After hundreds of patients suffered infections in just three years, Olympus Corp. has announced that it is recalling its medical scopes. The recall comes after Olympus had notice of the fact so-called quote superbug” infections were being found in plaintiffs who underwent an endoscopy with the company’s scopes, but the company delay taking the scopes off the market while it waited for FDA approval of a new scope design so the effect of on the company’s bottom line would be minimized.
The San Francisco Chronicle recently reported on this recall. The duodenoscope being recalled is used to identify and treat problems in the pancreas and bile ducts. Each year, about 500,000 U.S. patients undergo a procedure known as an ERCP which uses the scope. Olympus is the largest manufacturer of duodenoscopes in the U.S.
lawsuits previously filed by victims have alleged that the design of the scope made it hard to sterilize. This allowed bacteria to grow and then move into the patient during procedures. At least 250 people in the U.S. and Europe have been sickened this way, and some patients have died as a result of overwhelming infections, according to the Chronicle report.
Olympus officials have stated that its new duodenoscope design will be more watertight and promote easier and better sterilization. The recall announcement came two days after a U.S. Senate health committee investigating the matter criticized Olympus, along with the FDA and hospitals, for not reporting the infections or alerting the public in a timely manner.
Through the years the Walkup Law Firm has handled many cases where an FDA approved product or drug has failed and injured hundreds or thousands. What the public doesn’t know is that the FDA is unable to properly investigate or evaluate the majority of drugs and devices on the market. Indeed, there are so many medical products and drugs on the market or in development that the agency does not have sufficient personnel to monitor and police private industry. As a result, in the overwhelming majority of cases, new drugs and devices are never actually tested by the agency. The agency simply relies on information provided by manufacturers, including complaint or injury information, which is regularly understated and underreported.
Resort to the civil courts is typically an injured person’s only avenue to hold a manufacturer accountable – and for this reason manufacturers spend millions of dollars every year on negative advertising directed at eliminating personal injury and product liability lawsuits, and supporting political candidates who pledge to eliminate “frivolous lawsuits”.
It’s unlikely that any patient who became overwhelmingly septic because of an Olympus duodenoscope, who spent months in a hospital, and lost part of their intestine, believes their claim is “frivolous”.