Medtronic Deep Brain Stimulation (DBS) Lawsuit Claims Device Caused Permanent Neurological Injury

Lawsuit claims Medtronic should have known the DBS components may degrade in the body, leading to “irreversible harm.”

A Maryland woman has filed a lawsuit claiming that she received a defective Deep Brain Stimulation (DBS) implant, which could not be fully removed from her body after the components began to degrade, resulting in ongoing neurological decline, infections and other complications.

The complaint (PDF) was brought by Katie Merkle in the U.S. District Court for the District of Maryland on November 14, naming Medtronic Inc. as the sole defendant. Merkle’s lawsuit was filed pro se, meaning she has not retained an attorney and is choosing to represent herself.

The Medtronic Deep Brain Stimulation device named in Merkle’s complaint is an implanted system that delivers controlled electrical pulses to targeted areas of the brain to help manage certain neurological disorders. The system consists of a battery-powered generator placed under the skin in the chest, thin electrodes implanted in the brain, and a wire that connects the components. 

This type of therapy is commonly used to treat movement disorders, such as Parkinson’s disease and essential tremor, and it can also be an option for some patients with epilepsy or obsessive-compulsive disorder.

In Merkle’s case, the device was used to treat Myoclonus-Dystonia (DYT11), a genetic movement disorder she was diagnosed with as a child. DYT11 causes sudden muscle jerks and episodes of muscle tightening due to mutations in the SGCE gene, which can be passed to a child if one parent carries the altered gene. Symptoms often begin in childhood or adolescence, and many patients also experience related mental health challenges such as anxiety and depression.

According to her lawsuit, Merkle was originally implanted with a Medtronic DBS system in 2005, consisting of a Model 3387 intracranial electrode lead, a subcutaneous extension wire, and an implantable pulse generator (IPG) that was placed in the chest wall. Merkle was also provided with an external controller to turn the unit on and off.

Merkle claims the only component intended for periodic replacement was the IPG, which requires occasional battery changes to deliver electrical stimulation through the leads made of platinum-iridium contacts within a polyurethane body and fluoropolymer insulation.

The complaint indicates that Merkle chose the DBS system based on the manufacturer’s claims that it was a reversible and removable alternative to other neurosurgical procedures. She contends those assurances were unsupported by long-term data and conflicted with information the company already had when the device was implanted.

In particular, Merkle says that the fluoropolymer sheaths were susceptible to breaking down into component plastics, including dangerous per- and polyfluoroalkyl substances (PFAS), which have been known to cause cancers and other health problems among individuals exposed to them.

Furthermore, the claim states that the platinum-iridium leads present additional problems, since they too are subject to breaking down in the body and releasing platinum ions and other micro-particulates into neural structures, which can activate microglia, inflammatory symptoms and other stressors on surrounding neurons.

She alleges that prior device failures, toxicological literature and regulatory findings should have alerted Medtronic that the insulation and metal components were prone to degrading inside the human body before the device was ever implanted in her.

“Device degradation was never disclosed by Defendant to inform patient or provider decision-making. While Plaintiff raised concerns, her physicians appeared to lack both the diagnostic tools and the manufacturer-supplied information necessary to link her symptoms ot device failure or to justify explant.”

— Katie Merkle v. Medtronic Inc.

Starting in 2011, Merkle says she began experiencing worsening fatigue and unusual stimulation side effects that included mild fine motor issues on her left side. By 2017, she claims she kept the device turned off, having steadily experienced increasing left-side weakness and emerging cognitive decline in the six years leading up to that period. 

However, when the procedure was performed in 2022, doctors discovered that the intracranial lead had disintegrated inside her brain, leaving permanent fragments and byproducts that cannot be retrieved or located with MRI because the retained material makes the scan unsafe.

To illustrate her point, Merkle indicates that an infection occurred earlier this year at the site of one of the fragments that was unable to be removed during the 2022 procedure.

Merkle raises allegations of strict liability/negligence — failure to warn, fraudulent concealment/misrepresentation, breach of express warranty, prenatal and developmental injury, violation of the Maryland Consumer Protection Act, punitive damages, negligent design, strict liability design, misbranding/false or misleading labeling, failure to report adverse events, failure to update labeling with newly acquired information, and negligent training and failure to educate physicians.

She is seeking compensatory, special, statutory and punitive damages.

Spinal Cord Stimulator Lawsuits

Merkle’s complaint is not the only stimulation device lawsuit Medtronic currently faces.

In April, a separate complaint was filed after a Medtronic Spinal Cord Stimulator worsened a patient’s pain. Spinal cord stimulators (SCS) are implantable neuromodulation devices that send mild electrical pulses to the spinal cord to disrupt pain signals before they reach the brain.

According to that lawsuit, hundreds of design changes and functional upgrades over the years dramatically altered the SCS device’s safety profile and therapeutic mechanism, yet the U.S. Food and Drug Administration (FDA) never required Medtronic to seek new approval or conduct updated clinical trials, allowing substantially modified devices to enter the market under the original 1984 approval.

A similar lawsuit was filed over a Boston Scientific Spinal Cord Stimulator, alleging that the FDA failed to properly evaluate later versions of the device. The complaint claims that these significantly modified models were cleared under the original 2004 approval, leading a Virginia man to experience worsening symptoms and multiple surgeries.

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