Law Firm Vs. Medical Device Company: Who Wins?

Medical device manufacturing companies are responsible for ensuring the devices they produce are safe for patients to use. If a device causes injury, a law firm can help victims pursue a claim for compensation. Law firms with experience in this area can help victims of defective medical devices receive the support and resources they need from the companies that injured them. They can also help companies get their products approved by the relevant authorities, such as the Food and Drug Administration (FDA) in the US.

Medical device defects and liability

Medical devices range from simple tongue depressors and bedpans to complex programmable pacemakers with microchip technology and laser surgical devices. In vitro diagnostic products, such as lab equipment and test kits, are also considered medical devices.

Medical device manufacturing companies are responsible for ensuring the devices they produce are safe for patient use. If a company withholds any information regarding potential risks, it can be held liable for negligence. There are three types of defects that may occur: design defect, manufacturing defect, and marketing defect. A design defect is when there is an actual flaw in the design. A manufacturing defect occurs during the production of a device and may not affect all units. If a medical device company advertises a device for improper use, it is known as a marketing defect. Any of these defects can make a medical device unreasonably dangerous.

If a defective medical device causes injury, the injured party can file a lawsuit against both the manufacturer and the medical provider. Under strict product liability claims, medical devices must be free from any defects. The plaintiff must prove that the defective device caused their injury. They must also prove that the defect existed in the product when it left the manufacturer's control and that it caused unreasonable danger.

In many situations, the plaintiff will need to show that there was a safer alternative design possible that would not have imposed a much greater cost. A plaintiff may also need to prove negligence, for example, if a medical device is inherently dangerous or risky, the courts will not want to hold the manufacturer liable in all situations.

The Food and Drug Administration (FDA) regulates medical devices, and manufacturers must comply with FDA standards and practices. Evidence of compliance can bolster a defendant's claim that it is not liable for injuries. On the other hand, evidence of non-compliance with FDA regulations can help prove the plaintiff's case.

Regulatory challenges and compliance

The medical device industry is highly regulated, with companies facing a plethora of rules and regulations across all facets of their business. The regulatory landscape is complex and inconsistent across a wide range of functions, activities, and geographies. In addition, the industry is constantly evolving, with new devices and technologies being introduced to meet patient needs. This dynamic nature of the industry presents unique compliance challenges.

One of the key regulatory challenges faced by medical device companies is determining whether their product is subject to medical device regulation or if it falls under “general wellness” consumer products or non-medical mobile apps. With the advancements in technology, the line between what constitutes a medical device and a consumer product has become blurred. For instance, the FDA now considers mobile medical apps that function like medical devices to be subject to medical device regulations.

Another challenge is gaining market approval for new products and ensuring compliance with regulatory bodies. The process of obtaining approvals and certifications can be lengthy and complex, requiring companies to create and submit extensive reports and documentation. This includes conducting literature reviews, pre-market research, and collating clinical data to support the safety and efficacy of their devices. Failure to adequately prepare for these requirements can result in delays, fines, and loss of market access.

Furthermore, the medical device industry operates in a global marketplace, with companies facing regulatory requirements from multiple jurisdictions. Compliance requirements vary across different countries and regions, and companies must navigate the complexities of these varying standards. For example, companies need to comply with regulations from the European Union, Canada, the United States, and the International Organization for Standardization (ISO). The simultaneous implementation of new regulations from multiple jurisdictions can create a challenging environment for medical device companies.

To address these regulatory challenges and ensure compliance, medical device companies must adopt innovative strategies and remain agile. They need to invest significant time and resources into understanding and adhering to the applicable rules and regulations. By embracing complexity and staying abreast of regulatory changes, companies can turn compliance into a source of competitive advantage, leading to economic benefits and enhanced product quality and safety.

Product liability claims and compensation

If a person suffers an injury due to a defective medical device, they may be entitled to compensation. To establish a successful product liability claim, it must be shown that there was a defect in the product that made it unsafe, and that this defect caused the harm or injury. The harm must have occurred while using the device as it was intended to be used, i.e. in line with the instructions.

There are three types of defects that may occur: design defect, manufacturing defect, and marketing defect. A design defect is when there is an actual flaw in the design of the device. A manufacturing defect occurs during the production of the device and may only affect some units. A marketing defect occurs when safety risks or instructions for use are not properly outlined in the labelling materials, or when a device is advertised for improper use.

Defendants in a product liability case can include anyone in the "chain of distribution" of the device, from the manufacturer to the patient. This includes doctors who recommended the device, and retailers who supplied the device.

The goals of product liability include compensation for individuals, deterrence of unsafe products, and punishment of socially irresponsible firms. A Compensation Board could be established to receive injury claims and provide uniform, expeditious, and equitable awards.

Medical device registration and certificates

Medical device companies face a multitude of regulatory challenges. These include determining whether their product is subject to medical device regulation or simply classified as a "general wellness" consumer product or non-medical mobile app. Medical devices range from simple tongue depressors and bedpans to complex programmable pacemakers with microchip technology and laser surgical devices.

In the United States, the Food and Drug Administration (FDA) regulates medical devices. Owners or operators of establishments that are involved in the production and distribution of medical devices intended for use in the US are required to register annually with the FDA. This process is known as establishment registration (Title 21 CFR Part 807). The FDA does not issue any type of device registration certificates to medical device facilities. Instead, the purpose of registering and listing a medical device is to provide the FDA with the location of all facilities involved in the manufacture of a medical device, including what is being manufactured and where. This system ensures the FDA has the information it needs to respond to public health needs.

If a device requires a premarket submission before being marketed in the US, then the owner/operator should also provide the FDA premarket submission number (510(k), De Novo, PMA, PDP, or HDE). All registration and listing information must be submitted electronically, unless a waiver has been granted.

In the event of a defective medical device causing injury, a law firm can help take legal action against the manufacturing company and recover the compensation owed.

Medical device manufacturers' responsibilities

Medical device manufacturing companies are responsible for ensuring that the devices they produce are safe for patient use. They must also ensure that they are complying with the regulations set by the Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

In the United States, the FDA regulates medical devices, and companies must adhere to premarket notifications, establishment registration, device listing, quality systems, labelling, and reporting requirements. The FDA also requires that drug and medical device manufacturers disclose any payments made for the benefit of physicians regarding drugs or devices. The FDA has also issued the Quality Management System Regulation (QMSR) Final Rule, which amends the current good manufacturing practice (CGMP) requirements of the Quality System (QS) regulation.

In the European Union, medical devices must undergo a conformity assessment to demonstrate that they meet legal requirements to ensure they are safe and perform as intended. The conformity assessment usually involves an audit of the manufacturer's quality system and a review of technical documentation on the safety and performance of the device. Manufacturers can place a CE (Conformité Européenne) mark on a device once it has passed this assessment. The CE marking indicates that the device has undergone the necessary checks and meets the required standards.

Manufacturers must also be aware of potential defects in their devices, including design defects, manufacturing defects, and marketing defects. A design defect refers to an actual flaw in the design of the device, while a manufacturing defect occurs during the production process and may not affect all units. Marketing defects happen when safety risks or instructions for use are not properly outlined in the labelling materials or when a company advertises a device for improper use. These defects can make a medical device unreasonably dangerous, and manufacturers can be held liable for any damages caused, even without proof of negligence or fault.

Overall, medical device manufacturers have a crucial responsibility to ensure the safety and effectiveness of their products through regulatory compliance, defect prevention, and proper labelling and instructions. By doing so, they can help protect people's health and well-being.

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