Compensation for Harm Caused by Medicinal Products and Medical Devices

 

March 18, 2022

BRACE Law Firm ©

 

The use of medicinal products and medical devices has become standard in the modern world. However, cases unfortunately occur where the use of such products or devices causes harm to human health or results in death. As a general rule, the person who caused the harm must provide full compensation for harm caused to an individual.

Harm caused to human health refers to the violation of the anatomical integrity and physiological function of human organs and tissues resulting from the influence of physical, chemical, biological, and psychological environmental factors.[1]

The primary conditions for the occurrence of liability include:

• unlawfulness of the actions of the person who caused the harm;
• the actual occurrence of harm;
• a causal link between the unlawful actions and the occurrence of harm;
• the proven fault of the person who caused the harm.

The presumption of fault of the person who caused the harm, established by Article 1064 of the Civil Code, implies that the person who caused the harm must present evidence of the absence of their fault. The victim presents evidence confirming the fact of injury or other health damage, the amount of harm caused, and evidence that the defendant caused the harm or is the person obligated by law to compensate for the harm.[2]

To minimize influence and exclude, as much as possible, the causation of harm to human health, safety is a priority in the use of medical devices and medicinal products. In accordance with Federal Law No. 323-FZ dated November 21, 2011, On the Fundamentals of Health Protection of Citizens in the Russian Federation (the "Law No. 323-FZ"), medical devices in circulation within the Russian Federation are subject to safety monitoring to identify and prevent adverse events.[3] Furthermore, Federal Law No. 61-FZ dated April 12, 2010, On the Circulation of Medicinal Products (the "Law No. 61-FZ" or the "Law on the Circulation of Medicinal Products") establishes the priority of state regulation of the safety, quality, and effectiveness of medicinal products during their circulation.[4] The Federal Service for Surveillance in Healthcare (Roszdravnadzor) is responsible for the state function of monitoring the safety of medical devices in circulation in the Russian Federation[5] and state supervision in the sphere of medicinal product circulation through pharmacovigilance.[6]

Compensation for Harm During the Use of Medicinal Products

Despite the extensive existing legislation in the field of the use and control of medicinal products and medical devices, compensation for harm is a frequent issue considered by courts. The primary consequence of such cases is the occurrence of liability for causing harm to a patient.

Caused harm may be compensated in material or moral form. In accordance with civil legislation, harm is subject to compensation regardless of to whom it was caused and what it consisted of, except for specific cases provided for by law. In fact, the existence of harm is a mandatory condition for the occurrence of civil liability.

The use of medicinal products implies the possibility of undesirable consequences, which is associated with side effects present in almost all medicinal products. Medical personnel must be aware of this when prescribing a course of treatment and must warn the patient accordingly.

Medical personnel and patients must use medicinal products in accordance with the instructions for medical use, which are part of the registration dossier for the medicinal product. The requirements for the instructions for medical use of a medicinal product are approved by an order of the Ministry of Health of Russia.[7] As a result of using a medicinal product according to the instructions, the patient should not experience side effects other than those specified in the instructions for the use of the medicinal product.

Situations occur where the instructions for the use of a medicinal product are followed, but storage conditions are violated, leading to substandard consequences for the patient.

In the event of an unusual event within the framework of medicinal product use, medicinal product circulation entities must report to Roszdravnadzor regarding side effects, adverse reactions, serious adverse reactions, unexpected adverse reactions during the use of medicinal products, individual intolerance, lack of effectiveness of medicinal products, as well as other facts and circumstances posing a threat to human or animal life or health during the use of medicinal products and identified at all stages of medicinal product circulation in the Russian Federation and other states.[8]

Furthermore, the activity of monitoring the effectiveness and safety of medicinal products aimed at identifying, evaluating, and preventing undesirable consequences of medicinal product use is referred to in legislation as pharmacovigilance,[9] the procedure for which is regulated by an order of Roszdravnadzor.[10]

The performance of the supervisory function regarding pharmaceutical market entities allows for the identification of violations in this area that could lead to undesirable consequences and influence the life and health of the patient. Roszdravnadzor performs pharmacovigilance by analyzing information provided by medicinal product circulation entities regarding side effects, adverse reactions, serious adverse reactions, and unexpected adverse reactions during medicinal product use, individual intolerance, and lack of effectiveness, as well as other facts and circumstances posing a threat to human life or health. This is done to identify possible negative consequences of their use, individual intolerance, and to warn medical workers and patients and protect them from the use of such medicinal products.

Harm caused to life and health in connection with the use of medicinal products, like harm caused by other possible sources of influence on the human body, is subject to compensation by the person who caused it. Compensation for harm caused to a patient's health is a form of protection for a violated right.

Compensation for harm caused to the health of citizens due to the use of medicinal products is regulated by Article 69 of the Law No. 61-FZ. The norms of this article distinguish between the liability of the manufacturer of the medicinal product and the liability of the organization (or person) that sells or dispenses a medicinal product that has become unusable.

In the first case, the manufacturer of a medicinal product must compensate for harm caused to the health of citizens due to the use of the medicinal product if it is proven that:

1. the medicinal product was used for its intended purpose in accordance with the instructions for use, and the cause of harm was the release into civil circulation of a substandard medicinal product;
2. harm to health was caused due to unreliable information contained in the instructions for use issued by the manufacturer.

Because it is quite difficult to establish a link between the use of a medicinal product and the resulting adverse health consequences for the patient, such cases are not common. Often, the patient themselves must justify the reasons why health harm occurred during the use of the medicinal product, find support for this, and prove causal links in court. As a rule, a forensic medical examination can establish the presence or absence of a causal link between the use of a medicinal product and the resulting consequences. Conducting an examination in cases concerning compensation for harm is justified by the need to prove a direct link between the use of the medicinal product and the consequences; usually, it is quite difficult for a court to establish this link independently without specialized knowledge.

As an example of when a substandard medicinal product was released into civil circulation, a case can be cited where a patient experienced pain in the liver and stomach due to the poor quality of a medicinal product.[11] During the court proceedings, it was established that the patient took the medicinal product. Upon opening the package, the product had a sharp smell of acetone. These circumstances served as the basis for the patient to file a lawsuit. During the consideration of this case, tests of the medicinal product were conducted, and it was established that the medicinal product (film-coated tablets) failed the tests because the tablets had a sharp extraneous smell. The circulation of this medicinal product was suspended by the Territorial Body of Roszdravnadzor, and the manufacturing plant withdrew this series of the medicinal product from circulation.

In the second case, if harm to the health of citizens is caused due to the use of a medicinal product that became unusable as a result of a violation of medicinal product storage rules, wholesale trade rules, dispensing rules, or manufacturing and dispensing rules, compensation for harm is provided by the wholesale organization, pharmacy organization, individual entrepreneur licensed for pharmaceutical or medical activities, or medical organization licensed for pharmaceutical activities (including its separate subdivisions such as outpatient clinics, paramedic centers, and general practice offices located in rural settlements without a pharmacy) that allowed the sale or dispensing of such a medicinal product.

The correct storage of medicinal products is an important element of providing medical services, as storage often must be carried out in compliance with specific temperature regimes, which may differ for different medicinal products.

The Rules for the Storage of Medicinal Products[12] and the Rules of Good Practice for the Storage and Transportation of Medicinal Products for Medical Use are the primary regulatory documents governing the storage and transportation of medicinal products.[13]

Regulatory authorities actively apply these legal norms and hold individuals and organizations liable for violations of medicinal product storage conditions to exclude possible undesirable consequences and avoid harming the health of citizens. For example, a case involved holding a company administratively liable for storing medicinal products in violation of the temperature regime,[14] and as a result of an inspection, the company was held administratively liable.

Compensation for harm caused to the health of citizens due to the use of medicinal products or the commission of unlawful actions by medicinal product circulation entities is carried out in accordance with the legislation of the Russian Federation.

In this regard, claims for compensation for harm caused to the life or health of a patient are filed within the statutes of limitations established by civil legislation.[15]

Compensation for harm caused to the life and health of a citizen is also carried out in accordance with the civil legislation of the Russian Federation. A disputed issue arises when medicinal products must be classified and, for example, categorized as a source of increased danger.

The difficulty of establishing liability is associated not only with the classification of medicinal products as a source of danger but also with the complexity of proving a direct link between the use of the medicinal product and the resulting undesirable health consequences for the patient.

Compensation for Harm Due to the Use of Medical Devices

According to Article 41 of the Constitution of the Russian Federation, everyone has the right to health protection and medical care. The intentional causation of harm to human life and health is prohibited by the legislation of the Russian Federation, including criminal law. Harm caused to human life and health during the provision of medical care is a significant aspect of the issue of compensation for harm; in most cases, this is accompanied by the poor quality of medical services, specifically the use of substandard medical devices and medicinal products. A crucial condition for using and applying a medical device is its safety for the patient and the personnel of the medical organization. Providing a medical service, especially a medical intervention, implies causing harm through direct interference with the integrity of the body. These actions are justified actions of medical personnel aimed at the recovery of the person. In such cases, there is no causal link or unlawful actions, which are elements of the composition of an obligation arising from the causation of harm. In this instance, the harm caused is justified, lawful, and necessary.

Medical devices are a vital element in providing medical services; however, cases occur where their use results in adverse consequences for the patient. This may be due to their incorrect use, in which case the fault and liability of the medical organization arise, or it may be related to the quality of the medical device itself. To ensure compliance with all norms in this area, supervision is provided for the proper execution of legislation. Regulatory authorities attempt to hold individuals who use medical devices and fail to report adverse events during their use to Roszdravnadzor administratively liable. For example, the Novocherkassk City Court of the Rostov Region dismissed an appeal by a company director against a decision by the deputy head of the territorial body of Roszdravnadzor because the obligation established by part 3 of Article 96 of the Law No. 323-FZ was not met.[16] As revealed during the case, an adverse reaction occurred during the provision of dental care using a medical device—the breakage of a ProTaper Gold endodontic instrument and its entrapment in the apical part of the root canal of a minor patient.

Problems associated with the undesirable movement of a device caused by a malfunction, incorrect diagnosis, or improper handling, as well as actions or omissions that lead to a different result than intended by the manufacturer or expected by the operator, causing device failure, are included in the Classifier of Types of Adverse Events Associated with the Use of Medical Devices. The types of adverse events associated with the use of medical devices were identified in the classifier approved by Decision of the Board of the Eurasian Economic Commission No. 47 dated April 03, 2018.[17]

The safety of medical devices used in providing medical services is a fundamental point. However, often even state medical institutions use medical devices without documents confirming their quality. According to part 2 of Article 18 of the Law No. 323-FZ, the right of citizens to health protection is ensured by the sale of high-quality, safe, and accessible medicinal products and medical devices, as well as the provision of accessible and high-quality medical care. During an inspection of a city hospital, it was established that documents confirming the quality of medical equipment did not correspond to the equipment actually delivered under the municipal contract. Medical devices were in circulation without quality documents. The institution allowed the use of medical devices that were not registered in the established manner and were absent from the register of medical devices, which led the court to find the institution guilty of an administrative offense.[18]

Cases frequently occur where even small medical organizations store and likely use substandard medicinal products and medical devices. In accordance with paragraph 13 of Article 38 of the Law No. 323-FZ, a substandard medical device is a medical device that does not meet safety and effectiveness requirements, labeling requirements, or regulatory, technical, and operational documentation, and which cannot be safely used for the purpose established by the manufacturer. For example, a case involved the Territorial Body of Roszdravnadzor conducting an inspection of an organization and imposing a fine. The head of this organization disagreed with the findings of the regulatory authorities and filed a lawsuit. It followed from the materials of the case that a medicinal product and a medical device with an expired shelf life were stored in the operating room.[19] The substandard medicinal product and substandard medical device were stored together with other high-quality medicinal products and medical devices and were intended for medical use. Consequently, having considered this case, the court decided to leave the decision of the regulatory body unchanged and the appeal unsatisfied.

The storage of medical devices intended for use alongside medical devices with an expired shelf life is a practice frequently encountered in medical organizations. To eliminate such cases, regulatory authorities conduct supervisory activities to identify possible adverse consequences for the patient's life and health. Another example of a case where a medical organization was held liable is one where an inspection revealed medical devices that were substandard due to the expiration of their shelf life.[20] They were stored together with high-quality medical devices under conditions that did not exclude the possibility of their use. The Territorial Body of Roszdravnadzor issued a decision in the administrative offense case imposing an administrative fine. The medical organization disagreed with the regulatory body's decision and filed an appeal with the court. Having studied the materials of the case, the court decided to leave the regulatory body's decision unchanged.

When committing such offenses, representatives of medical organizations should consider that, in accordance with paragraph 2 of Article 98 of the Law No. 323-FZ, medical organizations, medical workers, and pharmaceutical workers bear liability in accordance with the legislation of the Russian Federation for violating rights in the sphere of health protection and causing harm to life and (or) health during the provision of medical care to citizens.

It should also not be forgotten that harm caused to the life and (or) health of citizens during the provision of medical care is compensated by medical organizations in the amount and manner established by the legislation of the Russian Federation.

For instance, a case occurred where a patient was provided with a poor-quality medical service involving the use of braces. The patient turned to a clinic for the medical service of installing braces; as a result of wearing the braces, a positive result did not occur, and the doctor constantly repositioned the braces, which damaged the enamel of the plaintiff's teeth.

As a result of the poor quality of paid medical services (consultations, installation of braces to eliminate an aesthetic smile defect, and their maintenance) provided by the defendant's employee, harm was caused to the plaintiff's health, resulting in diagnoses of distal occlusion, TMJ dysfunction, critical thinning of tooth enamel, and periodontitis. Health restoration is possible through complex medical intervention, which is a paid, expensive medical service and a quite painful procedure.

Due to the improper provision of medical care, orthodontic defects could not be corrected, and a perfect smile could not be achieved with the braces; the plaintiff was not warned of these risks. Consequently, the Sverdlovsk District Court of Irkutsk partially satisfied the plaintiff's claims.[21]

Another example of a case involving dental services was one where the installed dental prostheses were of poor quality, causing the patient not only physical but also moral suffering.[22] On the day the medical service was provided, defects in the installed dental prostheses were discovered: the jaws did not close, the teeth caught on each other (preventing the plaintiff from eating or speaking), and there was a lack of symmetry between the left and right sides in terms of the size, height, and shape of the teeth. As a result of the case consideration, the court partially satisfied the plaintiff's claims.

Court cases related to poor-quality dental prostheses are quite common. For example, another case involved a poor-quality dental prosthesis becoming the basis for a lawsuit. The plaintiff first approached the defendant with a claim demanding the return of funds paid for the poor-quality prosthesis, as well as the payment of a penalty and compensation for moral harm. The defendant refused to satisfy the plaintiff's claim, believing there were no grounds for it. The plaintiff filed a lawsuit in court,[23] and the claims were partially satisfied.

Cases occur where medical services were provided poorly, and the medical devices used did not perform the required function due to their poor quality. As an example, a case can be cited where a representative of a medical organization in a court session did not deny the fact that a violation of the fixing capacity of a bolt and nut with a washer could have been caused by the poor quality of the device itself, leading to the medical service being provided improperly.[24] Experts in this case established that one of the bolts did not fix the fracture and lay loosely in the tissues; this was also confirmed by an X-ray examination by a professor, where the expert noted: "one of the nuts is located outside the screw thread at the literal contour of the condyle of the femur". As a result of considering this case, the court concluded that there was a causal link between the defects in the plaintiff's health status—in the form of an incorrectly healed fracture of the medial condyle of the right femur, varus deformity of the right knee joint, and orthopedic shortening of the right lower limb—and the actions of the medical personnel. The plaintiff's claims were partially satisfied, with the medical organization ordered to pay compensation for moral harm, compensation for treatment expenses, and a fine.

It should also be noted that compensation for harm caused to the life and (or) health of citizens does not exempt medical workers and pharmaceutical workers from being held liable in accordance with the legislation of the Russian Federation. In accordance with the Civil Code of the Russian Federation, liability is provided in the form of compensation for moral harm; under the Labor Code of the Russian Federation, liability is provided in the form of disciplinary sanctions. Liability is also provided for by the Code of Administrative Offenses and the Criminal Code of the Russian Federation in the form of administrative and criminal liability.

Compensation for harm due to the use of medicinal products and medical devices is a compensatory measure for protecting patient rights in cases involving harm to the health and life of patients.

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References

[1] Decree of the Government of the Russian Federation No. 522 dated August 17, 2007, On the Approval of the Rules for Determining the Severity of Harm Caused to Human Health.

[2] Resolution of the Plenum of the Supreme Court of the Russian Federation No. 1 dated January 26, 2010, On the Application by Courts of Civil Legislation Regulating Relations on Obligations due to the Causation of Harm to the Life or Health of a Citizen.

[3] Paragraph 1 of Article 96 of the Law No. 323-FZ.

[4] Paragraph 2 of Article 1 of the Law No. 61-FZ.

[5] Paragraph 5.1.2.3 of the Regulations on the Federal Service for Surveillance in Healthcare, approved by Decree of the Government of the Russian Federation No. 323 dated June 30, 2004.

[6] Ibid., paragraph 5.1.4.3.

[7] Order of the Ministry of Health of Russia No. 724n dated September 21, 2016, On the Approval of Requirements for the Instructions for the Medical Use of Medicinal Products.

[8] Paragraph 3 of Article 64 of the Law No. 61-FZ.

[9] Ibid., paragraph 52.1 of Article 4.

[10] Order of Roszdravnadzor No. 1071 dated February 15, 2017, On the Approval of the Procedure for Performing Pharmacovigilance.

[11] Ruling of the Eighth Cassation Court of General Jurisdiction No. 88-8055/2021 dated May 13, 2021, in case No. 2-108/2020.

[12] Order of the Ministry of Health and Social Development of Russia No. 706n dated August 23, 2010, On the Approval of the Rules for the Storage of Medicinal Products.

[13] Order of the Ministry of Health of Russia No. 646n dated August 31, 2016, On the Approval of the Rules of Good Practice for the Storage and Transportation of Medicinal Products for Medical Use.

[14] Decision of the Arbitration Court of the Irkutsk Region dated December 12, 2018, in case No. A19-24481/18.

[15] Paragraph 4 of Article 44 of the Law No. 61-FZ.

[16] Decision of the Novocherkassk City Court of the Rostov Region dated September 02, 2021, in case No. 12-720/2021.

[17] Decision of the Board of the Eurasian Economic Commission No. 47 dated April 03, 2018, On the Classifier of Types of Adverse Events Associated with the Use of Medical Devices.

[18] Resolution of the Georgiyevsk City Court of the Stavropol Territory dated August 13, 2013, in case No. 5-319/13.

[19] Decision of the Krasnoperekopsky District Court of Yaroslavl No. 2-94/2017 dated July 19, 2017.

[20] Decision of the Yaroslavl Regional Court dated April 08, 2016, in case No. 30-2-272/2016.

[21] Decision of the Sverdlovsk District Court of Irkutsk No. 2-27/2020(2-3673/2019;)~M-3160/2019 dated May 15, 2020.

[22] Decision of the Arsenyev City Court of the Primorsky Territory dated December 26, 2011.

[23] Decision No. 2-1047/2019 dated December 13, 2019, in case No. 2-1047/2019.

[24] Decision of the Kirovsky District Court of Omsk dated December 02, 2016, in case No. 2-6227/2016~M-6289/2016.

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