Legal Journal on Consumers and Users - Issue No. 4. Sanitary Responsibility, January 2019

Author: Ignacio Montoro Iturbe-Ormaeche

Position: Lawyer. Managing Partner at Summons Abogados and Director of the Litigation Department

Pages: 3-18

vLex ID: VLEX-757841437

Link: http://vlex.com/vid/paciente-nuevo-cliente-757841437

Summary

Lawyers specializing in the defense of healthcare providers have been hearing from their clients in recent years that "the patient is no longer a patient, but merely a user of services," and "the doctor is no longer a doctor, but merely a provider of healthcare services." This is one of the main complaints of healthcare professionals, and they may have some justification. There has been a radical change in the nature of the doctor-patient relationship, which also explains the increase in medical malpractice claims and even the rise in assaults on healthcare workers. KEYWORDS: Patient, user, negligence, prosthetics.

Text

Contents

• Introduction
  • 1. Application of the TRLGDCU in the healthcare sector
  • 2. The patient as a consumer or user
• The patient as a consumer and the increase in claims
  • 1. Approval of the law on consumers and users
  • 2. Expansion of regulations guaranteeing patient rights
  • 3. The phenomenon of "defensive medicine"
  • 4. Inadequate information
    • 4.1. Awareness among healthcare professionals
    • 4.2. Incorrect patient perception of information
  • 5. Teamwork in the medical field
  • 6. "DR. GOOGLE"
  • 7. The role of the media and the "call effect"
  • 8. Patient advocacy groups and law firms
  • 9. Litigation culture and insurers
  • 10. Rise of voluntary medicine
• Application of consumer and user law to medical negligence
  • 1. Cases where TRLGDCU applies
  • 2. Difference between organizational acts and medical acts
• Scandal of defective prosthetics worldwide
• Conclusions

1. Introduction

Before delving into the rest of the issues, which I will attempt to develop from a practical standpoint, we must analyze whether Royal Legislative Decree 1/2007, of November 16, approving the revised text of the General Law for the Defense of Consumers and Users [See] and other complementary laws (hereinafter TRLGDCU) applies in the field of Healthcare Law, and whether the patient should be considered a consumer or user.

1.1. Application of the TRLGDCU in the healthcare sector

It is common for patient defenses and healthcare providers to argue in procedures the application of legal arguments contained in the TRLGDCU - primarily concerning burden of proof, its possible inversion, and the objectification of fault - each denying the application or non-application of consumer and user regulations in Healthcare Law according to their own interests.

On this matter, as we will explain later, neither party usually has complete justification, although it is undeniable that the TRLGDCU applies to damages caused by healthcare services. In this regard, paragraph 2 of Article 148 of the TRLGDCU states:

"In any case, healthcare services, repair and maintenance of appliances, elevators and motor vehicles, rehabilitation and repair services for homes, review, installation or similar services for gas and electricity, and services related to transportation shall be subject to this liability regime."

Therefore, in cases of damages caused by healthcare services falling under consumer protection regulations, the burden of proof will be reversed in accordance with Article 147 of the TRLGDCU, which states:

"Service providers shall be liable for damages caused to consumers and users, unless they prove they have complied with the legally established requirements and other care and diligence required by the nature of the service."

Thus, there is no doubt that consumer and user regulations apply in the field of Healthcare Law. However, do patient defenses have a point when they assert the automatic application of these regulations in their claims?

However, consumer and user regulations do not always apply to claims for medical negligence, as we will further develop below. Case law has limited its application to "organizational aspects or provision of healthcare services, unrelated to the medical activity itself"1, so the TRLGDCU cannot be applied to every case of medical negligence.

1.2. The patient as a consumer or user

As noted above, one of the main complaints of the healthcare community is that they consider the patient should not be regarded merely as a consumer or user, given that medical activity cannot be equated to other services, because the most important human good is at stake: their health.

However, despite this author's view that including healthcare services under other services like "repair and maintenance of household appliances, elevators and motor vehicles, rehabilitation and repair services for homes, gas and electricity inspection, installation or similar services, and transportation-related services" is not appropriate, according to legislators, patients must be considered consumers or users in cases where the General Law for the Defence of Consumers and Users (TRLGDCU) applies, despite the discontent this categorization of patients generates among healthcare professionals.

Therefore, in such cases, the general concept of consumer and user as defined in Article 3 of the TRLGDCU will apply:

"For the purposes of this standard and without prejudice to the provisions expressly set forth in its third and fourth books, natural persons acting for purposes outside their commercial, business, trade or profession shall be considered consumers or users."

One question that may arise is whether the TRLGDCU applies when the intervention occurs in a public healthcare center, given that it does not fit the literal concept of entrepreneur under Article 4 of said Law, nor does the center profit from the activity performed.

In this regard, our Supreme Court has already settled this issue, ruling in favor of applying the TRLGDCU to public healthcare as well, considering patients in public hospitals as consumers or users and public healthcare centers as risk-generating entities concerning patients' health.

In conclusion, two points stand out from this introductory section:

1) Consumer and user regulations apply to claims for medical malpractice in certain cases.

2) The patient should be considered a consumer or user in such cases.

2. The patient as consumer and the increase in claims

In this second part of the article, I will analyze the main reasons explaining the shift from seeing patients as mere consumers to understanding them as such, linking it to an exponential increase in the number of claims, and introducing other reasons for the rise in medical malpractice lawsuits in recent years.

2.1. Approval of the Consumer and User Law

As noted above, the 2007 consumer and user regulations cover healthcare services among potential causes of harm, requiring patients to be considered consumers or users in such cases.

However, the assimilation of patients as consumers of services was not introduced in 2007 but rather dates back to the predecessor legislation, the General Law for the Defence of Consumers and Users, Law 26/1984 of July 19, which considered healthcare services as sources of harm and provided for the application of the law in these cases.

Thus, Article 28.2 of the aforementioned 1984 Law stated

"In any case, the following are subject to this liability regime: food products, hygiene and cleaning products, cosmetics, pharmaceutical specialties and products, healthcare services, gas and electricity, household appliances and elevators, means of transport, motor vehicles, toys, and products aimed at children."

Additionally, Article 26 (now Article 147) provided for the burden of proof reversal in these cases, requiring the defendant to prove that the healthcare service had been provided in compliance with "the requirements and regulations established and other care and diligence required by the nature of the product, service, or activity", which contradicts Article 217.2 of the Civil Procedure Act (LEC) of January 7, 2000.

2.2. Expansion of regulations guaranteeing patient rights

The democratization of our institutions 40 years ago with the approval of the Spanish Constitution also led to the enactment of legislation aimed at improving healthcare services and protecting and developing patient rights.

A first step in this direction was the enactment two years after the TRLGDCU of the General Health Law 14/1986, of April 25, which remains in force today. Article 10 of this law included various patient rights such as respect for their personality, privacy, and dignity; confidentiality; choice of medical practitioner; access to their medical records; and information and consent for medical treatment.

The next significant milestone for the development and protection of patients was the enactment of Law 41/2002, of November 14, which regulates patient autonomy and rights and obligations regarding information and clinical documentation (hereinafter the Patient Autonomy Law), still in effect today. Among other things, this law guarantees patient access to medical documentation and information, both critical aspects in the adjudication of medical malpractice cases.

Thus, the Patient Autonomy Law includes the patient's right to information and their consent before undergoing medical treatment, primarily in Articles 4, 8, and 10:

Article 4. Right to healthcare information.

Patients have the right to know all available information about any action related to their health, with exceptions provided by law. Additionally, every person has the right for their wish not to be informed to be respected. Information, generally provided verbally and recorded in the medical record, must include, at a minimum, the purpose and nature of each intervention, its risks, and consequences.

Clinical information is part of all healthcare actions, must be truthful, communicated comprehensively and appropriately to the patient's needs, and must assist them in making decisions according to their own free will.

The responsible physician guarantees the patient's right to information. Professionals attending to the patient during the healthcare process or applying a specific technique or procedure are also responsible for informing them.

Article 8. Informed consent.

Every action in the health field concerning a patient requires the affected person's free and voluntary consent once they have received the information provided for in Article 4 and have assessed the options specific to the case.

Consent is generally given verbally. However, it must be provided in writing in the following cases: surgical intervention, diagnostic and therapeutic invasive procedures, and, in general, procedures entailing risks or disadvantages of notable and foreseeable negative repercussions on the patient's health.

The patient's written consent is necessary for each of the actions specified in the preceding point of this article, with the possibility to include annexes and other general data, and it must provide sufficient information about the procedure and its risks.

Every patient or user has the right to be warned about the possibility of using prognostic, diagnostic, and therapeutic procedures applied in an educational or research project, which in no case may entail additional risk to their health.

The patient may freely revoke their consent in writing at any time.

Article 10. Conditions for information and written consent.

Before obtaining the patient's written consent, the physician shall provide the following basic information to the patient:

1. a) The significant or important consequences resulting safely from the intervention.
2. b) Risks related to the patient's personal or professional circumstances.
3. c) Likely risks under normal conditions, according to experience and state of science, or directly related to the type of intervention.
4. d) Contraindications.

In each case, the responsible physician shall consider that the more doubtful the outcome of an intervention, the more necessary the prior written consent of the patient.

Additionally, Article 18.1 regulates patient access to their medical records:

"The patient has the right to access, with the reservations indicated in section 3 of this article, the documentation of their medical history and obtain a copy of the data contained therein. Healthcare centers shall regulate the procedure ensuring compliance with these rights."

In conclusion, over the years, legislators have endowed patients with rights and protection in healthcare services, breaking the traditional vertical relationship between physician and patient, where the physician enjoyed an almost authoritative role, to a more horizontal relationship today, where the patient has more rights, especially regarding information and treatment choice.

In my opinion, this shift in the physician-patient relationship has been taken to extremes in recent years, often leading to a complete loss of respect towards healthcare professionals and their work due to a misunderstood "obligation to achieve results" from treatment. In some cases, patients and their families have been heard saying phrases like "I pay, and you act" or "I pay your salary with my taxes", which leads, among other things, to a deterioration in healthcare assistance and a worsening of the physician-patient relationship.

The most extreme example of this change in patient perception of physicians often manifests in assaults and insults towards healthcare professionals in the exercise of their duties, a phenomenon that institutions should more vigorously combat.

In conclusion, the assumption of rights by patients and the obligations acquired by healthcare centers and medical professionals have generally been very positive, balancing both positions and creating a horizontal relationship. However, it has also led to an increase in medical malpractice claims—often unfounded—and aggression and insults towards healthcare professionals.

What other causes may have motivated the increase in claims?

2.3. The phenomenon of "defensive medicine"

The transformation of patients into consumers and the substantial increase in claims has led to the prevalent practice of "defensive medicine" for many years. This refers to the indiscriminate use of diagnostic tests such as CT scans, ultrasounds, and X-rays, even when they are unnecessary and sometimes harmful due to the increased radiation exposure to patients. This practice is driven by the fear among healthcare professionals of facing a claim.

Indeed, this fear is not unfounded, as from my professional experience, many defenses use the absence of some tests or unnecessary treatment as grounds for a claim.

Therefore, "defensive medicine," aside from being economically costly for healthcare services, has contributed to the rise in medical malpractice claims. Patients often complain about unnecessary tests being performed or the unnecessary prolongation of medical processes. In other cases, patients demand that all diagnostic or curative means be exhausted—even if their ineffectiveness is widely known—and they file claims when a healthcare professional fails to do so.

2.4. Inadequate information

Another cause behind the rise in claims, closely linked to increased patient rights, is the information provided to patients.

In forensic practice, the absence of information is possibly the primary allegation in medical malpractice claims. Beyond debating whether this allegation is justified in most claims, there are two issues that could prevent or limit claims of inadequate information:

2.4.1. Awareness among healthcare professionals

As mentioned earlier, providing information to patients during medical treatment is a patient's right and a healthcare professional's duty under the Patient Autonomy Law, especially in cases where the outcome of treatment is uncertain.

Despite this, there are still healthcare professionals in our country who underestimate the importance of patient information and the obligation to obtain written informed consent in legally prescribed situations such as surgical interventions, invasive diagnostic and therapeutic procedures. Therefore, healthcare professionals must realize that information is a cornerstone of any medical care.

2.4.2. Incorrect perception of patient information

It often happens that patients claim a lack of information even when there is a properly signed written informed consent between patient and physician, alleging issues such as "they didn’t tell me; they didn’t warn me; they didn’t give me other options; I signed without information," etc.

At this point, patients need to understand that medicine involves risks, is not an exact science, and cannot guarantee outcomes. Therefore, the mere occurrence of an informed risk does not automatically constitute a breach of the appropriate standard of care.

2.5. Teamwork in the medical field

The teamwork emphasized in current medical services is crucial for providing quality healthcare. However, it also often leads to an increase in medical malpractice claims.

These claims frequently stem from problems such as patient referrals, transfer of information between healthcare professionals that is not followed through in subsequent interventions, etc.

2.6. "Dr. Google"

The ease of access to information through the internet has made it common for patients to arrive at medical consultations with a diagnosis or treatment plan from what is commonly referred to in medical practice as "Dr. Google." Some patients attempt to impose a diagnosis or change prescribed treatment after reading a website or online forum. They then file claims when healthcare professionals do not comply with their requests or when results differ from those shared by other patients on online forums.

2.7. The role of the media and the "call-out effect"

It is understandable that media outlets report cases of medical malpractice where patients receive significant financial compensation or have suffered considerable harm, in an effort to attract readership. This phenomenon causes a "call-out effect," prompting discontented patients to file claims based on media reports about medical treatments they have received.

2.8. Patient defense associations and law firms

In recent years, there has been a substantial increase in patient defense associations aiding individuals who have suffered harm due to medical malpractice. These associations play a critical role in helping affected individuals access medical treatments and provide information to help patients file claims for damages incurred in healthcare services. This factor also contributes to the rise in claims.

Similarly, law firms specializing in patient defense have emerged, many of which advertise through media, internet, social networks, etc. This accessibility makes it easier for patients to claim damages resulting from medical malpractice, thus contributing to the increase in claims.

2.9. Litigation culture and insurance companies

The change in perception of patients as clients and healthcare professionals as service providers, combined with a litigation culture in our country in recent years claims for transportation delays, banking products, traffic accidents, etc. has also led to an exponential increase in medical malpractice claims.

In the past, patients were more reluctant to file claims against "their doctor," as the concept of healthcare providers as service providers did not exist, and trust between patient and physician was paramount. Patients would refrain from claiming damages despite suffering harm. It is true that in the past, there was a closer relationship with the family doctor, possibly due to fewer changes in healthcare professionals at medical centers or the increase in health insurance and private medical centers, expanding the choice of medical professionals available to patients.

This change in the public's perception can also be explained by the proliferation of professional liability insurance companies for healthcare providers and medical centers. Patients are aware of the existence of these insurance companies and, therefore, are less hesitant to file claims, often saying, "if the insurance pays for it," as if dealing with damage to a vehicle.

2.10. The rise of voluntary medicine

Over the past twenty years, the increase in so-called satisfactory or voluntary medicine not considered curative medicine: aesthetic medicine, plastic surgery, aesthetic dentistry, etc. has also influenced the rise in claims for medical malpractice and the change in the view of doctors as service providers. Despite repeated rulings by our Supreme Court that even in this type of medicine, the doctor's obligation is one of means and not results, thus involving subjective liability.

3. Application of the Consumer and User Law to Medical Negligence Cases

As mentioned in the introduction, the Consumer and User Law is not always applicable in claims for medical negligence, despite some defenses by patients attempting to invoke its application by default in all their claims, seeking to objectify fault and shift the burden of proof.

3.1. Cases where the TRLGDCU is applicable

Case law has restricted its application to "organizational aspects or the provision of health services, unrelated to the medical activity itself," thus the TRLGDCU cannot be applied to any issue where medical negligence is claimed.

In this regard, the First and Third Chambers of the Supreme Court have been clarifying this issue for years, and the cases to which it applies are well-established, despite many defenses arguing for its application by default.

By way of example, the following Supreme Court judgments stand out:

Supreme Court Judgment No. 333/2012, First Chamber, May 18, 2012, rapporteur: The Honorable Mr. D. José Antonio Seijas Quintana, appeal No.: 2002/2009, (Id. vLex: VLEX-375394594):

"According to recent case law, due to its specific nature, this type of liability does not affect medical acts themselves, since liability for these acts is inherently based on criteria of negligence due to non-compliance with the lex artis ad hoc. Therefore, liability established by consumer legislation applies only to organizational aspects or the provision of health services, unrelated to the medical activity itself."

Supreme Court Judgment No. 4598/2011, Third Chamber, November 20, 2012, rapporteur: The Honorable Mr. D. Enrique Lecumberri Martí, (Id. vLex: VLEX-410179606):

"The former Article 28 of Law 26/1984 considered liability for failure to meet certain verifiable standards of demand for health services to be objective. This type of liability does not affect medical acts themselves, since liability for these acts is inherently based on criteria of negligence due to non-compliance with the lex artis ad hoc. Therefore, liability established by consumer legislation applies only to organizational aspects or the provision of health services, unrelated to the medical activity itself."

Supreme Court Judgment No. 1377/2007, First Chamber, January 5, 2007, rapporteur: The Honorable Mr. D. Juan Antonio Xiol Ríos, appeal No.: 161/2000, (Id. vLex: VLEX-26668954):

"The third legal ground of the appealed judgment answers this question, applying Supreme Court Judgment of July 1, 1997, by considering healthcare liability included in the content of Articles 1, 26, and 28 of the July 19, 1984 Law, insofar as the plaintiff is a consumer of health services and the production of harm generates objective liability.

(...) "The invocation by various judgments of this Chamber of the LCU regarding health services (which must be projected onto the functional aspects of the health service and cannot reach damages directly attributable to medical acts: Supreme Court Judgments of February 5, 2001, and those cited therein) has a sense analogous to the criteria under examination."

Supreme Court Judgment No. 267/2004, First Chamber, March 26, 2004, rapporteur: The Honorable Mr. D. Clemente Auger Liñán, appeal No.: 1458/1998, (Id. vLex: VLEX-16808395):

"Certainly, more and more judgments of this Chamber apply Article 28 of the General Law for the Defense of Consumers and Users in cases of claims based on deficient medical or hospital care, whose paragraph 2 expressly mentions 'health services'.

(...) these judgments usually concern cases of infections contracted or reactivated in the hospital environment (judgments of July 1 and 21, 1997, and December 9, 1998) or as a result of blood transfusions (judgments of December 3 and 30, 1999), failures in certain implant devices or surgical instruments (judgments of September 24 and November 22, 1999), or disproportionate damages in relation to the minimal risk attributable in principle to a specific intervention (judgment of June 29, 1999)."

Similarly, our Provincial Courts and Superior Courts of Justice generally follow the criteria of our Supreme Court.

The Valencia Provincial Court Judgment No. 424/2016, 6th Section, November 2, 2016, rapporteur: The Honorable Ms. Dña. María Eugenia Ferragut Pérez, appeal No.: 776/2016, (Id. vLex: VLEX-679554709) applies the Supreme Court's case law doctrine on the application of consumer and user regulations only to organizational aspects, but understands that in a case of defective breast implants it is applicable:

"According to recent case law, due to its specific nature, this type of liability does not affect medical acts themselves, since liability for these acts is inherently based on criteria of negligence due to non-compliance with the lex artis ad hoc.

But in this case, it is not an action brought against the surgeon who performed the PIP prosthesis implant operation, but against the clinic where this intervention took place, so this doctrine does not apply to the case.

(...) It is reiterated doctrine that, in accordance with the guarantees and liability system established in Articles 147 and following of said Law, users of health services have the right to be compensated for proven damages and losses caused by the use of the service.

This is precisely the case before us.

This doctrine is applicable to the present case in which breast prostheses were implanted that turned out to be defective.

(...) In this way, although the operation to implant the breast prostheses was not defective, and liability cannot be derived from it, it is true that the clinic's offer, commercialization, and use of ultimately defective prostheses make it liable to those affected by the resulting consequences because the clinic is responsible for the use of the products itself, without prejudice to the responsibilities of the manufacturer and the requirements thereof by the distributor, which is not reasonable in this area of special protection, to be transferred to the user. This is required for the protection of consumers' health and safety."

The Madrid Provincial Court Judgment No. 230/2017, 13th Section, May 19, 2017, rapporteur: The Honorable Ms. Dña. Mª Carmen Royo Jiménez, appeal No.: 921/2016, (Id. vLex: 687822261) does not apply consumer and user regulations to a case of bladder, prostate, seminal vesicles, ureters, and urethra removal due to carcinoma, stating that:

"The consumer regulations have not been applied in the judgment, nor could they be applied. According to recent case law, due to its specific nature, this type of liability does not affect medical acts themselves, since liability for these acts is inherently based on criteria of negligence due to non-compliance with the lex artis ad hoc."

The Cantabria Superior Court of Justice Judgment (Santander) No. 382/2018, Administrative Chamber, September 28, 2018, rapporteur: The Honorable Mr. D. Rafael Losada Armada, appeal No.: 72/2018, (Id. vLex: 744341649) applies consumer and user regulations to a case of gas toxicity used in retinal detachment surgery:

"This type of liability does not affect medical acts themselves (...) Therefore, liability established by consumer legislation applies only to organizational aspects or the provision of health services, unrelated to the medical activity itself.

(...) This is the type of surgical intervention as a health service that has been developed in the analyzed case, distinguished from medical activity, as reflected in the medical report.

(...) Deficiencies have been found in the controls of the raw material and the manufactured lots, and that this manufacturing process did not guarantee the quality of the product, which must justify the objective patrimonial liability of the health service sued for the risk created by the use of the gas that turned out to be toxic."

The Castilla-La Mancha Superior Court of Justice Judgment (Albacete) No. 340/2015, Administrative Chamber, November 20, 2015, rapporteur: The Honorable Mr. D. José Antonio Fernández Buendía, appeal No.: 133/2014, (Id. vLex: 591767062) does not apply consumer and user regulations to a case of alleged misdiagnosis of a fracture:

"As for the alleged applicability of the General Law for the Protection and Defense of Consumers and Users to the analyzed case, it is evident that it is not applicable as argued by the opposing party (...) This type of liability does not affect medical acts themselves, since liability for these acts is inherently based on criteria of negligence due to non-compliance with the lex artis ad hoc.

(...) Moreover, the overlap of the two liability regimes inevitably leads to a consequence in itself as undesirable and unjustifiable, even on a purely practical level, of measuring the diligent doctor by the same yardstick as the negligent one, the careful one as the careless one."

3.2. Difference between organizational acts and properly medical acts

We see how the jurisprudence is unanimous in the cases in which the consumer and user regulations apply in the field of Health Law, but what should we understand by organizational or functional aspects of a health service? What differences exist with the properly medical activity?

At this point, beyond analyzing the decisions of our courts and tribunals on the issue, we must be able to explain from a technical point of view the difference between both concepts, given that in most cases the judgments do not explain this distinction.

Therefore, to answer this question we have consulted Dr. Juan Carlos Prados Frutos, Associate Professor of Legal and Forensic Medicine at the Juan Carlos University, who helps us understand the difference between both concepts, indicating that:

"It is evident that the healthcare professional carries out his activity in a healthcare environment over which he may not have organizational or decision-making capacity in the procedures that are followed, whether in public or private healthcare. The role of this professional is limited to applying his knowledge and experience towards the ultimate goal of safeguarding the health of the patients under his care.

Consequently, what is expected from healthcare professionals is the correct application of their knowledge and experience, in addition to the various resources provided by healthcare centers, aimed at prevention, diagnosis, treatment, and proper evolutionary monitoring of the patients under their care, whether individually or as members of a therapeutic team.

On the contrary, healthcare centers are expected to maintain rigor in regulated procedures and their management.

In this way, evaluating the regulations and jurisprudence from a purely medical point of view, deviations from these approaches may or may not generate liability cases, but it is essential to define the same in each case.

Thus, if the healthcare center does not comply with the legal requirements or due diligence in any of its activities, and the healthcare professional is not aware of it, who acts according to the lex artis in a generic sense and to the lex artis ad hoc in each particular case, we understand that any resulting liability should be exclusively attributed to the center. Examples of these cases of organizational defects could be the acquisition of defective prostheses; non-compliance with protocols on the prevention of transmission of infectious diseases to patients; lack of technical and human resources; proper maintenance and operation of radiotherapy units; control of the sterility of operating rooms, etc.

It could also be the case that the healthcare center diligently complies with its organizational obligations and it is the healthcare professional who carries out acts of incompetence, imprudence, or negligence arising from his specific medical practice.

In this regard, it should be noted that we are faced with two possible, but not exclusive situations. On the one hand, what we understand as organizational acts, which would be those whose responsibility lies with healthcare centers in a broad sense -including various Central Services or strictly Clinical Services-, that is, responsibility for a defective service, and, on the other hand, what is defined as properly medical acts that would be those exercised by healthcare professionals in a specific manner.

Likewise, a third situation arises, which would be cases of shared or potentially shared responsibility, that is, the concurrence of responsibilities, both in cases where the professional is aware of anomalies in the management of procedures that may result in harm to patients and does not act, as well as in those cases where there are defects both in healthcare organization and in the specific medical activity of the professional."

After analyzing the words of Dr. Juan Carlos Prados Frutos, it is evident the difference between negligence in the properly medical activity and the defects in organizational aspects of the healthcare service, the latter being the only ones to which the TRLGDCU should be applied.

4. Scandal of defective prostheses worldwide

Months ago, the alarm was raised following the publication of the "implant files," an international journalistic investigation coordinated by the International Consortium of Investigative Journalists (ICIJ) that uncovered the scandal of defective prostheses worldwide, which would have caused injuries and even the death of many patients.

This investigation shows defects in prostheses, implants, surgical materials, contraceptives, and even contact lenses used by millions of patients worldwide in recent years, a scandal that would affect large companies such as Medtronic or Traiber, among others.

According to the investigation, in which media outlets from our country such as laSexta or El Confidencial have participated, and hundreds of journalists, defects in thousands of prostheses, implants, or insulin pumps placed in patients worldwide have been verified.

It is not the purpose of this article to delve into the investigation carried out by the ICIJ, but rather to analyze, albeit briefly given the short space of this work, whether public and private medical centers and the Public Administration could be liable in accordance with consumer and user regulations.

In this regard, beyond determining possible responsibilities of manufacturers or distributors of prostheses, it is certain that, in the application of the TRLGDCU, public and private medical centers could be liable for damages caused by such defective materials.

Thus, in the application of the jurisprudential doctrine and casuistry analyzed in the previous section, there is no doubt that deficiencies in the verification controls of healthcare products and the placement of defective prostheses would mean that we are in the case that our Supreme Court has defined as "organizational aspects or provision of healthcare services, unrelated to the medical activity proper," so the TRLGDCU would be applicable regarding the objectification of liability and the shifting of the burden of proof.

The application of this doctrine will be fundamental in our country for the adjudication of cases of defective prostheses investigated in the "implant files" case, with multiple interests at stake: patients, healthcare professionals, healthcare centers, administrations, and insurers.

5. Conclusions

1) The patient is considered a consumer or user susceptible to suffering damages caused by a healthcare service.

2) Consumer and user regulations apply to claims for medical negligence when the defect derives from organizational or functional aspects of the healthcare service, despite the fact that defenses of affected patients often allege its application to all types of cases.

3) Organizational or provision of healthcare services will be considered: the acquisition of defective prostheses; non-compliance with protocols on the prevention of transmission of infectious diseases to patients; lack of technical and human resources; proper maintenance and operation of radiotherapy units; control of the sterility of operating rooms, etc.

4) Purely medical acts will include: diagnosis, treatment, and proper evolutionary monitoring of patients.

5) Public healthcare centers are considered centers generating risks to patients' health, and therefore the TRLGDCU applies to them.

6) There is currently a clear change in the doctor-patient relationship: we have moved from a vertical relationship to a horizontal one in which the patient is considered a consumer or user and the healthcare professional a service provider.

7) The increase in patient rights and the conversion of the patient into a consumer or user and the doctor into a healthcare service provider are among the main causes of the increase in claims for medical negligence and aggression against healthcare professionals.

 

---

 

[1] See, for example, among other judgments, the SSTS of February 5, 2001; March 26, 2004; November 17, 2004; January 5, 2007, and April 26, 2007.

[2] See, for example, STS 1377/2007 of January 5, 2007.

[3] Some of these rights were repealed from the General Health Law to be included and developed in Law 41/2002, of November 14, which regulates the autonomy of the patient and the rights and obligations regarding clinical information and documentation.

[4] These issues are also regulated in regional legislation in some Autonomous Communities.

[5] It was not uncommon for certain figures in certain villages, such as the priest, the mayor, and the doctor, to practically enjoy a public authority function above the rest of the population.

[6] Therefore, the legislator included healthcare officials through LO 1/2015 as subjects of the crime of attack under article 550 of the Penal Code (hereinafter CP).

[7] As measures, this author proposes that lege ferenda expressly include in the CP the consideration of a healthcare professional as a subject of attack; allocate more economic resources to raise awareness among the population -from schools, media, etc. that healthcare professionals must be respected, and that despite doubts about their actions, behaviors that threaten their integrity or dignity cannot be resorted to.

[8] See, for example, STS Sala Primera No. 250/2016 of April 13, 2016, Rec. 2237/2014.

[9] Dr. Juan Carlos Prados Frutos is, among other things: Doctor in Medicine and Surgery and Bachelor in Dentistry, Associate Professor of Legal and Forensic Medicine, European Diploma in Oral Surgery by the European Federation of Oral Surgery Societies, Master in Implantology, Master in Oral Surgery, University Expert in Prosthetics on Implants, Diploma in Health Expertise and Assessment of Bucodental Damage, Master in Forensic Medicine, Diploma in Surgical and Legal Dentistry, Diploma in Legal Dentistry and Identification, University Expert in Civil and Criminal Liability of Healthcare Professionals, Judicial Expert in Assessment of Corporal Damage as a result of traffic accidents, Professor of Forensic Pathology of the Official Master "Forensic Profiles of Criminal Hazard," Qualified to perform the functions of General Medicine Physician in the National Health System (Royal Decree 853/1993. of June 4), Qualified as "Director of Research" by the University of Toulouse III (France), Mis Iberia® Research Award in Implantology 2015, registered with the Official College of Dentists and Stomatologists of the I Region, expert for said professional College, member of the Professional Association of Judicial Experts and Collaborators with the Administration of Justice", etc.

[10] News available among others at the following links: https://www.elconfidencial.com/tecnologia/ciencia/2018-11-25/implant-files-fallos-espana-implantes-medicos_1650634/ [View] (last access: 7/1/19). https://www.actasanitaria.com/implant-files-normativa/ (last access: 7/1/19). https://www.diariomedico.com/tecnologia/implant-files-los-profesionales-manifiestan-su-confianza-a-sanidad (last access: 7/1/19).

 

Source: Vlex

http://vlex.com/vid/paciente-nuevo-cliente-757841437