Yes, you may be able to sue for spinal cord injuries caused by faulty equipment. State product liability laws hold manufacturers, distributors, and even retailers strictly liable if a device is defective and causes harm. This applies to a wide range of products, from a medical implant like a spinal cord stimulator (SCS) to a piece of industrial machinery.
Unlike a medical malpractice claim, your injury may have nothing to do with a doctor's error. If a device's battery overheats and damages your nerves, a lead wire migrates because of a poor design, or a safety guard on a machine fails, the legal responsibility typically shifts to the product's creator. The core of the case becomes the product's failure, not the user's or a doctor's actions.
These cases are notoriously difficult without legal assistance. Manufacturers have significant resources and frequently argue that an injury was simply a known complication, a result of the patient's unique physiology, or user error. They might point to the consent forms you signed as proof that you accepted the risks.
However, the law and the data provide a path forward. A claim for a neurological deficit, such as paralysis or nerve damage, is statistically more likely to result in a verdict for the injured person than other types of claims. The compensation pursued in these cases is substantial because it must cover a lifetime of medical costs, which could easily exceed $1.2 million for a spinal cord injury. Our practice focuses on the technical and engineering failures of a device to build a case for the financial resources you need for your recovery.
If a device failure caused your spinal cord injury, call us. We provide a free consultation to discuss your situation with no obligation to hire our firm.
Key Takeaways for Spinal Cord Injury Claims From Faulty Equipment
- A defective product can make the manufacturer strictly liable. This means you may not need to prove they were careless, only that the product had a dangerous defect that caused your injury.
- Spinal cord stimulators (SCS) are a major source of these injuries. Widespread recalls and high complication rates for devices from major manufacturers like Abbott and Medtronic often form the basis of these lawsuits.
- Preserving the faulty device is the most important step. Do not let the hospital or manufacturer take possession of an explanted medical device or a failed piece of machinery, as it is the central piece of evidence for your claim.
Understanding Product Liability in Spinal Cord Injury Cases
When you think of a personal injury lawsuit, you might assume you have to prove someone was careless—like a driver who ran a red light. That concept is called negligence. But when it comes to faulty equipment, the law uses a different standard: strict liability.
Simply put, strict liability means you do not have to prove the manufacturer was sloppy or cut corners. You only need to prove that the product had an unreasonably dangerous defect that caused your injury when it left the manufacturer's control.
This legal principle exists because consumers cannot be expected to test every product for hidden dangers. The responsibility rests with the company that profits from selling it.
Product defects generally fall into one of three categories:
- Design Defects: The problem is with the entire product line. The design itself is inherently flawed, making every single unit potentially dangerous. An example would be a spinal cord stimulator lead that, due to its shape and materials, is prone to fracturing and migrating near the spinal cord.
- Manufacturing Defects: The design was safe, but something went wrong during production. This error made your specific unit dangerous. Think of a device's battery that was improperly sealed at the factory, allowing it to short out and burn surrounding tissue.
- Failure to Warn (or Marketing Defects): The manufacturer knew about a specific risk but failed to provide adequate warnings or instructions to the doctor or the end user. For example, if a medical device is incompatible with MRI scans and the manufacturer fails to make that danger clear, they may be held liable for injuries that result.
The failure to warn issue is particularly relevant for medical devices. Some manufacturers get their products on the market through an accelerated FDA 510(k) clearance process by claiming their device is substantially equivalent to one already approved.
However, if they fail to disclose high complication rates discovered after the product is launched, their initial clearance may not protect them from liability. A spinal cord injury lawyer with experience in this area can investigate whether the manufacturer was transparent about the risks they uncovered.
High-Risk Medical Devices: The Spinal Cord Stimulator (SCS) Crisis
While any piece of faulty equipment, from a factory hoist to a piece of gym equipment, could cause a devastating spinal cord injury, implantable medical devices have become a significant source of product liability litigation. Spinal Cord Stimulators (SCS) are at the center of this crisis.
These devices are intended to relieve chronic pain, but they have been linked to a troubling number of injuries. FDA data has flagged more than 80,000 injuries related to SCS devices since 2008. Some studies report that these implants have a complication rate as high as 30-40%, forcing many patients to undergo painful revision surgeries.
Recent manufacturer recalls highlight the specific dangers:
- Abbott issued a Class I recall for over 155,000 Proclaim™ and Infinity™ SCS generators because a Bluetooth connection failure could prevent a doctor from turning the therapy off, which is sometimes necessary before an MRI.
- Boston Scientific has faced recalls related to battery failures that can cause the device to overheat.
- Medtronic has also dealt with recalls concerning battery and software issues that could lead to unexpected shocks or loss of therapy.
Common Mechanical Failures Leading to Injury
Some of the most common issues cited in lawsuits include:
- Battery and IPG Malfunction: The implantable pulse generator (IPG), or battery pack, is the device's engine. One study found that battery issues, such as overheating and delivering unexpected shocks, were involved in over 35% of malpractice cases related to SCS devices.
- Lead Migration: The thin wires, or leads, that deliver electrical pulses to the spinal cord can move from their original position. If they migrate and press against the spinal cord, they could cause compression, nerve damage, or even paralysis.
- Software Failures: The device's software is responsible for controlling the intensity of the stimulation. A glitch could cause sudden, powerful shocks that are intensely painful and could cause a patient to fall and suffer further injury.
Distinguishing Between Manufacturer Liability and Medical Malpractice
When a medical device injures a patient, the first question is usually: who is at fault? The manufacturer will almost certainly try to blame the surgeon for improper placement, while the surgeon's defense may be that the device itself failed.
This is where a legal concept known as the learned intermediary doctrine comes into play. The law states that a medical device manufacturer's duty is to warn the doctor, not the patient directly. The doctor, as the learned intermediary, is then responsible for weighing those risks and advising the patient.
This doctrine creates two primary legal pathways:
- If the manufacturer provided complete and accurate warnings to the doctor, and the doctor went ahead with the procedure leading to a foreseeable complication, the case may point toward medical malpractice.
- If the manufacturer did not adequately warn the doctor of a known defect or a high failure rate, the case points toward product liability.
Data shows that the device itself is frequently the focus. A comprehensive study of lawsuits related to SCS devices found that 64.44% of suits targeted the manufacturer, compared to just 35.56% that targeted the physician. This suggests that in the majority of injury cases, evidence points toward a failure of the product rather than the surgeon. The same study noted that claims involving neurological deficits, like paralysis, were more likely to result in a verdict for the plaintiff when compared to claims for issues like infection.
Determining the correct defendant affects how much compensation is available. Suing a manufacturer generally provides access to larger corporate insurance policies. Additionally, Florida law imposes caps on noneconomic damages in medical malpractice cases that may not apply in the same way to product liability claims. An attorney can help evaluate the evidence to determine the strongest and most appropriate legal strategy for your specific injury.
Steps to Take From Home After an Equipment Injury
What you do in the days and weeks after your injury could have a significant impact on your ability to bring a successful claim. Once you are home from the hospital, your focus should be on preservation and documentation.
Preserve the Evidence
If the faulty device was explanted (removed from your body), you have a right to it. Do not let the hospital or the manufacturer take possession of it. That device is the primary piece of evidence in your case, and it needs to be preserved so your legal team can have it inspected by an independent expert. The same applies to a piece of machinery; ensure it is not repaired, altered, or discarded.
Document the Chain of Events
Your memory is a powerful tool. As soon as you are able, write down everything you can remember about how the failure occurred. Did the SCS device suddenly feel hot? Did the remote stop working? If it was industrial equipment, did it make an unusual sound right before it failed? No detail is too small.
Gather Your Medical and Device Records
Request copies of all your medical records related to the injury. For a medical implant, this should include the device logs, which may show performance data leading up to the failure. For workplace equipment, this would include any available maintenance logs.
Watch the Clock on the Statute of Limitations
Every state has a strict deadline for filing a personal injury lawsuit, known as the statute of limitations. In Florida, the statute of limitations for personal injury cases is generally two years from the date of the injury, and product liability claims follow the same timeline. While a discovery rule may extend this deadline if the defect was hidden, this area of law is complicated. Consulting with a personal injury attorney immediately is the only way to ensure your rights are protected.
Frequently Asked Questions About Faulty Equipment Injuries
Can I sue if I signed a consent form before surgery?
Yes. A consent form is an acknowledgment of known and properly disclosed medical risks associated with a procedure. It is not a waiver that allows a manufacturer to provide a defective product. You cannot consent to a device failing due to a design or manufacturing flaw.
What if the manufacturer has already recalled the device?
A recall does not protect a company from liability. In many cases, a recall serves as powerful evidence that the product was, in fact, defective and dangerous. It can strengthen your claim.
Do I have to join a class action lawsuit?
Not necessarily. For severe injuries like those involving the spinal cord, an individual lawsuit is almost always preferred. A class action lawsuit groups together many people with similar, often minor, injuries. Your damages—including lifelong paralysis, lost wages, and pain and suffering in personal injury case—are unique and likely far higher than what a standard class action settlement would provide.
Who pays my medical bills while the lawsuit is pending?
Initially, your own health insurance (or workers' compensation, if the injury happened at work) will typically cover your medical bills. If you receive a settlement or verdict, these insurers have a right to be reimbursed from those funds for what they paid out. This process is called subrogation.
Can I sue if the injury was caused by a gym machine or workplace hoist?
Yes. Product liability laws are not limited to medical devices. Any manufacturer of any product may be held liable if a flaw in its design or construction leads to a spinal cord injury. The same legal principles apply.
Don't Let a Manufacturer's Negligence Define Your Future
When a device designed to improve your life or a machine you trusted to be safe fails, the physical, emotional, and financial consequences are devastating. You should not have to pay for the financial consequences of a corporation's shortcut, design error, or failure to warn.
Let us review the details of what happened and outline a clear path forward. Call Holliday Karatinos Law Firm today to start the conversation.
James Wayne Holliday
James Wayne Holliday has been practicing law since 1995. He has been named as a “Best Attorney” Lifetime Charter Member in Florida, an honor awarded to less than one percent of the nation’s lawyers.
Mr. Holliday has earned a reputation as a relentless trial lawyer because of his outstanding work ethic and thorough preparation of his cases for trial.
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