Medical Device Failures in India — Determining the Liability

Introduction

Medical devices have become an integral part of modern healthcare, serving as critical tools in diagnosis, treatment, and patient management. From life-saving implants such as pacemakers and artificial joints to diagnostic tools like magnetic resonance imaging (MRI) machines and computed tomography (CT) scanners, the reliance on medical technology has significantly increased. However, this dependence also brings the risk of device failures, which can occur for various reasons. The legal framework governing such failures is complex, raising critical questions of liability involving manufacturers, hospitals, medical professionals, and insurers. It is, therefore, crucial for all stakeholders to be aware of their responsibilities and adopt preventive measures to mitigate liability.

This article examines how responsibility is determined based on the nature of the failure — whether due to manufacturing flaws, improper maintenance, lack of user training, or medical negligence. It explores the legal framework governing medical devices in India, including consumer protection laws, regulatory approvals, and criminal negligence provisions. Through key judicial precedents, it highlights how courts assess liability, particularly using the Bolam test for medical negligence. Finally, it discusses preventive measures that stakeholders can adopt to minimise legal risks and ensure patient safety.

Understanding liability in medical device failures

When a medical device fails and causes harm, the fundamental question that arises is: who is responsible?

The answer depends on the nature of the failure and the extent of negligence. In broad terms, liability may be attributed to three key parties: the manufacturer, the hospital, and the doctor.

Typically, the first party held accountable is the manufacturer, especially if the device has inherent defects. The Consumer Protection Act, 2019¹ enshrines product liability, meaning that manufacturers are responsible for any harm caused by defective products. These defects could stem from flaws in design, manufacturing errors, or inadequate instructions or warnings. In addition, the Medical Devices Rules, 2017² mandate that manufacturers obtain approval from the Central Drugs Standard Control Organisation (CDSCO) before marketing any device. If a device is introduced without proper certification or without undergoing necessary clinical trials, the manufacturer may be held liable.

However, while manufacturers bear primary responsibility for faulty devices, hospitals can also be held accountable. This is particularly the case when hospitals fail to ensure the proper handling, maintenance, and monitoring of the devices they use. Under the Clinical Establishments (Registration and Regulation) Act, 2010³ healthcare institutions are required to follow strict safety and quality standards, including performing routine servicing and adhering to manufacturer guidelines. If a hospital knowingly continues to use a faulty device or fails to properly train medical staff in handling specialised equipment, it may face legal action for deficiency in service.

Doctors and other healthcare providers play an equally important role in ensuring the safe use of medical devices. While they are generally not responsible for a device’s manufacturing defects, they can still be held liable if they fail to exercise due diligence when selecting, operating, or monitoring the device. Under Section 304-A of the Penal Code, 1860⁴ (now Section 106(1) of the Nyaya Sanhita, 2023) criminal negligence charges can be levied if the reckless or improper use of a device results in patient harm. However, simply making an error in judgment does not constitute criminal negligence unless it amounts to gross recklessness. To minimise liability, healthcare professionals should ensure they only use CDSCO-approved devices, obtain informed consent from patients, and keep detailed records of device usage and any complications that arise.

Legal framework governing medical device liability in India

The legal framework governing medical devices in India consists of multiple statutes, regulations, and ethical guidelines that collectively regulate the manufacturing, sale, usage, and accountability of medical devices. Medical devices come under the ambit of the Consumer Protection Act, 2019 (CPA) and the Medical Device Rules, 2017 (MDR) which are framed under the parent legislation, the Drugs and Cosmetics Act, 1940⁵ (DCA).

(1) Consumer Protection Act, 2019: This law provides patients with the right to seek compensation for defective medical devices under the concept of product liability. Affected patients can file complaints before consumer forums at district, State, and national levels, holding manufacturers, sellers, and service providers accountable.

(2) Penal Code, 1860⁶ (now, Nyaya Sanhita, 2023⁷): The IPC lays down provisions for criminal negligence under Sections 304-A (causing death by negligence)⁸, 336⁹ (act endangering life or personal safety)¹⁰, 337¹¹ (causing hurt by an act endangering life)¹², and 338¹³ (causing grievous hurt by an act endangering life)¹⁴. A medical professional or hospital may be prosecuted if recklessness in handling a device leads to patient harm or fatality.

(3) Drugs and Cosmetics Act, 1940: These laws regulate the approval, import, sale, and clinical evaluation of medical devices in India. The definition of drugs in the DCA includes medical devices as its sub-set with effect from 1-4-2020 as the Government vide Notification dated 31-3-2020 has announced that all medical devices shall be regulated by the Government as drugs for quality control and price monitoring¹⁵ and the same was upheld by the Delhi High Court¹⁶ and subsequently the Supreme Court also declined to interfere with this decision of the Delhi High Court.¹⁷ The CDSCO oversees the certification of medical devices and ensures compliance with safety standards. Non-adherence to regulatory requirements can result in the seizure of devices, monetary penalties, and criminal prosecution. It criminalises the import, manufacture, and sale of medical devices which are: (i) not of standard quality; (ii) adulterated, misbranded, or spurious; and (iii) otherwise prohibited under law. In the event the abovementioned provisions are violated, the manufacturer or importer of the medical device, as the case may be, would be held liable.

(4) Medical Devices Rules, 2017: These rules lay down certain principles, standards, and regulatory framework that needs to be conformed with for the manufacturing of medical devices and the penal actions that can be taken by the CDSCO or State licensing authorities (SLAs) in case the manufacturers do not conform to the guidelines.¹⁸

(5) Essential principles for safety and performance of medical device Guidelines released on 19-4-2018¹⁹ lays guidelines differentially for all medical devices except medical devices with in vitro diagnostic (IVD). These essential principles encompass manufacturing, design, performance, usage, and evaluation guidelines for all the medical guidelines.

(6) Guidance on performance evaluation of in vitro diagnostic medical devices was also notified by the Government regarding submission of performance evaluation report by the applicant to the State licensing authority or Central licence authority. The performance evaluation has to be undertaken by the laboratories mentioned in the guidance document.²⁰

(7) Clinical Establishments (Registration and Regulation) Act, 2010: This law mandates hospitals and healthcare facilities to comply with prescribed standards for medical equipment maintenance and service quality. Failure to follow these regulations can result in penalties, cancellation of registration, or liability claims under consumer protection laws.

(8) Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002²¹: These regulations outline the professional responsibilities of doctors, including their duty to ensure safe and ethical medical practices. A violation can result in disciplinary action by the Medical Council of India (now under the National Medical Commission).

(9) Materiovigilance programme of India (MvPI): This initiative by CDSCO aims to monitor and evaluate adverse events related to medical devices. Healthcare professionals and manufacturers are encouraged to report device failures to enhance patient safety and improve regulatory oversight.

(10) The Legal Metrology Act, 2009²²: This law applies to medical devices that are sold based on weight, volume, or number, ensuring they meet labelling and quality requirements.

Standard of care and liability in medical negligence: Judicial perspectives in India

Indian courts have consistently relied on the Bolam test, established in Bolam v. Friern Hospital Management Committee²³ to determine the standard of care expected from medical practitioners.²⁴ Under this test, a doctor is not considered negligent if their actions align with a practice accepted as proper by a responsible body of medical professionals, even if other experts hold a differing opinion.²⁵

However, the Bolam principle does not grant absolute immunity. A doctor may choose a procedure with a higher degree of risk if they genuinely believe it offers a better chance of success compared to a safer alternative.²⁶ If the treatment does not yield the desired result, this alone does not constitute negligence. That said, where a medical professional’s actions are found to be unreasonable, they cannot escape liability merely by citing professional opinion in their defence.²⁷

The Supreme Court has reinforced this standard by holding hospitals accountable for failing to adhere to established medical protocols. In one instance, a hospital was found negligent for not monitoring a patient’s critical parameters, violating guidelines issued by the World Health Organisation (WHO) and the Directorate of National Vector Borne Diseases Control Programme (DNVBDCP).²⁸ The Court ruled that such non-compliance amounted to a breach of reasonable care. Similarly, medical practitioners who disregard standardised guidelines may be deemed negligent under the Bolam principle. However, patients alleging negligence due to medical equipment failure must provide substantive proof — mere claims are insufficient to establish liability.²⁹

The role of medical equipment maintenance and liability has also been a subject of judicial scrutiny. The National Consumer Disputes Redressal Commission (NCDRC) has clarified that the liability of manufacturers depends on factors such as the existence of Annual Maintenance Contracts (AMCs) and whether the defect is inherent. For example, in a case involving an interferential therapy (IFT) machine used in physiotherapy, the manufacturer was absolved of liability because the device’s warranty had expired, and no Annual Maintenance Contract (AMC) was in place. Instead, the hospital and physiotherapist were held responsible.³⁰

Conversely, manufacturers have been held liable where defects in medical equipment were evident. In one instance, a patient received an intraocular lens that was later found to be opaque and ineffective, requiring corrective surgery. The NCDRC held the manufacturer accountable for supplying a defective product. Additionally, the Court emphasised the surgeon’s duty to verify the quality and suitability of the lens before implantation. The surgeon’s failure to do so amounted to contributory negligence, reinforcing the principle that medical professionals must exercise due diligence when relying on medical devices.³¹

Preventive measures to mitigate liability

Given the complexities of medical device failures, all stakeholders — manufacturers, hospitals, and medical professionals — must take proactive steps to minimise risks and ensure patient safety.

Manufacturers must implement strict quality control measures, conduct thorough testing, and comply with the Medical Devices Rules, 2017. There is a need for providing clearer usage instructions and warnings, actively monitor devices after they enter the market, and establish recall mechanisms for defective products. Securing product liability insurance can also help protect against financial risks in case of litigation. Additionally, regulatory oversight by the Central Drugs Standard Control Organisation (CDSCO) plays a crucial role in ensuring medical devices meet safety standards. Manufacturers should actively engage with CDSCO Guidelines and reporting mechanisms to enhance compliance and avoid legal pitfalls.

Hospitals play a crucial role in device management and must ensure regular inspections, servicing, and compliance with manufacturer guidelines, as failure to do so could expose them to liability. They should implement a standardised monitoring system for tracking device performance and addressing technical issues promptly. Further, staff should be thoroughly trained in the safe handling and operation of medical equipment, with periodic refresher courses to prevent errors. Hospitals should establish well-defined contractual agreements with manufacturers that clearly allocate liability in the event of device malfunctions, ensuring legal accountability is pre-established. Additionally, proper documentation of device maintenance and patient interactions can serve as critical evidence in legal disputes.

Doctors and medical professionals must use only approved, well-maintained devices and exercise caution when operating them. They should closely monitor patients for any device-related complications and promptly report adverse events to the Materiovigilance Programme of India (MvPI). Obtaining professional indemnity insurance can further safeguard them from potential legal claims. As medical devices increasingly incorporate artificial intelligence (AI) and software-driven mechanisms, medical professionals must also stay informed about potential risks associated with algorithmic errors or cybersecurity threats, particularly in robotic-assisted surgeries and digital diagnostic tools.

Conclusion

Medical device failures raise complex legal and ethical questions, requiring a multi-faceted approach to liability prevention, making it essential for all stakeholders to take proactive measures to ensure patient safety and reduce liability risks. Strict quality control, regular maintenance, comprehensive staff training, and adherence to regulatory guidelines are essential to prevent harm. As the healthcare industry evolves with technological advancements, such as AI-driven devices and cybersecurity concerns, it is crucial for all stakeholders to stay vigilant and adapt to emerging challenges. By fostering a culture of accountability and compliance, the healthcare system can better protect patients and mitigate legal risks.