About us

About us: Ramos Mesonero
The José Antonio Ramos law firm is integrated with an affiliate program of the chambers of commerce in Europe and has representative lawyers throughout Europe. With over 20 years of specialized cases involving only medical negligence / medical malpractice and pharmaceutical negligence / pharmaceutical malpractice.
MEDICAL NEGLIGENCE

W We provide assistance for medical negligence victims in cases such as cancer misdiagnosis, surgical errors, failure to produce consent forms, delay in detecting complications, bacterial infections, failure to provide the correct medical equipment, hepatitis and blood infections, plastic surgery, corrective eye surgery, provision of incorrect medication, etc.

You can view some of our verdicts from real cases by pressing "verdicts" on our home page. Our high success rate is maintained at 75% and we attribute this to:

  • Specialist medical negligence advice.
  • Coordinating with a specialist medical malpractice Doctors who has over 30 years experience in this field (gynecologists, urologists, neurologists, dentists, orthopedic, ophthalmologists, pharmaceuticals, plastic surgeons, etc.).
  • Support and guidence in obtaining your full medical history.
  • Provision of a free consultation without obligation.
  • Acceptance of cases supported by effective evidence based on your medical history within the medical framework adhering to medical guidelines.

Please, follow the instructionsin order to receive your full medical documentation in accordance to Spanish Law. This will provide us with the necessary means to provide you with an unbiased opinion as to whether you have a case or not.

PHARMACEUTICAL NEGLIGENCE:

P Pharmaceutical malpractice (or pharmaceutical negligence) is one of the fastest growing types of personal injury lawsuits occurring today. It has been estimated that over a million people each year are potential victims of pharmaceutical malpractice. While there may be different causes for pharmaceutical negligence, they all have a common element – prescription medication. Lawsuits in this area are filed based on four major causes.

  • 1. Defective drug recalls.
  • 2. Negative long-term side effects of prescription drugs.
  • 3. Improperly prescribed medication.
  • 4. Improperly filled prescriptions.
Pharmaceutical Negligence

Since the drug company itself is the party that conducts the tests, and with a financial interest to get approval quickly, sometimes drugs are placed on the market with incomplete testing. If that happens, users may experience unanticipated reactions that can lead to serious injuries and/or death.

Once discovered, responsible drug manufacturers should issue warnings that the drug is defective, inherently dangerous, its use should be immediately discontinued and remove the product from the stream of commerce. Unfortunately, by then, the harm has already been done.

Even if the testing is done properly and the existing data is correctly interpreted, most testing processes are performed on a limited number of test subjects, relatively short in duration, and may not reveal the cumulative effect the drug may have on a person over an extended period of time.

A clinical test that lasts three years is unlikely to reveal the effect the drug may have on a person who takes the drug for five or ten years. If a specific side effect only affects one out of 10,000 people taking the drug, and the test group used is only 7,000 participants, it is reasonable to presume that many potential people that could sustain adverse reactions may be missed in the testing process.

Instructions when you have a medical negligence.

Unfortunately, it is impossible to give you an opinion unless we look into your medical history. CONTACT US FOR A FREE CASE CONSULTATION. You are requested to follow these stages:

  • 1 You must prepare a list of facts about your case and all the circumstances around your complaint.
  • 2 We provide assistance to obtain your medical history. To begin with, you have to request your medical records (Medical History), then fill out the form on our website here. Your request to the hospital must be made by “Burofax”, this can be done from any Post Office. This is how official documents are requested in Spain.
  • 3 We will require you to provide us with your copies of your medical history along with your burofax receipt for the request made to the hospital and a written summary of exactly what happened
  • 4 You will be referred to an independent Doctor who will provide a report to your lawyer, and your case will then be definitively assessed. Provided we receive this information, we will be in a position to offer you a professional legal opinion as to whether you have a case or not.
  • 5 We will define how we work and our price structure. We have a vested interest in your case as we operate on a no win no fee basis.
  • 6 Should you decide to continue with the legal process, the independent doctor will write a report and file this document with the court. Then, the legal process will be started.
About us: Ramos Mesonero
With over 20 years of specialized cases involving medical negligence / malpractice, we have a high success rate which is currently maintained at 75%, in cases such us:
  • Amputation compensation
  • Cancer claims
  • Cosmetic surgery claims
  • GP negligence claims
  • Nerve Injury claims
  • Medication errors
  • Spinal injuries
  • Accident & Emergency (A&E) compensation claims
  • Anaesthetic awareness claims
  • Brain injury compensation
  • Dental negligence
  • Hospital negligence claims
  • Orthopaedic claims
  • Surgery claims, etc.
Verdicts about our medical negligence´s cases. See Veredicts
Discover our practice areas:

One of the most frequent complaints when it comes to public health is the waiting time. In some cases, this waiting time may fall within normal limits, but in other cases it puts the patient's life at risk.

According to the Patient Advocate Association, a person who is in a serious situation - for example, after arriving by ambulance at the hospital - should not take more than 15 minutes to be seen. If the patient dies while waiting, we will have the right to file a legal claim.

On the other hand, patients have the right to be regularly informed of their health status, or if they can not receive this information, a family member is notified. Precisely the situation of family and companions is also often problematic in some cases, for example because they do not let them pass or because they do not have a place to sit.

These behaviors can also be claimed at the medical center. Obviously, we will also have the right to receive a medical report once we have been discharged. If they do not give us any report or we are discharged when we still feel bad, we would be facing a possible case of medical malpractice.

Faced with all these examples we have given, it is important to contact a lawyer specialized in the matter to guide us. In this way you can inform them of your specific case and initiate the appropriate legal actions. Bear in mind that in the case of public health, the Public Administration is being sued for patrimonial responsibility.

On the other hand, in cases of private health care, a civil liability claim must be filed, which It will be carried out through the Civil Courts

For more details on the subject, please contact us directly.

Among the various situations in which medical malpractice can occur, is found those that take place during the period of pregnancy and childbirth of a woman, to which we want to make reference.

Pregnancy is a very delicate moment from the medical point of view, since it is in I play both the life of the mother and that of the fetus itself. That is why negligence in these cases have a very large physical and psychological impact. Some cases that can be give are the ones we are going to point out below:

Do not perform periodic checks on the pregnant woman: ultrasound, analysis of blood...

Administer medications that are incompatible with your condition, causing damage or the death of the fetus.

Excessive waiting times, for example if the woman is in the emergency room and it takes time a lot in serving you.

In addition to this we also want to point out a circumstance that is known by the name of neonatal hypoxia. It means that the fetus does not receive enough oxygen, especially during the moment of delivery The consequences of hypoxia are very serious, since the fetus can damage vital organs, have irreversible neurological problems or even die.

If you or someone in your family is in this situation and seeks legal help, We invite you to contact us as soon as possible. It is very important to go to a negligence lawyer, because he will have previous experience in these cases. In addition, since scientific terms are used in this legal branch, not all lawyers possess enough knowledge Hence, it is essential to choose a professional who is qualified for this type of cases.

If you want more information, just contact us.

In this article we want to collect some useful indications for people who are going to undergo (or have already undergone) surgical medical interventions.

Before an operation there is an obligation to present the patient with the Informed Consent, a document where the possible risks and consequences of the process must be detailed. If you are not given this document and then it is operated, you will be entitled to claim.

We recommend that you always read this document and that you ask your doctor questions if some aspect is not clear to us or we have doubts. It often happens that the paper is signed without reading, which is not advisable in these

Once the operation is over, if you are not satisfied with the result or an error has occurred, you will also have the right to claim it as medical malpractice. Some of the most common cases are usually:

  • Administer anesthesia improperly.
  • Forgetting remains of surgical material inside the patient.
  • Do not take into account a previous illness of the patient-hypertension, diabetes, circulatory problems.

It is important that you do not throw away any documents that have been given to you by the doctors or nurses, since these documents could serve as proof in case of a possible claim. They can be all kinds of documents, not only medical parts but also x-rays, analysis results, or others

If you need help with the subject or believe you have suffered negligence do not hesitate to communicate it to our Office in Madrid. We are a team of lawyers specialized in negligence with extensive legal experience, so we can help you with your case

Keep in mind that the term to claim is shorter in public health-Social Security-than in private, so it is important not to let much time pass if we want to have options to ask for compensation.

Below we present a true case of medical malpractice, to illustrate this concept and provide information to people who have passed or could go through a similar situation.

This case took place in Zaragoza. It was the patient Sofía G.H., who had a fortuitous fall in the public road as a result of which she had to undergo surgery. However, after the operation, some problems arose (she could not move her legs, due to a bruise pressing on her spinal cord, as a result of the anesthesia) and the woman had to undergo surgery again. In this second operation, which was performed 25 hours later. it was found again that the patient still could not move her legs. This ultimately led to her becoming paraplegic, needing the help of another person for her daily activities. He also needed a probe to relay some of his physiological activities.

Later it was declared that medical malpractice had existed, and that the second operation should not have delayed so many hours. The patient received compensation for the damages, but could not benefit from this amount since she died during the years that the process lasted.

This is undoubtedly a very unfortunate case, which could have been avoided. That is why we remember that the Rights of the Patient must be respected at all times. Any situation, including a long waiting period as in this case, can lead to very serious consequences. Therefore, it is important to claim our rights and have specialized legal assistance.

Remember that if you need to ask for more information or want to claim a neligencia, just call our Madrid Office or visit our website. We recommend that you save as many documents as possible, as they could be used as evidence during the judicial process.

Medical malpractice is the malpractice behavior that is committed within the health field. This can occur both by action and by omission. There are many cases related to this topic, but in these lines we would like to refer to those that take place during the moments of pregnancy and childbirth.

These moments are critical in a woman's life, and her health can be delicate. On the other hand, the well-being of the fetus must also be taken into account; so we are talking about two lives in games. Some cases of negligence in this situation are the following:

  • Inadequate follow-up of pregnancy, for example for not performing prenatal exams.
  • Prescribe medications that are incompatible with pregnancy, putting the fetus at risk.
  • Incorrect use of forceps during delivery.
  • Fetal distress or death of the fetus.

We have cited these examples, but logically there are many more. The important thing in these cases is to keep the evidence that allows us to demonstrate negligence (such as medical parts, ultrasound, etc.). Then we recommend that you consult with a lawyer specialized in health law. The deadlines are important at the time of claiming, and therefore it would be convenient not to let much time pass. Otherwise it could happen that we lose the right to compensation for having filed the claim after the deadline. Although we understand that it is difficult, since they are moments of great emotional burden, it is a necessary step from the legal point of view.

Our Law Firm in Madrid has a long history in this field, so all our lawyers have experience in medical negligence.

If you need help with the subject, please contact us for a first appointment. We will study your case individually and guide you through the rest of the process.

Before medical treatment or surgical operation we have the right to receive informed consent.

It is the information about the process to which we are going to submit, which must be clear enough for the patient to understand. Usually this information must be written in writing, and we have to sign it to show that we actually give our consent. Only minor medical procedures are exempt from this obligation: routine reviews; Treat superficial wounds, etc.

Keep in mind that if doctors do not offer you this information, in case of later errors this situation could be claimed directly as medical malpractice.

In some cases we tend to sign this type of information without reading it in depth, but this carries a risk. For your own integrity or to avoid legal problems in the future, we strongly recommend that you read the documents you submit to us before an operation or treatment.

If in spite of all our precautions something goes wrong we will be in our right to claim it through the judicial process. In this sense we will have to look for a specialized lawyer in the matter and, if possible, do not delay much with the formalities. We make this paragraph because the deadline to claim medical malpractice is not excessively broad, especially in public health (Social Security). That is why it is convenient that we start up without letting much time pass, in order to have options to receive compensation.

We remind you that our office in Madrid can help you claim medical malpractice of any kind: aesthetic operations with an unwanted result; Errors during the pre or postoperative period; etc. We have a prepared team and a consolidated trajectory that allows us to offer security to our clients.

If you need more information or want us to study your case, do not hesitate to contact us to make an appointment.

It is considered that medical malpractice has occurred when the professional has not had the care objectively due and as a consequence there have been damages in his patient.

As an impact to this type of actions are generated legal consequences that can be either criminal or civil or administrative. And recognizes a bad praxis on the part of the actor, since it has not acted according to its code. The professions most affected are clearly the one of doctor, followed by the one of police and security forces of the state and even of the one of advocacy

There are several causes for medical malpractice, but let's move on to explain the most common one by way of example. If a patient should receive a treatment consisting of a post operative of three months, with the obligation to ingest certain medications and physiotherapy sessions during the same time. And the doctor does not inform you for example of all the pills you should prescribe, either by omission or simple dismissal, and it turns out that the patient does not recover so a damage is generated. We can ask the doctor to be responsible for recklessness and for not following the rules that the treatment demanded. Whenever damage has been caused to the patient and proven to be due to a medical error, it is a punishable cause and can have economic consequences for both the physician and the health institution

Professional faults, such as failure to take proper care, failure to follow protocols in the event of specific accidents or to act outside the rules of the medical profession, can have important consequences for the convalescent. From here we invite you to contact our Madrid attorneys, experts in medical malpractice. You can call the number available on the website.

What does the compensation include? If it is finally considered that the health professionals did not act correctly, we will be entitled to receive compensation. This deals with two types of damages: personal and material. Personal injury involves three types of situations: permanent injuries, temporary incapacity, and moral (psychological) damages derived from the causative event.

Compensation for permanent injuries is provided by Social Security, whenever caused in the workplace. The mutual collaborators with the SS and the National Institute of Social Security, are responsible for the incapacities termanentes, through their inspections. And, finally, compensation for moral damages is applied according to the Scale for death, injury and damages published on September 23, 2015. The compensation must be made according to the days of hospital stay and days off work. The materials, on the other hand, include the emergent damage and the lost profit, that is to say, the gain lost by the affected one because of not being able to develop the habitual activity or profession. The specific amount depends on a scale that is updated every year.

How to start the proceedings The first step is undoubtedly to advise you by a lawyer specializing in the field. Let us also take into account that the deadlines to claim are somewhat limited (especially in public health) so we must contact as soon as possible. Obviously, an expert physician will also be involved in the process, who will be responsible for examining the injuries. It is important at this point that we keep all the information we can (including photos), as any document can be useful.

If you have had an accident at work do not hesitate to contact our Madrid lawyer, we will inform you of all your rights.

Clients sometimes require the attention of specialists in criminal law experts, in turn, in medical malpractice.

Clients sometimes require the attention of specialists in criminal law experts, in turn, in medical malpractice. The lawyers will have to carry out all legal action aimed at the accomplishment of the repairs due for the victims of medical malpractices. Claims for medical errors must be made under the rules established by law, through evidence that demonstrates malpractice, neglect or any other negligence in this area. Professionals will have to deal with legal problems arising from failed aesthetic operations.

Aesthetic operations with undesirable results are the most complex in terms of their determination. This type of interventions can produce consequences that are undesirable for the patient, such as asymmetries or areas deformed by the operation itself. It is also necessary to act in the case of other types of surgical interventions. When errors occur you have to settle the responsibilities, however, it is not so easy.

Sometimes, professionals who commit in failure, do not recognize it, but instead try to hide it so that it does not splash to their professional or academic reputation. Many clients who are in unfair situations before the medical establishment, are unaware that there are possibilities for the demonstration of irregular behavior, malpractice and other actions that can seriously damage the health of patients. Through an attorney specializing in claims for medical errors, legal action may be taken to restore the rights of the affected person.

While it is true that some practitioners try to overlap their mistakes with the testimony of friends or other related professionals, teams of specialized lawyers include specialists who will help resolve the case in favor of the client, professionals such as forensic experts and other Field of medicine.

Up-to-date scales, amendments relating to different allowances and other factors relating to medical malpractice must be fully known by lawyers specializing in this area. Criminal lawyers will assist you in Madrid to provide you with solutions regarding medical negligence. These can occur in both public and private institutions. Versatility is one of the best qualities of a law firm that is dedicated to customizing actions so that each client finds the best resolution for their case. An attorney specializing in medical malpractice will help you when, for example, you or a family member has had problems following poorly performed.

Corporatism is common in the professional field of medicine, but specialist lawyers will take appropriate action to avoid injustices in a particularly sensitive area. Medical malpractice or errors in surgical interventions are often not recognized by those responsible, so the patient will have to resort to lawyers who make the corresponding demands, resources and all legal procedures leading to the recognition of the rights of the affected.

When necessary, and in order to avoid the aforementioned corporatism, medical malpractice lawyers will collaborate with medical or forensic experts, who will proceed to the writing of reports that will prevent professionals from overlapping by said corporatism.

Experts in Medical Malpractice will coordinate their actions in the most appropriate way for each circumstance, so that the person affected by the medical error, obtain the necessary compensation, as well as the responsible professional (s), the penalties or penalties imposed by the judicial bodies . Expert lawyers in this branch must possess several characteristics, including perfect communication among clients, so that they understand each step that is focused on solving their situation and getting what is required by law.

With the aim of balancing justice in favor of clients.

Law firms must have options for individuals and companies through a comprehensive service that includes different branches of law. One of these branches is Corporate and Commercial Law.Through specialized lawyers, you will access to the constitution of business groups (of any size), competitions of creditors, splits, UTEs, mergers, liquidation of companies.

Another area that the lawyers deal with is Civil Law, Through which hiring, claims, litigation about the legal status of minors, procedures on incapacity, inheritance rights and any aspect related to inheritance are obtained. Lawyers who provide legal services in Madrid provide versatility so that any client, in any situation, can find exactly the coverage they need. Likewise, actions related to another branch of the law of radical importance are carried out: Criminal Law. In this sense, the specialists carry out actions to expedite trials for minor crimes, for corporate crimes, against public finances.

Another fundamental aspect is the family, which can encompass different branches of law. Clients will have to agree with different specialists, such as forensic experts, when there are situations of ill-treatment or the like. Likewise, all kinds of investigations will be carried out to expose probable negligence and disregard for maintenance and different circumstances related to non-compliance with judicial decisions. On the other hand, legal actions will be taken in regard to claims for traffic accidents, labor and others.

Medical malpractice lawyers: Who should be complained about malpractice?

The person harmed by medical malpractice has to consider certain circumstances when submitting claims in this regard. Attorneys specializing in medical malpractice claims will tell you in detail about the different aspects of the acts to be carried out. To begin with, it must be considered relevant whether negligence has occurred in the private sector or in the public sector. There are times when medical errors occur in institutions to which you are financially paid to receive assistance. At other times, we must act in the public health sector. When the medical error occurs in a private medical center, the claim must be made before legal or physical persons who have attended and therefore have been paid financially. In the case of negligence in public medical centers, the claims will be carried out before the incumbent administrations responsible for the provision of such public assistance. In the circumstance where malpractice occurs within a framework of a criminal offense, a claim must be made to the natural person who has given rise to an unlawful practice; This does not remove so that, in this case, civil claims can also be claimed.

In order to obtain the best options in this complicated sector in which medicine and law are associated, the interested party must contact highly qualified lawyers in this field. In many cases, it is difficult to prove medical errors. Specialized lawyers must have medical experts, who are responsible for detecting medical errors, even when they try to be hidden by third parties or by the professionals who have performed malpractice. The experts will be in permanent contact with the lawyers, so that the tasks are coordinated so that they can be solved, always in favor of the client or injured person, medical negligence and delays in surgical interventions, negligence in clavicle interventions, respiratory arrest for medical errors , Errors in herniated disc operations and many other assumptions.

You can communicate with confidence to get information on all the options that health law has in your favor. Thanks to the specialization in this sector, people who suffer injustice in a field as hermetic as the doctor, can tip the balance of justice in their favor. You can expose your case to obtain not only information, but advice and of course personalized and tailored assistance.

Representation of clients who have suffered malpractice.

From an office of attorneys specialized in medical malpractice, who has suffered an error in medical treatment, malpractice or similar situation, may be properly represented before the appropriate courts, should the case be brought to trial.

This is precisely the wish of many victims of malpractice and medical errors, undesirable situations that in many cases may be fatal and, if they occur, should be examined very carefully. It is the case that many sufferers do not report because of the difficulty presented by the cases in the medical and health field.

Corporatism can be a factor to consider, which is an obstacle that must be saved. Frequently, those who are subject to medical malpractice think that medical professionals hide their errors from one another. This is not always the case, but if it does happen, medical malpractice lawyers should test evidence for the offense.

When thinking about a lawyer in Madrid who specializes in medical claims, get the idea that you will coordinate with as many professionals as necessary to prove the truthfulness of the situation. A team harmonizes with each other in order to achieve the best alternatives. The team may be composed of forensic experts, who will make the corresponding reports valid before the conclusion of the potential judgments.

Medical malpractice attorneys handle any situation arising from this undesirable situation. Complaints due to improper prognosis, medical malpractice, mistakes in cosmetic surgery operations ... you have to take into account that not any lawyer can take care of (and even less individually) cases that carry added complexity .

In the medical field, it is not so easy to settle responsibilities and measure the consequences of acts.

A medical malpractice is an action that takes place on a patient that due to a wrongful action of the doctor or a malpractice results in physical or psychic damage.

It may be due to an error in the diagnosis, due to a lack of diligence in the doctor, etc. If you believe that a medical malpractice has occurred and that is why you have health problems or have had sequels, it is advisable to seek the advice and help of a professional lawyer.

If it is determined that a medical malpractice has occurred, there are several types of fault, such as the unconscious, which is the lack of anticipation of an outcome that could have been foreseen in acting, through reckless behavior.

Conscious guilt is one that occurs after an act that can have negative consequences but the doctor trusts that it is not.

Likewise, professional guilt occurs when the rules of an activity have been broken, and medical guilt is similar to professional guilt, for failing to act properly and responsibly.

Some causes of medical errors can be caused by misinterpretation of diagnostic tests, mistakes of surgeries in the wrong places, failure to detect malformations, errors during the follow-up of pregnancy and childbirth, or lack of practice in the analytics indicated in the Guides and protocols. A concept to be taken into account in these cases is the doctrine of disproportionate harm to the suppression of the probatory difficulties with which a patient is when complaining.

In addition, the patient has the right to know all the available information that the medical professional will usually provide verbally and that understands the purpose and nature of each intervention and all its risks.

If you believe you have a permanent injury or suffer from sequelae due to a medical error, ie a malpractice, as a patient you are entitled to initiate a medical malpractice claim process.

What is intended in these cases is to do justice so that it does not happen again and compensate for its damages in some way. Before beginning with such a process, which is not simple, you should know that it is a long process like any judicial procedure, you must be aware that the denunciation of a certain situation can be lengthened, so it is advisable to leave the case in the hands of A professional lawyer in this area. In addition, a medical report must be submitted to the judge to show the physical consequences and the negative consequences of negligence.

A medical expert must make a valuation and this has a high cost. Although you end up receiving compensation you should know that sometimes the management costs could be even higher than the compensation itself. As a patient it could happen that you begin the process convinced of the error that had in a certain doctor's day but you could lose the case and even be condemned by the courts to pay the costs of the whole procedure like those of the lawyers, expenses for the formalities Judicial proceedings, pay a procurator, etc. You must know that before starting the claim you have to study carefully the possibilities of success of each case having in your hands all the documentation and reports and counting with the help of a lawyer. It may happen that you are convinced of your case but that you have numerous difficulties to prove and collect the evidence and your claim is forgotten.

Because of this it is essential to make an assessment, see if it is worth the claim and take into account the expenses. It is best to tell your case to a professional medical malpractice attorney and make an assessment.

The Medicines and Healthcare products Regulatory Agency (MHRA) jointly with European healthcare product regulators of member states has been informed of the suspension of the CE certificate for all medical devices made by the Brazilian manufacturer Slimed.

The German notified body, has recently carried out an inspection of the manufacturing plant in Brazil and established that the surfaces of some devices were contaminated with particles. The devices covered by the suspended CE certificate are implants for:

  • Silicone implants for plastic surgery: implants: breast implants, pectoral implants, gluteal implants, calf implants, implantsfor hand surgery, tissue expanders, facial implants, nostril retainers, suspension sheets for breast surgery.
  • Bariatric surgery: gastric bands and balloons.
  • Implants for urology: testicular implants, penileimplants, vesical conformers, periurethal constrictors, tubes for hypospadias, vaginal stents.
  • Silicone implants for general surgery: blocks and sheets.
  • Silicone invasive devices: sizers for silicone implants.

MHRA is investigating in collaboration with other European regulators and recommends that none of these devices should be implanted until further advice is issued. For the moment there has been no indication that these issues would pose a threat to the implanted person's safety. EU health regulators have initiated test in go samples of products to establish if there are any health risks.

In general, a medical device cannot be marketed in Europe without carrying a CE mark of conformity. A CE mark is applied by the manufacturer and means that the device meets the relevant regulatory requirements and, when used as intended, works properly and is acceptably safe. CE marking for a device is a claim of compliance with the essential requirements of European Directives. We continually monitor the safety of all medical devices.

MHRA Directorof Devices, John Wilkinson said: "There has been no indication at this time that these issues would pose a threat to patient safety. We are urgently investigating this issue and are working closely with our European counter parts. In the meantime we would recommend that people who have questions about their implants should seek advice from their implanting surgeon or clinic."

The European Medicines Agency (EMEA) has completed a review of the safety and effectiveness of veralipride. The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that veralipride's benefits do not outweigh its risks, and that all marketing authorisations for medicines containing veralipride should be withdrawn throughout Europe.

SCIENTIFIC CONCLUSIONS OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF MEDICINAL PRODUCTS CONTAINING VERALIPRIDE.

Veralipride is a benzamide neuroleptic medicine indicated in the treatment of vasomotor symptomsassociated with the menopause. It was first authorised in 1979 and is currently authorised in the EU inBelgium, France, Italy, Luxembourg and Portugal under the names Agreal and Agradil.

Until June 2005, veralipride was authorised in Spain. Following reports of serious side effectsaffecting the nervous system, the Spanish National Competent Authority concluded that its benefitsdid not outweigh its potential risks. Spain therefore withdrew veralipride's marketing authorisation on27 June 2005. Regulatory actions were also taken in some other EU Member States where the productis authorised and veralipride's product information was restricted with the aim to reduce the risk ofpatients developing side effects.

Consequently, the European Commission triggered a referral procedure on 7 September 2006 andrequested the CHMP to give its opinion on whether the marketing authorisations for productscontaining veralipride should be maintained, varied, suspended or withdrawn across the EuropeanUnion following the assessment of these safety risks their impact on the benefit/risk assessment ofveralipride.

Efficacy:

In this review, the CHMP assessed all of the available information on the safety and efficacy ofveralipride. This included mainly 11 studies involving around 600 women, in which veralipride wascompared with placebo, and two studies in around 100 women where it was compared with conjugatedoestrogens. The CHMP also looked at other small studies.

Based on the submitted data, there appears to be an effect for veralipride in the treatment of vasomotorsymptoms associated with the menopause. The benefit could be qualified as limited, however the effectsize cannot be accurately quantified due to methodological deficiencies of available studies (e. g. inmost cases baseline values were not stated, precluding an adequate assessment of the improvementobserved; neither the statistical nor the clinical significance of this effect size could be preciselyquantified, as the statistical plan was not clear or was absent; the presentation of the results was poor).In addition, the duration of the trials was too short to allow for proper assessment of maintenance ofefficacy. Few data are available beyond 3 months, mostly in non comparative studies.

The CHMP concluded that the data submitted showed only limited effect of veralipride in thetreatment of vasomotor symptoms associated with the menopause. In addition, the effect size cannotbe accurately quantified due to methodological shortcomings and the duration of the trials was tooshort to allow for proper assessment of maintenance of efficacy.

Safety:

The 27-year post-marketing period offers a long period of safety profile surveillance. Neurological adverse events referred to extrapyramidal symptoms and particularly tardive dyskinesiashave been reported with veralipride and represent a real concern due to their potential seriousness andirreversibility. It has to be noted that tardive dyskinesias are not predictable and can develop even afterthe treatment has been discontinued.

Psychiatric adverse events mainly referred to depressive and anxiety states have also been reportedwith veralipride. Most of them occurred beyond 3 months of treatment. It should be noted that in theevaluation of the causality assessment of veralipride in the psychiatric events, the role of veralipride isnot always clear.

In order to avoid psychiatric AE, extrapyramidal symptoms and tardive dyskinesia, the MAHproposed a maximally allowed duration of 3 months veralipride treatment. However, cases of tardy dyskinesia have also been reported within the first 3 months of treatment. The proposal of closemonitoring including neurological examination after each 20 day treatment cycle might reduce theserisks, but is a measure of considerable burden to both patient and doctor.

As for the other adverse events related with the blockage of the dopamine receptor, especiallyhyperprolactinemia is a concern. Veralipride treatment is contra-indicated in patients with prolactin-dependent tumours such as pituitary gland prolactinoma and breast cancer. But the effect ofhyperprolactinemia in women with history of breast cancer is not elucidated. The proposedintermittent treatment of 20 days, followed by a 10 day period of non-treatment, may temper thiseffect on the prolactin level, but it is unknown whether this measure has any effect on the adverseevent pattern.

Lastly, QT-prolongation is a class-effect of dopamine-antagonists. The absence of cases of suggestiveQT-prolongation in the database is not sufficient to conclude that this effect does not occur withveralipride. No studies were performed to evaluate whether veralipride has an effect on QT.

Benefit/risk:

In view of the available clinical data the CHMP concluded that the risks associated with the use ofveralipride in the treatment of hot flushes associated with the menopause, mainly the neurologicalreactions (dyskinesia, extrapyramidal disorder, Parkinson syndrome) and psychiatric reactions(depression, anxiety, withdrawal syndrome) outweigh the limited benefits.

Cases of not predictable and potentially irreversible tardive dyskinesia, as well as early extrapyramidalsymptoms, depression, anxiety and withdrawal reactions have been reported with veralipridetreatment; these risks together with the risk of hyperprolactinemia, and the class effect risk on QT-prolongation are considered a concern.

The CHMP took note of the MAH's proposals, some of which had already been introduced in somecountries, in an effort to limit these risks like:

  • Restriction of the treatment duration to 3 months in combination with monthly examination in aneffort to limit the psychiatric and neurological adverse events. However, tardive dyskinesia may stilloccur within the first 3 months of treatment.
  • Introduction of the contraindications in patients with Parkinson's disease, or in combination withother neuroleptics and dopaminergic agonists.
  • Introduction of warnings regarding class effects of neuroleptic medicines (neuroleptic malignantsyndrome, QT prolongation, tardive dyskinesia) and withdrawal symptoms such as anxiety anddepressive syndrome.
  • Recommendations of medical breast monitoring and intermittent schedule (20 days followed by a 10-day period of non-treatment) to reduce the risk of hyperprolactinemia, aimed to improve the breastsafety (however, it is unknown whether this measure has any effect on the observed adverse eventpattern related to hyperprolactinemia like breast enlargement, galactorrhoea and risk for patients withprolactin-dependent tumours such as pituitary gland prolactinoma and breast cancer).

Overall, the restriction to limit the use of veralipride to 3 months in combination with monthly medicalneurological examinations and breast monitoring is not considered adequate to limit the risk of alladverse effects reported with veralipride and adequately treat the vasomotor symptoms associated withthe menopause.

In addition, some of these side effects can occur not only during treatment, but also after it is stoppedand it is also impossible to predict which women may be at risk.

The CHMP therefore concluded on 19 July 2007 that the benefit/risk balance of veralipride containingmedicinal products is not positive under normal conditions of use. Therefore, the CHMPrecommended the withdrawal of all Marketing Authorisations for medicinal products containingveralipride throughout Europe.

Whereas

  • The Committee considered the referral made under article 31 of Directive 2001/83/EC, asamended, for medicinal products containing veralipride.
  • The Committee considered that veralipride containing medicinal products only showed limitedefficacy in the treatment of hot flushes associated with the menopause.
  • The Committee considered that neurological reactions (dyskinesia, extrapyramidal disorder,Parkinson syndrome) and psychiatric reactions (depression, anxiety, withdrawal syndrome) havebeen reported with veralipride, including tardive dyskinesia which may be potentiallyirreversible. In addition, hyperprolactinemia and the risk of QT prolongation are also concerns.
  • The Committee concluded, in view of available data, that the risks associated with the use ofveralipride in the treatment of hot flushes associated with the menopause outweigh the limitedbenefits. In addition, the Committee considered that the proposed risk minimisation activitieswere not able to reduce the risks to an acceptable level or predict which women may be at risk.
  • The Committee, as a consequence, concluded that the benefit/risk balance of veralipridecontaining medicinal products is not positive under normal conditions of use.

We all go to a doctor's office, whether it is Public Health - Social Security - or private. Sometimes we can find behaviors that seem strange or give unexpected results, but we do not know if this falls within the 'normal'. That is why many people never come to claim.

We all go to a doctor's office, whether it is Public Health - Social Security - or private. Sometimes we can find behaviors that seem strange or give unexpected results, but we do not know if this falls within the 'normal'. That is why many people never come to claim.

So, what is medical negligence? From the point of view, it is considered negligence to an act carried out by a health professional who, by act or omission, deviates from the medical standards. Some examples would be the following:

Diagnostic errors: Not inform the patient of the risks involved in their treatment; Surgical operations in which material is forgotten inside the patient; Cosmetic surgery treatments that end with a different result than expected;

If we have doubts and we do not know very well if what happened to us is a negligence or it is not, it is advisable to go to a negligence lawyer to assess our case and guide us.

In our Firm we have professionals who are specialized in this specific field and who have experience in all types of cases, so they can tell you if the mishap that has suffered is a medical malpractice and act accordingly. We want to remind our clients that negligence can occur in public health as well as in private consultations, although the legal way to present the claim will be different. In any case we will take care to explain the whole process and help you with the same.

For more information, we invite you to contact our team, either by phone or through the form that can be found on our website.

Medical Negligence: Offices in Madrid, Barcelona and Valencia Free Consultation
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