The Cost of Medical Device Settlements

by | Mar 29, 2021 | Cost, FDA, Medical Devices, Quality, Settlement

Medical devices are made to save lives; but what happens if these devices cause more harm than good? There can be varying consequences, typically dependent upon the size of the organization. If there is a life-threatening or serious issue with a medical device product from a smaller organization, they will typically have to pull their products from the market and may not survive the incident. Industry giants that have products that cause serious health hazards will usually resort to legal settlements or paying money to victims. Neither situation is ideal, so medical device manufacturers should fully understand the risks of their products and mitigate them to the best of their ability.

In recent news, Boston Scientific just announced it will pay $188.6 million to 47 states to settle allegations around its transvaginal surgical mesh devices.1 This settlement stems from claims from the state of California that Boston Scientific failed to disclose serious risks with the devices, which included health hazards such as infection and incontinence. Boston Scientific is just the most recent firm to be forced to pay out large settlement fees; just last year, Johnson & Johnson paid out $344 million for similar deceptive marketing of mesh devices.2

Nobody wants to pay out millions of dollars to settle claims against their product, and for many organizations that are not the size of Boston Scientific or J&J, there are more permanent consequences if their devices are found to present serious health risks. So how do you prevent this situation from ever occurring in the first place? The best piece of advice I can give is to pay very serious attention to risk management. Medical device manufacturers should focus a lot of attention on robust risk management, and subsequently provide exceedingly sufficient labeling and documentation to identify any risks that cannot be fully mitigated.

Additionally, all the regulatory requirements in 21 CFR 820, and the requirements outlined in standards such as ISO 13485 & ISO 14971, are intended to prevent any dangerous situations to patients or users of medical devices. Each requirement is important and should be fully implemented to prevent serious injury or death. We have helped several clients implement, maintain, and optimize their quality systems to ensure compliance with all regulatory requirements. If you need help understanding how to implement critical processes such as design controls or risk management for your medical device, EMMA International is here for you! Call us at 248-987-4497 or email info@emmainternational.com to find out more.


1California DOJ (March 2021) California Department of Justice Announces $188.6 Million Multistate Settlement with Medical Device Manufacturer Boston Scientific Corporation, retrieved on 03/28/2021 from: https://oag.ca.gov/news/press-releases/california-department-justice-announces-1886-million-multistate-settlement

2Rachal, M (Jan 2020) J&J hit with $344M verdict in California pelvic mesh trial, retrieved on 03/28/2021 from: https://www.medtechdive.com/news/jj-hit-with-344m-verdict-in-california-pelvic-mesh-trial/571474/

Madison Wheeler

Madison Wheeler

Director of Technical Operations - Ms. Wheeler serves as EMMA International’s Director of Technical Operations. She has experience in technical writing, nonconforming product management, issue evaluations, and implementing corrective and preventative actions in the pharmaceuticals and medical device industries. She has experience cross-functionally between R&D, lean manufacturing operations, and RA compliance. Ms. Wheeler also has academic and work experience with human health-risk engineering controls, physiological biophysics, and clinical research. Ms. Wheeler holds a Bachelor of Science in Biosystems Engineering with a concentration in Biomedical Engineering from Michigan State University. She is also a Certified Quality Auditor (CQA), and is currently pursuing her M.S. in Quality Management.

More Resources

De Novo Classification

De Novo Classification

A device can be registered for the De Novo pathway if there is evidence of the safety and effectiveness of the device and there is not a previously legally marketed predicate device1. When determining if your device can go through the De Novo process there are two pathways available to determine the device classification.
Abbreviated 510k submission

Abbreviated 510k submission

There are three types of 510K, Premarket Notifications, which can be submitted to the Food and Drug Administration (FDA) traditional, abbreviated, and special. Abbreviated and Special 510K submissions can be utilized when the submissions meet the certain factors presented by the FDA. When submitting an abbreviated 510K the submission must include the elements that are identified in 21CFR 807.87 for the information required in a premarket notification submission.
Is your product a medical device?

Is your product a medical device?

Many marketed products are classified as medical devices and you would not even know it. Medical devices range from latex gloves and tongue depressors to respirators and heart valves. To determine if the product is considered a medical device by the Food and Drug Administration (FDA) you will need to analyze if your product meets the definition of a medical device per the Food, Drug, and Cosmetic Act1.

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