A Medical Device That Put Patients at Risk

There is an unspoken agreement every time you check into a hospital or clinic for a procedure. You trust that the equipment going inside your body has been properly designed, properly tested, and properly cleaned. For thousands of patients across South Carolina and the rest of the country, Olympus broke that agreement — and people paid for it with their health, and in some cases, their lives.

Olympus is one of the world’s largest producers of endoscopic medical equipment. Their scopes are used daily in hospitals and surgical centers from Charleston and Columbia to Greenville, Myrtle Beach, Florence, and Hilton Head. For years, a fundamental design flaw in certain Olympus devices allowed dangerous bacteria to survive standard sterilization procedures, putting patient after patient at risk without their knowledge or consent.

The FDA’s response has been severe and telling. The agency recalled at least five separate Olympus products and later issued an import alert blocking more than 50 Olympus devices from entering the U.S. market — one of the broadest regulatory actions ever directed at a single medical device manufacturer. These are not the actions of a regulatory body responding to minor technical violations. They reflect years of documented harm to real patients.

At Joye Law Firm, we have spent decades fighting for South Carolina families against powerful opponents. We know how to build these cases, and we know what it takes to hold a corporation accountable when it puts profit ahead of patient safety.

Understanding the Design Flaw That Caused the Harm

The core problem with Olympus duodenoscopes and other endoscopic devices comes down to engineering. These scopes contain narrow internal fluid channels, complex hinged elevator mechanisms, and microscopic crevices that create environments where bacteria can survive even aggressive cleaning protocols.

Research published in the journal Gastrointestinal Endoscopy demonstrated that contamination and cross-patient transmission of drug-resistant bacteria occurred even when healthcare workers followed Olympus’s own manufacturer-recommended cleaning steps without deviation. That finding matters enormously — it means this was never a story about hospital negligence or staff cutting corners. The device itself was the defect.

A 2022 technical report from the Association for the Advancement of Medical Instrumentation (AAMI) reached the same conclusion: flexible endoscopes are among the most challenging medical devices in existence to adequately disinfect, and protecting patients requires redesigning the devices — not simply revising the instructions handed to nurses and technicians.

The Infections That Followed

When bacteria survive inside an endoscope and are introduced into the next patient’s body during a procedure, the results can be catastrophic. The CDC has directly linked Olympus and similar duodenoscopes to outbreaks of Carbapenem-Resistant Enterobacteriaceae (CRE) — a class of bacteria that has been called one of the most urgent public health threats in the world. The CDC reports CRE mortality rates as high as 50% in certain high-risk patient populations.

Confirmed outbreaks tied to contaminated endoscopes caused patient deaths at respected institutions including UCLA Medical Center and Virginia Mason Medical Center in Seattle. These were not small, poorly staffed facilities. They were major hospitals with experienced staff following established protocols — and patients still died because the equipment was fatally flawed.

For South Carolina patients — particularly older adults, cancer patients, those with compromised immune systems, or anyone managing a chronic illness — a scope-related infection can spiral quickly into extended hospitalization, permanent organ damage, or death. None of it should have happened.

How the Government Responded — A Timeline of Failures

2013 — Red Flags Emerge

The FDA began receiving reports connecting Olympus endoscopes to patient infections. Hospital investigators simultaneously began flagging the same manufacturer across multiple separate outbreak investigations.
2015 — FDA Goes Public

The FDA issued a formal safety communication warning healthcare facilities about duodenoscope contamination risks. Olympus continued distributing the same flawed design with no meaningful structural correction made to the devices.
2019 — Senate Investigators Weigh In

A U.S. Senate investigation found that Olympus had internal documentation showing awareness of the contamination problem years before any public disclosure. Both Olympus and the FDA were criticized for delayed responses while patients continued being harmed.
Five Formal Recalls Issued

The FDA formally recalled at least five distinct Olympus products. Each recall represented patients who had already been exposed — people who underwent procedures trusting that their care was safe.
50+ Products Blocked From U.S. Entry

The FDA’s import alert preventing more than 50 Olympus products from entering the United States was one of the most sweeping actions ever taken against a medical device manufacturer — a clear signal of how serious the ongoing risk was determined to be.
Federal Courts Advance Patient Claims

In re: Olympus Corp. Duodenoscope Products Liability Litigation, federal courts allowed mass tort claims to proceed on theories of negligent design, failure to warn, and strict product liability — providing a legal foundation for injured patients across the country.

South Carolina Law and What It Means for Your Claim

South Carolina’s legal framework gives injured patients meaningful avenues to pursue justice against negligent manufacturers. Under the South Carolina Products Liability Act and established common law principles, manufacturers can be held strictly liable when a product is defective in its design or when it reaches consumers without adequate warnings about known risks. Both theories apply directly to what Olympus did — and failed to do.

South Carolina courts recognize claims for strict liability, negligence, and breach of warranty in product injury cases. The 2019 Senate investigation’s findings that Olympus possessed internal knowledge of the contamination risk long before disclosing it publicly are highly relevant to negligence and failure-to-warn claims under South Carolina law. A manufacturer that knows its product is harming patients and continues selling it without adequate disclosure has crossed a clear legal line.

Damages recoverable under South Carolina law in these cases can include all past and future medical expenses, lost wages and earning capacity, physical pain and suffering, emotional distress, and loss of enjoyment of life. In cases where a manufacturer’s conduct is found to be willful, wanton, or reckless, South Carolina law also allows for punitive damages — an important tool for cases involving corporate concealment of known safety risks.

For families who lost a loved one, South Carolina’s Wrongful Death Act (S.C. Code § 15-51-10) provides a path to compensation for the losses the family has suffered, including the financial and emotional impact of losing the deceased’s companionship, support, and presence.

South Carolina generally allows three years from the date of injury to file a product liability claim — but when an infection develops gradually or is not immediately connected to the procedure, determining when that clock actually started requires careful

Does Your Situation Qualify?

To qualify, your endoscopic procedure must have taken place in 2018 or later at a South Carolina hospital, outpatient surgical center, or specialty clinic, and medical records must be obtainable to confirm that an Olympus device was used. The following procedure types are currently covered:

  • Colonoscopy
  • ERCP (Endoscopic Retrograde Cholangiopancreatography)
  • Upper Endoscopy
  • Laparoscopy
  • Bronchoscopy
  • Ureteroscopy
  • Hysteroscopy
  • Sinus Endoscopy
  • Cystoscopy

Not sure which type of procedure you had? Your discharge paperwork, explanation of benefits from your insurance company, or a direct records request to your provider will typically include this information. Our intake team is happy to help you figure out what to ask for.

Injuries That May Qualify

Your injury must have required a separate hospitalization or medical appointment following your procedure. Qualifying injuries currently include:

  • Bacterial infection requiring hospitalization within 90 days of the procedure
  • Sepsis or bacteremia following the procedure
  • Drug-resistant superbug such as CRE or resistant E. coli diagnosed within 180 days
  • Pneumonia or severe pulmonary infection within 90 days
  • Tuberculosis within 90 days of the procedure
  • HIV diagnosis within 90 days of the procedure
  • Organ or tissue damage or perforation caused by the scope
  • Internal burning caused by the device during the procedure
  • Device component that broke or dislodged inside the body, causing injury or requiring surgical retrieval
  • Qualifying hemorrhage following the procedure
  • Death caused by infection or device component failure

Additional Things We Will Need to Know

When you submit your case evaluation, our intake team will ask you a series of questions to help us understand your situation fully. Here is what to expect and why each piece matters:
Who Is the Claim For?

We will ask whether you are contacting us for yourself or on behalf of a family member. If you are filing for someone else, we will need to confirm that you have the legal authority to act on their behalf — such as being a spouse, parent, legal guardian, or executor of an estate.
Your Medical History

A brief overview of your relevant medical history helps our team understand the full context of your injuries. Pre-existing conditions do not automatically disqualify you — but they help us assess the strength of your claim and anticipate potential defenses.
Notification Letters

Did you receive a written notice from your hospital, physician’s office, or from Olympus directly warning you about a possible device contamination or failure? If so, please locate that letter before submitting your evaluation. It can be one of the most powerful pieces of evidence in your case.
Prior Legal Consultation

We will ask whether you have previously spoken with or retained another attorney about this specific claim. If you are currently represented by another lawyer for the same injury, we are unable to move forward — but if that representation has ended or you only had an informal consultation, please let us know the details.

Frequently Asked Questions

South Carolina hospitals and surgical facilities are required to maintain records of the medical devices used during procedures, including manufacturer names and device tracking information. A standard written medical records request directed to the facility where your procedure was performed will often include this in the procedure or operative notes. If you received any written communication after your procedure warning of a possible scope contamination issue, that letter is even more direct evidence. Our team can guide you through exactly what to request and how to ask for it.

Not necessarily. The delay between an endoscopic procedure and the appearance of a related infection is actually well-documented in the medical literature — and it is one of the main reasons so many patients were never told their illness was connected to their procedure. A physician treating your infection as an unrelated condition does not close the legal question. What matters is whether your infection falls within the qualifying timeframes, meets the severity threshold, and whether records can confirm an Olympus device was used. All of that is what our review process is designed to determine.

South Carolina’s Wrongful Death Act provides a legal pathway for surviving family members when a loved one dies as a result of a defective product or another party’s negligence. If your father’s sepsis developed within 90 days of his procedure and records can confirm an Olympus device was involved, your family’s situation warrants a careful review. The person bringing the claim will need to have legal standing to do so under South Carolina law — typically the personal representative of the estate — but our team will walk you through what that means if you reach out.

That letter is significant. Keep it safe and have it available when you complete your case evaluation. Hospital notification letters serve as direct acknowledgment that a contamination or device failure risk was identified and that you were a patient within the affected timeframe. In litigation, these letters have been used to establish that both the facility and the manufacturer had knowledge of the problem — which is directly relevant to negligence and failure-to-warn claims.

Your case evaluation is completely free and comes with no obligation. If our team decides to move forward with your case, we represent you on a contingency fee basis — meaning you pay absolutely nothing unless we recover compensation for you. No upfront costs, no retainer, no financial risk. The only way we get paid is if you do.

No — and we think it is important to be transparent about that. Submitting your information starts a review process, not an attorney-client relationship. Our legal team will carefully evaluate your procedure details, your injuries, your medical history, and the other relevant facts before making any determination about representation. We will give you a straightforward, honest answer about where your situation stands. No pressure, no guarantees, no runaround.

Current intake criteria are focused on procedures from 2018 forward. That said, we encourage you to submit your information anyway. The date an injury was discovered — as distinct from the date of the procedure itself — can sometimes affect how legal deadlines are calculated under South Carolina law. Do not make assumptions about your eligibility before our team has had a chance to look at your specific facts.

Joye Law Firm Is in Your Corner

South Carolina patients trusted their healthcare providers and the equipment used in their care. Olympus violated that trust — and the paper trail left by FDA recalls, Senate investigators, and federal courts confirms it. If you were harmed, you should not have to fight a billion-dollar corporation alone.

Joye Law Firm has been standing up for South Carolina families for decades. We handle cases across Charleston, Columbia, Greenville, Myrtle Beach, Spartanburg, Florence, Hilton Head, and every corner of the state. We understand South Carolina courts, South Carolina juries, and what it takes to hold large corporations accountable when they put profit ahead of the people they were supposed to serve.

Your evaluation is free. Your review is thorough. If we take your case, you pay nothing unless we win.
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