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Diagnostic Scope Lawsuit

Patients throughout the United States have filed lawsuits claiming that contaminated diagnostic scopes transmitted dangerous pathogens and antibiotic-resistant bacteria because the devices were difficult to properly clean and disinfect between uses. The Diagnostic Scope lawsuits allege that reusable medical scopes  caused serious bacterial infections in patients undergoing colonoscopies, endoscopies, ERCP procedures, and other minimally invasive scope diagnostic treatments. 

The litigation primarily centers on duodenoscopes, endoscopes, colonoscopes, bronchoscopes, and related reusable medical devices used in hospitals and outpatient healthcare facilities nationwide. 

Our free consultation will explain the Diagnostic Scope litigation, what you should know if you experienced an infection after a scope procedure, and if you are eligible for compensation.

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Additional Insight on the Diagnostic Scope Lawsuit

What Are Diagnostic Scopes?

Diagnostic scopes are reusable endoscopic medical devices used to examine and treat internal organs without invasive surgery.

Diagnostic scopes are commonly used during:

• Colonoscopies
• Upper endoscopies
• ERCP procedures
• Bronchoscopies
• Gastrointestinal procedures
• Urological procedures
• Pulmonary procedures

These procedures rely on flexible medical instruments equipped with cameras, lighting systems, and internal channels that allow physicians to insert tools into the body.

During a colonoscopy, a physician inserts a colonoscope through the rectum to examine the large intestine and identify abnormalities such as polyps, inflammation, bleeding, or cancer. During an upper endoscopy, doctors use an endoscope inserted through the mouth to examine the esophagus, stomach, and upper digestive tract.

Duodenoscopes are specialized scopes used during Endoscopic Retrograde Cholangiopancreatography (ERCP) procedures to diagnose and treat conditions involving the pancreas, bile ducts, liver, and gallbladder.

The lawsuits allege that many diagnostic scopes shared similar contamination risks because of intricate internal designs that made proper sterilization difficult or impossible.

Alleged Defects in Diagnostic Scopes

The central allegation in the Diagnostic Scope litigation is that the devices contained dangerous design flaws that allowed bacteria and biological materials to remain hidden inside the scopes after cleaning.

According to plaintiffs, diagnostic scopes contained narrow channels, sealed components, and movable mechanisms that could trap infectious material beyond the reach of traditional sterilization methods.

One of the most heavily criticized features involved the “elevator mechanism” used in certain duodenoscopes. This movable component allegedly contained microscopic crevices and hard-to-access spaces where bacteria could accumulate and survive even after hospitals followed manufacturer cleaning instructions.

Plaintiffs claim that reusable scopes posed contamination risks because the devices could not be consistently disinfected between procedures.

The lawsuits generally allege that the manufacturers:

• Designed scopes that were difficult to sterilize
• Failed to adequately test contamination risks
• Failed to warn healthcare providers and patients
• Delayed implementing safer designs
• Continued selling defective scopes despite known dangers
• Provided insufficient cleaning instructions

According to allegations raised in litigation, patients undergoing routine colonoscopies and endoscopies may have unknowingly been exposed to contaminated devices previously used on other patients.

Colonoscopy and Endoscopy Infection Risks

Although the litigation initially focused heavily on duodenoscopes used in ERCP procedures, concerns later expanded to include colonoscopes, endoscopes, bronchoscopes, and other reusable scopes.

Millions of patients undergo colonoscopies and endoscopies every year to diagnose gastrointestinal disorders, screen for cancer, investigate digestive symptoms, or remove precancerous polyps. These procedures are generally considered safe and minimally invasive.

However, lawsuits allege that contaminated scopes exposed patients to dangerous bacteria during these otherwise routine procedures.

According to reports and investigations, bacteria allegedly linked to diagnostic scopes included:

• Carbapenem-resistant Enterobacteriaceae (CRE)
• E. coli
• Klebsiella pneumoniae
• Pseudomonas aeruginosa
• Salmonella
• Other multidrug-resistant organisms

Some plaintiffs reportedly developed infections shortly after undergoing colonoscopies, upper endoscopies, or ERCP procedures involving these devices.

Patients allege that they entered medical facilities expecting routine preventive care but instead suffered life-threatening infections requiring hospitalization and intensive medical treatment.

Superbug Outbreaks and FDA Investigations

The Diagnostic Scope controversy gained national attention after multiple hospitals reported outbreaks involving antibiotic-resistant bacteria connected to reusable scopes.

The FDA launched investigations into duodenoscopes and other endoscopic devices after reports emerged linking contaminated scopes to serious infections nationwide. Federal investigators concluded that the devices presented contamination risks even when healthcare providers followed approved cleaning and disinfection procedures. 

The FDA later issued multiple safety communications warning hospitals and healthcare professionals that reusable duodenoscopes and endoscopes might retain bacteria despite proper reprocessing.

According to the FDA, the complex design of reusable scopes could impede effective cleaning and disinfection. The agency ordered the manufacturers to conduct post-market surveillance studies to evaluate contamination rates associated with reusable devices.

Investigators reportedly found contamination rates higher than expected even after cleaning procedures were performed according to manufacturer instructions.

As concerns grew, hospitals across the country began reviewing sterilization protocols and infection-control procedures involving reusable scopes.

Major Hospital Outbreaks Linked to Diagnostic Scopes

Several hospitals reported serious bacterial outbreaks allegedly connected to diagnostic scopes.

One of the most widely publicized outbreaks occurred at Virginia Mason Medical Center in Seattle, where multiple patients developed dangerous CRE infections after ERCP procedures involving duodenoscopes. Reports indicated that several patients later died from complications related to the infections.

Another major outbreak occurred at UCLA Ronald Reagan Medical Center in Los Angeles, where contaminated scopes allegedly exposed numerous patients to antibiotic-resistant bacteria.

Some hospitals were forced to notify thousands of former patients that they may have been exposed to contaminated scopes during colonoscopies, endoscopies, ERCPs, and other procedures.

These outbreaks triggered nationwide concern regarding the safety of reusable endoscopic devices and the effectiveness of existing sterilization methods.

Diagnostic Scope Lawsuits

Following reports of widespread infections, patients and families began filing lawsuits.

The lawsuits generally allege that manufacturers failed to properly design, manufacture, test, and warn users about the infection risks associated with reusable scopes.

Plaintiffs claim the company knew that certain scope models could retain bacteria after cleaning yet continued marketing and distributing the devices without adequate warnings.

The litigation includes claims involving:

• Product liability
• Defective design
• Failure to warn
• Negligence
• Breach of warranty
• Fraudulent concealment
• Wrongful death

Patients filing lawsuits often seek compensation for:

• Medical expenses
• Hospital bills
• Lost income
• Pain and suffering
• Emotional distress
• Long-term disability
• Future medical care
• Wrongful death damages

Many lawsuits specifically allege that manufacturers failed to act quickly enough after learning about contamination risks and infection outbreaks.

Federal Criminal Proceedings Against Manufacturers

The controversy surrounding diagnostic scopes intensified after federal prosecutors accused the manufacturer of failing to properly report infection-related adverse events to regulators.

In 2018, a former manufacturer executive pleaded guilty to charges involving the failure to file FDA-required reports concerning infections connected to duodenoscopes. Federal authorities alleged that the manufacturer continued distributing the devices despite failing to properly disclose serious infection risks.

The criminal proceedings increased scrutiny surrounding regulatory compliance and the handling of contamination concerns.

According to investigators, the manufacturer allegedly possessed information regarding infection outbreaks and contamination issues before broader public disclosures were made.

Injuries Alleged in Diagnostic Scope Cases

Patients filing Diagnostic Scope lawsuits allege a wide range of serious injuries and complications.

Severe Bacterial Infections

Many plaintiffs developed dangerous infections shortly after colonoscopies, endoscopies, or ERCP procedures involving diagnostic scopes.

Sepsis

Sepsis is a life-threatening condition caused by the body’s overwhelming response to infection. Several lawsuits allege contaminated scopes caused sepsis requiring emergency treatment and intensive care.

Organ Damage

Some patients reportedly suffered kidney damage, liver failure, respiratory complications, or other forms of organ dysfunction resulting from severe infections.

Repeat Procedures and Surgeries

Patients often required additional medical procedures, surgeries, and prolonged antibiotic treatment following infection diagnoses.

Emotional Trauma

Many patients experienced significant emotional distress after learning they had been exposed to antibiotic-resistant bacteria during routine medical procedures.

Wrongful Death

Families who lost loved ones after severe infections linked to diagnostic scopes may pursue wrongful death claims seeking compensation and accountability.

Colonoscopy Lawsuit Concerns

More recently, lawsuits and investigations have expanded beyond duodenoscopes to include concerns involving colonoscopes and gastrointestinal endoscopy equipment.

Colonoscopies are among the most commonly performed medical procedures in the United States and play a critical role in colorectal cancer screening and prevention.

Some lawsuits now allege that reusable colonoscopes may present similar contamination risks due to internal channels and hard-to-clean components.

Patients who developed infections after colonoscopies or gastrointestinal endoscopies involving scope equipment may be entitled to receive significant compensation.

Who May Qualify for a Diagnostic Scope Lawsuit?

Individuals may qualify for a Diagnostic Scope lawsuit if they:

• Underwent a colonoscopy, endoscopy, ERCP, or related procedure involving a diagnostic scope
• Developed a bacterial infection after the procedure
• Were diagnosed with CRE or another serious infection
• Required hospitalization or additional treatment
• Suffered complications linked to contaminated scopes
• Lost a loved one due to infection-related injuries

Eligibility depends on several factors, including medical records, infection diagnoses, procedure history, and applicable statutes of limitation.

Patients who received notification letters from hospitals regarding possible contamination exposure may also be entitled to receive significant compensation.

Settlements and Litigation Developments

The manufacturers have reportedly resolved numerous lawsuits involving contaminated scopes through confidential settlements.

One notable case resulted in a jury award of $6.6 million connected to a superbug outbreak involving diagnostic scopes at Virginia Mason Medical Center. Additional lawsuits involving injured patients and wrongful death claims have also reportedly settled.

Settlement amounts vary depending on factors including:

• Severity of injuries
• Medical expenses
• Long-term complications
• Lost wages
• Wrongful death damages
• Strength of evidence

The Impact on Medical Device Safety

The Diagnostic Scope controversy significantly changed how hospitals, regulators, and manufacturers approach reusable endoscopic device safety.

The litigation and investigations prompted:

• Enhanced sterilization procedures
• Increased FDA oversight
• Development of disposable scope components
• Additional contamination monitoring
• Greater hospital infection tracking
• New reprocessing protocols

Many healthcare providers have transitioned toward scopes with disposable caps or partially disposable designs intended to reduce infection risks.

The controversy also raised broader questions regarding patient safety, corporate accountability, and the long-term risks associated with reusable medical devices.

Case Review

Patients who developed severe infections after undergoing colonoscopies, endoscopies, ERCP procedures, or other treatments involving diagnostic scopes may be entitled to receive significant compensation.

Families who lost loved ones due to alleged scope-related infections may also qualify for significant compensation.

If you or a loved one has experienced an infection after a colonoscopy, endoscopy, or similar diagnostic scope procedure, you may be entitled to significant compensation. Understanding your rights and seeking timely legal guidance can help determine whether compensation may be available.