Medical Device Company Ordered to Pay $6.6 Million in “Superbug” Infection Case

Case Overview

Case Name: Theresa Bigler, individually as personal representative of the Estate of Richard Bigler v. Olympus America, Inc. and Virginia Mason Medical Center, No. 15-2-05472 (King County Superior Court, WA)

Case Type:

• Medical Malpractice – Hospital; Infection Control
• Products liability – Design Defect; Failure to Warn; Medical Devices; Marketing Defect
• Wrongful death – Survival Damages

Injury: Death resulting from infection

Plaintiff Attorneys:

• Joel D. Cunningham, David M. Beninger, and John E. Gagliardi of Luvera Law Firm

Defense Attorneys:

• Mark E. Anderson of McGuireWoods LLP for Virginia Mason Medical Center, Olympus America Inc., Olympus Corporation of the Americas, and Olympus Medical Systems Corp.
• Samuel L. Tarry Jr. and Davis Walsh of McGuireWoods LLP for Olympus America Inc., Olympus Corporation of the Americas, and Olympus Medical Systems Corp.
• E. Pennock Gheen and Evelyn E. Winters of Bullivant Houser Bailey PC or Olympus America Inc., Olympus Corporation of the Americas, and Olympus Medical Systems Corp.
• Jameson B. Carroll of Carroll & Weiss LLP for Olympus America Inc., Olympus Corporation of the Americas, and Olympus Medical Systems Corp.
• Miranda K. Aye, Rando Wick, and Karin J. Mitchell of Johnson, Graffe, Keay, Moniz & Wick for Virginia Mason Medical Center

Case Outcome:

• Verdict-Plaintiff: Bigler Estate against Virginia Mason Medical Center
• Verdict-Defendant: Olympus defendants in Bigler Estate’s claims
• Verdict-Plaintiff: Virginia Mason Medical Center against the Olympus defendants

Amount: $26,430,000.00

Actual Award: $7,600,000.00

What Happened?

In 2012, a physician diagnosed decedent Richard Bigler (age 57 at the same) with pancreatic cancer. Then. in August 2013, he underwent an endoscopic retrograde cholangiopancreatography (also known as an ERCP). An ERCP is a procedure that uses a combination of an endoscope and X-ray. The procedure examines and treats problems that affect the pancreas. Physicians conducted the ERCP at the Virginia Mason Medical Center, in Seattle, with a device referred to as a duodenoscope. This device is a flexible tube that is equipped with a light. It is inserted through the mouth to examine the duodenum, the first part of the small intestines. Later that month, Bigler died from an infection of superbug Hyper Amp-C. The infection was spread from the duodenoscopes used in the ERCP procedure. Bigler was one of the hospital’s 39 patients infected by the device.

The Duodenoscope Lawsuit’s Allegations and Trial Testimony

Bigler’s wife, Theresa Bigler, as a representative of Bigler’s estate, filed a wrongful death lawsuit against Virginia Medical Center as well as the manufacturer of the duodenoscope, which included the Tokyo-based company, Olympus Medical Systems Corporation, and its American companies, Olympus America Inc. and Olympus Corp.

Design Defect Allegations

The Bigler estate raised product liability causes of action against the Olympus defendants. The estate alleged that the company redesigned its Olympus TJF-Q180V duodenoscope. The new model replaced an open elevator channel design to a closed elevator channel design. Furthermore, the Bigler estate alleged that the redesigned duodenoscope was defectively designed and unsafe. The plaintiffs also claimed the device could not be adequately disinfected even when reprocessed according to the manufacturer’s instructions.

The estate further alleged that Olympus failed to obtain clearance from the Food & Drug Administration (FDA) pertaining to the new design. According to the estate, the corporation knew of the dangers of the design but failed to warn others. Rather, the company deceptively concealed the device’s defects. The plaintiffs alleged that Olympus knew about the problems associated with the closed channel on its redesigned device.

The plaintiffs also asserted that Olympus issued safety warnings in 2013 and 2014 within the European Union. However, the company did not issue any warnings in the United States until February 2015. This was after the media began reporting on “superbug” infections occurring at the UCLA Medical Center. The company then recalled the TJF-Q180V duodenoscope. Afterward, Olympus modified the design and labeling. The company also issued a new brush to assist in reprocessing and make the scope easier to clean. Later, in 2016, the device received FDA clearance.

Product Liability

The Bigler estate also brought claims in the duodenoscope lawsuit against the Olympus defendants for violations of the Washington Product Liabilities Act and the Consumer Protection Act. The estate also sought punitive damages under Pennsylvania law, the state in which the American arm of the corporation is based. The Virginia Mason Medical Center then joined the Bigler estate as a co-plaintiff and brought cross-claims against the Olympus defendants. These claims included product liability defects and violations of applicable state laws.

At trial, the plaintiffs introduced internal emails from an Olympus executive. In the emails, the executive directed the company’s U.S. managers, back in February 2013, not to issue warnings concerning scope-related infections. Other documents also indicated that the company received a complaint from Virginia Mason back in January 2011 concerning patient debris getting trapped inside the scope and being difficult to remove.

The Olympus defendants argued that its closed elevator channel design complied with the FDA standards at the time of manufacture. Furthermore, the company issued adequate instructions and warnings as required by law. The defendants also challenged whether the device proximately caused Bigler’s injury and death. The company blamed Virginia Mason Medical Center for conducting inadequate reprocessing of the device and failing to follow instructions.

Who Won the Duodenoscope Lawsuit?

As to the Bigler estate’s claims against Virginia Mason Medical Center, the jury found that the hospital was negligent in its handling of the duodenoscope and that negligence was a proximate cause of the subsequent infection that spread from its use. The court ordered the hospital to pay a total award of $1 million in damages—$750,000 to the Bigler estate and $50,000 to each of the five family members.

Additionally, the jury found that the Olympus defendants failed to provide adequate warnings and instructions for its redesigned TJF-Q180V duodenoscope. However, the jury didn’t find that this failure was the proximate cause of Bigler’s injury and death. The jury also sided with Olympus regarding the design defect claims, finding that the scope’s design was reasonably safe.

As to Virginia Mason Medical Center’s claims, the jury found that Olympus’s failure to warn did proximately cause injury to the hospital. The court then ordered Olympus to pay the hospital $430,000 in economic damages and $25 million in noneconomic damages. However, because the jury deemed Virginia Mason negligent and that the hospital failed to mitigate 57% of its damages, the award was reduced to $6.6 million. The jury also found in favor of Olympus as to the alleged violations of the Consumer Protection Act.

The Awards Breakdown

• Estate of Richard Bigler – $750,000 Wrongful Death: Survival
• Jeffrey Bigler – $50,000 Personal Injury: pain and suffering
• Theresa Bigler – $50,000 Personal Injury: pain and suffering
• Stephanie Burrell – $50,000 Personal Injury: pain and suffering
• Cheryl Davis – $50,000 Personal Injury: pain and suffering
• Melissa Gustafson – $50,000 Personal Injury: pain and suffering
• Virginia Mason Medical Center
  • $430,000 Personal Injury: economic damages
  • $25,000,000 Personal Injury: noneconomic damages (reduced to $6.6 million)

Expert Specialties

The plaintiffs retained expert witnesses in:

• FDA Regulatory Affairs
• Gastroenterology
• Infectious Diseases
• Economics
• Epidemiology

The defendants retained expert witnesses in:

• Microbiology
• Economics
• Gastroenterology

The trial, which lasted nine weeks and went on four days of deliberations, involved testimony from experts in infection control and prevention. The infection-control expert testified that there was “completely inadequate premarket validation testing” that amounted to “essentially nothing.” Interestingly, the expert had previously served as an expert witness on behalf of Olympus. However, he had refused to do so for this trial because he found that the “device was intrinsically defective.” As the expert testified, “I have been deceived. I thought there were meaningful data associated with [reprocessing] validation.”

The duodenoscope lawsuit also involves the expertise of engineers, especially in light of the fact Olympus disregarded its own independent expert’s report when the engineer warned the company should conduct a worldwide investigation. Olympus contested its engineer’s report, arguing that it contained “many unscientific views.”

Key Takeaways

One of the most important aspects of the Bigler case occurred post-trial. During this time, it was discovered that Olympus violated its discovery obligations and failed to properly disclose documents and witnesses. Olympus had previously turned over the documents in question. However, it failed to translate the thousands of pages of documents into English. Olympus also failed to flag certain hospital test results in response to specific plaintiff questions. In response to what the judge describes as a “massive impropriety,” the court ordered Olympus to pay the Bigler estate $250,000 in sanctions as well as cover their legal expenses for a new trial. The Bigler estate later settled the case out of court.

The jury’s verdict found that although Olympus failed to issue adequate warnings, it was not liable for Bigler’s death. This verdict is a classic example of a proximate cause and how it can affect product liability cases when another contributor of negligence (i.e., a hospital) is involved. Whether representing a patient, hospital, or medical device company, the Bigler case is certainly a lesson for all attorneys to have a strong case strategy for establishing one of the requisite elements of negligence claims.

But more important to remember, failure to comply with discovery obligations can hurt a party even after the trial is long concluded.