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Article Questioning Medical Device Industry’s Commitment to Safety Grabs the Attention of Rottenstein Law Group


(New York, NY, April 25, 2012) The Rottenstein Law Group, which represents clients with claims stemming from the severe side effects of vaginal mesh and other defective medical devices, commends the New York Times for recently publishing an article explaining why St. Jude Medical’s manufacturing of a defective defibrillator implant that has recently been identified as the possible cause of 20 patient deaths, casts doubt on a pledge that the company, and other medical device manufacturers made several years ago, to safeguard recipients against medical device malfunctions.
The article, which ran on April 18, chronicles the history of St. Jude Medical’s “Riata,” a device that connects a defibrillator to a patient’s heart. The product was recalled, but not before approximately 128,000 patients worldwide had already been implanted with it.
Now, a recent study conducted by an independent researcher, Dr. Robert Hauser of Minneapolis, indicates that short-circuits and other failures of the Riata might have played a role in some 20 patient deaths. Dr. Hauser’s report also points to “a separate and potentially more serious problem,” according to the article: “the likelihood that the Riata’s insulation could wear away, short-circuiting the device.”
Since Dr. Hauser’s study was based on reports of possible Riata-related deaths that St. Jude had filed with the U.S. Food and Drug Administration (FDA), his findings have called into question the company’s failure to notify doctors early on about the Riata’s underlying insulation problem. Although St. Jude Medical had been receiving reports of faulty insulation since 2010, the company did not send out an alert warning doctors about the exposed wires until late 2011.
“It was not supposed to be this way,” the authors of the Times article point out, referring to the safeguards that major defibrillator makers, including St. Jude Medical, adopted after discovering in 2005 that another major manufacturer of heart defibrillators, Guidant, had not warned doctors about a potentially fatal flaw in its products. The safeguards the device makers adopted, stated that they would “quickly investigate malfunctions in their products and alert doctors to potential problems,” according to the Times. “The key to preventing a repeat episode, specialists say, was for manufacturers to scrutinize every death to see if it pointed to an underlying flaw that could kill or injure other patients.”
As an advocate of patients who have been injured or killed as a result of defective medical implants, the Rottenstein Law Group hopes the publicity surrounding St. Jude Medical’s missteps will prompt other medical device manufacturers to take a closer look at reports of patient deaths that may be related to their devices in a more timely manner, so they can pinpoint the devices’ underlying problems before the devices injure or kill more patients.
Like Dr. Hauser, the Rottenstein Law Group has long been publicizing the fact that many medical devices were granted FDA approval without having been tested on humans based solely on the products’ substantial similarity to implants that were once approved by the FDA by subsequently taken off the market for safety reasons. The firm has even commissioned an infographic that illustrates the history of the FDA’s approval of dangerous vaginal mesh products.
Anyone seeking more information about transvaginal mesh can visit the Rottenstein Law Group’s Vaginal Mesh Lawsuit Information Center. The site has vital information about the dangers of this medical device, along with easy-to-use social media features that allow for easy sharing on sites like Facebook and Twitter. Visitors are also encouraged to link to their own Web sites and blogs in order to spread the word about defective medical products and dangerous drugs.
About the Rottenstein Law Group
The Rottenstein Law Group is a New York-based law firm that represents clients in mass tort actions. The firm was founded by Rochelle Rottenstein, a lawyer with over two decades of experience in compassionate representation of clients in consumer product injury, mass tort, and class action law suits. For more information, please visit their Web site, or call (888) 9-ROT-LAW.


 medical devices
 vaginal mesh
 defective medical devices

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