Endoscope /  Duodenoscope Superbug Infection Lawsuit

Patients who underwent a complicated diagnostic procedure using a medical camera called a duodenoscope are at elevated risk of developing a serious infection after their examination. This resulted from a design that made it close to impossible to fully sterilize and reuse the device. However, the companies ignored known dangers and did not disclose what they knew about these hazards. As a result, scores of people are dead and injured from severe infections that resist antibiotics. These companies are now being sued for allegedly defective products. If you are looking to file a Duodenoscope Superbug Infection lawsuit, contact a Superbug Infection Lawsuit lawyer.

What Is a Duodenoscope?

A duodenoscope is the hollow tube that the doctor inserts down the patient’s throat to get a closer look at the intestine, pancreas or gallbladder. The duodenoscope is a hollow tube with a light at the end of it that allows that physician to see in better detail. Doctors will use this medical instrument to diagnose conditions such as pancreatitis, gallstones or cancer. This is not the same thing as the endoscope that it used in millions of procures each year. Physicians will use this for more complex procedures that require precision.

The duodenoscope is inserted in a medical procedure where the patient is placed under mild or full sedative. This is a common procedure that is done on an outpatient basis. According to the Food and Drug Administration, there are over 500,000 procedures performed on Americans each year that use a duodenoscope. This is an instrument that is used in lifesaving procedures that can diagnose critical illnesses that need to be treated.

Multiple-Use Duodenoscopes Are Complex and Expensive Instruments

The duodenoscope is a very complex instrument given that it must be inserted deep into the patient’s body to detect even minor abnormalities. There are many sensitive parts of the camera, and the medical instrument requires a very precise manufacturing and design. Reusable duodenoscopes can run a medical practice over $40,000. Recently, in light of the issues described below, some physicians have been moving towards single-use duodenoscopes. To give you an idea of the complexity of these instruments, even a medical device for one-time use can cost $1,500.

Patients who need procedures using duodenoscopes often face either life-threatening or debilitating illnesses. They have no choice but to undergo a procedure using these medical instruments. However, in the past seven years some risks to using a duodenoscope have become apparent. Specifically, there is a chance that patients can develop a dangerous and deadly superbug infection due to this medical device.

The Design of Duodenoscopes Raises the Risk of Infection

Post-surgical infection, in general, is a leading cause of death among patients in the United States. 45% of post-operative deaths in the U.S. are from sepsis. An invasive procedure where the body is opened or something is inserted causes an elevated risk of infection, even under the best circumstances. However, the duodenoscope presents an even greater risk of  Superbug infection.

Three Companies Control the U.S. Market

In the United States, the duodenoscope market is largely controlled by three companies. They are:

• Olympus America
• Fujifilm
• Pentax

As you can see, companies that have a specialty in cameras and film have medical instruments divisions, especially because surgical instruments are immensely profitable. Olympus America is by far the largest duodenoscope maker in the country with an 85% market share. Recently, Boston Scientific has also entered the market with a single-use duodenoscope. This has challenged the dominant market position of Olympus. Doctors afraid of the infection issue have begun to switch to single-use instruments.

The CDC Detected Infections Tied to the Use of a Duodenoscope

In 2013, the Centers for Disease Control brought to the FDA’s attention a critical problem involving the duodenoscope. The CDC’s role is to study infections and act to prevent them. The FDA approves medical instruments for use. The two agencies share information and work together to ensure safety for patients. According to the CDC, physicians were not able to properly sterilize these instruments. The result was that patents developed serious infections that were resistant to antibiotics.

The Companies Did Not Provide Information to the FDA in a Timely Manner

This was just a start of serious legal and regulatory issues for duodenoscope makers. The situation went from bad to worse as the FDA learned more. Unfortunately, these companies allegedly stonewalled rather than come clean about the full extent of the problems with their product.

• The FDA has the power to direct devicemakers to conduct additional postmarket studies when it learns of dangers associated with a certain project. In October 2015, the FDA ordered the three product makers to perform this research to learn about infections.
• Unfortunately, the device makers must either not have taken the FDA seriously or were trying to get away with providing minimal data. In 2018, the regulator issued warning letters to each of the three companies for failure to provide sufficient data in response to the FDA’s direction. The companies promised that they would broaden their studies to give more data.
• When the FDA finally reported the full numbers in 2019, they were much worse than initially expected. Previously, it was thought that there would be a 0.4% contamination rate associated with duodenoscopes. The actual numbers exceeded that.
• The contamination rates for each of the three manufacturers were frightening. Over 5% of repurposed Olympus devices tested positive for some sort of organisms. Pentax had a rate of over 9%, meaning that almost one in every ten procedures conducted with a repurposed Pentax duodenoscope potentially could cause an infection.

Olympus Was Fined $85 Million for Misconduct

By mid-2016, 35 people were dead from infections after duodenoscope procedures. Hundreds more developed serious infections. Even after news first hit of the infection risks, additional cases piled up in outbreaks across the country. For example, in late-2018, there were hundreds of new reports of post-procedure complications that resulted in three deaths and 45 injuries.

Aside from the influx of lawsuits described below, Olympus has also been punished by federal regulators. In a criminal case against Olympus, a judge fined the company and a top executive a total of $85 million for egregious corporate misconduct. The evidence in the trial showed that the company knew as far back as 2008 that its duodenoscopes could cause severe infections. However, the company did not file adverse event reports with the FDA as it was required to do by law. Instead, Olympus kept marketing and selling these medical instruments as if nothing was wrong. A former executive pleaded guilty for failing to file these reports in spite of his exact knowledge of the requirement.

As a result of the infections described above and the alleged product defects, the makers of duodenoscopes have faced scores of lawsuits accusing them of designing a defective product and then looking the other way when evidence began to emerge that these instruments were dangerous.

Olympus Was Handed a $6.6 Million Jury Verdict

The first trial in this series of cases resulted in a sizable verdict against Olympus. The family of Richard Bigler was awarded $6.6 million, although a judge vacated the verdict for a new trial in light of the discovery of even worse evidence against Olympus. The family had filed a lawsuit alleging fraud, negligence and wrongful death when their loved one died from an infection after a procedure using a duodenoscope.

In 2018, two Washington women settled their cases against Olympus. One of these was the widow of Richard Bigler, who stood to get a lot more money in a second trial with Olympus facing possible punitive damages. The other case settled before trial for an undisclosed sum.

Duodenoscope Superbug Infection Lawsuit

There was a series of lawsuits after a cluster of outbreaks tied to the duodenoscope in California. Patients are still filing lawsuits as they develop severe infections from this instrument. So long as reusable duodenoscopes are still on the market, patients will continue to be sickened due to the difficulties in sterilizing these instruments.

If you or a loved one have contracted an infection after a procedure that used a duodenoscope, you may be entitled to substantial financial compensation. Contact a product liability attorney to learn more about how you can file a lawsuit against one of these companies that sold a potentially defective product.

http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm434871.htm

https://www.law360.com/articles/882030/pentax-medical-devices-carry-infection-risk-fda-says