Can I Sue for an Infection After an Endoscopy? Olympus Scope Lawsuits and Liability Explained

An infection occurred a few days after an endoscopy. The patient was admitted to the hospital, treated with intravenous antibiotic therapy, and eventually learned that the medical facility was investigating potential equipment-related contamination.

Who was at fault?

An equipment design feature may complicate cleaning. An incompatible method of reprocessing the equipment may be used. The accessory may not have been disassembled. Alternatively, the infection may have been caused by a completely different source.

In order to define who may be liable in a court of law, the cause of the injury has to be investigated. That’s where Morgan & Morgan comes in.

If you or a loved one have experienced adverse health effects after being treated with Olympus endoscopes and/or accessories, contact Morgan & Morgan for a free case evaluation to learn more about whether a contaminated device contributed to an illness and whether the resulting injuries could support a lawsuit.

When an Infection After Endoscopy Might Support a Legal Claim

Various complications may arise from a properly performed endoscopy and related procedures. Even when standard of care is observed by the treating physicians and healthcare personnel, injuries and complications may occur.

A legal claim may be pursued when it is demonstrated that an actionable defect or failure by the healthcare professionals caused the patient’s injury.

When dealing with surgical scopes suspected of containing contaminants, an investigation might look into the design of the scope, how it was serviced, what the scope manufacturer’s instructions were, and what procedures the healthcare facility followed.

A claim might be brought under product liability, medical malpractice, or other relevant legal theories.

Distinguishing between the various legal theories can impact the evidence that must be produced, who can be named as a defendant, and the time limits for bringing a claim.

Product Liability Claims Against Olympus

Manufacturers of medical devices have legal duties regarding the safety of products they make and sell.

There are multiple potential grounds for a product liability claim against Olympus.

Design Defects

Some designs of endoscopes contain narrow channels, recessed areas, and moving parts that can make it difficult to remove contaminants.

A design defect claim might be made on the basis that the endoscope design created an unreasonable risk of infection because it was not cleanable in reasonable foreseeable circumstances.

The scope of an investigation might include alternative design possibilities, risks that were known at the time, and the performance of the endoscope in its intended use.

The requirements of the law differ among the states.

Manufacturing Defects

A manufacturing defect occurs with a single component of a device or a single device itself.

For instance, if a component is manufactured so that it impedes the cleaning of the instrument or device, it can create an unreasonable risk of an infection.

Evidence can include inspection of the product, comparisons to specifications, and reviews of manufacturing records.

Generally, a plaintiff must prove that an alleged product defect caused the injury.

Failure to Warn

Also, manufacturers may be named in a failure to warn claim for inadequate instructions or warnings regarding a product’s foreseeable risks.

Certain instructions, especially with reusable medical devices, may alert users to clean, disassemble, and maintain the device and may advise on the device’s compatibility with a reprocessing system.

A claim may review if the manufacturer adequately provided a warning of the device’s potential risks. A failure to warn claim may consider if a manufacturer’s failure to provide adequate instructions could have resulted in an injury. 

When a Hospital or Surgical Center May Be Responsible

As with product liability claims, the evidence may show what happened to a medical device between patient surgeries.

Reusable medical devices should undergo the appropriate cleaning and disinfecting or sterilization processes, as determined by the device’s intended use.

A Healthcare facility should implement and enforce appropriate procedures and policies to train its personnel on the safe use and reprocessing of devices.

A hospital may be liable for failing to implement the most current instructions for use.

Establishing malpractice typically requires expert testimony and evidence to prove that the standard of care owed to the patient was breached and that the patient’s injuries were caused by that breach.

Not every failure to follow a device manufacturer’s instructions for use constitutes malpractice, and what constitutes malpractice is generally determined by a state’s malpractice laws.

Can both the manufacturer and hospital be liable?

Yes, they can be liable based on the law and the facts of the case. An infection may result from a combination of product-related and healthcare-related failures.

For example, consider an instrument with a design that makes a component difficult to clean. What if the manufacturer failed to adequately address that risk, and the facility also did not follow required disinfection/reprocessing procedures? In that case, it is possible both could be liable.

Ultimately, it would depend on the evidence of each alleged failure and its contribution to the injury.

Courts may be required to determine how to apportion fault, apply a theory of comparative negligence, and assess the quantum of damages, if any, based on the evidence in each case.

Identifying all potentially responsible parties is important because pursuing the wrong legal theory can affect the outcome of a case.

What evidence can establish that a scope caused an infection?

A patient's medical chart may note the presence of an infection and its consequences; however, it may not explain the origin of the bacteria.

The health care facility may maintain other records. For example, the maintenance history of the endoscope, reprocessing logs, equipment tracking records, laboratory culture results, and communications concerning known equipment contamination.

Ultimately, a court may be required to address these issues. Evidence concerning other similar infections at the health care facility may become relevant, particularly when an infection-control investigation points to a common source.

No single kind of proof will prove that legal liability exists. A good case requires both the medical evidence and technical evidence to support the same theory as to how the injury occurred.

What if the Hospital Never Told You There Was a Problem?

A patient could develop a serious infection while the hospital never notified the patient that the medical device was being investigated.

The absence of a notification does not mean that the hospital concealed information or broke the law. An individual can always request her/his medical records.

If there is a reasonable basis to investigate a possible equipment-related infection, an attorney can obtain additional records through a court order.

The timing of the infection and information about safety actions and any treatment related to it may support the need for further review of the equipment.

Your Legal Options After an Olympus Scope Infection

A patient may suffer from a serious infection with added financial and emotional stresses and physical limitations without knowing if the injury was preventable.

Answering these questions can be long and complex and requires a determination of defect or failure of the medical equipment that was used in the procedure.

Morgan & Morgan can evaluate the available evidence and determine if further review is warranted. Contact Morgan & Morgan today for a fast and free case evaluation.

Frequently Asked Questions

Can I Sue a Hospital for an Infection Caused by Using Equipment that Was not Properly Cleaned?

If a hospital or surgical center fails to abide by the applicable standard of care, and, as a result, a patient contracts an infection, the hospital may be held liable for the infection.

An infection may be the result of several factors, such as inadequate disinfection of equipment, mishandling of equipment, or a facility's failure to comply with established procedures relating to infection control.

Medical malpractice generally means more than proving that an infection occurred. The patient must prove a legally actionable failure and a connection between that failure and the injury.

An attorney may evaluate a variety of items, including the patient’s medical records, reprocessing documentation, hospital policies and procedures, and the opinions of experts, to decide whether a claim is supportable.

Who is Liable if the Endoscope is Defective?

Generally, liability may consist of the endoscope manufacturer, the facility where the endoscopy was performed, or both.

A manufacturer may be held liable for a design or marketing defect of a product, or for failure to provide adequate warnings. A facility may also be liable for its failure to properly maintain and use the endoscope.

Sometimes, several parties may be liable for the same injury. The types of claims that may be asserted and how fault is allocated are determined by the laws of the relevant state.

Is Proof that Olympus Equipment Was Used During My Procedure Necessary?

It may be necessary, or very helpful, to identify the specific equipment in order to have a valid claim against a particular manufacturer.

Procedure records may name the instruments or provide information to help determine the location of additional equipment records. Endoscopes are sometimes tracked by the hospitals where they are used, and additional records may be available through those facilities.

A patient’s standard medical chart may not contain all information about the equipment used on the patient. An attorney may be able to secure those additional records using appropriate legal procedures.

It is important to determine whether the equipment had an applicable legal defect and was a cause of the infection.

What is the difference between a product liability and a medical malpractice claim for an Olympus endoscope case?

A product liability claim is brought against a manufacturer or supplier regarding an equipment defect or a failure to provide an adequate warning.

Medical malpractice is brought against a healthcare provider regarding the failure to provide proper care. In a case involving an endoscope infection, it may be against the hospital, ambulatory surgical center, or healthcare provider for failure to properly clean the endoscope or for some other negligence.

These claims may involve different rules and legal standards, including the deadline to bring a claim.

The facts may support a claim, both claims, or neither claim. A review of the legal standards may address what claims may be brought.