Medtronic SynchroMed II Litigation Moves Forward

Written By:
Jessie Paluch
Jessie Paluch

Attorney Jessie Paluch, founder of TruLaw, has over 25 years of experience as a personal injury and mass tort attorney, and previously worked as an international tax attorney at Deloitte. Jessie collaborates with attorneys nationwide — enabling her to share reliable, up-to-date legal information with our readers.

This article has been written and reviewed for legal accuracy and clarity by the team of writers and legal experts at TruLaw and is as accurate as possible. This content should not be taken as legal advice from an attorney. If you would like to learn more about our owner and experienced injury lawyer, Jessie Paluch, you can do so here.

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Medtronic SynchroMed II Litigation Moves Forward

Lawsuits against the Medtronic SynchroMed II Infusion pump, initially approved by the U.S. Food and Drug Administration’s controversial Pre-Market Approval (PMA) program, have successfully survived a preemption challenge and cases continue to move forward in California and Pennsylvania.

Medtronic pain pump

Over the past several years, the Medtronic SynchroMed II Infusion Pump line has been plagued with problems that have allegedly caused many users to suffer severe and potentially life-threatening health issues.

Table of Contents

What is the Medtronic SynchroMed II Infusion Pump?

The Medtronic SynchroMed II Infusion pump was designed to deliver bactofen and Morphine to intrathecial space in the spinal area of the body.

Originally approved for delivery of cancer and pain medication to the terminally ill, there have been multiple types of recalls and manufacturing violations affecting over 270,000 devices.

The failure of the device to comply with manufacturing and reporting regulations triggered a multi-agency complaint by the Department of Health and Human Services (DHHS), Department of Justice (DOJ), U.S. Attorneys Office (USAO) and the Food and Drug Administration (FDA).

A Minnesota District Court Judge signed a consent decree imposing a moratorium on the marketing and sale of the product last year.

Basis of the Consent Decree

The consent degree was based on Medtronic’s repeated failure to correct certain violations related to the manufacture of the Synchromed II Implantable Infusion Pump Systems.

The violations, determined on the grounds of quality control and manufacturing, were arrived at during 2006-2013 in the course of five FDA inspections at Medtronic’s Minnesota plant, which resulted in three warning letters issued to Medtronic.

The consent decree will remain in effect until the FDA is convinced that Medtronic has met all the provisions of the decree, and once the company receives a go-ahead from the agency, it can resume the designing, manufacture, and distribution of the product, although it must submit to at least two years of continued oversight so that the FDA can verify that the company remains in compliance.

Written By:
Jessie Paluch
Jessie Paluch

Experienced Attorney & Legal SaaS CEO

With over 25 years of legal experience, Jessie is an Illinois lawyer, a CPA, and a mother of three.  She spent the first decade of her career working as an international tax attorney at Deloitte.

In 2009, Jessie co-founded her own law firm with her husband – which has scaled to over 30 employees since its conception.

In 2016, Jessie founded TruLaw, which allows her to collaborate with attorneys and legal experts across the United States on a daily basis. This hypervaluable network of experts is what enables her to share reliable legal information with her readers!

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