All Posts in Category: Product Liability Ireland

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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Swine Flu Vaccine Caused Narcolepsy According to Legal Action of Woman (26)

26-year-old Aoife Bennett has taken a vaccine compensation action as, she claims, she developed narcolepsy after having the Pandemrix swine flu vaccine administered.

Ms Bennet, who  broke down in the High Court while testifying, said that she began suffering waves of excessive tiredness within weeks of having the vaccination administered. She told the court that she was informed that it was her responsibility to get the vaccine as Ireland faced a possible swine flu pandemic in 2009. She went on to say that she would never have had it if she had been are of the possible negative outcomes.

Mr Justice Michael MacGrath was informed that Ms Bennett was just 16 years of age when she had the vaccine in December 2009 as part of a mass vaccination programme. She advised the judge that she was “absolutely exhausted, before this I was very energetic and active. By Christmas Day 2009 the situation had become so bad that  she said she had to drag herself downstairs for Christmas dinner with her family.

A special comfortable chair was provided for Ms Bennett to give evidence from and she snoozed before the judge came to the bench and she was sworn in to give evidence. In addition to this Justice MacGrath told her that she could take any breaks she required during her evidence.

In students were vaccinated at school on a class-by-class basis. Ms Bennett told the Judge that she asked to read a brochure. However she was informed that she did not need to read it. She said “I was reassured it was going to be fine”. She also told the Judge that, when narcolepsy was diagnosed in 2011, she had never heard of it  prior to this point in time.

Ms Bennett, of Lakelands, Naas, Co Kildare, took the vaccination compensation action against the Minister for Health, the HSE, vaccine producer Glaxosmithkline Biologicals and the Health Products Regulatory Authority (HPRA).

The action alleged that Health Service Executive produced brochures misled those who viewed them as to the safety of the Pandemrix vaccine and the alleged risk linked to it being administered. The Judge was informed that the brochures included guidance which was factually incorrect.

The action alleged that Glaxosmithkline requested an indemnity from liability from the State before it would agree to produce the vaccine. The HPRA, it is alleged, was aware there was a different vaccine which had more clinical data to support its safety and efficacy.

All of the defendants in the legal action refute the claims made against them and deny liability.


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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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TUV Ordered to Pay Compensation for PIP Breast Implants

A court in France has ordered German safety company TUV Rheinland to pay 17,000 women compensation for PIP breast implants which were manufactured by the bankrupt company Poly-Implant-Prothese.

The class action against the German company – which certified the safety of the PIP implants – was brought on the basis that TUV Rheinland had a responsibility to check the quality of the implants before issuing Poly-Implant-Prothese with a guarantee that they conformed to European standards. However, it was alleged, no such checks were made, and Poly-Implant-Prothese substituted a low grade of industrial silicone in place of the approved type in order to reduce costs.

According to a French study last year, up to a quarter of the PIP breast implants burst or leaked; some causing medical complications when the silicone gel secreted into the victims´ lymph nodes, and one woman in France is known to have died due to anaplastic large cell lymphoma. No long-term side effects have yet been confirmed, and experts believe that it may be many years before the full effect of the faulty PIP breast implants is known.

Solicitors on behalf of TUV Rheinland argued in court that the company was a victim of fraud, and that they were only expected to audit Poly-Implant-Prothese´s paperwork – not the implants themselves. However, solicitors representing the claimants said that TUV Rheinland failed to do its job properly and gave “global credibility” to a product which did not deserve it. It also emerged in court that the employee in charge of quality control had only a cookery diploma, while another in charge of the laboratory had previously trained as a pastry chef.

After hearing evidence on behalf of TUV Rheinland and the 17,000 claimants from Britain, France and South America, judges at the Commercial Court in Toulon found TUV Rheinland had “neglected its duties of vigilance” and awarded each claimant €3,000 (£2,500) immediately for the removal of their faulty breast implants, and a further €13,000 (£10,900) compensation for PIP breast implants to be received at a later date subject to an appeal by TUV Rheinland.

The verdict provides an opportunity for up to 400,000 women worldwide to claim compensation for PIP breast implants, and Jan Spivey – spokeswoman for the British plaintiffs and the PIP Action Campaign group – said “I am delighted. It is a first important victory for PIP victims worldwide and especially those British victims who have received no help from the health service or the Government. It means that they can start to get the surgical help [to replace defective implants] that they urgently need.”

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Injuries Board Awards Increase by 8 Percent

Injuries Board awards of compensation have increased by more than 8 percent during the first six months of the year according to a report published on the government body´s website.

Both the total number of applications for assessment (16,162) and the average value of Injuries Board awards (€22,349) increased in relation to the corresponding period in 2012, but Patricia Byron – CEO of the Injuries Board in Ireland – commented that the higher volume of claims and increased value of accepted compensation assessments did not provide an excuse for insurance companies to increase the premiums they charge.

She said that, as the Board´s processing fee for respondents had been reduced from €850.00 to €600.00, the savings made by insurance companies should counter the increased value of Injuries Board claims and added that early indications from the third quarter of 2013 show a general decline in the number of applications for assessment being received by the Injuries Board.

The highest proportion of Injuries Board awards were made for traffic accident compensation claims (75.5 percent), with claims for injuries sustained in public places (public liability claims) accounting for 16.4 percent of accepted Injuries Board assessments and the balance (8.1 percent) being made up of awards of compensation for accidents at work.

One figure understandably not highlighted by the Injuries Board is that the percentage of accepted assessments (Injuries Board awards that plaintiffs agree to) fell from 37.2 percent in 2012 to 32.7 percent in 2013 – a statistic that would indicate a higher proportion of claims for personal injury compensation are being settled outside of the Injuries Board process.

However, it should be noted that – even if you are in advanced stages of negotiating a compensation settlement with an insurance company – an application for assessment should still be submitted to the Injuries Board. If your negotiations are unsuccessful, and court action is required to resolve your claim, you (or your solicitor) will require that an Authorisation” is issued by the Injuries Board before court action can proceed.

Please also note that the Injuries Board does not accept applications for assessment when plaintiffs have sustained a loss, injury or the deterioration of an existing condition due to medical negligence, and it is always recommended that you seek the advice of a solicitor in these circumstances.

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DePuy Faulty Hip Replacement Court Case Sees Further Delays

Further delays have hit the multidistrict litigation DePuy faulty hip replacement court case in Ohio after Judge Katz agreed to a two-week postponement to allow additional time for discovery to take place.

The first of the DePuy `Bellwether` trials – McCracken -v- DePuy Orthopaedics Inc – had already met with delays after Anne McCracken replaced the original plaintiff Faye Dorney-Madgitz in July. At the time, the faulty hip replacement court case was scheduled to begin on September 9th, but it has now been rescheduled to commence on September 24th.

Ann McCracken (57) from Rochester in New York made her claim against DePuy Orthopaedics in March 2011; alleging that she had suffered a dislocated hip due to metal particles discharged from her DePuy ASR XL Acetabular Hip Replacement System which was implanted in August 2009.

She claims that when her orthopaedic surgeon removed the DePuy metal-on-metal hip replacement system in January 2001 he saw evidence of metallosis which had killed healthy tissue around the implant, which caused the dislocation of her hip.

Ann had to undergo further operations in October 2011 to implant a device which restricts the movement of her hip and which has decreased her mobility further. This restrictive device will also result in her present hip replacement system wearing out quicker than normal, meaning that Ann will have to undergo further revision surgery in the future.

Ann´s faulty hip replacement court case is also to be decided without reference to the August 2010 recall of the DePuy ASR hip replacement systems. Judge Katz ruled that Ann´s injury “began with the initial implementation” and agreed with DePuy´s lawyers that mentioning the recall during the faulty hip replacement court case might deter other voluntarily recalls of potentially harmful medical devices in the future.

The ‘Bellwether’ trials will be used to determine the relative strengths and weaknesses of the plaintiffs´ claims and DePuy Orthopaedic´s defence. The motive for consolidating 7,800 claims against DePuy Orthopaedics is to discover if an acceptable yardstick can be determined for the settlement of compensation claims against DePuy Orthopaedics and their parent company Johnson & Johnson.

If no yardstick can be established – or negative verdicts are returned by the jurors – the outstanding claims will be remanded back to the U.S. District Courts in which they were originally filed. Each faulty hip replacement court case would then have to be heard individually; delaying the outcome of the claims and potentially inflicting financial hardship on the plaintiffs.

This would also be the case in Ireland, where plaintiffs who have served notice of cases against Johnson & Johnson, DePuy Orthopaedics and the Health Service Executive may not receive an offer of compensation and will have to pursue their claims against the alleged negligent parties through the Irish court system.

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First Claim for DePuy ASR Hip Replacement Compensation heard in Los Angeles

The first claim for DePuy ASR hip replacement compensation to be heard in open court has been concluded, with the plaintiff receiving an award of $8.3 million.

The claim, made by South Dakota resident Loren Kransky (65), was heard at the Los Angeles Superior Court ahead of the ongoing Multi District Litigation (MDL) due to be heard in Ohio in May as the plaintiff is terminally ill from diabetes, heart disease and kidney cancer.

Solicitors in Court argued that Kransky had to undergo a second hip replacement operation – causing him significant pain and suffering – due to high levels of chromium and cobalt in his bloodstream caused by metal-on-metal friction within his original ASR XL Acetabular hip replacement system.

They claimed that DePuy Orthopaedics Inc had marketed the faulty hip replacement system in 2007 – the year in which the plaintiff had the DePuy ASR XL Acetabular hip replacement system implanted – knowing that the ASR systems were defective; effectively accusing the company of fraud in addition to negligence, which would have entitled Kransky to qualify for significant punitive damages.

Solicitors representing DePuy Orthopaedics Inc disputed that the company knew the ASR hip replacements were faulty at the time, and contested Kransky´s claim for DePuy ASR hip replacement compensation on the grounds that Kransky´s pain and suffering was due to his pre-existing medical conditions.

The jury at the Los Angeles Superior Court found that DePuy Orthopaedics Inc had not acted “with malice” by marketing their product fraudulently in 2007, but agreed that the product was defective at the time and awarded Kransky $8 million in settlement of his DePuy ASR hip replacement claim; with a further $338,000 to account for the medical expenses he has incurred to date.

Johnson and Johnson – the parent company of DePuy Orthopaedics Inc – announced immediately after the jury´s verdict was announced that the company intends to appeal the decision; as the precedent of $8 million in compensation for pain and suffering could be greatly inflated when claims for plaintiffs who do not have a terminal illness are heard in the MDL action in Ohio next month.

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DePuy Failure Rate Heightens British Orthopaedic Association Fears

Research released by the British Orthopaedic Association indicates that as many as 49% of the DePuy ASR Hip Replacement Systems implanted in Ireland since 2003 could fail within the next six years.

Orthopaedic surgeons at the British Hip Society Annual Conference in Torquay this month discussed the topic of large diameter metal-on-metal –bearing total hip replacement systems, with particular attention to the DePuy ASR hip replacement recall.

In Ireland, 3516 people were given the faulty hip replacement system and, in figures which contradict assurances given by the Health Service Executive, it was announced that new projected failure rates for the DePuy ASR hip replacement systems are 35% within four years and 49% within six years.

The surgeons also recommended that patients being monitored for potential hip replacement system failure should have MRI or CT scans to detect any collection of fluid in the vicinity of the hip area, or the presence of cobalt or chromium ions which can lead to neurosurgical problems.

The publication also confirmed that revision surgery for DePuy ASR hip replacement systems can be more difficult than the original implant when soft tissue damage has been sustained, and that specialist hip reconstruction surgery may be required in these instances.

These findings add further support to lawsuits and class actions currently going through the courts in the United States, where over 500 people have already filed compensation claims against DePuy Orthopaedics Inc.

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Medical Council Investigates GP Malpractice Claim Against A Dublin GP

The Medical Council is investigating a GP malpractice claim against a Dublin GP who allegedly over-prescribed psychoactive benzodiazepines.

It is claimed that Dr Mohammed Ahmed Khan, who practices in Wicklow Street, Dublin, prescribed up to four times the correct dosage of drugs such as Valium to patients suffering from anxiety and depression. The Medical Council are also looking into allegations that Dr Khan failed to make adequate enquiries as to whether any of the patients he was prescribing these drugs to were already being treated by another doctor.

In addition Dr Khan has been accused of poor professional performance due to his alleged failure to refer patients with a dependency on benzodiazepines to drug treatment centres or specialist substance misuse practitioners and also due to his reliance on prescription drugs where an alternative form of treatment may have been more beneficial to the patient or in their best interests.

The Medical Council regulates doctors to practise medicine in the Republic of Ireland and its statutory role, as detailed in the Medical Practitioners Act 2007, is to protect the public by promoting and better ensuring high standards of professional conduct and professional education, training and competence among registered medical practitioners.

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