A duodenoscope is a kind of endoscope. It enables vision to the side as opposed to forward, as a regular endoscope does. It is a lighted tube inserted through a person’s mouth into the throat and then the digestive tract. The device is used to perform a procedure called an “endoscopic retrograde cholangiopancreatography” (ERCP).
In plain language, a duodenoscope is used to pass instruments into and examine the duodenum, which is the first and shortest section of the small intestine. It is a critical part of the digestive system. The most important function of the small intestine is to digest food and pass nutrients into the bloodstream. The ERCP procedure aids in diagnosing and treating conditions of the bile ducts and pancreas.
The Safe Medical Devices Act (SMDA) requires all healthcare facilities to report to manufacturers of the duodenoscopes any illnesses or injuries caused by their devices. In 2013, there was an outbreak of infections caused by antibiotic-resistant bacteria around the U.S. The outbreak was traced to the use of contaminated duodenoscopes.The specific bacteria involved is resistant to multiple antibiotics. This means that the antibiotics that are used in standard medical practice to cure bacterial infections are not effective against this bacterium.
In addition, infection caused by this bacterium, known as “CRE”, has a mortality rate that may be as high as 50 percent. In other words, infection with the CRE bacterium is fatal for 50 percent of the people who are infected
How Do Infections Occur When a Duodenoscope is Used?
Apparently the problem is that the duodenoscope has many tiny parts. Fluid and tissue from one patient can remain on the device even after it is cleaned. If there are bacteria in the fluid or tissue, they can be passed to other patients and cause an infection.
Infections can be severe and may cause complications from the medical treatments administered after diagnosis with the duodenoscope. The infection would undoubtedly necessitate additional medical treatments, certainly efforts to cure it with antibiotics. Or, as noted above, they can be fatal.
Can I Sue For a Duodenoscope Infection?
Depending on the circumstances, an individual who suffered a duodenoscope infection may bring certain types of lawsuits, such as:
What Is a Strict Product Liability Lawsuit?
A strict product liability lawsuit is a lawsuit in which a person claims that they were injured in using a product because the product was defective. When a defective product is placed on the market and harms people, liability can fall on the following:
- The manufacturer of the product, including the designer;
- Any distributor of the product;
- Any retailer of the product.
Any of these people or entities are strictly liable. This means that the victim does not have to prove that any of them were negligent in some way. Rather, the injured victim only has to prove that the product they designed, manufactured or distributed was in some manner defective and the defect caused the victim’s injury.
There are a number of ways in which a product, such as a duodenoscope can be defective, although it appears that the problem with the duodenoscope in 2013 was small parts that could not be adequately cleaned and sterilized between uses. However, other defects are possible as follows:
- Design Defects: A design defect comes about when a product is designed. Reportedly, this is the problem with the duodenoscope. The designers failed to recognize the risk from parts that were sized so as to be impossible to clean and disinfect. The complexity of the design was also part of the problem;
- Manufacturing Defects: A manufacturing defect arises because something occurs in the course of manufacturing a product that results in a defect;
- Marketing or Labeling Defects:
- Failure to Warn: The manufacturer and distributors of a product should warn consumers of the known dangers of using a product. A product that can be dangerous in some way should come with warning labels;
- Inadequate Use Directions: A product should be distributed with directions on how to use it in a safe manner. If a product is sold without proper directions for its safe use, a manufacturer or retailer can be held liable for injury or damage it causes;
- Misleading Advertisements: Finally, advertisements should accurately show the use that should be made of a product as well as potential dangers. If advertisements are misleading, a company can also be held liable for injury caused by their product.
Evidence to prove a case of strict product liability would usually have to include expert testimony about the product defect and how it caused harm to the victim. .
In addition, evidence would include medical records showing the treatment received by the victim, hospital records, eyewitness testimony, and any photos or video footage that might be available. An expert might also have to testify as to the medical treatment the victim received after being harmed, why it was justified and any long-term consequences of the injury for the victim.
The victim could recover money damages to compensate them for their losses, both economic and non-economic. Damages for economic losses compensate a victim for the expense of their medical care, including doctor’s bills, hospital bills, medication, physical therapy and any other legitimate medical treatment. Economic damages would also cover lost wages and, possibly, lost future earnings.
Non-economic damages would compensate the victim for their pain and suffering and emotional distress. In cases in which the behavior of the entity being sued, the defendant in legal terminology, was especially egregious, punitive damages are possible.
A strict product liability action focuses on the product defect. The victim does not have to prove any fault on the part of the manufacturer or distributors. But this is not a barrier to obtaining punitive damages. In the appropriate case, the victim may recover punitive damages. The victim would have to show that the defendant’s conduct was in some way outrageous or worthy of having to pay a financially punishing amount of money to the victim.
For example, the victim might find evidence that the manufacturer engaged in an orchestrated cover up of their product’s danger, even after receiving reports that it was causing injuries. This is the type of conduct that might justify an award of punitive damages.
When Can I File a Wrongful Death Lawsuit?
A wrongful death lawsuit is a legal option for the family member of a person who has died because of a duodenoscope infection. The family member filing the lawsuit must be a close relative such as a parent, sibling, spouse, or child of the deceased. The lawsuit can be filed against a company, individual, or government.
The family member would seeks to recover compensation for losses such as:
- Funeral expenses;
- Medical expenses;
- Lost earnings and benefits;
- Loss of consortium;
- Pain and suffering;
- Punitive damages.
Should I Hire an Attorney for Help with a Duodenoscope Lawsuit?
As with other types of cases related to medical equipment and procedures, duodenoscope lawsuits can be complex. If you or a close family member have been harmed by a medical procedure that involved the use of a duodenoscope, you should consult with an experienced personal injury attorney.
Your attorney can assess the facts of your case and determine if a defective duodenoscope was the cause of injury or death to your loved one. An experienced personal injury attorney will be able to enlist the help of experts needed to prove the case and the full extent of damages. Prosecuting a case for strict product liability is challenging and something that is best handled by a knowledgeable personal injury attorney.