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Superbug Outbreak from Redesigned Duodenoscope

Posted by Brendan Faulkner of D'Amico & Pettinicchi, LLC on Apr 16, 2015 in Product Liability

Two recent news items serve as gruesome reminders of the need for meaningful punitive damages against mega-corporations that recklessly or knowingly allow their defective products to hurt people.

In the first story CNN reported that Olympus started selling its TJF-Q180V duodenoscope in 2010, but the FDA didn't notice until late 2013 or early 2014 that the company had never asked for clearance to put it on the market, according to the deputy director of strategy for the FDA's Office of External Affairs. (A few days ago, the FDA issued a safety communication stating that Olympus has since validated new reprocessing instructions for these duodenoscopes.) The problem stems from the complex design of duodenoscopes, which can impede effective "reprocessing." Reprocessing is a detailed, multistep process to clean and disinfect or sterilize reusable devices. Recent medical publications and adverse event reports associate multidrug-resistant bacterial infections in patients who have undergone ERCP (endoscopic retrograde cholangiopancreatography) with reprocessed duodenoscopes, even when manufacturer reprocessing instructions are followed correctly. The manufacturer's alleged failure to provide safe instructions for use has led to at least one lawsuit according to the L.A. Times. The patient's lawsuit contends that Olympus redesigned its Q180V duodenoscope last year and failed to provide an "effective and validated reprocessing protocol" for the new version. The new model expanded the range of scope positions in which a guide wire could be securely placed, the complaint says. Despite the design change, the company gave hospitals and doctors cleaning instructions for an older model, which meant that users "were not able to effectively sanitize and clean the new redesigned Q180V scope," according to the suit.

The second story involves Johnson & Johnson (J&J), a repeat offender. In sum, McNeil Healthcare, a J&J subsidiary, recently pleaded guilty to a federal criminal charge that it sold over-the-counter infant's and children's liquid medicine containing metal particles, agreeing to pay a $25M fine. The company discovered that metal particles, including nickel, iron and chromium, were introduced during the manufacturing process, but failed to take immediate steps to fix the problem. Thankfully, there are no known injuries.

Had either Olympus' or McNeil's apparently reckless conduct injured a Connecticut resident, the available punitive damages would be significantly less than in many other jurisdictions and would likely be insufficient to deter these and other mega-corporations from such behavior in the future. (Olympus, which is best known for its cameras, reportedly has a roughly 70% share of the global market in gastro-intestinal endoscopes, whose estimated value is US$2.5 billion. In 2014, Johnson & Johnson reported $74 billion in U.S. revenue, and U.S. assets of more than $130 billion.) The deterrent effect of punitive damages on this type of conduct by such large corporations is a critical function of our civil justice system, especially where history has shown that the agencies charged with protecting the public are often incapable (commonly due to inadequate resources or conflicts of interest) of doing so in a meaningful way. When it comes to punitive damages, there is no good reason punitive damages.

the family of a Connecticut resident injured as a result of this type of corporate behavior should not be on equal footing with the residents of most other states.

D'Amico & Pettinicchi is committed to ushering in a more equitable punitive damages era in Connecticut's law and jurisprudence.