Medical device companies have many tools available to prevent injuries and another one was introduced last month.
At KBA Attorneys, we have been litigating medical devices cases for decades. One of the attorneys at KBA worked at the Food And Drug Administration (FDA) and all of us have litigated medical device lawsuits. We are passionate about these cases because they involve complicated relationships between engineering, science, medicine, law, FDA regulations and other industry standards. The common issue is – what risks did the device present to patients and how did the company address those risks?
To encourage proper risk management, the FDA implemented regulations that require medical device companies to monitor their products to identify potential risks. These regulations require medical device companies to investigate risks and to report adverse events caused by their products. To accomplish these goals, medical device companies have lots of tools at their disposal.
First and foremost, there are industry standards. This includes the FDA’s regulations, as well as guidance documents created to ensure quality standards, and prior decisions. It also includes standards that other organizations publish, like the International Organization for Standardization (“ISO”).
ISO has a standard, ISO 13485, that sets forth Quality Management System Requirements. It is a comprehensive system for the design and manufacture of medical devices. There are many tools to help companies ensure compliance with FDA’s regulations and industry standards including ISO 13485.
Last month another tool was made available to the medical device industry. NSF, a public health organization, published a whitepaper (an authoritative report), US FDA System Regulation vs. ISO 13485: 2016 Quality Management System Requirements, to help the medical industry. It presents a table comparing FDA to ISO 13485. “This tool clarifies the corresponding relationships between the US FDA Quality System Regulation and ISO 13485:2016 – Medical devices – Quality management systems – Requirements for regulatory purposes clauses.” [Robert Ruff and Samuel Brown, NSF INTERNATIONAL 21 CFR § 820 &
ISO 13485:2016 ALIGNMENT CHART]
In addition to published materials like this new one, there are conferences, an army of consultants, software, and many other resources available to medical device companies. There is no excuse for device failures that go unchecked.
As attorneys, we are often busy litigating against medical device companies because they fail to do what they’re supposed to do. We bring medical device lawsuits when people get hurt because a company failed to study potential risks and failed to control those risks through design changes or labeling changes.
Most of the time, the cases we take do not involve mere mistakes, an honest, accidental human oversight. We’re all human, we make mistakes too. The law allows for some reasonable margin of error. The cases we have litigated involve egregious, bad conduct like companies keeping the truth about serious risks from doctors and patients, companies creating “fake news” via dishonest data or ghostwritten studies, and companies destroying evidence of risks to patients.
Companies like this fight back hard. They stand to lose millions and employ excellent lawyers from top-notch firms to litigate for many years. It takes a lot of time, resources, and knowledge from experience to secure a recovery for clients.
We at KBA have been fortunate enough to have success doing this for many years and will continue suing medical device companies until they adhere to industry standards and keep patients safe. If you or a loved one has been hurt due to a faulty medical device, contact us now.
Justin Browne, Esq
Partner