Claims for birth defects due to taking Epilim while pregnant have been made in France on behalf of up to 4,100 children with foetal valproate syndrome.
Epilim is the trade name of an anti-epilepsy drug that uses the active ingredient sodium valproate to control electrical activity in the brain. Introduced in France in 1967, Epilim was passed for use in Ireland in 1983, and is now also often prescribed to treat bipolar disorder, migraine and chronic pain.
At the time it was introduced into Ireland, claims for birth defects due to taking Epilim while pregnant were being investigated in France. It was alleged that the sodium valproate entered the bloodstream as valproic acid, which caused foetal congenital and development issues.
The evidence of birth defects due to taking Epilim was considered inconclusive, and the drug continued to be prescribed to pregnant mothers. It was only in 2006 that the manufacturers of the drug – Sanofi – warned that sodium valproate may have adverse effects and advised the medical profession to advise pregnant mothers of the potential risks.
Research conducted several years later by France´s social affairs inspectorate – IGAS – found the majority of doctors and pharmacists were unaware of the risks associated with Epilim. The research prompted the inspectorate to conduct a small scale study in the Rhone-Alpes region last year, where a much higher than expected rate of birth defects due to taking Epilim while pregnant was discovered.
France’s National Agency for the Safety of Medicines (ANSM) looked deeper into the issue and researched the health of 8,701 children born between 2007 and 2014 whose mothers were known to have taken Epilim during their pregnancies. ANSM identified up to 4,100 children suffering from foetal valproate syndrome and discovered hundreds of Epilim-related stillbirths.
ANSM´s study has resulted in the families of those affected by the adverse effects of sodium valproate to form a class action in order to jointly make claims for birth defects due to taking Epilim. The families claim that Sanofi did not do enough to adequately inform the medical profession of the risks associate with the drug. It also claims the drug manufacturer failed to put adequate warning on its packaging.
In Ireland, the Disability Federation has called on the government to conduct an audit of children diagnose with foetal valproate syndrome. The organisation claims the scale of the problem in Ireland should be identified in order that adequate support measures are provided for families. If a member of your family has been affected by foetal valproate syndrome, and you would like to know more about claims for birth defects due to taking Epilim while pregnant, you should speak with a solicitor.
A French court has ordered TUV Rheinland to compensate thousands of victims of faulty Poly Implant Prothese breast implants.
The German company TUV Rheinland was brought to the Commercial Court in Toulon in order to answer claims raised in a class action that it negligently awarded the faulty Poly Implant Prothese breast implants the European seal of approval, without noticing that the implants contained low grade industrial silicone instead of the higher grade gel that had been originally approved.
The class action was comprised of PIP breast implant victims from Britain, Ireland, France and South America; some of whom had sustained terrible injuries after the silicone gel from the implants leaked into their lymph nodes when the implants leaked or ruptured. One woman in France is acknowledged to have died due to the faulty Poly Implant Prothese breast implants.
TUV Rheinland´s legal team argued that they had been defrauded by Jean-Claude Mas – the founder of Poly Implant Prothese, who is waiting a verdict on the charge of aggravated fraud – and that their role had been to inspect the manufacturing process rather than the finished product. However, solicitors on behalf of the class action contested that TUV Rheinland failed to do its job properly and gave “global credibility” to a product which was clearly faulty.
After hearing evidence from both parties – during which time it emerged 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 – judges at the Toulon court found that TUV Rheinland had “failed its obligations of checking, caution and vigilance” and awarded each claimant €3,000 with immediate effect for the removal of their faulty breast implants.
Future awards of up €13,000 for faulty Poly Implant Prothese breast implants could be made to each of the 17,000 plaintiffs subject to an individual assessment and an appeal against the settlement by TUV Rheinland to be heard early next year. If unsuccessful in their appeal, up to 400,000 other victims could claim compensation for faulty Poly Implant Prothese breast implants – suggesting that TUV Rheinland could be faced with a bill of €6.4 billion for their negligence.
Speaking after the verdict was announced, spokesperson for the PIP Action Campaign Group Jan Spivey said “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.”
“The Irish Medicines Board (IMB) notes the scientific opinion [from the European Scientific Committee on Emerging and Newly Identified Health Risks] which states that ‘There is currently no convincing medical, toxicological or other data to justify removal of intact PIP implants as a precautionary approach. Implant removal in the absence of malfunction may be considered for women who are experiencing significant anxiety because they have a PIP breast implant. However, the decision to remove an intact PIP implant for this reason should be based on an individual assessment of the woman’s condition by her surgeon or other treating physician after consultation’.
Women with health enquiries about the faulty Poly Implant Prothese breast implants, should contact the IMB on 01 6764 971.
For more information about compensation for faulty Poly Implant Prothese breast implants, speak with a solicitor on 1-800 989 900.
The twice-postponed DePuy ASR hip replacement court case has been put back in date again – this time after a change of plaintiff and a ruling about referring to the DePuy recall as evidence.
The first Federal DePuy ASR hip replacement case was delayed again last week after the parties in McCracken -v- DePuy (Case No 1:11 dp 20485) were allowed additional time by U.S. District Judge David A. Katz for discovery to take place and to deal with other legal matters.
The first `Bellwether` DePuy ASR hip replacement case has now been rescheduled for September 24th, and will revolve around the hip dislocation sustained by Ann McCracken (57) from Rochester in New York, which is alleged to have been due to metal particles displaced by her DePuy ASR XL Acetabular Hip Replacement System causing the soft tissues around her hip to decay.
Ann had a DePuy ASR XL Acetabular Hip Replacement System implanted in August 2009, but had to undergo revision surgery in January 2011 after she had suffered her dislocated hip. In October 2011, Ann had to undergo further surgery to insert a device restricting the movement of her hip, which has reduced her mobility and will result in her present hip replacement system wearing out quicker – resulting in another hip replacement operation in the future.
The latest delay is due to Judge Katz agreeing that the worldwide recall of the DePuy hip replacement systems should not be referred to in court – not only because the DePuy ASR hip replacement case to be heard on its individual merits, but DePuy´s lawyers successfully argued that any reference to the DePuy recall at trial might prevent other companies from voluntarily withdrawing potentially dangerous medical devices because of the legal consequences.
One of the purposes of this first ‘Bellwether’ DePuy ASR hip replacement case is to evaluate the relative strengths and weaknesses of the plaintiffs´ claims and DePuy Orthopaedic´s defence. If Ann´s case – and others still to be scheduled among the `Bellwether’ trials – results in a yardstick for compensation settlements, DePuy Orthopaedics are likely to negotiate settlement offers with the 7,800 plaintiffs also attached to this DePuy ASR hip replacement case through the consolidated multidistrict litigation (MDL).
If no compensation yardstick is established by the juries in each of the trials – or if there are both positive and negative verdicts returned – all of the remaining DePuy ASR hip replacement cases will be referred back to the US District Courts in which they were originally filed – each to be heard individually and prolonging the how long it will take for each plaintiff to receive a fair settlement of DePuy hip replacement injury compensation.
This second scenario would also have an impact on plaintiffs in Ireland who have made a claim for DePuy hip replacement injury compensation, as each DePuy ASR hip replacement case in Ireland would then have to go through the court process.
A Californian judge has upheld the DePuy hip replacement settlement of $8.3 million awarded by a Los Angeles jury to Loren Kransky and denied the company their request for a new trial.
Loren Kransky (65) from South Dakota was awarded the DePuy hip replacement settlement after a hearing at the Los Angeles Superior Court in March this year, in which the jury had found DePuy Orthopaedics negligent for supplying the plaintiff with a faulty ASR XL Acetabular hip replacement system and awarded the former prison office $8.3 million compensation for a faulty hip implant.
DePuy Orthopaedics´ parent company – Johnson & Johnson – appealed the decision and requested that a new trial be held on the grounds that “the court did not let the company tell the jury about the Food & Drug Administration’s review and clearance of the device”. However, Judge J. Stephen Czuleger upheld the jury´s verdict and said that the plaintiff had provided enough evidence during the original trial to establish that the products were defective in design.
The judge´s decision to deny DePuy Orthopaedics a re-trial has prompted Johnson and Johnson to delay the Multi District Litigation (MDL) being heard in Ohio, by filing a motion requesting that any DePuy hip replacement settlements awarded in the case are based on typical injury compensation awards in the company´s home state of Indiana – where compensation settlements are much lower than the national average.
Johnson and Johnson are also preparing to defend a second MDL in Texas; where more than 4,000 claims brought by plaintiffs complaining of defects in DePuy´s Pinnacle hip replacement system have been brought together in one action. The first of the DePuy Pinnacle hip replacement compensation claims is scheduled to be heard in September 2014.The company recently announced that it would discontinue manufacturing and selling the allegedly faulty Pinnacle hip replacement system from August this year.
DePuy Orthopaedics has announced that it will cease to produce and sell metal-on-metal Pinnacle hip replacements systems from August 2013
The company´s decision to stop producing and selling Pinnacle hip replacement systems is believed to coincide with the United States´ Food and Drug Administration (FDA) closing the ‘510(k) process’ loophole which allowed the faulty DePuy ASR hip implants onto the market in the USA without clinical testing first being conducted (the company claim that demand for the implants from orthopaedic surgeons has declined).
Although the Pinnacle hip replacement systems passed the FDA´s clinical testing standards in 2000 when they were first launched in the USA, the ASR hip implants which were recalled in August 2010 were given FDA clearance on the grounds that they were “similar to an existing product” – in this case the DePuy Pinnacle metal-on-metal hip replacements.
After the worldwide recall of the ASR hip implants, the Food and Drug Administration asked DePuy Orthopaedics to conduct further clinical tests on the Pinnacle hip replacement systems to ensure that the same problems did not exist as with the recalled ASR hip implants. DePuy declined and, in January 2013, new legislation was passed in the States to force all manufacturers of metal-on-metal hip implants to prove through retrospective clinical studies that their products were safe.
The announcement to halt the production and sale of DePuy Pinnacle hip replacement systems also coincides with the scheduled start of the Multi District Litigation being heard at the US Northern District Court in Ohio (DePuy Orthopaedics, Inc. ASR Hip Implant Products Liability Litigation – MDL 2197) in which more than 7,500 plaintiffs are attempting to recover compensation for injuries caused by the DePuy ASR Articular Surface Hip Replacement System and the DePuy ASR XL Acetabular Hip Replacement System.
A jury has now been sworn in for the court case, but a delay to proceedings has been caused by solicitors representing DePuy Orthopaedics putting forward a motion that any award of compensation for injuries due a faulty hip replacement system should be based on compensation levels in the company´s home state of Indiana – where personal injury compensation settlements are significantly lower than Ohio.
Since the class action against DePuy for the ASR hip implant recall began, a second MDL class action has been started in the States against DePuy Orthopaedics in which more than 3,300 plaintiffs allege that they have suffered an injury due to the DePuy Pinnacle hip replacement systems. In the UK meantime, an investigation by the British Medical Journal revealed that recipients of the DePuy Pinnacle hip implants were at serious risk of system toxicity, while at home there have been calls for the Health Service Executive to initiate a DePuy Pinnacle hip replacement recall in Ireland.
The first DePuy ASR hip replacement claim to be heard in court has resulted in an award of $8.3 million being made to a former prison officer.
The claim made by Loren Kransky (65) from South Dakota was brought forward ahead of the Multi District Litigation (MDL) due to be heard in Ohio in May, as the claimant is terminally ill from diabetes, heart disease and kidney cancer.
Solicitors at the Los Angeles Superior Court claimed that Kransky had to undergo a second hip replacement operation – causing him pain and suffering – due to high levels of chromium and cobalt in his bloodstream caused by metal-on-metal friction within his ASR XL Acetabular hip replacement system.
They claimed that Johnson and Johnson – the parent company of DePuy Orthopaedics – marketed the faulty hip replacement products knowing that the ASR systems were defective, effectively accusing them of fraud in addition to negligence which would have entitled Kransky to qualify for significant punitive damages.
Johnson and Johnson disputed that they knew the ASR hip replacements were faulty in 2007 – the year in which Kransky underwent his original hip replacement surgery – 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 Johnson and Johnson had not acted “with malice” by marketing their product in 2007, but agreed that the product was defective 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 announced immediately after 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 claimants who do not have a terminal illness are heard in the MDL action in Ohio.
The first Multi District Litigation (MDL) DePuy faulty hip replacement cases – which will establish a benchmark of how much compensation for a faulty DePuy hip replacement many thousands of plaintiffs should be entitled to receive – have been set to be heard in May and July.
The announcement that the first “Bellwether” trial of Faye Dorney-Madgitz v DePuy Orthopaedics (MDL2197) will be heard in May at the Ohio Northern District Court in Cleveland was made by Judge David A. Katz; who also revealed that a secondary case – Ann McCracken v DePuy Orthopaedics – will be scheduled for July 2013 in the event that the Dorney-Madgitz v DePuy faulty hip replacement case is settled before it goes to trial.
The setting of the two trial dates is expected to increase DePuy Orthopaedics´ attempts to negotiate a settlement with plaintiffs in the Multi District Litigation (MDL), after the company successfully settled three DePuy revision surgery claims in Nevada for approximately $200,000 each. If the “Bellwether” Dorney-Madgitz v DePuy faulty hip replacement case proceeds to court, future settlements of DePuy faulty hip replacement compensation could be influenced by the verdict of the jury.
Whereas a low trial settlement of the DePuy faulty hip replacement case would be advantageous to DePuy Orthopaedics and their parent company Johnson & Johnson, should the jury in Cleveland award substantial damages in the case against Faye Dorney-Madgitz, this would set a benchmark for all future claims against DePuy for faulty hip replacements and painful revision surgery.
It may not be too late to initiate DePuy faulty hip replacement claims for compensation in Ireland if you have undergone revision surgery within the past two years or suffered any form of injury due to the recalled DePuy ASR hip replacement systems. Call our 24-hour helpline for more information.
A judge in Australia has approved a settlement of DePuy knee replacement compensation following a class action suit brought following the recall of the DePuy LCS Duofix Femoral implants.
More than 5,000 DePuy LCS Duofix Femoral implants were implanted in patients in Australia prior to the recall in July 2009 due to a higher than expected failure rate. In March 2010, Pamela Casey became the lead plaintiff in a class action suit against DePuy seeking DePuy knee replacement compensation and, on 29 August 2012, a provisional settlement of the DePuy knee replacement class action was agreed.
Under the terms of the provisional agreement, DePuy are to pay plaintiffs who underwent one revision to the faulty knee implant but required no further surgery A$30,000. Plaintiffs who needed two or more surgical procedures after their initial revision surgery will be paid A$65,000, and plaintiffs who have suffered significant complications due to the faulty knee implants will have their claims for DePuy knee replacement compensation assessed on an individual basis.
At the Federal Court in Melbourne, Justice Robert Buchanan formally approved the compensation settlement following a review period during which he received 430 inquiries into the proposed DePuy compensation agreement. He said that the few complaints about the settlement he received during the review period did not give him sufficient reason to delay from approving the DePuy knee replacement compensation class action agreement.
The European Commission is relaunching the debate about class action suits (also called collective redress) for faulty product in the European Union with the objective of developing common standards across the 27 member countries. Three EU commissioners, justice commissioner Viviane Reding, competition commissioner Joaquín Almunia and consumer commissioner John Dalli, have drafted a paper on the subject and will be launching public consultations in November.
The Financial TImes has today revealed some of the issues covered in the briefing paper, including making class actions cheaper than individual claims, financing class action suits, consensual resolutions through mediation, enforcing judgements throughout the EU, and avoiding abusive litigation.
A previous attempt to introduce EU-wide rules failed due to strong lobbying by business groups worried about potential costs.
As with other EU countries, current legislation in Ireland makes it very difficult to pursue class action suits.