The product liability lawyers at SHOOP | A PROFESSIONAL LAW CORPORATION
have a deep understanding of medical device litigation. Recently, our
team has resolved claims against a medical device manufacturer for $3.1
million. These claims involved implantable, Class III medical devices
occurring subsequent to an FDA recall. Our litigation team now also includes
a former litigator with the largest biotech in the world. He brings a
practical understanding of not only the science - but of the regulatory,
and safety approval process involving medical devices. Finally, the trial
team at SHOOP Law recently secured a $5.1 million jury verdict with an
accompanying award of $3.5 million in punitive damages in a fraud case.
Put simply, we understand medical device litigation and know how to try cases.
We are writing to advise of a recent outbreak of superbug infections caused
by the use of endoscopes (also known as duodenoscopes). Duodenoscopes
are flexible, lighted tubes that are threaded through the mouth, throat,
stomach, and into the top of the small intestine (the duodenum). They
contain a hollow channel that allows the injection of contrast dye or
the insertion of other instruments to obtain tissue samples for biopsy
or treat certain abnormalities. Unlike most other endoscopes, duodenoscopes
also have a movable "elevator" mechanism at the tip. The design
of these devices, however, has also made them difficult to clean, disinfect,
and sterilize. This has led to recent cases of infection and even death.
On February 19, 2015, the Food & Drug Administration issued a general
warning letter involving these endoscopes and infection. See
That warning has since been updated multiple times as physicians continue
to contact the agency about the benefit/risk of these devices and question
whether they should continue to use them. The FDA has advised physicians
to continue use of these devices but with greater caution, increased warnings,
and greater awareness around cleaning these devices in order to prevent
From January 2013 through December 2014, the FDA received 75 Medical Device
Reports involving 135 patients in the United States relating to possible
microbial transmission from reprocessed duodenoscopes. In addition, in
Los Angeles, there may have been as many as 179 patients who have been
exposed to Carbapenem-Resistant Enterobacteriaceae, an infection resistant
to most antibiotics after undergoing an Endoscopic retrograde cholangiopancreatography
("ECRP") procedure at Ronald Reagan Medical Center at the University
of California at Los Angeles between October 2014 and January 2015.
There are currently three manufacturers of these devices. One of the manufacturers,
Olympus, does not currently have FDA clearance under 510(k) for one specific
model of duodenoscope (model TJF-Q180V). See
A 510(k) is a premarket submission made to the FDA to demonstrate that
the device to be marketed is at least as safe and effective as a legally
marketed device (21 CFR 807.92(a)(3)) that is not subject to premarket
approval. A 510(k) requires demonstration of substantial equivalence to
another legally U.S. marketed device. Substantial equivalence means that
the new device is at least as safe and effective as the predicate.
Although the FDA has decided not to take any action against Olympus pending
its 510(k) application, it made the decision because the FDA felt that
removal of the device from the market could lead to an insufficient number
of available duodenoscopes to meet the clinical demand in the United States
(approximately 500,000 procedures per year). Despite this decision, this
means that these allegedly unapproved medical devices are still in use
and potentially exposing patients to life threatening injuries.
The attorneys at SHOOP | A PROFESSIONAL LAW CORPORATION handle product
liability cases involving medical devices in both California and across
the nation. We understand the science, we understand the companies that
manufacturer these devices, and we know how to win at trial. There is
simply no substitute for experience in a complex medical device case.
Call us today for a free consultation if you have suffered an injury as
a result of a procedure involving a duodenoscope.
SHOOP | A PROFESSIONAL LAW CORPORATION
Defective Product Lawyers with a National Presence.
We Get Results. Period.
Call us today for a FREE consultation at 866.884.1717