablets for her – her GP, Dr. Michael Madigan, and Dr. M Molloy -her consultant doctor at the Cork University Hospital.

In her claim against Dr. Madigan, Lorna alleged that her GP had not investigated her skin condition fully and had negligently prescribed Deltacortril when he was (or should have been) aware of the possible side effects.  In her action against Dr. Molloy, Lorna alleged the consultant had failed to identify the symptoms of Avascular Necrosis and continued to prescribe the steroids.

Lorna also made a claim for compensation for Deltacortril side effects compensation against the manufacturer of the steroids – the pharmaceutical company Pfizer – alleging that the company had failed to include a warning in the literature accompanying the steroids that their continued use could cause Avascular Necrosis, and by neglecting to advise against drinking alcohol while taking the tablets.

The estate of Lorna´s GP (Dr. Madigan died in 1999), the HSE (of behalf of the Cork University Hospital where Dr. Molloy worked) and Pfizer denied that they had been negligent; and Pfizer applied to have Lorna´s claim for compensation for Deltacortril side effects dismissed on the grounds of “an inordinate and inexcusable delay” in bringing the case to court.

Mr Justice George Birmingham ruled that the delay was “excusable” after hearing that the delay in bringing the case to court was due to Lorna being unable to instruct her solicitors as she had recently undergone several major operations. The judge refused Pfizer´s application to dismiss the case – stating that Lorna´s claim for compensation for Deltacortril side effects would be listed for a full court hearing later in the year.

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