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.
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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.
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.
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.
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.
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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Camp Lejeune’s water contamination issue spanned several decades starting in the 1950s. Exposure to these chemicals has been linked to various serious health issues, including cancer, organ diseases, and death.
Research is increasingly suggesting a link between the use of Tylenol during pregnancy and the development of neurodevelopmental disorders, such as autism and ADHD, in infants.
Legal action is being taken against manufacturers of Aqueous Film-Forming Foam (AFFF), a chemical used in fighting fires. The plaintiffs allege that exposure to the foam caused health issues such as cancer, organ damage, and birth and fertility issues.
Here, at TruLaw, we’re committed to helping victims get the justice they deserve.
Alongside our partner law firms, we have successfully collected over $3 Billion in verdicts and settlements on behalf of injured individuals.
Would you like our help?
Austin, Kentucky-based Kenny’s Farmhouse Cheese has recalled batch 231129 of its St. Jerome cheese after routine testing conducted by the Kentucky Department of Public Health showed the organism Listeria monocytogenes to be present in a single package, reports the FDA. While healthy people infected with
East Windsor, New Jersey-based Aurobindo Pharma USA, Inc. has recalled a single lot of Healthy Living Migraine Relief, Acetaminophen 250mg, Aspirin (NSAID) 250mg & Caffeine 65mg tablets on behalf of AuroHealth because the product does not have a manufacturer label, reports the FDA. The voluntary,
Indio, California-based Stutz Packing Company has recalled its 1-pound bags of shelled walnuts because a potential Listeria monocytogenes contamination has been identified in the product, reports the FDA. While healthy people infected with the organism may only experience short-lived symptoms like “high fever, severe headache,