After a medical device implant many people are not aware that they even have a defective device inserted into their body. They most likely do not even know that the device may be causing harm or injury to their bodies even though they may have symptoms. Since medical devices can result in a billion dollar bonanza for the medical device industry you can imagine why a medical device company may withhold very important safety information from the FDA or from even the physicians inserting the devices and the patients who have the devices inserted.
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In my practice as an attorney, I have investigated and
represented families and individuals throughout Texas and
Arkansas in medical device injury cases.
I have investigated potential claims involving many potentially dangerous medical devices and I continue to investigate medical devices which may be particularly dangerous to your health.
I generally associate with other lawyers on these types of claims because of their complexity; due to the fact that many of these claims initially get assigned to a Multi-District Litigation (MDL) judge in another part of the country; and the need to have an attorney locally and also have attorneys stationed near the MDL court. Examples of some medical devices which have been recalled or which are the subject of pending litigation are as follows:
A number of hip replacement devices have either been recalled or MDK courts have been set up for other hip replacement devices. The DePuy ASR hip replacement device was recalled in August, 2010. The DePuy Pinnacle hip replacement device is currently involved in an MDL Federal Court in the Northern District of Texas and discovery was expected to begin in 2013. The Stryker Rejuvenate Modular Primary Hip was recalled in early 2009; in April, 2012 an Urgent Safety Field Notice was sent to surgeons; and a voluntary recall was issued by Stryker in July, 2012. In 2007 Smith and Nephew released the R3 metal liner under an “extension” to its Birmingham Hip Resurfacing Device but by June 2012 the R3 liner was recalled. In 2004 Biomet, Inc. and Biomet Orthopedics, LLC began selling the Biomet M2a Magnum Total Hip device. In October, 2012 the Federal Courts set up an MDL to consolidate the Biomet Hip System lawsuit for discovery and court rulings. An MDL was set up in February, 2012 regarding the Wright Conserve Total Hip Resurfacing System lawsuits and only involves the Conserve line of products (no Profemur neck fracture cases) and only involves implants with a CoCr acetabular shell.
From 2005 to 2010 the FDA fielded nearly 4,000 reports of adverse effects related to transvaginal mesh, which is used to treat women with pelvic organ prolapsed (POP) or stress urinary incontinence. In 2008 the FDA issued a Public Health Notification regarding serious complications with transvaginal mesh. By 2011 the FDA had found that complications occurred in at least 10% of the 75,000 surgeries performed in 2010. The FDA has now ordered the 33 mesh manufacturers to conduct safety reviews.
Da Vinci robotic device or machine is manufactured by
Intuitive Surgical, Inc. of Sunnyvale, CA. It generally
consists of a console in the surgical suit which
remotely operates various arms which are inserted into
the patient. These arms contain parts for cutting,
cauterizing and the like. Another arm has a camera so
that the surgeon can see what is going on.
Generally, two types of surgery make up the majority of the uses of the robot: hysterectomy and prostatectomy. However, other types of surgery have been assayed on the Da Vinci, some of which could be considered in the experimental category.
The asserted bases of liability in this new litigation have been both related to the machine and the training. As to the machine, a major design flaw is the use of monopolar current which permits arcing—the passage of electricity into adjacent tissue. This can cause burning.
The second major theory of liability relates to training and credentialing. Information has suggested that, while Intuitive Surgical, Inc states that it gives full training to hospitals which buy its machine, it may actually skimp on it. This would potentially allow a surgeon with little training on the machine, let alone in laparoscopy, march into surgery, and possibly get overwhelmed by its technicalities, improperly utilize the robot and even have to call for help.
For more information see the Article about the Da Vinci robotic device or machine under the Articles heading of this website.
For the latest information on medical device and recalls, use this link to visit the Food and Drug Administration's web site. Please also refer to the Articles heading of my website for articles about medical devices and other areas of litigation.
If you or a family member has suffered a medical device injury, or have had a medical device implanted, you can schedule a free consultation with me regarding your medical device and its status from the standpoint of adverse effects being reported, potential MDLs being set up, and any other information regarding your medical device by calling 903-792-4513 or 877-792-4513 or by contacting my law firm via e-mail in Texarkana, Texas.
Contact me today!