The road to a recall: a medical device intended to ease patients' discomfort during lung examinations instead transmitted bacteria that could be deadly. Here's what the manufacturer knew, and when.

A procedure less invasive than a biopsy is a blessing to people suffering lung ailments. But when the instrument used is contaminated with potentially lethal bacteria, the boon becomes a bust. When the instrument manufacturer knows there is a problem but doesn't work swiftly to fix it, the problem becomes a legal issue.

A bronchoscope is a thin, tubelike instrument that physicians use to examine the inside of lungs and to collect pulmonary tissue samples through a channel port. The device is about the width of a pencil, and its tip holds a tiny camera that uses fiber-optic technology. During a bronchoscopy, a doctor inserts the scope through the patient's nose or mouth. Bronchoscopes are commonly used on lung-transplant recipients and patients suffering from cystic fibrosis, AIDS, or lung cancer. About 460,000 patients undergo bronchoscopies each year in the United States. (1)

In September 2001, a defect was discovered in several bronchoscopes manufactured by Olympus America, Inc., a subsidiary of the Japanese camera maker Olympus Optical Co., Ltd. An investigator from Skyline Hospital in Nashville, Tennessee, working with the Centers for Disease Control and Prevention (CDC), analyzed unusually high infection rates in the hospital's patients. Cultures from 17 patients who had been examined with Olympus bronchoscopes tested positive for pseudomonas, a type of bacteria that can cause pneumonia and can be lethal to those with compromised immune systems. The bacteria--generally not harmful to healthy people--can be resistant to many types of antibiotics, and doctors often treat an infection with two or more types of antibiotic at once.

The CDC investigator concluded that a loose valve on the instrument allowed bacteria to grow in a pocket where the organisms could not be reached by standard sterilization equipment. As a result, the contaminated bronchoscopes transferred the trapped bacteria from patient to patient. Both the CDC investigator and a doctor from the Tennessee Department of Health warned the FDA and Olympus about the problem in October 2001.

Weak recalls

Recently, Olympus acknowledged that it knew in September 2001 that a screw-on part of the bronchoscope could come loose and that bacteria could get trapped inside the opening. Olympus officials said the company initiated an "immediate and vigorous investigation" and sent notices to 2,361 heath care institutions, resulting in a "prompt voluntary recall." (2) However, the company did not initiate the voluntary recall until November 30, 2001--two months after it learned about the defect.

To compound the problem, the recall notice was poorly worded and intentionally vague. It stated that "Olympus would like you to return the bronchoscope at your convenience" so that the company could "upgrade" the device. The company said it was initiating the recall because of "potential looseness" in a part that allowed microbial contamination of the instrument.

The notice suggested that the outbreak of contamination was not entirely caused by a design flaw. It said, "An additional contributing factor in this instance was the failure by the user to maintain the automated endoscope reprocessor (AER) [a machine used to clean the instrument] to the manufacturer's recommended instructions."

The FDA ordered the company to send a more direct "urgent recall" notice. On February 27, 2002, Olympus notified hospitals that they were "required" to return the devices to the company. Olympus also issued a press release on March 6 explaining its actions during the recalls. So far, about 48 percent of the 4,418 machines exported to the United States and 82 percent of the 3,176 devices in Japan have been returned. The recall has cost Olympus more than $758,000. (3)

Olympus has been criticized for not following the aggressive procedure used to recall drugs, in which the FDA distributes advisories and warnings about a drug, the manufacturer sends letters to the home and office addresses of all doctors who might prescribe the drug, and company sales representatives tell their customers about the recall. Although the FDA insists it acted properly because the Olympus recalls were voluntary, the agency is investigating its response.

This is not the first time that infections caused by Olympus bronchoscopes have been reported. In 1999, the FDA and CDC issued a public health advisory alerting hospitals to several incidents in which patients developed serious infections because bronchoscopes were poorly cleaned. (4) Two cases in Maryland and South Carolina resulted in the spread of tuberculosis. In 1996 and 1998, the New York State Department of Health found three clusters of culture-positive specimens in patients who had bronchoscopies at local heath care facilities. (5)

Federal authorities are also investigating at least 59 other reports of problems with the Olympus bronchoscope over the past six years. The FDA is looking into claims ranging from bacterial contamination to cracked valves, rings tumbling off into patients' lungs, and laser surgery devices (inserted through the channel ports) that burst into flames inside patients' throats. The agency's files contain reports of 12 deaths and 60 infections. (6)

Precautions against contamination

Significant precautions must be taken to clean bronchoscopes because of their potential to spread deadly bacteria. They can be cleaned either by hand or by using the automated endoscope reprocessor. Patient-to-patient transmissions of infection have been linked to bronchoscopes that were inadequately reprocessed by AERs. In these instances, Olympus and the AER manufacturers may have provided inconsistent instructions.

The guidelines published by the Society of Gastroenterology Nurses and Associates are the ones usually followed for cleaning bronchoscopes. (7) They recommend an eight-step process and suggest repeating some of the steps by hand if the instrument is cleaned in an AER. However, the society cautions, hospitals must review the manufacturer's guidelines for each model.

As discussed above, a bronchoscope has not only a camera, but also a portal on the tube, from which a biopsy is taken. The portal is supposed to be fixed in one place. In Olympus bronchoscopes, the portals come loose, and bacteria resistant to the scope-cleaning process can grow inside. When the scope is used on another patient, it transmits the bacteria to infect his or her lungs.

Theories of liability

Defective product design. Olympus may be held strictly liable for defective design of the device. To prove liability, plaintiffs must show that an alternative design is safer, cost-effective, and practical. Because not all models of the bronchoscope have been recalled, the attorney might present a differently designed scope that performs the same functions as the recalled scope. He or she can also show that there might be a better way to design the recalled models so that the biopsy portal does not loosen during use. In addition, experts can compare the recalled Olympus models to other models to demonstrate that other bronchoscopes do not have the same design flaw that permits deadly bacteria to evade sterilization.

Defective warning. The hospitals that have been using the recalled bronchoscopes claim they follow the manufacturer's cleaning instructions. Therefore, Olympus may have provided defective instructions. In addition, once Olympus became aware of the potential problem with the biopsy portal, it immediately should have sent a warning to all heath care facilities using its scopes and should have included a warning on new bronchoscopes alerting health care facilities to check the portal.

A plaintiff may include the manufacturer's failure to provide adequate warnings and/or sterilization instructions as part of the design defect claim. The failure-to-warn claim against the manufacturer may be brought under both strict liability and negligence theories.

Negligence. Olympus may be negligent for design of the scope, improper warnings, and failure to recall the bronchoscopes in a timely manner. A hospital may be culpable if it failed to clean the bronchoscopes properly or failed to act promptly once it received the recall notices.

Either the breach (if suing in negligence) or the defect (if alleging strict liability) must be the actual and proximate cause of the patient's damages either death or increased illness. Proving "but for" causation may require DNA testing to link the pseudomonas cultured from the scope (if any) with the bacteria found in the patient to prove that the bacteria the patient acquired were from the scope, not from some other source.

For patients infected with harmful bacteria from a bronchoscope, successful litigation against the manufacturer for their injuries may bring some measure of relief.

Notes

(1.) This article relies on investigative reports by Tom Pelton published in The Baltimore Sun beginning March 3, 2002. These are archived at www. baltimoresun.com.

(2.) Gretchen Parker, CDC: Company Delayed on Medical Recall, NEWSDAY, Mar. 5, 2002, available at www.ohio.com/mld/ohio/news/nation/2792736. htm.

(3.) Yuri Kageyama, Bronchoscopes Likely Weren't Clean, NEWSDAY, Mar. 6, 2002, available at www.yourlawyer.com/practice/news.htm?story_id= 176&topic=Olympus%20Bronchoscope.

(4.) David Feigal & James M. Hughes, Infections from Endoscopes Inadequately Reprocessed by an Automated Endoscope Reprocessing System, FDA and CDC Public Health Advisory, Sept. 10, 1999, available at www.fda.gov/cdrh/safety/endoreprocess. html.

(5.) Bronchoscopy-Related Infections and Pseudoinfections--New York, 1996 and 1998, 48 MORBIDITY & MORTALITY WKLY. REP. 557 (1999), available at www.cdc.gov/mmwr/preview/mmwrhtml/ mm4826a1.htm.

(6.) Tom Pelton, FDA Looking into More Complaints About Olympus Bronchoscopes, BALT. SUN. Mar. 29, 2002, at 6A. available at www.baltimore sun.com.

(7.) SOC'Y OF GASTROENTEROLOGY NURSES & ASSOCS.n, RECOMMENDED GUIDELINES FOR INFECTION CONTROL (2d ed. 1992).

Robert K. Jenner is a partner with Janet, Willoughby, Gershon, Getz & Jenner in Baltimore.